ICTR

The Johns Hopkins Institute for Clinical and Translational Research

Photo Credits: Joshua Franzos

Photo Credits: Joshua Franzos & Sherrie Fornoff

Photo Credits: Joshua Franzos

This scholarship was developed in 2011 to support a promising graduate of Paul Laurence Dunbar High School. Located on Orleans Street in close proximity to the hospital, Dunbar has long been a vibrant part of the Hopkins community. This $40,000 scholarship ($10,000/year for up to 4 years) will be awarded annually to a junior of Paul Laurence Dunbar High School who chooses to pursue a career in health or science. In addition to the financial assistance, the awardee will be provided opportunities to explore medicine, including: shadowing a physician, access to the medical stimulation center, participating in college readiness activities and be paired with a mentor. By supporting a student of this exemplary Baltimore City Public School in Mrs. Lacks’ name, we hope to educate, motivate, and inspire the next generation of physicians, nurses, scientists, and health science professionals.

Round 8

Gary Hayward, PhD, Professor of Oncology
“Pre-Clinical Evaluation of Potential Novel Anti-Herpesvirus Drug Agents”

Roselle Abraham, MBBS, Assistant Professor of Medicine
“Development of Biodegradable Scaffolds for Cell Therapy”

Round 7

Julius Birnbaum, MD, MHS, Assistant Professor of Medicine
“Development of an In-Vitro Neurotoxicity Model and Identification of Novel Autoantibodies Associated with a Painful Sjogren’s Neuropathy”

Kathryn Wagner, MD, PhD, Associate Professor of Neurology
“A Xenograft Animal Model for Facioscapulohumeral Muscular Dystrophy”

Jessica Yeh, PhD, Assistant Professor of Medicine
“Comparative Effectiveness Study of Glycemic Reduction Strategies in Elderly with Type 2 Diabetes”

Clifford Weiss, MD, Assistant Professor of Radiology
“Pulse Sequence Development, Testing and Implementation for MR-guided Vascular Malformation Embolization”

Linda Smith Resar, MD, Associate Professor of Medicine & Hematology
“Development of Novel Micro-RNA Technology to Treat Pancreatic Cancer “

Leo Luznik, MD, Associate Professor of Oncology
“GVHD Prevention and Immune Reconstitution After Post-Transplant Cyclophosphamide”

Round 6

James Barrow, MD, PhD, Associate Professor, Department of Pharmacology and Molecular Sciences, Principal Investigator, Lieber Institute for Brain Development
“High Throughput Screening and Hit-to-Lead Medicinal Chemistry for IP6 Kinases”

Ling He, MD, PhD, Assistant Professor of Pediatrics
“Identification of a Biomarker for Metformin Action”

Betty Tyler, BA, Assistant Professor of Neurosurgery
“Determining the Safety of Intracranially Implanted Temozolomide in a Non-Human Primate Model”

Donald Shaffner, MD, Associate Professor of Anesthesiology and Critical Care Medicine
“End-tidal Carbon Dioxide (ETCO2) Directed Cardiopulmonary Resuscitation (CPR)”

Arvind Pathak, PhD, Assistant Professor of Radiology
“LSC EYE – A Low Cost Portable Retinal Imager”

Andreia Vasconcellos Faria, MD, PhD, Research Associate of Radiology
“Retrospective Study of Patients with Primary Progressive Aphasia – Imaging as a Tool for Automated Diagnosis”

Janet Staab, PhD, Assistant Professor of Medicine
“Development of a Point-of-Care Diagnostic Device for Aspergillosis”

Round 5

Aaron Milstone, MD, Assistant Professor of Pediatrics
“Safety of Chlorhexidine in Premature Infants”

James Casella, MD, Professor of Pediatrics
“Randomized Pilot Study of Hydroxyurea for the Primary Prevention of Neurologic Complications in Children with Sickle Cell Disease”

Nilofer Azad, MD, Assistant Professor of Oncology
“Combinatorial Cytotoxic and Epigenetic Therapy in Colorectal Cancer”

Donald Zack, MD, PhD, Professor of Ophthalmology
“Development of a Novel Neuroprotective Agent for the Treatment of Glaucoma and Other Optic Neuropathies”

Round 4

Robert Wood, MD, Professor of Pediatrics
“A Sublingual Film for Peanut Allergy”

Karl Womer, MD, Assistant Professor of Medicine
“The Role of MYH9 in Renal Transplantation”

Harry Silber, MD, PhD, Assistant Professor of Medicine
“Noninvasive Device for Assessing Cardiac Filling Pressure in Heart Failure”

Mohamed Farah, PhD, Research Associate of Neurology
“BACE1 Inhibition as a Therapy for Neuropathies”

Jeanne Nunez, MD, Instructor of Pediatrics
“Temporal Association of Polysomnographic Cardio-Respiratory Events with Gastro-esophageal Reflux Detected by MII-pH Probe in the Premature Infant with Persistent Cardio-Respiratory Events at Term”

Neeraj Vij, MS, PhD, Assistant Professor of Pediatrics
“Development of PLGA-PEG Based Nano-Drug Delivery System for Chronic Obstructive Lung Diseases”

Roy Brower, MD, Professor of Medicine
“STIP: Statin Trial for Influenza Patients”

Round 3

Patrizio Caturegli, MD, Associate Professor of Immunology
“A New Serum Test for the Differential Diagnosis of Pituitary Masses”

Allen Everett, MD, Associate Professor of Pediatric Cardiology
“Validation and Quantification of Biomarkers of Subacute Brain Injury in Children with Sickle Cell Disease”

Kelvin MacDonald, MD, Research Associate in Pediatric Pulmonology
“Pre-Clinical Assay of Prostone Compounds in Cystic Fibrosis”

Deborah Persaud, MD, Associate Professor of Pediatrics
“Optimization and Development of Diagnostic Assays for HIV Infection in Infants Living in Resource-Constrained Settings”

Dorry Segev, MD, Associate Professor of Transplant Surgery
“Identifying Appropriate Recipients for Kidneys from Infectious Risk Donors”

Charlotte Sumner, MD, Assistant Professor of Neurology
“Evaluation of Histone Deacetylase Inhibitors in Spinal Muscular Atrophy Mice”

S. Darius Tandon, PhD, Assistant Professor of Pediatrics
“Translating an Efficacious Depression Intervention to Prevent Postpartum Depression”

Round 2

Ravit Boger, MD, Assistant Professor of Pediatrics
“Genetic Variation in Toll-like Receptors and Immune Response to Cytomegalovirus (CMV) glycoprotein B Vaccine”

Edward Fuchs, PA-C, Instructor of Clinical Pharmacology
“Accelerator Mass Spectrometry Technology to Measure Intracellular Nucleoside Triphosphate Formation in HIV-Seronegative Volunteers”

Neeraj Vij, MS, PhD, Assistant Professor of Pediatrics
“Nano-Delivery of Bortezomib in Cystic Fibrosis”

David D. Yuh, MD, Associate Professor of Surgery
“3-D TEE-based Computational Modeling of the Mitral Valve”

David E. Newman-Toker, MD, PhD, Assistant Professor of Neurology
“Automated Medical Interviewing for Diagnostic Decision Support”

Round 1

Ken Brady, MD, Assistant Professor of Pediatric Anesthesia/Critical Care Medicine
“Preventing Brain Injury in Premature Neonates by Monitoring Cerebrovascular Autoregulation”

Robert Getzenberg, PhD, Professor of Urology
“Autologous Myoblast Injection Therapy for Urinary Sphincter Deficiency: Pre-Clinical Testing Study”

Richard Roden, PhD, Associate Professor Department of Pathology
“Design Synthesis and Evaluation of Candidate Proteasome Inhibitors that Prevent E6-Mediated p53 Degradation and Selectively Kill HPV+ Cervical Cancer Cells”

Guy M. McKhann, MD, Professor of Neurology
“Valproate and Neuroprotection in Aortic Surgery (VANAS)”

Dan Stoianovici, PhD, Associate Professor of Urology
“Intraoperative Ultrasound Imaging of the Prostate during Robot-Assisted Laparoscopic Radical Prostatectomy”

Cornelia L. Trimble, MD, Associate Professor of Obstetrics and Gynecology
“A Pilot Study to Compare Intramuscular Injection with Particle-Mediated Delivery of a Therapeutic HPV 16 DNA Vaccine, in Patients with HPV 16+ Cervical Intraepithelial Neoplasia 2/3″

Martha Zeiger, MD, Associate Professor of Surgery
“Differentiating Thyroid Tumor Classes through Analysis of Alternative Time Splice Variant Patterns”

Susan Dorman, MD, Assistant Professor of Medicine
“Pharmacokinetic Issues in the Use of Daily Rifapentine plus Moxifloxacin”

Martin Pomper, MD, PhD, Professor of Radiology
“Imaging infection with Radiolabeled Nucleoside Analogs”

Steven P. Schulman, MD, Professor of Cardiology
“Phenotypic Characteristics of Beta Adrenergic Receptor Polymorphisms in Health and Disease”

Johns Hopkins University — in partnership with Johns Hopkins Health System and its hospitals, community clinics and other affiliates; the Johns Hopkins Urban Health Institute; Priority Partners MCO; Baltimore Medical System, a Federally Qualified Health Center; and local skilled nursing facilities, is receiving an award to create a comprehensive and integrated program, the Johns Hopkins Community Health Partnership (J-CHiP).  J-CHiP is designed to increase access to services for high-risk adults in East Baltimore, MD, especially those with chronic illness, mental illness, and/or substance abuse conditions.  The intervention improves care coordination across the continuum and comprises early risk screening, interdisciplinary care planning, enhanced medication management, patient/family education, provider communication, post-discharge support and home care services, including self-management coaching, and improved access to primary care.  The program will target inpatients at The Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center, expanding to nearly all admissions by year 3.  The intervention will also include a specific focus on high risk Medicare and Medicaid beneficiaries who receive primary care from Johns Hopkins providers in the seven zip code area adjacent to these hospitals.  The program will reduce avoidable hospitalizations, emergency room use, and complications and increase access to care and other services.

Over a three-year period, Johns Hopkins University will train and hire 111 new health care workers, including patient/family educators, care coordinators, and behavioral coaches, and will retrain nurse case managers, nurse transition guides, nurse screeners, pharmacists, and physicians already on staff.

Click the links below to learn more about this new partnership.

J-CHiP Program Overview (PDF)

J-CHiP Organization Chart (PDF)

Johns Hopkins Medicine News Release

The Centers for Medicare & Medicaid Services (CMS) established the  Health Care Innovation Awards to provide funding of up to $1 billion in awards to organizations that are implementing the most compelling new ideas to deliver better health, improved care and lower costs to people enrolled in Medicare, Medicaid and Children’s Health Insurance Program (CHIP), particularly those with the highest health care needs.  The awards are distributed in rounds, with each round seeking projects that meet the specified goals listed in the funding opportunity announcement.

Round One (Closed)
The CMS Innovation Center announced the first batch of awardees for the Health Care Innovation Awards on May 8, 2012 and the second (final) batch on June 15, 2012.  The awarded organizations will implement projects in communities across the nation that aim to deliver better health, improved care and lower costs to people enrolled in Medicare, Medicaid and the Children’s Health Insurance Program (CHIP), particularly those with the highest health care needs. Funding for these projects is for three years.

The objectives of the Health Care Innovation Awards Round One were to:

  • Engage a broad set of innovation partners to identify and test new care delivery and payment models that originate in the field and that produce better care, better health, and reduced cost through improvement for identified target populations.
  • Identify new models of workforce development and deployment and related training and education that support new models either directly or through new infrastructure activities.
  • Support innovators who can rapidly deploy care improvement models (within six months of award) through new ventures or expansion of existing efforts to new populations of patients, in conjunction (where possible) with other public and private sector partners.

Johns Hopkins School of Nursing received an award to fund its Community Aging in Place–Advancing Better Living for Elders (CAPABLE) Program. To learn more about this program, visit:
http://nursing.jhu.edu/faculty_research/research/projects/capable.

Johns Hopkins University received an award to fund the Johns Hopkins Community Health Partnership (J-CHiP).  To learn more about this program, visit: http://ictr.johnshopkins.edu/service/johns-hopkins-community-health-partnership-j-chip.

Round Two (Letter of Intent due June 28, 2013)

On May 15, 2013, the Centers for Medicare & Medicaid Services (CMS) released a Funding Opportunity Announcement for round two of the Health Care Innovation Awards.   The second round of the Health Care Innovation Awards will support public and private organizations in four defined areas that have a high likelihood of driving health care system transformation and delivering better outcomes.  Specifically, in this second round, CMS is seeking proposals in the following categories:

  • Models that are designed to rapidly reduce Medicare, Medicaid, and/or CHIP costs in outpatient and/or post-acute settings.
  • Models that improve care for populations with specialized needs.
  • Models that test approaches for specific types of providers to transform their financial and clinical models.
  • Models that improve the health of populations – defined geographically (health of a community), clinically (health of those with specific diseases), or by socioeconomic class – through activities focused on engaging beneficiaries, prevention (for example, a diabetes prevention program or a hypertension prevention program), wellness, and comprehensive care that extend beyond the clinical service delivery setting.

In this round, CMS specifically seeks new payment models to support the service delivery models funded by this initiative.  All applicants must submit, as part of their application, the design of a payment model that is consistent with the new service delivery model that they propose.  All applications must be submitted electronically through www.grants.gov.

In order to coordinate responses to this program, the ICTR created a collaboration site on Microsoft SharePoint.  Anyone with a JHED ID can access the site via:  https://collaborate.johnshopkins.edu/sites/ICTR/CMSInnovation.  Look for the “SharePoint Help Documents” link on the left toolbar to learn more about using this collaborative workspace.

Key Dates and Deadlines:

  • Letter of Intent : June 28, 2013, by 3:00 p.m.
  • Application : August 15, 2013, by 3:00 p.m.
  • Anticipated Awardee Announcements: Phase 1 – January 15, 2014; Phase 2 – January 31, 2014
  • Anticipated Notice of Cooperative Agreement Award: Phase 1 and Phase 2 – February 28, 2014
  • Anticipated Period of Performance: April 1, 2014 to March 31, 2017.

*Thanks to all those who attended the event. For a summary of the day, click here.*
The Johns Hopkins Institute for Clinical and Translational Research (ICTR) cordially invites you to attend The Third Annual Henrietta Lacks Memorial Lecture on Saturday, October 6, 2012, from 10:00 am to 1:00 pm in Turner Auditorium on the East Baltimore (Medical) Campus. Continental breakfast and check-in begin at 9:00 am. The program will begin at 10:00 am, and will feature a talk by David Ewing Duncan, author of Experimental Man: What One Man’s Body Reveals about His Future, Your Health, and Our Toxic World and Masterminds: Genius, DNA, and the Quest to Rewrite Life. The program will be followed by a lunch reception and book signing, with book copies available for purchase.

THIS EVENT IS AT CAPACITY. TO BE PLACED ON THE WAITLIST, EMAIL ICTR@JHMI.EDU WITH THE SUBJECT LINE “HELA WAITLIST”. YOU WILL BE NOTIFIED IF SPACE BECOMES AVAILABLE.

The goal of this event is to describe the reach and complexity, both biomedically and ethically, of the story of Henrietta Lacks and HeLa cells as well as to provide some insight into the past, present, and future of the conduct of clinical research. By honoring Mrs. Lacks and the positive global impact of HeLa cells through this lecture series, ICTR also hopes to draw attention to the thanks and honor due to everyone who participates in the clinical research process.

This event is free and open to the public. Advance registration is required. View and download an event flyer here.

The ICTR is deeply grateful to the individuals and organizations listed below for their contributions to the inaugural Henrietta Lacks Memorial Lecture in 2010.

Thank you to:

The Lacks Family

Contributors and Volunteers

Sue Ahn

Miranda Baxendale

Robert Blum, MD, PhD, MPH

Darian Burwell

Sherrie Fornoff

Amy Gawad, MPH

Karen Grethlein

Noah Guiberson

Diana Gumas

Dalal Haldeman, MBA, PhD

Jess Holzer

Challis Ireland

Kristina Kelvy

Tanziyah Mugeem

David Nichols, MD

Dr. Roland and Mrs. Patricia Pattillo

Tyler Pernes

James J. Potter

Zoe Rammelkamp

Cathy Rosenbaum, MBA

Renee Ryberg

Rebecca Skloot

Gary Stephenson, MS

Donna Beer Stolz, PhD

Jeremy Sugarman, MD, MPH, MA

Amit Thakrar

Kate Tschudi

Irene Turner, MA

Darcy Wilson

Lauren Zerbe, MBA

Organizations

Galludet University

Johns Hopkins Berman Institute of Bioethics

Johns Hopkins Urban Health Institute

Johns Hopkins Digital Media Group

Johns Hopkins Corporate Security, Parking & Transportation

Morehouse College

University of Pittsburgh Center for Biologic Imaging

ICTR Staff

Kelly Crowley

Crystal Evans, MS

Daniel E. Ford, MD, MPH

Andrea D. Lively, MA

Liz Martinez, RN, BSN

Cynthia MacInnis

Linda Post, RN, BSN

Roxanne Stambaugh

Sandra Schaefer, RN, BSN

Gerald Stacy

Stephanie Swords, MA

Shardai Thomas

Laurel Valenti, MBA

Crystal Williams

Vendors

Blake Meister Music

C & A Sportswear

Chef’s Expressions

Greater Talent Network, Inc.

Hearing and Speech Agency

Imprint Products

Joshua Franzos Photography

Morris Millman

Neil Donnelly Design

Swanson Graphics

Zanninos Catering

The ICTR is deeply grateful to the individuals and organizations listed below for their contributions to the Henrietta Lacks Memorial Lecture in 2012.

Honored Guests

The Lacks Family

Speakers

David Ewing Duncan

Daniel Ford, MD, MPH

Damisha Hazelton

Nancy Kass

Ralph Moore

Roland Pattillo, MD

Paul Rothman, MD

Daniel Teraguchi, EdD

Pamela Zeitlin, MD, PhD

Contributors and Volunteers

Ibukun Alo

Andrew Anderson

Antonio Backmon

Zyneeya Baker

Pamela Bechtel

Edward Bennett

Aliyah Brockington

Shy’keira Cannon

Anisha Contractor

Kelly Crowley

Crystal Evans

Sherrie Fornoff

Saleemah Franklin

Shardai Gaines

Mamie Green

Kathleen Harrelson

LaShawn Henderson

Robyn Hinke

Mike Humphreys

Kameron Ingram

Challis Ireland

Rickiya Johnson

Alexis Kennedy

David Lowry

Ajia Lynch

Elizabeth Martinez

Taylor Mohr

Linda Post

Kenara Powell

Tierra Queen

Cathy Rosenbaum

Michelle Rosenbaum

Erica Roy

Haley Rue

Courtney Schoeberlein

Candace Scott

Sasha Sewell

Brina Smith

Jasmine Spearman

Gerald Stacy

Roxanne Stambaugh

Stephanie Swords

Irene Turner

Elizabeth Toft

Michael Washington

Erin Williams

Iman Williams

Anna Zetkulic

Richard Zhu

Organizations

Paul Laurence Dunbar High School

Johns Hopkins Urban Health Institute

Johns Hopkins Digital Media Group

Johns Hopkins Corporate Security, Parking & Transportation

Matthews Johns Hopkins Medical Book Center

Vendors

4 All Promos

Blake Meister Music

C & A Sportswear

Greater Talent Network, Inc.

Innovative Gourmet

Joshua Franzos Photography

Plants Alive

The ICTR is deeply grateful to the individuals and organizations listed below for their contributions to the Henrietta Lacks Memorial Lecture in 2011.

Thank you to:

The Lacks Family

Speakers and Panelists

Heather Bakalyar

Barbara Bates Hopkins

Robert Blum, MD, PhD, MPH

Lee Bone, MPH

Alfred Chandler

Subroto Chatterjee, PhD

M. Chris Gibbons, MD

S. Darius Tandon, PhD

Melvin Dupree, MDiv

Crystal Evans, MS

Amy Gawad, MPH

James J. Potter

Nancy Kass

R. Keith Baker, PhD

Frederick Luthardt, MA

Liz Martinez, RN, BSN

Inez Robb

Dr. Roland and Mrs. Patricia Pattillo

Robert Rosenbaum

Susan Roy, DMin

Landon S. King, MD

Paula Teague, DMin, MBA

Danny Teraguchi, EdD

Patricia Tracey

Harriet Washington

Contributors and Volunteers

Antoine Backmon

Lauren Bauer, MBA

Donna Beer Stolz, PhD

Briyana McNeil

Aliyah Brockington

George Bugarinovic

Alexis Cannon

Ifta Choiriyyah

Kevin Chun

Gerard Dailey

Damisha Hazelton

Darian Dorsey

Jasmine Dorsey

Taylor Dorsey

Asha Elmore

Sherrie Fornoff

Saleemah Franklin

Diana Gumas

Dalal Haldeman, MBA, PhD

Jahmad Holland

Mike Humphreys

Cynthia Idada

Challis Ireland

Rickiya Johnson

Catonya Lester

Brad Metzer

Elizabeth Posey

Cathy Rosenbaum, MBA

Rich Sebour

Melissa Ssajnani

Gary Stephenson, MS

Amanda Stolz

Genene Strickland

Jeremy Sugarman, MD, MPH, MA

Irene Turner, MA

Organizations

Paul Laurence Dunbar High School

Johns Hopkins Berman Institute of Bioethics

Johns Hopkins Urban Health Institute

Johns Hopkins Digital Media Group

Johns Hopkins Corporate Security, Parking & Transportation

Morehouse College

University of Pittsburgh Center for Biologic Imaging

ICTR Staff

Kelly Crowley

Crystal Evans, MS

Daniel E. Ford, MD, MPH

Robyn Hinke

Andrea D. Lively, MA

Cynthia MacInnis

Abbas Rattani

Roxanne Stambaugh

Sandra Schaefer, RN, BSN

Candace Scott

Gerald Stacy

Stephanie Swords, MA

Shardai Thomas

Crystal Williams

Richard Zhu

Vendors

4 All Promos

Blake Meister Music

C & A Sportswear

Greater Talent Network, Inc.

Hearing and Speech Agency

Innovative Gourmet

Joshua Franzos Photography

Neil Donnelly Design

Swanson Graphics

Zanninos Catering

The Johns Hopkins Institute for Clinical and Translational Research (ICTR) was honored to sponsor the first annual Henrietta Lacks Memorial Lecture on Saturday, October 2, 2010. More than 20 members of the Lacks family were warmly welcomed and recognized by the approximately 600 attendees gathered in Turner Auditorium.

The occasion marked the inauguration of the Henrietta Lacks Memorial Lecture Series, which was announced by Daniel E. Ford, MD, MPH, ICTR director and vice dean of clinical investigation at Hopkins. Also announced were the Henrietta Lacks East Baltimore Health Sciences Scholarship, sponsored by the Johns Hopkins Health System, which provides up to $10,000/year to support promising graduates of Paul Laurence Dunbar High School; and the Henrietta Lacks Award for Community-University Collaboration, sponsored by the Johns Hopkins Urban Health Institute, which provides a $15,000 annual award to recognize outstanding, pre-existing community-university collaborations in Baltimore.

ICTR would like to acknowledge all of the individuals and organizations who contributed to this program.

The program featured a presentation on the scientific relevance of HeLa cells by Hopkins faculty member James J. Potter; a presentation on the history of HeLa cells by special guest Roland Pattillo, MD, professor of obstetrics and gynecology at Morehouse School of Medicine; and a talk by The Immortal Life of Henrietta Lacks author Rebecca Skloot. A question-and-answer period with Ms. Skloot, Dr. Ford, and Harvey M. Meyerhoff Professor of Bioethics and Medicine Jeremy Sugarman, MD, MPH, was followed by lunch and a book-signing by Ms. Skloot and members of the Lacks family.

For additional perspective on the events and significance of the day, ICTR recommends this unsolicited blog entry written by a Johns Hopkins Nursing student:

http://blogs.nursing.jhu.edu/first-annual-henrietta-lacks-memorial-lecture-at-johns-hopkins.

