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Institutional review board

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An institutional review board ensures that research involving human beings both meets the criteria of medical ethics, and also that the research does not pose undue risks to the subjects. While the term is most commonly associated with clinical trials, an IRB commonly would approve an academic research project, in the social sciences, involving human subjects.

The medicolegal definition in the United States, as established by the National Institutes of Health, is
1. A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. All clinical trials in the U.S. must be approved by an IRB before they begin. 2. Every institution that conducts or supports biomedical or behavioral research involving human participants must, by federal regulation, have an IRB that initially approves and periodically reviews the research in order to protect the rights of human participants. — clinicaltrials.gov[1]
.

While this definition is U.S. specific, it is representative of many national policies, and draws from the ethical principles of the Declaration of Helsinki, a response to the Nazi medical atrocities.

Project approval

A basic principle of projects that may be approved is that if there is risk to the subject(s), that risk must be justified by reasonably expected benefits to the subject, society, or both. For example, collecting blood for a study of population genetics, where the subjects will be anonymized, has the slight risk of drawing blood, no anticipated benefit to the patient, but, if the study has a well-considered purpose, has a benefit to society and thus is ethical. An experimental procedure judged to be dangerous but having potential for some patient benefit, may be ethical if the subjects are terminal and no existing treatment exists for their disease. A very wide range of cases fall between these two extremes.

In recent years, one of the changes in clinical trials, brought about by current thought in bioethics, is that when a treatment is currently accepted as the best available for a condition with a particular condition, it is unethical to give that patient a placebo if they are not assigned to receive the investigational treatment. Further, the investigational treatment should reasonably be expected, in the opinions of experts, to offer a potential benefit over the existing "gold standard" treatment.

"Risks to research subjects posed by participation in research should be justified by the anticipated benefits to the subjects or society. This requirement is clearly stated in all codes of research ethics, and is central to the federal regulations. One of the major responsibilities of the IRB, therefore, is to assess the risks and benefits of proposed research.[2]

Certain experiments have revealed an unexpected danger; while they were approved by the standards of the time, no such experiment could be approved in the future. IRBs did not always exist, either for approval or monitoring, and ensuring safety was the responsibility of the principal investigator. For example, Philip Zimbardo stopped the Stanford Prison Experiment quite quickly,[3] when the experimental "guards" began to exhibit dangerous tendencies, and the experimental "prisoners" were in emotional distress. That level of risk was not expected, but it would be extremely unlikely that such an experiment would be approved if proposed to an IRB.

Safety monitoring

References

  1. National Institutes of Health, Glossary of Clinical Trials Terms
  2. Penslar, Robin Levin, IRB Guidebook, Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services
  3. Zimbardo, Philip G., Prison Experiment