PRIM&R Resources
NEW!Delay of the Revised Common Rule: What Does it Mean For Me?
Resources with an next to it are for PRIM&R members only. You must be logged in to the Knowledge Center to access these members-only resources.
Resources developed by the SBER Network
Research Ethics Snapshots
Other Resources
Resources Developed by the PRIM&R Community
The resources below were created by members of the PRIM&R community and shared with permission. PRIM&R has not verified or endorsed these materials. Any questions about these resources should be directed to their respective owners. If you have a Common Rule resource you think the community should know about, please use the Submit a Resource form to share it with us.
- Revised Common Rule Guidance Tools:
Informed Consent Template and accompanying Assent Signature Page (.doc) - Revised Common Rule Incorporated
Resource developed by Patrick Herbison, MEd, CIP
Jefferson (Philadelphia University + Thomas Jefferson University)
Flowcharts and Decision Trees for the Revised Common Rule (.zip file)
Resources developed by Molly Klote, MD, CIP
Topics include exempt categories, limited IRB review, whether to convert ongoing studies to the 2018 Common Rule, using the burden reducing provisions, and how to document conversion of a study to the 2018 Common Rule.
Exemption Decision Charts for General Guidance
Resource developed by Guilaine D. Senecal
Office of Research Integrity and Assurance, Cornell University
New Common Rule Implementation Guide
Resource developed by Mariette Marsh, MPA, CIP
Office for Research and Discovery, University of Arizona
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Resources developed by June Walker, MS, MSCR, CIP
Duke University Health System IRB New Rule Exemption Categories Handout
Resource developed by Ada Sue Selwitz, MA and Belinda Smith, MS, RD, CCRC
University of Kentucky Office of Research Integrity
New Rule Summary of Changes and Summary of Changes in the Consent Documents
Resources developed by Melissa Epstein, PhD, MBE, CIP
Albert Einstein College of Medicine
Resources from Friends of PRIM&R
These resources have been created by our partners and colleagues who have agreed to share them here. Other items will be added as they are identified. If you have a Common Rule resource you think the community should know about, please use the Submit a Resource form to share it with us.
Revised Common Rule Q&As
Office for Human Resource Protections (OHRP)
July 2018
Infographic: The Common Rule Implementation Timeline
July 18, 2018
Quorum Review
Revised Common Rule Videos
OHRP
June 2018
Comments on the Interim Final Rule
American Medical Informatics Association
March 19, 2018
Comments on the Interim Final Rule
American Association of Medical Colleges, Association of American Universities, and Association of Public and Land-Grant Universities
March 19, 2018
Comments on the Interim Final Rule
Council on Governmental Relations (COGR)
March 16, 2018
- Resources shared by the Flexibility Coalition
February 21, 2018
2018 Common Rule Implementation Checklist
Verrill-Dana, LLP
January 18, 2018
Sample Temporary SOP Addendum
HRP Consulting
December 21, 2017
Higher Education Association Meeting with OIRA and Federal Agency Staff on Proposed Delayed Implementation of the Common Rule
Council on Governmental Relations (COGR)
December 12, 2017
How the New Common Rule Will Impact Research in 2018 and Beyond
Kinetiq
August 18, 2017
Final Rule Resources
Resources developed by CITI Program
How to Prepare for the Common Rule Changes
Resources developed by HRP Consulting
Overview of the New Rules (with a Focus on Tribal Sovereignty)
Ivor Pritchard, PhD, senior advisor to the director, Office for Human Research Protections, at the 2017 Collaborative Research Center for American Indian Health Summit
April 4, 2017
New Final Common Rule Published, Many Changes Are Required
HRP Consulting
January 20, 2017
Redline of Unofficial Final Revised Common Rule (January 18, 2017) Against Health and Human Services Common Rule at 45 CFR Part 46, Subpart A (2005)
Verrill Dana, LLP
January 19, 2017
Federal Register Quietly Publishes Final Changes to the Common Rule
Kinetiq
January 19, 2017