Ethics Review Board – Faculties of Science and Geosciences

Ethics Review Board – Faculties of Science and Geosciences

Welcome

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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.

We are having a vacancy! The Science-Geo Ethics Review Board is looking for a new member representing the Department of Pharmaceutical Sciences. If you are interested to become a member of the ERB, please contact the secretary of the Board, Willem Rump.

[collapse title =”Contact”]
Secretary: Dr. H.H. (Willem) Rump
Email address: etc-beta-geo@uu.nl[/collapse]

[collapse title =”Application form”]
The ERB application form for an ethics review of your project proposals you may find on the intranet site on ethics assessments: https://intranet.uu.nl/en/knowledgebase/ethics-assessment.
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[collapse title =”ERB leaflet”]
The leaflet (in Dutch or in English) provides a short introduction to the ERB and illustrates the location of the ERB in the process of preparing your research project.
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Frequently-asked questions (FAQ)

[collapse title=”Part 1: Questions on the Ethics Review Board (ERB)”]

  1. What is the purpose of the ERB?
    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.
  2. Why should I apply for an ethical review of my research plans?
    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.
  3. What research proposals does the ERB evaluate?
    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).
  4. What expertise does the ERB have to assess the research plans submitted
    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.

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[collapse title=”Part 2: Questions on research plans”]

  1. Is a sample information letter and informed-consent form available?
    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).
  2. In my research, I do not collect data from people. Can I still apply for ethical review from the ERB for this research?
    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 will not be reviewed by the ERB.
  3. There are participants under 16 years old involved in my study. What should I pay attention to?
    For participants aged 12 – 15 years, both 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, 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).
  4. What is the retention period for my research data?
    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.”).
  5. My research involves patients and/or observation in the clinic. What should I consider when applying for ethical review?
    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.
  6. I am planning to do an online questionnaire. How do I ask informed consent from the participants?
    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.[/collapse]

[collapse title=”Part 3: Questions on the ERB review procedure”]

  1. When do I have to submit a proposal for the ethics review?
    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.
  2. How can I apply for an ethics review at the ERB?
    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.
  3. What documents do I need to submit for the ERB review procedure?
    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 .
  4. What does the ERB pay attention to when evaluating research proposals?
    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.
  5. Can I get a statement from the ERB that my research is not subject to WMO requirements?
    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.
  6. As a student, can I have my research proposal reviewed by the ERB?
    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.)
  7. Does consent for my research also apply to later follow-up research?
    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.
  8. Can I stop completing the online application form in the interim?
    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.
  9. How long does the review process of a research plan take?
    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.
  10. Does the ERB have sufficient expertise to assess the research proposals submitted?
    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.
  11. How much time do I have to respond to the ERB’s supplement request?
    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.
  12. I have little time to submit my research for ethical review because I want to start the study quickly. What should I consider?
    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.
  13. Can I already start collecting data while the ERB is still doing the review?
    Starting with the data collection is not allowed as long the proposal is under review. Critical issues should be solved beforehand.
  14. Can I amend my application after the committee’s final decision?
    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.
  15. Will the ERB monitor the conduct of my research?
    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.
  16. Can I ask for approval of my study after the research project has been carried out?
    Ideally, the project should be ethically approved in advance.

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Other information

[collapse title =”Examples”]
The ERB is presenting  here some exemplary illustrations of research ideas and the related risks of misconduct.
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[collapse title=”Supporting documents – downloads”]

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[collapse title=”Some journals and publishers that asked for ethical approval”]

  • Ethnic and Racial Studies (Taylor & Francis Online)
  • BMC Health Services Research (Springer Nature)
  • Fashion and Textiles (Springer)
  • International Journal of Environmental Research and Public Health – IJERPH (MDPI)
  • Education Sciences (MDPI)
  • American Journal of Pharmaceutical Education (in method section + uploading letter ERB as part of the submission process)
  • Currents in Pharmacy Teaching and Learning (in method section)
  • Pharmacy Education (on title page and in method section)
  • MDPI-Pharmacy (in method section + ERB statement + informed consent statement)

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.

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[collapse title=”Members of the ERB”]

Vacancy

The ERB is looking for a new member of the Board, representing the Department of Pharmaceutical Sciences. If you are interested, please contact the secretary of the Board, Willem Rump, at etc-beta-geo@uu.nl.

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