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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

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informed consent

Informed Consent

Country example:

the Netherlands

nl de maat
“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
nl de maat1
“NL de Maat”

1. Informed Consent at the door:

  • height
  • weight

2. Informed Consent at the examination site:

  • height
  • weight
  • waist/hip
  • bloodpressure
  • blood
steps in obtaining informed consent
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
informed consent 1
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.
informed consent 2
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.
informed consent 3
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.

informed consent 4
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

informed consent 5
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%)
informed consent 6
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%)

informed consent1

Informed Consent

Country example:

the Netherlands