Institutional review board

Institutional Review BoardsInstitutional Review Board (IRB)IRBethics committeeinstitutional review boards (IRBs)IRBsethical approvalethics boardhealth authority/ethics committeehealth research ethics committees
An 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.wikipedia
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Human subject research legislation in the United States

many institutions and policies
In 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.
With growing public awareness of such experimentation, and the evolution of professional ethical standards, such research became regulated by various legislation, most notably, those that introduced and then empowered the institutional review boards.

Office for Human Research Protections

Office of Human Research Protections (OHRP)OHRP
In 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.
The office's primary duty is the implementation of, a set of regulations for Institutional Review Boards (IRB) that mirrors the U.S. Food and Drug Administration (FDA) regulation that covers clinical research conducted by pharmaceutical companies as well as other regulations under the guidance of the Federal Policy for the Protection of Human Subjects, which is also known as the "Common Rule".

Institutional Animal Care and Use Committee

IACUCInstitutional Animal Care and Use Committeesanimal protocol approval
The equivalent body responsible for overseeing U.S. federally funded research using animals is the Institutional Animal Care and Use Committee (IACUC).
The corresponding, parallel, and equivalent local ethical body responsible for overseeing U.S. federally funded research involving humans is the Institutional Review Board (IRB).

Tuskegee syphilis experiment

Tuskegee Syphilis StudyTuskegee experimentTuskegee Study of Untreated Syphilis in the Negro Male
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.
It also led to federal laws and regulations requiring Institutional Review Boards for the protection of human subjects in studies involving them.

Informed consent

consentPrior Informed Consentconsensual
A bona fide process for obtaining informed consent from participants is also generally needed.
Such cases in a clinical trial in medical research are anticipated and prevented by an ethics committee or Institutional Review Board.

New Drug Application

NDANew Drug ApplicationsFood and Drug Administration
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.

Ethics committee

research ethics committeesResearch Ethics Committee
Numerous other countries have equivalent regulations or guidelines governing human subject studies and the ethics committees that oversee them.
In the United States, an ethics committee is usually known as an institutional review board and is dedicated to overseeing the rights and well-being of research subjects participating in scientific studies in the US.

National Research Act

National Research Act of 1974
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".
The Act also formalized a regulated IRB process through local institutional review boards, also overseen by the Office of Human Research Protections.

Belmont Report

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".
Today, the Belmont Report continues as an essential reference for institutional review boards (IRBs) that review HHS-conducted or -supported human subjects research proposals involving human subjects, in order to ensure that the research meets the ethical foundations of the regulations.

Milgram experiment

Milgramexperiment on obedienceMilgram obedience experiment
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.
In 2009, Burger was able to receive approval from the institutional review board by modifying several of the experimental protocols.

Stanford prison experiment

The Stanford Prison ExperimentStanford experimentStanford experiments
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.
Before they are implemented, human studies must now be reviewed and found by an institutional review board (US) or ethics committee (UK) to be in accordance with ethical guidelines set by the American Psychological Association.

Psychology

psychologicalpsychologistpsychologists
IRBs are most commonly used for studies in the fields of health and the social sciences, including anthropology, sociology, and psychology.
In the U.S., the National Institutes of Health established the Institutional Review Board in 1966, and in 1974 adopted the National Research Act (HR 7724).

Human subject research

human experimentationhuman experimentsguinea pig
While the IRB approval and oversight process is designed to protect the rights and welfare of the research subjects, it has been the subject of criticism, by bioethicists and others, for conflicts of interest resulting in lax oversight.
After the passage of the Pure Food and Drug Act in 1906, regulatory bodies such as the Food and Drug Administration (FDA) and institutional review boards (IRBs) were gradually introduced.

Clinical trial

clinical trialsclinical studiesclinical study
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. It defines Good Clinical Practice (GCP), which is an agreed quality standard that governments can transpose into regulations for clinical trials involving human subjects.
They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought.

Declaration of Helsinki

Helsinki DeclarationHelsinki Committeeethical
It also introduced the concept of oversight by an 'independent committee' (Article I.2) which became a system of Institutional Review Boards (IRB) in the US, and research ethics committees or ethical review boards in other countries.

Good clinical practice

clinical practicegood clinical practice (GCP)clinical research standards
It defines Good Clinical Practice (GCP), which is an agreed quality standard that governments can transpose into regulations for clinical trials involving human subjects.

Children in clinical research

Ethical problems using children in clinical trialsclinical trials on children
These approving groups are typically called Institutional Review Boards (IRB) in the United States, in Europe they are typically called Independent Ethics Committees (IEC).

Inside the Ethics Committee

Each episode is a discussion of a real life case facing a clinical ethics committee.

Data monitoring committee

Data Monitoring CommitteesData and Safety Monitoring BoardData Safety Monitoring Board

Unethical human experimentation in the United States

Human experimentation in the United Stateshuman experimentationmedical experimentation
Further investigation revealed financial ties to AstraZeneca by Markingson's psychiatrist, Dr. Stephen C. Olson, oversights and biases in AstraZeneca's trial design, and the inadequacy of university Institutional Review Board (IRB) protections for research subjects.

Committee

standing committeeexecutive committeesteering committee
An 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.

Research

researcherresearchersoriginal research
An 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.