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IU Human Subjects Office: New IRB Initiatives

January 3, 2013

Exempt Guidance

The Human Subjects Office (HSO) is happy to announce new guidance for investigators conducting Exempt Research. In an ongoing effort to ease compliance and university burdens while providing adequate protection of research subjects, this new guidance accompanies an updated form to be used for Exempt Research submissions to the Human Subjects Office.

As of January 1, 2013 the updated Exempt Research Checklist should be used for all Exempt submissions. It is available for download from our forms page at http://researchadmin.iu.edu/HumanSubjects/hs_forms.html. We hope that this checklist will better elicit the information needed for staff in the HSO to more quickly determine if a study is eligible for exemption.

Please review the guidance document before submitting your IRB application if you are considering conducting minimal risk research. If you have any questions or concerns about these or any IRB-related process, please contact your HSO team. Team information is available on the HSO website at http://researchadmin.iu.edu/contacts.html?officeId=S3.

Expedited Approval Changes

The Human Subjects Office is proud to announce that qualifying expedited studies that are neither federally funded nor federally regulated are eligible for an approval of two years.

Qualifying Expedited Studies

Effective January 1, 2013, expedited new studies that are not federally funded or subject to federal regulations may be approved for a period of two years. In addition, as current expedited studies are renewed via continuing review, studies that qualify may receive approval for two years.

Federal funding includes federal pass-through funding so that any expedited study receiving federal funds directly or indirectly is ineligible for a two-year approval period. Likewise, expedited studies that are subject to federal agencies such as the FDA, VA, or DOJ are ineligible for a two-year approval period. Instead, expedited studies receiving federal funding or subject to federal regulations are eligible for a one-year approval period.

In light of these changes, it is imperative to update the HSO if your source of funding changes.

The HSO and the IRBs believe this change to the approval process will benefit investigators conducting minimal risk studies without increasing risks to subjects. If you have any questions or concerns about these or any IRB-related process, please contact your HSO team. Team information is available on the HSO website.