Hello Colleagues,
My institution is refining our policy regarding IRB applications that have been reviewed and returned to investigators with review comments/request(s) for revision(s) but are languishing in our online system with no additional response from the investigators. So I'm hoping to get input on whether or not other institutions have a policy in this regard. Specifically, I'm interested in finding out whether or not your institution has a policy regarding withdrawal/closure of an IRB application/submission
by your office due to a lack of response by investigators. If your institution has such a policy;
- Is the policy unofficial or official (posted on website, noted in the notification of review comments/request(s) for revisions, etc.)?
- What is the timeframe after which your office would withdraw/close the application/submission (e.g., 90 days, one year)?
- Does your office send a reminder/notification that the study will be closed/withdrawn after a certain date and, if so, can the investigators request an extension?
- Have you had any issues arise after withdrawing/closing a study?
- Is there any other relevant/related information you'd like to share?
If your institution does not withdraw/close for a lack of response, I'm interested in the reasoning for not doing so.
I thank you in advance for any input you can provide!
Jenn
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Jennifer Dier CIP, CIM, CHRC, CCRP
Assistant Director, Office of Research Compliance Administration (ORCA)
University of California Santa Cruz
jdier@ucsc.edu------------------------------