Ethics Committee BMS

Research with human subjects can take many different forms. Basically, it is scientific research that depends on the participation of humans to generate data for further analysis. It includes interviews, surveys, observations, laboratory and field experiments, recording and manipulation of physiological functioning, interventions in human behaviour and/or physiological functioning, focus groups, ethnography, but also living labs and analysis of social media content. In all these cases, the interests of the human beings studied may conflict with the interests of the researcher and the value of science as a whole. Therefore, careful ethical assessment is necessary. Such assessment is carried out by the BMS Ethics Committee (EC) or (in case of research that is medically oriented) by a Medical Ethical Committee (METC).  

In the Netherlands, medical research involving human subjects is regulated by the Medical Research Involving Human Subjects Act (WMO). Research is subject to the WMO if:

1. It concerns medical-scientific research, and
2. Participants are subject to procedures or are required to follow rules of behaviour. 

If your research satisfies these two criteria, you have to submit your research proposal to a (local) medical ethical committee (METC), instead of to the BMS Ethics Committee. More information to decide if your research falls under the WMO is provided on the CCMO website.

If you plan to submit to an METC, contact details and more information about the assessment procedure by the METC Twente can be found here.

In all other cases, if you are an employee of BMS or a student in the BMS Faculty and you want to do research involving humans, you have to submit you research for ethical approval to the BMS EC. The BMS procedure for such EC application is described further below.

Non-WMO Research 

Please note that Dutch METCs increasingly also assess research that do not fall under the scope of the WMO according to the criteria mentioned above, but which is carried out in a hospital or another medical institution. If your non-WMO research project is carried out in Medisch Spectrum Twente (MST) in Enschede ethical approval by the METC Twente is required. It is advised that non-wmo research carried out in Ziekenhuisgroep Twente (ZGT) and Roessingh Research and Development (RRD) should also be assessed by METC Twente. Documents that need to be delivered to the METC for assessing non-WMO research in MST, ZGT & RRD are listed in the checklist. METC is developing a non-WMO research statement for research in ZGT and RRD also, as such a similar procedure as in MST will follow soon.

Other medical institutions may require approval by an METC as well; please check this with the institution where you plan to do your research.

ASSESSED AND APPROVED BY AN METC? NOTIFY US!

If your research has been assessed and approved by an METC, the BMS Ethics Committee will take over this decision. This way, we strive to avoid double ethical assessment. However, you should always notify the BMS Ethics Committee that you plan to submit your research project to an METC. You need to provide us a copy of your METC-submission and the METC’s formal reaction. Both documents concerning the METC assessment should be send to the secretary (Lyan Kamphuis-Blikman), please use the following notification form.

If you follow this procedure the costs of the main study METC approval will be covered by centrally administered research funds of the BMS Faculty, instead of by the department. Please note, that if you submit an amendment of your study to the METC later on, the costs of this amendment will not be covered by the BMS Faculty, but will have to be paid by your department. If you have questions about this procedure you can contact the secretary of the BMS EC, Lyan Kamphuis-Blikman.

Please note that the BMS Ethics Committee assesses research with human subjects carried out by, or under supervision of, employees of the BMS Faculty only. Researchers from other faculties have to comply with the rules and procedures within their own faculty. If researchers from different faculties are involved in the same project, the human subjects research should be assessed by the faculty of the principal investigator.

Students from programs offered by other UT-faculties, in which BMS employees are involved as supervisors, should comply with the ethical regulations of their (first) supervisor’s faculty. This means that students from, for example, the Health Sciences program, should submit their project for ethical approval to the BMS Ethics committee only if their first supervisor is a BMS-employee.

Bachelor and Master students

Ethical review of research by students is obligatory for all bachelor and master thesis projects using human subjects. In addition, teachers may decide that ethical review of research by students in the context of courses, modules or internships is necessary after all. If this is the case, the teacher should contact the representative of the EC assigned to the department of the teacher to discuss how this can best be arranged.

Ethically responsible research is based  on a broad set of general ethical principles, which guide the ethical assessment. These include:

• Avoidance of exploitation;
• Just distribution of benefits and burden;
• Respect for persons:
  1. Participants are treated as autonomous agents;
  2. Participants with diminished autonomy are entitled to protection;
• Respect for human dignity;
• Scientific validity;
• Scientific, societal and/or educational relevance;
• Respect for rights and specific interests of (specific groups of) research participants, and/or the community/society
• Safeguarding confidentiality and respecting privacy matters.

