Ethics committee

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This article is about the human experimentation and medical meaning. For other uses, see Ethics committee (disambiguation).

An ethics committee is a body responsible for ensuring that

medical experimentation 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[1]
  • A Medical Research Ethics Committee (MREC) in the Netherlands.[2]
  • A Comité de Protection des Personnes (CPP) in France.

In the United States, an ethics committee is usually known as an

research ethics board
(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

Department of National Defence and Health Canada.[8][6] 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.[6]

History

concentration camp
inmates and sentenced to 20 years in prison.

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

Tuskegee syphilis experiment.[10]

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 vaccine he was developing on himself said that he was not at risk of AIDS so could not possibly benefit.[11]

An important element of an ethics committee's oversight is to ensure that

U.S. Army's research into Yellow fever in Cuba in 1901. However, there was no general or official guidance at this time.[12] That remained the case until the yellow fever program was referenced in the drafting of the Nuremberg Code.[13] This was further developed in the Declaration of Helsinki in 1964 by the World Medical Association which has since become the foundation for ethics committees' guidelines.[14]

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).[15] A controversy arose over the fourth revision (1996) concerning placebo trials in developing countries. It was claimed that US trials of the anti-HIV drug zidovudine in India was in breach of this requirement. This led the US Food and Drug Administration to cease incorporating new revisions of Helsinki and refer instead to the 1989 revision.[16]

Ethics committees are also made a requirement in

International Ethical Guidelines for Biomedical Research Involving Human Subjects, produced by the Council for International Organizations of Medical Sciences (CIOMS), a body set up by the World Health Organization. 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.[17]

See also

References

  1. PMID 28523118
    .
  2. PMID 28523118
    .
  3. ^
    JSTOR 1174532
    .
  4. ^ "Acts of the Parliament of Canada (30th Parliament, 2nd Session, Chapter 1-32), 1976-1977". Queen's Printer. Internet Archive. October 1977.
  5. ^ a b Fisher, Donald; Rubenson, Kjell; al, et (2006). Canadian Federal Policy and Postsecondary Education (PDF). Vancouver: The Centre for Policy Studies in Higher Education and Training.
  6. ^ a b c d "TCPS 2 Interpretations - Scope". Government of Canada. Panel on Research Ethics. 2022-06-24.
  7. ^ "Navigating the Ethics of Human Research". Interagency Advisory Panel on Research Ethics. 2020-02-25.
  8. ^ "NRC policy for research involving human participants". Government of Canada. National Research Council Canada. 2019-03-26.
  9. ^ The Nuremberg Code, U.S. Department of Health & Human Services, accessed and archived, 20 December 2015
  10. ^ Altman, pp. xv-xvii
  11. ^ Altman, p. xx
  12. ^ Gandevia, p. 43
  13. ^ Altman, pp. xvi,157
  14. ^ Gandevia, pp. 43–44
  15. ^ Riis, p. 173
  16. ^
    • Carlson, Boyd & Webb, pp. 698-699
    • Levine, p. 170
  17. ^ Largent, p. 207

Bibliography

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