External IRB

Investigators may partner with two or more institutions to conduct human subjects research or be involved in multi-site research studies. To enhance and streamline the institutional review board (IRB) review process when such collaborations occur, regulations allow institutions to “enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort” (45 CFR 46.114). In other words, regulations allow research partners to agree to rely on a single IRB for review and approval.

If a non-USA owned IRB is chosen as the reviewing IRB, it is called an ‘External IRB’, as it is external to our organization.  The following are different types of external IRB models:

  • Central IRB: A reviewing IRB provides the ethical review for all sites participating in more than one multi-site study. The relying sites are usually in a network, consortium or particular program, such as the National Cancer Institute Adult Cooperative Groups and Children’s Oncology Group. (e.g. National Cancer Institute, Central IRB)
  • Single Independent or Commercial IRB: The IRB is independent, established for commercial purposes, developing products and services to support the research industry. Pharmaceutical companies conducting multi-site studies may rely on ‘Single Independent (Commercial) IRBs’ to coordinate IRB review services (e.g. Western IRB - WIRB).
  • Single IRB, or sIRB: A reviewing IRB, selected on a study-by-study basis by partner institutions, provides the ethical review for all relying sites participating in that multi-site study (2 or more sites)

For each model, the USA IRB enters into a ‘reliance agreement’ (IRB Authorization Agreement) with the Reviewing IRB. A reliance agreement is a formal, written document that provides a mechanism for institutions partnering in research to rely on one IRB to be responsible for multi-site IRB review.

 External IRB & Collaborative Research
Quick Guide: Requests for USA to Rely on External IRBs
Reliance on External IRB
Policy on Single IRB for Multi-Site Federal Grants
Relying on a Single IRB: Standard Operating Procedures
USA is Prime - Review by External IRB
IRB Reliance Request/Registration Form
Single IRB 

Single IRB Plan for Grant Application

National Institutes of Health (NIH)
NIH Single IRB Policy Announcement
NIH Revised Implementation Date Announcement
NIH Single IRB Frequently Asked Questions
NIH Guidance about Single IRB Costs
NIH Guidance on Implementation of the Single IRB Policy
NIH Guidance on Requesting an Exception to the Single IRB
PHS Human Subjects and Clinical Trials Information Form Application Guide