The Revised Common Rule Institutional Review Board

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

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

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

*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.

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

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 Add template (here it is)

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. Include website language

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

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.

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