Informed consent is an ethical requirement for most research and must be considered and implemented throughout the research lifecycle, from planning to publication to sharing.
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.
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:
- are 16 years or older (adult);
- have the capacity to make choices about a proposed course of action;
- know about the risks, benefits and alternatives;
- understand that consent is ‘voluntary and continuing permission’;
- understand that consent ‘can be withdrawn at any time’.
Use of personal identifiable data?
If personal identifiable information of individuals will be processed in your research, active consent is required, according to EU General Data Protection Regulation GDPR.
If you process sensitive personal data than explicit consent is required for collecting those data. For explanation on personal identifiable information check our BMS Datalab guidelines on personal information and the UT Personal Data website on privacy rules and definitions.
Informed consent procedure
The informed consent procedure consist of an information sheet AND an informed consent form
Specifically, the information provided in advance addresses (where applicable):
- the voluntariness of participation;
- the nature and purpose of the investigation, including if the data collection is meant only for training purposes
- any reasonably foreseeable factors regarding the nature, purpose and duration of the research that may influence participants’ willingness to participate (such as extent of strain, potential risks, and discomfort)
- the right to decline to participate and withdraw from the research at any time, without any negative consequences, and without providing any reasons;
- any recording of voices and images (where applicable);
- confidentiality protection and the limitations thereof;
- procedures for incidental findings (where applicable);
- additional insurance guarantees (where applicable);
- period of time to which the consent applies;
- time and nature of data storage
- re-use of specified data in the current, future or other research;
- incentives for participation;
- names and details of the responsible researcher and contact person(s) for questions about the research and rights of research participants;
There are some more points to consider in the informed consent procedure, 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. It are examples, which can be used as a template for your own, customized version. Before signing the informed consent form, participants needs 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
- The form is in line with the new GDPR-requirements.
- Please make sure that the form is well understandable for the participants.
- Consider once more the need for audio-visual materials for your research (and anonymization afterwards).
- 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.
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
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 use via firstname.lastname@example.org