Lesson 21 · IRB and HRPP Administration: From Coordinator to CIP

21. Single IRB, Reliance Agreements, and Local Context: 45 CFR 46.114

55 min

After this lesson you can

  • 1. State the single IRB requirement in 46.114 and its exceptions
  • 2. Distinguish the NIH sIRB policy, the Common Rule requirement, and FDA 56.114
  • 3. Explain reliance agreements, IRB Authorization Agreements, and SMART IRB
  • 4. Allocate responsibilities between the reviewing IRB and the relying institution, including local context
  • 5. Describe international research considerations, including equivalent protections

Video coming soon

Scheduled for release on October 7, 2026.

Single IRB, Reliance Agreements, and Local Context: 46.114 explains how one IRB of record can review a study for twenty sites without erasing twenty sets of local law. This lesson covers the NIH single IRB policy, the 2020 Common Rule mandate, reliance agreements and SMART IRB, and exactly what stays local.

5 Key Facts from This Lesson

  1. The NIH single IRB policy took effect January 25, 2018, and the Common Rule requirement at 45 CFR 46.114 took effect January 20, 2020.
  2. Section 46.114 covers cooperative research at US institutions for the US portion of a study, so foreign sites fall outside it.
  3. Exceptions apply where more than single IRB review is required by law, including tribal law, or where the federal agency determines single review is not appropriate.
  4. Reliance transfers the IRB review, not the HRPP, so conflict of interest management, training, and ancillary reviews stay with each local institution.
  5. FDA's 21 CFR 56.114 encourages but does not require single IRB review, and exempt research falls outside the single IRB requirement.

Exam traps

The distinctions exam questions on this topic are most often built to test. Know them cold.

  • 46.114 covers US institutions and the US portion; foreign sites are outside it

  • Tribal law is an explicit exception

  • NIH policy 2018; Common Rule requirement 2020; different scopes

  • Reliance transfers the review, not the HRPP; COI, training, and ancillary reviews stay local

  • FDA 56.114 encourages but does not require single IRB review

  • Exempt research is outside the single IRB requirement because it is not approved by an IRB

Practice quiz

  1. Question 1
    The single IRB requirement in 45 CFR 46.114 became effective on:
  2. Question 2
    Which of the following is an exception to the single IRB requirement in 46.114?
  3. Question 3
    Under a reliance arrangement, which responsibility typically remains with the relying institution?
  4. Question 4
    The document by which one institution agrees to rely on another institution's IRB for a specific study is commonly called:
  5. Question 5
    21 CFR 56.114 states that for cooperative research projects, FDA:

Recap

  • 46.114: US institutions must rely on a single IRB for the US portion of Common Rule cooperative research since January 20, 2020; exceptions for law including tribal law and agency determination
  • NIH policy 2018 versus Common Rule 2020 versus FDA 56.114 encouragement
  • IAAs, master agreements, SMART IRB, independent IRBs, and 46.103(e) documentation
  • Reviewing IRB does the review; the relying institution keeps COI, training, ancillary reviews, local context, and its FWA obligations
  • International research: 46.101(h), foreign FWAs, dual review, the International Compilation

Coming next

Lesson 22 covers written procedures, IRB records, and retention.

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This course is for educational purposes only and is not legal, regulatory, or compliance advice. Regulations and guidance change, so confirm every requirement against the current eCFR text, OHRP and FDA guidance, and your institution's IRB policies before relying on it. CIP® is a registered certification mark of Public Responsibility in Medicine and Research (PRIM&R). This course is produced independently by Subthesis and is not affiliated with, endorsed by, or reviewed by PRIM&R or the CIP Council. The instructor is not a Certified IRB Professional. Completing this course does not confer CIP certification, satisfy CIP eligibility requirements, or count as CIP recertification continuing education.