Research and Informed Consent in Africa--Another Look
IJsselmuiden, Carel B.
Faden, Ruth R.
New England Journal of Medicine. 1992 Mar 19; 326(12): 830-834.
The current practice of requiring the informed consent of research subjects is relatively new....The fundamental justification for requiring consent from human subjects as a matter of U.S. public policy is best stated in the Belmont Report of 1978, which bases the obligation to obtain consent on the ethical principle of respect for persons....This strong emphasis on respect for autonomy is, however, neither unchallenged in the United States itself nor necessarily accepted elsewhere in the world, including Western Europe and Africa. The challenge centers on the validity of applying ethical guidelines for research that are accepted in one part of the world to a different cultural setting. It is in this context that the appropriateness of first-person informed consent (i.e., informed consent given by the subjects themselves), as practiced in the West, is being questioned....The most fundamental argument against modifying the obligation of researchers to obtain informed consent from individual subjects is that such an obligation expresses important and basic moral values that are universally applicable, regardless of variations in cultural practice. Although we are sympathetic to this position, our arguments in this paper do not turn on claims about universal morality or criticism of cultural relativism. Instead, our aim is to argue the inapplicability of arguments that appeal to cultural relativism on factual grounds, rather than the unjustifiability of such arguments on moral grounds. Broadly speaking, the appropriateness of first-person informed consent in developing countries has been questioned on three grounds: that it is culturally or anthropologically inappropriate; that potential subjects have questionable competence to give informed consent or that there are insurmountable communication problems; and that the need for immediate research findings makes informed-consent requirements unreasonable. We shall consider these arguments in turn....
Aids; Anthropology; Autonomy; Communication; Competence; Consent; Developing Countries; Ethical Relativism; Ethical Review; Evaluation; Guidelines; Hepatitis; Human Experimentation; Immunization; Informed Consent; International Aspects; Investigator Subject Relationship; Investigators; Moral Policy; Morality; Motivation; Policy Analysis; Political Systems; Public Policy; Research; Research Findings; Research Subjects; Researchers; Review; Socioeconomic Factors; Standards; Third Party Consent; Values;
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