Novel Coronavirus (COVID-19): IRBMED News and Updates

March 27, 2020

IRBMED is committed to responding to matters associated with human participant research as the COVID-19 circumstances evolve. We encourage study teams to monitor the IRBMED website for any changes in workflows and for additional guidance.

At the current time, IRBMED and its review functions are fully operational. IRBMED staff are working remotely. 

NEW! COVID-19 Research Prioritization Committee

The U-M Office of the Vice President for Research (UMOR) has organized a Research Prioritization Committee to review and prioritize new or modified research projects related to the study of COVID-19. During this COVID-19 situation, resources are expected to be limited in the health care system, in laboratories, and compliance committees. Therefore, any project that involves university resources, including human subjects, basic laboratory and animal research, or requires significant university resources must complete an intake form for committee review. This process is needed to prioritize these projects, to relieve the burden on resources and to ensure the timeliness and benefit of the research.

For more information about the committee, and to access the intake form, go to the UMOR page (https://research.umich.edu/covid-19). The section titled “COVID-19 Research Opportunities” contains important information for researchers, and the blue box on the right side of the page has a link to the intake form.
For new research or an amendment to an existing application involving human subjects (including exempt, exempt self-determinations, and not-regulated activities), project approval by the prioritization committee is required before IRB approval or acknowledgement can be issued. Submit the committee’s approval/authorization in Section 44 of the IRB application.

If you have questions, please email research.covid19@umich.edu
 

FDA Guidance on Conduct of Clinical Trials of
Medical Products during COVID-19 Pandemic 

On March 18, 2020, the U.S. Food and Drug Administration issued guidance for institutional review boards (IRBs), industry, and investigators conducting clinical trials during the coronavirus (COVID-19) pandemic. The FDA recognizes that challenges during the pandemic may lead to difficulties in following procedures, including administering or using investigational products, adhering to protocol-mandated visits, and conducting laboratory/diagnostic testing. FDA also recognizes that protocol modifications may be required, and that protocol deviations due to COVID-19 illness and/or COVID-19 control measures may be unavoidable. The guidance provides considerations for ongoing trials and a recommendation for sponsors, clinical investigators, and IRBs to establish policies and procedures to manage study conduct and protect trial participants if such policies and procedures are not already in place. 

Of note regarding documentation for missed protocol-specified procedures, the FDA urges investigators to capture specific information in the case report form that explains the basis of missing data, including the relationship to COVID-19 for missing protocol-specified information (e.g., from missed study visits or study discontinuations due to COVID-19).

Access the full FDA Guidance here.

IRBMED COVID-19 Related Guidance for Researchers 

IRBMED guidance detailing when and how to submit urgent modifications to either eliminate an apparent immediate hazard to subjects (rare), OR submit time-sensitive modifications in response to COVID-19 when subject safety is not a concern. When subject safety is not a concern a standard amendment should be submitted unless one is in progress. When an amendment is progress, some urgent modifications are eligible for approval through an ORIO submission in eResearch. See below.

  • Submit study-specific questions to the IRBMED staff owner identified for the study in eResearch.  
  • Submit any general questions to irbmed@umich.edu.  This email will be monitored during normal business hours and over the weekend. Responses will be provided within one business day.

Other Important U-M Resources: COVID-19 Related Research Operations