Master Reciprocal Common IRB Reliance Agreement
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The Master Reciprocal Common IRB Reliance Agreement (MRA) supports institutions and investigators who propose multicenter studies.
The goal of the Master Reciprocal Common IRB Reliance Agreement is to reduce duplicative IRB review and in that way, promote and accelerate collaborative research efforts among investigators at the signatory institutions. The MRA accomplishes this goal by providing a legal framework to support single or consolidated IRB review for multisite studies.
- MIT joins the MRA, facilitating cross-institutional collaborations between MIT researchers and their colleagues at other universities, hospitals, and clinical practice organizations in the New England region and beyond. Read more.
- Learn how the IRB Reliance Agreement helped fast forward a study on blast-related trauma following the Boston Marathon bombings, and watch coverage of the study on CBS Evening News.
- Read about how the MRA helped accelerate a longitudinal follow-up to the National Faculty Survey at Massachusetts General Hospital and Tufts CTSI.
- IRB Reliance: A New Model for Accelerating Translational Science: The NIH highlights the nationwide movement toward IRB reliance and cites the success of the MRA in accelerating collaborative research.
The Master Reciprocal Common IRB Reliance Agreement is composed of over 30 signatory institutions across the United States including institutions affiliated with Harvard Catalyst, Boston University Clinical and Translational Science Institute, Dartmouth Synergy | The Dartmouth Clinical and Translational Science Institute, Tufts Clinical and Translational Science Institute (Tufts CTSI), the Southern California Clinical and Translational Science Institute (SC CTSI), and the University of Rhode Island.
The following institutions have signed the agreement:
||Maine Medical Center
|Beth Israel Deaconess Medical Center
||Massachusetts Eye & Ear
|Boston Children's Hospital
||Massachusetts General Hospital
|Boston University - Charles River Campus
||Massachusetts Institute of Technology
|Brigham and Women's Hospital
||MGH Institute of Health Professions
|Cambridge Health Alliance
||Mount Auburn Hospital
|Dana-Farber Cancer Institute
||New England Baptist Hospital
||Schepens Eye Research Institute
|Harvard Medical School (HMS)
||Spaulding Rehabilitation Hospital
|Harvard Pilgrim Health Care
||St. Elizabeth's Medical Center
|Harvard T.H. Chan School of Public Health
||Tufts Medical Center
|Harvard University Faculty of Arts and Sciences (FAS)
||Tufts University Health Sciences Campus
||Tufts University Medford/Somerville Campus
|Joslin Diabetes Center
||University of Rhode Island
|Judge Baker Children's Center
||University of Southern California - Health Sciences
|Lahey Hospital & Medical Center
||University of Southern California - University Park
Harvard University's 12 degree-granting schools in addition to the Radcliffe Institute for Advanced Study all receive regulatory coverage from the Harvard University FAS IRB.
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Elements of the Agreement
When signatories join the MRA they must agree to the following three key elements:
Common language and regulatory interpretation:
- "Uncheck the Box"
Institutions must uncheck the box on their FWA, meaning they will not apply each subpart of 45 CFR 46 to all human subject research, regardless of funding.
- Harmonization of Subject Injury Language
Institutions agree to one set of common subject injury language or to "substantially equivalency" review.
- Insurance Coverage
The MRA includes an insurance provision that requires all participating institutions to have appropriate and sufficient coverage.
- Privacy Compliance Requirements
All participating sites must be able to comply with HIPAA, HITECH, and related privacy laws when reviewing research on behalf of a covered entity.
Common processes and consistent approach:
- Identifying the reviewing IRB
The principal investigator's (PI) institution is presumed to be the reviewing IRB, though another IRB may be determined to be more appropriate for a particular study.
- Defining Chain of Responsibility and Communication
The overall PI is ultimately responsible for the conduct of the research; local site investigators report to the PI, who reports to the reviewing IRB.
- Quality Assurance Mechanisms
Participating institutions that are not accredited by AAHRPP must engage OHRP's Quality Assessment Program.
- Aligning Certification and Continuing Education Requirements
Institutions agree to a three-year continuing education (CE) schedule and accept one another's trainings when feasible. The CITI Program is the preferred program.
- Controlling Study Activation
Each IRB must to be able to delay the activation and initiation of a study until institutional processes are complete (i.e. completion of clinical trial negotiations).
- Unanticipated Problems, (Serious) Adverse Events, and Deviations
Institutions report relevant issues to each other: the reviewing IRB is responsible for reporting; relying institution(s) can also make, review, and comment on reports.
- Requesting and Agreeing to IRB Reliance
The Harvard Catalyst IRB Cede Review Request System allows investigators to request reliance and participating IRBs to review requests and enter determinations.
- Access to the request system is limited to Harvard Catalyst-affiliated investigators and staff, and requires HMS eCommons or HUID login.
- Investigators not affiliated with a Harvard Catalyst-participating institution but collaborating with a Harvard-affiliated investigator may work with that investigator to request reliance via the IRB Cede Review Request System.
- Investigators not collaborating with a Harvard-affiliated investigator should contact their IRB Cede Review Request contact for further instructions.
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Common standard operating procedures (SOPs):
- Reliance Agreement Policy
Institutions create or amend a policy stipulating the use of reliance agreements (including the MRA), or other arrangements for reducing duplicate review.
- Audit SOP
Sites may conduct not-for-cause and for-cause audits.
- SOP for Reporting Serious Adverse Events (SAEs) and Unanticipated Problems
For non-federally funded research, institutions must report SAEs and unanticipated problems to a high-level institutional official, reserving the right to report to OHRP.
- SOP for Data Protection and Incident Responses
Institutions must have a set of procedures that delineates duties when managing a data breach when there is IRB reliance.
- SOP for Managing Conflicts of Interest (COI)
The reviewing IRB will return a COI ("zero dollar" threshold) to the relying institution to reduce, eliminate, or manage, subject to the reviewing IRB's approval.
- SOP for Training
A policy or process is recommended to agree to accept one another's trainings, when appropriate and possible.
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Additional signatories may now join the Master Reciprocal Common IRB Reliance Agreement through a joinder agreement. Interested in joining the MRA? Please contact us for more information.
For more information please contact:
Sabune J. Winkler, JD
Director, Regulatory Foundations, Ethics, and Law Program