|Page Updated: 05/09/03|
IRBs and Their Purposes
An Institutional Review Board (IRBs) (also sometimes called Independent Ethics Committees or Research Ethics Committees) is a group of persons who (i) review and ethically evaluate research protocols before a study can begin, and (ii) continue to monitor a study while it is underway. The central purpose of the IRB is to ensure that the rights, safety, and welfare of participants in research studies are adequately protected. IRBs have the authority to approve, to request modification of, and to disapprove a research protocol.
Regulations and guidelines specify (among other things): (i) that IRB members should be independent of the investigators who are submitting the research for review, (ii) the size and membership criteria of IRBs, and (iii) the criteria for IRB approval of research.
All the major international research ethics guidelines require the ethical review of research involving human subjects.
World Health Organization - Operational Guidelines for Ethics Committees
An IRB Guidebook prepared for the U.S. Office for Human Research Protections, an excerpt:
U.S. Regulations regarding IRB membership, IRB functions and operations, IRB review of research, Expedited review procedures, Criteria for IRB approval of research, and IRB record keeping.
Office of Human Research Protections (OHRP)
The OHRP provides guidance to interpret the U.S. Regulations regarding IRBs. Guidance topics by subject can be found at the OHRP website.
IRB knowledge of local research context
Registering your IRB with the OHRP (for institutions who plan to do human subject research funded at least in part with U.S. funds)
The IRB at Miriam Hospital/Lifespan, Rhode Island, U.S.A.
(i) general information and instructions for investigators submitting a research protocol for The Miriam Hospital IRB review, (ii) continuing review report form, (iii) request to the IRB for revision to a protocol form, (iii) adverse event reporting form
Meeting dates, procedures for and elements of EC review of research proposals, decision-making, communicating a decision, follow-up, documentation and archiving.
Institutions engaging in human participant research funded at least in part by the U.S. must rely on an IRB to review its research, but an institution may rely on another institution's IRB to review its research. "Under what circumstances can one institution rely on another organization's IRB?"
Institution A can rely on Organization B's IRB any time Organization B's registered IRB agrees to the arrangement and satisfies the guidelines of knowledge of the local research context
General Guidance on the use of another Institution's IRB
Suitability of a Designated Institutional Review Board (IRB)