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Submissions :: Protocol review process :: Expedited/Exempt Review :: Exemption

Exemption

The federal regulations identify categories of research methods that can be exempted from IRB review. These categories imply that the protocol is minimally risky and certain aspects of the study do not require the Board’s continuous review.  This section describes the categories in the federal regulations that specifically relate to the social and behavior sciences and highlights some of the qualifications a protocol must meet in order to satisfy the requirements for exemption:

Why do I submit an exempt protocol?
If a protocol is exempt from IRB review, why does the IRB still review it? In order to determine if a protocol meets the requirements for exemption, a neutral third party experienced in IRB review needs to make this determination and the IRB is equipped to make such a review. Some exempt studies involve participants that are considered risk-sensitive, so it is important that these studies still receive a careful review even if they are ultimately considered minimally risky. An exempt protocol goes through the same pre-review process as an approved study. Our experienced staff often receives protocols that are not exempt but could be if a few changes are made to the study protocol. We work with researchers to help them meet the requirements for exemption where possible by reducing risks, thus saving time and future hassle for the researcher while still protecting participants. 

Comparing exempt protocols with full board protocols:

  • Shorter review time: Exempt protocols go through our expedited review process.  An exempt protocol is reviewed by a pre-reviewer and then sent to a Board Member, who gives the final designation of exemption. On average the review can take two weeks, though this can depend on the number of protocols in the queue.  A protocol that needs full board review usually requires at least one month for review. For more information about the review process, please see Submission: Review.

  • Modified consent requirements: If a protocol is exempt, the Board does not have to require the researcher to consent participants.  In some cases, providing the information on a consent form is advisable.  For more information about consent issues, please see When Consent Is Not Required.

  • No continuous review: Exempt protocols are given a four year “open protocol” status.  During that time, our office will contact you once pre year via email to find out if you are still collecting data, etc, to which you need only respond.  Approved protocols are required to submit requests for continuation every year as the approval period is only granted for one year.  If the exempt study will continue beyond four years, you will be asked to resubmit the protocol with an explanation of the current status of the study. 

  • Submission requirements and pre-review requirements are the same.

Section Topics

Normal Educational Practice
Educational tests, survey procedures, interview procedures, observation of public behavior
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