§ 56.114 Cooperative research

In complying with these regulations, institutions involved in multi-institutional studies may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed at avoidance of duplication of effort.

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FDA guidance that cites § 56.114

• Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs 5 Feb 2025
• Conducting Clinical Trials With Decentralized Elements 18 Sept 2024
• Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for Industry 1 Mar 2022
• Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for Industry 1 Mar 2022
• Waiver of IRB Requirements for Drug and Biological Product Studies: Guidance For Sponsors, Clinical Investigators, and IRBs 3 Oct 2017
• Considerations When Transferring Clinical Investigation Oversight to Another IRB: Guidance for IRBs, Clinical Investigators, and Sponsors 23 May 2014
• IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed: Guidance for IRBs, Clinical Investigators, and Sponsors 27 Aug 2013
• Exception from Informed Consent Requirements for Emergency Research: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors 1 Apr 2013
• IRB Continuing Review After Clinical Investigation Approval: Guidance for IRBs, Clinical Investigators, and Sponsors 27 Feb 2012
• Frequently Asked Questions – Statement of Investigator (Form FDA 1572): Guidance for Sponsors, Clinical Investigators, and IRBs 4 Jun 2010
• Using a Centralized IRB Review Process in Multicenter Clinical Trials: Guidance for Industry 16 Mar 2006
• Cooperative Research: Guidance for Institutional Review Boards and Clinical Investigators 1 Jan 1998
• CHAPTER 48 - 7348.809 Bioresearch Monitoring

Amendment history

Federal Register documents that created or amended this section.

• 46 FR 8975 27 Jan 1981