The BMS Faculty subscribes to the Dutch Code of Ethics for Research in the Social and Behavioral Sciences involving human participants that is intended as a guideline involving research not covered by the WMO. [new version become available soon]

BMS Data management Policy

In 2015 the UT published the Research data policy UT. This document sets out minimum criteria for the management and storage of data. Since the way in which research data is handled varies from one academic discipline to another, it is up to each faculty to supplement the university’s policies by setting up their own faculty data policy. These policies specify how scientists within the faculty are required to handle research data. Because of national and international laws, regulations and funder requirements, data management soon becomes very important for research department and researchers. The BMS data policy is available in Dutch & English. Many steps in improving the infrastructure, facilities and support have already been taken, which can be found on the BMS LAB website and the BMS Datalab website.

You can submit the request for ethical assessment of your research via a web application. The person responsible for the research fills in a number of questions regarding the project. The questions in the web application consist of a general part (questions on, for example, purpose and research question) and a specific part (questions on, amongst others, sessions, consent, provided information and expectations of participants). If you do not finish the questionnaire right away, the web application allows for provisional saving of the filled in answers, so you can continue later.

Once you have completed and submitted the questionnaire, the web application will automatically forward the request to the supervisor involved (if any). After the supervisor has approved the request, it will be sent by the EC secretary to the relevant member of the Ethics Committee. For more information, read the review procedure at this website. The questionnaire is made available in PDF format to all concerned when the Ethics Committee has approved the request.

Attach files to your research request?

It is not yet possible to attach files (for example, an informed consent form) to the webapplication. If you want to add an attachement to your research request, please send them (after finishing the web application) including your requestnumber to Lyan Kamphuis-Blikman. 

Changes to your research after the ethical review is completed?

If any substantive changes (amendement) are made to the research proposal (eg., methods or design) after the ethical review has been completed, these changes must be submitted to the ethical committee. Send your changes to Lyan Kamphuis-Blikman stating your requestnumber. The changes will be presented to the involved EC-member and it will be decided if they are approved or if it the changes are too substantial such that a new research request should be submitted. 

The Ethics Committee member will first assess whether the submitted research proposal satisfies the characteristics and conditions for standard research as defined by the department involved. If this is the case, the Ethics Committee member can independently assess the proposal. He or she may ask some further questions for clarification or suggest some improvements, to which the applicant is expected to respond. The final assessment (approval/rejection) will be communicated via the web application within 10 working days after the initial submission of the request.

If the submitted research is not classified as ‘standard research’, the proposal will be forwarded to a subset of EC members for a more extensive assessment. Again, further questions may be asked, via the web application or via e-mail. The EC may pose additional conditions before giving approval. The final decision will be communicated within 10 working days after the full EC received the submission. In difficult cases, the researcher may be invited to a committee meeting to personally explain and discuss the proposal before a decision is taken. This means the procedure may take more time; if so, the researcher will always be informed when a decision can be expected.

Each BMS department has formulated what is considered as ‘standard research’ within that department, and under which conditions such research is thought to be ethically responsible. Please consult the description of the relevant department before you submit your research proposal. If you are uncertain as to whether, or under which conditions, the research proposed would be acceptable, please consult the EC member or contact person of your department, mentioned at the top of each standard research description.

In many scientific disciplines professional codes for ethical conduct of research have been published, outlining what is considered good ethical practice in a specific domain of research. These codes offer general principles and guidelines to take into account when you are designing your own research, and are often slightly more specific than the general ethical principles mentioned above. We have listed a few of them here. Please note that you need to consult only the code that is relevant to your discipline and/or research method, and that the list is not exhaustive.

For your convenience, we provide standard informed consent forms (in Dutch and English). 

The Ethics Committee has representatives in all BMS departments; they are listed below. Some of them are EC members, and others are EC contact persons. They all function as the first person to consult in that department when you have questions regarding ethics of human subjects research. They also stimulate attention for research ethics in their department. EC members are involved in the assessment of research proposals and participate in policy discussions in committee meetings. Some of the EC contactpersons are involved in the assessment of research proposals, but do not participate in committee meetings.

The Committee members meet 4-5 times a year to discuss controversial cases, reflect on ongoing developments on research and their ethical implications, and advise the dean on policy issues regarding the ethics of human subjects research.

The EC is supported by a secretary, who you can contact in case of general questions concerning the EC and its functioning, the web application and also in case of complaints. Current secretary is Lyan Kamphuis-Blikman. Administrative tasks with regard to the assessment procedure and SONA are taken care of by the secretariat, whom you can also contact with questions regarding the webapplication.