The single IRB mandate is intended to streamline multi-site IRB approval without compromise to ethical conduct and patient safety. Single IRB's apply with: 1) Conduct of the same protocol by multiple (more than one) institutions 2) Domestic research funded by the NIH and 3) Research involving non-exempt human subjects. This section will provide education, guidance and/or a mechanism for the customer to seek support regarding single IRB determination. This applies to the new 2018 single-IRB mandate according to the Revised Common Rule.

 

Four Key Resources Headlining Single IRB Information:

  • Emory University IRB: The Emory IRB website provides a detailed explanatory section on collaborative/multi-site research regarding single IRBs, reliance agreements and templates.
  • SMART IRB:  SMART IRB is a platform designed to ease common challenges associated with initiating multisite research and to provide a roadmap for institutions to implement the NIH Single IRB Review policy (effective date: January 25, 2018). Freely available for institutions and investigators, SMART IRB is an integrated, comprehensive platform   
    • For a comprehensive list of all participating institutions, click here. All CTSA hubs are members as well as greater than 600 other organizations.
  • NIH Single IRB Explanation: The intent of a single IRB of record for multi-site studies that are conducting the same protocol is to help streamline the IRB review process by eliminating the unnecessary repetition of those IRB reviews across sites.
  • Frequently Asked Questions (NIH-Single IRB): The NIH recognizes that the single IRB policy has spurred questions. Answers to frequently asked questions are presented here.

 

For a comprehensive list of Single IRB-related terminology and acronym definitions, click below!

IRB Terms and Acronym Definitions

Online Educational and Collaborator sIRB Links

  • NIH Single IRB Policy for Multi-site Research 
  • The Office for Human Research Protections (OHRP): Provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services. OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social-behavioral research. OHARP has FAQ's and guidance documents to support ethical research in compliance with Health and human services (HHS) regulations. 
  • The NIH Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Platform: Provides flexible resources that investigators nationwide can use to harmonize and streamline IRB review for their own multisite studies. 
  • Public Responsibility in Medicine and Research (PRIM&R): Aims to advance education to professionals and communities regarding research ethics, regulatory compliance and public policy. 

 

Georgia CTSA Frequent Partners/Collaborative Links

 

Request RKS Navigator or STUDIO Support (CTSA-RAPID System) 

 

Interested in requesting IRB-related RKS navigator or STUDIO support? Click the link below, and follow the steps listed to request help today!

RAPID Request Instructions