• Every person who is asked to participate in a study should be informed about the study, before he/she decides whether to participate or not (participant information).
• Every person who is asked to participate in a study should give informed consent before study enrollment (informed consent).
In case of WMO research the information letter and informed consent form should be written according to a specific format. The format of the MUMC+ ethical review committee is the same as the National CCMO format, and can be found here: https://english.ccmo.nl/investigators/standard-research-file
NB: Specific rules apply to research that is done among children or among people who are not able to give consent. If this is the case, the informed consent procedure should always be approved by an METC.
Non-WMO research with enrolled participants
There is no specific format for participant information and informed consent forms in case the research does not fall under the WMO. However, it is general policy that all potential participants should be informed about the study and should give informed consent. The researcher should adhere as much as possible to the formats of participant information and informed consent mentioned above. We suggest starting with the complete format, to consider all elements mentioned, and to keep all elements that are relevant to the study.
Non-WMO research with not-enrolled subjects
Generally, if you want to use data from individuals, they need to give their explicit consent to use their data.
However, if getting informed consent from each individual would require an unreasonable effort from the researcher, the use of (anonymous) data is allowed. This could be the case for example, if the researcher wants to use data from medical records databases. There are some additional requirements for the usage of such data, so if you consider using such data read these laws carefully.
Gedragscode Gezondheidsonderzoek: https://www.federa.org/sites/default/files/bijlagen/coreon/gedragscode_gezondheidsonderzoek.pdf
Wet bescherming persoonsgegevens: http://wetten.overheid.nl/BWBR0011468/2017-07-01