Ethics approval - points of interests and tips

Personal data, anonymity and pseudonymisation

  • Do not request personal data from participants if there is no valid reason to do so. If the collection of personal data is necessary, you must demonstrate this.
  • Do not collect data in a form that unnecessarily increases the identifiability of the participants, e.g. date of birth (when processing the results you usually only use the year of birth).
  • Develop a procedure by which either the anonymity of the respondents can be effectively guaranteed or pseudonymisation is used. Anonymisation is often impossible.

Take into account:

  • A combination of data that are each in themselves insufficient to identify someone (such as place of residence, age, external features, etc.) can also lead to identification (e.g. the only person over 65 among the Master of Philosophy students). The omission of some data or the replacement of a name by a pseudonym is usually not sufficient.
  • Do not promise anonymity if this is not possible. Promised anonymity should be complete, i.e. indirect data (places, times, etc.) should also be removed or adjusted if they could give rise to identifiability.
  • Create two separate data collections: the collection of contact data of potential participants and the collection of background data of the participants. In this way you make a clear distinction (also for the participant) between non-identifiable data that can be passed on and personal data that you only use to contact the potential participants.
  • Make clear how you deal with all possible information that can reveal the identity of the participant. Encryption is recommended. (encryption tools - in Dutch) (encryption manual for researchers - in Dutch, pdf)

Recruitment of participants

  • Avoid any pressure to participate at all times.
  • Do not leave the recruitment to someone in a position of authority or power that may jeopardise free participation (e.g. a civil servant recruiting participants among asylum seekers). 
  • Give the potential participants time to think about their participation. Preferably provide the information letter to potential participants in advance.
  • To ensure voluntary participation, do not encourage participants to do their best to answer the questions. 

Sensitive topics and vulnerable groups

  • Think about the welfare of your (potential) participants.
  • Make sure the participants can speak freely and are not disturbed (e.g. you cannot conduct an interview on a sensitive topic in a waiting room). 
  • Do not ask participants for information they cannot or should not provide because of professional secrecy or at least their duty of discretion. For example, in interviews with mediators, no identifiable information may be derived about the perpetrators and/or victims they have supervised. Questions about general (case-transcending) data, opinions and attitudes are allowed.
  • Check whether it is useful or necessary for a trusted representative of the participant to be present.
  • Sometimes the physical presence of a researcher is not appropriate. For example, in an asylum interview this can increase the stress of an asylum seeker while the presence is not necessary for data collection.
  • Provide guidance or support to participants where necessary, including after the research. If possible, you can work together with agencies that remain accessible after the study.

More information on vulnerable persons.

Informed consent: the researcher's duty to inform

  • You have a duty to inform the participant. The initiative for this lies with you.
  • This duty to properly inform potential participants cannot be passed on to someone else. If you cannot recruit the participants yourself, written information is required.
  • An information letter to the (potential) participants contains all the elements that can be found in the template for the information letter. Please read the instructions carefully.
  • Address the information letter to the potential participants and not to third parties. Do not write "the participants will..." but "you will...".
  • Do not thank the potential participant for his/her participation in the research, but for his/her interest in the research. 
  • Make it clear that the participants can refrain from participation at any time without any consequences for them. Make clear that they do not have to give a reason for doing so.
  • When using deception (such as in an experiment), make an exception because communicating the objective of the research in advance may influence the course of the research and/or the results. In this case, you must inform the participants of the real purpose of the research afterwards. The initiative for this lies with you: you do not just give information to participants who ask for it themselves.  

