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As explained, informed consent (IC) is an essential component for collecting and reusing data. Research that falls under the WMO must undergo a review by an accredited Medical Research Ethics Committees (MREC) or the Central Committee on Research Involving Human Subjects (CCMO). Non-WMO studies are reviewed by the a an MREC. Research is not allowed to start without a positive decision of the approriate reviewing committee.

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Andere relevante zinnen om toe te voegen?

  • Delen met commerciele partijen??

  • <if applicable> If we collaborate with countries outside the European Union?? Met die veiligheidseisen

Next

Go to Step 3.

Step 2 - Study is not subject to WMO

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If data is anonymised, it is no longer considered personal data under regulations like the GDPR.

Step 4 - Finally

With your SIS and ICF now complete and fully FAIR ready, get it reviewed by the appropriate committee:

  • An accredited MREC for Non-WMO studies

  • An accredited MREC or the CCMO for WMO studies

Informed Consent Research Roadmap Amsterdam UMC

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