Informed consent and information letters
Before you collect data from participants, it is important that you have their consent. This is usually done via a signed form, in which the participant agrees to the research. If Personal Data are processed during scientific research, explicit consent must be given.
In addition, to make sure your data can be used in future research projects, you should ask consent for future use explicitly. Meaning, that the researcher should add a checkbox to his/her informed consent form, which can be ticked by the participant, in which the consent for future use is made explicit and linked to a certain field of research, such as marketing, psychology, etc.
To ensure that participants are truly informed, we require that you send them an information letter. This information to the participant gives them a chance to consider their participation in your research and allowed them to give truly informed consent. Ideally, the information ‘letter’ is sent out some time before the consent form is signed.
As a rule, the Ethics/Institutional Review Boards of Tilburg University do not supply templates. We do, however, provide checklists.
Checklist information to participant
Title of the study, if necessary simplified, abbreviated or translated
What does the study entail?
including if the data collection is meant only for training purposes
What does taking part in the study entail?
- Expected duration
- Disadvantages/consequences/risks or possible advantage for the participant
Information about the participation
- Voluntariness of participation.
- Right to decline to take part and withdraw from the research once participation has begun, without any negative consequences, and without providing any explanation.
- Right, in principle, to request access to and rectification, removal, restriction of or object to the processing of the personal data.
Read more about privacy and security
- Confidentiality protection and limitations
- Applicable insurance guarantees
Only if there is additional insurance to the standard insurance
- Period of time to which the consent applies
Normally the length of the study
- Re-use of specified data in current, future, or other research projects, when applicable How the data will be processed
- Period of time that date will be stored and encrypted
- Approval Ethical Review Board (ERB)
- Request for participation The following text should be included:
If you have any remarks or complaints regarding this research, you may also contact [email address of your E/IRB]
- Closing / whom to contact in case of question or additional information (name and telephone number/ email address researchers)
- Appendices: Informed Consent
- Applicable insurance guarantees (only if there is additional insurance to the standard insurance)
- Deliberation time
- Re-use of specified data in current, future, or other research projects.
- Incentives for participation (traveling expense, pp hours)
- Procedure for incidental findings
Checklist Informed consent
In case of a mentally incompetent participant, informed consent is obtained from the legal representative(s). It is good practice to also ask the participant where possible.
Younger than 12 years
In case of minors younger than 12 years of age informed consent is obtained from the parent(s) or legal representative(s). It is good practice to also ask the child where possible.
Older than 12 and younger than 16 years
In case of minors older than 11 and younger than 16 years of age informed consent is obtained from both the minor and the parent(s) or legal representative(s).
From 16 years
From 16 years of age, consent is only obtained from the participant. For some types of research, it may nevertheless be good practice to inform the parents or legal representatives.
Mentally competent participants and minors 12-16 year
Title of the study, if necessary simplified, abbreviated or translated)
- Confirmation that the information is read
- Confirmation that there was room for questions
- Reminder on voluntariness of participation. Right to decline to take part and withdraw from the research once participation has begun, without any negative consequences, and without supplying any explanation
- Right, in principle, to request access to and rectification, erasure, restriction of or object to the processing of the personal data.
Read more about privacy and security
- Permission processing of anonymous/coded data as mentioned in the information letter
- Permission for storing the research data for a period of at least ten years
- Permission participation in the study
- Date, name, signature participant
- Give the participant a copy of the signed informed consent form
Addition/correction for mentally incompetent adults
- Date, name, signature legal representative, relation to participant
Addition/correction for minors
- Date of birth participant
- Date, name, signature (if possible both) parents/guardians