The suitable and specific measures for data processing provided for in Section 36 of the draft Data Protection Act 2018 are given further and more specific effect through the Health Research Regulations 2018 (formally titled Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018).
The Health Research Regulations 2018:
- outline the mandatory suitable and specific measures for the processing of personal data for the purposes of health research (Regulation 3(1))
- provide a definition of health research for the purposes of the regulation (Regulation 3(2))
- provide for the possibility of applying for a consent declaration for new research (Regulation 5)
- provide for transitional arrangements in respect of the granting of consent declarations for health research that is already underway (Regulation 6)
- provide for the establishment and operation of a committee of persons to make decisions on applications for consent declarations, including an appeals process (Regulation 7-13 and Schedule)
- include a number of miscellaneous provisions (Regulations 14-16)
The Health Research Regulations 2018 can be viewed in full here.
The Department of Health has prepared a note in response to requests from health researchers for guidance on what information needs to be provided researchers in order that consent is informed. Dowload the 'Guidance on information principles for informed consent for the processing of personal data for health 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.