The NIAID reliance (authorization) agreement toolkit contains general information and customizable tools related to clinical trial review by institutional review boards (IRBs), both for those institutions providing review for another institution and those delegating review to another institution’s IRB or to an independent IRB.
Disclaimer: These sample authorization agreements are provided for informational purposes only and do not constitute legal advice or opinions as to current laws, regulations, or guidelines. In addition, new laws, regulations, and guidelines are issued on a continuing basis, and institutional requirements vary. These sample documents are not a reflection of all current applicable laws, regulations, guidelines, or institutional requirements relating to reliance (authorization) agreements. While reasonable efforts have been made to ensure the accuracy and completeness of the information provided, in the ever-changing regulatory environment, institutions should consult with regulatory affairs and legal advisors regarding current applicable laws and regulations prior to executing agreements.
- Frequently Asked Questions
- Points To Consider: Delegating IRB Review
- Template Outline
- U.S. Regulations, Guidances, and Related Links
- Selected References
These template tools are intended to be generic starting points for institutions entering into relevant agreements. The specific content will need to be determined by the nature of the research and consistent with each institution’s policy requirements, as advised by institutional officials and legal counsel.
While these templates may be used for international agreements, they may require additional content and approval specific to host country laws. Future expansion of this toolkit may include more information on the use of reliance (authorization) agreements in the international setting.
- Template 1, IRB Authorization Agreement—Basic template from the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP)
- Template 2, IRB Authorization Agreement—Basic template for a single protocol or a subset of protocols
- Template 3, IRB Authorization Agreement—Combination of the OHRP standard form with content from other sample agreements, providing the option for programmatic reliance but probably best suited to agreements for single protocols or a subset of protocols (more detailed than Template 2 and includes references to both OHRP- and Food and Drug Administration-applicable regulations)
- Template 4, Memorandum of Understanding—Structured to cover a broader program of research than a standard IRB authorization agreement