Informed consent: the consent of the participant

  • An informed consent form contains the different parts of the informed consent template. Read the instructions carefully.
  • If you are asking for consent for different things (e.g. for participation in the study and use of the recordings for educational purposes), state this clearly in the consent form.
  • Make clear that the participants can refrain from participation or further participation at any time without any consequences for them and that they do not have to give a reason for doing so.
  • If you do not collect personal information, make no recordings and only save the data in an anonymised form in the case of questionnaires (e.g. online survey), no written consent is needed. You do need to fully inform the participants about the project. Indicate that participation in the study is regarded as consent.
  • If the participant is unable to give written informed consent (e.g. illiterate), make an audio or video recording of the verbal informed consent. This contains all the points mentioned in the written form. During the recording, clearly state that the participant is not obliged to participate and can stop the conversation at any time.
  • Make clear that the participants can withdraw their participation up to a certain point. Specify a time frame for this. For example, it is usually not possible to remove certain data from the collection once processing has started. 

Informed consent in the case of children or adolescents

  • Persons under 18 cannot legally give informed consent. In that case, you prepare two standard information letters and two informed consent forms: one for the parents (you ask all guardians for their consent) and one for the child or adolescent (except when the child cannot yet read sufficiently). In this way, the minors themselves can also consent, although this form will have a different value.
  • Both documents should be in a language the reader can understand.
  • If the forms are sent to parents and children via an organisation (e.g. a school), you cannot use opt-out consent. You cannot assume implicitly that the parents and children consent and that the parents must respond if they do not want their child to participate.

Informed consent in the case of adults with impaired legal capacity

(e.g. persons with dementia, people with intellectual disabilities)

  • The aim is to also ask consent from a person with impaired legal capacity (to the extent of their ability). You provide adapted information to the potential participant (if necessary, this can be done verbally).
  • In addition, you ask permission from a family member or guardian, of course after fully informing them.  
  • Potential participants who make it clear in any way that they do not wish to participate cannot be included, regardless of e.g. the degree of dementia or the consent obtained from family members or guardians.

Use of video and/or audio recordings

  • If you make audio or video recordings, you must ask the participants for their explicit permission. Include at least the following aspects in the forms: the creation of the recordings, the way and duration of keeping the recordings, the destination and use of these recordings. Discuss these aspects with the participants.
  • Inform the (potential) participants that it is not possible to anonymise audio or video recordings. 
  • Make clear that if the conversation during the recording becomes very personal or emotional, the recording can be stopped, deleted and/or replaced by a later recording at the request of the participant.
  • Make sure that at the start of each recorded session the participant who is making the recording announces: "I am now starting the recording" (in the language in which the conversation is being recorded and clearly audible to the interlocutors present). This prevents recordings being made without the knowledge of any interlocutors of the research participants (e.g. in language research and an analysis of conversations recorded by the research participant in the absence of the researcher). This should be repeated with each new person who joins the conversation.
  • Describe as specifically as possible what will happen to the collected audio and video recordings after the study. If you are destroying the material, indicate when this will happen (e.g. 2 years after the end of the study). If you still want to play the files, you state where and for which audience.
  • When using audio and video recordings, it is best to encrypt the files (= technical encryption). This can be done, for example, using boxcryptor for everything that has to be transferred to Dropbox or axcrypt for files that remain offline (see tools - in Dutch and manual - in Dutch).

Access to the results

  • It is recommended that participants who wish to do so, be given access to the results of the study.
  • If you administer tests or trials that may be of interest to the participants themselves (e.g. language tests on children, psychological tests on job seekers), the participants (or their legal representatives) should be able to obtain these results and ask questions.
  • In the context of informing about tests or trials that contain sensitive information (such as a test that may reveal a language deficiency in a child), researchers should provide the necessary professional guidance. To this end, researchers usually work together with existing services to which the participant can turn even after the conclusion of the study (free of charge).
  • Sensitive information (e.g. the result of a language test that reveals a language deficiency in a child) is never sent to the participant just like that, but is discussed with the participant by a professional.

Involvement of an organisation

  • The management of an organisation involved in the study must only grant permission for the study to be conducted (e.g. in a school or care home). The permission of the management is separate from the permission of the potential participants to participate.
  • People who do not wish to participate should not suffer any negative consequences (e.g. miss a class).