Information letter and consent form (ICF)

Before people participate in research, it is important to provide them with all relevant information. This is important among other things to explain to them what the research involves, what they can expect during the study and what rights they have in terms of processing their personal data.

After they have received the necessary information, data subjects can consent to participate in the study (the "ethical consent"). In addition, in most cases, they must also consent to the processing of their personal data (the 'GDPR consent').

The preparation of an information and consent form thus contains many components. Therefore, the FPPW Ethics Committee provides templates to guide researchers in developing the information letter and consent form (ICF).

The templates are not a ready-made prescription of how to write an ICF, but describe the information an ICF should contain. The templates are modular so they can be adapted relatively easily for varying settings. The wording should also be adapted to the target population (e.g., adolescents).

In addition to the templates themselves, some good examples are offered.

Templates

  • ICF-template with public interest as legal ground
    This template can only be used when 'public interest' is the legal basis for processing personal data. See this page for more information.
  • ICF-sjabloon anonymous
    This template can only be used when no personal data are collected. This means that the data collection is completely anonymous. In other words, the researcher does not have any personal data of the participants at any time. For more information about personal data, see this research tip.

Examples

On the link below, you will find a portfolio of ICF examples created on the basis of the above templates.

Important

  • If you wish to use other (external) templates, you must submit a motivated request to the EC.
  • If you have to submit an application to the Medical Ethics Committee, you should use the HIRUZ ICF templates.
  • If you have any questions or problems with the preparation of an ICF, please contact rso.pp@ugent.be.

Deviation from written consent

The registration of a consent should be properly documented, regardless of how the consent is obtained.

Although it is the most convenient form, it may sometimes be necessary to deviate from a signed written consent. For example, when the target group distrusts this formal method, or when placing an analogue signature is not possible (e.g., online surveys).

With regard to obtaining consent for the processing of personal data (in the context of the AVG), it is sometimes thought that it is not possible to deviate from written consent. However, this is not the case. The AVG does stipulate that there must be an explicit consent for the processing of personal data.

However, a signed statement is not the only way to obtain this explicit consent, and it is not the case that the AVG provides that in all circumstances where valid explicit consent is required, a written and signed statement is required. For example, in the digital or online context, a data subject may consent by filling out an electronic form, by sending an e-mail, by uploading a scanned document bearing a signature, or by using an electronic signature.

In theory, the use of oral statements may also be sufficient to obtain valid explicit consent. Here, however, it may be difficult for the researcher to prove that all the conditions for valid explicit consent were met when the statement was recorded. Therefore, it is very important to properly document the recording (e.g. note where and when consent was obtained, what information the person was given, what questions the person was required to answer, who was present,. etc.). The presence of a witness can provide a solution for this.

Also, for when providing information, it does not necessarily have to be in writing.

(Source: GBA Recommendation No. 01/2021 of December 1, 2021, in Dutch)