The Health Research Authority (HRA) and the devolved administrations are developing a new UK Policy Framework for Health and Social Care Research which sets out the high-level principles of good practice in the management and conduct of health and social care research in the UK, as well as the responsibilities that underpin high-quality ethical research .
This new policy framework aims to help make the UK an even better place to do research. It is aimed at all those responsible for health and social care research in the UK. When finalised, it will replace the current research governance frameworks published by each of the UK health departments.
The UK Policy Framework for Health and Social Care Research was issued for public consultation between 18 December 2015 and 24 March 2016. A copy of the consultation version is available here.
The consultation questions we asked are available as a free-standing document here.
How will the policy framework affect me?
We have prepared some short summaries that outline the main issues for key stakeholder groups:
- Patients, service users and the public
- Researchers and research sites
- Funders, sponsors and employers
What is the new policy framework for?
The policy framework provides the basis for operational provisions and sets the tone of what they should be like. These include things like guidance and systems to support applicants, standard operating procedures for research ethics committees and, in due course in England, operational arrangements for HRA Approval. The policy framework does not go into operational details itself; it sets out high-level principles and responsibilities that will be met through operational arrangements, supported by detailed operational guidance.
What are the benefits of the new policy framework?
The policy framework takes account of what we and our partners have heard since the four separate Research Governance Frameworks were issued in each UK country over ten years ago. In particular, it reflects what we learned from a series of projects that looked into key known issues affecting good practice in the management and conduct of research, and the feedback received during our call for comments on the initial draft and follow-on engagement.
The policy framework supports appropriate safeguards in research while avoiding the ambiguity in the current Research Governance Frameworks and the obstacles that this has contributed to. The policy framework focuses on the real risks in research, the benefits of research and proportionate risk assessment and management. This will ensure that people feel confident when they take part in research, that researchers find it straightforward to do high-quality ethical research and that funding goes into carrying out research, not into navigating needless bureaucracy.
Who will the policy framework apply to?
This policy framework will apply to health and social care research that is within the responsibility of any of the four UK Health Departments. This includes: research concerned with the protection and promotion of public health; research undertaken in or by a UK Health Department, its non-Departmental public bodies or health and social care providers; and clinical and non-clinical research, research undertaken by NHS, social care or (in Northern Ireland) HSC staff using the resources of health and social care providers and any research undertaken by industry, charities, research councils and universities within the health and social care systems that might have an impact on the quality of those services.
What will be done with the responses to this consultation?
Following the consultation period, a summary of the responses received will be published. Individual responses will be summarised in a way that does not identify individual respondents unless we have permission to identify them. Organisational responses may be identified. The HRA and each Devolved Administration will analyse and summarise the responses in order to inform a UK-wide perspective.
The steering group that is overseeing this work will agree a revision of the policy framework in light of analysis of the consultation responses. That version is intended to be published in summer 2016, replacing the Research Governance Frameworks previously issued by each of the UK Health Departments.