Wayne State University

Common Rule Changes

Common Rule Changes

The Office of Human Research Protections (OHRP) has announced changes to federal regulations that protect the rights and welfare of human research participants, known as the Common Rule. The Common Rule changes seek to modernize, strengthen and make more effective the federal policies for the protection of human research participants.  The revised Common Rule can be viewed at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html.

*Please note there is a Interim Final Rule that has delayed the effective date and general compliance date to July 19, 2018. 

Common Rule changes include: 

  • New Exemption & Revised Exemption Categories 

  • Continuing Review changes for minimal risk studies

  • Single IRB review for multi site research (effective January 20, 2020)

  • Consent Form Changes 

WSU's Institutional Review Board has reviewed applicable policies, procedures, and forms to comply with the revised Common Rule by the *effective date.  WSU Education Guidance documents have been created to provide information regarding the revised common rule, see the following:

Exempt Reviews   

At the forefront of those changes are revisions to the exemption research categories, including the following changes:

  • revisions to Exempt Categories 1, 2, 4, and 5 
  • New Category 3 for behavioral research: Benign Behavioral Interventions
  • Limited IRB Review option for research meeting certain conditions within Exempt categories 2 and 3
  • New biannual status update reports for all minimal risk research

With the noted changes, applicable WSU polices have been updated, and Exempt Forms/information have been revised and created. These include the following: 

  • updated Exempt Research Guidance Tool
  • updated Exempt Protocol Submission Forms with corresponding Exempt Appendices
  • updated WSU IRB Exempt Review Policy
  • updated WSU Flexible Review Policy and Oversight Policy
  • New Limited IRB Review Appendix
  • Status update Form 
  • Please review the Exempt Research Guidance Tool which provides information regarding the new and revised exempt categories and updated instructions regarding submitting exempt projects the IRB Administration Office. 

 




Please check this website for more updates, new information will be provided on an ongoing basis.

The revised and new IRB forms are forthcoming.

UPDATE:

*The effective date and general compliance date for the revised common rule has been delayed for 6 months.  The effective date and compliance date is July 19, 2018.  

To view the Interim Final Rule delay annoucement click here.

Please continue to monitor this website for additional information.




Upcoming Informational Sessions on the revised Common Rule 

The IRB Administration Office is available to conduct training on the revised Common Rule upon request. 

For more information, please contact IRB Training Coordinator, Heather Park-May at 313-993-7157 or gp2126@wayne.edu.