An ethics committee is a body responsible for ensuring that
medical experimentation
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
and
human subject research are carried out in an ethical manner in accordance with national and international law.
Specific regions
An
ethics committee in the European Union is a body responsible for oversight of medical or human research studies in EU member states. Local terms for a European ethics committee include:
* A Research Ethics Committee (REC) in the United Kingdom
* A Medical Research Ethics Committee (MREC) in the Netherlands.
* A Comité de Protection des Personnes (CPP) in France.
In the United States, an ethics committee is usually known as an
institutional review board
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 applies research ethics by reviewing the methods proposed for research to ens ...
(IRB) or
research ethics board
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 applies research#Research ethics, research ethics by reviewing the methodolog ...
(REB) and is dedicated to overseeing the rights and well-being of research subjects participating in scientific studies in the US. Similarly in Canada, the committee is called a Research Ethics Board (REB).
In Australia, an ethics committee in medical research refers to a
Human Research Ethics Committee (HREC).
Since 1977 for the purposes of its subsidies to university research the
Government of Canada
The government of Canada (french: gouvernement du Canada) is the body responsible for the federal administration of Canada. A constitutional monarchy, the Crown is the corporation sole, assuming distinct roles: the executive, as the ''Crown ...
, under the
GOSA Act
Gun Owners South Africa (abbreviated to GOSA) is a firearms rights and advocacy group in the Republic of South Africa. It was founded on 26 January 2004 by Thomas Eastes and nine associates invited by him, Abios Khoele, Charl van Wyk, Pieter van Wy ...
in the person (since 2015) of its
Minister of Innovation, Science and Industry
The minister of innovation, science, and industry (french: ministre de l'Innovation, des Sciences et de l'Industrie) is the minister of the Crown in the Canadian Cabinet who is responsible for overseeing the economic development and corporate ...
, donates annually to several of the federal funder agencies; these in turn disburse the funds into person-sized chunks.
These persons typically are university professors, who are selected according to success in the wielding of soft power as measured by track record.
[ In Canada, the Interagency Advisory Panel on Research Ethics (IAPRE) promotes "the ethical conduct of research involving human participants" under a document sometimes referred to as ]TCPS2 The Interagency Advisory Panel on Research Ethics ("The Panel") was formed in 2001 by three of the research funding agencies of the Government of Canada: CIHR, NSERC and SSHRC ("The Agencies"). The Panel "develops, interprets and implements the ''T ...
. The panel was jointly started in 2001 by three of the federal university research-funding agencies CIHR
The Canadian Institutes of Health Research (CIHR; french: Instituts de recherche en santé du Canada; IRSC) is a federal agency responsible for funding health and medical research in Canada. Comprising 13 institutes, it is the successor to the M ...
, NSERC
The Natural Sciences and Engineering Research Council of Canada (NSERC; french: Conseil de recherches en sciences naturelles et en génie du Canada, CRSNG) is the major federal agency responsible for funding natural sciences and engineering rese ...
, and SSHRC
The Social Sciences and Humanities Research Council of Canada (SSHRC; french: Conseil de recherches en sciences humaines du Canada, CRSH) is a Canadian federal research-funding agency that promotes and supports post-secondary research and traini ...
. The IAPRE FAQ says that "Failure to comply with the requirements of the TCPS2 by researchers or their institution may result in a recourse by the Agencies."[ Other organizations have opted to adhere to the TCPS2, for example the ]National Research Council Canada
The National Research Council Canada (NRC; french: Conseil national de recherches Canada) is the primary national agency of the Government of Canada dedicated to science and technology research & development. It is the largest federal research ...
, the Department of National Defence Department of Defence or Department of Defense may refer to:
Current departments of defence
* Department of Defence (Australia)
* Department of National Defence (Canada)
* Department of Defence (Ireland)
* Department of National Defense (Philipp ...
and Health Canada
Health Canada (HC; french: Santé Canada, SC)Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the Structure of the Canadian federal government#Departments, with subsidiary unit ...
.[ The IAPRE maintains that some private REBs have opted to adhere to TCPS2 as well. It is worthwhile to note that not all research in Canada is dependent on federal funds.][
]
History
One of the most fundamental ethical principles in human experimentation is that the experimenter should not subject the participants in the experiment to any procedure they would not be willing to undertake themselves. This idea was first codified in the Nuremberg Code
The Nuremberg Code (german: Nürnberger Kodex) is a set of ethical research principles for human experimentation created by the court in '' U.S. v Brandt'', one of the Subsequent Nuremberg trials that were held after the Second World War.
Tho ...
in 1947, which was a result of the trials of Nazi doctors at the Nuremberg trials
The Nuremberg trials were held by the Allies of World War II, Allies against representatives of the defeated Nazi Germany, for plotting and carrying out invasions of other countries, and other crimes, in World War II.
Between 1939 and 1945 ...
accused of murdering and torturing victims in valueless experiments. Several of these doctors were hanged. Point five of the Nuremberg Code requires that no experiment should be conducted that is dangerous to the subjects unless the experimenters themselves also take part. The Nuremberg Code has influenced medical experiment codes of practice around the world, as has the exposure of experiments that have since failed to follow it such as the notorious Tuskegee syphilis experiment
The Tuskegee Study of Untreated Syphilis in the Negro Male (informally referred to as the Tuskegee Experiment or Tuskegee Syphilis Study) was a study conducted between 1932 and 1972 by the United States Public Health Service (PHS) and the Cente ...
