Consent form requirements

As part of your informed consent procedure, you will need to properly inform your respondents through an information document about what you are using their personal data for. You also need a consent form (or consent through a survey) where your respondents state their consent. Here you can find what information you need to provide to your respondents and the requirements for the information document and consent form. You can draft an information document and a consent form separately or combined.

Information document

The respondent should be informed about:

  • The name and contact details of the researchers involved, including a contact person.
  • The name and contact details of Radboud University’s data protection officer.
  • The research procedures: describe the data collection procedures and their aim, and provide information on the amount of time the data subject is expected to spend on participation (number of sessions, duration of sessions, total time spent). Additionally, include information on the expected benefits for the community or society as well as what scientific knowledge is expected to be gained from the research. If the aim of the project cannot be made public yet, you should inform the data subject in a later phase of the research.
  • Benefitsdiscomfort and risks: mention all factors that may influence the willingness of the data subject to participate. This includes benefits as well as expected discomfort, inconveniences, possible risks and harmful effects, even if these are negligible.
  • The purposes of the processing: explain in detail why you use a data subject’s personal data and be clear in case of multiple purposes.
  • The recipients of the personal data: explain in detail with who you share a data subject’s personal data. This includes anyone that processes personal data on your behalf. There might be a difference in the recipients of pseudonymized research data (which are often shared with the general public via data repositories), raw research data, and personal data that have been collected for administrative purposes only. You should specify the recipients for these various types of data.
  • The retention period for the personal data: explain how long you retain the personal data collected, and if/when (part of the data) data will be deleted. There might be different retention periods for pseudonymized research data, raw research data, and personal data that have been collected for administrative purposes only. You should specify these various retention periods. Note that research data underlying a scientific publication must be stored for at least 10 years after the date of publication according to Radboud University's research data management policy.
  • Data subject’s rights with regard to the processing of personal data, i.e. the rights of access, rectification, erasure, restriction, objection and data portability.
  • The right to withdraw consent: inform a data subject that he or she can withdraw consent for processing personal data at any time.
  • The right to withdraw data: include in the informed consent procedure that a data subject can request disposal of personal data (including the experimental/research data) up to one month after participation in the study.
  • The right to lodge a complaint with the Autoriteit Persoonsgegevens (Dutch DPA).
  • Compensation and insurance: if compensation for participation is applicable, explain the terms and conditions of payment. If applicable, include information on the terms and conditions for the insurance arrangements made.

Consent form

At a minimum, a written informed consent form must:

  • Be stated in the I-form
  • State that the data subject has taken note of the content of the information document and understands it fully
  • Present the option to consent separately in case of multiple research purposes and/or aims
  • Mention the right to withdraw consent
  • Include a clear reference to the information document
  • Be signed by both the researcher and the respondent
  • Include the name of the organisation, involved researcher(s) and contact details