What is a consent declaration?
Health Research Regulations 2018, Regulations 5(2) and 6(5)
A consent declaration is a declaration made by the Health Research Consent Declaration Committee that the explicit consent of the data subject is not required.
When might a consent declaration apply?
A researcher may apply for a declaration that explicit consent is not required if:
For new research:
- the public interest of the research significantly outweighs the public interest in requiring the explicit consent of the individual whose data is being processed (Regulation 5(1)).
For current research (refer to transitional arrangements):
- the public interest of the research significantly outweighs the public interest in requiring the explicit consent of the individual whose data is being processed (Regulation 6(4)(a))
- the researcher has obtained the consent of the individual 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Data Protection Directive (95/46/EC) and the previous Data Protection Acts 1988 and 2003 and that consent has not been withdrawn (Regulation 6(4)(b))
Where can I find "consent declarations" in the Health Research Regulations 2018?
Health Research Regulations 2018, Regulation 5 (new research) and Regulation 6 (current research)
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.