For a worldwide perspective, see ethics institutional review board (irb), also known as an independent ethics committee (iec), ethical review board (erb), or research ethics board (reb), is a type of committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical.
Such boards are formally designated to approve (or reject), 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 completed. 1] the purpose of the irb is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study.
Along with developed countries, many developing countries have established national, regional or local institutional review boards in order to safeguard ethical conduct of research concerning both national and international norms, regulations or codes.
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 the united states, the food and drug administration (fda) and department of health and human services (specifically office for human research protections) regulations (see human subject research legislation in the united states) 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". 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 also: human subject research legislation in the united review procedures for institutional human subject studies were originally developed in direct response to research abuses in the 20th century.
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 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 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.3] 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 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.
4] 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.
5] 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.Human research ethics guidelines require that decisions about exemption are made by an irb representative, not by the investigators themselves. However, the organizational responsibilities and the scope of the oversight purview can differ substantially from one nation to another, especially in the domain of non-medical research.