Ethical aspects: Information letter and consent form

Minimum requirements:

• Letter in plain language, tailored to the target group
• Purpose, character and duration of the research
• Procedures for participation
• Consequences / advantages / risks / disadvantages of participation
• Right to refuse participation and possibility to withdraw prematurely
• How much time does it take?
• Is there a fee for participation?
• How is the data processed?
• Guarantee that data will be handled and stored with care (confidentiality, anonymity)
• Reuse of the data in future or other research
• Contact details researcher / contact details complaints committee and confidential advisor for scientific integrity / contact details privacy officer
• Attachment: consent form

Who is to sign:
- mentally incompetent:
   consent required from legal representative(s) + where possible from participant themselves
- minors <12 jaar:
   consent required from parent(s) or legal representative(s) + where possible from the child themselves
- minors >11 jaar and <16 jaar:
   consent required from both the minor and the parent(s) or legal representative(s)
- from the age of 16:
   only participant consent required

Minimum requirements:

• Title
• Confirmation that the information letter has been read
• Confirmation that there was time for questions
• Reminder of voluntary participation
• Reminder of the right to refuse participation or to withdraw prematurely
• Reminder of the right to access, rectify, erase, restrict or object to the processing of personal data
• Consent to the processing of anonymous/encoded data as stated in the information letter
• Consent to store the data for at least 10 years
• Consent to participate in the research
• Datume, name, participant's signature
• Addition mentally incompetent persons: signature of legal representative + relationship to participant
• Addition minors: participant's date of birth + signature of (both) parents/representatives

In addition to the minimum requirements for the information letter:

• Possible risks and objections
• Risks associated with discontinuing participation prematurely
• Information about the independent doctor
• Information about the insurance
• In the case of special participants (minors and persons lacking legal capacity), include:
  "In the event of resistance by the participant, the research will be stopped immediately."

For medical research, information and consent are integrated into one single format.

For research not subject to the WMO, you should use (only available in Dutch):

For research subject to the WMO, use the CCMO's “Research Participant Information” form:

For more information on ethical aspects, see the tab 'Ethics in different disciplines'.