Wayne State University

Revision to Federalwide Assurance increases flexibility of review and oversight of human participant research

Wayne State University (WSU) revised Section 4 of its Federalwide Assurance (FWA) with the Office for Human Research Protections (OHRP) and will no longer voluntarily apply the “Common Rule” federal regulations (45 CFR 46) to all research. Referred to as “unchecking the box,” this revision allows WSU to have more flexibility in the review and oversight of human participant research.

What does this mean to me? 

Previously, the maximum term for Institutional Review Board (IRB) approval of human participant research at WSU was one year.  By unchecking the box, research projects that present no more than minimal risk to human participants are potentially eligible for flexible review and oversight with maximum approvals of three years.

Additionally, some eligible studies that previously required expedited review may now qualify for an exemption from IRB review. Two new exempt research categories involving review of records, surveys, interviews, focus groups, and other low risk activities with both adults and minors have been added.

This revision should reduce the turn-around time for IRB submissions, especially those that fall within the eligibility criteria. 

What studies are eligible?

Only research projects that present no more than minimal risk to human participants are potentially eligible for flexible review and oversight (at the discretion of the IRB).  Federally sponsored studies, projects with Food and Drug Administration (FDA) regulated components (for example, clinical trials), projects targeting prisoner participants, and projects with contractual obligations or restrictions that require adherence to federal regulations are not eligible for flexible review and oversight.

IRB review is still a requirement for all human participant research conducted at WSU and the WSU Human Research Protection Program still provides ethical oversight of all human participant research.

Please see: Policy 1-5, Flexible Review and Oversight of Research Not Covered by Federalwide Assurance, at: http://irb.wayne.edu/policies-human-research.php