a. General aspects
Mandatory application procedure
Effective July 1, 2019 staff members are obliged to submit every research project for ethical review. Ethics, scientific integrity and careful scientific practice are themes that require constant attention. Developments in the field of data management and privacy (in particular the introduction of the General Data Protection Regulation (GDPR; in Dutch abbreviated to AVG)) require more explicit documentation than in the past. At the start of each research project researchers need to describe in detail how ethical, privacy and data aspects will be dealt with in a proposed research project.
The GDPR requires every organisation to keep a register of all its activities in which personal data are processed. The Faculty Board has therefore mandated that every new research project must be registered and ethically reviewed. To this end, an application for ethical approval must be submitted to the Faculty Ethical Review Board (FERB) of the faculty. In addition to the ethical aspects of the research project, the privacy aspects and research data management are also evaluated.
Exemption for projects without participants
Effective September 1, 2021, staff members (including PhD students) are no longer required to obtain ethical review of research projects without participants, because of the following considerations:
- Ethical issues are very unlikely to arise;
- GDPR does not apply, as no personal data are processed;
- UU regulations for research data handling do apply. However, as a publication package will be prepared for any project-related publications, there is no need to register data management during the research project.
Research without participants pertains to the following types of research:
- Studies using synthetic/artificial data (data that are not obtained from observations/derivations in physical reality). Examples include simulation studies and modelling studies. This pertains mostly to studies from the department of Methods and statistics.
- Studies using aggregated data that cannot be traced back to individuals, such as averages, effect sizes and correlation matrices, including meta-analyses performed on non-individual data.
Researchers intending to process aggregated data that can be traced back to individuals, such as cross-tabulations and meta-analysis data based on individual data, still need to apply for ethical approval.
The above holds for staff only: they are not required to send in an application in PRIDE for research without participants. Students, on the other hand, are required to apply via UU-SER, and this application will be designated Exempt. This application is required for educational purposes, cf. a decision by the vice-deans of education.
How long does the procedure take?
Ethical approval is required before the start of a new research project and, in any case, before the data collection or recruitment of participants takes place. The FERB aims to give its first response to an application within two weeks (see also the regulations). This may not necessarily be a final decision about the approval. The more careful the researcher is in submitting sufficient information to the FERB, the quicker and more adequately the FERB can respond. The FERB strives to take a final decision within 30 days after submission of the protocol.
What is the status of a ruling by the FERB?
Can I lodge an objection against a FERB ruling?
Yes, you can, first by sending your objection to the FERB itself. If the outcome is not satisfactory, you can appeal to the Faculty Board using this designated e-mail address:
Who is liable for any damages arising from the study?
In principle, the researchers themselves are responsible for the ethically responsible execution of their studies. For any damages arising from a study, the university has a general liability insurance policy. For studies subject to the Medical Research (Human Subjects) Act, human subject insurance should be taken out by the researcher. For more information, please see Chapter 10, “Insurances”.
Can I start my study before I have received the FERB’s official approval?
No, you have to wait for the outcome of the review procedure.
When can a research proposal be rejected?
A research proposal is rejected if the FERB does not consider a study to be ethically and/or GPDR-permissible: for instance when the burden on the participants is disproportionate, the informed consent is not in order, or an agreement on the adaptation of the research proposal cannot be reached between the FERB and researchers.
Who may submit research proposals?
Since July 2019 researchers (from the levels of PhD student, post-doctoral researcher and lecturer onwards) can submit their applications through the FERB website called PRIDE.
For students a separate procedure was launched in the academic year 2020-2021, through UU-SER.
b. Specific procedures
Please note that example questionnaires of the specific application procedures can be found on the website of the FERB:
1.1 Single projects
What is a single project?
Single research projects are projects in a defined period and which contain a defined participant group and defined data collection. A single project is not part of a research program.
For single research projects, researchers propose a time period for the data collection. Once approval from the FERB is obtained, they are limited to this period for data collection. There is no time limit for the researchers to analysing the data and writing manuscripts for the purposes as laid out in the application.
