HSE National Policy for Consent in Health and Social Care Research (Version 2.0)
The HSE National Research and Development | Office of the Chief Clinical Officer announced (January 2025) the publication of Version 2.0 of the HSE National Policy for Consent in Health and Social Care Research addressing the age of consent for young people, aged 16-17 years old. This revision ensures alignment with clinical trials legislation and acknowledges the autonomy of young people to participate 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.
What’s Changed?
- Recognising “Young People”: The Policy now defines individuals aged 16 and 17 years old as “young people” who are capable of independently consenting to participate in research and to the processing of their personal data. Parental involvement is still encouraged but not needed.
- Changed Definition of “Child”: The Policy now defines a child as person under 16 years old. Parental consent is still required for their participation in health and social research.
- New Definition of “Minor”: The Policy now defines a minor as a person under the age of 18 years.
- Respecting Autonomy: Young people lacking capacity should be supported where possible to fully exercise their right to provide a valid consent. The same principles related to adults lacking capacity should be applied to research involving young people.
- Valid Consent in Special Circumstances: Where prospective participants are acutely unwell or involves vulnerable groups, the process for obtaining consent should be carefully considered. Researchers should ensure consent is freely given, is not given under duress. This now includes young people who are providing their consent for themselves.
These changes were developed in consultation with stakeholders, including the HSE R&D Patient and Public Involvement (PPI) Advisory Group, the HSE National Policy for Consent in Health and Social Care Research Implementation Steering Group, Tusla, the Department of Children, Equality, Disability, Integration and Youth, the Department of Health and Chairs, the Health Research Consent Declaration, the National Office of Clinical Audit, the National Disability Authority, experts in areas of areas of medicine, nursing, health and social care professions, and the fields of paediatrics, mental health, quality improvement, law, data protection, genetics/ genomics and medicine for the elderly and psychiatry, researchers and representatives from Research Ethics Committees.
Full details are available on this link: https://www2.healthservice.hse.ie/organisation/national-pppgs/hse-national-policy-for-consent-in-health-and-social-care-research/