1 / 11

Informed Consent

Informed Consent. Country example: the Netherlands. “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

zia
Download Presentation

Informed Consent

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Informed Consent Country example: the Netherlands

  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. “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. 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 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 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 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 4 I have read, understood and signed, Participant Name Participant Signature Date: ___ ___ _____ day month year I have read, understood and signed, Research assistant Name Research assistant Signature Date: ___ ___ _____ day month year

  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 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. Informed Consent Country example: the Netherlands

More Related