TABLE 1—

Examples of Research Lapses Relating to Individual Informed Consent

Lapse	Explanation	Examples
Lack of voluntariness	Potential coercion to influence participation has occurred	Conflict of interest: Investigator is the subject' physician10
		Subjects are asked to participate when under considerable duress11–13
		Subjects are asked to participate when they have few or no options (e.g., placebo-controlled surgical trials)14–16
Incomplete disclosure	Subjects are misinformed or not fully informed about the intent of the research in question, potential risks associated with the research, or previous pertinent research	In a multisite breast cancer prevention trial of the drug tamoxifen, pertinent information about side effects was omitted or minimized in consent forms17–18
		In a New York study, parents were not informed that their children with attention deficit–hyperactivity disorder were taken off their medication and subjected to brain chemistry tests19
		In a study of serodiscordant couples in Haiti, subjects were not told that the purpose of the study was to observe couples in which 1 partner was HIV-seropositive20–21
		In a zidovudine (AZT) trial in Cote d'Ivoire, 1 female subject was not told that the experimental treatment had been proven to reduce vertical transmission of HIV in a US trial13,22–23
		In a trial of isoniazid (INH) for tuberculosis in Uganda, HIV-positive subjects were not told that INH is routinely used in the United States to prevent tuberculosis24–25
		In a study conducted in Los Angeles, researchers did not properly inform parents providing consent for their children about previously reported adverse side effects of an investigational measles vaccine26–27
Confusion about study terminology	Subjects do not fully understand the scientific terminology or the study' purpose as presented to them	Parents of critically ill babies were confused about the words random and placebo; they perceived random assignment to mean either acceptance or rejection of their babies as subjects in a UK study11
		One female subject in an AZT trial in Cote d'Ivoire perceived that participating would help her child and ease her childbirth13
		HIV-positive subjects in a trial of INH for tuberculosis in Uganda were told that they would be assigned to one of the treatment groups, with one of the groups being “treatment with a placebo drug”24–25
		Subjects may not have understood that placebo-controlled surgical trials in the United States were risk-free14–16