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The Health Research Authority is responsible for publishing policy and guidance on principles of good practice in the management and conduct of health and social care research in England. We have worked with the three Devolved Administrations to develop a draft UK-wide policy framework that sets out these principles.
In spring 2015 the HRA invited comments from English organisations on the draft UK policy framework for health and social care research and there was a parallel exercise in Wales, Scotland and Northern Ireland – with comments from those countries invited through the Devolved Administrations.
Responses to the call for comments have now been analysed and a summary has been published on our website. This has fed into the further development of the policy framework and a revised version has been issued for formal public consultation.
What is the new draft policy framework for?
The draft UK policy framework for health and social care research aims to help make the UK an even better place to do research. It sets out clearly the high-level principles and responsibilities, applicable in all health and social care research, that underpin high-quality ethical research.
The draft 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 draft 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.
In making our intentions public as early as possible, the draft version of the policy framework that has been issued for comment strengthens the platform for us to lead and manage change right now, in view of developments such as implementation of the new EU Clinical Trials Regulation and, in England, implementation of HRA Approval.
What are the benefits of the new draft policy framework?
The draft 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.
The draft policy framework supports appropriate safeguards while avoiding the room for interpretation in the current Research Governance Frameworks and the obstacles that has contributed to. The draft policy framework focuses on the real risks in research, the benefits of research, and proportionate risk assessment and management. This will ensure that people continue to feel safe when they take part in research, that researchers find it easy to do high-quality ethical research, and that funding goes into carrying out research, not into getting through unnecessary hoops before it starts.
Who does the draft policy framework apply to?
This draft policy framework will apply to research projects involving providers of care that are within the legislative and policy responsibility of any of the four UK Health Departments (see appendix). This will apply to research that care users take part in, either directly (e.g. research involving a treatment or an interview) or indirectly (e.g. research involving previously collected data or tissue that could identify the individual). It also includes research involving the providers’ employees or partners, either as research participants or as researchers. Relevant providers include hospitals that are part of the NHS*, independent contractors to the NHS (such as GPs), local authorities and private or voluntary organisations that provide health or social care under contract with the NHS or with local authorities.
What will be done with the comments HRA has received?
Following the comment period, we will publish a summary of the comments we received. We will aim to summarise individual responses in such a way that does not identify individual respondents unless we have your permission to identify you, although organisational responses may be identified. Each Devolved Administration will analyse and summarise the comments for their country in order to inform a UK wide perspective.
The steering group will agree a revision of the draft policy framework in the light of analysis of the comments received. We will issue the revised version for formal public consultation later in 2015. When that consultation is complete, a revised version will replace the Research Governance Frameworks previously issued by each of the UK Health Departments.
* References to the NHS include Health and Social Care (HSC) in Northern Ireland.