Remembering and Interpreting Informed Consent: A Qualitative Study of Drug Trial Participants

Abstract

Background and Objectives: Federal regulations require that research subjects provide informed consent for their participation in biomedical research. Before giving consent, subjects are presented with information about study procedures, risks, benefits, and alternatives. Although investigators have assessed subjects’ retention of consent material, little is known about how participants view methodologic dimensions of biomedical research, such as placebos and randomization, or the distinction between medical treatment in a research protocol versus personal health care. These issues were examined with a qualitative interview study.

Methods: Research interviews were conducted with 14 subjects who had recently completed their participation in one of two drug trial studies. The interviews were tape-recorded and transcribed. The transcripts were analyzed and coded for thematic content.

Results: Participants showed a thorough understanding of important study elements, such as randomization and placebos. They described primarily altruistic motives for participating in the drug trial. There was evidence that subjects might not make a clear distinction between personal medical care and treatment in a research protocol.

Conclusions: Participants viewed their involvement in research very positively. They understood most important methodologic dimensions. The findings, however, suggest that the consent process should include greater attention to the distinction between research and clinical practice.