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
If your institution does not have an IRB or IEC, these guidelines can help. (an excerpt:) "The Guidelines are intended … to serve as a basis upon which ethics committees (ECs) can develop their own specific written procedures for their functions in biomedical research… The Guidelines should be used by national and local bodies in developing, evaluating, and progressively refining standard operating procedures for the ethical review of biomedical research." These guidelines address: the role of an EC, establishing a system of ethical review, constituting an EC, submitting a research proposal for ethics review, review of the research proposal, decision-making, communicating a decision, follow-up, and documentation and archiving.
An IRB Guidebook prepared for the U.S. Office for Human Research Protections, an excerpt:
"It is hoped that the Guidebook will provide precisely what its title is intended to denote: guidance. The Guidebook does not itself constitute regulations but rather has been prepared for the convenience and reference of IRB members and administrators. The issues with which IRBs must concern themselves are many and complex. The guidebook is not designed to tell IRBs whether or not specific protocols should be approved … it does point out issues to which IRBs should pay attention and presents, wherever possible, areas where ethicists and others concerned with these issues have arrived a at consensus on the ethical acceptability of a particular activity or method (e.g., in clinical trials, the use of placebo arms where a standard therapy is available.)" [excerpted from the Preface]
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 "is responsible for overseeing human research subjects protections functions and related functions where research involves the use of human subjects…"
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.
At these sites you will find:
(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.
Must Each Institution Have its Own IRB?
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)