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 Revised Common Rule (RCR) changes seek to modernize, strengthen and make more effective the federal policies for the protection of human research participants. There was a delay of the common rule revising the effective and general compliance date to 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
Effective and general compliance date is January 21, 2019
Common Rule changes include:
- New Exemption and revised exemption categories
- Elimination of continuing review for certain minimal risk studies*
- Consent form changes (key information section added to the beginning of the consent, added statements regarding biospecimen use)
- Revisions of consent waiver information
- Posting of consents to a publicly available website
- Broad consent (WSU has opted not to implement broad consent)
- Single IRB review for multi-site research (effective January 20, 2020) Cooperative Research Provision
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
- Key Information Guidance Tool
- Exempt Research Guidance Tool
- Benign Behavioral Interventions: Exempt Category Three Guidance Tool
- Waiver and Alteration of Informed Consent Guidance Tool
- Common Rule Agencies and Departments
- Cooperative Research Provision Guidance Tool & also review IRB Policy 4-17 External IRB & Reliance Agreements for Multi Site Research
Common Rule Implementation Process
- NEW SUBMISSIONS: Any new research protocol/proposal submissions received on or after January 14, 2019 will be reviewed under the Revised Common Rule (45 CFR 46) on or after 1/21/2019. Please submit using the Revised Common Rule Forms and guidance tools (found below).
For submissions received during this week modification requests and approval memos will be issued on or after January 21, 2019.
- CURRENTLY PENDING SUBMISSIONS: Investigator's with pending submissions will be notified of Revised Common Rule changes impacting their submission. Based upon IRB review it may be recommended that the submission may need to be withdrawn and resubmitted under the RCR, using the RCR forms. The withdrawal determination of the submissions currently under IRB review (pending modification) will be determined by end of business January 14, 2019. If you have a currently pending expedited, exempt, or minimal risk study the IRB Administration Office will contact you regarding the submission's status.
- CURRENTLY APPROVED STUDIES: Studies that are currently approved will be reviewed on a case-by-case basis to determine transition eligibility. Studies will be reviewed:
(I) at the time of continuation/renewal
(II) during a routine amendment (an amendment should not be submitted solely for the purpose of transitioning to the revised common rule)
Please review the guidance tools and information on this website which provides information regarding how the revised common rule may impact your human research submission.
At the forefront of the Common Rule changes are revisions to the exemption research categories, which includes:
- 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
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 Medical Exempt Protocol Summary Form
- updated Social Behavioral Education Exempt Protocol Summary Form
Additional updated & Revised Common Rule Submission Forms
- updated RCR PSF Appendix D Participant with impaired decision making ability
- upated RCR PSF Appendix H Use of Biological Specimens
- The current Protocol Summary Form should be used for Expedited Submissions found on the IRB Forms and Submission Requirements webpage
- updated Human Participant Research Determination Form
- New Limited IRB Review Appendix M
- New Minimal Risk Studies Status Update Form
- Transition to Revised Common Rule Appendix (update 3.2019)
(release of documents pending)
- updated Exempt Policy
- updated WSU Flexible Review and Oversight Policy
- Transition to the Revised Common Rule Policy
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.
Video 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
CITI Training Module Available at https://about.citiprogram.org/en/homepage/
WSU IRB Revised Common Rule (RCR) Training Sessions:
Visit the IRB's Education webpage for upcoming training sessions.
The IRB Administration Office is available to Revised Common Rule training 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.