Research ethics review committee

More information about BETHCIE

• About BETHCIE

  Researchers at the VU Amsterdam Faculty of Science are highly advised to review their upcoming research projects in which human subjects participate for any ethics issues. The BETHCIE provides guidance in dealing with ethical issues concerning research with human participants that is not subject to the medical research act.

  Tasks of BETHCIE:

  • To review research in human participants that does not fall under the Medical Research Act (WMO) for compliance with the code of ethics.
  • To provide support for researchers in reflecting on ethical questions and the code of ethics.
  • To give advice about ethics and integrity of research to the faculty board, departments, research groups and individual researchers.
  • To carry out unexpected checks to assess whether applicants have filled in the Self-Check correctly.  
  • To stimulate ethical research practices in general.
  • To increase awareness for research ethics.

  Members of the BETHCIE

  • Dr. Elke Vlemincx, Health Sciences, chair
  • Dr. Sandra Hasanefendic, Science, Business & Innovation, vice chair
  • Prof. dr. Martijn van den Heuvel, Neurosciences
  • Dr. Michel Klein, Computer Science
  • Dr. Mark Koetse, Institute for Environmental Studies
  • Dr. Michiel van Oudheusden, Athena Institute
  • Dr. Ruurdtje Hoekstra, secretary

• Review procedure

  Before starting the review procedure

  Before starting the ethics review procedure of a new research project, you should have a good understanding of the societal and scientific relevance of the research, the research questions, the research design and the data collection procedures, and have reflected on these in the context of research ethics and integrity.

  Please follow the steps listed below.

  1 – The online Self-Check

  The first step in the review procedure of your planned research with human participants is to complete the online Self-Check (link to the questions, not to the self-check). The online Self-Check tells you whether your research may raise some ethical concerns or requires a full ethics review. Please note that if you are a master or PhD student, your supervisor has to complete the Self-Check.

  Indications for a full ethics review of your research plan are:

  • The need for a formal advice letter of research ethics (e.g. for funding bodies or publication)
  • Merging multiple data sets of the same participants
  • Atypical informed consent procedures
  • Potential risk to participants or researchers during or after the research
  • Inclusion of vulnerable participants
  • Exposure of participants to material, social or psychological recruitment incentives that are stronger than usual
  • Exposure to distressing, offensive or age-inappropriate research materials
  • Deception of participants without debriefing
  • Incomplete assurance of anonymity or confidentiality

  If the Self-Check concludes that your research does not require a full ethics review, and you do not require a formal advice letter of research ethics (e.g. for funding bodies or publication), you can start your research.

  If the online Self-Check concludes that your research does require an ethics review, or you need a formal advice letter of research ethics, proceed with step 2.

  Complete the online self-check.

  2 – Application for Ethics Review
  
  Prepare the following documents:

  • Application Form
  • An information letter for participants, see example.
  • A consent form for participants, see example.
  • If applicable, other documents as indicated in the application form

  Send these documents, together with the results of the self-check, to bethcie.beta@vu.nl. You will receive a confirmation of your application from the BETHCIE secretary.

  Please note that research data management and privacy aspects will not be reviewed by the BETHCIE, and are therefore not part of your application for review by the BETHCIE.

  However, keep in mind that you also (may) require

  • A data management plan, in line with data management procedures of the Faculty and/or funding bodies. RDM support is available from the VU RDM support desk (rdm@vu.nl) or the data steward of the Faculty of Science.
  • If applicable, a data protection impact assessment, privacy statement, and/or data processing agreement. Support on privacy aspects is available from the privacy champion of the Faculty of Science.

  
  3 –Review by the BETHCIE

  The BETHCIE will assess your application within 4-6 weeks after submission, provided that it is submitted at least two weeks prior to a BETHCIE meeting. 

  See the meeting schedule:

  • 18/01/2024
  • 08/02/2024
  • 14/03/2024
  • 11/04/2024
  • 16/05/2024
  • 13/06/2024
  • 11/07/2024
  • 12/09/2024
  • 10/10/2024
  • 14/11/2024
  • 12/12/2024

  If your application raises minor or no ethical issues, a light review will be performed by one of the BETHCIE members.

  If your application raises more complex ethical issues, the committee will discuss your research at a BETHCIE meeting.

  4 – Advice

  The committee will respond to your application with a formal advice. This advice can be a positive advice or not.

