Article Text

Download PDFPDF
Informed consent, participation in, and withdrawal from a population based cohort study involving genetic analysis
  1. K Matsui,
  2. Y Kita,
  3. H Ueshima
  1. Department of Health Science, Shiga University of Medical Science, Japan
  1. Correspondence to:
 K Matsui MD
 Department of Health Science, Shiga University of Medical Science, Tsukinowa-cho, Seta, Otsu, Shiga, 520–2192, Japan;


Objective: Population based cohort studies involving genetic research have been initiated in several countries. However, research published to date provides little information on the willingness of the general population to participate in such studies. Furthermore, there is a need to discover the optimal methods for acquiring fully informed consent from the general population. We therefore examined the results of a population based genetic cohort study to identify the factors affecting the participation rate by members of the general public and also specifically to examine the impact of different consent procedures on the rate of participation by prospective candidates and their subsequent withdrawal rate from the study.

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.

  • cohort
  • genetic
  • informed consent
  • participation
  • population based

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.


  • Financial support for this descriptive study and the parent Takashima study, which is part of the Japan arteriosclerosis longitudinal study, was provided by grants from the Grant-in-Aid for Scientific Research (grants 13670361 and 15012227), the Ministry of Education, Culture, Sports, Science and Technology, Japan, and the Japan Arteriosclerosis Prevention Fund. The funding agreements ensured that these organisations had no role in the design and conduct of the study, data collection, management, analyses, interpretation, writing, and publishing of the manuscript. All authors had full access to all the data and take responsibility for their integrity and the accuracy of the analyses.

  • K Matsui designed the study and the consent forms for the Takashima study, and contributed to the consent process, data collection, interpretation of results, statistical analysis, and writing of the manuscript. Y Kita managed the Takashima study and contributed to the consent process, data collection, statistical review, and critical revision of the manuscript. H Ueshima designed the concept and protocols for the Takashima study, and contributed to the statistical review and critical revision of the manuscript.

Other content recommended for you