Pharmacogenetic Research: Perceptions of Informed Consent
GlaxoSmithKline (formerly Glaxo Wellcome Genetics Directorate) undertook a descriptive study to elicit volunteers’ perceptions of a pharmacogenetic research consent form, an educational brochure, and a video; and to identify modifications in these materials that would enhance their usefulness. Face-to-face interviews were conducted to obtain feedback on the material and assess volunteer understanding of the basic components of the study. Although repeated exposure to key information in different formats resulted in improved comprehension, almost one-third of respondents could not accurately describe the two options for participating in the pharmacogenetic research. Almost all of the respondents reported that they would like to have the brochure, video, or both, in addition to the consent form. These results underscore the importance of providing volunteers with the opportunity for discussion with the study physician. They also support the use of supplementary aids to accommodate different styles of processing information. The respondents’ suggestions will be considered when the materials are revised.
Key WordsInformed consent Descriptive study Pharmacogenetic research Written and audiovisual materials for informed consent Perceptions of informed consent
Unable to display preview. Download preview PDF.
- 1.Rapoport DM. Consent process. Reg Aff Focus. July 2000;7–3.Google Scholar
- 2.President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Protecting Human Subjects. Washington, DC: US Government Printing Office; 1981.Google Scholar
- 3.National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Washington, DC: US Government Printing Office; 1988.Google Scholar
- 4.Protection of Human Subjects. 46 Federal Register. 8386 (1981) (codified at 45 CFR §46).Google Scholar
- 12.Hinds C, Streater A, Mood D. Functions and preferred methods of receiving information related to radiotherapy. Cancer Nurs. 1995;5:374–384.Google Scholar
- 15.Protection of Human Subjects. 46 Federal Register. 8951 (1981), as amended at 61 Federal Register. 57289 (1996) (codified at 21 CFR §50).Google Scholar
- 16.Agre P, McKee K, Gargon N, et al. Patient satisfaction with an informed consent process. Cancer Pract. 1997;5:62–67.Google Scholar