The Health Research Regulations 2018 provide for a 12-month transional period until 7 August 2019 to allow for current health research projects that commenced on or before 7 August 2018 to reach the consent standard laid down by the GDPR or else to obtain a consent declaration where it can be demonstrated that this consent standard cannot be achieved.
When is a research project considered to be current for the purposes of these transitional arrangments?
- For the purposes of these Regulations, health research will be considered to be already underway where on or before 7 August 2018 it has been approved by a research ethics committee
If a researcher:
- believes that the public interest in carrying out the health research significantly outweighs the public interest in requiring the explicit consent of the data subject whose personal data is being processed for the purposes of the research ( Regulation 6(4)(a))
- has obtained the explicit consent of the individual(s) to use his or her data for the purpose of the health research in accordance with previous EU Data Protection Directive (95/46/EC) and the previous Data Protection Acts 1988 and 2003 ( Regulation 6(4)(b))
then the researcher may apply to the Health Research Consent Declaration Committee to make a declaration that the explicit consent of the data subject is not required.
Health Research Regulations 2018, Regulation 6 applies to health research that is currently underway and that commenced on or before 7 August 2018
This guidance has been prepared by the HRB to help researchers in the health domain comply with GDPR requirements.
It is intended to be general guidance for educational and informational purposes only.
It is not legal advice.