1.2 Research Programs
For staff members, is it also possible to submit an application for a group of studies, i.e. for a research programme? If so, how should it be drafted? Which types of modifications would then require an additional application at a later stage?
A research programme (i.e. a series of related studies) involves the following: a series of studies with
- similar procedures (the same methods and instruments)
2. similar ways of asking for consent
3. similar participant populations.
A research programme as a whole should be clearly described by the researcher(s) in terms of the maximum burdens on its participants (e.g. maximum duration, stress, types of stimuli, dosage and frequency, etc.). The researcher should submit the information of the most invasive study within the research program as an example in the application.
- For subsequent, new studies where no personal data are collected: later studies that are equally or less invasive need not be submitted, but later studies that are more invasive should be submitted as an amendment.
- For subsequent, new studies where personal data are collected: later studies must always be submitted to the FERB by means of an amendment, irrespective of invasiveness.
Ethical review of a research programme can be requested through PRIDE. The greater the invasiveness of the studies in the programme, the less the FERB will be inclined to approve the research programme as a whole and/or the more it will probably need more detailed information for its assessment. If the details of all studies in the programme are not fully developed at the time of FERB submission, a researcher may choose to indicate possible components for resubmission to the FERB as amendments (see below) at a later stage.
For Research programmes the approval obtained for new data collections will hold for three years (this was two years). After three years, if the researchers want to prolong the approval, an application for a new research programme has to be offered to the FERB using track changes in the old application.
Research programmes are meant for studies where data are collected and not for existing data.
When should I submit an amendment?
We distinguish amendments for single research projects and for research programmes.
Single research projects
As from May 1st 2022 the FERB applies a stricter use of the amendment procedure. New data collections/studies cannot be offered as amendments.
For data collected in a research project, an amendment must be sent to the FERB for approval when anything changes in the application that obtained approval. The FERB would like to receive a rationale for the amendment (in the form of an attachment, to be uploaded at the end of the application), such as:
- The time period has to be changed as the data collection is not finished yet in the time period laid out in the approved application
- Researchers from other research groups will play a role in the analysis of the data
- Minor adjustments in the research methods or population
- Changes in data management
For new data collections in a research programme it is not necessary to send amendments to the FERB, unless:
- The new studies are not fully covered by the original application (for example, the new project has a different kind of participants, has new measurement instruments, or a different kind of research questions). If this happens an amendment has to be sent to the FERB;
- The new data collection involves personal data. Then, to be compliant with the GDPR, a new registration is necessary for which an amendment suffices.
If I decide that it would be better to make some modifications to my study (delete or add a condition; change or include a task), should I send the FERB a new application?
If anything changes in the research protocol during the data collection phase of the study, the approval of this protocol is cancelled, and you should submit an amendment describing the altered components.
Please note: once the data collection of the project is completed, and the researcher chooses to replicate the study with or without changes to the original data collection (such as an extra or new target group, an instrument is added), a new application for a single research project must be submitted instead of an amendment.
1.4 Pilot studies
Should pilot studies also be submitted to the FERB? Even if the participants give their informed consent?
Since Spring 2022 the procedure for pilot studies has changed: the option of pilot studies will not be offered anymore. Pilot studies are research projects, and the major study can be applied for as a new study.
1.5 (Preliminary) review within the scope of a European grant or NWO
The FERB is sometimes asked to issue a preliminary declaration to show that the current design of the research proposal does not entail any ethical issues. If such a statement is required, a researcher may notify either the FERB or the Research Support Office. The FERB then broadly assesses the documents submitted and reviews the study in detail once its design has been finalized. Also note that a declaration of the Data Protection Officer of the UU (DPO) statement is often required, which follows a separate and lengthy procedure (mostly a Data Privacy Impact Assessment). Start as early as possible to determine what is applicable to your project.
The secretary of the FERB can be asked individually to review the ethical paragraph in a research (grant) proposal, and give specific advice to formulate ethical and privacy aspects throughout the document.
