1. 113 september 2010 Informed Consent Country example: the Netherlands

2. Informed Consent | 13 september 2010 2 “NL de Maat” 5 municipalities in 2009 → 3000 physical examinations Low response rate: 30% 2 municipalities in 2010 → 1500 physical examinations Changes in the recruiment strategy: ●Incentive: from €10 to €50 ●Inviting people at their homes, measuring height and weight ●Several locations per municipality ●Possibility to participate without giving blood and without fasting

3. Informed Consent | 13 september 2010 3 “NL de Maat” 1. Informed Consent at the door: –height –weight 2. Informed Consent at the examination site: –height –weight –waist/hip –bloodpressure –blood

4. Informed Consent | 13 september 2010 4 Steps in obtaining Informed Consent ●Leaflet? ●Questions? ●Introduction physical examination –height –weight –waist and hip (2x) –bloodpressure (3x) –giving blood ●Fill in Informed Consent twice

5. Informed Consent | 13 september 2010 5 Informed Consent 1 I, the undersigned ●have read the leaflet with information about ‘NL de Maat’ (version 150710) and understand the information provided. ●have been able to pose questions which have been answered clearly. ●have had enough time to think about participation. ●am giving consent to process my personal data for purposes described in the leaflet. ●know that I participate completely voluntary and that I can withdraw without giving reasons at any time, taking into account that stored samples and data can be destroyed if requested by me. ●know that, regarding my blood test results, will only receive information about cholesterol and glucose levels.

6. Informed Consent | 13 september 2010 6 Informed Consent 2 Also, I am giving consent for the following: We ask your consent for the next 50 years, because chronic diseases reveal themselves in the long run. ●I am giving consent that a part of my blood samples are stored for future determinations as far as these are related to the occurrence or the course of chronic diseases. If the samples are used for future research, I will receive no results. ●I am giving consent that my blood will be used for research after hereditary factors, as far as these are related to chronic diseases. If the samples are used for future research, I will receive no results. ●I am giving consent that in the future my personal data can be requested again from the municipal population register.

7. Informed Consent | 13 september 2010 7 Informed Consent 3 I am giving consent that some medical data might be asked for in the future. This may include data from: ●The general practitioner, specialist or hospital registration ●The pharmacy or the pharmaceutical registration ●The CBS (Central Statistical Office) ●The National Cancer Registry I am giving consent to be approached for possible additional research that will be linked to ‘NL de Maat’ in the future.

8. Informed Consent | 13 september 2010 8 Informed Consent 4 I have read, understood and signed, Participant Name Participant SignatureDate: ___ ___ _____ day month year I have read, understood and signed, Research assistant Name Research assistant SignatureDate: ___ ___ _____ day month year

9. Informed Consent | 13 september 2010 9 Informed Consent 5 Also, I am giving consent for the following: We ask your consent for the next 50 years, because chronic diseases reveal themselves in the long run. ●I am giving consent that a part of my blood samples are stored for future determinations as far as these are related to the occurrence or the course of chronic diseases. If the samples are used for future research, I will receive no results. (3%) ●I am giving consent that my blood will be used for research after hereditary factors, as far as these are related to chronic diseases. If the samples are used for future research, I will receive no results. (3%) ●I am giving consent that in the future my personal data can be requested again from the municipal population register. (6%)

10. Informed Consent | 13 september 2010 10 Informed Consent 6 I am giving consent that some medical data might be asked for in the future. This may include data from: ●The general practitioner, specialist or hospital registration (10%) ●The pharmacy or the pharmaceutical registration (11%) ●The CBS (Central Statistical Office) (9%) ●The National Cancer Registry (8%) I am giving consent to be approached for possible additional research that will be linked to ‘NL de Maat’ in the future. (4%)

11. 1113 september 2010 Informed Consent Country example: the Netherlands