Health research governance
We hope that many of you across the organisation are engaged in activities from promoting, conducting and using research in order to improve the current and future health and care for us all. DCHS is committed to supporting research so that everyone benefits from participation. Read the DCHS Research & Innovation Strategy here.
If you are involved in research remember that it is a regulated activity and you will need to ensure that you have all the appropriate approvals in place so that you as the researcher, your participants and your employer are all adequately protected.
The regulation of health research provides participants with assurance that the research that they take part in is of high quality, safe and ethical. It also ensures that the results of research can be relied on and used as evidence to inform future decisions about healthcare and treatment.
Health Research Authority (HRA) Approval must be obtained for ALL research. This is essential wherever NHS organisations in England have a duty of care to participants in relation to the research activity either as service users or NHS staff or volunteers, or when the resource required for the study (i.e. data or human biological material) are under the responsibility of the NHS organisation as a healthcare provider.
Health research approvals
Approvals needed depend on the type of study and include:
- HRA Approval for the NHS in England
- NHS management permission in Scotland, Wales or Northern Ireland
- Research Ethics Committee (REC)
- Medicines and Healthcare products Regulatory Agency (MHRA) – clinical trial authorisation (Investigational Medicinal Products)
- Medicines and Healthcare products Regulatory Agency (MHRA) – Notice of No Objection (Medical Devices)
- Confidentiality Advisory Group (CAG; previously the National Information Governance Board (NIGB) for Health and Social Care)
- National Offender Management Service (NOMS)
- Administration of Radioactive Substances Advisory Committee (ARSAC)
- Human Fertilisation and Embryology Authority (HFEA)
- Human Tissue Authority (HTA)
Find out more: http://www.hra.nhs.uk/research-community/before-you-apply/
If you are not sure whether your work is defined as research you can use the following tools to help you decide: http://www.hra.nhs.uk/resources/before-you-apply/is-it-research/
The Research & Innovation team can also be contacted for advice. We would be pleased to hear from you, drop us an email: email@example.com
Get to know your DCHS Research & Innovation Team: https://my.dchs.nhs.uk/Teams/Research-Team