1.6 Ex post facto review
Can I also apply for an assessment after the fact, when the study has already been conducted but has not yet been approved?
The application procedure is mandatory as of July 1, 2019, and for research projects that started after this data you are in violation of the mandatory rule. Please contact the Chair of the FERB.
Which formulation can I use in articles once the FERB has given its approval?
In principle, the FERB uses the following general standard formulation, but advises always to consult the relevant journal first regarding the exact requirements:
The research reported in this article involves healthy human participants and does not utilise any invasive techniques, substance administration or psychological manipulations. Therefore, compliant with Dutch law, this study only required, and received, approval from our internal Ethics Review Board of the Faculty of Social and Behavioural Sciences of Utrecht University, see letter of approval attached. Furthermore, this research was conducted, and written informed consent of each participant obtained, according to the principles expressed in the Declaration of Helsinki.
Does the FERB also monitor the protocols it has approved?
Research is subject to the Medical Research (Human Subjects) Act (in Dutch, Wet Medisch-wetenschappelijk Onderzoek met mensen, WMO) if the following two criteria are met:
- It concerns medical scientific research, and
- Participants are subject to procedures or are required to follow rules of behaviour.
On the CCMO website you will find more information on when research is subject to the WMO: Your research: Is it subject to the WMO or not? | Investigators | The Central FERB on Research Involving Human Subjects (ccmo.nl)
When in doubt, you can complete the WMO /Non-WMO Form and submit it to the Medical Research Ethics FERB (MREC) so they can advise you on this. You can download this form via the website of the METC:
Is review required? – METC (metc-utrecht.nl)
If the MREC decides that the study is non-WMO, you need to submit your study for review by the FERB. If the study falls under the WMO, then the MREC reviews the study and the FERB takes over the decision of the MREC.
If your study is determined to fall under the WMO you will be required to purchase insurance for your participants (see more information about this in section 7).
2.2 Invasiveness of the Study
The FERB can judge a study to be invasive on the following criteria (this is not an exclusive list):
- All studies that may be subject to the Medical Research (Human Subjects) Act (in Dutch Wet Medisch-wetenschappelijk Onderzoek met mensen, WMO);
- All studies that include a vulnerable population (e.g., incapacitated, children, mentally challenged, traumatized, pregnant);
- All studies that propose to use passive consent as their legal grounds for lawful processing;
- All studies that involve a (more or less) invasive intervention (physiological or psychological, e.g. EEG, fMRI, audio, video, new technique);
- All studies that involve topics subject to sensitive societal debate, or taboo topics (e.g., own or others’ sexual activity, hard drug use, suicidal thoughts, religious belief, political preference);
- Large time investment for participants or invasive tasks;
- All studies that use deception;
- All studies where processing of personal data is involved.
2.3 Power Analysis
The FERB typically requests a power analysis or any other form of rationale behind the number of participants required for the relevant study.
Currently, the accepted standard is a power of 0.80, with a type-I error of 0.05. In case of deviation from this standard, the FERB would like to examine the rationale behind this deviation. As for making a power analysis in itself, considerations of the FERB are as follows:
1) do we not burden too many subjects? Do we have more participants than required for the rejection of a null hypothesis if this null hypothesis is false?
2) do we have sufficient subjects? Is the number of participants sufficient for the rejection of a null hypothesis if this null hypothesis is false?
The more ethically sensitive or invasive the study, the more attention the FERB will pay to the data analyses and the more meticulous and detailed the study’s description should be. The more invasive the study is, the more important the power analysis and its review by the FERB will be.
2.4 Informed Consent
How explicit should I be in obtaining informed consent?
The FERB advises you to be as clear as possible and takes the view that for some research topics–such as sexuality, depression, bullying or other invasive subjects–certain questions, video and audiotaping and requesting personal data and other privacy issues might cause agitation or be otherwise emotionally stressful to the participant. Therefore the FERB advises you to describe the kind of data that you want to collect as clearly as possible in the information letter preceding the informed consent form, and to tie the privacy issues in as closely as possible to the actual content so that the participant can make their own assessment as to whether the study will be too demanding or stressful for them.