  In case of a positive advice, you will receive a formal advice letter.

  In case no positive advice can be given, please follow the instructions of the committee. If changes are requested by the committee, please resubmit the application form with tracked or highlighted changes, and discuss your revisions in a rebuttal letter, and send these to bethcie.beta@vu.nl.

• Who should apply?

  Only the principal investigator, project leader and/or research supervisor can submit research for an ethics review. PhD students and master thesis students must ask their supervisor to submit an application for review.

• Documents and Links

  Documents

  1. Research Ethics Review Committee regulations (in Dutch)
  2. Code of Ethics for Research involving Human Participants Faculty of Science
  3. Netherlands Code of Conduct for Research Integrity
  4. KNAW Scientific Integrity Complaint Procedure
  5. Beslisboom WMO-plichtigheid VUmc

  Links

  1. For information on medical research: https://www.ccmo.nl/
  2. For information on the Netherlands Code of Conduct for Research Integrity: https://www.universiteitenvannederland.nl/onderwerpen/onderzoek/wetenschappelijke-integriteit
  3. For information on privacy: https://libguides.vu.nl/rdm/gdpr-privacy
  4. For information on research data management: https://vu.nl/en/employee/research-data-support
  5. For registration of research with personal data and for writing data management plans: https://dmponline.vu.nl/?perform_check=false

• Complaint procedure for stakeholders in reviewed research

  Stakeholders in research that is reviewed by the BETHCIE can submit a complaint. The complaint procedure is as follows:

  a. Complaints concerning a researcher or research project

  If it is believed that a member of the faculty is not complying with the ethical principles laid down in this document, or is behaving unethically otherwise when performing academic work, a written complaint backed up by arguments and where possible documentation can be submitted to the BETHCIE, bethcie.beta@vu.nl  
  The (vice)-chair will conduct a conversation with the person against whom the complaint is made, in order to give the researcher the opportunity to respond. The BETHCIE will publish its decision in writing to the person making the complaint and the person against whom the complaint is made, with a copy to the head of the department in question and the Faculty Board. The BETHCIE may advice the Faculty Board on whether the research project in question should be allowed to continue.

  If the researcher or the research project concerns a BETHCIE member, then the committee will treat the complaint without this member. The member will be absent from the relevant (part of) the meeting, and will be excluded from the committee’s internal communication on the matter. The member, like any other researcher, will be allowed to respond. Moreover, a chair or senior member of any of the other Ethics Review Committees at the VU will take seat to independently monitor the decision process.

  If the researcher or the research project concerns the BETHCIE chair, then the same rules apply, plus the chair will be replaced by the vice chair.

  In case of grave violations of ethical or scientific integrity, the BETHCIE will advise the board to file a complaint with the central committee for scientific integrity http://www.vu.nl/nl/over-de-vu/wi/index.aspx.

  b. Complaints concerning the BETHCIE itself

  In case the complaint concerns the decisions or functioning of the BETHCIE itself, the first step is to explain the problem to the BETHCIE chair, through bethcie.beta@vu.nl. If this is for some reason not preferred, or turns out unsatisfactory, a complaint can be filed with the Faculty Board.

• Other review committees

  Medical Ethics Committee (METC)

  Researchers must submit their research protocol to the Medical Ethics Committee (METC) when the research is subject to the provisions of the WMO. According to the Central Committee for Research on Humans (Centrale Commissie Mensgebonden Onderzoek; CCMO), a study falls under the scope of the WMO if both the following conditions are met:

  • It concerns medical-scientific research and
  • Participants are subject to procedures or are required to follow rules of behavior

  Since Condition II is almost always met in behavioral research (except in observation studies in natural environments), the crucial judgement is whether the study is medical in nature. Here the BETHCIE uses the following criteria:

  • The study involves a medical or clinical research question
  • The study involves a considerable medical health risk for the participant (more so than in daily life)
  • The study involves medical intervention or treatment (as registered by law).

  See the Appendix 3 of the Code of Ethics, Faculty of Science for more clarification on these assessment criteria.

  It is the responsibility of the principal investigator, project leader and/or research supervisor to determine with reference to these regulations whether a given research proposal falling under their authority needs to be submitted to the METC for review. The BETHCIE can be asked for advice and an educated opinion.

  Dierenexperimentencommissie (DEC)

  Plans for animal testing need to be submitted to the Dierexperimentencommissie (DEC).