Science-Geo Ethics Review Board (SG ERB)
The Science-Geo Ethics Review Board (SG ERB, further ERB) includes staff from both the Faculty of Science and the Faculty of Geosciences. The ERB is responsible for the professional and independent assessment of research proposals involving human subjects and issues advice on forthcoming ethical issues. Furthermore, the ERB members serve as ambassadors for the ERB. As such, they aim to enhance the insight among faculties’ employees in scrupulous academic practice and scientific integrity as well as responsible conduct regarding the participants’ rights, safety, and well-being.
An overview of the questions and requested or optional documents can be found here (in pdf). A Word-version of this overview is available here (download starts automatically). For information on data management (e.g., dmp) and privacy (e.g., privacy scan), you may contact your faculty’s Data Stewards and Privacy Managers/Officers, respectively: In general, when you submit a manuscript describing research in which human participants were involved, this may trigger the question about an ethics review being done. Some journals ask you just to describe the procedure of informed consent, other journals want to see prove of ethical approval.
A handout for using Pride for researchers can be found here.
Frequently-asked questions (FAQ)
The ERB was set up by the Faculties of Science and Geosciences to allow researchers of these faculties to have their research proposals tested (in advance, i.e., before the start of the data collection) on ethical aspects. The committee also aims to promote understanding of careful and honest science.
There are various reasons why ethical approval of your project is desirable or even obligatory. 1) Funders and publishers increasingly are asking for a proof of ethical approval of your project before they are willing to fund the study or publish its results, 2) you may be intrinsically motivated of doing the right thing, and 3) it may be of an added value when data collected in an approved project can be reused.
The ERB reviews proposals for human-related research. This refers to research involving the collection of data from individuals through questionnaires, observations, recordings, measurements, etc. (research through interventions or interactions), or research with personal data already previously collected or publicly available (i.e., database- or desk-based research).
The following applies: The ERB only assesses proposals for human-related research which, in the committee’s opinion, do not fall under the scope of the Medical Research Involving Human Subjects Act (WMO), or which have been declared non-WMO-compliant by a Medical Ethics Review Board (MERB).
The members of the ERB are drawn from the participating departments of both faculties. Of course, it may happen that additional knowledge in a particular field is needed to complete an assessment properly. The ERB then has the option of (strictly confidentially) consulting external experts, either from the participating faculties or from elsewhere within or outside the university. Your application will be reviewed by two ERB members from different departments.
Yes, a sample information letter is available at this site. A sample informed-consent form can also be downloaded here (Jump to Other information: Supporting documents – downloads).
The ERB not only evaluates proposals for research involving the collection of personal data, but also proposals for research involving personal data already collected (database research).
Non-human research plans, however, will not be reviewed by the ERB.
For participants aged 12 – 15 years, both the [one of the] parents/legal representatives and the underage participant themselves must give their consent for or agree to participation in the study by signing an informed-consent form. For participants under 12 years of age, only parental/legal representative consent is required.
Your research plan will specify what information about your study you will make available to participants and their parents/legal representatives. It will also describe how you will seek informed consent.
Please note that, according to the WMO, non-therapeutic scientific research with minors is only allowed if it involves research that cannot be carried out other than with that group of persons, and whose risks are negligible (see also the CCMO website: http://www.ccmo.nl/). In the WMO, persons aged under 16 are minors (in the Netherlands; check the list for regulations in other European countries).
According to the Dutch code of scientific conduct, the legal term of raw research data is 10 years (see also for example: https://www.uu.nl/sites/default/files/university_policy_framework_for_research_data_utrecht_university_-_january_2016.pdf. There it says: “Archived research data are to be retained for a minimum of ten years, commencing from the date that the research results are published.”).
The hospital where the study is to be performed must be informed about the planned study in advance and asked for its consent. Subjects/patients must be informed about the study in advance and give informed consent. If this is not possible, someone else (the legal representative, partner, family, mentor, curator, etc.) must give informed consent for this.
The research plan for research subject to the WMO must be assessed and approved by an MERB. In case of doubt about WMO liability, the MERB can be asked to issue a statement in this regard. If the MERB has declared that a study is not subject to WMO requirements, the ERB can review and approve the study.
