Advertisement

Pharmacogenetic Research: Perceptions of Informed Consent

  • Elizabeth C. McPherson
  • Susan C. Ray
  • Patricia A. Rieser
  • Penelope K. Manasco
Article

Abstract

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 Words

Informed consent Descriptive study Pharmacogenetic research Written and audiovisual materials for informed consent Perceptions of informed consent 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Rapoport DM. Consent process. Reg Aff Focus. July 2000;7–3.Google Scholar
  2. 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. 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. 4.
    Protection of Human Subjects. 46 Federal Register. 8386 (1981) (codified at 45 CFR §46).Google Scholar
  5. 5.
    Reilly PR, Boshar MF, Holtzman SH. Ethical issues in genetic research: Disclosure and informed consent. Nature Genetics. 1997;15:16–20.CrossRefGoogle Scholar
  6. 6.
    Meade CD. Improving understanding of the in-formed consent document. Semin Oncol Nurs. May 1999;15:124–137.CrossRefGoogle Scholar
  7. 7.
    White LJ, Jones JS, Felton CW, Pool LC. Informed consent for medical research: Common discrepancies and readability. Acad Emerg Med. 1996;3:745–750.CrossRefGoogle Scholar
  8. 8.
    Philipson SJ, Doyle MA, Gabram SGA, Nightingale C, Philipson EH. Informed consent for research: A study to evaluate readability and processability to effect change. J Investig Med. 1995;43:459–467.PubMedGoogle Scholar
  9. 9.
    Tankanow RM, Burgunda VS, Weiskopf JA. Patients’ perceived understanding of informed consent in investigational drug studies. Am J Hosp Pharm. 1992;49:633–635.PubMedGoogle Scholar
  10. 10.
    Verheggen FWSM, Jonkers R, Kok G. Patients’ perceptions on informed consent and the quality of information disclosure in clinical trials. Patient Educ Counsel. 1996;29:137–153.CrossRefGoogle Scholar
  11. 11.
    Harris KA. The informational needs of patients with cancer and their families. Cancer Pract. 1998;6:39–46.CrossRefGoogle Scholar
  12. 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
  13. 13.
    Silva MC, Sorrell JM. Enhancing comprehension of information for informed consent: A review of empirical research. IRB: A Review Human Subjects Research. Jan/Feb 1988;10:1–5.CrossRefGoogle Scholar
  14. 14.
    Shmerling A, Schattner P, Piterman L. Qualitative research in medical practice. Med J Aust. 1993;158:619–622.CrossRefGoogle Scholar
  15. 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. 16.
    Agre P, McKee K, Gargon N, et al. Patient satisfaction with an informed consent process. Cancer Pract. 1997;5:62–67.Google Scholar

Copyright information

© Drug Information Association, Inc 2002

Authors and Affiliations

  • Elizabeth C. McPherson
    • 1
  • Susan C. Ray
    • 1
  • Patricia A. Rieser
    • 1
  • Penelope K. Manasco
    • 1
  1. 1.GlaxoSmithKlineResearch Triangle ParkUSA

Personalised recommendations