Informed Research Participation Procedure

Why care about informed participation procedures in research?

Informed participation is an ethical and legal requirement for research involving human participants. Consent for research ethics is composed of providing information regarding study, purpose, risks, benefits, voluntary participation, as consent as a legal basis can be used for the processing of personal data under GDPR.
It is the process where a participant is informed beforehand about all aspects of your research to enable the participant to make an informed decision on their willingness to participate in your research. Informed participation is an essential requirement prior to every research involving people as subjects for research. It involves informing the subject about his or her rights, the purpose of the research, procedures to be undertaken, potential risks and benefits of participation, expected duration of the research, the extent of confidentiality of personal identification and demographic data, so that the participation of subjects in your research is entirely voluntary.  
Informed consent - when a person actively provides consent to participate in your research - is also increasingly important for use of data after your research, as failure to properly address issues of consent may restrict the opportunities for initial use of data, the publishing of your results and the sharing of the data.

NOTE: you always have to inform people who participate in your research about your research. Obtaining explicit consent (e.g. signing a form or tick a box) is not always required; if research data is gathered completely anonymously you do not need to register the participants' consent. 

Who is capable to give consent? 

Participants, or their legal representatives, must be given ample opportunity to understand the nature, purpose and anticipated consequences of research participation. So that they will be able to give informed consent to the extent to which they are capable of doing so. Please note that not all human beings are capable of consent. Individuals with the capacity or competence to consent:

If an individual is non-competent or less competent to provide consent, you should ask for informed consent from the individual’s legal representative(s). For adults who are unable to provide informed consent (incapacitated subjects), their legal guardians must sign consent for participation. It is good practice to also ask the participant where possible.
More info on individuals competence to consent on CCMO website (English/ Dutch).

Research with minors

According to Dutch law, minors younger than 12 years of age are not able to give informed consent, and parent(s) or legal representative(s) must sign consent for the child’s participation. It is good practice to also ask the child where possible. In the 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). In both cases, consent from one parent/legal representative is considered sufficient, unless the Ethics Commission decides that a particular research project requires consent from both parents.
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.


The standard is to completely inform your participants/respondents/informants about the aims, activities, burdens, and risks of the research before they decide whether to take part in the research. However, sometimes your research may ask you to be incomplete or even deceive your participants because else it may bias your results. So, information may not be withheld from participants unless it could bias subsequent findings (e.g. if information about the research question/hypothesis is likely to influence participants’ behavior or responses to questions) or if doing so has been found to be in the public interest. Incomplete information is if part of the information has been withheld from participants. Deception is used when participants are deliberately misled about the true nature of a study and what is expected from them. Examples include using covert methods of observation, observing types of behavior other than those announced beforehand, or intentionally misinforming participants about specific aspects of the study. Please note that withholding some information about the research does not count as deception, although special care is warranted in such cases. Although deception can be necessary in order to avoid socially desirable answers or other forms of bias, it also goes against the principle of active, informed consent. It should therefore be applied only when the knowledge sought cannot be obtained in any other way.
In addition, participants should never be withheld information/deceived about potential inconveniences, harm, risk, intrusiveness or stress associated with participating in the study.
Any deception or withheld information must be explained to participants as early as possible, immediately after participation, and no later than at the end of data collection. Participants must then also be informed that they have the right to withdraw their data without any negative consequences. Such debriefing should allow participants to confirm/withdraw their initial consent. 

Consent under the GDPR (EU privacy law)

Consent is one of the six legal grounds for lawful processing of personal data, often 'consent' or 'public interest' is the most appropriate legal basis in research. If personally identifiable information of individuals will be processed in your research, obtaining consent for the processing is required, according to EU General Data Protection Regulation GDPR. Consent under the GDPR is: valid, freely given, unambiguous, specific, informed, and explicit actively given consent. The 'consent' requires action: it needs to be given by a written(signed)/oral statement or by clear affirmative action. Silent consent, inactivity or pre-ticked boxes are not valid. 

If you process sensitive personal data than explicit consent is required for collecting those data. For an explanation on personally identifiable information check our BMS Datalab guidelines on personal information and the UT Personal Data website on privacy rules and definitions. Should you have any questions on this topic, please contact the BMS Privacy Contact Person (PCP) for Research: Lyan Kamphuis-Blikman.

The DPO & PCPs of the UT made a document that contains a decision aid & flow chart with further explanation is now available to help researchers comply with the GDPR

What does 'Informed consent procedure' entail?

The informed consent procedure consists of an information sheet AND an informed consent form 

Specifically, the information provided in advance addresses (where applicable):

There are some more points to consider, see the Code of Ethics for Research in the Social and Behavioural Sciences involving Human participants 

Types of informed consent

Consent should be provided in an intelligible and easily accessible form using clear and plain language establishing a freely given, specific, informed, and unambiguous indication of the participant’s agreement to the processing of personal data relating to him or her, such as by a written statement, including by electronic means, or a (recorded) oral statement. Consent should cover all processing activities carried out for the same purpose or purposes. When the processing has multiple purposes, consent should be given for all of the separate purposes.

Read more on different types of consent

Informed Consent forms

Here you can find several informed consent forms. They are examples, which can be used as a template for your own, customized version. Before signing the informed consent form, participants need to be provided with sufficiently detailed information on the study so that they can make an informed, voluntary and rational decision to participate. Check also some recommended language on data sharing under 'further guidance' below.
Our consent forms may not be appropriate for all participants, as sometimes language is challenging for your population. There are tools available to find more easy language for difficult words, check 'writing a text on language level B1' (dutch site).

Interviews and experiments

See the download below for a template (example by Delft and EUR) for an Informed Consent you may use for interviews and experiments. The content differs.

Some notes:

- The form is in line with the new GDPR-requirements.
- Please make sure that the form is well understood by the participants.
- Consider once more the need for audio-visual materials for your research (and anonymization afterward).
- In some cases, you need proxy-consent (children, or if a person is considered unable to give informed consent) by a legal representative. In such cases, our advice is to prepare an additional information sheet with plain language for the actual participants.

Online Questionnaires

For an online questionnaire/survey, you can use this as a starting point:
Opening statement for an online survey

NOTE: We will continue to work on the further improvement of the informed consent forms, if you have any remarks or suggestions please notify us via  

Further Guidance