The Centers for Disease Control and Prevention (CDC) has recommended the implementation of several community actions in an effort to reduce people’s risk of being exposed to COVID-19. These actions slow the spread, reduce the impact of disease (i.e., “flatten the curve”), and include items such as washing your hands and encouraging people to limit their exposure to others.
As organizations start to implement their response to the spread of COVID-19, it is likely that human subjects research will be affected. Possible changes to research protocols might include:
- Moving in-person focus group meetings online
- Decreasing the frequency of patient visits to healthcare facilities
- Shipping investigational products directly to research participants
- Increasing the frequency of home visits or an increased dependence on telemedicine
- Finding alternate procedures to provide medically necessary study care to participants who have been placed in isolation or quarantine
Federal regulations [21 CFR 56.108(a)(4)] require each IRB to:
… (a) Follow written procedures for ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects.
So – what is the appropriate process for making and reporting changes to your research study in response to the current COVID-19 pandemic?
Pearl IRB urges sponsors and investigators to take those actions they deem necessary to eliminate apparent immediate hazards to study participants. While considering your response to the pandemic, Pearl IRB urges an investigator to assess the risks (if any) to the enrolled subjects of suspending, or even continuing, the study. If a sponsor or investigator needs to make a change to research plans in order to eliminate apparent immediate hazards to research subjects, these changes can be made and then reported to Pearl IRB within 5 business days. Notification of the change in research may be a letter or other document that explains the changes being made and provides enough information for the IRB to evaluate the relative risks stemming from the change(s). Following this notification, the IRB will be able to provide further guidance as to whether an amendment or a protocol deviation is appropriate.
If you have questions, please contact Pearl IRB.