On October 1, 2011, the Johns Hopkins Institute for Clinical and Translational Research sponsored and produced the second annual Henrietta Lacks Memorial Lecture in Turner Auditorium on the Johns Hopkins East Baltimore (Medical) campus. Several hundred attendees, including numerous members of the Lacks family, came together to mark the occasion and to honor the 60th anniversary of HeLa cells.

The morning session featured the announcement of the first recipient of the Urban Health Institute’s Henrietta Lacks Memorial Award. This $15,000 award, previously known as the Henrietta Lacks Award for Community-University Collaboration, was given to Newborn Holistic Ministries to support their work with the underserved in the Sandtown-Winchester and Upton communities.

Then the host of the event, Dr. Daniel E. Ford, vice dean for clinical investigation and director of ICTR, took the opportunity to encourage attendees to join the discussion surrounding the current revision of the Common Rule that governs human research ethics in the United States. Keynote speaker Harriet Washington, author of Medical Apartheid and Deadly Monopolies, concluded the morning plenary session, then the group split into one of several breakout sessions designed to facilitate more focused discussion and reflection on a variety of topics.

After lunch and a second round of breakout sessions, attendees regrouped in Turner Auditorium for the afternoon program, where Dr. Ford announced that the first Henrietta Lacks East Baltimore Health Sciences Scholarship will be awarded in April 2012 and recognized four members of the Lacks family who will be part of the selection committee. Subroto Chatterjee, the Hopkins researcher who currently works in the lab where George Gey first cultured HeLa cells sixty years ago, then gave a brief talk about how he uses the cells in his own work.

After Dr. Chatterjee’s presentation, Henrietta’s oldest son Lawrence Lacks and his own son Ron Lacks stood together at the podium for the first public announcement of the formation of the Lacks Family HeLa Foundation, which is focused on helping individuals and families challenged with cancer and other serious illnesses. Hope Harrell, executive director of the foundation, then gave a brief presentation outlining the foundation’s goals.

The final surprise of the day was the unveiling of an educational display honoring Henrietta Lacks and HeLa cells, which is now permanently located on campus at the left base of the staircase leading from Turner Concourse to Turner Auditorium.

ICTR would like to acknowledge all of the individuals and organizations who contributed to this program.

Choose from the following list of breakout activities for the morning and
afternoon breakout sessions on October 1.

Please note that seating in some rooms is limited and will be available in order of arrival.

Bioethics, Clinical Research, and Informed Consent
11:15 am Session: Room G05
1:30 pm Session: Room G07

Dr. Nancy Kass from the Johns Hopkins Berman Institute
of Bioethics will introduce and discuss the field of
bioethics and its applications to research and the study
consent process.

Clinical Research and Faith: Room for Both?
11:15 am Session: Daily Grind, 3rd Floor Broadway Research
Building
1:30 pm Session: Tilghman Auditorium

A diverse group of clergy, including Rev. Alfred Chandler
from Clover, Virginia and Revs. Susan Roy and Melvin
Dupree from the University of Maryland, will look at
HeLa from a spiritual perspective in this discussion-oriented
session.

Community-Engaged Research: What Makes It Work?
11:15 am Session: Darner Conference Room
1:30 pm Session: Room G03

Dr. S. Darius Tandon, Johns Hopkins ICTR Deputy
Director of Community Engagement, will host this panel
of members of the ICTR’s Community Research Advisory
Council (C-RAC) to discuss ways that researchers and
communities can work together.

Creating A Healthier East Baltimore Together Project
11:15 am Session: Room G03
1:30 pm Session: Darner Conference Room

Dr. M. Chris Gibbons, Associate Director of the Urban
Health Institute, and community partners will lead the
overview of this large-scale, community-oriented study
currently taking place in East Baltimore.

The History of HeLa: Henrietta Lacks in Juxtaposition to
Vivien Thomas

Room G01, both sessions

Dr. Roland Pattillo of Morehouse School of Medicine and
his wife, writer and journalist Patricia Pattillo, will explore
the HeLa story and the story of Vivien Thomas, the
African-American surgical technician who developed the
Blue Baby operation.

An In-Depth Discussion with Harriet Washington
*11:15 am Session Only, Tilghman Auditorium

Dr. Robert Blum from the Urban Health Institute will
moderate an extension of author Harriet Washington’s
question-and-answer period.

The IRB: How Are Studies Reviewed Before They’re
Started?

*1:30 pm Session Only, Turner Auditorium

Dr. Daniel Ford and the ICTR’s Research Participant
Advocates will explain the crucial role of the Institutional
Review Board (IRB) in ensuring research participant
safety.

The Science of HeLa: Cell Biology 101
11:15 am Session: Turner Auditorium
1:30 pm Session: Daily Grind, 3rd Floor Broadway Research
Building

An extended version of James J. Potter’s popular science
talk from last year. Learn from a scientist’s perspective
how HeLa cells are unique and why they are so important
in the laboratory.

Technology Transfer: From Clinical Discovery to the
Marketplace

11:15 am Session: Room G07
1:30 pm Session: Room G05

Dr. Landon S. King, Johns Hopkins Vice Dean for
Research, will join Robert A. Rosenbaum, President and
Executive Director of TEDCO, and representatives from
Johns Hopkins Technology Transfer in this overview
of the challenges of getting a scientific discovery to the
marketplace.

HeLa Reflected: The 60th Anniversary Art Show
Upper Level Entrance to Turner Auditorium

Spend a breakout session chatting with the curators of
this special exhibit of scientific images and photographs,
or stop by at any point of the day to enjoy.

Thumbnail of ICTR lecture poster

*Thanks to all those who attended the event. For a summary of the day, click here.*

The Johns Hopkins Institute for Clinical and Translational Research (ICTR) cordially invites you to attend the Henrietta Lacks Memorial Lecture: HeLa Reflected on Saturday, October 1, 2011, from 9:30 am to 3:00 pm, in Turner Auditorium on the East Baltimore (Medical) Campus.

The program will feature a talk by Medical Apartheid and Deadly Monopolies author Harriet Washington, other special guests, and presentations on the scientific and social relevance of HeLa cells. As this year marks the 60th anniversary of both the world-changing discovery of HeLa cells and of the passing of Mrs. Henrietta Lacks, in addition to the lecture we will be holding a number of breakout sessions, panels, and associated educational activities throughout the day. The program will include a lunch reception and book signing, with book copies available for purchase.

Click here for a list of breakout sessions.

SORRY, THIS EVENT IS AT CAPACITY. TO BE PLACED ON THE ICTR MAILING LIST FOR FUTURE UPDATES ABOUT THIS AND SIMILAR EVENTS, EMAIL ICTR@JHMI.EDU WITH THE SUBJECT LINE “SUBSCRIBE HELA”

This event is free and open to the public. Advance registration is required.

The goal of this event is to describe the reach and complexity, both biomedically and ethically, of the story of Henrietta Lacks and HeLa cells as well as to provide some insight into the past, present, and future of the conduct of clinical research. By honoring Mrs. Lacks and the positive global impact of HeLa cells through this lecture series, ICTR also hopes to draw attention to the thanks and honor due to everyone who participates in the clinical research process.

Thumbnail of ICTR lecture poster

*Sorry, but this event is at capacity and registration is closed. Standby on-site registration will be available at 9:45 am the day of the event, but seating is not assured.*

The Johns Hopkins Institute for Clinical and Translational Research (ICTR) cordially invites you to attend the first annual Henrietta Lacks Memorial Lecture on Saturday, October 2, 2010, at 10:00 am. The program will feature a talk by The Immortal Life of Henrietta Lacks author Rebecca Skloot and presentations on the scientific relevance of HeLa cells. The program will be followed by a lunch reception and book signing, with copies of the book available for purchase.

The goal of this event is to describe the reach and complexity, both biomedically and ethically, of the story of Henrietta Lacks and HeLa cells as well as to provide some insight into the past, present, and future of the conduct of clinical research. By honoring Mrs. Lacks and the positive global impact of HeLa cells through this lecture series, ICTR also hopes to draw attention to the thanks and honor due to everyone who participates in the clinical research process.

This event is free and open to the public. Advance registration is required.

To be placed on the priority invitation list for future Henrietta Lacks Memorial Lectures, please email your name, email address, phone number, and/or mailing address to ictr@jhmi.edu

Read Johns Hopkins Medicine’s official statement on Henrietta Lacks and HeLa cells.

Learn more about The Immortal Life of Henrietta Lacks and The Henrietta Lacks Foundation by visiting author Rebecca Skloot’s informative website.

*Update*
Thanks to all of you who attended this event. For a summary of the occasion, click here.

 

More than 500 community members and Johns Hopkins employees gathered with members of the Henrietta Lacks family to honor a woman whose contributions continue to further science more than 60 years after her death.

The Third Annual Henrietta Lacks Memorial Lecture, featured a lecture by science journalist and author David Ewing Duncan, presentations from Johns Hopkins leadership and the awarding of a new educational scholarship named after Mrs. Lacks. The half-day event, which, concluded with a lunch reception and book signing, was held October 6th in Turner Auditorium.

Keynote speaker David Ewing Duncan gave a talk on the potential of personalized medicine through the lens of his experience undergoing genomic sequencing and extensive medical testing while writing Experimental Man: What One Man’s Body Reveals about His Future. “We’re now moving into an era where we as individuals can participate in this research and in unlocking the secrets hidden within our body and cells,” said Duncan, who has authored eight books and written for national media outlets like The Atlantic and National Geographic.

Dan Ford, Hopkins’ vice dean for clinical investigation and ICTR director, emphasized the vital role that research participants like Henrietta Lacks play in finding cures for disease. He pointed out that the HeLa cell line — developed from a sample taken during Mrs. Lacks’ treatment for cervical cancer at Johns Hopkins in 1951 — has helped to develop the polio vaccine and cancer treatment protocols, as well as to advance AIDS research.

“For those suffering with diseases, the process to find new cures cannot go fast enough,” Ford said. “Many of us at Johns Hopkins work to balance the need for research to go fast with the rights of research participants every day.” Ford noted that satisfaction surveys, workshops to enhance the safety of clinical trials and meetings with East Baltimore community members are among the ICTR’s most recent efforts to enhance the partnership between scientists and study participants.

Paul B. Rothman, dean of the medical faculty and CEO of Johns Hopkins Medicine, who participated in the lecture for the first time, said he was proud of the institution’s many efforts to recognize Henrietta Lacks, including a new timeline display at Hopkins Hospital that features Mrs. Lacks among the institution’s pioneers of medicine. Rothman also acknowledged the instrumental role that HeLa cells played in his own career as a molecular immunologist.

Damisha Hazelton was named the first recipient of the Henrietta Lacks Dunbar Health Sciences Scholarship. Awarded annually to a rising senior at Paul Laurence Dunbar High School who is interested in pursuing a career in science, the scholarship will provide mentorship and up to $40,000 in college tuition. “I want to change the world for the better, just as Henrietta Lacks did,” Hazelton said. The 17-year-old winner plans to major in psychology and someday work with homeless youth.

Other highlights of the event included the presentation of the Urban Health Institute’s second Henrietta Lacks Memorial Award to Moveable Feast, a Baltimore-based nonprofit that provides meals to homebound individuals living with HIV/AIDS or cancer, and an update from the Lacks family on The Lacks Family HeLa Foundation. Also, Pamela Zeitlin, co-director of the Johns Hopkins Cystic Fibrosis Center, shared how a cell line developed from a research participant has improved treatment for cystic fibrosis patients.

Courtesy of:
Shannon Swiger
Senior Communications Specialist

The ICTR would like to acknowledge all of the individuals and organizations who contributed to this program.

Henrietta-Lacks (2)-thumb-400xauto-7959-Edithenrietta.david.lacks

Henrietta Lacks was an African-American woman who underwent treatment for an aggressive form of cervical cancer at Johns Hopkins Hospital in 1951.  In addition to providing her with medical care, Henrietta’s doctor at Hopkins removed some of her cancerous cells to use in research without getting her written consent. (It’s important to note that at this time the practice of obtaining informed consent from cell or tissue donors was essentially unknown among academic medical centers.)

Despite receiving a high standard of medical treatment, Mrs. Lacks ultimately succumbed to this cancer at the young age of 31.  However, her cells—called “HeLa” from the first two letters of her first and last names—remarkably continued to reproduce in the laboratory.  Researchers around the world had been trying to identify or develop a standardized human cell line that could be reproduced in a laboratory setting; they knew that this kind of cell line would provide numerous opportunities to improve the human condition by allowing them to better understand, treat, and prevent a wide range of diseases.

Because of their unique ability to reproduce indefinitely, HeLa cells have been instrumental in the development of the polio vaccine, cancer treatment protocols, AIDS research, and much more, and they continue to play an important role in medical advances worldwide.

Thank you Henrietta t-shirtLecture Photo

The Johns Hopkins ICTR is privileged to be the establishing sponsor of the Henrietta Lacks Memorial Lecture Series. The goal of the series is to honor Henrietta Lacks and the positive global impact of HeLa cells. This series will also serve as an annual reminder of the gratitude, respect, and clear communication due to all research participants.

Keeping biomedical research connected to the people it is intended to serve is an ongoing process rooted in the open exchange of ideas among all stakeholders. To facilitate this process, speakers for the Henrietta Lacks Memorial Lecture Series are selected for their ability to communicate the current ethical complexities and challenges facing biomedical research in a way that is engaging and accessible to scientists, health care providers, and members of the lay community alike.

By coming together each year to remember the woman behind this lifesaving, world-changing development in biomedical science, the Johns Hopkins research community will never again forget that HeLa stands for Henrietta Lacks.

The Henrietta Lacks Memorial Lecture will always be free and open to the public.

Click the links below to view information on past lectures and other Henrietta Lacks related initiatives.

Read Johns Hopkins Medicine’s official statement on Henrietta Lacks and HeLa cells.

Lecture Photos

October 2, 2012 Lecture

October 1, 2011 Lecture

October 5, 2010 Lecture

IT Infrastructure

The signal acquisition data are streamed through a multi-directional network switch and the data are able to be recorded on any of 14 computers. The video is controlled using an HTML webpage, and is recorded along with audio via a coaxial cable in the polysomnographic (PSG) recording. Infrared light is used to illuminate the research participant without disrupting the study and while capturing the participant’s every movement. Post acquisition, the data are copied to a Network Attached Storage (NAS) unit, which has a redundant array of independent disks. There are multiple NAS units deployed to ensure additional redundancies to equipment and prevent potential data loss.

Electronic forms are used in the collection of questionnaire data (i.e. – Hopkins Morning and Evening questionnaires, The Epworth Sleepiness Scale, Sleep Apnea Quality of Life Index, etc). These forms reside within a custom tracking software, along with the quality assurance data for the PSGs. The tracking software uses Microsoft Access in the frontend and SQL server in the backend. The sleep report data obtained from the scoring of the PSGs are also stored in SQL. These unique tools enable CISRE to accurately database the entire spectrum of a principle investigators protocol.

Scoring Hub

The polysomnographic (PSG) recordings are scored by registered polysomnography technologists (RPSGT). The quality assurance of the scored PSG is regularly assessed using the American Academy of Sleep Medicine standards of inter-scorer reliability. CISRE provides virtual machines for RPSGTs to access the PSGs within the SQL server. This ensures that data integrity is maintained along with data security.

The development of a new customizable sleep report will give investigators complete access to raw and scored data in an easily accessible database format. The provision of on-line access to raw data and scored reports to investigators allows immediate access to polysomnographic recordings minutes after they are completed.

Dr. McCann is Co-Director of the Center for Interdisciplinary Sleep Research and Education (CISRE) at the Johns Hopkins Bayview Medical Center. She joined the Department of Psychiatry and Behavioral Sciences at Hopkins in 1999, and has been conducting research related to sleep and sleep deprivation since 1989. Her work at the Walter Reed Army Institute of Research was focused on identifying brain mechanisms involved in cognitive and behavioral decline during prolonged wakefulness. Later, at the NIH, she conducted research on sleep problems in anxiety disorders, and the neurological and neuropharmacological underpinnings of sleep panic attacks. Current research seeks to identify the effects of monoaminergic neurotoxic injury from methylenedioxymethamphetamine (MDMA) and methamphetamine on sleep macro- and micro-architecture, as well as sleep disordered breathing. In addition, as Director of the Anxiety Disorders Program at Hopkins, she continues to conduct research directed at elucidating the role of disordered sleep in the pathophysiology of post traumatic stress disorder and other anxiety disorders. Dr. McCann serves as collaborator on a number of multidisciplinary sleep research efforts, including projects investigating sleep in traumatic brain injury, substance abuse and chronic pain.

Dr. Schwartz has been a member of the Johns Hopkins University School of Medicine in Pulmonary, Critical Care and Sleep Medicine for the past 25 years. He has investigated sleep disordered breathing mechanisms with special emphasis on effects of obesity on sleep apnea pathogenesis. He has helped to elucidate the interrelationships between sleep apnea and metabolic dysfunction in severe obesity. He has also examined the metabolic effects of nocturnal intermittent hypoxemia on hemodynamic and metabolic stress biomarkers in heart failure patients. Dr. Schwartz has developed novel approaches for the diagnosis and management of these disorders. He has developed physiologic approaches for characterizing respiratory loads during sleep, and for alleviating these loads with hypoglossal nerve stimulation and high flow tracheal and nasal insufflation. He has collaborated extensively with colleagues on translational studies examining pathogenic mechanisms and consequences of sleep disordered breathing. He is an established investigator with a record of continuous NIH funding for over 20 years, an author of approximately 150 articles and inventor on 3 patents. He also serves as the Co-Director of the Center for Interdisciplinary Sleep Research and Education (CISRE), Director of the Johns Hopkins Sleep Center at Bayview Medical Center and the Director of the Sleep Medicine Fellowship Training Program at Johns Hopkins.

NIH 01/15/2005 – 07/31/2013
Mechanisms of sleep apnea in severe obesity
It is the goal of this study to elucidate the mechanisms and causal pathways linking obesity with upper airway dysfunction during sleep, and will provide novel approaches for the detection and treatment of sleep apnea in the clinical setting.

NIH 09/14/2007 – 08/31/2012
SCCOR: Mechanisms and Treatment of COPD Progression
Project 3 (PI: Alan R. Schwartz, M.D.): Mechanisms and Impact of Sleep Disordered Breathing in COPD”
The overall goal of this SCCOR program is to understand the complex interplay of mechanisms that promote the progression of COPD and to translate that understanding into treatments that can benefit persons who suffer from COPD. Project III will elucidate the mechanisms and impact of sleep disordered breathing in COPD.

Research Agreement (Schwartz) 01/05/2009 – 12/31/2012
ResMed Corporation
Sleep Apnea Treatment Device
The purpose of this project is the development and testing of novel treatment devices for sleep apnea.

NIH 07/01/2009 – 06/30/2012
Effects of sex and fat distribution on sleep disordered breathing
The major purpose of the proposal is to investigate the influence of visceral and peripheral obesity on reflex mechanisms leading to upper airway obstruction during sleep.

NIH 07/28/2010 – 04/30/2013
Mechanisms and Effectiveness of Weight Loss Methods on Diabetes and Sleep Apnea
This project is designed to pilot the use of bariatric surgery for treatment of diabetes and sleep apnea in moderately obese patients.

NIH 12/01/2011 – 11/30/2015
Pathogenesis and Outcomes of Sleep Disordered Breathing in COPD
This project pilots novel methods for exploring sleep disordered breathing pathogenesis and treatment in COPD.

NIH 07/01/2011 – 06/30/2014
Effect of Positive Airway Pressure on Reducing Airways Reactivity in Asthma
Project Goal: To determine the effects of low levels of nocturnal CPAP on airways reactivity and nocturnal symptoms in asthmatics.

Previous Studies

  1. R Vandrey, M.T. Smith, U. D. McCann, A.J. Budney, E.M. Curran. Sleep disturbance and the effects of extended-release zolpidem during cannabis withdrawal. Drug and Alcohol Dependence. (2011) 38-44. http://www.ncbi.nlm.nih.gov/pubmed/21296508
  2. U.D. McCann, F.P. Sgambati, A.R. Schwartz, G.A. Ricaurte. Sleep Apnea in Young Abstinent Recreational MDMA (“ecstasy”) Consumers. Neurology. 2009 Dec 8;73 (23): 2011-7. Epub 2009 Dec 2. http://www.ncbi.nlm.nih.gov/pubmed/19955499
  3. A.R. Schwartz, S.P. Patil, S. Squier, H. Schneider, J.P. Kirkness and P.L. Smith. Obesity and upper airway control during sleep. J Appl Physiol. 2010 Feb;108(2):430-5. Epub 2009 Oct 29. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2822668/
  4. R.P. Allen, P. Stillman, A.J. Myers. Physician-diagnosed restless legs syndrome in a large sample of primary medical care patients in Western Europe: prevalence and characteristics. Sleep Med. 2010;11(1):31-7. Epub 2009 May 22. http://www.ncbi.nlm.nih.gov/pubmed/19464949
  5. J.P. Kirkness, M. Verma, B.M. Mc Ginley, M. Erlacher, A.R. Schwartz, P.L. Smith, J.R. Wheatley, S.P. Patil, T.C. Amis and H. Schneider. Pitot-tube flowmeter for quantification of airflow during sleep. Physiol Meas. 2010 Dec 22; 32(2):223-237. (Epub ahead of print) http://www.ncbi.nlm.nih.gov/pubmed/21178245
  6. K.I. Bolla, S.R. Lesage, C.E. Gamaldo, D.N. Neubauer, N.Y. Wang, F.R. Funderburk, R.P. Allen, P.M. David and J.L. Cadet. Polysomnogram changes in marijuana user who report sleep disturbances during prior abstinence. Sleep Med. 2010 Oct;11(9):882-9. Epub 2010 Aug 3. http://www.ncbi.nlm.nih.gov/pubmed/20685163
  7. S.B. Squier, S.P. Patil, H. Schneider, J.P. Kirkness, P.L. Smith and A.R. Schwartz. Effect of end-expiratory lung volume on upper airway collapsibility in sleeping men and women. J Appl Physiol. 2010 Oct:109(4):977-85. Epub 2010 Jun 24. http://www.ncbi.nlm.nih.gov/pubmed/20576839
  8. R.E. Salas, C.E. Gamaldo and R.P. Allen. Update in restless legs syndrome. Curr Opin Neurol. 2010 Aug;23(4):401-6. http://www.ncbi.nlm.nih.gov/pubmed/20581683
  9. R.E. Salas, R. Rasquinha and C.E. Gamaldo. All the wrong moves: a clinical review of restless legs syndrome, periodic limb movements of sleep and wake, and periodic limb movement disorder. Clin Chest Med. 2010 Jun;31(2):383-95. http://www.ncbi.nlm.nih.gov/pubmed/20488295
  10. R. P. Allen, J.R. Connor, K. Hyland, et al., Abnormally increased CSF 3-Ortho-methyldopa (3-OMD) in untreated restless legs syndrome (RLS) patients indicates more severe disease and possibly abnormally increased dopamine synthesis, Sleep Med (2008). Epub Jan 26 2008 http://www.ncbi.nlm.nih.gov/pubmed/18226951
  11. C. Gamaldo, A.R. Benbrook, R.P. Allen, et al., Evaluating daytime alertness in individuals with Restless legs Syndrome (RLS) compared to sleep restricted controls, Sleep Med (2008). http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2650846/
  12. V.E. Pearson, C.E. Gamaldo, R.P. Allen, et al., Medication use in patients with restless legs syndrome compared with a control population, Eur J Neurol 15 (2008), 16-21. http://www.ncbi.nlm.nih.gov/pubmed/18005055
  13. A.R. Schwartz, S.P. Patil, A.M. Laffan, et al., Obesity and obstructive sleep apnea: Pathogenic mechanisms and therapeutic approaches, Proc Am Thorac Soc 5 (2008), 185-192. http://pats.atsjournals.org/content/5/2/185.full.pdf
  14. C.J. Earley, A. Horska, M.A. Mohamed, et al., A randomized, double-blind, placebo-controlled trial of intravenous iron sucrose in restless legs syndrome, Med (2008). http://www.ncbi.nlm.nih.gov/pubmed/18280205
  15. J. Kirkness, A. Schwartz, H. Schneider, N. Punjabi, J. Maly, A. Laffan, B. McGinley, T. Magnuson, M. Schweitzer, P. Smith, and S. Patil. Contribution of male sex, age, and obesity to mechanical instability of the upper airway during sleep. J Appl Physiol. 2008, June 104(6): 1618-1624 http://www.ncbi.nlm.nih.gov/pubmed/18420722
  16. C. Gamaldo, R.E. Salas, N.A. Collop. Complex arrhythmia during a sleep study –what to do? J Clin Sleep Med. 2009 Apr 15;5(2):171-3. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2670338/
  17. C.J. Earley, A. Horska, M.A. Mohamed, P.B. Barker, J.L. Beard, R.P. Allen. A randomized, double-bind, placebo-controlled trial of intravenous iron sucrose in restless legs syndrome. Sleep Med. 2009 Feb;10(2):206-11. Epub 2008 Feb 14 http://www.ncbi.nlm.nih.gov/pubmed/18280205
niederhuber_pic_small.jpg

Executive Vice President/CEO
Inova Translational Medicine Institute and Inova Health System

Co-Director, Johns Hopkins Clinical Research Network

John E. Niederhuber, M.D., recently joined Inova Health System as Executive Vice President and CEO of the Inova Institute for Translational Research and Personalized Medicine. He is also Professor of Oncology and Surgery at the Johns Hopkins University School of Medicine. He also serves as Co-Director of the Johns Hopkins Clinical Research Network. Prior to that he served as Director of the National Cancer Institute, one of the National Institutes of Health from 2006 until July, 2010. Dr. Niederhuber was elected to the Institute of Medicine in recognition of his outstanding scientific accomplishments and commitment to service in health science.

