Health Research Authority to take role in research access to patient data
The Health Research Authority will host transparent expert advice to support decisions on access to personal health information, the Department…
The Health Research Authority will host transparent expert advice to support decisions on access to personal health information, the Department of Health announced today. All research applications needing access to identifiable patient information without consent require Health Secretary approval, when it is impractical to gain individual consent for that access or it is insufficient to anonymise the data.
Currently, the Ethics and Confidentiality Committee of the National Information Governance Board advises the Health Secretary which research proposals should have exceptional access to such data. From April next year when the National Information Governance Board ceases to exist, the Health Research Authority will host that expert advice function, providing open and transparent expert advice for all applications for access to patient identifiable information. Decisions on applications for anything other than research purposes will continue to be decided by the Health Secretary whilst HRA will itself be able to make research decisions on behalf of the Secretary of State, again based on that on that open and transparent expert advice.
Health Minister Lord Howe said:
“It is good news for patients and medical researchers that there will be a single place from which this important advice is provided. The credibility and independence of the Health Research Authority will ensure a smooth transfer that continues to protect the interests of patients.”
Chief Executive of the Health Research Authority, Janet Wisely, said:
“The HRA will work closely with the NIGB in the coming months as we transfer these important advisory functions. In addition, the transfer of the approval for use of confidential data without consent for research purposes, under section 251, will enable further improvements to protect the interests of patients and the public, whilst making it easier to do good quality, ethical research in the UK.”
ENDS
Notes for Editors
1) For media enquiries, please contact Eileen Phillips on 0207 210 5224.
2) S251 of the NHS Act 2006 provides the Secretary of State with a power to make regulations that set aside obligations of confidentiality, allowing researchers, public health staff and others to access information where there is no reasonably practicable alternative way of undertaking important work that is in the public interest. The NHS (Control of Patient Information) Regulations 2002 are the only regulations that have been to date. These provide support for public health surveillance and risk management, work associated with cancer registration and, on a case by case basis, a mechanism for approving a limited set of purposes that support research.
3) The Information Governance Review, led by Dame Fiona Caldicott, is considering information governance issues, and will report next year.
4) The Health Research Authority is a Special Health Authority established on 1 December 2011. Its purpose is to protect and promote the interests of patients and the public in health research. It aims to do this by supporting and promoting a robust and efficient regulatory and governance framework in the UK and providing the National Research Ethics Service (NRES).
Its vision and ambition is to develop a Health Research Authority:
• driven by the key purpose of protecting and promoting the interests of patients and the public in health research
• underpinned by leadership in creating a unified health research approval process and promoting consistent, proportionate standards for compliance and inspection
• with success being acknowledged by key stakeholders, as well as seen through improved approval times, increased numbers of research participants and projects, and greater confidence in health research.