The Revised Common Rule

1. The Revised Common Rule Institutional Review Board

2. The Common Rule • The Common Rule = Federal Policy for the Protection of Human Subjects • AKA: 45 CFR Part 46 • Initially published in 1991, amended in 2005 • Revised again in 2017  Implemented 2019 • The Revised Common Rule (RCR) • Effective January 21, 2019 • Includes: • Modifications and additions to exempt research categories • Greater freedom for IRBs to set review policies, especially for exempt categories of research and for continuing review • Changes to informed consent documents

3. NMSU IRB POLICY • Although we recognize that the RCR provides new guidelines and greater freedom for what constitutes “research” (i.e., what is “exempt” from IRB review) • …and we recognize that some activities are no longer considered research under Revised Common Rule • …The NMSU IRB will continue to review all activities that might be considered human subjects research • IRB will continue to make decisions regarding what is/is not exempt from IRB review

4. WHAT SHOULD BE SUBMITTED TO IRB? *All projects that might be considered research projects must be submitted to the IRB* Note: • Revised Common Rule research category changes apply ONLY to exempt research. • There is NO change to the expedited categories under the revised common rule

5. *Potentially Exempt from Review • Certain scholarly and journalistic activities (oral history) • Certain public health surveillance activities • Criminal justice activities • Authorized operation activities in support of national security missions. *(Again) NMSU IRB will make the determination of whether or not projects are exempt from review.

6. Changes to Exempt Categories Link: compliance.nmsu.edu/irb

7. RCR Informed Consent • There are several major changes to the general requirements for the informed consent in the RCR • Applies to Expedited and Full Board Review • The intent of these changes is to promote autonomy among prospective research participants

8. Informed Consent • Information needs to be presented in sufficient detail and organized and presented in a way that facilitates an understanding of why one might, or might not, want to participate. • A new consent form template in compliance with the Revised Common Rule is available on the website. • For an efficient and timely review, we strongly recommend using the provided template.

9. Change to Reporting Requirements • Continuations • NMSU IRB transitioning from “continuing reviews” to “annual status reports” • For all approved exempt and expedited protocols • Limited information will be required: • Team members • Human Subject Training • Brief summary • Starting date • Updates or problems encountered • Summary of findings • Last approved consent form • Protocol modifications, final reports, and adverse event reports will remain unchanged

10. When do (did) the changes take effect? • For new protocols: • Protocols submitted after January 21, 2019 must conform to the new guidelines • For currently approved protocols • Protocols that are continuing to enroll participants will be required to have a new consent form submitted with a status report or protocol modifications, whichever comes first • Researchers should begin using the new consent form after approval by the IRB.

11. Institutional Review Board (IRB) Vice President for Research/Graduate School Office of Research Integrity and Compliance compliance.nmsu.edu 575-646-7177 ovpr@nmsu.edu