.
Another ethical principle is that volunteers must stand to gain some benefit from the research, even if that is only a remote future possibility of treatment being found for a disease that they only have a small chance of contracting. Tests on experimental drugs are sometimes conducted on sufferers of an untreatable condition. If the researcher does not have that condition then there can be no possible benefit to them personally. For instance, Ronald C. Desrosiers in responding to why he did not test an AIDS
Human immunodeficiency virus infection and acquired immunodeficiency syndrome (HIV/AIDS) is a spectrum of conditions caused by infection with the human immunodeficiency virus (HIV), a retrovirus. Following initial infection an individual m ...
vaccine he was developing on himself said that he was not at risk of AIDS so could not possibly benefit.
An important element of an ethics committee's oversight is to ensure that informed consent
Informed consent is a principle in medical ethics and medical law, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatme ...
of the subjects has been given. Informed consent is the principle that the volunteers in the experiment should fully understand the procedure that is going to take place, be aware of all the risks involved, and give their consent to taking part in the experiment beforehand. The principle of informed consent was first enacted in the U.S. Army
The United States Army (USA) is the land service branch of the United States Armed Forces. It is one of the eight U.S. uniformed services, and is designated as the Army of the United States in the U.S. Constitution.Article II, section 2, cla ...
's research into Yellow fever
Yellow fever is a viral disease of typically short duration. In most cases, symptoms include fever, chills, loss of appetite, nausea, muscle pains – particularly in the back – and headaches. Symptoms typically improve within five days. In ...
in Cuba
Cuba ( , ), officially the Republic of Cuba ( es, República de Cuba, links=no ), is an island country comprising the island of Cuba, as well as Isla de la Juventud and several minor archipelagos. Cuba is located where the northern Caribbea ...
in 1901. However, there was no general or official guidance at this time. That remained the case until the yellow fever program was referenced in the drafting of the Nuremberg Code. This was further developed in the Declaration of Helsinki
The Declaration of Helsinki (DoH, fi, Helsingin julistus, sv, Helsingforsdeklarationen) is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA) ...
in 1964 by the World Medical Association
The World Medical Association (WMA) is an international and independent confederation of free professional medical associations representing physicians worldwide. WMA was formally established on September 18, 1947 and has grown to 115 national m ...
which has since become the foundation for ethics committees' guidelines.
The convening of ethics committees to approve the research protocol in human experiments was first written into international guidelines in the first revision to the Declaration of Helsinki (Helsinki II, 1975). A controversy arose over the fourth revision (1996) concerning placebo trials in developing countries
A developing country is a sovereign state with a lesser developed industrial base and a lower Human Development Index (HDI) relative to other countries. However, this definition is not universally agreed upon. There is also no clear agreem ...
. It was claimed that US trials of the anti-HIV
The human immunodeficiency viruses (HIV) are two species of ''Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune ...
drug zidovudine
Zidovudine (ZDV), also known as azidothymidine (AZT), is an antiretroviral medication used to prevent and treat HIV/AIDS. It is generally recommended for use in combination with other antiretrovirals. It may be used to prevent mother-to-child ...
in India was in breach of this requirement. This led the US Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
to cease incorporating new revisions of Helsinki and refer instead to the 1989 revision.
Ethics committees are also made a requirement in '''', produced by the Council for International Organizations of Medical Sciences
The Council for International Organizations of Medical Sciences (CIOMS) is an international non-governmental organization of 40 international, national, and associate member groups representing the biomedical science community. It was jointly est ...
(CIOMS), a body set up by the World Health Organization
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...
. First published in 1993, the CIOMS guidelines have no legal force but they have been influential in the drafting of national regulations for ethics committees. The COIMS guidelines are focused on practice in developing countries.[Largent, p. 207]
See also
*Guidelines for human subject research Various organizations have created guidelines for human subject research for various kinds of research involving human subjects and for various situations.
Instructions for the Directors of Clinics, Outpatient Clinics and Other Medical Facilities ...
References
Bibliography
* Lawrence K. Altman, ''Who Goes First?: The Story of Self-experimentation in Medicine'', University of California Press, 1987 {{ISBN, 0520212819.
* S. C. Gandevia, "Self-experimentation, ethics, and efficacy", ''Monash Bioethics Review'' (Ethics Committee Supplement), vol. 23, no. 4, 2005.
* Povl Riis
"Planning of scientific-ethical committees"
''British Medical Journal'', vol. 2, pp. 173–174, 1977.
* Emily A. Largent
"Recently proposed changes to legal and ethical guidelines governing human subjects research"
''Journal of Law and the Biosciences'', vol. 3, iss. 1, pp. 206–216.
* R. J. Levine
"Some recent developments in the international guidelines on the ethics of research involving human subjects"
''Annals of the New York Academy of Sciences'', vol. 918, pp. 170–178, November 2000.
* Robert V Carlson, Kenneth M. Boyd, David J Webb
"The revision of the Declaration of Helsinki: past, present and future"
''British Journal of Clinical Pharmacology'', vol. 57, iss. 6, pp. 695–713, June 2004.
Medical ethics
Design of experiments
Human subject research
Clinical research ethics
Drug safety
Social research
Ethics organizations
Ethics and statistics
Applied ethics
Regulatory compliance