Resources & Tools

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

• Video: SBER Network Virtual Roundtable: Things to Consider when Implementing the Final Rule
• Things to Consider when Implementing the Final Rule
• Final Rule Topics
• Minimal Risk Categories – University of New Mexico (UNM) IRB
• Final Rule Case Study – UNM IRB

Research Ethics Snapshots

• Development of a Broad Consent Document
• Reviewing Patient Records Without Consent
• Limited IRB Review
• Decision-Making for Preexisting Studies
• Broad Consent
• Research Subject to Multiple Regulations
• Benign Behavioral Interventions
• Scholarly and Journalistic Activities

Other Resources

• Webinar series: Focus on the Revised Common Rule

• PRIM&R's quick reference guide to the most significant changes in the revised Common Rule

• Ampersand Commentary

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:
  • Introduction to the Revised Common Rule Guidance
  • Required Elements of Informed Consent Guidance
  • Exempt Research Guidance Tool
  • Waiver and Alteration of Informed Consent Guidance Tool
  • Common Rule Agencies and Departments
    Resources developed by Heather Park-May
    Wayne State University

• 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

• • Concise Summary Examples
  • Revised Consent Template
  • FAQs on Common Rule Changes (for Researchers)
  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
  • Flexibility with Minimal Risk Research (resource developed by Lisa Leventhal, MSS, CIP, Oregon State University)
  • Implementing Flex ahead of the New Rule (resource developed by Linda Petree, CIP, University of New Mexico)
  • • Draft Minimal Risk Review Form
    • Revised Flexibility Policy
    • Creative Flexibility
    • Flexibility with Informed Consent
    (resources developed by Susan Rose, PhD, University of Southern California)
   

• 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