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Non-Exempt Reviews

Non-Exempt:  Expedited Review

The Institutional Review Board (IRB) will provide expedited review for proposed research that presents no more than minimal risk to human subjects and consists of:

  1. research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior); or
  2. research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation or quality assurance methodologies; or
  3. other research for which expedited review is authorized by the U.S. Department of Health and Human Services (HHS) Office for Human Subjects Research Protection (OHRP)

Investigators submitting a request for approval of non-exempt research should submit a Standard IRB Application for Non-Exempt Research, paying special attention to the submission checklist on the last page of the application to ensure that the submission is complete. 

Expedited Review Procedure

"Expedited review" does not mean a "fast" review.  Under an expedited review procedure, review of certain types of research which meet the specified criteria may be carried out by the IRB Chair and by one or more experienced reviewers selected from members of the IRB (not Full Board) outside of the time of a convened IRB Committee meeting, in accordance with 45 CFR 46.110.  In reviewing the proposed research, the reviewers may exercise all of the authorities of the IRB, except that they may not disapprove the research. A research activity may be disapproved only after a Full Board Review.

Proposed research shall be deemed approved by the IRB when it is approved by the designated reviewer or reviewers and by the chairperson. Investigators shall receive an email notification of approval, as well as an official Notice of Approval document signed by the IRB Chair or Vice Chair.  If applicable, faculty sponsors will be copied (cc'd) on the email notification. 

Excluded from Receiving Expedited Review

No expedited review shall be available if identification of the subjects 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.

Non-Exempt:  Full Board Review

When an IRB reviewer determines that a study does not meet the criteria for Exempt or Expedited Review, a Full Board Review is requested, at which a majority of the IRB members review and vote on the proposal.  The need for a Full Board Review typically involves projects that place human subjects at more than minimal risk, and/or that involve sensitive topics* or vulnerable populations, such as children, prisoners, institutionalized individuals, or persons with diminished capacity to consent (e.g., Alzheimers patients).

*Sensitive topics include:  sexual orientation, sexually-transmitted diseases, incest, rape or date rape, sexual harassment, molestation, race relations, use of licit or illicit drugs, eating disorders, abortion, contraception or pregnancy, the subjects' own mental health (suicide, depression, compulsive behaviors), religion, illegal conduct, stressful experiences.