Johns Hopkins COVID-19 Clinical Research Coordinating Committee

All COVID-19 research involving participant interaction must be reviewed and approved by the COVID-19 Clinical Research Coordinating Committee

 

APPLY TO THE COMMITTEE (Approval letter is a required component of the IRB application)

 

CONTACT THE COMMITTEE:  COVID19ResearchCtr@jhmi.edu

 

PRIORITIZATION PROCESS FOR COVID-19 RESEARCH INVOLVING PARTICIPANT INTERACTION

APPLY
Before IRB submission, investigators must submit their study for review by the COVID-19 Clinical Research Coordinating Committee (CRCC) as noted above. The purpose of the CRCC review is to establish the study priority according to the guiding principles below, and to provide consultative advice on trial implementation.

PRESENT
Investigators for interventional clinical trials will provide the CRCC members with the study protocol and present an overview of their clinical trial via Zoom using the provided PowerPoint template.

Investigators should present the study in the framework of the guiding principles for COVID-19 clinical research at Johns Hopkins and outline the specific plans for study implementation. Ongoing studies should provide an update of study progress and review any barriers to successful implementation.

CRCC members will evaluate interventional studies considering the guiding principles below, and prioritize the clinical trial in the context of other actively recruiting trials at Johns Hopkins by ranking the studies. The priority list linked below is updated weekly and posted on Microsoft Teams, and is used to guide study recruitment when a patient is a candidate for more than one active clinical trial.

Current Priority Ranking for Enrolling Hospitalized Patients in COVID-19 Clinical Trials (JHED login required)

 

GUIDING PRINCIPLES FOR PRIORITIZING COVID-19 RESEARCH

Research Imperative: Given uncertainty about the appropriate treatment of COVID-19 as well as its diagnosis and prevention there is an imperative to conduct research.

Scientifically and Ethically Sound Research: Research must be scientifically sound and meet standard ethics and regulatory criteria.

Potential to Be Informative: Research that is rigorously designed and most likely to be informative gets priority.

Responsible Stewardship: Prioritization will take into account the impact of research on precious resources (including patients, staff, materials and funds) to minimize risks and burdens.

Balanced Portfolio: Prioritization will aim to achieve a balanced institutional portfolio with regard to characteristics including stage of disease, phase of research, population, equity, and expected enrollment target.

Collaboration: Contribute to large multi-center randomized controlled clinical trials that are likely to be completed and thereby have the potential to establish or change standards of care or to identify convincingly which interventions are safe and effective.

Equity: Prioritization will take into account the needs and interests of those most affected by COVID-19.

Changing Priorities: Rapidly changing understanding and contours of the pandemic may shift priorities.

Fair Allocation: Access to scarce resource opportunities must be allocated fairly.

Transparency: The process of decision-making regarding research prioritization must be transparent to relevant stakeholders.

 

COMMITTEE MEMBERS
 Richard Rothman, MD, PhD (co-chair)  Janet Mighty, MBA
David Thomas, MD, MPH (co-chair) Richard Moore, MD
Robin Avery, MD Sumati Murli, PhD
Ryan Belecanech, MD Megan Ossing
Roy G. Brower, MD VInciya Pandian, PhD, MBA, MSN, RN, ACNP-BC, FAAN
Shaker M. Eid, MD, MBA, CPE, SFHM Deborah Persaud, MD
Daniel Ford, MD, MPH Sarina Sahetya, MD,MHS
Rachel Hampton Lauren Sauer, MS
Craig Hendrix, MD Zishan Siddiqui, MD
Maureen Horton, MD Megan Singleton, JD
Noreen Hynes, MD, MPH Jeremy Sugarman, MD
Kim Kafka, BSN, RN Mark Sulkowski, MD
Gregory Kirk, MD, PhD, MPH Stephanie Swords, MA, CCRP
Carol Kobrin, PhD Bob Wise, MD
Jackie Lobien, BSN, ACRP-CP Tamara Lotan, MD