During his tenure as NCI director, Dr. Niederhuber shaped the Nation’s investment in cancer to address areas likely to pay the largest health dividends. He began The Cancer Genome Atlas, an effort to comprehensively identify the genomic changes in all major cancer types and subtypes. In addition to genomic studies of cancer and work in cancer immunotherapy, programs in nanobiology, systems biology, investigations into the tumor microenvironment, cancer initiating cells, and subcellular imaging benefited under his direction.

photo of Adrian Dobs, MD, MHS

Professor of Medicine and Oncology, Division of Endocrinology and Metabolism

Vice-chair of Faculty Development, Department of Medicine The Johns Hopkins University School of Medicine

Co-Director, Johns Hopkins Center for the Reduction of Cancer Disparities
The Johns Hopkins Bloomberg School of Public Health

Director, Johns Hopkins Clinical Research Network

Dr. Adrian Dobs is a professor of medicine (Division of Endocrinology and Metabolism) and Oncology at the Johns Hopkins University School of Medicine. She earned her undergraduate degree from Cornell University and obtained her MD from Albany Medical College in Albany, NY. She completed her residency in internal medicine at the Albert Einstein College of Medicine, where she also served as chief resident. Dr. Dobs then came to Baltimore to complete her fellowship in Endocrinology and Metabolism at the Johns Hopkins University School of Medicine (Carnegie Mellon Fellow in 1984-1985), joining the faculty upon completion. She went on to earn her MHS in Cardiovascular Epidemiology in the Bloomberg School of Public Health.

Dr. Dobs’ research and clinical interests include:

  • Sex Hormone Disorders
  • Metabolic Abnormalities Associated with HIV Infection
  • Clinical Trials
  • General Endocrinology

She is an active investigator in the field of male gonadal function and is particularly interested in new forms of male hormone replacement therapy. She has published extensively in the area of hormonal changes with aging. As director of the Clinical Trials Unit, she oversees a team of individuals dedicated to facilitating clinical research within an academic medical center environment. In 2000, she was awarded an $8 million grant from the National Institutes of Health to direct the Johns Hopkins Complementary and Alternative Cancer Center.

At Johns Hopkins, Dr. Dobs continues to be an active mentor to undergraduate and medical students, PhD and post-doctoral candidates, and for the Women’s Task Force. She sits on many editorial boards and is a member of the American Federation for Clinical Research, the American College of Nutrition, the Endocrine Society, the American College of Physicians, the American Andrology Society, and the Association of Clinical Research Professionals. She has been a visiting professor at a number of universities and has given more than 50 invited lectures and symposia.

Dr. Dobs is a recipient of the Davidoff Award for Clinical Teaching at Montefiore Medical Center, the Stetler Foundation Research Award for Women Physicians, and the David M. Levine Excellence in Mentoring Award at the Johns Hopkins University School of Medicine.

Lynne A. Armiger is the Network Coordinator for Peninsula Regional Health System, an affiliate site of the Johns Hopkins Clinical Research Network (JHCRN), a program of the Johns Hopkins institute for Clinical and Translational Research. She has greater than 25 years of healthcare experience, holding a Bachelors of Science in Nursing, a Master’s of Science in Nursing Administration and a Post-Master’s Certificate as an Adult Nurse Practitioner.

Lynne’s past experiences include 10 years of bedside nursing in oncology and critical care, clinical nurse instruction at two community colleges near her home in Delaware, and functioning as the Director of Performance Improvement at a small community hospital. More recently Lynne was the Research Manager for a private cardiology practice for 10 years before going back to pursue her nurse practitioner degree, which led her to function as an adult nurse practitioner in cardiology and primary care. Now within her current role as Network Coordinator, Lynne is responsible for coordinating research studies between the Johns Hopkins Clinical Research Network and Peninsula Regional Health System.

Melissa Gerstenhaber RNC, MAS, MSN, CCRC is the Johns Hopkins Network Coordinator for Anne Arundel Medical Center (AAMC). She has more than 30 years of experience as a registered nurse and has earned Master’s Degrees in Administrative Science and Nursing Management. She holds certificates through the American Nurses Credentialing Center in Psychiatric and Mental Health Nursing and Guided Care Nursing. She is also a Certified Clinical Research Coordinator through the Association of Clinical Research Professionals.

Melissa worked as a Senior Research Nurse Coordinator for the Morris K. Udall Center of Excellence at Johns Hopkins University for 10 years. Prior to that, she was a Senior Clinical Nurse at Johns Hopkins Hospital. In her current role as Clinical Network Coordinator, Melissa’s is responsible for coordinating studies between the Johns Hopkins Clinical Research Network and AAMC.

Cynthia A. MacInnis, BS, CCRP is the Network Coordinator for Greater Baltimore Medical Center (GBMC) and Johns Hopkins University in the Johns Hopkins Clinical Research Network. She holds a Bachelor’s of Science in Biological Sciences from the University of Maryland Baltimore County (UMBC), and is currently enrolled in a dual degree Masters of Science degree in Biotechnology, and a Masters in Business Administration program at Johns Hopkins University.

Ms. MacInnis has over seven years experience in clinical trials management. Prior to being offered the role as Network Coordinator with the JHCRN, she had overseen the oncology clinical trials program at GBMC, Berman Cancer Institute. In this capacity, she was responsible for clinical research program trial and staff oversight, budget development, contract negotiations, and had also gained experience in data management and regulatory submission. While at Berman Cancer Institute, Ms. MacInnis implemented a quality improvement initiative with internal audit processes and standard operating procedure implementation. More recently, she has developed a research website for the institution. In her current role as Network Coordinator, Ms. MacInnis acts as a primary liaison between JHU and GBMC to facilitate opening JHU research at the affiliated institution.

Sandra J. Schaefer is a network coordinator for the Johns Hopkins Clinical Research Network (JHCRN), a program of the Johns Hopkins Institute for Clinical and Translational Research. Her responsibilities include coordinating research activities between the JHCRN and the Peninsula Regional Medical Center and the Inova Health System, both members of the JHCRN. A graduate of the Christ Hospital School of Nursing and the University of Cincinnati School of Nursing and Health, Ms. Schaefer has worked in a variety of nursing specialties including operating room nursing, urology, reproductive endocrinology, and oncology over the course of her 35-year career.

In 1992, Ms. Schaefer discovered her enthusiasm for oncology research by managing cancer clinical trials in her hometown of Cincinnati, Ohio, for both a large community hospital and the largest private oncology practice in the region. In 2002, Ms. Schaefer was recruited by the National Institutes of Health/National Cancer Institute in Bethesda, Maryland, to help create and manage the Tobacco Intervention Research Clinic to conduct behavioral clinical research in tobacco cessation.

In 2004, she came to Johns Hopkins as a senior research nurse at the Sidney Kimmel Comprehensive Cancer Center, first as a research nurse focusing on vaccine therapy in the division of immunology and then as the Phase I solid tumor research nurse/ program coordinator for the center. She brings 19 years of research experience to her position having been involved in all phases of cancer clinical trials as well as behavioral studies. Her experience includes all aspects of clinical trial management from regulatory to clinical care of research subjects. She has a particular passion for pursuing the “art” of the informed consent process and advocating for patients with their insurance companies to participate in clinical trials.

Ms. Schaefer is a member of the Oncology Nursing Society (ONS) and has been certified in oncology nursing since 1994. She is the Membership Chairman of the Washington, DC chapter ONS. A co-author of several publications and abstracts, she is also a member of the Society of Clinical Research Associates (SOCRA), National Capital Area Chapter, and was inducted into the Sigma Theta Tau International Honor Society of Nursing, Cincinnati Beta Iota Chapter, in 1999. In 2011, she was added as a member to Stanford University Who’s Who registry.

Lunch Lectures

Study Coordinator Career Advancement Opportunities
Stephanie Swords
June 29, 2012

**Recording is not available due to technical difficulties. It will be rerecorded and available soon.**

Trials at Hopkins Overview
Gerry Stacy
April 20, 2012

Engaging Community Clinicians in Clinical Research: A Case Study and Principles for Success
Lawrence Appel, MD, PhD
Gary Norohna, MD
April 12, 2012

What Makes the “Perfect” Study Coordinator?
Panelist:
Todd Brown, MD
Craig Hendrix, MD
Tracy Chambers -Thomas
Jaime Dahm
March 23, 2012

ORR Symposium: Customizing Your Toolbox 
April 29, 2011

Recruitment and Retention: State of the Science
Rhonda Kost, MD

Social Media in Clinical Research: The Evolution of a New Tool
Stacy J. Poliseo and Michelle Landrum

Strategies for Recruiting Critically Ill Patients
Dale Needham, MD

Tips for Successful Recruitment of Pediatric Populations
Kristin Riekert, PhD

Identifying Potential Participants
John W. Shepard and Diana Gumas

“Old School Networking”: Enhance Participant Recruitment & Retention through Community Engagement
Crystal Evans, MS

Engaging Community Clinicians in Clinical Research
Gary Noronha, MD

Improving Clinical Research Communication Skills, Part 1
Improving Clinical Research Communication Skills, Part 2
Lidia Schapira, MD

Technical “How to” with Social Media Strategies
Jeanine Estrada, MBA

Implementing Strategies and Tools to Boost Retention
Jeanne Charleston and Liz Martinez BSN, RN, CCRC

Developing Low Literacy Recrutiment and Retention Materials
Barbara Fletcher, RN, MN, FAHA, FP

Grant Prep Phase: Preparing a Plan and Budget to Support Recruitment and Retention
Larry Appel MD, MPH and Karen Roz, MS

Panel Discussions

Lunch Lectures

Johns Hopkins Clinical Research Network (JHCRN)
Video
Charles Balch, MD
February 11, 2011

Ethical Factors in the Recruitment and Retention of Research Participants
Video (Apologies for audio difficulties)
Frederick W. Luthardt, MA, MA
January 21, 2011

Budgeting for Success
Karen Roz, MS
September 24, 2010

Institutional Databases for Recruitment
Lois Brass, BSN, Senior Research Nurse
Sabra Shay, MPH, Infection Control Epidemiologist
July 30, 2010

ORR Symposium: How to Succeed in the Face of Obstacles

April 30, 2010

Welcome and Introduction
Video
Cheryl Dennison, PhD, RN, ANP

Overview of the Recruitment and Retention Landscape: What Have We Learned and What Are We Missing?
Video
Kenneth A. Getz, MBA

Creating the Buzz: How to Implement Effective Internet and Social Networking Strategies for Recruiting Research Participants
Video
Jeanine Estrada, MBA

How to Maximize Recruitment and Retention, While Complying with IRB and HIPAA Regulations (Video)
Slides (Appel)
Slides (Carrithers)
Lawrence Appel, MD, MPH
Judith Carrithers, JD, MPA, CIP

Marketing Strategies to Maximize Participant Recruitment
Video
Keith Langrehr, MAS
CJ Michalak
Kristen Kulik, BA

Improving Communication and Cultural Competence to Enhance Participant Recruitment and Retention
Video
Lisa Cooper, MD, MPH

Exploring Which Participant Incentives Work Best and Why
Video
Liz Martinez, BSN, RN, CCRC

An Overview of ResearchMatch.org–The National Recruitment Registry Project
Video
Kirstin Woody-Scott, MPH

Panel Discussion: Facilitated Problem Solving (Video)
Cheryl Dennison, PhD, RN, ANP
Lawrence Appel, MD, MPH
Jeanne Charleston, BSN, RN
Jeanine Estrada, MBA
Crystal Evans, MS
Cassia Lewis-Land, MA, CCRP
Liz Martinez, RN, BSN, CCRC

Lunch Lectures

Recruiting Healthy Volunteers for Clinical Research
Karen R. Charron, BSN, MPH
March 18, 2010

Community-Based Participatory Research as a Tool to Maximize Recruitment and Retention of Linguistic Minorities in Health Promotion Research
Hae-Ra Han, PhD, RN
December 17th, 2009

Multi-Site Trial Recruitment and Retention
Lee Swartz, MBA
November 19, 2009

Key Features of a Recruitment Plan
Cheryl Dennison, RN, ANP, PhD
October 16, 2009

Use of the Web to Recruit Study Participants: One Size Does Not Fit All
Larry Appel, MD, MPH
September 17, 2009

Tracking and Retaining Study Participants
Lisette Johnson-Hill, MS
June 19, 2009

Improving Participation in Oncology Research Trials (IMPORT)
Mollie Howerton, MPH, PhD
May 15, 2009

Recruitment of Hard-To-Reach Populations
Cassia Land, MA, CCRP
April 17, 2009

ORR Symposium Meeting Your Goals: Strategies for Research Participant
March 20, 2009

Skills as a Tool in Recruitment & Retention
Denise Ernst, PhD

Recruitment of Minority Populations
Nancy Houston Miller, RN

Mass Mailing: Materials and Process
Jean Charleston, BSN

Nuts, Bolts & Other Pearls from Home Depot: A Primer on Recruitment and Retention
Larry Appel, MD, MPH

Recommended Tables

Relevant Literature & Scholarship
ORR Literature Spreadsheet (Microsoft Excel)

Sample Tracking Tables
This file includes logs for ID assignment, phone calls & contacts, visits, and serious adverse events. Please make adjustments or changes to fit the needs of your study.

Study Tracking Tables (Microsoft Excel)

Recommended Links

Glossary of Clinical Research Terms at ClinicalTrials.gov.

Current HIPAA Forms at the Johns Hopkins Medicine IRB.

Current HIPAA Consent Form (Microsoft Word) from the Johns Hopkins Medicine IRB.

Sample Recruitment Brochures
Sample 1
Sample 2
Sample 3
Sample 4

The regulatory guidances, templates, and other materials provided at this site are available to the public and are for researchers to use with appropriate acknowledgement of source material. All material provided on this site is for informational purposes only. The Johns Hopkins Institute for Clinical and Translational Research makes no representations as to the accuracy, completeness, correctness, suitability, or validity of any information on this site and will not be liable for any errors, omissions, or delays in this information or any losses, injuries, or damages arising from its display or use.

Progess in Community Health Partnerships: Research, Education and Action (PCHP) Journal

PCHP is dedicated to publishing the work of community health partnerships that involve ongoing collaborations between community representatives and academic or government partners. Published quarterly by the Johns Hopkins University Press, PCHP is a peer reviewed, Medline indexed journal.

Editor in Chief: S. Darius Tandon, PhD

Managing Editor: Mark Newgent

Website

Research Training

The Community Engagement Program offers trainings and workshops for faculty, postdoctoral fellows, students, and research staff who are interested in community-based participatory research (CBPR)- an approach to research characterized by ongoing and meaningful involvement of community stakeholders throughout a research project.

Click here for resources on previous training events and lectures.

AIDS Linked to the Intravenous Experience (ALIVE) Study

ALIVE is a long-standing community based research effort that includes past and current injection drug users (IDUs). ALIVE has been ongoing since 1988 and is one of the longest-running community-based cohorts of IDUs in existence. The primary objectives when the study started were to characterize the incidence and natural history of HIV among injection drug users (IDUs). Since 1998, the research objectives have evolved to include characterization of access to and impact of treatment for HIV, evaluation of non-AIDS outcomes among an aging cohort as well as ascertainment of the incidence, natural history and treatment of co-infections such as hepatitis C virus. Importantly, the ALIVE study serves as a platform for numerous other research studies focused on IDUs in Baltimore. These range in scope from focusing on HIV associated co-infections and comorbidities (e.g., HCV and pulmonary disease) to intervention studies.

The study design is prospective observation. Two cohorts are followed in parallel. The ALIVE I cohort involves the clinical immunologic follow-up of all of the HIV seropositive IDUs with an unselected sample of HIV seronegative IDUs to provide laboratory controls and preservation of confidentiality of the HIV positive cohort. The ALIVE II cohort follows the rest of the HIV seronegative IDUs, with continued referral to ALIVE I of HIV seroconverters.

At each study visit, participants undergo a series of questionnaires that elicit information about substance use and risk behavior and medical history and health care utilization, a blood draw, other clinical assessments and ALIVE I participants undergo a clinical exam. Numerous blood tests are conducted at each visit including HIV antibody testing, CD4 cell count and HIV RNA levels for HIV positives, a complete blood count and a liver panel.

Study of HIV Infection in the Etiology of Lung Disease (SHIELD)

SHIELD is a collaborative and systematic investigation of lung disease among HIV-infected persons and those at risk for HIV exposure within the ALIVE Study cohorts. At each ALIVE Study visit, all participants undergo an interviewer-administered respiratory questionnaire and spirometry test to obtain more detailed information regarding lifetime tobacco and other inhaled drug use as well as pulmonary functioning.

The Liver Study

This study focuses on characterizing the natural history of liver disease (primarily secondary to hepatitis C virus infection) among ALIVE participants. Greater than 80% of ALIVE participants are infected with hepatitis C. Currently we are using a non-invasive device (FibroScan) to estimate liver fibrosis. This technology measures liver stiffness using elastic waves, a process similar to ultrasound scanning.

The Neurocognitive Function Study

This study assesses memory function as well as general brain function across a range of domains, such as attention, concentration, motor speed, and executive function. Our objective is to determine if HIV, hepatitis C, illicit drug use, or additional associated circumstances may be risk factors for increased impairment in memory or these other domains of brain function. Measurements include the International HIV Dementia Scale (IHDS) and a more intensive battery of neurocognitive tests for a subsample.

Exposure Assessment in Current Time (EXACT) Study

EXACT assesses exposure to drug use and psychosocial stress in near-real time through Ecological Momentary Assessment (EMA). Participants use handheld electronic diaries to record events as they occur and report recent or ongoing events in response to randomly timed prompts throughout the day. Global Positioning System (GPS) devices also track their whereabouts.

Introduction to Community Based Participatory Research: Principles and Methods (410.631.01)

Health Behavior and Society 2nd Term (3 Credits)

Instructors: Janice Bowie, Lee Bone, Darius Tandon

Description: Introduces students to the fundamental principles of, rationale for, and key considerations in conducting community based participatory research (CBPR). Offers knowledge of and skills in CBPR that emphasize the importance of community inclusion and partnership as a viable approach to constructing and increasing the acceptance of interventions and improving the health and well being of populations.

Graduate Seminar in Community Based Research

Health Behavior and Society 1st-4th Term (1 credit per term, First and Third Tuesdays)

Instructors: Lee Bone and Janice Bowie

Description: Explores faculty community partnership in community based research (CBPR), education, and practice. Seminar topics may include CBPR principles and ethics, coalition and partnership building, implementation, dissemination, translation and sustainability, media and marketing, advocacy, policy, cultural diversity, collaborative grant writing, and publishing. Speakers include faculty, Kellogg scholars, and community patrons. This seminar is open to all divisions in the University and community.

A collection of presentations from previous lectures and events.

The Nuts and Bolts of Community-Based Participatory Research
April 12, 2013

Video

Slides

Definitions and Characteristics of CBPR

Beat the Blues Case Study

Developing Community Advisory Board

Developing Relationships with Community Partners

Community Engaged Research Resources at Johns Hopkins

 

Effective Communication of Meaningful Data: Innovative Ways of Disseminating Research Findings
December 7, 2012

Ben Peterson, MA
Video

Slides

Handout

 

Researcher Recertification Course
April 25, 2012

Darius Tandon
Adrian Mosley
Inez Robb
Engaging Communities in Research: The Unexpected Rewards of Keeping it Real

 

The Nuts and Bolts of Community-Based Participatory Research
January 27, 2012

Richard Matens, M.Div
Developing a Community Advisory Board

Airin Martinez, PhD
Key Issues Getting Started: Issue Selection, Research Design, and Sustainability

Darius Tandon, PhD
Definitions and Characteristics of Community-Based Participatory Research

Hae-ra Han, RN, PhD, FAAN
A Community Partnership to Address Health Disparities

Darius Tandon, PhD
Community Based Particpatory Research Resources List

 

The Future of Community-Engaged Research
May 3, 2011

Video

Lawrence Green, MPH, DrPh
Presentation

Frances Phillips, RN, MHA
Presentation

Marshell Prentice, DD, DHL
Presentation

Each member institution has a designated Network Coordinator, who acts as a primary liaison between JHU and that institution. The Coordinator facilitates the identification, prioritization, and implementation of clinical trials jointly approved by investigators at JHU and the network site. Network coordinators may be contacted for more information on the JHCRN.

