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 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 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.

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 Data and Safety Monitoring Service (DSMS) offers both consultation and direct assistance with the creation of Data Safety Monitoring Plans (DSMPs) and Data Safety Monitoring Boards (DSMBs).

Specifically, The DSMS offers assistance to investigators who need Data Safety Monitoring Plans, as required by the IRB, ICTR CRUs, NIH, or industry sponsors. This assistance ranges from advising PIs on the adequacy of submitted DSMPs to generating comprehensive DSMPs commensurate with the scale, risk level, and design of a protocol.

In addition, investigators may engage the DSMS in the preparation of Data Safety Monitoring Boards, including advising upon and drafting DSMB operational Plans, or “charters.”

For more information contact:

Frederick Luthardt, MA, CCRP
Research Participant Advocate
IRB Compliance Specialist
Phone: 410-550-1850
Email: fluthar1@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.

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.

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.

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.

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.

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.

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.

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