IRBMED: Human Research During COVID-19

During the COVID-19 pandemic, IRBMED has committed to responding to matters associated with human participant research as circumstances evolve. Study teams are encouraged to monitor this website for changes in workflows and guidance. IRBMED and its review functions remain fully operational.

  • Direct questions for specific IRBMED applications to the IRB staff owner of the submission (this information is available in eResearch). 
  • Send general questions regarding IRBMED submissions to irbmed@umich.edu

Recent U-M Research Guideline Announcements During COVID-19

  • Michigan Medicine teams must adhere to all of the most up-to-date policies of Michigan Medicine (i.e., Masking requirements). 
  • U-M research team members must wear a face covering, regardless of vaccination status, when conducting face-to-face interactions with human research participants. This applies both on and off U-M property.
  • If a research participant has had a recent COVID-19 diagnosis or screens positive on any university-required screening (ResponsiBLUE daily health screening survey), except for studies related to COVID specifically, the study visit must be rescheduled. If the individuals accompanying the participant to the study visit have a recent COVID-19 diagnosis or screen positive on any university-required screening (ResponsiBLUE daily health screening survey), the individuals may not accompany the participant to the study visit, or the study visit must be rescheduled.

 

May 25, 2021

The requirement that studies submit a Human Research Activation Checklist has been suspended as of 5/25/2021. This suspension does not indicate the return to pre-COVID-19 research conditions. The safety of research participants, individuals accompanying them in their research participation, the research workforce, and our broader communities, is the leading priority. Study teams must adhere to all of the most up-to-date university policies as outlined on the UMOR Research Re-engagement website.

 

U-M Office of Research Guidelines During COVID-19

UMOR Research Re-engagement Website

Important Communications from U-M Vice President Dr. Cunningham

 

IRBMED Guidance During COVID-19

Reporting Time-Sensitive Modifications

IRBMED Guidance: Reporting Time-Sensitive Modifications (December 14, 2020)
 

Single IRB and Multi-Site Research Information for Research Reactivation

Ceded studies

Studies that are utilizing an external IRB must still follow all UMOR procedures for human research during COVID-19. 

sIRB Instructions

All UM study teams will need to collect current information from each participating site regarding current, local study status. If UM is the IRB of Record, as the lead study team, download this Single IRB COVID-19 Checkpoint Survey for Participating Sites and fill out the study title and HUM#. After that is done, send this document to all of the participating sites that UM IRBMED is the IRB of record for. Each site will need to fill out the survey and return it as directed at the bottom of the survey.  

 

Emergency Use of a Test Article

Procedures to request emergency use of an investigational test article will remain the same. For additional information, refer to https://az.research.umich.edu/medschool/guidance/emergency-use-test-article-life-threatening-circumstances

 

 

IRBMED FAQs: Research During COVID-19

  • Also see the UMOR Research Re-engagement website for guidelines on how to safely continue research and scholarship on Human during COVID-19.

Archive of IRBMED News, Updates and Announcements Related to COVID-19

An archive of IRBMED news, updates and announcements related to COVID-19 are published here​​​. 

Additional Human Research Guidance During COVID-19

COVID-19 Guidance Related to Informed Consent Procedures

Research Informed Consent Procedures for COVID-19 Positive Patients (April 22, 2020)

Note: The ‘Wet Ink Signature / No Photo’ and ‘No Signature’ methods are not to be utilized outside of COVID-19 circumstances as they represent FDA guidance for obtaining consent during the pandemic. Contact IRBMED (irbmed@umich.edu) or 734-763-4768) with questions about these procedures.

PREP ACT Language for COVID-19 Research Informed Consent (April 16, 2020)​​

Informed Consent Procedures Using Electronic Systems & Remote Use of Paper Documents (Updated April 9, 2020)

​​​​SignNow for Electronic Informed Consent Procedures (April 9, 2020)

U-M SignNow, E-Signature Service available for use by U-M staff, faculty, researchers, and students.

Medical School Research Operations

Current status of U-M Medical School COVID-19 Research Operations 

OHRP Guidance

OHRP Research Guidance on Coronavirus  (April 8, 2020)

FDA Guidance

  • 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)

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.