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
Add template (here it is)

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.
Include website language

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