Research Design Service: East Midlands
National Institute for Health Research
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Changes to consent for children in clinical trials from May 2018

  Created on Monday, 11 Sep 2017. Posted in News Items

A change in the EU Directive 95/46/EC General Data Protection Regulation (GDPR) affects consent conditions for use of data from children within clinical trials where the data is considered identifiable personal data.

Currently, trials may use an opt-out strategy for parents (negative assent).  When the new directive comes into force in May 2018, positive parent assent will be needed to process the data.

Researchers who think their study protocols may be affected should contact their sponsors for more information and advice.