Informed consent and ethics committees
In research involving people, the GDPR states that you need to identify and document your lawful basis (‘grondslag’) for the processing of personal data. Informed consent is one of these lawful bases (GDPR art.6.1.a).
Informed consent is an agreement between the researcher and the data subject (i.e. participant), which includes the following two points in particular:
- The data subject is informed: the informed consent procedure includes information that is received and understood. Usually this is in the form of an information brochure
- The data subject gives consent: the informed consent procedure includes the explicit statement that the data subject freely agrees to participation in the research project
Informed consent implies that a researcher gives the data subject a genuine choice in and control on how his or her data will be processed. This includes the right to withdraw consent at any time during participation without having to give a reason. If the data subject isn’t given a choice before participation, the consent is invalid.
This webpage provides information about:
- How to obtain and register informed consent procedures
- What an informed consent procedure should contain
- Formats and examples
- How to store informed consent forms
- How to manage the right to withdraw consent
- Ethics committees
- WMO research and animal experiments
- Research in institutions, with minors or incompetent participants
How to obtain and register informed consent procedures?
Informed consent needs to be explicit. Additionally, the researcher has to demonstrate a data subject’s consent (GDPR art.7.1). As a researcher, you can obtain and register explicit consent in various ways, as long as the data subject is asked to actively opt-in.
|A widely used way of obtaining informed consent is physical informed consent. The data subject signs a paper document and hands over/sends the document to the researcher. For registration, keep a copy of the data subject’s signed and dated form. It is insufficient to keep a spreadsheet with the data subject’s name and a column with ‘consent provided’.
|Another way of obtaining informed consent is online, for example via an online survey. To register informed consent procedures using online forms, a researcher should:
|Digital informed consent is also a possibility, for example by sending an email, by uploading a signed document, or by using an electronic signature. For registration, the researcher should retain information on the session in which the consent was expressed, for example by making exports of emails in which consent was given. Documentation of the consent workflow and a copy of the information presented to the data subject at that time should be registered.
If participants cannot read or write, an oral consent may be obtained and either recorded (audio/video taped) or explicated in the presence of a witness. Oral consent is also sufficient if written consent would entail a risk to the participant or the researcher, or if participation is better supported by oral consent than by written consent.
An oral informed consent procedure is based on the same principle: you have to inform the data subject, followed by asking explicit consent.
Make sure to keep a record of the script you used. A good record of informed consent should demonstrate:
What should an informed consent form contain?
During an informed consent procedure, the data subject needs to be informed before he or she gives consent. The consent form and the information document can be separate or combined.
Informed consent is usually a required legal and ethical aspect in a research design. It is also an important aspect in research data management (RDM). It includes critical decisions - to be mentioned in the informed consent procedure – on data sharing, anonymisation, making data public etc. The decisions made in the stage of designing the informed consent procedure, determine what a researcher can legally do with the research data in a later stage. This is particularly relevant for deleting personal data. As contact data should be deleted as soon as possible, be careful with promising to delete personal data that you may need to store for the long term to prove scientific integrity.
In the informed consent procedure, the data subject 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
- Benefits, discomfort 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 (categories of) 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.
- 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
At a minimum, a written informed consent form must:
- Be stated in the I-form
- Be signed by both the researcher and the data subject
- Include the name of the organisation, involved researcher(s) and contact details
- Present the option to consent separately in case of multiple research purposes and/or aims
- State that the data subject has taken note of the content of the information document and understands it fully
- Mention the right to withdraw consent
- Include a clear reference to the information document
Formats and examples
- The Ethics Committee Social Science provides several formats of informed consent forms and information about the video/audio materials
- The Ethics Assessment Committee Humanities provides sample documents on information documents and consent forms
- The Donders Institute provides several formats for information documents and informed consent forms
- The Ethics Assessment Committee Faculty of Law and Nijmegen School of Management (EACLM) provides sample documents on information documents and consent forms.
How to store informed consent forms
Paper informed consent forms can best be digitalized (except WMO obligated research). This process of digitizing has to be in accordance with the guidelines from the RU substitution manual. The paper version can be destroyed six months after digitization. If, during the first 6 months, any issues emerge (e.g. skewed or missing pages, unreadable page, etc.) the paper version can be digitalized again. Exceptions and more information can be found here. Make sure to check your institute’s policy for information about informed consent procedures, including substituting and storage.
How to manage the right to withdraw consent?
Withdrawal of consent is given a prominent place in the GDPR. Article 7(3) of the GDPR states that the controller must ensure that consent can be withdrawn by the data subject as easy as giving consent and at any given time. Thus, the data subject should have the ability to withdraw his or her consent the same way in which they gave consent. For example, if a data subject gave informed consent by means of a phone call, the data subject should have the option to withdraw consent by calling.
A data subject has the right to withdraw from the research project without giving a reason at any time. To make this workable in the context of the research process, it is proposed to 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. Additionally, by anonymising data, data is no longer personal, and does thus not fall within the scope of the GDPR. This means that a data subject no longer can request data to be deleted.
Due to their ethical nature, information consent procedures are generally handled by the faculty's ethics committees. We advise you to contact your ethics committee in case of questions, additional information or feedback on your informed consent procedure.
- Ethics Assessment Committee Law and Management
- Ethics Committee Faculty of Social Sciences
- Ethics Assessment Committee Humanities
- Ethics Committee Science
- Ethics Committee Radboud Teachers Academy
WMO research and animal experiments
Please note that the requirements can be different in case of research that falls under the Medical Research Involving Human Subjects Act (WMO). Human studies can be categorized as either subject to the WMO or not subject to this act. In general, studies are subject to the WMO act when using intrusive or interventional methods (pharmaceutical interventions, blood drawing, MRI, TMS) and/or a vulnerable study population (i.e. minors, patients).
You may contact an accredited medical research ethics committee or the Central Committee on Research Involving Human Subjects (CCMO) in case of questions on informed consent procedures. Information on the CMO procedures at Radboudumc is also available, just like general information on the METC/CCMO. This latter site has various documents, forms and models for research involving human subjects, among others a model information letter that includes an informed consent form (document E1. Model informatiebrief).
Experiments on animals should be reported to the Central Authority for Scientific Procedures on Animals, CCD. Research with Genetically Modified Organisms (GMO) must be in line with EU legislation.
Research in institutions, with minors or incompetent participants
In case your research concerns an institutional environment such as a school, health care institution or company that recruits participants, make sure that individuals all sign a consent form. A passive informed consent procedure is not allowed.
A standard participant is a healthy adult (16 years or over) and competent volunteer, who participates in a research study, receives a non-disproportionate compensation, and is not dependent whatsoever on the person carrying out the research.
If minor participants, children or babies are to participate in research, permission from the parent or legal guardian must be provided (advisably, from 12 years onwards, in addition to the consent of the child itself). In case of (mentally or physically) incompetent or incapable respondents, you need to have permission from a legal guardian.
Make sure to check the regulations of your faculty's ethics committee, as research with minors and incompetent data subjects does not meet the above mentioned criterion of competence. Always ask yourself whether the research in question might be conducted with healthy, competent adults, instead of minors or incompetent data subjects.
Informing participants afterwards
There are situations in which informed consent procedures are restricted to informing participants afterwards, to prevent influencing participants during data collection. Clearly, this creates an extra responsibility for the researcher to prevent unfavourable effects for the participants and to guarantee the participants’ anonymity.