Ethics of Research: Protection of Human Subjects


Medical research involving human subjects is invaluable for answering both scientific and clinical questions, notably those centred on making medical intervention as effective and safe as possible. But it raises a number of difficult moral issues: such experimentation can impose risk, questions arise about the adequacy of informed consent, and clinical research creates a tension between the roles of clinical therapist and research scientist. Many of these are encapsulated in the various regulations that exist – this article focuses on the guidelines for the United States – so part of what is required to be an ethical researcher is an understanding of these regulations, but it also requires ethical reasoning about such issues as informed consent, confidentiality, randomisation, placebos, vulnerable populations and special issues that arise in research across national boundaries.

Key Concepts:

  • A data and safety monitoring board (DSMB) is a committee set up for a given trial, independent from the researchers, which monitors (unblended) data as they accumulate, so as to make judgements about changes in the study including recommending early termination of the study.

  • Informed consent is the fundamental (legal and ethical) requirement that a human subject give his or her voluntary and informed consent before being subject to research.

  • An institutional review board (IRB) is a committee given the responsibility for approving or rejecting research protocols to be carried out within a given institution (such as a hospital or university).

  • Randomized clinical trials (RCTs) are studies where participants are assigned by chance to receive one or another clinical intervention, thus controlling for the effect of other variables.

  • Equipoise is the situation where there is no way to judge the difference between values of the different arms of a clinical trial, and it is often said that this must obtain to ensure the ethical acceptabilty of the trial.

Keywords: regulations; informed consent; experimental treatment; clinical trial; equipoise


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Further Reading

Childress JF, Meslin EM and Shapiro HT (eds) (2005) Belmont Revisited: Ethical Principles for Research with Human Subjects. Washington, DC: Georgetown University Press.

Emanuel EJ, Crouch RA, Arras JD, Moreno JD and Grady CC (eds) (2003) Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Baltimore, MD: Johns Hopkins University Press.

Emanuel EJ, Grady CC, Crouch RA et al. (eds) (2011) The Oxford Textbook of Clinical Research Ethics. Oxford: Oxford University Press.

Emanuel EJ, Wendler D and Grady C (2000) What makes clinical research ethical? Journal of the American Medical Association 283(20): 2701–2711.

Levine R (1988) Ethics and Regulation of Clinical Research. Baltimore, MD: Urban and Schwarzenberg.

US Federal Government (1991) Federal policy for the protection of human subjects (45 CFR 46). Federal Register 56(117): 28013–28028.

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Gifford, Fred(Sep 2014) Ethics of Research: Protection of Human Subjects. In: eLS. John Wiley & Sons Ltd, Chichester. [doi: 10.1002/9780470015902.a0003482.pub3]