Institutional Review Board for Research Involving Human Subjects
The Committee on Clinical Investigations (CCI), is the institutional review board (IRB) for the Beth Israel Deaconess Medical Center and reviews all Medical Center research involving human subjects. The CCI is charged with safeguarding the rights and welfare of human subjects by making determinations regarding ethical standards and by evaluating the risk/benefit ratio of all studies.
The CCI discharges its responsibilities in accordance with its Federal Wide Assurance, also referred to as the FWA (FWA#00003245), signed by the BIDMC Institutional Official for Human Subject Protections,
Compliance with Federal Wide Assurance
Randall S. Mason, MBA,sets forth the structure under which human subject research may be conducted at BIDMC. Strict compliance with this Assurance by all BIDMC investigators, the CCI, and the medical center is required in order to maintain authorization to conduct human subject research at BIDMC. This includes compliance with state and federal regulations governing the conduct of human subject research (45 CFR Part 46 and 21 CFR Parts 50 and 56) and adherence to the ethical principles set forth in the Belmont Report.
The CCI is required to maintain written documentation of its policy and procedures, which can be found online in the CCI Policy and Procedure Manual.
The CCI is composed of the Committee which is the decision-making entity and CCI staff who manage and support the IRB process.
- The Committee is divided into three sections, the East Campus, West campus, and Continuing Review Committees.
- The combined CCI membership is comprised of approximately thirty five members.
- The CCI meets twice each month, generally on the first and third Mondays, to review new protocols.
- The CCI Continuing Review Committee meets on the second and fourth Monday to review ongoing research protocols.
- The CCI Chair for all sections is Alan Lisbon, M.D. The Director of IRB Operations for the CCI is Angela Lavoie.
Clinical Research Studies at BIDMC