Information letter and consent form

Information letter

Participants are informed about the research by means of an information letter. The ERB has drawn up a number of guidelines for the information letter. The following points are obligatory in the information letter:

What does the research entail?

• Title (title of the study, possibly simplified, abbreviated, or translated)
• Purpose
• Nature of the research (publication or educational purposes)

What does participation in the research entail?

• Procedures
• Disadvantages / consequences / risks or benefits for the participant

Information on participation:

• Voluntariness of participation;
• Right to refuse participation and withdraw from the research once participation has begun, without negative consequences and without any explanation;
• The right, in principle, to access, rectify, delete, restrict, or object to the processing of personal data.
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• Confidentiality is protected;
• Period covered by the consent (normally the duration of the research);
• How the data are processed;
• Period during which the data is stored and encrypted;
• Approval of Ethics Review Board (ERB);
• Closure/who to contact in case of questions or additional information (name and phone number /email address of researchers);
• Attachments: consent form.

If applicable

• Insurance guarantee (only if there is an additional insurance to the standard one);
• Deliberation time;
• Procedure for incidental findings;
• Re-use of specified data in current, future, or other research;
• Compensation for participation (travel expenses, human subject hours)

Consent form

As soon as a participant decides to participate in the research, he or she must sign a consent form. This consent form also has a number of compulsory sections:

• In the case of a mentally incapacitated participant, permission will be obtained from the legal representative(s). It is customary to ask the participant for permission as well if possible.
• For minors under the age of 12, consent is obtained from the parent(s) or legal guardian(s). It is customary to ask the child for permission if possible.
• For minors older than 11 and younger than 16, consent is obtained from both the minor and the parent(s) or legal representative(s).
• From the age of 16 onwards, consent is only obtained from the participant. For some types of research, it may still be customary to inform the parent(s) or legal representative(s).

The consent form contains at least the following sections:

• Title (title of the research, possibly simplified, abbreviated, or translated);
• Confirmation that the information has been read;
• Confirmation that there was room for questions;
• Reminder that participation is voluntary;
• Reminder of the right to refuse participation and to withdraw from the study once participation has begun, without negative consequences and without any explanation;
• Reminder of the right, in principle, to access, rectify, delete, restrict, or object to the processing of personal data;
• Consent to the processing of anonymous/coded data as mentioned in the information letter;
• Consent for the storage of research data for a period of at least 10 years (in the case of research for educational purposes, the storage period is until the student graduates);
• Permission to participate in the study;
• Date, name, and signature of the participant.

Addition for mentally incompetent adults:

• Date, name, and signature of legal representative, relationship to participant

Addition for minors:

• Date of birth of the participant;
• Date, name, and signature of (if possible both) parents/guardian.

Templates information letter and consent form

As ERB, we have created templates for both the information letter and the consent form. These templates contain a number of standard texts, but also need to be completed with research specific data.

• Template Information letter
• Template consent form