It is also necessary to state how the data are being processed and stored.
See also our document ‘instructions for drafting an informed consent letter’ and the accompanying examples on our intranet page.
Provision of aftercare
The FERB believes that, in case of invasive topics (e.g. suicide, trauma, addiction), it should always be made clear to the participants where they can go for help.
If a participant chooses to quit the study, may the data collected up to that point still be used?
Where social research is concerned, there is as yet no single and definitive answer to this question. It depends on the type of research (does it involve multiple measurement occasions or does it have a single measurement occasion?) as well as the subject’s reason for withdrawing from the study. The question here is whether the subject has the right to retroactively ask for their data to be destroyed. The answer is No if any of the results of the study have already been published. This highlights the importance of being as clear as possible in the informed consent letter and form.
According to the CCMO (Central FERB on Research Involving Human Subjects, the authority on medical research), the research data that have been collected up to the moment of the subject’s choice to withdraw may be used. See: https://english.ccmo.nl/human-subjects/your-rights-and-obligations/stopping
The Medical ERB (MERB) policy is that a subject’s right to the destruction of the personal data collected up to the moment of their opting out applies solely to studies in which bodily material has been collected. The MERB also explicitly states in their subject information letter that all the collected data may be used, even if the subject should later choose to terminate their participation.
When does passive informed consent suffice and when is active informed consent required?
The norm is active consent. Passive consent may be permissible for non-invasive studies, provided that it is adequately substantiated (i.e. poor recruitment outcomes due to active consent would be inadequate substantiation). As a guideline, the FERB follows the principle that the more invasive the nature of the study is, the greater the necessity of active rather than passive consent. This also applies to the consideration of whether the subjects’ legal representatives should be asked for their active/passive consent. With passive parental consent, it is of great importance that there is an adequate procedure to ensure that the information letter actually reaches the parents. For more information, see the Nijmegen memorandum “Active or passive parental consent for minors?”.
On what subjects do participants have the right to be informed before they give their consent?
Several codes pertaining to ethics in research with human subjects state that the subjects have the right to be informed about a number of aspects of the study. This concerns the study’s objective, the burden and risks, what happens to their data, who is allowed to inspect the data, whether they will receive remuneration and, if so, the specifics of this remuneration. It should also be made plainly clear that their participation is voluntary and that they may terminate their participation in the study at any time, with or without reason.
In Article 8.02 of the APA Ethics Code for Psychology, the objective of the study is a top priority in participant information, but the FERB regularly sees that researchers fail to mention the objective or even state a different objective. This is called deception. The researcher should justify why they use deception. Deception should be substantiated with arguments, and the lack of adequate information prior to the study should be remedied as soon as possible afterwards in a debriefing (see the following sections).
Also, with the GDPR (AVG) coming into force, when personal data are collected, participants must be informed about the confidentiality and processing of these (personal) data. See also our instruction document for informed consent, which can be found here: https://ferb.sites.uu.nl/relevant-documents/
Right to withdraw or correct data: will be specified later.
Right to inspect own personal data: will be specified later.
Is there a guideline for phrasing the content of the informed consent or the way in which the participants should be informed?
The FERB advises you to thoroughly consider the target group beforehand and phrase the formulation accordingly. A good guide here is the style guide of the CCMO Central FERB on Research Involving Human Subjects: https://www.ccmo.nl/zoeken?trefwoord=schrijf&search-submit=
The Accessibility Reading Level Tool is also a good source for reference (in Dutch): https://www.accessibility.nl/kennisbank/tools/leesniveau-tool.
Also the ‘Stichting Makkelijk Lezen’ has several tips for making text accessible (e.g. for children, in Dutch): https://www.stichtingmakkelijklezen.nl/page/6/makkelijk-lezen.html
This website has adequate information about including participants who have a vulnerable situation (in Dutch): Inclusief onderzoek – Pharos
Storage of informed consent forms
As of 1 July 2021, Informed Consent forms collected on paper with a “wet” signature and original questionnaires completed on paper will only be stored digitally.
