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
- Provide a definition of health research for the purposes of the Regulations
- Provide for the possibility of applying for a consent declaration for new research
- Provide for transitional arrangements in respect of the granting of consent declarations for health research that is already underway
- Provide for the establishment and operation of a committee of persons to make decisions on applications for consent declarations, including an appeals process (HRCDC)
The purpose of the Regulations is to support health research and promote necessary and desirable public confidence in such research.
If you are unsure if your processing activity or research project falls within the scope of the Regulations please contact the Trinity College Data Protection Officer for further assistance.
Trinity College Templates
- Risk Assessment
- Data Protection Impact Assessment (Research)
- Participant Information Leaflet
- Explicit Consent Checklist
- Consent Form
- HRCDC 'Re-Consenting' Application Form (Trinity template with generic answers and guidance)
Explicit Consent and Consent Declarations
The Regulations make explicit consent the default position for processing personal data for health research. In other words, a health researcher planning to use an individual’s information for health research must obtain the consent of the individual to do so. This is about empowering the patient in relation to his or her medical records.
However, it is recognised – as it is in other countries – that sometimes, in limited situations, obtaining consent will not be possible and that the public interest of doing the research significantly outweighs the need for explicit consent. It is in cases like this that HRCDC has a decision making role.
The Regulations provide for a statutory consent declaration process. That enables a data controller carrying out health research using personal data to apply for a consent declaration which means that the consent of the individual is not required for the obtaining and use of his or her personal information for the health research concerned.
Further information on the functions of the HRCDC is available at https://hrcdc.ie/.
The Department of Health Guidance on Information Principles for informed consent for the processing of personal data for health research are available at:
If you are unsure of your requirements in respect of consent declarations for ongoing or new/proposed research projects please contact the Trinity College Data Protection Officer for further assistance.
Application forms for consent declarations are available at https://hrcdc.ie/apply/
The HRB has developed a decision tree to help researchers assess:
- whether they might be eligible to submit an application to the Health Research Consent Declaration Committee to obtain a consent declaration, and
- whether such an application should be made under the transitional arrangements or as a new research project.
This decision tree also outlines a number of important preliminary steps that must be completed by researchers prior to the submission of any application to the Health Research Consent Declaration Committee.