Showing papers on "Informed consent published in 1969"

Obtaining Informed Consent: Form or Substance

Abstract: Sixty-six subjects, 64 of whom were female hospital or medical school employees, were asked if they were willing to take two tablets of "acetylhydroxybenzoate" or a placebo when they next had a headache, after receiving varyingly detailed descriptions of the actions and hazards of the drug. Comprehension and consent to volunteer were inversely related to length of form. In the groups receiving the longer form two subjects volunteered to take the drug despite the presence of contraindications; five subjects missed the point that fatal reactions might occur. When told that the drug described was in fact aspirin, 20 of 21 who had refused to take "acetylhydroxybenzoate" said that they would continue to take aspirin. The data suggest that the information provided to subjects should be brief and to the point, to maximize comprehension and intelligent decision-making. These results have important implications for consent procedures, drug advertising, and drug warnings.

Experimentation in children. A reexamination of legal ethical principles.

Abstract: Reexamination of legal and ethical principles in the United States and England yields suggestions concerning standards for the use of children in clinical investigation. Where the research is therapeutic, a minor may be included if informed consent is obtained from the parents or guardian. Where the research is not therapeutic, minors may be included if 14 years of age or older and if intelligent and mature enough to give informed consent. Parental consent is also required with discernible risks or hazards. For tissue and organ donation, the donor should be 14 years old or older and intelligent and mature enough to give informed consent and have parental or guardian consent also. Donations should be restricted to relatives or close friends. Also children under 14 may participate in clinical investigation which is not for their direct benefit where the studies are sound, promise important new knowledge for mankind, and there is no discernible risk.