What is the impact of the GDPR on the informed consent letter?

What is the GDPR?

The General Data Protection Regulation (GDPR) is the new law on privacy for the European Union. The GDPR is also know as the AVG (Algemene Verordening Gegevensbescherming) in Dutch. In the GDPR the privacy rights are enhanced and expanded, are more responsibilities given to companies that collect and process personal data, and all Euopean Privacy Authorities are given the same legal compentences.

The GDPR will come into force on the 25ht of May 2018. This implies consequences for the privacy paragraph in the informed consent letter. The Template Informed Consent Letter has therefore been amended to adhere to the GDPR. See also the website of the CCMO on this topic.
The new Template Informed Consent Letter (Dutch and English version) is also available via our Documents page.

Recently, different parties have approached the METc UMCG for clarification on the point of view of the committee regarding the impact of the GDPR on the informed consent letter.

Regarding new to submit research applications (primary submission).

When a clinical trial is not yet approved according to the WMO, we strongly advise to use the most recent Template Informed Consent Letter (version May 2018).

Regarding already approved and running clinical trials.

When a participant has already given consent, s/he doesn’t need to reconsent because of the amended paragraph.

You may change the privacy paragraph (#10, see newest version Template Informed Consent) and use this altered version of your informed consent letter. You do not require to submit the (new) of the informed consent letter as a substantial amendment.
The METc UMCG is of the opinion that these changes reflect ‘practical information’ that the (potential) participant needs to know, but that this information has no influence on the execution of the clinical trials and/or risks for the participant.

Please note! This is only valid when the text used is as described in the Template Informed Consent Letter (version May 2018).

Any other text that is submitted as a substantial amendment will not be taken into consideration or reviewed.

The METc UMCG appreciates receiving the most recent version of the informed consent letter that is currently used in your clinical trial. You can send us the current version as notification.

More information on this topic can be found on the website of the CCMO.