|
The Committee on Clinical Investigations or
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). This
Assurance, signed by the BIDMC Institutional Official for Human Subject
Protections, 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
Mary M. Williams, RN.
For Committee Rosters and Meeting dates click here
For contact information for various IRB
functions click here
|