Researchers recommend community advisory boards to prevent lapses in informed consent

nder duress and another in which they were asked to participate when they had few or no options.

Incomplete disclosure also can be a problem, Strauss said. In several studies, investigators did not tell patients and parents of child patients enough about potential side effects. In a New York study, doctors did not inform parents that their children with attention deficit-hyperactivity disorders were taken off medications and subjected to brain chemistry tests. Researchers in Uganda did not tell HIV-positive patients that a tuberculosis drug they were given as part of a study was not routinely used in the United States for TB.

Not infrequently, participants misunderstand study terminology, he said.

For example, parents of critically ill babies in a United Kingdom study were confused about the words random and placebo. Health workers told HIV-positive subjects in a Ugandan tuberculosis study that they would be treated with a placebo drug, although placebos are chosen so as not to produce any physiologic effect. A woman in an Ivory Coast study thought participating in a study of the AIDS drug formerly called AZT would help her child and ease her childbirth.

Individual informed consent has traditionally been understood as a substantive ethical requirement, an agreement between the researcher and the research subject concerning the roles and obligations of each party in a study, Strauss said. The researcher seeks to enroll fully informed, consenting individual subjects in a study. When informed consent is not obtained, or when subjects are not fully informed, research abuses can occur.

Since the Nuremburg Code of 1947, several organizations have worked to provide ethical guidelines and principals for human subject research, he said. These include the Council for International Organizations of Medical Sciences, the World Medical Association and the National Commission for the Protection of Human Subjects of Biomedical and Behavi

Contact: David Williamson
University of North Carolina at Chapel Hill

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