Every researcher is expected to adhere to the standards of good research (see Universities of the Netherlands). Each researcher is therefore responsible for safeguarding the scientific integrity and ethical aspects of their own research. The VCWE helps with this by evaluating research protocols for ethical aspects and advising on the integrity and ethical aspects of the scientific research at the Faculty.
Before a researcher from the Faculty of Behavioural and Movement Sciences (FGB) offers a research protocol to the VCWE, the researcher is advised to first study the code of ethics of The National Ethics Council for Social and Behavioural Sciences (NETHICS). This explains, for example, in which cases a research proposal must be submitted to the Medical Ethical Review Committee (METc), because the research falls under the Medical Research Act (WMO; see also the CCMO). In the event that the METc is only approached for a non-WMO statement, it is recommended that if this non-WMO statement is granted, the research protocol is also submitted to the VCWE for ethical review. This ethical assessment is not carried out by the METc in the case of a non-WMO statement.
Before protocols can be submitted to the VCWE, a number of other matters must be settled, such as:
- A data management plan. A data management plan is not part of the research protocol that is to be submitted to the VCWE, but must be arranged by the researcher before the research protocol is submitted to the VCWE.
- Control of privacy according to the General Data Protection Regulation (GDPR): Privacy (see also GDPR checklist).
- Completing a privacy statement. The VCWE does not review or assess the privacy measures in research or the submitted privacy statement. The researcher is personally responsible for ensuring that all privacy-related matters are properly arranged before the research protocol is submitted to the VCWE. The privacy statement must be attached to the information letter or must be accessible via the project’s website. An example privacy statement can be found here. For the most recent privacy statement template and questions regarding the privacy statement, please contact: research.data.fgb@vu.nl.
When submitting the study protocol to VCWE, a participant information letter and an informed consent (IC) should be added:
- Applicants are strongly advised to use the VCWE Participant Information Letter template:
- Applicants are also strongly advised to use the VCWE Informed Consent template:
- For research involving children (up to 16 years of age), applicants are strongly advised to use one of the VCWE templates below for the consent form. In this context, only the parent/guardian needs to provide consent for participation if the participant is younger than 12 years old, while both the parent/guardian and the participant must give consent if the participant is between 12 and 16 years old:
In case of deviations from the template, please indicate these changes clearly (using track changes) in the document and upload this document when submitting the study protocol. In case the templates are not used or are altered without justification (especially the informed consent forms), the applicant will be asked by the VCWE to make revisions.
The study protocol, with the necessary attachments, can be submitted by completing the form online at the VCWE Editorial Manager:
When filling out the online form, keep a few things in mind:
- The application can only be submitted via the Editorial Manager by an employee (researcher) of FGB, not by students.
- Provide clear, complete and concise descriptions of the study in the form. It is helpful to attach a separate research proposal or research protocol, but it is not intended to be referenced in the form. The form itself must contain the information to test the protocol.
- For (student) projects it can be useful to prepare to fill in the form with a blank form and to copy and paste the text into the online form.
AMENDMENTS:
Amendments may be submitted to already approved proposals, under the condition that the proposal was approved no longer than 5 years ago. Amendments consist of relatively small additions or changes in the approved proposal. When larger changes are considered, such as changes in the research design or involvement of different, more vulnerable populations, a new proposal should be submitted for review.
CLUSTER PROPOSALS
In addition to submitting a proposal for one specific study, there is the option to submit proposals for lines of research involving a series of studies that typically involve research aims and complementary methods. We call such proposals “cluster proposals” (a term with an identical meaning is umbrella proposal).
Cluster proposals concern “lines of research” of individual researchers or research teams or groups. For example, there may be a research line focusing on broader topics such as “self-control in children”, “the genetics of happiness, ”sensorimotor control in non-elite soccer players”, or “human cooperation”. The cluster proposals are similar to other proposals for individual studies, except that they provide information about various methods and procedures that will be used in a particular line of research instead of in an individual study.
All studies conducted under a cluster proposal must fall within the ethical scope, level of risk, participant characteristics, and methodological framework described in the approved cluster proposal. Cluster approval does not constitute a blanket approval for any type of study; studies that introduce new risks, procedures, burden, or populations beyond the approved scope require a formal amendment or a new, separate proposal.
It is also important to note that individual researchers can later submit amendments to an existing cluster proposal, even if they were not part of the original research team that received positive advice about their cluster proposals. Note that, as always, any amendments’ duration is determined by the original proposal – that is, it is valid for five years after the positive advice regarding the original proposal.
Cluster proposals should clearly specify the anticipated level of risk and participant burden associated with the proposed line of research. This includes whether the studies involve minimal risk procedures, the inclusion of vulnerable populations, and the general nature of the measurements involved.
It is not required to detail all individual studies. However, the cluster proposal needs to include information about the sample, recruitment, procedures, burden, risk, and methods that will be used in the proposed line of research. The cluster proposal should provide a clear description of the general characteristics of the participant populations involved in the proposed line of research. This includes, at a minimum, information on the target population(s) (e.g. healthy participants, patients, children, students), relevant age ranges, and whether vulnerable groups are involved. General inclusion and exclusion criteria should be described at a high level, sufficient to define the scope of the research line, without requiring detailed specifications for each individual study.
It is important that the VCWE has sufficient information for all aspects of research to review the proposal. It may help to provide not only global descriptions but also examples of earlier research that has been approved by the VCWE or references to published research, especially when it involves relatively well-validated (and established) procedures and methods. Importantly, within a cluster proposal, the informed consent (IC) forms will be the same for all individual studies of the cluster application and should be included when submitting the application to the committee. However, there may be an exception: In case the study population consists of multiple age groups that require different ICs (e.g., participants younger than 12 years, between 12-16 years and participants of 16 and older) these ICs should all be included. Also, an information letter of an individual study that provides a suitable example of the studies in the cluster proposal should be included, so that reviewers can evaluate the communication to the participants.
Questions?
Email: vcwe.fgb@vu.nl
Summary: check flowchart / decision tree
Contact details
Chair: Prof.dr. P.A.M (Paul) van Lange
Secretary: dr. M. (Mariët) van Buuren
E-mail: vcwe.fgb@vu.nl
Huidige commissieleden
Dr. Anne Marije Kaag (vice-chair)
Dr. Nadia Dominici
Dr. Martin Gevonden
Dr. Jolanda Maas
Dr. Anouk Zuurmond
Dr. Jo de Ruiter
Dr. Marvin Neumann
Dr. Jan Willem Grijpma
Prof.dr. Wendy Scholten - Peeters
More background information