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  • What data will be shared or linked: The type and nature of the health data (e.g., genetic data, medical history, treatment outcomes) that will be shared or linked with external registries. 

  • Who the data will be shared with: This includes identifying the external registries, research institutions, or third parties that will have access to the data. 

  • Purpose of data sharing/linking: The consent form should explicitly state the research purposes for which the data will be shared, such as epidemiological research, clinical studies, or public health monitoring. 

  • Data security and anonymisation/pseudonymisation: Participants should be informed about how their data will be protected, whether the data will be anonymised or pseudonymised, and what security measures are in place during data sharing. 

WMO-studiesStarting a new study may require a multitude of documents. Here, we focus specifically on the FAIR components that can be included in the PIF (Patient Information Folder) and the Informed Consent (IC).

Step 1

Determine whether your study is subject to the Medical Research Involving Human Subjects Act (WMO) or not. The Central Committee on Research Involving Human Subjects (CCMO) executes the WMO and the Embryo’s Act. Research that falls under the WMO or the Embryo’s Act must undergo a review by an accredited Medical Research Ethics Committees (MREC) or the CCMO. Research is not allowed to start without a positive decision of this committee.

Research is subject to the WMO if the following criteria are met:

  1. It concerns medical scientific research and

  2. Participants are subject to procedures or are required to follow rules of behaviour.

To learn more, see the CCMO website or the ELSI Servicedesk (ToDo: check whether they have great pages about this)

TBD: perhaps we don’t need this step? Since this guidance isn’t about “how to get your study approved”?

Step 2

Study is subject to WMO

Study is not subject to WMO

Step 1

The CCMO has published a standardised Patient Information Form (PIF), which includes informed consent questions. (?) a

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