Skip to main content
PMC home page
Journal of Medical Ethics logoLink to Journal of Medical Ethics
. 2005 Jul;31(7):385–392. doi: 10.1136/jme.2004.009530

Informed consent, participation in, and withdrawal from a population based cohort study involving genetic analysis

K Matsui 1, Y Kita 1, H Ueshima 1
PMCID: PMC1734191  PMID: 15994356

Abstract

Design: Descriptive analyses.

Setting and participants: The study evaluated two non-genetic subcohorts comprising 3166 people attending for a health checkup during 2002, and two genetic subcohorts comprising 2195 people who underwent a checkup during 2003.

Main outcome measurements: Analysis endpoints were differences in participation rates between the non-genetic and genetic subcohorts, differences between providing non-extensive and extensive preliminary information, and changes in participation status between baseline and at 6 months.

Results: Participation rates in the genetic subcohorts were 4·7–9·3% lower than those in the non-genetic subcohorts. The odds ratios (OR) of participation in genetic research were between 0·60 and 0·77, and the OR for withdrawal from the research was over 7·70; providing preliminary extensive information about genetic research reduced the withdrawal risks (OR 0·15 for all dependent variables) but worsened participation rates (OR 0·63–0·74).

Conclusions: The general population responded sceptically towards genetic research. It is crucial that genetic researchers utilise an informative and educational consent process worthy of public trust.

Full Text

The Full Text of this article is available as a PDF (88.4 KB).

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Andrykowski M. A., Munn R. K., Studts J. L. Interest in learning of personal genetic risk for cancer: a general population survey. Prev Med. 1996 Sep-Oct;25(5):527–536. doi: 10.1006/pmed.1996.0086. [DOI] [PubMed] [Google Scholar]
  2. Annas G. J. Reforming informed consent to genetic research. JAMA. 2001 Nov 14;286(18):2326–2328. doi: 10.1001/jama.286.18.2326. [DOI] [PubMed] [Google Scholar]
  3. Burton Bob. Proposed genetic database on Tongans opposed. BMJ. 2002 Feb 23;324(7335):443–443. doi: 10.1136/bmj.324.7335.443/a. [DOI] [PMC free article] [PubMed] [Google Scholar]
  4. Cassileth B. R., Lusk E. J., Miller D. S., Hurwitz S. Attitudes toward clinical trials among patients and the public. JAMA. 1982 Aug 27;248(8):968–970. [PubMed] [Google Scholar]
  5. Cassileth B. R., Zupkis R. V., Sutton-Smith K., March V. Informed consent -- why are its goals imperfectly realized? N Engl J Med. 1980 Apr 17;302(16):896–900. doi: 10.1056/NEJM198004173021605. [DOI] [PubMed] [Google Scholar]
  6. Chadwick R. The Icelandic database--do modern times need modern sagas? BMJ. 1999 Aug 14;319(7207):441–444. doi: 10.1136/bmj.319.7207.441. [DOI] [PMC free article] [PubMed] [Google Scholar]
  7. Cyranoski David. Dispute over data privacy halts cancer study. Nature. 2003 Jul 24;424(6947):359–359. doi: 10.1038/424359a. [DOI] [PubMed] [Google Scholar]
  8. Durfy S. J., Bowen D. J., McTiernan A., Sporleder J., Burke W. Attitudes and interest in genetic testing for breast and ovarian cancer susceptibility in diverse groups of women in western Washington. Cancer Epidemiol Biomarkers Prev. 1999 Apr;8(4 Pt 2):369–375. [PubMed] [Google Scholar]
  9. Helmes A. W., Bowen D. J., Bowden R., Bengel J. Predictors of participation in genetic research in a primary care physician network. Cancer Epidemiol Biomarkers Prev. 2000 Dec;9(12):1377–1379. [PubMed] [Google Scholar]
  10. Ingelfinger F. J. Informed (but uneducated) consent. N Engl J Med. 1972 Aug 31;287(9):465–466. doi: 10.1056/NEJM197208312870912. [DOI] [PubMed] [Google Scholar]
  11. Kaye J., Martin P. Safeguards for research using large scale DNA collections. BMJ. 2000 Nov 4;321(7269):1146–1149. doi: 10.1136/bmj.321.7269.1146. [DOI] [PMC free article] [PubMed] [Google Scholar]
  12. Lerman C., Hughes C., Benkendorf J. L., Biesecker B., Kerner J., Willison J., Eads N., Hadley D., Lynch J. Racial differences in testing motivation and psychological distress following pretest education for BRCA1 gene testing. Cancer Epidemiol Biomarkers Prev. 1999 Apr;8(4 Pt 2):361–367. [PubMed] [Google Scholar]
  13. Lowrance W. W. The promise of human genetic databases. BMJ. 2001 Apr 28;322(7293):1009–1010. doi: 10.1136/bmj.322.7293.1009. [DOI] [PMC free article] [PubMed] [Google Scholar]
  14. Lynöe N., Sandlund M., Dahlqvist G., Jacobsson L. Informed consent: study of quality of information given to participants in a clinical trial. BMJ. 1991 Sep 14;303(6803):610–613. doi: 10.1136/bmj.303.6803.610. [DOI] [PMC free article] [PubMed] [Google Scholar]
  15. Macer D. R. Public acceptance of human gene therapy and perceptions of human genetic manipulation. Hum Gene Ther. 1992 Oct;3(5):511–518. doi: 10.1089/hum.1992.3.5-511. [DOI] [PubMed] [Google Scholar]
  16. Schaeffer M. H., Krantz D. S., Wichman A., Masur H., Reed E., Vinicky J. K. The impact of disease severity on the informed consent process in clinical research. Am J Med. 1996 Mar;100(3):261–268. doi: 10.1016/S0002-9343(97)89483-1. [DOI] [PubMed] [Google Scholar]
  17. Willison Donald J., Keshavjee Karim, Nair Kalpana, Goldsmith Charlie, Holbrook Anne M., Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness investigators Patients' consent preferences for research uses of information in electronic medical records: interview and survey data. BMJ. 2003 Feb 15;326(7385):373–373. doi: 10.1136/bmj.326.7385.373. [DOI] [PMC free article] [PubMed] [Google Scholar]

Articles from Journal of Medical Ethics are provided here courtesy of BMJ Publishing Group

RESOURCES