Consent for research in health and social care

Obtaining consent from prospective research participants (i.e. health and social care service user, patients, their families or carers, staff, and the public at large) is essential to ensure they remain at the centre of all research activity taking place in the HSE and HSE-funded organisations. The process of obtaining consent for research in health and social care needs to be adjusted to the needs of the participant, involving a suitable and clear process of information where questions can be asked and answered so that the participant is fully informed and can freely decide whether to participate or not.

REGISTRATION is now OPEN for the public launch of the HSE National Policy for Consent in Health and Social Care Research on Thursday 09th February 2023 by live webinar.

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The HSE National Policy for Consent in Health and Social Care Research details the recommended guidance for obtaining consent for prospective participants to take part in health and social care research.  It provides one overarching HSE policy to guide healthcare services hosting research, particularly to those conducting research and to Research Ethics Committees approving research in the HSE and its funded organisations, including:

  • Patients/ service users
  • Patients’/ service users’ personal data
  • Patients’/ service users’ biological materials and/ or samples
  • Health and social care staff (and their personal data)
  • The use of healthcare services, premises or infrastructure, including that which takes place in third-level collaborative institutions and/ or clinical research facilities (CRFs)
For the purpose of this policy, the term ‘consent’ refers to the informed and explicit agreement of a prospective research participant to take part in a research study and, when relevant, to the use of their personal data for such research. The agreement for both must be ethically obtained, recorded, and retained; the proposed consent protocol must be approved by an appropriate Research Ethics Committee (REC) and, when applicable, comply with Irish data protection legislation

The policy clearly outlines that consent is a choice. Participants must understand what they are being asked to take part in and be given sufficient information about the study including any potential risks and benefits. They should be given time to consider their participation and be given the opportunity to ask questions. They should be aware that they can choose to take part (give consent), choose not to take part (refuse consent), choose to consent to specific elements of the study (and not others) and choose to withdraw their consent. It should be explained to them that their usual care will not be affected. The policy also describes the following:

  • What is consent for health and social care research
  • What is informed and valid consent
  • How to process personal data for health research
  • Obtaining, recording and retaining consent
  • Participant Information Leaflet
  • Re-consent
  • Withdrawal of consent
  • Capacity to consent in adults
  • Research involving children
  • And other considerations should as broad consent, retrospective chart reviews for research purposes and research involving biological materials. 

This policy does NOT APPLY to other knowledge-generating activities such as clinical audits, standard service evaluations, or public health or advanced health analytics work carried out by the HSE to fulfil its legal obligations for the planning and delivery of health and social care services. See What is Research for further information.

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Data protection considerations

The Health Research Regulations 2018 place additional consent requirements for the processing of personal data for research in Ireland. The policy explains how to comply with such data protection requirements in various common scenarios and it also explains how to obtain valid consent for the use of personal data for future research purposes. Such consent, while it may be broader (i.e not as specific as research for a given project), it needs to be as informed as possible and the choices made by the participant have to be appropriately recorded and documented (explicit).

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In certain and occasional circumstances, when obtaining consent for research involving the processing of personal data is not possible, a consent declaration from the  Health Research Consent Declaration Committee (HRCDC) can be applied for. This statutory committee, set up by the Minister for Health, will evaluate the merits of the application and determine if the public interest of the research significantly outweighs the privacy rights of the data subject,  and decide whether a consent declaration can be granted to allow the research to go ahead.  A full description of how the HR-CDC and how to apply to the HRCDC are on its website.

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HSE National R&D are in the process of developing a number of plain language guides to accompany the HSE National Policy for Consent in Health and Social Care Research. The guides will be available on the HSE National R&D website in 2023. They will be accompanied by a series of the training modules that will be available on HSELanD.

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