Sandra Schaefer, BSN, RN, OCN
Inova Heath System
sschaef5@jhmi.edu
410-209-7385

Cynthia MacInnis, BS, CCRP
Greater Baltimore Medical Center
cmacinn1@jhmi.edu
443-226-1788

Melissa Gerstenhaber, RN, MAS, MSN, CCRC
Anne Arundel Health System
mgerste1@jhmi.edu
443-890-3503

Lynne Armiger, MSN, CRNP
Peninsula Regional Medical Center
lynne.armiger@jhmi.edu

Johns Hopkins Leadership

Adrian S. Dobs, MD, MHS
Network Director

John E. Niederhuber, MD
Network Co-Director

Julie Brahmer, MD (Oncology)
Associate Program Director

Fred Brancati, MD (Internal Medicine)
Associate Program Director

Tim Pawlik, MD (Surgery)
Associate Program Director

Melissa Gerstenhaber, RN, MAS, MSN, CCRC (AAMC)
Network Coordinator

Cynthia MacInnis, BS, CCRP (GBMC)
Network Coordinator

Sandra Schaefer, BSN, RN, OCN (INOVA)
Network Coordinator

Lynne Armiger, MSN, CRNPM (PRMC)
Network Coordinator

Robyn Hinke
Administrative Coordinator

Charmaine Cummings, RN, PhD
Educational Consultant

Janet L. Mighty, BS, MBA
Pharmacy Support Services

Anne Arundel Leadership

Joseph D. Moser, MD
Senior Vice President of Medical Affairs

Stanley Watkins, MD
AAHSRI Medical Director

Greater Baltimore Medical Center Leadership

Paul Celano, MD
Chief Medical Oncologist, Berman Cancer Institute

Gary I. Cohen, MD
Medical Director, Berman Cancer Institute

James H. Mersey, MD
Director, Geckle Diabetes and Nutrition Center

Inova Health System Leadership

John E. Niederhuber, MD
Executive Vice President/CEO Inova Translational Medicine Institute and Inova Health System
Co-Director of the JHCRN

Zobair M. Younossi, MD, MPH, FACP, FACG, AGAF
Executive Vice- President for Research
Chairman, Department of Medicine, Inova Fairfax Hospital

Gity N. Porjosh, MPH, MBA
Research Director, Inova Research Center

Peninsula Regional Medical Center Leadership

Peggy Naleppa, MS, MBA, PhD, FACHE
President/CEO Peninsula Regional Medical Center and Peninsula Regional Health System

Thomas Lawrence, MD, MBA
Vice President/CMO Peninsula Regional Medical Center

Timothy Feist, MSW, MBA, FACHE
Vice President of Performance Improvement and Safety Officer Peninsula Regional Medical Center

Bennett Yu, MD
Director, Oncology Clinical Research, Richard A. Henson Cancer Institute, Peninsula Regional Medical Center

Sandra Heineken, BSN, RN, OCN
Manager, Oncology Clinical Research, Richard A. Henson Cancer Institute, Peninsula Regional Medical Center

The operational foundation of research structure and conduct within the Johns Hopkins Clinical Research Network is based on centralization of a few key aspects which unify JHCRN member institutions. Key aspects include:

  • Single Principal Investigator:The JHU principal investigator will serve as PI for all sites. A lead site co-investigator is identified at each JHCRN member site to serve as a main investigator point of contact for the PI and aides in overseeing study activities at their respective site. Investigators should read the “Investigator Responsibilities” document for information on PI and lead site co-investigator requirements.
  • Single Point of Contracting for Sponsors:Outside sponsors maintain one main research contract with JHU and the JHU PI. The Johns Hopkins Medicine Office of Research Administration creates and executes a subcontract agreement between JHU and the member sites to incorporate these sites.
  • Single Study Budget:JHU and member sites agree upon a single budget which is sent to the study sponsor. Affiliate sites are offered use of the JHU prospective reimbursement analysis (PRA) for budget development.
  • Single Institutional Review Board:The JHM IRB is the authorized IRB of record for all JHCRN-affiliated research. Study team personnel from member sites are added to the JHM IRB application after meeting research training compliance requirements. Members sites use only JHM IRB approved study documents, including informed consent.
  • Single Research Information Database:The required JHU Clinical Research Management system (CRMS) is used to enter screening and enrollment data at member sites.
  • Single Network Coordinator for each site:Each member institution has a designated Network Coordinator, who acts as a primary liaison between JHU and that institution. The Coordinator facilitates the identification, prioritization, and implementation of clinical trials jointly approved by investigators at JHU and the network site. Network coordinators may be contacted for more information on the JHCRN.

Introduction

If you are an investigator interested in fast participant accrual, diversity in subject recruitment, and cross-institutional collaborations, you should consider utilizing the Johns Hopkins Clinical Research Network (JHCRN) to expand your research across regional academic and community settings. All eligible Johns Hopkins University faculty members are welcome to submit their research studies to JHCRN for review by filling out a JHCRN Study Information Form. You may also download our printable brochure.

Study Initiation Process

JHU investigators are encouraged to submit study information to the JHCRN by filling out a Study Information Sheet or by contacting the JHCRN by e-mail or phone for assistance. Once the form is received, appropriate member site investigators are indentified and basic interest and feasibility is assessed. Each member institution encompasses its own unique patient population and research strengths. Study information submissions will be reviewed at monthly JHCRN Clinical Investigator’s Committee (CIC) meetings. Principal investigators (PIs) may present their research projects to key JHCRN leadership at these meetings.

Once a study has been vetted and approved by the JHCRN leadership, a JHCRN network coordinator will work with the principal investigator and research team to implement the study at the member site. As another option, investigators interested in receiving future information on potential research projects may become part of the JHCRN Investigator Registry by filling out an Investigator Information Registration Form.

Peer Resources for Investigators

The JHCRN Director and associate program directors serve as peer resources to aide investigators in navigating JHCRN and its capabilities. Investigators may contact director, Adrian Dobs, MD; co-director, John Niederhuber, MD; or associate program directors in specific disciplines for additional information. Associate program directors include: Fred Brancati, MD for internal medicine, Julie Brahmer, MD for oncology, and Tim Pawlik, MD for surgical related studies.

Investigator Responsibilities

Both Principal Investigators and affiliate site co-investigators should read the “Investigator Responsibilities” document before deciding to utilize the JHCRN. Since the principal investigator is ultimately responsible for pertinent research activity at the member institution, some guidelines and responsibilities are outlined for everyone’s understanding.

Research Agreements

Johns Hopkins University, on behalf of the JHCRN, has entered into research agreements with member sites. The main research affiliate agreement includes obligations of both JHU and affiliate investigators that contains requirements for research compliance and JHU policy compliance. Each member site has also entered into a general confidentiality non-disclosure agreement to establish general obligations of confidentiality and non-disclosure related to the sharing of JHU information. The JHCRN Network Coordinators can verify with the JHU Office of Research Administration whether or not an additional agreement by sponsors is required to determine whether additional confidentiality agreements are required.

Investigators seeking more information, click the links below.

Investigator FAQs

Investigator Registration Form

Study Information Sheet

JHCRN Brochure

Video Presentations

Clinical Trials Education Series: Understanding Patient-Centered Outcomes Research & Comparative Effectiveness Research
Albert W. Wu, MD, MPH
March 16, 2011

Auditing and Monitoring Clinical Trials
Jacki M. Yonkers
March 16, 2011

Johns Hopkins Clinical Research Network
Charles M. Balch, MD, FACS,
February 11, 2011

Clinical Trials Education Series: Toxicities, Adverse Events and the Monitoring Process
Charles M. Balch, MD, FACS
Elizabeth Ness, RN, MS
February 08, 2011

Recruitment and Retention of Patients
Stephanie Swords, MA, CCRP
January 08, 2011

Discussing Clinical Trials with Patients in the Office: Common Pitfalls and Best Practices
Lidia Shapira, MD
January 08, 2011

Clinical Trials in Community Practice: Funding, Resources and Budget
Gary Cohen, MD
Daniel Ford, MD
Cynthia MacInniss, BS, CCRP
November 15, 2010

Tips for Incorporating Clinical Trials into a Busy Practice
Joseph Moser, MD
Frederick L. Brancati, MD
Charles M. Balch, MD, FACS
Gary Cohen, MD
James Welker, DO
Erika Schroeder, MS, RN.OCN, CNL
Margaret Matula, RN, MGA, CCRP
October 10, 2010

All investigators must submit an application to a Johns Hopkins Institutional Review Board (IRB) before beginning their ICTR Clinical Research Units (CRUs) application.

There are two ways to submit an application to the ICTR Clinical Research Units (CRUs)– one method applies if you are using the School of Medicine eIRB system, while the second applies if you have submitted to another Johns Hopkins IRB. Please read through the materials below to

First method: For investigators who apply to the School of Medicine IRB through eIRB.

  1. Begin by submitting an IRB application via the eIRB. When completing your application, you MUST answer “Yes” to question 2.0 of Section 9.0 “Will you apply to the Bayview CRU or JHH CRU (includes NBRU) for funding or use of facilities?
  2. After you have submitted your eIRB application, e-mail crus@jhmi.edu to let us know that you plan to submit a CRU application. We will then initiate your CRU application by pulling information from your eIRB application. Please wait for a notification email that this has occurred before moving on to the next step.
  3. When you have received your notification email, please log on toCRUOnline. You will find your new application under the “My Protocols” menu option. Review the uploaded information and then follow the instructions online to complete and submit your application.

Second Method: For investigators who submit applications to other Johns Hopkins IRBs (Bloomberg School of Public Health, for example).

  1. Complete your IRB submission; many of the same documents you use for this process will be needed for your CRU application.
  2. Log on to CRUOnline. Choose the menu option “My Protocols”, and click on the “Add a New Application” button.
  3. Follow the instructions online to complete your application, and upload your supporting documentation.
    • You may save your work at any time as your work on your application.
    • The people you designate as Co-Investigators or Study Coordinators on your application will also have access to your draft application. That way, members of your study team can also work on your application.
    • Finally, you may have a Co-Investigator or Study Coordinator fill out a CRU Application on your behalf through CRUOnline.
  4. When you’ve completed the application, the system will allow you to submit it to the CRU and begin the review process.

Once your application is submitted, it will be pre-reviewed. You will be sent an e-mail detailing the changes necessary and/or questions to be addressed so that your study can be forwarded to the full protocol review committee to begin the Protocol Review Process.

How to Access CRUOnline

 

The ICTR Clinical Research Units (CRUs) are required by NIH to have a Protocol Review Committee that must review and approve all research protocols before they use CRU funds. There are three Protocol Review Committees: the Adult Protocol Review Committee, the Pediatric Protocol Review Committee, and the NeuroBehavioral Research Unit Protocol Review Committee.

These committees do the in-depth reviews, communicate with investigators, and give final approval.  Protocols conducted primarily in the pedicatric population are reviewed by the Pediatric Protocol Review Committee, chaired by Beth Laube, Ph.D.  Protocols conducted primarily in the adult population are reviewed by the Adult Protocol Review Committee, co-chaired by Suzanne Jan de Beur, M.D. and Wendy Post, M.D., MS, FAAC.  Protocols requiring the expertise of the Neuro Behavioral Research Unit at the Kennedy Krieger Institute are reviewed by the Neuro Behavioral Research Unit Protocol Review Committee, chaired by Dr. Michael Johnston, M.D.

The Review Process:

  1. Application is submitted to the CRU prior to the deadline and assigned to the appropriate committee.
  2. Application is placed on the agenda for the next committee meeting and primary, secondary, biostatistical, and human subjects reviewers are assigned.
  3. Application is discussed at the committee meeting, culminating in a vote.
  4. Committee chair sends letter to the investigator informing of the committee’s decision, and including any relevent comments.

Possible Outcomes

Approved: The protocol is fully approved by the committee to proceed with the use of CRU resources.

Scientifically Deferred: The protocol may have a safety issue, concern regarding the study design, lack of an analytic plan, or significant human subjects’ issues.  A deferral letter including comments and concerns will be sent to the investigator and the application will be reconsidered once those issues have been addressed.  If the committee is not satisfied with the response and votes to defer again, the PI is usually invited to attend the next committee meeting.

Administratively Deferred:  The protocol requires relatively minor clarifications or responses, but does not need to be re-reviewed by the full committee.   This may include a lack of IRB approval, conflicts between consent form and study protocol, lack of acceptable Inclusion Children statement, or an unsettled budget issue.   A deferral letter including comments and concerns will be sent to the investigator.  Once a satidfactory response is received, full approval is granted.

Disapproved: The protocol has a serious design flaw or insufficient material to judge it fairly.  These applications are not reconsidered by the committee unless they are resubmitted with major revisions.

Once a study is fully approved a letter from the committee will be forwarded to the principal investigator.  To check on the approval status, contact:

Shernice Madison, Protocol Review Coordinator, 410-614-2717

Regulatory Binders

Participant Binders

Inquiries and Requests for Support

Please submit an ICTR Connection Request.

 

Guidance Documents

  1. Guidance for Data and Safety Monitoring Plans
  2. FDA Audit Preparation Resource and Checklist

Inquiries and Requests for Support

Please submit an ICTR Connection Request.

Resources

Inquiries and Requests for Support

Please submit an ICTR Connection Request.

Definition
Combination products are defined in 21 CFR 3.2(e). The term combination product includes:

  1. A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
  2. Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;
  3. A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or
  4. Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.

Guidance and Templates

Request for Designation

  • pending

Inquiries and Requests for Support

Please submit an ICTR Connection Request.

Guidance and Templates

IDE Application

Letters of Authorization for 510(k) or PMA

Device Study Risk Determination Request

Protocol Development Resources

Checklists

Inquiries and Requests for Support

Please submit an ICTR Connection Request.

Guidance and Templates
FDA Formal Meeting Requests

IND Exemption Request

IND Application

Letters of Authorization/Right of Reference for INDs

IND Annual Reports

IND Protocol Amendments

IND Information Amendments

Protocol Development Resources

FDA Audit Preparation Resource

Compassionate Use-Individual IND Application

Inquiries and Requests for Support

Please submit an ICTR Connection Request.

The information resources compiled at the various links below are available for use by all investigators and project teams at no cost. Through these documents, the Research Navigators can provide answers to general regulatory questions as well as access to a list of Frequently Asked Questions, templates, and other guidance documents. The list of informational resources will continue to grow as the DDRS develops.

Click the links below for information, guidances, templates, and forms.

*Disclaimer

 

Description and Criteria

In cooperation with the Berman Institute of Bioethics, the ICTR provides a Research Ethics Consulting Service.

  • This service is available for free to Johns Hopkins faculty, staff, trainees* and students* from the Schools of Medicine, Nursing, Public Health, Engineering, and the Kennedy Krieger Institute.
  • The goal of this service is to help raise awareness of, and to assist investigators in resolving ethical issues in research.
  • Consults may be requested for an ethical issue arising during study development, conduct, analysis, or publication such as:
    • Conducting first-in-human trials;
    • Determining appropriate interventions to include in studies;
    • Maintaining confidentiality in recruitment;
    • Using alternative approaches to informed consent; and
    • Responding appropriately when an unforeseen event occurs during data collection.
  • The service is not designed to “pre-review” submissions to the IRB nor to review or draft consent documents.

*Students and trainees will be asked to submit consults with their academic advisor or the PI of the project on which they are seeking a consult. Medical trainees are encouraged to include their mentors when they submit a consult.

History

The Research Ethics Consulting Service (RECS) was officially launched in March 2005 in the Johns Hopkins Bloomberg School of Public Health (JHSPH) and proved to be highly successful (see: Taylor H, Kass N, IRB 2009; 31: 9-14). As such, the ICTR incorporated and expanded RECS to provide research ethics consultation across Johns Hopkins. There are currently seven consultants, all affiliated with the Berman Institute. The consultants have faculty appointments in the Johns Hopkins School of Medicine, School of Public Health, and the School of Nursing.

The Research Ethics Consult Service (RECS) is designed to assist investigators in resolving ethical issues in research. Researchers may request consults arising during study development, conduct, analysis, or publication. Thanks to ICTR funding, consults are free for all Johns Hopkins faculty, staff, trainees, and students.

Apply

To place a Research Ethics Consulting Service (RECS) request, click here.

The system requests a JHED log-in and links the user to the ICTR Connection Request system. Consults will be handled by appropriate Berman Institute of Bioethics faculty.

May 14, 2013
Translational Research Enhancement Core: Patient Registry, Clinical Info Systems and Tissue Repository
Jim Potter

April 16, 2013
Technology Trends at Johns Hopkins
Mike McCarty

March 19, 2013
*Presentation not available*
Bubbler
Sean Fahey

February 19, 2013
REDCap
Andre Hackman

January 15, 2013
De-identification Koans
Darren Lacey

December 11, 2012
The Lab Bench for Mobile Health
Henry Li, Michael Lin and Ralph Passarella

November 13, 2012
Johns Hopkins University Data Management Services
Dave Fearon, Tim DiLauro, and Betsy Gunia

October 9, 2012
An Introduction to Medicare and SEER-Medicare Data
Jodi Segal, MD, MPH

September 13, 2012
Research Architecture: Values, Aspirations & Challenges
Chris Shafer

June 28, 2012
*Presentation not available*
Epic Update
Rob Richardson, Timothy Morgan and Mark Inge

May 7, 2012
*Presentation not available*
Using Medical Imaging Data for Research at Hopkins
Jim Philbin, PhD

April 17, 2012
Data Security and Steps You Can Take to Protect Your Data
Darren Lacey

March 13, 2012
Excitement, Panic and Genomic Data
Sarah Wheelan, MD, PhD

February, 17, 2012
Enhancing Johns Hopkins Research Data Quality: Prioritizing the Steps Forward
Scott Zeger, PhD

January 24, 2012
Working with Your Statistician: How We Can Make Each Others’ Jobs Easier
Jeannie-Marie Leoutsakos, PhD, MHS

December 12, 2011
*Presentation not available*
Panel Discussion about EPIC Development and Data Standards
Diana Gumas, Alan Coltri, MS, and Peter Greene, MD

November 16, 2011
REDCap Handout
Andre Hackman
Faculty Research Associate, Biostatistics Center

October 10, 2011
*Presentation not available*
Darren Lacey
Chief Information Security Officer

September 13, 2011
Clinical Research Data & System Strategy Session

Clinical Research Management System (CRMS) IT Overview

Using EPR2020 for Clinical Research
Diana Gumas
Director of Clinical and Clinical Research IT

April 15, 2011
PI Summary Results
Daniel Ford, MD, MPH
Vice Dean for Clinical Investigation and Director, Institute for Clinical and Translational Research

Data Manager’s Survey Results
Kerry Stewart, Ed.D., FAHA, FAACVPR, FACSM, FSGC
Professor, Medicine and Director, Clinical and Research Exercise Physiology

Sharon Ghazarian, Ph.D.
Director, Bayview Biostatistics, Epidemiology and Data Management (BEAD) Core

A joint venture between the Johns Hopkins Bloomberg School of Public Health and the Johns Hopkins School of Medicine, GTPCI trains clinicians to be more effective clinical scientists.

Participants gain the skills necessary to design and conduct clinical investigations of emerging medical treatments and technologies, and to apply new diagnostic techniques and approaches to the study of human pathophysiology.

Students  work mostly with faculty, postdoctoral fellows and other allied health professionals working with human subjects in clinical investigation.

Graduates pursue careers in academia, and as independent clinical investigators at pharmaceutical firms and federal regulatory agencies.

340.655.01 INTRODUCTION TO CLINICAL RESEARCH (JULY 15 – 26, 2013) 
Epidemiology – Summer term
(6 units)
Co-Directors: Daniel Ford, MD, MPH and Karen Bandeen-Roche, PhD, MS
Contact Person: Roxanne Stambaugh2013 Registration opens on June 11, 2013 by contacting Roxanne Stambaugh at rstamba1@jhmi.edu.

 

 

Hand-outs and homework exercises provided at each session. Student evaluations are based on paired pre- and post-test of knowledge base.

Course learning objectives: Define a research question. Understand the steps involved in conducting clinical research. Review and evaluate the main study designs used in clinical research: case-control, cohort, clinical trials, cross-sectional, metanalyses. Understand the basis of statistical analyses of clinical research studies. Understand the methodological basis of diagnostic and prognostic testing. Prepare and review a research project.

Location: East Baltimore, 2024 E. Monument Street Suite 1-500Q
Class Times: 
Monday 9:00 – 4:30
Tuesday 9:00 – 4:30
Wednesday 9:00 – 4:30
Thursday 9:00 – 4:30
Friday 9:00 – 4:30Enrollment Minimum: 5
Enrollment Maximum: 50

Prerequisites: Prior submission of an abstract for a research project.
Grading Restriction:
 Pass/Fail
Special Comments:
 Participants need to register with the Course Coordinator, Roxanne Stambaugh, by emailing rstamba1@jhmi.edu.

ARE YOU A PRINCIPAL INVESTIGATOR OR RESEARCH COORDINATOR WHO NEEDS HELP POPULATING YOUR STUDY?

The Office of Recruitment and Retention Consulting Service is a no-cost resource designed to assist researchers in developing and evaluating plans to recruit and retain study participants. Researchers may also request assistance with studies in progress when experiencing difficulty in meeting recruitment or retention goals.

Our consultants can help you with issues like:

  • Developing a recruitment plan
  • Developing a concise description of your target population
  • Reaching out to target populations
  • Reaching out to minority or underserved populations
  • Budgeting for recruitment and retention efforts
  • Marketing and advertising
  • Tracking recruitment and retention
  • Participant incentives

ORR’s consulting services are offered directly to principal investigators and study coordinators in the Johns Hopkins research community. Students and staff are also welcome to use the service but should coordinate their requests through a faculty advisor or principal investigator.

If you would like to take advantage of the expert assistance and support of the ORR consultants, use your JHED I.D. to complete a service request form through ICTR’s Connection Request. Upon receipt, we will contact you within 2-3 business days to review your request.

  • To initiate contact with the DDRS, investigators or team members must complete and submit a Connection Request.

  • Submitting a Connection Request can be done by logging into the ICTR Connection Request website and selecting the DDRS service from the available options.

  • All Connection Requests received will be reviewed by the Research Navigators in the order received in order to determine the basic nature of the request.

  • Initial responses to Connection Requests can be expected within 5 to 7 working days, so please plan accordingly.

  • Requests for general information requests will be answered directly by the Research Navigators wtihin 5 to 7 working days. Individuals submitting requests may also be referred to the DDRS website for additional information and resources applicable to their inquiry.

     

  • An Intake Questionnaire form will be provided to investigators or study teams members who have Project-Specific Consultation requests.

  • This form allows the Research Navigators to collect more detailed information in order to fully assess the project prior to meeting with investigator/project team.

  • After the Intake Questionnaire is completed and returned, Research Navigators will review the information provided and identify potential regulatory issues, support needs, and develop a preliminary plan.

     

  • Next, the Research Navigators will send a Project Analysis and/or meet with investigator/project team. If a meeting, this may be in person or via teleconference.

  • It is at this point that the eight-hour free consultation clock will start and an effort tracking tool will be used by the Navigators to record time spent with each project received.

  • Prior to discussing their initial review of the project, the Research Navigators will provide the investigator with an overview of the Navigator role; explain the initial consultation period and present information about the regulatory support available on a fee-for-service basis once the complimentary consult period is concluded.

  • Throughout the course of the eight-hour consultation period, the Research Navigators will discuss any identified regulatory concerns, provide necessary guidances, templates and resources to the investigator as appropriate via telephone, email and in person meetings as per investigator request and Research Navigator availability.

     

  • As Research Navigator effort approaches the eight-hour cut-off point, the Navigators will contact the investigator to discuss need for additional support.

  • It would be at this point that the investigator will either 1) conclude consultation without additional support from the Project Specific Consultation Service or 2) engage the services of the Research Navigators with their own funds or 3) submit an application for scholarship funding.

  • The scholarship program is available to subsidize Project Specific Consultation Service fees of those investigators without sufficient financial resources to engage the service on their own and whose project merits support.

  • Each scholarship application will be reviewed by members of an oversight committee.

  • As there are limited funds for the scholarship program, the committee may suggest cost sharing with the department/division as appropriate.

  • If the investigator has decided to pursue additional project support via the DDRS service, the funding status of the investigator has been finalized (e.g., the investigators receives ICTR sponsored scholarship funding or has adequate independent funds) and the level of the fee-for-service support has been agreed upon, a mutually determined start date of the 12-month service period will be set and a service agreement letter outlining the terms and conditions of the services and the scope of Research Navigator work to be done will be sent to the investigator for signature.

     

General inquiries and requests for support

Please submit an ICTR Connection Request.

The Project-Specific Consultation Service includes a complimentary eight-hour consultation. Additional regulatory support beyond the eight hours can be obtained on a fee-for-service basis for a 12-month period with an option to renew.

What is a “project”?

A project is a single IND or IDE application. If an investigator wishes to utilize the Project Specific Consultation Service for more than one IND or IDE, he/she may do so.

Each IND or IDE will be considered a separate ‘project’ and each will be provided an eight-hour consultation period free of charge. If, after the eight-hour consultation period has ended, the investigator requests additional regulatory support, he/she will need to pay a service fee for each individual project.

Complimentary Consultation

During the complimentary eight-hour initial consultation period, Research Navigators investigate concerns presented by the user via the completed Intake Questionnaire, suggest appropriate templates, guidance documents, and facilitate consultation with other appropriate ICTR resources (e.g. Drug, Device, and Vaccine Development Core, Biostatistics Consultation Service).

Regulatory Support on a ‘Fee-For-Service’ basis

There are three levels of regulatory support available to investigators via the DDRS at fee-for-service rates. Each service level offers a different degree of regulatory support and hands-on involvement by the Research Navigators.

Inquiries and Requests for Support

Please submit an ICTR Connection Request.

For more in-depth information about how the DDRS consultations work, please see below.

