UTFacultiesBMSResearchEthics (BMS/domain HSS)Informed participation procedure

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. 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 inform people that participate in your research, obtaining active consent (signing a form or tick a box) is not always required: if research data is gathered completely anonymously you do not need 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:

More info on individuals competence to consent on CCMO website (English/ Dutch).

Consent under the GDPR (EU privacy law)

Consent is one of the six legal grounds for lawful processing of personal data, often consent is the most appropriate legal basis in research. If personally identifiable information of individuals will be processed in your research, active consent is required, according to EU General Data Protection Regulation GDPR. Consent under the GDPR is: valid, freely given, unambiguous, specific, informed and active consent. The 'consent' requires action: it needs to be given by a statement or by clear affirmative action, no silence, inactivity or pre-ticked boxes. 

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.

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 

Different types of informed consent

Read more about the different types of informed 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. 

Interviews and experiments

See the download below for a template for an Informed Consent you may use for interviews and experiments.
Informed consent form template for research with human participants

Some notes: 

In a different format (from the EUR) we also have an example format available:
Standaard UT informed consent formulier (Dutch) and the similar consent form in English together with an Information sheet

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 ethicscommittee-bms@utwente.nl