The FERB has the policy that the informed consent forms can only be stored digitally. This means that after signing by the participants the consent form should be scanned and stored on the faculty server (YoDa for example). This has to be done by the regulations for Archively Valuable guidelines (pdf-A format). You can ask the secretary of the FERB for the specific instructions. After digitalizing and storing the consent form, the original paper version is allowed to be destroyed.
The information letter itself can be stored together with the research data. This is important when checking the informed consent for sharing data or contacting participants for new projects.
– the informed consent forms and/or questionnaires should be scanned in a durable, archivable (searchable) manner in accordance with the attached instructions (pdf-A format with a resolution of 300 dpi);
– this should be done by a competent person involved in the research (this can be a student assistant, in which case a declaration of confidentiality is required);
– and then saved from the mailbox of the authorised person in the folder created for this purpose (separated from the raw research data) on the faculty server;
– use a consistent naming for storage of such files; and
– destroy the paper versions using a container for confidential material
2.5 Debriefing and Deception
What is considered deception?
Deception concerns any form of deliberately misinforming the subject. Psychological research often goes with the assumption that clear information about the objective of (different conditions in) the study will affect the outcomes. In some cases, it may be necessary for the researchers to choose to deliberately not provide the participant with all the information.
In principle, deception makes a study more invasive, especially when a cover story or manipulation method is used. The FERB generally maintains that deception is only acceptable in research if it is substantiated with arguments. Moreover, the participant should be provided with the correct information as soon as possible afterwards (in the debriefing). See also questions Articles 8.07 and 8.08 of the APA Ethics Code and section 3.1 and 3.2 of the EU Guidance Note on Social Science and Humanities.
Can I postpone the debriefing?
According to the APA, postponement of the debriefing is permissible if scientific or human values render this necessary (Article 8.08 b APA), provided that the scientific interests involved outweigh the additional burden on the participants (e.g. being left with a bad feeling).
3.1 Existing Data
Will be specified later.
3.2 Research abroad
Studies conducted abroad are subject to the rule that ethical review should be requested in the country where the study will be conducted and where the researcher works (see Articles 10 and 23 of the Helsinki Declaration, as well as the information on p. 8 of the 2018 EU Guidance, Note for Researchers and Evaluators of Social Sciences and Humanities, both of which have been uploaded to the website). Researchers have to take local cultural habits into account when executing their research.
For online research no strict requirement exists for asking ethical approval abroad if all of the following conditions hold: (i) the study is conducted anonymously, (ii) the subject of the study is non-invasive and (iii) asking for ethical approval would place undue burden on the researchers .
3.3 Research at external organizations
Also staff or student research projects carried out at external organizations must be submitted for review in PRIDE or UU-SER. The FERB reviews in particular the content of the information letter and consent. Furthermore the FERB considers whether the data management procedure is in accordance with the guidelines of the Faculty/University and GPDR conditions. The FERB is aware of the fact it cannot set requirements to the data storage at the external organization, but it can indeed give (strong) advice to improve those aspects if necessary. Also the FERB considers whether a Data Transfer Agreement or Data Processor Agreement should be drafted.
3.4 Coincidental findings
Definition of coincidental findings
Coincidental findings are findings in subjects during their participation in a study for which the study was not designed and which the researcher was not looking for. Coincidental findings may either be physiological (EEG, EKG, EMG, SCR, eye movement measurements) or psychological (e.g. the discovery upon the administration of questionnaires of dyslexia, intellectual giftedness, severe depression or suicidal tendency).
Coincidental findings in physiological measurements
The potential discovery of results that may be important to the (health of the) subject, raises a number of questions:
- How reliable is the measurement instrument, in other words: how certain is the researcher that the finding is a coincidental finding? Will the researcher raise unnecessary fear and concern in the subject by informing them of a potential (medically relevant) deviation? In this respect, in research with questionnaires or experiments, the question is whether there are standard scores that indicate whether the finding should be seen as a clinically significant deviation.
