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:
- It concerns medical-scientific research, and
- 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.
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 secretariat (Marcia Clifford), 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.
Энсей Танкадо незаметно кивнул, словно говоря:. И тут же весь обмяк. - Боже всемилостивый, - прошептал Джабба. Камера вдруг повернулась к укрытию Халохота. Убийцы там уже не .