HRPP policies & procedures manual

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400: Exempt review

1. Purpose

The purpose of this policy is to describe the research process, review, and determinations for exempt reviews.

2. Policy

All research including that in the exempt categories must meet, at a minimum, the principles outlined in the Belmont Report and meet the University’s ethical standards. Determination of exemption will be based on regulatory and institutional criteria (see Exempt Application).

3. Specific policies

3.1 Exempt project submission requirements

Research activities that meet the requirements for one or more exempt research categories must be reviewed by the IRB staff.

The investigator must complete the appropriate exempt application and submit the application along with (if appropriate or requested by the IRB staff):

  • Research tools: questionnaires, surveys, etc.
  • Consent statements, informed consents, assents (Recommended and not required. IRB does not review these documents. However a statement saying that participants will be fully informed needs to be there.)
  • Recruitment materials
  • Translations (not required for exempt reviews, but reflects best practices per Belmont principles)

3.2 Exemption categories and determinations

Research activities in which the only involvement of human subjects will be in one or more of the exempt categories (see Appendix), may be approved as exempt. The chair, designee, ORA director, or IRB coordinator will review the exempt application and make a determination.

Policies do not allow exemption of research involving audio, video or digital recordings or photography, unless it is only for transcription purposes. Surveys or interviews that are extremely sensitive or personal will not be exempted.

3.3 Approval period

Studies receiving an exemption certification from the IRB staff will be valid for 3 years. IRB office will deactivate the projects after the expiration date. A new project submission, review and approval is needed to continue the study. During the active research, the investigator will keep the IRB informed of any changes in the study, so that the IRB can ensure that the study continues to meet the exempt criteria.  Any change to the study will be submitted as an amendment.

The investigator may close out the study when data collection has ended or when contact with subjects is complete.

3.4 Documentation of exempt review

If the study qualifies for exempt review, the reviewer will complete the Exemption Determination Checklist,

which will be used as documentation.

3.5 Investigator and IRB members notification

The investigator will be notified by e-mail of the exemption determination.

Each month exempt certifications will be listed on the IRB meeting agenda.

4. Applicable regulations and guidelines

21 CFR 56.104, 56.105

5. Forms

Exempt application (also known as the Exemption Determination Application)

6. Procedures employed to implement this policy & assignment of responsibility

IRB staffReview submitted projects to determine claims of exemption using the Exemption Determination Checklist. The staff may:
• Approve the request.
• Request revisions and/or additional documentation from the principal investigator.
• Disapprove claim of exemption and send for expedited or full-board review.
• Email determination of exemption.

Document approval of exemption category on exemption application.
IRB staffReport exemption determinations on IRB meeting agenda.

Maintain documentation of exemption application submissions and determinations.