Director

DANIEL E. FORD, MD, MPH
Vice Dean for Clinical Investigation
Johns Hopkins School of Medicine

Co-Director

SCOTT ZEGER
Vice Provost for Research
Johns Hopkins University

Deputy Directors

KAREN BANDEEN-ROCHE, PHD, MS
ICTR Deputy Director for Biostatistics and Research Design
Program Director, Biostatistics Center

CHERYL DENNISON HIMMELFARB, PHD, RN, ANP
ICTR Deputy Director for Interdisciplinary Research
Program Director, ICTR Office of Recruitment and Retention

STEVE DESIDERIO, MD, PHD
ICTR Deputy Director for Basic Science Translational Research

CHARLES FLEXNER, MD
ICTR Deputy Director for Clinical Research Resources and Facilities
Program Director, ICTR Clinical Research Units

EDGAR “PETE” MILLER III, MD, PHD
ICTR Deputy Director for Clinical Research Education, Training and Career Development

ELIZABETH JAFFEE, MD, PHD
ICTR Deputy Director for Translational Technology

PAMELA OUYANG, MBBS
ICTR Deputy Director for the Bayview Medical Center
Associate Program Director, ICTR Clinical Research Units

JEFFREY D. ROTHSTEIN MD, PHD
ICTR Deputy Director for Pilot Research Initiatives
Director, ICTR Accelerated Translational Incubator Pilot (ATIP) Program

S. DARIUS TANDON, PHD
ICTR Deputy Director for Community Engagement

PAMELA ZEITLIN, MD, PHD
ICTR Deputy Director for Pediatric Research
Associate Program Director, ICTR Clinical Research Units

Administrative Staff

ADMINISTRATIIVE DIRECTOR
Gerald Stacy

ADMINISTRATIVE MANAGER
Roxanne Stambaugh

EXECUTIVE ASSISTANT
Irene Turner, MA

ADMINISTRATIVE COORDINATOR
Kelly Crowley

COMMUNICATIONS COORDINATOR
Crystal Williams

RESEARCH NAVIGATOR
Linda Post, RN, CCRP

If you are a research team member who schedules patients in the Clinical Research Units using the new Epic system, the ICTR’s Matthew Courtemanche has recorded a brief demonstration video that walks you through the scheduling process, step by step. To view the video click below:

https://ictrweb.johnshopkins.edu/ictr/epic_demo/

The Johns Hopkins University School of Medicine and Bloomberg School of Public Health’s Graduate Training Programs in Clinical Investigation are accepting registrations for the Science of Clinical Investigation (SOCI) Award Program.

Aimed at scientists, clinicians, and support personnel fully engaged in clinical investigation or its regulation, this five course award program is designed to support translational clinical research by teaching the necessary skills to design, analyze, and interpret clinical investigations and implement studies in compliance with ethical and regulatory norms.

Click here for a flyer with more information about this innovative program.

The ICTR Study Coordinator Apprenticeship and Mentoring Program (SCAMP) is a two year internship program that trains inexperienced individuals to become study coordinators. This unique program will consist of several components: an educational component, a resource component, and a staff networking component.

The educational component of the program will provide the study coordinator apprentices with a structured training program utilizing the ICTR’s educational programs, clinical infrastructure and expert consultative resources. The apprentices will shadow experienced study coordinators and clinic staff providing a hands-on training experience for these new study coordinator apprentices. They will also gain first-hand experience working as study coordinators for teams throughout the Johns Hopkins Institution, providing them the opportunity to hone their study coordination skills over multiple research studies, all while under the oversight of the SCAMP manager.

As mentioned above, the program will create a pool of study coordinator who will be available to be hired on a part time basis by Johns Hopkins faculty and staff. These apprentices will be available on a free and low-cost basis, which will make the process of finding a part time coordinator easier, as well as provide junior faculty with smaller projects, or even seasoned investigators with pilot studies study coordinator support.

SCAMP will also help to develop the community of research support staff throughout Johns Hopkins, by providing monthly educational session, as well as networking and problem solving sessions open to all research staff at any of the Johns Hopkins Institutes.

To view a lecture detailing this program, click the link below.
https://connect.johnshopkins.edu/p5u78w8dlje/

 

photo of Sandra Heineken, BSN, RN, OCN

Manager of Oncology Clinical Research, Richard A. Henson Cancer Institute PRMC

Sandra “Sandy” Heineken, BSN, RN, OCN, is the Manager of Oncology Clinical Research at the Richard A. Henson Cancer Institute at Peninsula Regional Medical Center (PRMC).

As an Eastern Shore native, Sandy has a personal commitment to PRMC and its oncology program at the Richard A. Henson Cancer Institute. Upon graduation from Salisbury State College, now Salisbury University, she embarked upon her career at PRMC. After three years working as a staff RN on a Medical-Surgical floor, she transferred to Radiation Oncology as a radiation oncology nurse and remained in that position until her family relocated to Charlotte, North Carolina.

Pursuing her interest in oncology, she continued working in the field, only this time as a research nurse at Carolinas Medical Center. This position helped to expand her knowledge of cancer and now a new field – oncology clinical trials. Ultimately, this allowed her to return to PRMC as Manager of Oncology Research.

At Peninsula Regional, she is currently responsible for all oncology research activities including Cooperative Group as well as pharmaceutical studies. The position allows patient contact, which she particularly enjoys, and the opportunity to provide patients with cutting edge treatment – which Sandy describes as very rewarding.

Especially exciting now is the collaboration of PRMC with Johns Hopkins via the Johns Hopkins Clinical Research Network (JHCRN) which will allow Delmarva residents access to additional and new clinical trials. Recognizing the importance of research and the impact this will have on Delmarva Peninsula residents, Sandy is extremely proud to be a part of this network and the PRMC staff.

photo of Bennett W. Yu, MD

Director of Oncology Clinical Research, Richard A. Henson Cancer Institute, PRMC

Bennett W. Yu, MD, a specialist in Hematology and Medical Oncology, Joined Peninsula Regional Oncology and Hematology at Peninsula Regional Medical Center in Salisbury, Maryland in March of 2007.

Dr. Yu received his medical degree from the University of Michigan School of Medicine in Ann Arbor, Michigan. He completed an internship and residency in Internal Medicine at Albany Medical Center Hospital, Albany Medical College in Albany, New York. Dr. Yu also completed a research fellowship in Hematology at Albany Veterans Hospital in Albany, a hematology fellowship at the University of Virginia School of Medicine in Charlottesville, Virginia and a medical staff fellowship in Medical Oncology at the National Cancer Institute of the National Institute of Health in Bethesda, Maryland, where he also served as a senior clinical investigator.

Dr. Yu has also been a member of the medical staff of the Josephine Ford Cancer Center at Henry Ford Hospital in Detroit, Michigan, and has served as an assistant professor at both Wayne State University in Detroit and at the Eastern Virginia Medical School in Norfolk, Virginia. Before joining PRMC he was the Director of Oncology Therapeutics at Wyeth Research in Cambridge, Massachusetts.

Dr. Yu is board-certified in Internal Medicine, Hematology and Oncology by the American Board of Internal Medicine. In addition to his practice role, Dr. Yu serves as the Medical Director of Oncology Research at Peninsula Regional Medical Center.

With Dr. Yu expertise, Peninsula Regional has expanded the clinical trials it currently offers patients at its Richard A. Henson Cancer Institute.

photo of Timothy Feist, MSW, MBA, FACHE

Vice President of Performance Improvement and Safety Officer, PRMC

Tim Feist, Vice President of Performance Improvement and Safety Officer, joined Peninsula Regional in September 1985. He is currently responsible for and provides leadership to the Richard A. Henson Cancer Institute, and the departments of Clinical Performance Improvement, Infection Prevention, Service Excellence-Risk Management, Health Information Management, Medical Imaging and Case Management Services.

Tim holds a Bachelors Degree from Penn State University, a Masters from Pitt in Social Work and his MBA from Wilmington College and is a Fellow in the American College of Healthcare Executives.

Tim is extremely active in the local community serving as a past President of the Salisbury Area Chamber of Commerce and current President of the United Way of the Lower Eastern Shore.

He has previously served Peninsula Regional as its Executive Director of Performance Improvement, Director of Social Work and Addiction Services and Director of Satellite Health Services.

photo of Thomas Lawrence, MD, MBA

Vice President and Chief Medical Officer, PRMC

Chairman, Board of Maryland eCare

Thomas Lawrence, MD, MBA, Vice President and Chief Medical Officer of the Peninsula Regional Medical Group, provides executive leadership to a growing practice of over 70 physicians and 200 staff in three states who practice in multiple specialties including family medicine, endocrinology, cardiovascular surgery, gastrointestinal medicine, pulmonology, neurosurgery, occupational health, urgent care, oncology and hematology, and the hospitalists who manage patients while in the Medical Center.

Dr. Lawrence is also responsible for evaluating potential development opportunities in the expansion of PRMC ambulatory services, clinical information technology integration between medical practices and Peninsula Regional, medically-based wellness programs, a medical residency program and leading the exploration and creation of a medical education program to serve the needs of the Delmarva Peninsula.

Dr. Lawrence is the Chairman of the Board of Maryland eCare, a collaborative of six rural Maryland hospitals that have engaged the services of intensivists to remotely monitor and address the clinical concerns of ICU patients. He also developed and has overall responsibility for PRMC’s clinical relationship with DC Children’s National Medical Center, which provides for coverage of Peninsula Regional’s NICU and pediatric inpatient hospitalist services.

Dr. Lawrence is a graduate of the Medical College of Virginia and has been with Peninsula Regional Medical Center since 1999.

Ms. Gity Porjosh is currently the Research Director for the Inova Research Center (IRC). In this capacity, she directs and oversees the Inova Research Center operations for Inova Health System. She leads a team of professional research staff who develops and implements policies and procedures to support an academically productive research portfolio for multiple programs across the Health System. She is responsible for appropriate functioning of the Institutional Review Board and ongoing training within the IRC to ensure compliance with all regulations governing the conduct of research studies.

Prior to coming to Inova Health System, Ms. Porjosh was the Project Manager at EMMES Corporation in Rockville, Maryland. She directed and oversaw the work of a team of data managers, protocol monitors, programmers and administrative coordinators for two National Cancer Institute (NCI)-sponsored projects as well as a National Institute of Dental and Craniofacial Research (NIDCR) project. While at EMMES she was appointed to the Corporation Institutional Review Board. She has worked with both public and private sector study sponsors to monitor trials, conduct site audits, generate reports for Data Safety and Monitoring Boards, and define project goals, timeline and endpoints. She holds an MPH from George Washington University and an MBA from Virginia Polytechnic Institute and State University.

Zobair M. Younossi, M.D. is currently the Executive Vice President for Research at Inova Health System and the Chairman of the Department of Medicine at Inova Fairfax Hospital. He also is also Professor of Medicine at Virginia Commonwealth University and an Affiliate Professor of Biomedical Sciences at George Mason University where he serves as Co-Director of the Center for the Study of Genomics in Liver Disease. Dr. Younossi is a nationally recognized leader specializing in hepatology and gastroenterology. He is Board certified in Internal Medicine, Gastroenterology and Transplant Hepatology. His distinguished career includes positions at the Cleveland Clinic Foundation, and the Mellon Institute. He was recognized in 2011 in Best Doctors in America. In 2008 he was appointed by Governor Tim Kaine to the Virginia Biotechnology Research Partnership Authority.

Dr. Younossi’s clinical research focuses on chronic liver disease specifically biomarker discovery, detection and management of non-alcoholic fatty liver disease, Hepatitis B and C. He is also recognized for his work on non-alcoholic fatty liver disease and obesity. His experience in scientific publishing includes being associate editor for Evidence Based Gastroenterology, former associate editor of Liver International, and editorial board member and journal reviewer for Hepatology. He has also worked with many other journals in the areas of hepatology, gastroenterology, internal medicine, and with prominent publications such as The American Journal of Medicine and Journal of American Medical Association. He has authored over 225 articles and book chapters in his field.

photo of Janet Mighty, BS, MBA

Pharmacy Support Services, JHCRN

Janet L. Mighty is Assistant Director of the Investigational Drug Service at The Johns Hopkins Hospital (JHH). As a member of the JHH Department of Pharmacy leadership team she oversees comprehensive pharmacy services that support clinical research. She joined JHH in 1990 in the Investigational Drug Service and has continued to focus in this area. She leads a team of pharmacists and pharmacy technicians that support various functions to support clinical research such as protocol review and management, study drug inventory management, protocol compliance auditing, financial management of protocols and representation on various research related committees. She is a member of the Johns Hopkins Clinical Research Network (JHCRN) Executive Committee and the Working Group and is a liaison to the network pharmacies.

photo of Timothy Pawlik, MD, MPH

Associate Professor of Surgery and Oncology, Johns Hopkins University, School of Medicine

Hepatobiliary Surgery Program Director

Director, Johns Hopkins Medicine Liver Tumor Center

Timothy M. Pawlik is currently Associate Professor of Surgery and Oncology, the Hepatobiliary Surgery Program Director, and Director of the Johns Hopkins Medicine Liver Tumor Center. He is a Fellow of the American College of Surgeons. Dr. Pawlik serves as the Co-Director of the Center for Surgical Trials and Outcomes Research within the Department of Surgery. The Center helps facilitate surgical investigators in the design and implementation of clinical trials. Dr. Pawlik also currently serves as Associate Program Director of the Johns Hopkins Clinical Research Network with a focus in facilitating surgical clinical trials for the JHCRN.

Dr. Pawlik received his undergraduate degree from Georgetown University and his medical degree from Tufts University School of Medicine. He completed his surgical training at the University of Michigan Hospital and spent two years at Massachusetts General Hospital as a surgical oncology research fellow. Dr. Pawlik went on for advanced training in surgical oncology at the University of Texas M. D. Anderson Cancer Center in Houston. He also completed a fellowship in medical ethics at the Harvard School of Public Health as well as a Masters in Theology from Harvard Divinity School in Boston.

Dr. Pawlik’s main clinical interests include alimentary tract surgery, with a special interest in hepatic and pancreatobiliary diseases. He has published over 125 peer-reviewed articles and 15 book chapters. He is a frequent national and international lecturer on management of hepatobiliary malignancies. Dr. Pawlik has served on the American Society of Clinical Oncology (ASCO) and American College of Surgeons Oncology Group (ACOSOG) Ethics committees, ACOSOG By-Laws committee, Association of Academic Surgery executive council, as well as on the Scientific Program Committee for ASCO. Dr. Pawlik has also served on the Society of Surgical Oncology Scientific Program Committee, as well as was recently elected Councilor-at-Large.

The ICTR Community Engagement Program supports a consultation service to provide guidance to researchers and community partners seeking expert advice, feedback, and training on how to engage communities around research and evaluation.

This service is free and available to Johns Hopkins faculty, staff, students; as well as service providers and community leaders from organizations throughout Greater Baltimore. While a main focus of the ICTR is on research conducted throughout Greater Baltimore, consultations can take place for projects conducted with communities outside of Greater Baltimore.

To apply for this service, go to http://ictrweb.johnshopkins.edu/ictr/connection. You will be asked for your JHED I.D. to proceed.

Community-engaged research is an approach to research characterized by partnership between researchers and communities throughout the duration of a research project and a commitment to addressing identified health issues.

The Community Engagement Core of the ICTR is focused on promoting community-engaged research conducted by researchers and various community partners—including, but not limited to, community-based organizations, health and social service providers, and public agencies.

 

photo of Stanley Watkins, MD

Associate Professor of Clinical Oncology, Johns Hopkins Hospital

Medical Director of the Research Institute, Anne Arundel Medical Center, Annapolis

Dr. Stanley Watkins was born in Baltimore, Maryland. He attended Cornell University and the University of Cincinnati College of Medicine. He served as a medical intern at the University of Texas, Parkland Memorial Hospital in Dallas, Texas, and then spent three years as a research associate at the National Institutes of Health in Bethesda, Maryland. He then served a Medical Residency and Hematology and Oncology Fellowship at the University of Washington, Seattle, Washington. He joined this practice in Annapolis in 1970. He is currently an Associate Professor of Clinical Oncology at Johns Hopkins Hospital and Medical Director of the Research Institute at Anne Arundel Medical Center in Annapolis. Dr. Watkins is board certified in Internal Medicine, Hematology and Medical Oncology.

photo of Dr. Joe Moser

Senior Vice President for Medical Affairs, Anne Arundel Medical Center (AAMC)

AAMC Director, Johns Hopkins Clinical Research Network

Joseph D. “Joe” Moser, MD, is senior vice president for medical affairs at the Anne Arundel Medical Center (AAMC), where he supports Medical Staff activities and leadership initiatives and oversees the Medical Staff Office, Credentials Office, performance improvement (QA), outcomes data analysis, patient safety, and Pharmacy, Coding and Health Information Services (Medical Records). He also has some strategic planning roles within the administration, including serving on the Administrative Executive Board and the Strategic Planning Board, and is also currently head of the Anne Arundel Health System Research Institute.

Prior to his present position, he was in private practice in Obstetrics and Gynecology from 1975 to 1996. He served as chief of Obstetrics and Gynecology for four years from 1986-1990, and as Medical Staff secretary-treasurer and then vice president from 1990-94. He was president of the medical staff from 1994-96.

A native of Washington, D.C., Dr. Moser received his M.D. from the University of Maryland in 1972.

photo of Dr. Peggy Naleppa

President/CEO
Peninsula Regional Medical Center and Peninsula Regional Health System

Dr. Peggy Naleppa began her health care career as Director of Neurosurgical Services at George Washington University Medical Center in Washington, DC. She has served as a clinical leader or as a senior executive at several hospitals in Maryland including: Anne Arundel Medical Center, Calvert Memorial Hospital and St. Mary’s Hospital. She has served as President of the Maryland Chapter of the Healthcare Financial Management Association (HFMA) and has held several leadership positions with the Maryland Hospital Association. Dr. Naleppa is also a Fellow of the American College of Healthcare Executives.

Dr. Naleppa, who is a registered nurse, holds a BS in Healthcare Administration from St. Joseph’s College; a Master of Administration degree with a concentration in Finance from the University of Maryland University College; an MBA, with a concentration in medical services from Johns Hopkins University and a Doctorate in Management with a concentration in organizational process management from the University of Maryland University College.

Dr. Naleppa has a 30 plus year history as a healthcare executive and is the President/CEO of Peninsula Regional Medical Center (PRMC) and the Peninsula Regional Health System in Salisbury, Maryland.

In 2011, Dr. Naleppa was named one of Maryland’s Top 100 Women by the Baltimore-based The Daily Record newspaper for her outstanding achievements and contributions to Maryland healthcare, and one of the “56 Women Hospital and Healthcare Leaders to Know,” by the prestigious Becker’s Hospital Review. She and her husband Dan live in Salisbury and are the parents of two daughters, Adrienne and Renee and the proud grandparents of one granddaughter, Addison.

photo of James H. Mersey, MD

Director, Geckle Diabetes and Nutrition Center, GBMC

Dr. Mersey went to Johns Hopkins Medical School, and spent 3 years in a medical residency at Johns Hopkins. He completed a fellowship in Endocrinology at Peter Bent Brigham Hospital in Boston. He then spent 11 years on the full-time faculty at the University of Maryland. He is now in private practice and the chief of Endocrinology at Greater Baltimore Medical Center. In addition he retains faculty appointments at University of Maryland and Johns Hopkins. Dr. Mersey is a fellow of the American College of Physicians and the American College of Endocrinology. Dr. Mersey and his associates are actively involved in clinical research in diabetes, hypertension, lipid disorders and osteoporosis. He also teaches house staff and fellows and directs the Geckle Diabetes Center at GBMC.

photo of Dr. Gary Cohen

Director of the Sandra and Malcolm Berman Cancer Institute, GBMC

Assistant Professor of Oncology, Johns Hopkins School of Medicine

GBMC Director, Johns Hopkins Clinical Research Network

Dr. Gary Cohen is currently the Director of the Sandra and Malcolm Berman Cancer Institute at Greater Baltimore Medical Center (GBMC). He completed his undergraduate training at Duke University and attended medical school at the University of Maryland. He subsequently completed his fellowship training in medical oncology at the Dana Farber Cancer Institute of Harvard University. He remained on the staff at Harvard to pursue his research interest in bone marrow cell growth. During that time he also completed a fellowship in hematology. He currently holds an appointment as Assistant Professor in the Department of Oncology at The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. He is board certified in internal medicine, medical oncology, and hematology, and is a Fellow of the American College of Physicians.

Dr. Cohen established The Cancer Center at GBMC after being appointed Director in 1990. The Center has been listed by US News and World Report as one of the top 50 cancer programs in the U.S.He has won teaching awards from the housestaff at both Sinai and GBMC. He has co-authored numerous articles in the medical literature on various aspects of clinical cancer research. Dr. Cohen has been an active participant in the Eastern Cooperative Oncology Group (ECOG), a national cooperative clinical trials group, and chairs the Community Scientific Committee. He also serves as community co-chair of the ECOG Melanoma Committee. He has served on many committees and boards for health related organizations including the Board of Directors of Gilchrist Hospice in Baltimore. He currently serves as Administrative Director of the Sidney Kimmel Foundation for Cancer Research, which awards over $3 million dollars per year to outstanding young cancer scientists. Dr. Cohen has consistently been listed in the physician survey by Baltimore Magazine as “Best in Baltimore” for Medical Oncology.

photo of Dr. Paul Celano

Chief of the Division of Medical Oncology, GBMC

President, Maryland/DC Society of Clinical Oncology

Assistant Professor of Oncology and Gynecology and Obstetrics, Johns Hopkins School of Medicine

Dr. Paul Celano is currently Chief of the Division of Medical Oncology at Greater Baltimore Medical Center where he holds a special interest in treating gynecologic, genitourinary, gastrointestinal, and breast malignancies and also leads the oncology clinical trials program. He completed his medical training at Mount Sinai School of Medicine in New York and then subsequently completed his fellowship in oncology at the Johns Hopkins University School of Medicine and served on the full time faculty prior to joining GBMC.

Dr. Celano is also an Assistant Professor of Oncology and of Gynecology and Obstetrics at Johns Hopkins School of Medicine. He serves on the JHU SOM Advisory Committee for part time faculty where he contributes to the committee’s mission to enhance part-time faculty involvement in Johns Hopkins Medicine teaching, research, and patient care.

Dr. Celano serves as the President of the Maryland/DC Society of Clinical Oncology, where he leads the mission to improve the quality and delivery of care in medical oncology in Maryland and DC, promotes appropriate standards of care in oncology, and cooperates with investigators conducting cancer research. He also leads their mission to educate the public, the government, insurance carriers, and other health care providers about appropriate prevention of cancer and current therapeutic options for patients with cancer.

Dr. Celano has received numerous awards and honors for his work in cancer research and clinical care and has been recognized as on of Baltimore’s “Top Doctors” in Baltimore Magazine for numerous years.

photo of Julie Brahmer, MD

Associate Professor of Oncology, Johns Hopkins University, School of Medicine

Associate Program Director, Johns Hopkins Clinical Research Network

Julie Brahmer currently serves as an associate professor of oncology at the Johns Hopkins University School of Medicine. She completed her medical training at the University of Nebraska Medical Center, then subsequently completed her fellowship in oncology at the Johns Hopkins School of Medicine.

Dr. Brahmer’s research and clinical practice focuses on the development of new therapies for the treatment and prevention of lung cancer and mesothelioma. Dr. Brahmer has published several papers in this area of research and is a member of the American Society of Clinical Oncology and the Eastern Cooperative Oncology Group (ECOG) Thoracic Committee and Cancer Prevention Steering Committee. She is one of the founding board members for the National Lung Cancer Partnership (formerly Women Against Lung Cancer). Within the National Lung Cancer Partnership, she currently serves as a member and the Chairman of the Scientific Executive Committee. She is also on the medical advisory board of the Lung Cancer Research Fund and the Mesothelioma Applied Research Foundation.

