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Level of Review

Here we explain each of the three levels of IRB review that are available:

  • Exempt Review/Registration
  • Expedited Review
  • Full Committee Review

Exempt Review/Registration

Technically exempt from the need for IRB review, this type of research does require OIA review and registration. To qualify, research must fall into one or more of the eight federally-defined exempt categories.

Currently, OIA does not plan to use the Revised Common Rule (2018 Requirements) Exempt Category 7 or 8. Refer to the Exempt Categories section for a full list and descriptions.

 To be classified as exempt, the research:

  • Cannot involve any of the exceptions for the exempt categories for research that involve children; AND
  • The study cannot involve prisoners unless the research is aimed at involving a broader subject population that only incidentally includes prisoners and is funded by DHHS, DoD, the VA, NSF, or the Department of Education OR the research does not involve any interactions with prisoners.

Exempt Concurrence

OIA does not enter into reliance arrangements for exempt research. When collaborating with an outside entity that will be engaged in activities that meet the criteria of exempt research, OIA allows an investigator to request a concurrence with the outside entity’s exemption determination. An exempt registration application is required to be submitted for a concurrence determination.

Additional Important Information

Exempt studies have no expiration date and do not require continuing review.

For exempt research only, you can make changes to your study without notifying the IRB so long as the changes will not alter the IRB’s Exempt determination. See the Exempt Amendments guidance document for details.

Expedited Review

While the name of this review type implies a quick review, the term “expedited” has nothing to do with the speed of the review. Federal regulations allow certain types of applications to be reviewed by a single reviewer instead of a full committee of the IRB, and the term for this type of review is “expedited”.

To qualify for the expedited review procedure (for initial, amendment, and renewal submissions), the research: 

The expedited review process cannot be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

Full Committee Review

All human subject research projects that fall outside of the review criteria for exempt and expedited reviews are reviewed by the Full Committee at a convened meeting. There are five biomedical/clinical committees and one social and behavioral committee.

 Full committee review is required for:

  • Greater than minimal risk studies OR
  • Studies that are minimal risk, but do not fit in an expedited review category.