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.