e.g., funding agency, journal
For example an ethical review committee of a national or international funding agency, a VU or VUmc research institute, the ethical review committee of another faculty or the VUmc METC.
Ad a). The research question is medical in nature. The study makes use of test subjects with the objective of answering a question relating to a disease or medical condition. It should be noted that not all studies involving patients need have a medical objective.
Ad b). There is a medical risk to participants, in other words there is an immediate or predictable chance that they will suffer physical and/or mental harm or inconvenience. The inconvenience may be an integral aspect of the study, but is limited to the duration of the investigative session – for example, inflicting slight pain or a temporary increase in social pressure. The risk of harm is naturally greater in the case of patients – that is, people with pre-existing physical or mental conditions, who may be more vulnerable than others – but is not restricted to them. Mentally incompetent adults (for example people suffering from Alzheimer’s disease, who have learning difficulties or are unconscious) may also be at greater risk of physical or mental harm. On the other hand, not all patient groups need be vulnerable in the context of the proposed study, so research involving patients will not necessarily lead to a higher risk. Thus, persons with a complaint or disability that was diagnosed in the past but who can cope well with this condition and who are not mentally incompetent are not necessarily at higher risk. For example, this consideration would apply to the study of a new teaching method in a class where some or all of the children are dyslexic, the trial of a new educational approach for children with ADHD, and the study of how diabetes patients perceive pictures of everyday food products. As long as the proper precautions are taken, such studies will involve little or no risk. It follows that not all studies involving patients need be referred to the METC. After all, such studies involve selected patients. Some of the patients in the sample may be at risk, even if they were not selected for this; this can however be dealt with by suitable choice of the exclusion criteria.
Ad c). The study involves medical interventions – invasive procedures, or procedures performed by healthcare professionals whose name appears in the Dutch BIG register of healthcare professionals set up under the Professions in Individual Healthcare Act (Wet op de Beroepen in de individuele Gezondheidszorg; http://wetten.overheid.nl/BWBR0006251/2014-02-15#HoofdstukIV Invasive procedures include the taking of blood, tissue or DNA samples (unless through saliva), the giving of injections, the administration of substances in more than normal daily amounts and the withholding of medication or other medical treatment. The use of non-invasive methods, such as the taking of saliva samples and EEG, galvanic skin response, pulse rate or blood pressure measurements, does not require ethical review. fMRI measurements do currently require ethical review if they are carried out at VU University Amsterdam Medical Center (VUmc); the Spinoza Centre for Neuroimaging has its own review procedures.
Give a brief description of what you want to achieve in your research project. What is your research hypothesis or hypotheses?
Give a brief description of the background and impact of your research on theory and/or practice.
Is the load imposed on participants balanced by any benefits? These may be not only financial rewards (money or credits) but also knowledge, insights into ones own abilities and limits, general knowledge about the research and its results, the feeling that one is helping to develop a new treatment that may actually benefit each participant personally, a free course, a new skill. Describe the actual benefits participants derive from taking part in the study, and mention whether the benefits derived depend on anything (for example the participant's level of performance).
Give a brief description of the study design and procedure, including stimulus material, conditions and interventions, between vs. within subject measurements, whether the study is experimental or quasi-experimental, etc.
Describe the criteria used in the selection of participants, and the reasons for these criteria. Who is allowed to participate and who is not, and why?
Give a brief description of the way you approach potential participants. Please include any recruitment material you may have (e.g. flyers, adverts).
One possible approach is power analysis, but this is not obligatory. State the number of participants required for the study as a whole, and for the various subgroups. You can also mention whether you will be performing an exploratory or pilot study.
Where will the research be conducted?
For example through online research tools but also through collaboration with a foreign institute at which (part of) the data is being collected.
Describe exactly what you are going to measure and how you will measure it (observations, questionnaire, test scores, reaction times, eye movements, physiological parameters etc.).
For example questions, illustrations, statements, etc. that deal with emotionally charged or taboo topics. Or disagreeable or painful stimuli such as stress-inducing instructions.
The load imposed on the participants should take their vulnerability into account. Describe clearly the pressures put on the participants and/or the tasks they have to perform. Take mental as well as physical stress into consideration. If the study consists of several components, do this for each component – and please include follow-ups, if any. The following details should be included:
- Nature of the load
- Frequency of the load (how many sessions, and how much time between sessions)
- Duration of the load (per session and total)
Is some of the information given painful or embarrassing, or can the facts reported have far-reaching consequences for the participant? If so, what kind of support does he or she receive?
According to the guidelines of the Central Commission for Research involving Human Subjects in the Netherlands (CCMO), research is not permitted if the associated risk of harm to participants is higher than what may be expected in daily life. If unusual methods or interventions are used, please provide evidence from the literature or elsewhere, if possible.
a) Mentally competent people aged 12 or older give personal informed consent.
b) In case of children or adolescents younger than 18 years of age, informed consent is also provided by at least one of the parents (or legal guardian). Depending on the research, in some cases consent from both parents may be called for.
c) In case of mentally incompetent adults aged 18 or older informed consent is given by the legal guardian
d) It is clearly explained to participants that they are free to withdraw from the study at any time, without stating a reason.
e) In case specific data (e.g. audiovisual material) is being used for the purpose of teaching or presentation, then separate explicit consent for this is asked.
f) The informed consent is actively given.
