UNIVERSITY OF MICHIGAN MEDICAL SCHOOL

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IRBMED
517 W. William, Argus I,
Ann Arbor , MI 48103-4943
Email: irbmed@umich.edu
Phone: (734) 763 4768
FAX (734) 763 9603

Updated IRBMED Adverse Event Reporting and Other Reportable Information and Occurrences Guidance

On October 1, 2007, the Medical School Institutional Review Boards (IRBMED) will post new guidance for reporting adverse events (AEs) and other reportable information and occurrences (ORIOs). This update is in response to federal guidance from the HHS Office of Human Research Protections (OHRP) and draft guidance from the HHS Food and Drug Administration (FDA) issued this year.

Key Changes

1. Effective 10/1/07 —Submission to the IRB of reports of single AEs that occurred at non-UM sites (external AEs, including those on multi-site trials) will be required only if one of these criteria is met:

•  The AE is judged by the study sponsor, DSMB, or principal investigator (PI) to constitute an ‘unanticipated problem involving risks to the subjects or others' (hereafter referred to as ‘unanticipated problem'). Click here for detailed guidance on unanticipated problems.

•  The AE results in a change to the research (e.g. a change to the risk section of the informed consent document)

This change is effective October 1 even if the investigators received the reports prior to 10/1/07. The new federal guidance stresses that routine IRB review of external adverse event reports that do not constitute ‘unanticipated problems' is an inappropriate allocation of IRB resources.

If the PI has another justification (e.g. it is required by contract with a sponsor) the IRB will accept a non-required report.

Note that this change in policy does not alter requirements for investigators to submit a report that is an analysis, safety, or statistical report from an oversight entity (e.g. FDA letter, Periodic Sponsor Report of all AEs, Data and Safety Monitoring Board Report).

2. Effective 11/15/07 —Required timeframes for reporting will be in ‘calendar days' rather than ‘working days.' This change will not be enforced until 11/15/07 to give investigators the opportunity to adjust to the shorter turnaround time.

Main Impacts on Investigators and Study Teams

1. Studies involving drugs will have a significantly reduced reporting burden.

2. Study teams need to understand when events constitute an ‘unanticipated problem' (UaP). New guidance will be posted on the IRBMED website.

3. This change will open up IRB reviewer and meeting agenda time, allowing new studies and amendments to be presented more quickly after IRBMED receipt than under the current system.

4. Some reports that had been due in 7 or 15 working days will now have a shorter turnaround time with submission to the IRB required in 7 or 14 calendar days.

5. eResearch studies: AEs that result in a change in a study but are not an unanticipated problem will not need to be submitted via an adverse event (‘ADV') reporting form. Instead they can simply be included as a supporting document in section 44 of the amendment. This will reduce reporting burden on study teams and IRB reviewers/agendas.

For More Information

The IRBMED will be offering an information session to the research community on Monday, October 29, from 1:45 to 3:15 in the MCHC Auditorium. If you would like to request a session for your specific department/unit, please contact the IRBMED to arrange a date and time.

The revised guidance was posted on the IRBMED website on 10/1/07.

For more information see the IRBMED website or email irbmed@umich.edu .

For a PDF announcement letter suitable for sponsors, click here.

 

Posted 9/26/07, updated 10/5/07