When conducting research involving participants, you must obtain informed consent from them. Informed consent is an agreement between the researcher and the participant, in which the participant voluntarily decides whether to take part in the study and allow the processing of their data.
Below you will find more information about informed consent. On the websites of Radboud University’s ethics committees, you can find templates for drafting an information sheet and consent form:
- The Ethics Committee Social Sciences
- The Ethics Assessment Committee Humanities
- The Ethics Committee for Law and Management Sciences
- The Ethics Committee for the Faculty of Science
- The Ethics Committee of the Radboud Teachers Academy (internal Teams environment, website under development)
For medical scientific research — that is, research falling under the Medical Research Involving Human Subjects Act (WMO) — you must use the CCMO template.
Obtaining informed consent
Here’s how to obtain informed consent:
- Inform the participant about the research project.
The participant must have sufficient understanding of the project before agreeing to take part. This information is usually provided in writing, for example through an information letter or brochure, but can also be given verbally or via a video. Make sure participants have enough time to consider their participation. - Obtain a clear statement from the participant confirming that they voluntarily agree to take part in the study and consent to the processing of their data.
Note: For minors (under 16 years of age) and/or legally incompetent participants, you must (also) obtain consent from a legal representative (e.g. a parent). - Document this explicit consent statement to demonstrate that participants have given informed consent for your research project. Since consent forms contain personal data, they must be treated like any other personal data.
Requirements for the information document
An information document must include at least the following details. Refer to the templates on the ethics committee websites for more information:
- Names and contact details of the researchers involved, including a contact person.
- Research aim: Provide a brief and clear explanation of the research topic and objectives. Explain the scientific and/or societal relevance of the study.
- Research procedures: Provide a short, jargon-free explanation of what will happen during the study. Use clear language directed at the participant, and describe what they will be asked to do, how much time it will take, where the research will take place, etc.
- Benefits, discomfort, and risks: Mention all factors that may influence the participant’s willingness to participate. This includes both potential benefits and any expected drawbacks, discomforts, risks, or adverse effects, even if negligible.
- Voluntariness: Inform participants that participation is entirely voluntary and that they may withdraw at any time without providing a reason.
- Privacy and data management: Explain what personal data will be collected, for what purposes, and how they will be handled. Who will have access to the data, what is the retention period, and will the data be anonymized? Describe how data will be shared and why. Also mention the right to withdraw consent and request deletion of data, as well as the contact details of Radboud University’s privacy office.
- Compensation and insurance: If participants will receive compensation, explain the payment conditions. For medical scientific research, you must also provide information about the additional insurance for participants.
- Incidental findings: If there is a possibility of incidental findings (unexpected results relevant to the participant’s or others’ wellbeing), mention this and explain how these will be handled. Will they be communicated to the participant? Note: If incidental findings will be shared, explicit consent for this must be requested in the consent form. This consent is required for participation.
- Future research: If you or a colleague wish to contact participants for future research, inform them about this and state how long their contact details will be retained. Ask for explicit consent in the consent form to be contacted for future studies. This consent is not required for participation.
- Feedback and information: Explain how participants can provide feedback or obtain further information.
Requirements for the consent form
A consent form must at least:
- Be written in the first person.
- State that the participant has read and fully understood the information document.
- State that the participant is aware of the collection, storage, and sharing of (personal) data. Explicit consent must be given for the collection, storage, and sharing of directly identifiable data (e.g. audio, video, photos) and special categories of personal data (for example, via an additional checkbox).
- Mention that participants can withdraw their consent and request deletion of their (personal) data.
- Include a clear reference to the information document.
- Ask for the participant’s consent, for example via a signature (paper form) or a checkbox with timestamp (digital form).
- Include the name of the organization, the researcher(s) involved, and contact details.