Human Subjects Research Guidance for Wake Forest University

Wake Forest University issues the following guidance for the conduct of human subjects research in response to the COVID-19 global pandemic.

To minimize Coronavirus risks to human research participants and to our community, some research activities must cease immediately and until further notice.

Which studies or study procedures must be paused?

This temporary cessation applies to all ongoing studies that involve in-person interactions or interventions with human research participants except the following:

  • Studies involving interactions or interventions that comprise or that can be modified* to appropriate remote interactions (e.g., web-based, telephone calls, text messages, emails)
  • Research on the diagnosis, treatment, interventions, or other research activities directly focused on COVID-19 and for which there is a substantial likelihood of direct and meaningful biomedical or behavioral health-related benefit or outcome

The above exceptions are subject to IRB review and approval. To request any other exception not listed above, contact the Associate Director for Human Research Protection Pam Moser moserpc@nullwfu.edu .

If you wish to *modify your active protocol to replace in-person interactions with appropriate remote methods, you must file an application amendment in eIRB. If you plan to return to in-person interactions after the COVID-19 crisis, draft your revised methods to allow for it.  By doing so, a second application amendment will not be necessary to reverse the first.

If your in-person study has currently enrolled participants, you must inform them as soon as practicable about the cessation of research interactions/interventions. Advise them that the study team will be in touch regarding rescheduling/resuming study visits and remind them that they can withdraw from the research without penalty. Neither a safety event nor amendment is required for these actions; however, the study team should document the details of the contacts (when, how, who) and retain a copy of the notification message.

If an external IRB reviewed and approved your WFU study, the research activities are also subject to this guidance.  Contact the external IRB to determine what, if anything, you must officially report to them, the sponsor, or the participants.

The WFU Institutional Review Board will only accept new eIRB applications that involve in-person interactions or interventions with human research participants if the studies meet the above conditions. New applications currently under review must also comply with this guidance.

ORSP IRB Administrators are available to answer questions at irb@nullwfu.edu.