Clinical Trials at BIDMC
Review our current research studies.
Institutional Review Board
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.
Supporting the Human Research Review Process
The purpose of the scientific review process is to support the human research review process, including IRB review, by ensuring that human research conducted at BIDMC meets the highest level of scientific merit and design. To accomplish this goal, scientific reviewers representing the many clinical disciplines and the diverse human subject research portfolio at BIDMC are appointed to perform a scientific review of human research studies.
More About the CCI
Scientific Review Requirements
Scientific review is required of all research proposals prior to CCI submission. The Scientific Review Officer for the PI's department is required to review the entire Protocol and complete the Scientific Review Officer (SRO) Form. Proposals will not be accepted without the signed SRO Form.
In their review, Scientific Reviewer Officers (SRO) specifically evaluate whether or not the following criteria have been met:
- There is adequate merit to justify using human research subjects;
- Confirm that there is no other method to investigate this question that would not require the use of human subjects;
- The risk/benefit ratio is favorable;
- Risks to subjects have been minimized by employing sound scientific design, and to the extent possible employ procedures that subjects would undergo as part of their regular care;
- Potential risks have been accurately and fully described in the IRB application and consent form;
- The data and safety monitoring plan is adequate given the risk level of the study;
- The study design adequate to answer the scientific question posed;
- There is a reasonable likelihood the PI will be able to meet her/his enrollment goal.
SROs can require investigators to revise their submissions if they find the submission to inadequately address the points above, before giving their approval. In some cases, the SRO may feel that additional reviewers, perhaps from other disciplines, are required to adequately complete the scientific review of a research study.
CCI Team
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.
Contact the CCI Team
Director, Human Research Protection Program
Angela Lavoie, RN, CIP, CCRP
alavoie@bidmc.harvard.edu
Associate Director, IRB Operations
Andrea Collins, MHA, CIP
acollin3@bidmc.harvard.edu
IRB Manager
Lily Moy
lmoy@bidmc.harvard.edu