Explanation of active/passive consent:
Active consent means that the participant and/or parent/guardian must perform a recorded action to indicate consent. A signature is the best form of active consent, if possible, but clicking on a button or link, replying affirmatively to an E- mail or the like (digital informed consent) also counts as active consent. Participation is regarded as indicating implicit consent (as long as the relevant information has been received).
Passive consent means that the participant is assumed to wish to take part if no indication is given to the contrary. Since this conclusion is based on an assumption, care must be taken to ensure that this assumption is well based. For example, participants should be provided with the relevant information repeatedly and in different ways before a lack of response can be assumed to indicate passive consent. Moreover, closer attention must be paid to certain aspects of the investigation such as the load placed on the participant and the use of deception in the case of passive consent.
How and when is the information required for informed consent given? State whether the information is given in writing, in digital form or verbally, and indicate how long before the investigation it is given (thus allowing time for reflection). Also describe the response that people should give to indicate consent. If applicable, describe this for all groups involved (e.g. children, parents, teachers). Include the information brochure (if there is one) with the uploaded documents.
Research may study the effect of a change in a situation on a large group of people. Examples of this are studies of the general interactions between children in a class, of the effect of teaching methods on pupils’ out-of-school behaviour, of the effects of management techniques on shop-floor productivity, of the effect of road signs on driving behaviour and of the effect of the street scene on shopping behaviour. When studying group behaviour, it may not be possible to obtain informed consent from every individual – and it may not even be desirable to do so, since this could influence their response. Nevertheless, it may not be possible to collect the desired data in any other way. In such cases, the researcher may request exemption from the duty to obtain individual informed consent for the collection and use of data, under a number of conditions:
1. No informed consent is needed for simple observation of behaviour in a public space such as a shopping street, underground station or university campus, as no personal data are collected and no information about specific individuals can be derived from the research data.
2. In other cases, informed consent is obtained from the responsible institution or authority, such as the management of the institution or company or the council of the municipality where the measurements are performed. In the case of Dutch schools, consent is obtained from the school’s representative advisory board, constituted in conformity with the provisions of the Education Act (Wet Medezeggenschap Onderwijs 1992).
3. The study consists mainly of observation of the group in question in its daily setting. If the effect of a procedure is being studied, this procedure was set up and implemented by the institution in question, or was approved by the institution and implemented with its permission and under its supervision.
4. Interventions and/or procedures occur at group level and are not aimed at specific individuals. It goes without saying that the effect of an intervention can vary from one individual to another. For example, a measure may be applied to a whole class but the behaviour of some children may change more than that of others.
5. The research results are reported only at group level. This also applies to the institution where the research was performed. “Groups” in this context may be subgroups, as long as the data provided cannot be traced back to the individuals concerned.
In principle, participation in any investigation is on a voluntary basis, which presupposes that the participant knows what kind of study he or she is taking part in. In some cases, however, it is necessary to give participants false or misleading information about the nature of the investigation, for example if giving correct information could influence the outcome of the study. Withholding details of the investigation (such as full information about the experimental conditions) that could influence the outcome but are not otherwise relevant for participation does not count as deception.
The participants may for example be students taking a course given by the researcher or employees of the researcher.
Debriefing allows important extra information to be given about the nature and possibly the results of the research, and provides the participant with an opportunity to ask questions.
Long-term storage of personal data in the Netherlands may require registration of the database where the data are stored by the Dutch Data Protection Authority (College Bescherming Persoonsgegevens). The registration of identifiable genetic material must always be submitted to the METC for approval. The presence of a particular marker does not count as personal data as long as this information is made anonymous. CPB Documentation: https://autoriteitpersoonsgegevens.nl/nl/over-privacy/persoonsgegevens [in Dutch]
Instructions:
a) The permission of the participant or his/her legal representative has been requested for the storage of personal data
b) Personal data are kept separate from the research data, or the research data are anonymized in some other way
c) The connection between the research data and the personal data is at most indirect, for example via a code or participant number
d) Personal data are stored in a secure manner, for example by using a password and/or encryption
e) Access to the personal data is restricted to the relevant researcher, department or research group
f) Personal data are not shown to third parties or used for purposes other than research without prior written permission of the participant
g) Participants are allowed access to their stored personal data, and can have them deleted.
Long-term storage of personal data in the Netherlands may require registration of the database where the data are stored by the Dutch Data Protection Authority (College Bescherming Persoonsgegevens). The registration of identifiable genetic material must always be submitted to the METC for approval. The presence of a particular marker does not count as personal data as long as this information is made anonymous. CPB Documentation: https://autoriteitpersoonsgegevens.nl/nl/over-privacy/persoonsgegevens [in Dutch]
More than one option may apply.
Locally, on a desktop / laptop, number: …
On a VU-server, path: …
On an online platform (e.g. Qualtrics), account: …
In a cloud, account: …
Provide names, positions and e-mail address of all persons who have access to the data or recordings. [Members of the Department, research group, PI, co-authors, public access]
Give a brief description of how you plan to analyse the data.
For example, the application could concern a MSc student project which is part of the PI's larger research project. In this case "Master project" applies.
Please specify funding source (1: VU University; 2: NWO/ERC; 3: foundation support / contract research) and the name(s) of the funding agency and grant number(s). In case of multiple sources please mention them all.
Please upload a scanned version of your signature (for example a jpg, png or pdf file).