Informed consent and people’s responses towards genetic sample collection Kenji Matsui, MD, (PhD tomorrow!) Department of Health Science, Shiga University.

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Informed consent and people’s responses towards genetic sample collection Kenji Matsui, MD, (PhD tomorrow!) Department of Health Science, Shiga University of Medical Science, & Center for International Health, University of Bergen Conference on Ethical Aspects of International Collaborative Research and Health Ethics. Nov 29 th- - Dec 1 st, Jakarta, Indonesia.

General Background Population based genetic database (biobank): e.g. UK (1999~), Estonia (2001~), Japan (2005~) Purpose of biobank: - Collect genetic samples - interactions between lifestyles, genetic makeup, and onset of diseases - Goal for effective interventions and prevention according to individual genetic characteristics

Purpose of Following Analysis Little empirical data on biobank are available on: How people actually response to biobank enrollment ? What type of informed consent procedure for biobank is ethically more adequate?

Brief description of case - A population based cohort study which involves genetic analysis & database project - Homogeneous Japanese population - > 5,000 potential subjects (checkup attendees) - 2 cohorts composed of 2 research groups/each Cohort 2002 : NG1, 2 = NON-genetic study group Cohort 2003 : G1, 2 = Genetic study group

Summary of Cohorts NON genetic study groupsGenetic study groups NG1NG2G1G2 Number of checkup attendee 2,232 (m/f=36.8/63.2) 957 (m/f=29.0/71.0) 1,117 (m/f=32.3/67.7) 1,162 (m/f=39.2/60.9) Number of who passed IC 2, % ） % ） 1,065 （ 95.3% ） 1,130 （ 97.2% ） Mean age (SD) M: 64.2(12.0) F : 59.1(13.1) M: 58.1( 9.0) F : 55.7(10.1) M: 64.8(12.0) F : 60.7(13.3) M: 60.8(14.5) F : 56.5(14.6) How to be informed of the study a.Notification b.Explanatory Documents c.Oral explanations d. Lectures & Meetings

Analysis methods Three (or 5) Items for informed consent 1.Participation in a basic survey (questionnaires, blood & urine samples) 2.Storage of these samples for future use 3.Researchers’ access to their medical records & death certification 4.Participation in a genetic analysis study 5.Storage of DNA samples for future use

Analysis methods cont. 1.Initial participation rates 2.Withdrawal rates at 6 months 3.Remaining rates after 6 months Whether the cohort study involves genetic analysis Whether given more excessive information & opportunities to be informed in advance Any positive or negative impacts ?

Result (1) * * ns Consent Items 1-3

Result (2) 8 (0.4%) 4 (0.4%) 29 (3.2%)

Result (3): Remaining Rates at 6 mth Consent ItemsG1 subcohort (genetic) G2 subcohort (genetic) P value ( chi-square test) a. Participation in a basic survey 909 （ 85.4% ） 941 （ 83.3% ） ←0.003 b. Sample storage for future use 897(84.2%)938(83.0%) ←0.019 c. Access to medical records & death report 888(83.4%)934(82.7%) NS ←0.037 d. Participation in genetic analysis 890(83.6%)934(82.7%) NS ←0.038 e. DNA sample storage for future use 882(82.8%)934(82.7%) NS ←NS

Summary & Points for debate Non-genetic NG1 & NG2 Genetic G1 Genetic G2 Intensity of intervention Normal Excessive ParticipationHighLowerLowest Withdrawers0.4%3.2%0.4% Remaining as participants HighLowHigh Same remaining rates There are negative attitudes towards genetics. Giving excessive information can lead a more confirmed consent. Excessive information gives the same statistical consequences.

Conclusion Trustful partnership through human communication is a key to the ethically adequate and successful recruitment of participants