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IRB-HSR > Protocol Review Process > Levels of Review > Determination of Exemption







Determination of Exemption

See also Exempt Criteria

Investigator Responsibilities

  • If the investigator feels the project meet the criteria for exempt determination, he/she should submit an Exempt application to the IRB-HSR office. The application is obtained via Protocol Builder. In order to fulfill requirements for the proper review of research, investigators cannot "self-exempt" from IRB review.
  • Studies that meet the DHHS exemption criteria do not necessarily mean that the investigator is exempt from informed consent or HIPAA requirements.
  • The exemption granted is only for the protocol as written at the time of the initial review when the decision to exempt was determined.
  • Investigators who conduct research exempt from IRB oversight must report any changes that may alter the study in such a way that it no longer exempt from additional review (e.g. now keeping identifiers with the data)

Exempt Reviewers Responsibilities and Process

  • Determination of exempt status will be performed by an experienced IRB staff member.
  • Research will be determined to be exempt only when the sole involvement of human subjects will be in one or more of the categories listed in 45 CFR 46.101(b)(1-6) or 21 CFR 56.104(a-d). The IRB staff member will
    • not consider any research exempt that involves prisoners (Except certain epidemiological research under category 4 that may qualify for exemption), sensitive aspects of subject's behavior, sensitive surveys, or that takes place in settings where subjects have a reasonable expectation of privacy.
    • not consider any research exempt that involves survey or interview procedures or observation of public behavior of children except for research involving observation of public behavior when the investigator(s) does not participate in the activities being observed.
    • not consider any research exempt that involves a test article regulated by the FDA unless the research meets the criteria for exemption described in 45 CFR 46.101(b)(6).
    • review the proposed research and will validate or decline the investigator's claim for exemption, ensure that risks to individuals are minimized, and confirm that the research meets ethical standards.
  • The IRB will document the review and action of the IRB staff member including the category specified in 45 CFR 46.101(b)(1-6) or 21 CFR 56.104(a-d) justifying the classification of exempt.
  • The IRB will promptly notify the PI in writing/email of its decision regarding the research.
  • If it is determined that the research is not exempt or if modifications are required such as submission of a consent document or strengthening of protections in place to minimize risks to participants, the IRB will include in its written notification a statement of the reason for its decision and give the PI an opportunity to respond in person or in writing. Final approval of exempt research is pending resolution of all minor modifications identified by the IRB reviewer.
  • If the IRB staff member determines that an application does not qualify for exemption, the application will be processed either through Expedited Review or by Full Board review. The PI will be notified and instructed to return to Protocol Builder and re-answer the questions and subsequently submit a new application.

Submission Process

Proceed to Protocol Builder. Answer the questions appropriately. When you get to the question- "Does this study meet exempt approval criteria? Answer the question YES. Protocol Builder will then provide you with the appropriate documents to complete.