Dr. Brahmer currently serves as an associate program director of the Johns Hopkins Clinical Research Network with responsibility for developing clinical trials in oncology within the JHCRN. She plays an active role in collaborating with investigators at JHU and JHCRN affiliated institutions and in communicating with industry sponsors to educate and encourage relationships with the JHCRN. She has also mediated collaborations between other various oncologists at JHU and affiliate institutions which have led to numerous, successful collaborative project efforts thus far.

photo of Charmaine Cummings, RN, PhD

Educational Consultant, JHCRN

In addition to her role in the JHCRN, Charmaine J. Cummings recently joined Rockpointe Corporation, a science-based medical education company, as director of Oncology Education and Alliances. In this position she develops collaborative relationships with oncology societies both national and local to implement CME programs.

Dr. Cummings brings more than three decades of experience in the clinical, academic developmental, and program management aspects of continuing education to her position. As an experienced nurse, she fully understands the science of oncology and the treatment and research processes inherent in patient care. As an academician, she combines her clinical experience with her doctoral training in continuing education to develop curricula and methods of instruction that target the needs of specific health care audiences. As a program developer, she brings her well-honed skills as an educational designer—generating ACCME-approved continuing education programs from idea to implementation–by providing content in such areas as neuroscience, oncology, and palliative care within the context of a broad range of instructional methods and media.

Dr. Cummings has a continuously expanding pool of thought leaders to call on for collaboration to ensure content appropriateness and successful educational/training outcomes. As a program administrator, she has been at the helm of large and multiple departments in hospitals, government agencies (eg, the National Institutes of Health), and professional organizations (eg, the American Society of Clinical Oncology, the National Cancer Institute, and the American College of Radiology), efficiently managing budgets as large as $10 million for continuing education programs in the United States and abroad.

photo of Daniel Ford, MD, MPH

Director, Johns Hopkins Institute for Clinical and Translational Research
David M Levine Professor of Medicine

Vice Dean for Clinical Research in the Johns Hopkins School of Medicine

Daniel Ford, MD, MPH is the David M Levine Professor of Medicine who came to Johns Hopkins in 1982 to complete the Osler Medicine residency. After completing a fellowship in Clinical Epidemiology at the National Institute for Mental Health and his Masters of Public Health at Johns Hopkins, he joined the faculty and developed his approach to research as a member of the Welch Center for Prevention, Epidemiology and Clinical Research. He has joint appointments in Psychiatry, Epidemiology, Health Policy and Management and Nursing.

In 2005 he was appointed to be the Vice Dean for Clinical Research in the Johns Hopkins School of Medicine. As part of this role, he is the Institutional Official in charge of protection of human subjects for Johns Hopkins Medicine and the IRB committees. In recognition of his commitment to supporting clinical and translational research across the institution he was chosen to be the Principal Investigator of the CTSA grant and the first Director of the Johns Hopkins Institute for Clinical and Translational Research. Many trainees are introduced to Dr. Ford as the Director of the 2 week Introduction to Clinical Research course held each July.

Dr. Ford’s research has focused on understanding the relationships between depression and chronic medical conditions, particularly coronary artery disease, and how to improve care for patients with medical comorbidity. He was one of the first investigators to publish data documenting depression as a risk factor for myocardial infarction and stroke. In the spirit of translation, he has also sustained an interest in how to utilize Information Technology (IT) to improve care of patients with depression and tobacco abuse. Moving these interventions into the commercial world has been part of this process.

Dr. Ford has broad interests and is always willing to work with research teams and patient groups to learn more about the challenges they face and how we can address barriers as efficiently and effectively as possible.

Click the links below to learn more about the ICTR CRU services housed in our Broadway facility:

Click the links below to learn more about the ICTR CRU services housed in our Broadway facility:

Click the links below to learn more about the ICTR CRU services housed in our Broadway facility:

Click the links below to learn more about the ICTR CRU services housed in our Bayview facility:

Click the links below to learn more about the ICTR CRU services housed in our Green Spring facility:

Click the links below to learn more about the ICTR CRU services housed in our Broadway facility:

The mission of the ICTR Drug and Device Resource Service (DDRS) is to provide Johns Hopkins University investigators and project teams access to resources needed to help manage the development and use of investigational drugs and devices in research. The DDRS is comprised of an investigational drug, biologics, and device information repository (Resources) with a Project-Specific Consultation Service available for those who seek a higher level of assistance with management of the regulatory requirements of their research projects.

*Disclaimer

For assistance, please submit an ICTR Connection Request .

To learn more about the consultation service and available resources, click the links below.

Exercise physiology facilities are available to investigators at the
Johns Hopkins Health Care and Surgery Center at Green Spring Station in Lutherville, Maryland.


The exercise physiology facilities are available in the outpatient center at Green Spring and are coordinated by Kerry Stewart, EdD, director of clinical and research exercise physiology.

For more information contact:

Kerry Stewart, EdD
Phone: 410-550-0870
Email: kstewart@jhmi.edu

Services Housed at Green Spring Station

Exercise Physiology and Body Composition

The ICTR Bayview Clinical Research Unit (Bayview CRU) is located on the 4th Floor of 301 Mason Lord Drive on the Johns Hopkins Bayview Campus. This unit includes both outpatient space and beds for conducting overnight studies.

The 14,300 square-foot Bayview CRU provides full-service outpatient and inpatient facilities, with an emphasis on cardiovascular and sleep studies. Bayview also has strong laboratory core services (Core Laboratory for research assays, Cardiovascular Core, Body Composition Core). Exercise physiology facilities are also available.

To learn more about services and resources available at the Bayview CRU, click the links below.

The Neurobehavioral Research Unit (NBRU) is located on the Broadway (main medical) campus at the Kennedy Krieger Institute (KKI).

The NBRU is dedicated to research on disorders of the developing central nervous system. Inpatient scatter research beds are available for subjects who cannot be safely managed on other CRUs. Outpatient clinical evaluations are available for protocols requiring such data.

The unit provides special expertise in functional imaging, including a new 7.0 Tesla MRI scanner. Within the NBRU, the Kirby Center provides access to MRI support exclusively for research. The Center also houses two 3T scanners, three animal scanners, and a the Brain Imaging Library.

Beds in the Brain Injury Unit (BIU) are available for patients requiring intensive neurorehabilitation as the result of acute head injury, including those in coma. This unit is the primary acute brain injury resource in the region, and because of the close proximity to the neuroimaging center two floors below, imaging studies with this population can be safely carried out.

To learn more about services and resources available at the Neurobehavioral Research Unit, click the links below.

The Broadway Adult Inpatient Unit is located on the fifth floor of the Osler building in the Johns Hopkins Hospital on the main medical (E. Baltimore) campus.

The unit provides scheduled access to as many as 14 inpatient research beds on a general medical floor that includes capacity for continuous cardiac monitoring and biological isolation of subjects receiving potentially infectious agents.

A full-time clinical research nurse manager is assisted by Johns Hopkins Hospital staff nurses who are trained in research procedures and attend in-service orientations for all ICTR-supported protocols.

To learn more about services and resources available at the Broadway Adult Inpatient Unit, click the links below.

The Broadway Adult Outpatient CRU in located on the third floor of the Carnegie Building of the Johns Hopkins Hospital on the Broadway (main medical) campus.

The unit includes nine full-service exam rooms, two interview rooms, a phlebotomy room, sample processing lab, a -70 &deg F freezer, an infusion center, and a DXA scanner.

Full-time clinic support staff include three registered research nurses, as well as a phlebotomist and technicians. The unit staff assist investigators with protocol specific evaluations as requested (including vital signs, collection and processing of biologic specimens and administration of questionnaires.) Qualified nurses administer protocol guided medications for ICTR-approved protocols.

The unit also offers tutorials on creating research order sets and other study-related paperwork for investigators.

To learn more about services and resources available at the Broadway Adult Outpatient Unit, click the links below.

The Pediatric CRU (PCRU) is located on the ninth floor of the new Charlotte R. Bloomberg Children’s Center on the main medical (E. Baltimore) campus and provides both inpatient and outpatient pediatric care.

The PCRU includes a 7-bed inpatient unit, a 4-room outpatient clinic, a multi-purpose procedure room, pediatric phlebotomy laboratory, spirometry, metabolic formula room, and pediatric sleep lab. Pediatric-oriented nursing support and child life services are also provided.

To learn more about services and resources available at the Pediatric Clinical Research Unit, click the links below.

 

The ICTR Clinical Research Units (CRUs) and associated services are designed to support a wide range of clinical research at Johns Hopkins. From pilot studies to multi-center trials, the CRUs are available for investigators who need outpatient, inpatient, adult, pediatric, or neurological services.

To contact the ICTR CRUs, email CRUs@jhmi.edu or call 410-614-2717.

The ICTR CRUs are part of the Johns Hopkins Institute for Clinical and Translational Research (ICTR), which is funded by the National Institutes of Health as part of a consortium of Clinical and Translational Science Awards.

The ICTR Biomedical Informatics group concentrates on identifying gaps in current research IT services within the Johns Hopkins environment and creating strategies for filling these gaps. By using CTSA funds to leverage institutional resources to provide for these needs as identified by investigators and the committee, the entire research enterprise is benefitting through both the improvement of existing resources and the creation of new, enterprise-wide tools.

The group coordinates and/or supports the Clinical Research Management System (CRMS); the EPR2020 clinical data repository; the caTissue specimen tracking system, the Center for Clinical Data Analysis Services, the Center for Computational Genomics (genomics.jhu.edu); and the implementation and improvement of SciVal Experts.

For more information contact:

Harold Lehmann, MD, PhD
Director of Research and Training, Division of Health Sciences Informatics, JHU School of Medicine
Phone: 410-502-7569
Email: Lehmann@jhmi.edu

About the ICTR Community Engagement Program

The overarching goal of the ICTR Community Engagement Program is to promote the meaningful involvement of communities in translational research. The program maintains the Community Research Advisory Council (C-RAC), provides health and research information to the community, and coordinates a community engagement consulting service for researchers.

photo of Stephen Desiderio, MD, PhD

ICTR Deputy Director for Clinical Research Education, Training, and Career Development
ICTR Director, Clinical Research Scholars Program
Associate Professor of Medicine, Division of General Internal Medicine, Johns Hopkins University School of Medicine
Associate Professor of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University
Core Faculty, Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Medical Institutions

Dr. Miller is a staff clinician for the University Health Service at Johns Hopkins Hospital and an associate professor of medicine at the Johns Hopkins University School of Medicine in the Division of General Internal Medicine, with a joint appointment in epidemiology at the Johns Hopkins Bloomberg School of Public Health. He is also part of the core faculty of the Welch Center for Prevention, Epidemiology, and Clinical Research.

An authority on nutrition, hypertension and kidney disease, Dr. Miller arrived at Hopkins as a research fellow in 1994 and has remained active as a clinician, researcher, and educator. His active clinical involvement, coupled with his research interests in nutrition, hypertension, and kidney disease, make him the ideal person to direct the ICTR’s educational and training efforts.

As Deputy Director for Clinical Research Education, Training, and Career Development for the ICTR, Dr. Miller is responsible for the Predoctoral Clinical Research Training Program, which provides short- and long-term training for students interested in pursuing a career in clinical and translational research; and the Clinical Research Scholars Program, a two-year research fellowship through the postdoctoral (KL) training program for postdoctoral fellows and junior faculty.

Education and Training

  • BA (Science), Pennsylvania State University, State College, PA, 1979
  • MA (Oceanography and Limnology), Western Connecticut State University, Danbury, CT, 1981
  • PhD (Marine Ecology), University of Connecticut, Storrs, CT, 1988
  • MD, Jefferson Medical College, Philadelphia, PA, 1992
  • Internship and Residency (Internal Medicine, Clinical Investigator Program), Medical University of South Carolina, Charleston, SC, 1992-94
  • Research Fellow (General Internal Medicine), Johns Hopkins Hospital, Baltimore, MD, 1994-96

Accomplishments, Recognition, and Service

Dr. Miller has published more than 75 manuscripts in peer-reviewed journals and has also authored numerous book chapters, reviews, and invited articles. He has served as a reviewer for many journals, such as Ethnicity and Disease, American Journal of Clinical Nutrition and JAMA, and was associate editor for the Journal of General Internal Medicine from 2003-2005. He is a member of several professional societies, including the American Heart Association, the American Society of Hypertension, the American Society of Nephrology, and the Society of General Internal Medicine.

Dr. Miller’s commitment to clinical and research education is evident in his role as ICTR Deputy Director for Clinical Research education, Training, and Career Development. Throughout his career, he has mentored, advised, and served on committees for a long list of students and was selected as Outstanding Clinical Investigator Mentor by the Fellows of the Division of General Internal Medicine in 1999.

Current Research Interests

  • Power Study (Integrated Clinical-Behavioral Interventions to Accomplish Weight Loss): The goal of this NHLBI-sponsored trial is to test two strategies as a means to control weight and improve blood pressure control in overweight or obese medical patients with hypertension. (Role: Co-investigator, Chair of Measurement Committee)
  • OMNI-CARB: Carbohydrate: Amount and Type Affecting Risk for CVD and Diabetes: This NHLBI study is a controlled dietary trial that examines separately the effects on risk factors for CVD and diabetes in terms of amount and type of carbohydrate, thereby disentangling their influence. (Role: Co-investigator and Chair of Measurement Committee)
  • Atherosclerosis Risk in the Communities (ARIC): The ARIC study is an NHLBI-funded surveillance program for cardiovascular and coronary artery diseases in the community. (Role: Co-investigator and member of CHF adjudication committee)
  • NHLBI study on dietary carbohydrate and glycemic index effects on markers of oxidative stress, inflammation, and kidney function. (Role: PI)
  • NIDDK randomized controlled trial that examines the effects of Omega-3 fatty acid supplementation on urine protein excretion in diabetic kidney disease. (Role: PI)
  • This NCI/NHLBI randomized controlled trial looks at the effects of DASH diet advice and mineral and vitamin supplementation on blood pressure in African Americans with hypertension.
photo of Stephen Desiderio, MD, PhD

ICTR Deputy Director for Basic Science Translational Research

Professor of Molecular Biology and Genetics, Johns Hopkins University Schoo l of Medicine

Director, Institute of Basic Biomedical Sciences Immunobiology Program Director, Institute for Cell Engineering

Dr. Desiderio began his Hopkins career as a student, receiving both his medical degree and a doctorate in molecular biology from the Johns Hopkins University School of Medicine in 1981. He then served as a postdoctoral fellowship at the Center for Cancer Research at the Massachusetts Institute of Technology with David Baltimore, a 1975 Nobel Laureate in Physiology or Medicine for his discovery of reverse transcriptase.

Returning to Hopkins in 1984 as assistant professor of molecular biology and genetics, Dr. Desiderio also began serving as an associate for the Howard Hughes Medical Institute (HHMI). He became a full professor in 1995 and an HHMI Investigator in 2000. Dr. Desiderio is currently the director of the Johns Hopkins Institute for Basic Biomedical Sciences (IBBS). The IBBS promotes the fundamental research that drives advances in medicine, from solving protein structures to dissecting cell movement, from analyzing chromosome structure to deconstructing biochemical pathways. This type of basic science discovery provides the foundation for the translational work that ultimately results in better diagnostics, treatments, and cures for patients. Education and Training

  • BA (Biology and Russian), Haverford College, Philadelphia, PA, 1974
  • PhD (Molecular Biology), The Johns Hopkins University School of Medicine, Baltimore, MD, 1981
  • MD, The Johns Hopkins University School of Medicine, Baltimore, MD, 1981
  • Postdoctoral Fellow, The Massachusetts Institute of Technology, Cambridge, MA, 1981-1984

Accomplishments, Recognition, and Service Teacher and mentor to numerous researchers- and physicians-in-training, Dr. Desiderio received a Professors’ Award for Excellence in Teaching in 1993. From 1992-1999, he served as the director for the MD-PhD program at the Johns Hopkins University School of Medicine. Dr. Desiderio currently serves on the editorial board of the Journal of Molecular Medicine and has authored of more than 75 peer-reviewed research articles. An internationally in-demand lecturer and advisor, he is part of the board of the European Genetics Foundation in Bologna, Italy, and on the advisory committee of the Leder Human Biology Program at Harvard Medical School. He is also a member of the American Society for Clinical Investigation, the American Society for Biochemistry and Molecular Biology, the American Association for the Advancement of Science, and the Henry Kunkel Society. Research Interests Dr. Desiderio work addresses the molecular and genetic mechanisms responsible for the development of the immune system, with a focus on how genomic plasticity generates immunologic diversity. He is particularly interested in V(D)J, or somatic, recombination in health and disease and in the regulation of lymphocyte development. Using a combination of genetics and biochemistry, Desiderio’s group has defined a specific control mechanism restricting V(D)J recombination and has illustrated in murine models how this mechanism protects against the development of lymphoid cancers. The Desiderio laboratory also investigates the signaling mechanisms responsible for immunological response to environmental cues. For example, his team has uncovered a novel way in which calcium is regulated in response to antigen receptor stimulation. The team is currently testing whether this mechanism contributes to the decision between activation and anergy (blocked responsiveness) in immune cells.

The Community Engagement Program maintains Community Research Advisory Councils (C-RAC) for Johns Hopkins East Baltimore Medical Campus and Johns Hopkins Bayview Medical Center.  These advisory councils are intended to guide community-engaged research and education events that take place on both campuses and in the communities served by these campuses.

The  East Baltimore Campus C-RAC was established in October 2009 as part of the Johns Hopkins ICTR Community Engagement Core. The goals of the council are to promote trust,understanding, and involvement of the Greater Baltimore community in research activities.

The Johns Hopkins Bayview Medical Center C-RAC creates a forum for community members and researchers to discuss research conducted at Johns Hopkins Bayview that impacts patients, families,and residents of Baltimore City and Baltimore County.

Membership

The C-RAC membership is broad, inclusive, and includes stakeholders (e.g. community leaders, research participants, patients, service providers, faculty, staff and students from colleges and universities) with an interest in community- engaged research

Goals

The overarching goals of the councils are to provide guidance to the ICTR Community Engagement Core to:

  1. Improve community members’ awareness, trust, and understanding of the research process;
  2. Increase community members’ access to research studies as well as research findings;
  3. Partner with community-based organizations and agencies (e.g. faith community, educational institutions) to guide the dissemination and sharing of research information with the community at large;
  4. Work with community members to identify research interests and priorities and educate researchers about issues impacting community members;
  5. Enhance researchers’ awareness, understanding, and appreciation of community-engaged research; and
  6. Identify and recommend best practices for researchers conducting community based research

ICTR Deputy Director for Translational Technology

Dana and Albert “Cubby” Broccoli Professor of Oncology and Professor of Pathology, Johns Hopkins University School of Medicine

Medical Director of the Johns Hopkins Oncology Center Cell Processing and Gene Therapy Facility

Associate Director for Translational Research, Sidney Kimmel Comprehensive Cancer Center Faculty, Johns Hopkins University School of Medicine’s Graduate Programs in Immunology, Cellular and Molecular Medicine, and Pharmacology

Dr. Jaffee is the inaugural recipient of the Dana and Albert Cubby Broccoli Endowed Chair in Oncology. Currently the medical director of the Johns Hopkins Oncology Center Cell Processing and Gene Therapy Facility, since 1995 and 1999, respectively, she has been part of the faculty in the School of Medicine’s graduate programs in immunology and in cellular and molecular medicine. She also became part of the graduate program in pharmacology in 2000.

After receiving her medical degree from New York Medical College, Dr. Jaffee began her career with internship, residency, and a research fellowship at the University of Pittsburgh. Arriving in Hopkins in 1989, she completed senior clinical and research fellowships in oncology. In 1992, Dr. Jaffee joined the Hopkins faculty as assistant professor of oncology at the School of Medicine, becoming associate professor in 1997. In 1999 she received a joint appointment as associate professor of pathology, and in 2002 became professor of both oncology and pathology.

Dr. Jaffee has served, and continues to serve, in several key roles in the Department of Oncology and at The Sidney Kimmel Comprehensive Cancer Center, co-director of the Division of Immunology (since 2006) and of the Gastrointestinal Cancers Program (since 2007). In 2010 she became associate director for translational research. She established and continues to direct the Johns Hopkins Oncology Center Cell Processing and Gene Therapy cGMP Facility, whose purpose is to conduct clinical trials employing cellular and genetic based vaccine therapies for the treatment of cancer.

Education and Training

  • BA (Magna cum laude with highest honors in Biology/Immunology), Brandeis University, Waltham, MA, 1981
  • MD, New York Medical College, Valhalla, NY, 1985
  • Intern and Resident, University of Pittsburgh, Presbyterian Hospital, Pittsburgh, PA, 1985-1988
  • Research Fellow and Physician Investigator, University of Pittsburgh, Pittsburgh, PA, 1988-1989
  • Senior Clinical and Research Fellow in Oncology, The Johns Hopkins University School of Medicine, Baltimore, MD, 1989-1992

Accomplishments, Recognition, and Service

A member of the board of directors for the International Society for Biological Therapy of Cancer since 2008, Dr. Jaffee has received a wide range of honors for her research. In 2006, she received the NCI Spore Program’s Investigator of the Year Award. 1992 was a significant year of recognition for Dr. Jaffee; that year, she was the recipient of the Stetler Award, the American Cancer Society Research Fellowship Award, American Society of Clinical Oncology Young Investigator Award, a Physician-Scientist Award from the NIH, the Clinician-Scientist Award from Johns Hopkins School of Medicine, and the National Kidney Cancer Career Development Award.

A three-time recipient of the Department of Oncology’s Director’s Award for Outstanding Teaching, Dr. Jaffee has mentored more than 20 postdoctoral fellows along with numerous graduate and medical students and currently serves as supervisor of the Medical Oncology Fellows Clinic. She has published more than 100 peer-reviewed research articles, invited chapters, and reviews and currently serves as a reviewer for 11 scientific journals, including 4 journals which she has reviewed for nearly two decades (Cancer Research, the Journal of Immunology, the Journal of the National Institutes of Health, and the Journal of Immunotheraphy). Dr. Jaffee has spoken in nearly 50 invited lectures and symposia, and attended over 60 international meetings.

Research Interests

An internationally recognized leader in the development of immune based therapies for the treatment of pancreatic and breast cancers, Dr. Jaffee has served as principal investigator and/or mentor in 13 clinical trials and holds 6 patents. Her research focuses on the development of novel vaccine approaches that overcome immune tolerance to cancers. Her work has been funded by the National Cancer Institute’s (NCI’s) SPORE program, the NCI NCDDG program, and RO1s.

Dr. Jaffee’s group has completed clinical trials testing vaccine alone and in combination with immune modulatory agents in patients with pancreatic cancer. Using patient reagents, she has developed both functional and proteomic approaches to identify antigens that are the targets of both T cell and humoral immune responses. Using these approaches, her laboratory has identified a number of pancreatic cancer antigenic targets that are being validated as targets of the immune response in Phase II clinical trials. These antigens are also being evaluated for their biologic role in cancer development. Dr. Jaffee’s vaccine concepts are also being testing in patients with breast cancers.

Current projects include:

  • The evaluation of mechanisms of immune tolerance to cancer in a mouse model of breast cancer.Dr. Jaffee’s lab has characterized the HER-2/neu transgenic mouse model of spontaneous mammary tumors. This model demonstrates immune tolerance to the HER-2/neu gene product and is being used to better understand the mechanisms of tolerance to tumor. In addition, this model is being used to develop vaccine strategies that can overcome this tolerance and induce immunity potent enough to prevent and treat naturally developing tumors.
  • The identification of human tumor antigens recognized by T cells. Using a novel functional genetic approach recently developed in the Jaffee laboratory, human tumor-specific T cells from vaccinated patients are used to identify immune relevant antigens that are chosen based on an initial genomic screen of overexpressed gene products. Several candidate targets have been identified, and the prevalence of vaccine induced immunity has been assessed. This rapid screen to identify relevant antigenic targets will facilitate a better understanding of the mechanisms of tumor immunity induction and downregulation at the molecular level in cancer patients.
  • The analysis of antitumor immune responses in patients enrolled on vaccine studies. Focusing on breast and pancreatic cancers, Dr. Jaffee’s team is attempting to identify in vitro correlates of in vivo antitumor immunity induced by novel vaccine strategies currently under study in clinic.
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ICTR Deputy Director for Interdisciplinary Research
ICTR Program Director for Office of Recruitment and Retention
Associate Professor of Health Systems and Outcomes, Johns Hopkins University School of Nursing
Associate Professor, Division of Health Sciences Informatics, Johns Hopkins Medicine
Core faculty, Johns Hopkins Center for Global Health
Co-director, Center for Cardiovascular Health in Vulnerable Populations, Johns Hopkins University School of Nursing

Dr. Dennison began her career as a clinical nurse at the Baylor University Medical Center’s Medical Intensive Care Unit in 1991, becoming supervisor of that same unit the following year.  From 1993 to 1995, she served as a staff nurse at many locations, including American Mobile Nurses Critical Care Unit Staffing in San Diego, California; New York University Medical Center in New York, New York; Tulane University Medical Center in New Orleans, Louisiana; Straub Hospital and Clinic in Honolulu, Hawaii; and MRA Staffing Systems.

