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Ethics: Questions & Morality of Human Actions, 3rd Edition

Experimentation

by Sanford Golin

Definition: Conduct of practical scientific or medical research

Type of ethics: Scientific ethics

Significance: Experiments conducted on humans and animals are governed by formal and informal codes of ethics designed to protect the rights and welfare of the subjects, to ensure that the experiments serve a legitimate public interest, and to regulate the use of the information obtained as a result of the experiments.

What are the moral principles to be considered in evaluating the rightness or wrongness of using humans as research subjects? In The Patient as Partner (1987), Robert M. Veatch summarized the ethical principles and issues involved in research: The principle of beneficence, which has its roots in the ethics of medical treatment, states that research with humans is justified only when some good can come from it; this is the minimum justification for human research.

Research may do good (therefore meeting the criterion of beneficence) but may also cause harm. Research that causes harm is morally wrong; that is, it does not meet the principle of nonmaleficence. When research causes both good and harm, which principle, beneficence or nonmaleficence, takes priority? If avoiding harm takes priority, then a vast amount of research with human subjects with the potential for doing much good would be considered unethical. Therefore, the ratio of benefit to harm is a more reasonable criterion for justifying human experimentation.

If benefit/harm is adopted as the moral principle, a new problem emerges, because this principle would justify inhumane experimental procedures such as those employed by the Nazis as long as it could be shown that severe harm or death to a few human subjects was of benefit to large numbers of people.

Benefit/harm, a form of beneficence, is therefore a necessary but insufficient justification for research with human subjects. Additional principles are required. The principle of autonomy recognizes that among the inalienable rights of persons is the right to liberty. The principle of autonomy implies a right to self-determination, including the right, when informed of the benefits and harms, to consent to participate in research that may entail certain risks to the subject. Therefore, autonomy is the basis for the use of informed consent in research with human subjects; informed consent helps to mitigate some of the problems posed by sole reliance on beneficence as a moral criterion.

Still another principle involves considerations of justice (fairness) in the conduct of human research. According to one theory of justice, distributive justice, fairness involves attempting to equalize the benefits and harms among the members of society. This principle has implications for the selection of subjects for research in the sense that disadvantaged subjects—for example, members of minority groups—should not be chosen as subjects, since this would add another burden to an already unduly burdened group. This principle would not apply when minority status was a variable under study in the research.

The principles of beneficence, autonomy, and justice form the basis for some of the criteria set by the U.S. Department of Health and Human Services (DHHS) and used by institutional review boards (IRBs) for judging whether proposed research involving human subjects is ethically sound. These criteria are (1) risks to subjects are minimized, (2) risks are reasonable relative to anticipated benefits, (3) prior informed consent will be obtained from subjects or their legal representatives, (4) informed consent will be documented, and (5) selection of subjects will be equitable. Two additional criteria are that (6) subjects’ privacy and confidentiality will be maintained and that (7) the research plan involves monitoring the data, when applicable, so as to ensure subject safety.

The application of ethical principles to particular instances of research with human subjects highlights the complexities involved in the use of these principles. One question that arises concerns the obligations of a scientist when the nature of the research precludes informed consent, as in psychological research that involves the use of deception. While many people believe that deception is permissible under certain limited conditions—for example, when there is little or no risk to subjects and there are no alternative ways of gathering the data—others feel that deception is intrinsically harmful to subjects and is never justified.

Another question has to do with the issue of informed consent with subjects who may not be competent to give informed consent; for example, in cases involving children or individuals who were formerly competent but are no longer so (such as individuals who have some form of dementia). When risks are minimal, informed consent by parents of children and informed consent by guardians of the formerly competent have been employed as criteria. In circumstances in which the subject is competent but informed consent may be obtained under potentially coercive conditions, as in the case of prisoners or clinic patients, complex ethical questions are raised.

The ethics of experimentation also extend into such other areas as issues of animal care and rights, and the ethical obligations of scientists with regard to the integrity of the research process.

Further Reading

1 

Caplan, A. L. When Medicine Went Mad: Bioethics and the Holocaust. Totowa, N.J.: Humana Press, 1992.

2 

Cothran, Helen, ed. Animal Experimentation: Opposing Viewpoints. San Diego, Calif.: Greenhaven Press, 2002.

3 

Foster, Claire. The Ethics of Medical Research on Humans. New York: Cambridge University Press, 2001.

4 

Garattini, Silvio, and D. W. van Bekkum, eds. The Importance of Animal Experimentation for Safety and Biomedical Research. Boston: Kluwer Academic, 1990.

5 

Group for the Advancement of Psychiatry. A Casebook in Psychiatric Ethics. New York: Brunner/ Mazel, 1990.

6 

Institute of Medicine Committee on Assessing the System for Protecting Human Research Participants. Responsible Research: A Systems Approach to Protecting Research Participants. Edited by Daniel D. Federman, Kathi E. Hanna, and Laura Lyman Rodriguez. Washington, D.C.: National Academies Press, 2003.

7 

Sieber, J. E., ed. Fieldwork, Regulation, and Publication. Vol. 2 in The Ethics of Social Research. New York: Springer-Verlag, 1982.

8 

Veatch, R. M. The Patient as Partner: A Theory of Human-Experimentation Ethics. Bloomington: Indiana University Press, 1987.

See also: Animal research; Animal rights; Bioethics; Consent; Medical research; Milgram experiment; National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; Nazi science; Science.

Citation Types

Type
Format
MLA 9th
Golin, Sanford. "Experimentation." Ethics: Questions & Morality of Human Actions, 3rd Edition, edited by George Lucas & John K. Roth, Salem Press, 2019. Salem Online, online.salempress.com/articleDetails.do?articleName=Ethics_0711.
APA 7th
Golin, S. (2019). Experimentation. In G. Lucas & J. K. Roth (Eds.), Ethics: Questions & Morality of Human Actions, 3rd Edition. Salem Press. online.salempress.com.
CMOS 17th
Golin, Sanford. "Experimentation." Edited by George Lucas & John K. Roth. Ethics: Questions & Morality of Human Actions, 3rd Edition. Hackensack: Salem Press, 2019. Accessed December 14, 2025. online.salempress.com.