|
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be done.〔The Office of Human Research Protection. Institutional Review Board Guidebook. "Chapter 3, Section A: Risk/Benefit Analysis.” pp. 1-10 () Retrieved May 30, 2012〕 The purpose of the review process is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. A key goal of IRBs is to protect human subjects from physical or psychological harm, which they attempt to do by reviewing research protocols and related materials. The protocol review assesses the ethics of the research and its methods, promotes fully informed and voluntary participation by prospective subjects capable of making such choices (or, if that is not possible, informed permission given by a suitable proxy), and seeks to maximize the safety of subjects. In the United States, the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. IRBs are responsible for critical oversight functions for research conducted on human subjects that are "scientific," "ethical," and "regulatory." IRBs are most commonly used for studies in the fields of health and the social sciences, including anthropology, sociology, and psychology. Such studies may be clinical trials of new drugs or devices, studies of personal or social behavior, opinions or attitudes, or studies of how health care is delivered and might be improved. The equivalent body responsible for overseeing U.S. federally funded research using animals is the Institutional Animal Care and Use Committee (IACUC). ==United States mandate for IRBs== Formal review procedures for institutional human subject studies were originally developed in direct response to research abuses in the 20th century. Among the most notorious of these abuses were the experiments of Nazi physicians, which became a focus of the post-World War II Doctors' Trial, the Tuskegee Syphilis Study, a long-term project conducted between 1932 and 1972 by the U.S. Public Health Service, and numerous human radiation experiments conducted during the Cold War. Other controversial U.S. projects undertaken during this era include the Milgram obedience experiment, the Stanford prison experiment, and Project MKULTRA, a series of classified mind control studies organized by the CIA. The result of these abuses was the National Research Act of 1974 and the development of the Belmont Report, which outlined the primary ethical principles in human subjects review; these include "respect for persons", "beneficence", and "justice." An IRB may only approve research for which there is a ''bona fide'' informed consent process for participants, for which the risks to subjects are balanced by potential benefits to society, and for which the selection of subjects presents a fair or just distribution of risks and benefits to eligible participants. In the United States, IRBs are governed by Title 45 Code of Federal Regulations Part 46. These regulations define the rules and responsibilities for institutional review, which is required for all research that receives support, directly or indirectly, from the United States federal government. IRBs are themselves regulated by the Office for Human Research Protections (OHRP) within the Department of Health and Human Services (HHS). Additional requirements apply to IRBs that oversee clinical trials of drugs involved in new drug applications, or to studies that are supported by the United States Department of Defense. In addition to registering its IRB with the OHRP, an institution is also required to obtain and maintain a ''Federalwide Assurance'' or FWA, before undertaking federally funded human research.〔(Office of Human Research Protection - IRBs and Assurances )〕 This is an agreement in which the institution commits to abiding by the regulations governing human research. A secondary supplement to the FWA is required when institutions are undertaking research supported by the U.S. Department of Defense.〔(Human Research Protection Program (HRPP). )〕 This ''DoD Addendum'' includes further compliance requirements for studies using military personnel, or when the human research involves populations in conflict zones, foreign prisoners, etc.〔(HRPP Information Sheet for DoD Addendum. )〕 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Institutional review board」の詳細全文を読む スポンサード リンク
|