You are here Research > Health Research

Health Research

In Ireland, Health Research (see definition below) is governed by the GDPR, the Data Protection Acts 1988 -2018 and the Health Research Regulations 2018 (HRR) (as amended in 2021).

Health Research Definition

Reg 3(2) of the HRR defines health research as any of the following scientific research for the purpose of human health:

research with the goal of understanding normal and abnormal functioning, at molecular, cellular, organ system and whole body levels;
research that is specifically concerned with innovative strategies, devices, products or services for the diagnosis, treatment or prevention of human disease or injury;
research with the goal of improving the diagnosis and treatment (including the rehabilitation and palliation) of human disease and injury and of improving the health and quality of life of individuals;
research with the goal of improving the efficiency and effectiveness of health professionals and the health care system;
research with the goal of improving the health of the population as a whole or any part of the population through a better understanding of the ways in which social, cultural, environmental, occupational and economic factors determine health status;

Explicit Consent

A researcher planning to use an Irish individual’s information for health research must obtain the explicit consent of the individual.

Explicit Consent is an additional safeguard under the HRR. Please note that consent should not be used as the legal basis for the use of the participants data under GDPR.

The appropriate legal basis under GDPR is scientific research (Article 9(2)(j)) in the public interest (Article 6(1)(e). Please see here for more information on Research and the Legal Basis.

Consent Declaration in absence of Explicit Consent

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. In such circumstances, a researcher may apply to the HRCDC for a consent declaration and the following applies:

Applying for a consent declaration from the HRCDC is not an alternative to seeking consent. The HRCDC requires strong evidence to support a claim that obtaining consent is not possible and that the public interest in carrying out the proposed research significantly outweighs the public interest in requiring the explicit consent of the participant.
A consent declaration allows the processing of personal data of research participants without explicit consent for the health research concerned, subject to suitable technical and organisational data protection measures being in place, including that:

• A Data Protection Impact Assessment (DPIA) has been carried out.

• Research ethics approval has been granted for the research study.

• The public interest in carrying out the health research significantly outweighs the requirement for consent for the processing of personal data.105 This may be the case where certain collections of biological material and associated personal data are a unique resource.

• There are suitable and specific measures in place prior to the commencement of the research to ensure the fundamental rights and freedoms of the research participants are safeguarded. o Public and patient involvement activity is being carried out in order to ensure a patient- and public-centred approach regarding the development and implementation of the study, and to ensure that the perspective of the participant is always considered.

• Appropriate transparency measures have been implemented, such as: effective public display of information notices about the study; providing individuals from whom biological material and associated data may have been originally sourced the opportunity to opt out; and the use of websites and other techniques to inform individuals about further intended research and of how to make contact with the research team. However, it should be noted that transparency measures do not remove fundamental requirements for consent if such is possible.

HSE policy for Consent in Health and Social Care Research

The HSE National Policy for Consent in Health and Social Care Research provides one overarching policy to guide healthcare services hosting research, particularly to those conducting research and to Research Ethics Committees reviewing research proposals in the HSE and its funded organisations.

See link to Policy here.

If your research will involve health and social care research from patients, their families, and carers, as well as from the public at large being recruited through health care services, you must be familiar with this policy.

Contact

If you are unsure if your research project falls within the scope of the HRR, please contact the Trinity College Data Protection Officer (Research) for further assistance: ResearchDPO@tcd.ie.