From her arrival at Hopkins in 1995 through 2001, Dr. Dennison continued working as a clinical nurse in the Surgical Intensive Care Unit at Johns Hopkins Hospital.  From 1996 to 2000, she also served as a research assistant and project data manager for a study on “Comprehensive High Blood Pressure Care for Young Urban Black Men. ” From 1998 to 2001, she was a nurse practitioner at Johns Hopkins Hospital’s Ciccarone Preventive Cardiology Center.  In 2001, Dr. Dennison joined the faculty of the Johns Hopkins School of Nursing, becoming assistant professor in 2004 and associate professor in 2008.  In 2007, she received another faculty appointment at the Johns Hopkins University School of Medicine Division of Health Sciences Informatics.  While at Johns Hopkins, Dr. Dennison has concurrently worked as a research scientist at MEDTAP International, Incorporated Center for Health Outcomes Research (2001-2002), as adjunct associate professor of medicine at American University of Beirut’s Hariri School of Nursing in Beirut, Lebanon (2009-2010); as adjunct associate professor at University of Western Sydney, Sydney Australia (since 2008), and as an adjunct research fellow at Curtin University of Technology, Perth, Western Australia (since 2008).

Education and Training

  • BS, Texas Woman’s University, Dallas, TX, 1991
  • MS, Johns Hopkins University, Baltimore, MD, 1996
  • PhD (Philosophy), Johns Hopkins University, Baltimore, MD, 2001

Accomplishments, Recognition, and Service

Dr. Dennison is the recipient of numerous awards, including the American Association of Heart Failure Nurses Clinical Innovation Award in 2010 and the Shirley Sohmer Award for Evidence-Based Practice Research from Johns Hopkins Hospital in 2007.  In 2005, she claimed the NIH Roadmap Johns Hopkins Clinical Research Scholar K12 Award.  Dr. Dennison is a Fellow of the American Academy of Nursing (2010), of the Preventive Cardiovascular Nurses Association (2010), and of the American Heart Association’s Council on Cardiovascular Nursing (2007).  From 2007 to 2009, she served as President for the Nu Beta Chapter of Sigma Theta Tau, the international honor society for nursing, into which she was inducted in 1996.  In 2008, she was named a John A. Hartford Foundation Claire M. Fagin Fellow and has been a member of the Baltimore Albert Schweitzer Fellows Program since 2005.   Mentor and advisor to many doctoral and nursing students, Dr. Dennison is also the author of more than 50 peer-reviewed publications and has presented on issues in cardiovascular risk management and self care at local, national, and international scientific meetings. Recent advisory panels include the National Heart, Lung, and Blood Institute Cardiovascular Risk Reduction in Adults Initiative, Eighth Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure and the International Society of Hypertension in Blacks Summit Meeting on Behavioral Modification.

Research Interests

Dr. Dennison’s research involves developing and testing interventions to reduce cardiovascular risk among high-risk populations in acute care and community settings. She has been investigator or principal investigator on numerous NIH-funded randomized controlled trials with successful recruitment and high retention rates among high-risk urban populations.  Her current research—which bridges scientific research and clinical practice and develops and tests interdisciplinary approaches—examines how to reduce barriers to the implementation of heart failure guidelines in acute care settings.  To improve the quality of care and outcomes among heart failure patients, she is developing and testing an innovative online decision support system that would help clinicians around the country follow national evidence-based guidelines.  She is also developing and testing interdisciplinary and technology-based approaches to improve self-care among patients with cardiovascular disease.  Dr. Dennison is currently a co-investigator on two National Institutes of Health-funded trials testing the effectiveness of community-based cardiovascular risk intervention programs for high-risk urban populations and on another international study assessing total cardiovascular risk and barriers to high blood pressure care among black South Africans. Among her other clinical and research interests are chronic illness management, quality of care, interdisciplinary teamwork and provider behavior.

photo of Bandeen-Roche, MS, PhD

Deputy Director, Johns Hopkins Institute for Clinical and Translational Research
Hurley-Dorrier Chair, Department of Biostatistics, Bloomberg School of Public Health
Professor, Department of Biostatistics, Bloomberg School of Public Health
Interim Director, Center on Aging and Health

Dr. Bandeen-Roche has taught in the Department of Biostatistics at the Johns Hopkins Bloomberg School of Public Health since 1990 and received the Hurley-Dorrier Chair of Biostatistics in 2008. Also at the Bloomberg School, Dr. Bandeen-Roche served as co-director of the Epidemiology and Biostatistics of Aging Training Program from 1996 to 2008, after which she became its director. Since 2008, Dr. Bandeen-Roche has also served as interim director of the Johns Hopkins Center on Aging and Health.

Dr. Bandeen-Roche began her career at Cornell University as a Teaching Assistant in Operations Research and Industrial Engineering (1985 1990). During that time (1987), she also worked as a statistician for the Laboratory of Statistical Methodology, Division of Computer Research and Technology, National Institutes of Health.

Education and Training

  • BS (Mathematics, Academic Distinction and Honors), Andrews University, Berrien Springs, MI, 1985
  • MS (Operations Research), Cornell University, Ithaca, NY, 1988
  • PhD (Operations Research and Industrial Engineering), Cornell University, Ithaca, NY, 1990

Accomplishments, Recognition, and Service

Dr. Bandeen-Roche is the recipient of numerous awards and fellowships. In 2010, she received the Golden Apple Award for Excellence in Teaching, and the Advising, Mentoring, and Teaching Recognition Award (which award she also won in 2001 and 2005) at the Johns Hopkins Bloomberg School of Public Health.

Dr. Bandeen-Roche has been a Statistical Consultant to the Journal of Gerontology: Medical Sciences since 2006. She served as Associate Editor of Biometrics from 2002 to 2005, and Associate Editor of the Journal of the American Statistical Association from 2002-2003. Dr. Bandeen-Roche is published in more than 120 peer-reviewed research articles. She has presented in nearly 90 invited lectures, and participated in numerous other lectures related to her research interests.

From 2006 to 2008, she held the role of chair of the Biostatistical and Research Design Study Section at the National Institutes of Health from 2006 to 2008. She has also served as chair of the Biometrics Section of the American Statistical Association in 2006. Most recently she has been elected President of the International Biometric Society/ Eastern North American region for a 2012 term.

Dr. Bandeen-Roche is a continuing member of the American Statistical Association, The International Biometrics Society, and The Gerontological Society of America (for which she organized sessions in 1995, 1996, 1998, 2000, and 2001). She has also been responsible for section organization for the American Association for the Advancement of Science (2004), the Joint Statistical Meetings (1996, 2000, 2003, 2006, 2011), IBS/ENAR (2000, 2003), and the Society for Prevention Research (2002).

In 1999, Dr. Bandeen-Roche was the recipient of the Garland Clay Award from the American Academy of Optometry for co-authoring flagship journal’s most cited paper in the preceding five years. Fellowships include those with the American Statistical Association (2001) and as a Brookdale National Fellow, for Outstanding Research on Aging (1997). In 1987, she received a Citation in Recognition and Appreciation of Special Achievement from the U.S. Department of Health and Human Services, National Institutes of Health.

Research Interests

Current projects include:

  • Older Americans Independence Center: Co-Director and Director of the Biostatistics Core. The Center is dedicated to developing the next generation of research to determine the causes and treatments for frailty in older adults.
  • Johns Hopkins Alzheimer’s Disease Research Center (ADRC): Aims to coordinate and integrate all aspects of data management for ADRC, to provide statistical support and expert statistical consultation for all projects associated with ADRC, and to develop novel methods of analysis for studying progressive cognitive decline and dementia among aging individuals.
  • Pathogenesis of Disability in Aging Women (with Columbia University): Seeks to evaluate evidence as to the pathogenesis of physical disability in older women, assessing the independent and joint contributions to disability of blood-based measures of inflammation, hormonal and hematologic status, and micronutrient deficiencies, and heart rate variability as a marker of biologic vulnerability.
  • Institutional Clinical and Translational Science Award: Purpose is to enhance both the process and benefits of clinical and translational research by bringing together the diverse resources of the Johns Hopkins Medical Institutions and creating a new model for carrying out scientific research.
  • Center for Prevention and Early Intervention: Conducts substantive and methodological research on novel school and family based interventions to prevent mental disorders, substance abuse, and violence.
  • Comparative Effectiveness Studies to Improve Patient Outcomes in End Stage Renal Disease (ESRD): Goal is to address the comparative effectiveness of strategies to improve cardiovascular disease outcomes among patients with ESRD.
  • Drug Abuse and Crime across the Life Course in an African American Population: The major goals are to study how substance use in adolescence and early adulthood relates to the risk of being arrested and incarcerated and, conversely, how early arrests and incarceration influence later drug use and criminal behaviors.

The Motion Analysis Laboratory is available through the NBRU in the Kennedy Krieger Institute. The lab provides whole-body movement assessments that quantify discrete components of the mechanisms of movement and movement deficits and detect very small changes in performance over time or in response to treatment. Several techniques are used to quantify movement, including: three-dimensional tracking and reconstruction of movement kinematics, force plate recordings, recordings of muscle activity, and calculation of joint forces and torques.

The laboratory is equipped with an Optotrak motion measurement system (Northern Digital Inc.) with two infrared, 3-D position sensors. These sensors allow for tracking of infrared markers placed on the joints of the body, bilaterally. Using the Optotrak system, the Motion Analysis Laboratory can make very precise measurements of natural movements including but not limited to; walking, reaching , leg movements, hand movements and standing balance.

The laboratory houses two Kistler force plates, which allow for measurement of the forces exerted on the floor by a person standing, walking or running. In addition, equipment to record surface muscle activity (electromyography or EMG) is available. A custom treadmill allows for the control of the two legs independently (split-belt treadmill).

For more information call 443-923-2716.

State-of-the-art Operant Performance Measures are available to investigators through the NBRU at Kennedy Krieger Institute. Direct observation of behavior, conducted in areas that simulate naturalistic settings, is accomplished by the use of computers with accompanying customized software that allows for the simultaneous recording of up to twenty behaviors for real time analysis, including conditional probability calculations.

Neuropsychological testing, includes achievement tests, behavior checklists, measures of personality, developmental status, intelligence, executive function, language, visual spatial skills, and memory, are available to ICTR CRU investigators. Skilled psychologists are available to provide a broad range of testing, including assessments of children who are cognitively very limited; those less severely impaired; and learning disabled children and adults; and control groups.

Neuroimaging resources available through the NBRU include structural and functional magnetic resonance imaging, spectroscopic and diffusion analysis, fiber track mapping, fMRI protocol development, and training of pediatric and brain/behavior disordered subjects to cooperate with research protocols including motion control during scans. The F.M. Kirby Research Center for Functional Brain Imaging is dedicated to brain research using functional MRI technologies and is specifically designed to provide a uniquely comfortable scanning environment for studies in children, the elderly, and subjects with neurological and psychiatric disorders.

All CRU protocols are reviewed by a member of the Biostatistics Core prior to approval, and consultations with a Core biostatistician are strongly encouraged for all investigators who do not already have biostatistical support as part of their funded protocols.

In conjunction with the Biostatistics Center, ICTR offers researchers access to a research-related consulting service. The goal of the service is to promote the appropriate use of biostatistics in the design, implementation, and interpretation of clinical and translational research studies.

The Biostatistics Center supports JHU faculty with primary appointments by providing a maximum of 3-5 hours of free support per clinical and translational research project through the ICTR. Consultants can assist with: research study design, design of data collection systems and instruments, data entry and validation, data management and quality assurance, statistical analysis and data interpretation, and professional and scientific report-writing.

Once projects obtain independent funding, services will be provided on a fee-for-service basis. The goal of these consultations is to advise and educate the research by enabling him or her to both design and execute well-constructed studies and analyze the study data collected.

TIME FRAME: Please contact the Biostatistics Center as early as possible before your deadlines and with an awareness of the following guidelines:

  • Abstracts: The Center generally needs at least one month. Ideally, we hope you will give us two months or more. If it is less than one month before the deadline, we may be able to assist with some simple summary statistics; however we cannot guarantee more complicated analyses, such as multiple variable analyses.
  • Grants: The Center typically needs at least three weeks for new grant submissions. If it is a re-submission, we need at least two weeks to improve your score.
  • Manuscript Review: The Center requires a minimum of two weeks for manuscript reviews.

As the deadline approaches, the likelihood that you can provide helpful statistical support diminishes. On a case by case basis, The Biostatistics Center may decline requests that are too close to the deadline to provide anything useful.

Within two working days of receipt of a request, a consultant will contact you to arrange an initial meeting as soon as possible. To request a consultation with the Biostatistics Center through Connection Request, click here.

WALK IN SESSIONS: The Biostatistics Core also offers brief consultation through its walk-in consultation service. The walk-in session is designed to provide a quick evaluation of statistical issues concerning a clinical / translational research project to provide an answer during the consultation or to set up a subsequent appointment to work on the issues further.

Broadway Campus Walk-In Clinic

Bayview Campus Walk-In Clinic

Hours: 1-2 pm on Tuesdays and 2-3 pm on Fridays
Location: 301 Building on Bayview Campus, Room 2202

Signup begins 10 minutes prior to the start of each session. The clinic is “first come, first served.”

Contact the research unit to obtain walk in times. Please complete the Consultation Request Form and bring it with you to your consultation session.

For more information call 443-287-8793.

The Clinical Research Unit Core Laboratory is housed in the Asthma and Allergy Center at the Bayview Medical Campus. The Core also includes a Sample Processing Laboratory located in the Bayview CRU on the fourth floor of the 301 Building. Directed by Neal Fedarko, PhD, a professor in the Division of Geriatric Medicine and Gerontology, the laboratory offers 87 distinct assays of clinical chemical endpoints and biomarkers to support ICTR research protocols. It is designed to serve ICTR investigators at all CRU locations.

The ICTR CRU Core Laboratory supports ICTR-approved protocols by providing facilities, technical experience, and training for non-routine blood, saliva, CSF (cerebrospinal fluid), and urine biochemical analyses. The Core Laboratory is staffed by a director and three full-time technicians with the expertise to support investigators as they plan and implement their protocols.

The Core Laboratory provides standardized sample handling that upholds high quality control by, for example, minimizing freeze/thaw cycles. The high volume of assays processed in the lab supports reduced investigator cost through batch analysis of samples and direct manufacturer pricing. Quality control is maintained by including manufacturer’s controls as well as low, medium, and high value in-house controls in each assay. A listing of current assay costs, specimen volume requirements, and inter- and intra-assay coefficient of variance may be found below:

Click here for a downloadable list of available assays and costs.

Click here for assays performed and current assay statistics.

Sample Processing Laboratory

The Sample Processing Laboratory provides specialized services associated with the routine inpatient and outpatient needs of the Bayview CRU. The lab provides onsite sample processing and point-of-care testing, including Clinitek status for HCG and urine dipstick, Accu-chek for glucose, Hemocue for hemoglobin, and hemoccult for fecal occult blood. It is equipped with a Beckman refrigerator centrifuge that rotates at speeds ranging from 1 to 8,000 rpm.

For more information, please contact Neal Fedarko, PhD, at 410-550-2632 or nfedark1@jhmi.edu.

The Exercise Physiology and Body Composition Core’s laboratory provides DEXA measurements for body fat, muscle and bone composition, metabolic stress testing and supports exercise-training protocols. The facilities are located at the Bayview Clinical Research Unit and at the Green Spring Station Outpatient Clinic, and DEXA scanning is also available on the Broadway campus through the Adult Outpatient Unit.

Supported studies address issues like exercise testing and training and body composition of patients with chronic health conditions. The Core also provides coronary risk factor assessment and modification for approved users and works closely with CRU Research Nursing, Research Nutrition, and the Research Core Laboratory for sample collection and processing.

Stress Testing
ECG stress testing and metabolic stress testing is available for diagnostic screening and for protocols that require measurement of oxygen consumption and related cardiopulmonary parameters. The available software allows for continuous 12-lead ECG monitoring, automatic resting ECG interpretation, arrhythmia detection, ST level, and slope analysis. A treadmill or cycle ergometer can be interfaced with the computer in order to accommodate various research protocols. The system uses a pneumotachometer to acquire breath-by-breath gas exchange and ventilatory data. Gas samples are evaluated using oxygen and carbon dioxide analyzers. The system can also be used to assess pulmonary function and resting metabolic rate.The metabolic cart is on the computer network to allow for transfer of data into study databases for statistical analysis.

Muscle Strength Testing
Available equipment includes the Biodex System 3 dynamometer, which conducts isokinetic strength testing of various muscles groups. Pediatric attachments are available. Multi-station resistance trainers can also be used for isodynamic strength testing.

Anthropometric, Body Composition and Functional Assessment

    • Harpenden skinfold calipers, assorted tape measures, and a girth measurement tool are available for anthropometric assessment.
    • A bioelectrical impedance analyzer is available to analyze body fat percent and water retention.
    • A Dual X-ray Absorptiometry (DEXA) scanner is used to assess body composition which includes total and regional fat, lean tissue and bone mass.

For bone density, the analysis can provide focused scans that include the femur, forearm, and lumbar spine. Scans are available for both adults and children.

  • Walking wheel measure, plastic cones and arm chairs are available for gait and balance assessments.

Exercise training
Exercise training is available at both Bayview or Green Spring Station. Participants can perform workouts on a variety of aerobic and resistance exercise training equipment. There is also ECG telemetry equipment for heart rate and ECG monitoring in each gym. Blood pressure and heart rate can be taken before, during, and after exercise.

For more information contact:

Kerry Stewart, EdD
Phone: 410-550-0870
Email: kstewart@jhmi.edu

The Cardiovascular Imaging Laboratory is located at the Bayview CRU and is supervised by Pamela Ouyang, MBBS, ICTR Deputy Director and Director of the Johns Hopkins Women’s Cardiovascular Health Center. The Core provides echocardiographic and carotid imaging for approved CRU protocols, as well as measurement of endothelial function and arterial stiffness.


The Cardiovascular Imaging Laboratory provides the following services and equipment:

Echocardiogram
Echocardiograms are performed on a Toshiba Aplio ultrasound system. All cardiac studies are stored digitally and analyzed using the Philips Excelera System. Image acquisition and analysis protocols can be customized to meet the unique BayviewCV_HeartImage.jpgneeds of the investigator.

Carotid IMT
Carotid imaging is performed on a Toshiba Aplio ultrasound system. Using commercially available state of the art equipment that includes automated border detection, the core lab can accurately measure carotid intima-medial thickness and distensibility.

Bayview_CV_CarotidImage.JPG

Brachial Reactivity Studies
Brachial ultrasound studies are performed on a Toshiba Aplio system. A high frequency (15Mhz) ultrasound transducer is held in place by a mounted stationary device to insure reproducibility of brachial reactivity measures. Endothelial function tests are performed using both cuff inflation and nitroglycerin to induce brachial flow mediated dilatation (FMD). Analysis of both brachial diameter and flow velocity is performed using state of the art commercially available equipment with automated edge detection.

BayviewCV_BrachialImage.JPG

Endothelial Function
The EndoPat or Endothelix systems both measure endothelial response to reactive hyperemia following the release of arm bloodflow occlusion. The EndoPat system measures changes in bloodflow volume in response to reactive hyperemia, whereas the Endothelix measures changes in fingertip temperature

Vascular Stiffness
Vascular Stiffness is measured as the the pulse wave augmentation index (AGI). It is derived from measurement of the pulse wave contour and is a measure of the pressure wave is reflected back during pulse wave cycle, which is a measure of vascular stiffness. AGI can be obtained from the EndoPat and SphygMoCor, each of which measure the radial artery pulse wave.

For more information, please contact:
Sandy Lima, RDCS
CV Core Lab
Clinical Research Unit
Johns Hopkins Bayview
410.550.6720
slima1@jhmi.edu.

A broad scope of nursing services is offered in the CRUs, ranging from routine vital signs to intensive studies requiring intravenous infusions and specialized measures.

Some examples of nursing services include assisting with intravenous glucose tolerance tests and insulin clamps, intravenous infusion of approved and investigational drugs, specialized strength and joint testing, calculation of body mass index and body fat content, gynecologic examination, and polysomnography for sleep studies. Our nursing staff also participate in off-site research for subjects living in Baltimore.

For additional information call 410-614-2717 for the East Baltimore Campus and 410-550-1850 for the Bayview Campus.

ICTR Research Nutrition was established to support CRU investigators and protocols in developing and implementing the best nutritional plans for their research protocols for both pediatrics and adults. Services are located in the clinical research units at both the Johns Hopkins Bayview Campus and the Broadway (main medical) Campus.

Research Nutrition staff includes a diverse nutrition team which includes a research nutrition manager, research nutritionists, a kitchen supervisor, and research nutrition technicians.

This support includes providing nutrition experts to consult and help investigators with their protocols. The ICTR Research Nutrition staff can perform:

  • In-depth nutrition assessments
  • Diet intake analysis for both macro- and micro-nutrients
  • Nutrition counseling
  • Anthropometric and body composition measurements,
  • Energy expenditure assessments
  • Design and preparation of protocol-specific meals, snacks, and formulas.

If you are an investigator who would like to learn more about how to incorporate ICTR Research Nutrition support into your study, please contact the research nutrition manager as early as possible in your protocol development process.

Nutrition Assessment

A nutrition assessment includes, but is not limited to, an in-depth analysis of food intake, energy needs, anthropometrics and body composition measurements. It can also include nutrition recommendations and education.

Diet and Intake Analysis

Our research nutrition experts can help you analyze the diets of your research participants by various methods depending on your study population and protocol. The following are some of the methods we use:

  • 24-Hour Recall: Yesterday’s food/beverage intake based on memory or recall. Intake analyzed for nutrients.
  • Food Frequency Questionnaires (FFQ): Capture usual consumption frequency from a list of certain foods over a six or twelve month period. Can be self administered or obtained by telephone interview by research nutrition staff.
  • Food Records: Participant records at least three days of food, beverage, and supplement intake which will be analyzed for nutrients.
  • Keeping A Three Day Food Record for Research (Powerpoint with Flash Video)

We analyze the 24-hour recalls and food records using Nutrition Data System for Research (NDSR).

Nutrition Education

We provide diet counseling and nutrition education for numerous protocols that involve weight loss, food allergies, chronic diseases including diabetes and cardiovascular disease, and a wide range of rare metabolic disorders for both pediatrics and adults.

Anthropometrics and Body Composition

We offer several non-invasive techniques to measure body composition, including:

  • Height and weight,
  • Circumference measurements like waist, hip, head, thigh, and mid-arm,
  • Skinfold measurements to estimate percentage of body fat, arm muscle area, and arm fat area,
  • Bioelectrical Impedance Analysis (BIA): A small current is passed through the body to estimate body fat mass (weight and percent), fat-free or lean body mass (weight and percent), and body water.

Energy Assessment

  • Indirect Calorimetry– —The metabolic cart calculates energy expenditure (REE), which accounts for 75-95% of total energy expenditure. The remaining 5-25% is highly variable depending on age, sex, size, disease state, and daily activity.
  • Predictive Equations– —These equations calculate energy requirements based on height, weight, age, and activity factor. Examples are the Mifflin St. Jeor equation, the Harris-Benedict equation, DRIs, etc.

