Ethics committee

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 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:

In the United States, an ethics committee is usually known as an institutional review board, a committee dedicated to overseeing the rights and well-being of research subjects participating in scientific studies in the US.

In Australia, an ethics committee in medical research refers to a Human Research Ethics Committee (HREC).

History

Dr. Herta Oberheuser being sentenced at Nuremberg

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[1] in 1947, which was a result of the trials of Nazi doctors at the Nuremberg trials 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.[2]

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.[3]

An important element of an ethics committee's oversight is to ensure that informed consent 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's research into Yellow fever in Cuba in 1901. However, there was no general or official guidance at this time.[4] That remained the case until the yellow fever program was referenced in the drafting of the Nuremberg Code.[5] 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.[6]

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).[7] 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.[8]

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 (COIMS), a body set up by the World Health Organization. First published in 1993, the COIMS 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.[9]

References

  1. ↑ The Nuremberg Code, U.S. Department of Health & Human Services, accessed and archived, 20 December 2015
  2. ↑ Altman, pp. xv-xvii
  3. ↑ Altman, p. xx
  4. ↑ Gandevia, p. 43
  5. ↑ Altman, pp. xvi,157
  6. ↑ Gandevia, pp. 43–44
  7. ↑ Riis, p. 173
  8. ↑ Carlson, Boyd & Webb, pp. 698-699
    • Levine, p. 170
  9. ↑ Largent, p. 207

Bibliography

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