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Extended IRB Approval

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Extended IRB Approval

Extended IRB Approval

The campus Office for the Protection of Research Subjects (OPRS) allows flexibility in its application of human-subjects federal regulations to non-federally supported research. Effective January 17, 2017, OPRS will implement procedures for granting IRB approval, for eligible protocols, for an extended period of three years.

Studies Eligible for Extended IRB Approval

Studies Not Eligible for Extended IRB Approval

  • Research subject to Federal Oversight: Projects receiving federal support; implemented at the direction of federal agencies; or otherwise subject to federal oversight are excluded from this policy. Examples of Federal Oversight include:
    • Federal sponsorship, directly or indirectly, including federal training and program project grants
    • Research directed or overseen by a federal agency that has signed on to the Common Rule, including every agency within the Department of Health and Human Services
    • Student projects for which a faculty sponsor uses federal funding to support the project
    • Federal no-cost extension
    • Studies subject to FDA oversight
    • Studies employing a Certificate of Confidentiality (issued by the NIH)
    • Studies for which the U of I IRB is serving as the IRB of record for any institution which applies the federal standards to all research regardless of source of funding
    • Research subject to Conflict of Interest review
  • Studies invovling greater than minimal risk
  • Studies with contractual obligations or restrictions precluding eligibility to this policy (e.g., a non-federal sponsor or funder of the research which requires annual review)
  • Studies involving data collection or data analysis on prisoners or those under court order

The U of I IRB and OPRS reserve the right to make exceptions to this policy, and the conduct of any research project under this procedure will be at the IRB's discretion (e.g. prior noncompliance).

If the U of I IRB determines a study to be eligible for extended IRB approval, this determination will be referenced as part of the protocol approval letter. Studies granted an extended approval period will remain subject to all post-approval submission requirements. The Responsible Project Investigator (RPI) will remain responsible for submitting:

  • modifications to the study (must receive IRB approval prior to implementation);
  • reports of adverse events, protocol violations/incidents, and other safety information meeting OPRS reporting criteria;
  • a continuing protocol application (renewal form), at least 4-6 weeks prior to the study's expiration date, if the study is still active.

If there are any changes to the protocol that result in it being ineligible for extended IRB approval, the RPI is responsible for notifying the IRB via an amendment immediately. The protocol will then be issued a modified expiration date accordingly.