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Exempt Review Tip Sheet

Revised Human Subjects Regulations (Common Rule) Wednesday, June 20th 2018

The regulations that human subjects researchers must adhere to (referred to as the Common Rule Regulations) were established in 1991. In 2011, federal agencies began the long-awaited process to revise these regulations and, on January 18, 2017, the final revisions to the Common Rule (Final Rule) were posted in the federal register. The effective and implementation dates have recently changed. As posted in the federal register on June 18, 2018, the revised final Common Rule is both effective and to be implemented on January 21, 2019 with the option of implementing 3 burden-reducing provisions before January 21, 2019. Learn more about the regulations.

Research involving surveys, interviews, the use of existing data, taste and food-quality evaluation and standard educational research generally fall within the exempt category. Projects that are considered exempt must be less than minimal risk to the participants.

An IRB Coordinator or IRB member must review the application and determine that the project is exempt from expedite or full review. Once a protocol has been determined to be exempt, the protocol is not monitored by the IRB on an ongoing basis.

  • If the research qualifies for exemption, a notification will be forwarded to the PI & CoPI(s), if applicable.
  • Please keep the notification for documentation that the project is considered exempt.
  • A determination that research is exempt does not absolve the investigators from ensuring that the welfare of human subjects participating in research activities is protected, and that methods used and information provided to gain subject consent are appropriate to the activity.
  • The PI must notify the IRB Coordinator if any proposed changes to the research will be made. At that time, an IRB Coordinator or IRB member will determine whether the status of the research has changed.
  • Any complaints that may have been received during the course of the research must also be reported to an IRB Coordinator.

If your project meets the Exempt criteria, it will remain active for five years unless you inform an IRB Coordinator that the work is finished prior to the end of the five years. If you require it to remain open beyond the five year approval, submission of a new protocol with the current.

Data collection may not begin until the PI has been notified that the project has been determined to be exempt. The five years will begin at the time of final review.

The eight exempt categories can be found at §46.104

Below are exceptions that are NOT considered exempt:

  • Research involving prisoners is not allowed unless the researched aimed at involving a broader subject population and only incidentally includes prisoners.
  • Research that includes both exempt and non-exempt activities cannot be determined to be exempt and should be submitted for expedite or full review.
  • Research involving deception or risks or discomforts greater than encountered in daily life.