Like in other research projects, in the case of an online survey you should inform participants about your project, their task, their rights, and the protection of their privacy (Jump to Other information: Supporting documents – downloads). But the information can be presented somewhat condensed, for example on the introductory ‘page’ of your questionnaire. (If you need more space, however, it is suggested that you refer to a separate website containing the relevant information.)
Also, you should ask participants for informed consent. This can be done by asking participants to check a checkbox before the start of the questionnaire, confirming that they have understood the information you presented to them and confirming that you are allowed to use their data for your research project.
Only if all details of the research project are known, the ERB will be able to do the review. This means that the number of participants is determined, the questionnaires, interview guides, topic lists for the focus groups etc., should be available, at least in a draft version, a data management plan is being made, and, if necessary, a privacy review has been done. In this fase of the preparations, the application is ready to be submitted.
Please notice that the collection of the data should start after ethical approval of the research plan.
A researcher working at Utrecht University can find the link to an electronic application form for a review via the university’s intranet: https://intranet.uu.nl/en/knowledgebase/ethics-assessment. The form is available in Dutch and English.
Information sheet for the participants, informed consent form, research instruments (questionnaires, interview guides, topic lists), application form, a data management plan, and (in case you will collect personal data) a privacy review .
The purpose of the review is to ensure the rights, safety and welfare of the individuals participating in the study. It covers issues such as:
– Protecting participants’ (physical and psychical) personal integrity and privacy;
– Respecting the rights of participants;
– Observing rules of conduct towards participants in the context of the study.
To achieve this, the ERB always looks at issues such as participant burden, the information letter, informed consent, disadvantages of participating in the study, possible risks, deception and non-disclosure (non-disclosure is withholding information so as not to influence the results of the study).
The committee will also always consider whether the benefits of the research outweigh the potential risks to participants, and whether it is justified to expose individuals to a particular study.
The only body that can and may issue a declaration of non-WMO liability is a – legally recognised – MERB. Such a declaration can be requested via a form that can be found on the MERBs’ websites, for example here. The ERB is not allowed to issue such a declaration.
No, not at the moment. The ERB only evaluates proposals submitted by junior and/or senior researchers from both faculties. However, research proposals by master’s students can be submitted by their supervisor if they are employed at either faculty. Often, student research is part of a line of research, which includes several research projects with a similar structure. (See also the next question.)
No, the approval applies only to the research proposal itself. The ERB only evaluates ‘separate’ research proposals, which eventually can be the start of a “research line”. When submitting a follow-up proposal, you may refer to the original approval.
Yes, completion of the form can be interrupted (‘saved in the meantime’) at any time and resumed at a later time. Once your file has been submitted for review, it is no longer possible to make adjustments.
The ERB aims to give a decision on the assessment within a month of receiving the application. Conclusion may also mean that the ERB needs additional information to reach a proper assessment.
The turnaround time is influenced, among other things, by the completeness and clarity of the information offered by the applicant and the complexity of the ethical issues raised by the research.
The members of the ERB are drawn from the participating departments of both faculties. Of course, it may happen that additional knowledge in a particular field is needed to complete an assessment properly. The ERB then has the option of (strictly confidentially) consulting external experts, either from the participating faculties or from elsewhere within or outside the university.
If the ERB has not received a response from you within 30 days after sending a request for a necessary addition to the protocol, the ERB will close the assessment procedure. The ERB has then been unable to approve the protocol.
You can submit a new request for a review of the protocol. In that case, please allow for another one-month review period.
The ERB considers research proposals in order of receipt. If you have completed the application form completely and attached the necessary files, this will speed up the evaluation procedure.
Starting with the data collection is not allowed as long the proposal is under review. Critical issues should be solved beforehand.
Based on new insights, a research proposal may need to be modified. The ERB is willing to reassess a modified proposal that had already been approved. Depending on the kind of adjustment, the review may be expedited.
No, a researcher always remains personally responsible for how he/she conducts the research. The existing codes of conduct and other guidelines should provide sufficient guidance for the researcher to do so properly. The role of the ERB is to draw a researcher’s attention to the existence of the codes and guidelines and to support him/her to apply and follow them as well as possible when conducting the research.
Ideally, the project should be ethically approved in advance.Other information