COVID-19 Clinical Research

Guidance and Coordination Advisory Committee

Memo from the Vice President for Research April 17, 2020

The Vice President for Research has established an advisory committee to coordinate, integrate and enable clinical research initiatives related to COVID-19.

The committee will provide rapid-turnaround initial screens of proposed studies prior to IRB review to align studies as needed to maximize access to resources and enhance feasibility and merit. The committee will consider community impact and compliance with evolving state and federal guidelines for assuring adequate protections to the community. When required, the committee has access to subject matter experts with a wide range of expertise.

This mechanism is intended to expedite and support the efforts of the research and participant communities in a way that enhances the quality and usefulness of the resulting data while minimizing burden on participants and the health care delivery system.

All proposed studies involving COVID-19 must be submitted to this advisory committee.

Email the following information to COVID19Research@wayne.edu

• Brief summary of the proposal and protocol
• P.I. name, contact information and affiliation
• Informed consent (if applicable)
• Confirmation of Department Chair approval

Following the committee’s assessment of the proposed research, you will receive the committee’s recommendation and input by email within two days. The chair of this Guidance and Coordination Advisory Committee is Manuel Tancer, MD, assistant vice president, HRPP.

The COVID-19 Guidance and Coordination Advisory Committee assessment includes the following considerations:

• Qualification of the research team

• Protocol:
  • Clear delineation between clinical care and research
  • Minimization of risks to the participants and the community
  • Impact on university/affiliate health system resources  
  • Feasibility 
  • Mitigation of potential personal and institutional conflicts of interest

• Recruitment:
  • Inclusion of an individual with a clinical relationship to the participant
  • Facility accessibility to the participant/legally authorized representative

• Consent Document:   
  • Clearly identified risks, time commitments, and benefits including whether the participant will be informed of the research findings
  • Inclusion of clear opt-in authorization checkboxes for future use authorization of the data, storage of samples, and permission to be contacted in the future about other projects

• Biological Safety:
  • Adherence of the research to regulatory and institutional safety guidance for working with COVID-19

ADDITIONAL CONSIDERATIONS

It is important to appreciate the burden on the community in relation to COVID-19 research. Researchers must be mindful that participants may become overwhelmed by the many research opportunities presented to them. 

Community awareness of the public health crisis research is especially important at this time. The IRB non-scientist/community member’s input will be explicitly solicited during the IRB meetings. Their review will consider recruitment and consent procedures to ensure the participant’s comprehension of the research. In addition, researchers should seek input from relevant community advisory groups already involved with various targeted areas of research activities at the university.

In this context, in accordance with our commitment to the highest standards for our Human Research Protection Program and our responsibilities to the communities that we serve, all of our activities involving human subjects are guided by, and in compliance with the principles of the Belmont Report and ethical codes of conduct for research including the Declaration of Helsinki, and the Nuremberg Code and Good Clinical Practice.