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Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program

Master Institutional Biosafety Committee (IBC) Reliance Agreement

The Harvard Catalyst Regulatory Foundations, Ethics, and Law Program and Institutional Biosafety Committees (IBCs) covering 15 institutions developed the IBC Reliance Agreement to facilitate consolidated review of biological research (in the laboratory or with human subjects). The goal is to reduce the burden on Harvard Catalyst investigators by reducing the complexity of the IBC review process for multisite clinical and laboratory research studies involving recombinant or synthetic nucleic acids molecules, biological agents, and other biological materials.

Investigators conducting research at more than one site may submit a ceded IBC review application to request review by a single IBC for new protocols or when adding new site(s) to existing protocols. Each request will be considered by the relevant IBCs and a decision will be made on a case-by-case basis. Each participating IBC makes the decision whether to rely on the review of another IBC (to cede the review) or to conduct its own full review.

The following institutions have signed the agreement:

  • Boston Children's Hospital
  • Dana-Farber Cancer Institute
  • Forsyth Institute
  • Harvard COMS covering:
    • Beth Israel Deaconess Medical CenterH
    • Joslin Diabetes Research CenterH
    • Harvard Medical SchoolH
    • Harvard School of Dental MedicineH
    • Harvard School of Public HealthH
    • Harvard University Faculty of Arts and SciencesH
    • Massachusetts Eye and EarH
    • Schepens Eye Research InstituteH
  • Partners Healthcare IBC covering:
    • Brigham and Women's Hospital, Inc.P
    • Massachusetts General HospitalP
    • McLean Hospital Corp.P
    • Spaulding Rehabilitation Hospital NetworkP

H = Harvard COMS conducts IBC review for these institutions.
P = Partners Healthcare IBC conducts IBC review for these institutions

For investigators, a significant practical outcome of the reliance agreement is the ability to request ceded IBC review for multicenter studies before submitting a full IBC application. Investigators may request ceded IRB review via the IBC Ceded Review Request form.

For more information about the Harvard Catalyst Master IBC Reliance Agreement or to request a reference copy, please contact:

Director, Regulatory Foundations, Ethics, and Law Program
Barbara Bierer, MD
Professors of Medicine (Pediatrics)
Brigham and Women's Hospital
Harvard Catalyst
Email
617-998-6681

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