MDHHS IRB Replaces COVID-19 Related Restrictions with Guidance on In-Person Research Participant Interactions
Effective June 15, 2020, the MDHHS IRB ended its requirement to pause most in-person interactions with research subjects. The required pause had been in place since March 19, 2020 and applied only to research approved by the MDHHS IRB and to exempt human subjects research in which MDHHS is engaged. The end of the MDHHS IRB requirement impacts only research that had been paused as a result of the initial MDHHS IRB imposed requirement. Research that is not affiliated with MDHHS is not affected by the end of the MDHHS IRB requirement. Researchers engaged in research involving MDHHS and other institutions should continue to be aware of and operate under requirements imposed by all involved institutions. This change in MDHHS IRB requirements is not meant to supersede more stringent requirements that may remain in place at other institutions.
Researchers conducting research that includes in-person interactions with research subjects may resume those interactions while considering the following guidance:
- Any in-person research interactions that were paused under the prior requirement may only resume if those interactions can be conducted consistent with MDHHS emergency orders, other MDHHS policies and orders, and the policies and requirements of any other locality, institution, or facility involved in or affected by the research.
- Researchers should continue to limit in-person contact where that is practical to the conduct of the research. Where research can be conducted either in-person or through remote methods (e.g., phone calls or secure electronic communication) remote methods remain preferred to in-person interaction.
- Researchers planning to resume in-person research interactions should evaluate the appropriateness of doing so by considering the local rates of transmission of the virus in the area/facility in which they are conducting research, and with particular sensitivity to the involvement of populations that may be at higher risk for negative outcomes resulting from COVID-19. Understanding conditions may change over time, researchers should prepare to pause in-person interactions again after restarting them where that will be important to the health and safety of research subjects and/or research staff.
- If special communications (not previously approved by the MDHHS IRB) are required to notify subjects that in-person interactions are resuming, those special communications must be reviewed and approved by the MDHHS IRB before they are implemented. Given concerns some subjects may have about interacting with others outside of their own household, researchers are encouraged to emphasize the voluntary nature of research participation and the rights of subjects to withdraw at any point without penalty or loss of benefit.
Researchers with questions or concerns about resuming in-person research interactions are encouraged to consult the MDHHS IRB at MDHHS-IRB@michigan.gov.