Exemption Review

Exemption Review

Eligibility

The Exemption review procedure is applicable only for activities that fit the federal categories, which are listed on the Exemption Review Application. Questions of interpretation regarding the exemption application may be directed to the OIRB at 934-3789.

Any modifications to the protocol require IRB review to assure the modifications do not change the exempt status of the protocol.

Only the IRB can assign Exempt status.

Activities Not Allowed

Federal regulations specify that the following research activities cannot be exempt:

  • Review of records if the information gathered from those records is recorded in such a way that it can be linked back to the subject either directly or indirectly through the use of a code;
  • Surveys or interviews given to children (individuals younger than 19);
  • Observation of children if the investigator participates in the activities being observed unless there is a federal statute covering the activity.

Decision Trees

OHRP has published decision trees to help in determining whether a research proposal fits the criteria for Exempt, Expedited, or Full review. The charts are available at http://www.hhs.gov/ohrp/policy/checklists/index.html to help investigators determine whether their proposed research may be eligible for exemption.

Procedures for Requesting an IRB Exemption

The investigator obtains departmental review for scientific integrity and other required approvals (see "Before Applying for IRB Review"); completes, signs, and dates one copy of the Application for Exemption Review; and submits the application materials to the OIRB (AB 470, 0104). Additional application requirements are determined by specific protocols:
  • Faculty Advisor or Course Instructor’s name, signature, and e-mail address if the Principal Investigator is a student, resident, or fellow.
  • Funding application and OSP Assigned Number if the study is externally funded.
  • One copy of any questionnaire, survey, or test to be used.
  • One copy of the specimen release form or letter of approval if the investigator will be obtaining pathologic or diagnostic specimens.
There are no deadlines for submission of an Application for Exemption Review.

Page updated: May 8, 2013