Read a memo from the UNC School of Medicine’s Clinical Research Support Office regarding the elimination of required SOM review process to engage in study activities involving direct contact with research participants.
Dear SOM Clinical Research Community,
Thank you for all your continuing efforts to promote safety and mitigate risk for study personnel and research participants in the context of COVID-19. As we have faced the pandemic together, we have worked collaboratively with our SOM research peers, infectious disease experts, and University, SOM, and UNC Health leadership to re-open and manage our human subjects research studies in a phased, careful, and sustainable manner.
Through ongoing evaluation and careful consideration, we have made the decision to eliminate the required SOM review process to engage in study activities involving direct contact with research participants. As of today, October 1st, investigators will not be required to submit any specific SOM application to initiate, resume, or modify direct participant contact activities. Please note, this is unrelated to and does not alter requirements for IRB or other regulatory reviews. Additionally, your department, center, or unit may have other required processes.
Although the formal application and review process is being eliminated, it is essential that investigators and study personnel remain cognizant of the responsibilities and careful considerations that must endure in the context of COVID-19. All SOM personnel must acknowledge and commit to the following:
- Activities involving direct contact with research participants should be limited as much as possible, and investigators should consider whether offering participation in the study presents any direct benefit to the participant or opportunity for the participant to contribute to a study that enhances understanding, treatment, or prevention of human illness. Studies that do not meet these criteria should not engage in direct contact with participants.
- Every investigator must ensure that human subjects research is as safe as can be for participants, staff and the health care system. We must never cut corners on implementing safe practices, but also must not waste PPE.
- Every participant must be informed of the risks and benefits in the context of COVID-19 and supported in the informed decision-making to enroll or continue with study activities.
- Clinical research operations must remain at 50% or less workforce on campus at any given time, unless specifically exempted from this requirement (generally for COVID-19 research or other critical programs).
If you have questions or concerns about these essential responsibilities or if you would like consultation on any decision-making process related to conducting human subjects research in the context of COVID-19, please contact us at email@example.com. The SOM Human Subjects Research Guidelines document has been updated to reflect this change; please continue to reference this document to ensure you stay up-to-date and compliant with requirements.
Please note, this guidance is specific to human subjects research activities conducted in SOM facilities and/or by SOM personnel. For studies conducted outside the SOM or by personnel from other Schools, please consult with relevant institutional leaders.