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Human Subjects Division (HSD)

Announcements

IRB Records: Access and Copying for Researchers

Jul 8, 2009 at 1:27pm
The Human Subjects Division often receives requests from researchers for copies of IRB documents that are missing from the researcher's file.  Unfortunately, we will generally no longer be able to fulfill these requests, effective immediately. It is the researcher's responsibility, per federal regulations, to maintain a file of all documents relevant to IRB review throughout a research study and for at least three years after the study is closed.  The records should be a mirror image of the IRB's records, which means:  (1) all documents submitted by the researcher to HSD and the IRB, and (2) all correspondence between the researcher, HSD, and the IRB.  The IRB files at HSD are official University records and are required by federal regulations governing human subjects research.  Their integrity must be maintained at all times.  This means that individuals outside of HSD, the IRB, and compliance groups cannot be allowed unmonitored access to the files.  Due to staff time constraints, HSD staff are not available to assist researchers in comparing their files with the official IRB files.  We understand that there are unavoidable circumstances when an IRB document may be needed.  If this should occur, a request for copies may be fulfilled only if the researcher or designee provides HSD staff with sufficient written justification.