Transparency, public involvement, safety and proportionality must be at the centre of UK health research, a new position statement published today has demanded.
Regulators and government departments who promote and protect the interests of patients across the four UK nations have set out the key principles in a new UK Policy Framework for Health and Social Care Research. The 19 principles of good practice in research are for those who manage and conduct health and social research in the UK.
Bill Davidson, Joint Head of Policy at the Health Research Authority, who chaired the group that produced the framework, said:
“Health and social care research has clear benefits, but it relies on people. They give their money to fund and their time to participate in research. It crucial that in return that research is planned, regulated and conducted in a way that inspires confidence.
“The principles we have set out today recognise the benefits of research, stress the importance of a proportionate approach to risk, and promote appropriate safeguards. By doing this, people will feel confident about taking part in research, researchers will find it easier to do high-quality ethical research, and more funding will go into the research itself, not into navigating bureaucracy before it starts.”
The new guidelines replace separate Research Governance Frameworks in each UK country with a single, modern set of principles for the whole UK. It has been developed by the Health Research Authority and the health departments in Northern Ireland, Scotland and Wales, following public consultation.
Since the previous frameworks were issued over ten years ago, the environment for health research has changed considerably, with technological developments and shifts in societal attitudes meaning a number of new areas needed to be addressed. These include
- Patients, service users and the public being
more involved where appropriate in the design, management and conduct of
- Registering research and making it publicly
- Making sure that researchers pass the research findings
on to the people who take part in their studies.
- Taking an appropriate approach to risk. Different
types of studies expose participants to different levels of risk. For example,
someone completing a short questionnaire about smoking behaviour is exposed to
far less risk than someone testing a new medical treatment. Research regulation
should be proportionate to the level of risk the participants are exposed to.
- Tackling inappropriate or disproportionate bureaucracy - for example research can be slowed down by the procedures used by local research sites and as a result funding may be wasted.
The policy framework applies to health and social care research involving patients, service users or their relatives or carers. This includes research involving them indirectly, for example using information that the NHS or social care services have collected about them.
We recognise the infrastructure for social care research management is often different from the health sector and we will be taking forward further scoping and engagement with the social care research community.
Bill Davidson, Joint Head of Policy, Health Research Authority
Transparency is a fundamental aspect of health and social care research. Not only does it encourage trust in the work that is being done, but there is a very clear practical benefit in being aware of previous studies, avoiding an unwitting repeat of existing research, causing inconvenience and risk for participants. Ultimately a lack of transparency can mean that we do not have the evidence we need to know which treatments, care or services are safe and effective.
This framework largely sets out what should already be happening, so it is not an onerous new addition to researchers’ workload. By following these principles, we are confident of creating an environment where applying to do research is simple and quick, patients and the public are involved at every step, and safer, more effective care is developed through ethical and scientifically sound research for the benefit of society.