|Helping researchers navigate clinical & translational research regulatory processes.||Regulatory Foundations, Ethics, and Law Program|
Obtaining and ensuring appropriate review, approval, and oversight of research involving animals can introduce significant challenges and delays for investigators and institutions, especially if review and approval must be sought from multiple Institutional Animal Care and Use Committees (IACUCs).
Institutions may choose to streamline IACUC review and oversight1 for collaborative, multisite research projects by establishing a formal written reliance agreement to address responsibilities for animal care, use, and ownership. However, setting up separate, protocol-specific agreements can be a time-consuming and resource-intensive process.
To address this problem, Harvard Catalyst's Regulatory Foundations, Ethics, and Law Program has developed a Master IACUC Agreement that may be used for IACUC reliance on a protocol-by-protocol basis. The agreement has been signed by 18 Harvard affiliates and others. Additional IACUC templates for use with non-signatories and vendors have been developed to assist institutions and researchers in off-site animal research arrangements.
The Master Reciprocal Institutional Agreement for Animal Care and Use ("Master IACUC Agreement") supports the proper care and use of animals involved in multicenter studies among the signatory institutions. It is a formal umbrella agreement designed within a legal framework to reduce duplicative review of animal work.
18 institutions currently participate in the Master IACUC Agreement:
|Beth Israel Deaconess Medical Center||Harvard University Faculty of Arts and Sciences (FAS)|
|Boston Children's Hospital||Joslin Diabetes Center|
|Brigham and Women's Hospital||Massachusetts Eye & Ear|
|Broad Institute||Massachusetts General Hospital|
|Dana-Farber Cancer Institute||Massachusetts Institute of Technology|
|Forsyth Institute||McLean Hospital|
|Harvard Medical School (HMS)||MGH Institute of Health Professions|
|Harvard T.H. Chan School of Public Health||Schepens Eye Research Institute|
|Harvard School of Dental Medicine||Spaulding Rehabilitation Hospital|
When signatories join the Master IACUC Agreement they must agree to the following key elements:
Example 1: Animal work performed off-site[click to enlarge]
In this example, the research involves animal activities in one location that is funded by a different institution. By utilizing the Master IACUC Agreement, one institution (e.g., the institution receiving the funds) may choose to defer review to the other (usually the one doing the animal work).
Example 2: Subcontracted work[click to enlarge]
In this example, the researcher is outsourcing the animal work to another signatory institution with the appropriate expertise and facilities for the animal model. By utilizing the Master IACUC Agreement, one institution may choose to perform the IACUC review and provides oversight for the research, so that administrative burden for the researcher as well as the institution is reduced.
Coming soon: Sample template for requesting and tracking Master IACUC Agreement use.
You may use or modify the following templates with non-signatory institutions or vendors to speed the conduct of research involving animals while ensuring that all research is conducted ethically and with the appropriate oversight.
Template IACUC Agreement 1: Off-site Assurance [request]
For use with institutions that are NOT signatories of the Master IACUC Agreement.
Example:[click to enlarge]
In this scenario, the researcher is contracting with a facility to perform animal activities on behalf of Harvard. As the vendor is not a signatory to the Master IACUC Agreement, the Offsite Assurance Template may be used to establish a written agreement for one institution to assume oversight of the animal work.
Template IACUC Agreement 2: Custom Antibodies [request]
For use when contracting with a company, vendor, or academic institution for production of antibodies specific to the research.
Example:[click to enlarge]
In this scenario, the researcher is contracting with a third-party vendor to perform custom antibody services on behalf of the Broad Institute of MIT and Harvard. As the vendor is not a signatory of the Master IACUC Agreement, the Custom Antibody Agreement Template can be used to establish a written agreement for oversight of the animal work.
Investigators or institutions that want to utilize the Master IACUC Agreement or inquire about use of the templates for a proposed or existing research project should contact their respective IACUC office. See contacts below.
Additional signatories may join the Master IACUC Agreement. Interested in joining? Please email us for more information.
To share your ideas for IACUC agreements, templates, and forms, or for more information about the Master IACUC Agreement, please contact:
Sabune J. Winkler, JD
Director, Regulatory Foundations, Ethics, and Law Program
1 The NIH Office of Laboratory Animal Welfare (OLAW) and the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) agree that review of a research project by more than one IACUC is not a federal requirement. See: Guide page 15 and OLAW FAQ #8 http://grants.nih.gov/grants/olaw/faqs.htm#621