- How important is it for the subject to be aware of the coincidental finding? Is there an acute health risk? Is it something the subject would otherwise not have known? Can anything be done about it?
- What is the best way of conveying to the subject that something may be found by coincidence? How to ask in the consent procedure for permission to discuss any potential deviating findings with the subject?
Coincidental findings in psychological measurements
In case of coincidental psychological findings, the following questions are important:
- Is it self-reported (that is to say, might the subject already be (partly) aware of the issue)? If it is self-reported, it may be assumed that the subject already has some insight into the topic, but this is not necessarily the case. For self-reporting in studies where acute problems (e.g. serious suicidal thoughts or behaviour that may be an indication of the development of a severe eating disorder) may be revealed, the important question is whether someone should be informed and, if so, who (the subject or their GP?).
- Was it found using a clinically validated (perhaps diagnostic) instrument?
When the measurement method is clinically validated and is also applied in a standardised manner, there is a clear criterion for feeding back the scores that exceed the standard. When the measurement method is experimental and not validated, it is fair to say that feedback on these data is not useful, unless they clearly reveal alarming issues (e.g. suicidal thoughts).
Procedure for coincidental findings
The FERB believes that there should be a study procedure for findings that are potentially clinically relevant and become apparent in the sampling or analysis of the research data. In this case too, the more invasive the study, the more the FERB values such a procedure.
The FERB proposes to convey clearly in the informed consent procedure:
- whether the study comes with a chance of clinically relevant coincidental findings;
- that, if so, the subject will be informed and will be advised as to whether they should contact their GP. It is relevant to specify here that there will be no clinical evaluation (as the researchers at our faculty are not trained medical doctors).
- In studies into invasive topics like abuse, or depression or other disorders, the FERB deems it wise to include in the information to be received by the participant whom they should turn to if they have concerns or mental health complaints.
Furthermore, the researchers’ procedure in case of potentially clinically relevant findings should be made explicit on the registration form. For instance: which (senior) researchers will they consult about its clinical relevance; who will contact the subject if this consultation indeed reveals that the finding is clinically relevant; and to which professional or organisation will the participant then be referred (e.g. their GP).
Indicate whether a compensation is given for this research and the amount and whether this is paid pro rata when the participant stops earlier (based on minimum wage, compensation for effort and time, no travel costs). In case of a lottery draw, mention the chance of obtaining compensation (this must be a realistic chance).
Also mention that additional personal data may be requested (bank account number, e-mail address) and temporarily stored in order to pay out the compensation.
Also specific guidelines on this point are being developed at this moment.
Is there an independent contact/independent expert?
For some (major and more invasive) studies, the FERB advises appointing an independent contact or expert whom participants can contact with questions and/or complaints. In principle, this contact may be a fellow researcher (whether or not working in a different department) who is able to address such questions or complaints. “Independent” means that the contact is not involved in the study itself. The FERB takes the view that an independent contact person is not necessarily required, that the necessity increases with the greater invasiveness of the study. If participants wish to submit a complaint, they may alternatively send a response to the anonymous email address created for this specific purpose:
Complaints contact email address
Participants can voice their complaints about the study via this email address:
Address for privacy questions
Human subject insurance
The Faculty of Social and Behavioural Sciences has purchased human subject insurance with CNA. The Faculties of Veterinary Medicine and Science are insured under the same policy. The insurance policy is annually renewed (on 1st of October). It applies solely to studies that fall under the Medical Research (Human Subjects) Act and are not exempted and not insured via the MERB. The insurance certificate can be requested from the FERB Secretary as needed for MERB applications.
For 2022 the insurance company installed a new clause, namely that research that involves pregnant women and/or babies from 0-1 year old, has to be reported before and not after the annual renewal.
General liability insurance
Utrecht University has a general liability insurance with AON that may be claimed, should the need arise.
The liability insurance policy sheet can be requested from the FERB Secretary or Finance and Control as needed for MERB applications. The insurance policy is renewed on 1 July annually.