Visit Meals and Diets

We can provide standard or protocol-specific meals snacks, and formula.

The Center for Interdisciplinary Sleep Research and Education (CISRE) is housed in the Bayview Clinical Research Unit (CRU). CISRE provides an integrated center for education, training, coordination, and support of clinical and translational research in sleep medicine. This center offers support to all investigators conducting research in this area and also provides a mechanism to enhance collaboration between the disciplines working in Sleep Medicine.

Supported protocols include both adult and pediatric healthy volunteers and participants with a broad range of disorders, including sleep apnea, sleep-disordered breathing, congestive heart failure, drug addiction and withdrawal, hypogonadism, post traumatic stress disorder (PTSD), traumatic brain injury (TBI), and restless leg syndrome.

FACILITY

  • Eight private inpatient rooms with personal full-size bathrooms
  • Capability of monitoring up to 10 subjects simultaneously
  • Bariatric beds available with weight capacity up to 1000 lbs.
  • Voice-activated intercom systems allow continuous on-demand communication between subject and monitoring staff
  • Infrared high-quality cameras with zooming capability are integrated within the polysomnographic recording
  • Wall access allows intermittent venous blood sampling or drug administration during study without disturbing subject
  • Specialized Chronobiology suite for specific protocols allows isolation with sound proofing and light control

STAFF

  • Registered polysomnographic technologists and nurses monitor subjects and collect diagnostic polysomnographic data
  • Dedicated sleep informatics team supports database management and 24/7 technical support for acquisition of polysomnographic studies

EQUIPMENT

  • State-of-the-art EMBLA acquisition equipment for recording polysomnographic data: 32 referential channels, 8 bipolar channels, specialized sensors (position, oximeter, airflow, effort, snoring)
  • Specialized auxiliary equipment provide additional support to research protocols (actigraphy, advanced airway monitoring, CPAP, Pcrit)

FOR MORE INFORMATION, CONTACT
Christen Spencer, RPSGT
CISRE Sleep Manager
Phone: 410-550-2951
Email: cspencer@jhu.edu

Una McCann, MD
CISRE Co-Director
Professor of Psychiatry and Behavioral Sciences
Email: umccann@jhmi.edu

Alan Schwartz, MD
CISRE Co-Director
Professor of Medicine
Email: aschwar2@jhmi.edu

Frank Sgambati, MS
CISRE Informatics Specialist
Email: fsgambati@jhmi.edu

Data managers are an integral part of most research teams, and their services have a profound impact on the quality and efficiency of the research process. The goal of this group, formed at the recommendation of the ICTR Data Management Advisory Board, is to create an environment where data managers from throughout Johns Hopkins can meet to share expertise and discuss the challenges of their unique roles in the research enterprise.

If you wish to subscribe to the Data Managers Interest Group listserv, click on the link below and select “Subscribe” from the menu on the left side of the page.

https://lists.johnshopkins.edu/sympa/info/datamgrs

 

The Research Ethics Achievement Program (REAP) was established in recognition of the central role of ethics and research integrity in clinical and translational research. Accordingly, REAP provides leadership in enhancing the ethical aspects of research in a variety of ways including:

  • Providing service to the research community primarily by staffing a Research Ethics Consulting Service (RECS) that is available to researchers free of charge;
  • Coordinating training in research ethics for key personnel involved with conducting human subjects research as well as designing a discussion-based course called REWards (Research Ethics Workshops About Responsibilities and Duties of Scientists); and
  • Developing innovative approaches to research ethics both through ongoing empirical work and by linking with other ICTR programs.

REAPS is a collaborative project between the Johns Hopkins Berman Institute of Bioethics and the Johns Hopkins Institute for Clinical and Translational Research (ICTR). While all members of REAP have appointments in the Berman Institute, REAP includes a diverse faculty who have appointments in the Schools of Medicine, Nursing, and Public Health.

In cooperation with the Berman Institute of Bioethics, the ICTR Research Ethics Achievement Program (REAPS) is pleased to offer the Research Ethics Consulting Service (RECS) . RECS is a no-cost resource designed to help raise awareness of, and to assist investigators in resolving, issues of ethics in human subjects research. This service is open to everyone in the Johns Hopkins research community, although students are asked to coordinate their requests through their faculty advisor.

If you are currently considering or addressing any ethical issues that are related to the development, conduct, or analysis of a research study at Johns Hopkins, we hope you will consider this service. To access the expert assistance and support of the ICTR RECS consultants, go to ictr.johnshopkins.edu/researchethicsconsult.

ICTR has designed the Developing Innovative Methodologies in Clinical and Translational Research Grant to support collaborative teams that include both methodological experts and researchers active in their field. Teams are expected to focus on overcoming barriers to discovery translation and on disseminating their advancements to the local and national research community.

All Johns Hopkins University faculty are eligible to apply for up to $100,000 in direct costs per year for up to two years of funding. Costs are expected to include faculty salary support.

We are currently in the evaluation stage of this grant cycle.

Click here to read the RFA for the previous round of applications.

For more information, email ictr@jhmi.edu or call 443-287-4287.

ICTR is pleased to offer a new Study Design Consulting Service in cooperation through the Center for Clinical Trials (CCT). Faculty members from the CCT are now available for consultation on questions relating to study design and conduct. The goal of this consulting service is to provide intellectual and methodological input into clinical research studies and research synthesis initiated by faculty of Johns Hopkins University.

Housed in the Department of Epidemiology in the Bloomberg School of Public Health, the interschool CCT is dedicated to the promotion of clinical trials as a method of evaluation of preventive and therapeutic approaches to health problems. Directed by Milo Puhan, MD, PhD, the consulting program offers a thorough discussion and framing of research questions that can be addressed through a clinical study.

Specific types of support offered are:

  • Help in identifying appropriate study design, which is not restricted to clinical (randomized) trials.
  • Input into protocol development, including eligibility criteria, definition of interventions, randomization, outcome measurement, masking, stopping rules, etc.
  • the design of data forms, coordination of the study, data monitoring and reporting, including advice on registration of clinical studies and reporting and dissemination of protocols and completed clinical studies
  • Advice on dealing with sponsors of industry-funded studies.

Since systematic reviews of the literature including (network) meta-analysis are a core competence of CCT faculty, we also offer consulting on any aspect of systematic reviews and meta-analysis.

The statistical analysis and data management (coordinating center) is not covered by the CCT. Faculty needing support in this area will be referred to the consulting service of the Biostatistics Center and Data Management service offered by the ICTR. A close collaboration with these ICTR consulting services will be maintained in order to avoid overlap and duplication of consulting services.

Format of the CCT’s Consulting Service:
CCT Study Design Consulting will organize an initial meeting of 1 hour of CCT faculty with JHU faculty requesting the service (free of charge). JHMI faculty are strongly encouraged to submit a request for the service as early in the planning of the research project as possible to maximize potential benefit from the consulting. The CCT may decline requests that are too close to a deadline to provide anything useful.

After the initial meeting, the service provides an additional two hours of free support of the research project in order to provide supporting material or literature discussed during the initial meeting. A collaboration beyond the support through the ICTR (the 3 hours) is welcome but will depend on the JHU and CCT faculty and potential grant support.

Contact:
You can request the Study Design consulting service through the ICTR Connection Request system by clicking here.

CR Through ICTR, Center for Clinical Trials (CCT) faculty members offer a consulting service on questions relating to study design and conduct. Housed in the Department of Epidemiology in the Bloomberg School of Public Health, the interschool CCT is dedicated to the promotion of clinical trials as a method of evaluation of preventive and therapeutic approaches to health problems.The goal of this consulting service is to provide intellectual and methodological input into clinical research studies and research synthesis initiated by faculty of Johns Hopkins University.



Areas Covered by the CCT Consulting Service:

CCT Study Design Consulting offers a thorough discussion and framing of the research question that can be addressed through a clinical study. Types of support offered are:

  • Help in identifying appropriate study design, which is not restricted to clinical (randomized) trials.
  • Input into protocol development, including eligibility criteria, definition of interventions, randomization, outcome measurement, masking, stopping rules, etc.
  • the design of data forms, coordination of the study, data monitoring and reporting, including advice on registration of clinical studies and reporting and dissemination of protocols and completed clinical studies
  • Advice on dealing with sponsors of industry-funded studies.

Since systematic reviews of the literature including (network) meta-analysis are a core competence of CCT faculty, we also offer consulting on any aspect of systematic reviews and meta-analysis.

The statistical analysis and data management (coordinating center) is not covered by the CCT. Faculty needing support in this area will be referred to the consulting service of the Biostatistics Center and Data Management service offered by the ICTR. A close collaboration with these ICTR consulting services will be maintained in order to avoid overlap and duplication of consulting services.

Format of the CCT’s Consulting Service:
CCT Study Design Consulting will organize an initial meeting of 1 hour of CCT faculty with JHU faculty requesting the service (free of charge). JHMI faculty are strongly encouraged to submit a request for the service as early in the planning of the research project as possible to maximize potential benefit from the consulting. The CCT may decline requests that are too close to a deadline to provide anything useful.

After the initial meeting, the service provides an additional two hours of free support of the research project in order to provide supporting material or literature discussed during the initial meeting. A collaboration beyond the support through the ICTR (the 3 hours) is welcome but will depend on the JHU and CCT faculty and potential grant support.

Contact:
You can request the Study Design consulting service through the ICTR Connection Request system by clicking here.

Director: Milo Puhan
http://faculty.jhsph.edu/default.cfm?faculty_id=2198

Co-director: Kay Dickersin
http://faculty.jhsph.edu/default.cfm?faculty_id=1695

Co-director: Aynur Unalp-Arida
http://faculty.jhsph.edu/default.cfm?faculty_id=990

This predoctoral (TL) training program allows the ICTR provides short- and long-term training for students interested in pursuing a career in clinical and translational research. Long-term trainees pursue either an MPH in Epidemiologic & Biostatistical Methods for Public Health & Clinical Research or an MHS in Clinical Epidemiology.

For more information, visit the Predoctoral Clinical Research Training Program website.

 

CRMS is a web-based tool designed to organize and streamline clinical research management.  Accessible by JHED ID, CRMS supports electronic eligibility checklists, integrates with eIRB, and tracks signed consent forms.  

It is designed to improve communication among study team members, store subject enrollment information in a secure location, and run real-time reports.

To learn more about CRMS, email CRMShelp@jhmi.edu If you are already a CRMS user, you can access the software at https://research.jhmi.edu.

The Johns Hopkins University School of Medicine and Bloomberg School of Public Health’s Graduate Training Programs in Clinical Investigation are accepting registration for the Science of Clinical Investigation Certificate Program.

Aimed at scientists, clinicians, and support personnel fully engaged in clinical investigation or its regulation, this five-course certificate series is designed to support translational clinical research by teaching the necessary skills to design, analyze, and interpret clinical investigations and implement studies in compliance with ethical and regulatory norms.

Click here for a flyer with more information about this innovative program.

The multidisciplinary Johns Hopkins Center for Computational Genomics integrates the work of basic scientists (biologists and clinicians) and statisticians, computer scientists, and analysts to effectively and efficiently solve problems that have enormous potential to further public health, clinical applications and general scientific progress.

 

Collexis Research Profiles is a subscription tool used to identify JHMI faculty biomedical experts and their publications by areas of expertise. Designed to facilitate faculty research and project collaboration, the information in Collexis is based on published output indexed in the PubMed database. Collexis is located at www.researchprofiles.collexis.com/jhu.

If the answer to any of the questions below is yes, Collexis can likely help you:

  • Do you need to put together multidisciplinary teams to tackle translational and big-science research projects?
  • Could you use help to keep up with the constant influx of new faculty and post-docs who might be working in an area related to yours?
  • Would you like to know if there is a JHMI investigator who focuses on a complementary phase of the bench-to-bedside lifecycle, works on the same problems as you, and works in a lab or clinic just a few hundred feet away?
  • Are you looking for a potential mentor?

This expertise portal is a key component of our mission to catalyze the application of new knowledge and techniques to clinical practice at the front lines of patient care

The ICTR Data Management Advisory Board is designed to focus on data management within clinical research studies, including ways in which data management impacts study efficiency and the value of the data for both primary and secondary uses.

Within Johns Hopkins there are a wide range of approaches to data management, with most of the responsibility centered within the individual studies. There are a few centers of expertise related to database management that have not generally met with each other or collaborated with each other to create institutional approaches and standards.

The Data Management Advisory Board will work to answer the following questions:

  1. What are logical ways to group protocols in ways that the approach to data management is relatively consistent? (examples: individual prospective RCTs, retrospective reviews of patient data, multi-institutional protocols that utilize clinical data and research data)
  2. How should database management systems be rated? (ease of use, cost, ability to share data, security, data entry and capture, etc) Could this be communicated to faculty looking for assistance?
  3. What are the best practices for database management? What database management practices and processes should be discouraged or prohibited? Should there be a greater emphasis on data management plans in the IRB and ICTR review of protocols?
  4. Should Johns Hopkins provide a central office to support data management? If there was a charge to investigators, how would services be priced?
  5. What specific services should be supported? Database design based on the aims of the study, data capture and entry, interfaces with laboratory and clinical instruments, etc. Does Johns Hopkins have the right personnel to support data management?
  6. Should we standardize on 2-4 key databases to support the wide need of investigators? From small to large studies? Which data dictionaries should we use? Should we provide database access on enterprise or smaller unit servers (like ICTR), with appropriate processes for data security and backup?

 

 

The Drug, Device, and Vaccine Development Core provides consultation and a variety of services for moving basic therapeutic discoveries into preclinical, investigational new drug (IND), and clinical testing. Areas of expertise include medicinal chemistry resources, GMP synthesis of biological reagents, pharmacologic and biologic endpoint expertise, and protocol development.

For more information, email ictr@jhmi.edu or call 443-287-ICTR (4287).

The main goal of the Community Engagement Program is to promote the meaningful involvement of communities in translational research.   The program assists clinical investigators and research teams by offering both a toolkit of field-tested and successful strategies for designing, implementing, and sustaining community-based participatory research (CBPR); and providing training for researchers and community members on the conduct of CBPR.  The Community Engagement Program seeks to increase the number of clinical researcher and community collaborations aimed at improving the health and well-being of individuals in the Greater Baltimore region; as well as increase community knowledge about health issues, opportunities for participation in clinical trials, and promote the recognition of study participants’’’ contributions to the design and conduct of clinical trials.

The Community Engagement Program works in several main areas.  The program maintains Community Research Advisory Councils (C-RAC), comprised of various community and academic stakeholders that meet on a monthly basis.  The C-RAC is primarily focused on increasing awareness, understanding, and involvement in research that is conducted in the Greater Baltimore region and/or with residents of the region, with a particular emphasis on East Baltimore.   The Community Engagement Program also hosts health education events that provide information about an array of health topics and conditions to residents of the Greater Baltimore region, again with a particular emphasis on East Baltimore.  Much of this work has been done in the area of Alzheimer’s, although events have also provided information on diabetes, CVD, and depression.  The program disseminates information to communities to facilitate community awareness of research being conducted at Johns Hopkins and promotes understanding of results/findings from completed research studies.  Lastly, there is the Community Engagement Consulting Service that provides feedback and training for researchers and communities on how to engage communities around research and evaluation projects.

To learn more about available services and resources, click the links below.

The Johns Hopkins Clinical Research Network (JHCRN) is an integrated network of academic and community-based clinical researchers established within the Johns Hopkins Institute for Clinical and Translational Research (ICTR).

The purpose of the JHCRN is to accelerate the transfer of new diagnostic, treatment, and disease prevention advances from the research arena into patient care. This bridge between Hopkins and select community hospitals creates a collaborative system that ensures a seamless platform for conducting clinical research and a broader and more diverse pool of clinical investigators and patients for studies.

In addition to the five major hospitals within Johns Hopkins Medicine, other major hospitals have joined the JHCRN including Anne Arundel Medical Center (AAMC) in Annapolis, Greater Baltimore Medical Center (GBMC) in Northern Baltimore County, Inova Health System in Northern Virginia, and Peninsula Regional Medical Center on Maryland’s Eastern Shore.

The Genetics Translational Technology Core (Genetics TTC) bridges the gap between clinical genetic testing and research-driven molecular technologies with consulting and laboratory services and assistance with translation of molecular technologies to the clinical environment.


The Genetics TTC is part of the Johns Hopkins Institute for Clinical and Translational Research (ICTR), which is funded by the National Center for Research Resources at the National Institutes of Health as part of a consortium of Clinical and Translational Science Awards.

The ICTR Clinical Research Units (CRUs) and associated services are designed to support a wide range of clinical research at Johns Hopkins. From pilot studies to multi-center trials, the CRUs are available for investigators who need outpatient, inpatient, adult, pediatric, or neurological services. Be aware that use of the units and certain associated resources require CRUonline application and approval.

Click the links below to learn more about the CRUs and to apply.

REAP was established in recognition of the central role of ethics and research integrity in clinical and translational research. Accordingly, REAP provides leadership in enhancing the ethical aspects of research in a variety of ways including:

REAP is a collaborative project between the Johns Hopkins Berman Institute of Bioethics and the Johns Hopkins Institute for Clinical and Translational Research (ICTR). While all members of REAP have appointments in the Berman Institute, REAP includes a diverse faculty who have appointments in the Schools of Medicine, Nursing, and Public Health.

The ICTR is funded by the National Center for Advancing Translational Sciences at the National Institutes of Health as part of a consortium of Clinical and Translational Science Awards (CTSA). Members of REAP participate in the CTSA’s Clinical Research Ethics Key Function Committee (CRE-KFC) and its subcommittees.

The Office of Recruitment and Retention (ORR) is designed to facilitate the recruitment and retention of study participants into research activities throughout the Johns Hopkins Medical Institutions.

To contact the ICTR Office of Recruitment and Retention, email ORR@jhmi.edu.

ORR is part of the Johns Hopkins Institute for Clinical and Translational Research (ICTR), which is funded by the National Center for Advancing Translational Sciences at the National Institutes of Health as part of a consortium of Clinical and Translational Science Awards.

The Proteomics Translational Technology Core (Proteomics TTC) provides consultation and expertise on proteomics analysis and the discovery and validation of biomarkers.

For more information contact:

Jennifer Van Eyk, PhD
Phone: 410-550-8511
Email: jvaneyk1@jhmi.edu

LeLoni Cheeks
Phone: 410-550-8511
Email: cheekle@jhmi.edu

The ICTR also provides two-year research fellowships through this postdoctoral (KL) training program for postdoctoral fellows and junior faculty. These fellowships provide stipends or dedicated effort; tuition for an MPH, MHS, ScM or PhD in Clinical Investigation, Biostatistics or Clinical Epidemiology; travel; funding for faculty mentors; and/or dedicated research funds.

For more information, visit The Clinical Research Scholars Program website.

The Office of Recruitment and Retention (ORR) is designed to facilitate the recruitment and retention of study participants into research activities throughout the Johns Hopkins Medical Institutions.

For more information about ORR and how it can help you recruit for your study, click the links below.

The Innovative Methodology Workgroup (GWAS) is an ICTR-supported think tank of basic scientists, clinicians and biostatisticians, developing novel ways of working with genome-wide association study data.

For more information, email ictr@jhmi.edu or call 443-287-ICTR (4287).

The Imaging Translational Technology Core (Imaging TTC) facilitates one-on-one consultation with imaging experts for study design, imaging protocol development and study implementation.

For more information contact:

Katarzyna Macura, MD, PhD
Phone: 410-955-6500
Email: kmacura@jhmi.edu

The Genetics Translational Technology Core (Genetics TTC) bridges the gap between clinical genetic testing and research-driven molecular technologies with consulting and laboratory services and assistance with translation of molecular technologies to the clinical environment.

For more information contact:

Jennifer Cedeño, MS
Genetic Assistant, DNA Diagnostic Laboratory Administrative Liaison
Phone: 410-955-0483
Email: jmontgo6@jhmi.edu

The Exercise Physiology/Body Composition Core’s laboratory, located on the Bayview campus, provides body composition determination, cardiopulmonary testing, DEXA scanning, ECG stress tests, and exercise and physical activity assessments.

For more information contact:

Kerry Stewart, EdD
Phone: 410-550-0870
Email: kstewart@jhmi.edu

CRMS is a web-based tool designed to organize and streamline clinical research management. It is designed to improve communication among study team members, store subject enrollment information in a secure location, and run real-time reports.

CRMS is a web-based tool designed to organize and streamline clinical research management. Accessible by JHED ID, CRMS supports electronic eligibility checklists, integrates with eIRB, and tracks signed consent forms. It allows for electronic eligibility checklists, integrates with eIRB, and tracks consents signed. It is designed to improve communication among study team members, store subject enrollment information in a secure location, and run real-time reports.

For more information contact:

Diana Gumas
IT Director
Phone: 410-735-4604
Email: dgumas1@jhmi.edu

Joseph Dimaggio
IT Project Manager
Phone: 410-735-7278
Email: jdimagg1@jhu.edu

If you are already a CRMS user, you can access the software at

https://research.jhmi.edu.

SciVal Experts is a subscription tool used to identify JHMI faculty biomedical experts and their publications by areas of expertise. Designed to facilitate faculty research and project collaboration, the information in SciVal is based on published output indexed in the PubMed database. SciVal is located at www.experts.scival.com/jhu.

If the answer to any of the questions below is yes, SciVal Experts can likely help you:

  • Do you need to put together multidisciplinary teams to tackle translational and big-science research projects?
  • Could you use help to keep up with the constant influx of new faculty and post-docs who might be working in an area related to yours?
  • Would you like to know if there is a JHMI investigator who focuses on a complementary phase of the bench-to-bedside lifecycle, works on the same problems as you, and works in a lab or clinic just a few hundred feet away?
  • Are you looking for a potential mentor?

This expertise portal is a key component of our mission to catalyze the application of new knowledge and techniques to clinical practice at the front lines of patient care.

 

The Cardiovascular Core’s laboratory, located on the Bayview Campus, provides advanced echocardiography, vascular imaging, pulse wave velocity testing, and applanation tomography.

For more information contact:

Sandra Lima, RDCS
Cardiovascular Sonographer
Phone: 410-550-6720
Email: slima1@jhmi.edu

The milestone-driven ATIP program provides up to $100,000 over one year in targeted funding and project management for faculty conducting translational research projects.

For more information, submit a Connection Request or email the ICTR Navigators.

The next funding cycle for the ATIP program will begin in October.  Check back for the new RFA then.

 

All publications resulting from research using any ICTR resource, including Clinical Research Units, ATIP funding, and/or consulting services, should cite the ICTR grant as a contributing source of support. When publishing articles related to this research, please include one of the following citations:

  • “This publication was made possible by Grant Number UL1 TR 000424 from the National Center for Advancing Translational Sciences (NCATS), a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCATS or NIH.” OR
  • “The project described was supported by Grant Number UL1 TR 000424 from the National Center for Advancing Translational Sciences (NCATS), a component of the National Institutes of Health (NIH) and NIH Roadmap for Medical Research, and its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCATS or NIH.”

Thank you for your cooperation in acknowledging the ICTR’s support in your publications.

The ICTR offers consulting and, in some cases, direct assistance with research data collection and storage issues. Among the services provided by RDCS are: advice on database contruction, design, and remote data access; web-based and teleform data collection; and secure storage and backup for data associated with clinical research studies.

For more information contact:

Dave Holmack
Phone: 410-955-0409
Email: david.holmack@jhu.edu

Kerry Stewart, EdD
Phone: 410-550-0870
Email: kstewart@jhmi.edu

The Research Participant Advocacy (RPA) Office provides consulting expertise on human subjects and regulatory issues, including IRB applications, the informed consent process, study feasibility and good clinical practice (GCP).

For more information contact:

Liz Martinez, BSN
Research Participant Advocate
Phone: 410-614-2717
Email: liz@jhmi.edu

Frederick Luthardt, MA, CCRP
Research Subject Advocate
Phone: 410-550-1850
Email: fluthard@jhmi.edu