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 Interim Final Rule has been delayed, the effective date and general compliance date is now January 21, 2019.
For more information regarding the common rule interim delay visit https://www.federalregister.gov/documents/2018/04/20/2018-08231/federal-policy-for-the-protection-of-human-subjects-proposed-six-month-delay-of-the-general
The WSU IRB will continue preparations for the final rule implementation and is available to provide education regarding changes to the common rule.
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:
- Introduction to the Revised Common Rule Guidance
- Required Elements of Informed Consent Guidance
- Exempt Research Guidance Tool
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.
Revised and new IRB forms are forthcoming.
*The effective date and general compliance date for the revised common rule has been delayed to January 21, 2019.
Please continue to monitor this website for additional information.
Information/Education on the revised Common Rule
The Office of Human Research Protections has recently released a series of education videos about the Revised Common Rule.
Vidoes topics include:
- What's new in the Informed Consent?
- When Does the Common Rule Apply? Review of the Basics Under the Revised Rule
- Overview of Changes to Exemptions in the Revised Common Rule Exemptions 1, 2, 3, and 5
- Regulatory Options for Secondary Research with Priviate Information and Biospecimens
- What's New in the IRB Review Under the Revised Common Rule
The IRB Administration Office is available to conduct training on the revised Common Rule upon request.
For more information regarding the WSU IRB and the Revised Common Rule, please contact IRB Training Coordinator, Heather Park-May at 313-993-7157 or firstname.lastname@example.org.