We want everyone to have all the information that they need when they are deciding whether or not to take part in health and social care research.
We're working on new resources that will make sure that people have a clear understanding of how they can expect to be treated if they are part of a research study, and the safeguards in place to ensure this is the case.
We're doing this in response to one of the recommendations from a workshop informed by the Infected Blood Inquiry.
The recommendations asked the Health Research Authority (HRA) to develop a user-friendly explanation of the rights and responsibilities of people taking part in health and social care research, including what participants can expect and how concerns can be raised and responded to.
The report showed that much has changed since the failings exposed by the infected blood scandal, but that to earn the confidence of potential participants, we need to make the relationships between researchers and participants more equal.
What has changed?
Some victims of the infected blood scandal were subjected to unethical research practices in the 1970s and until the early 90s. This includes people who were not told that they were part of research, were not asked for their consent, and could not give it. It was a tragedy the likes of which must never be repeated.
Today, when people are invited to take part in research stronger protections exist to safeguard their interests. This includes organisations like the HRA, which was established to protect and promote the interests of patients, service users and the public in health and social care research.
The UK policy framework for Health and Care Research sets out principles of good practice in the management and conduct of health and social care research in the UK
Everyone involved in research, from sponsors and regulators to funders and NHS staff, has a part to play.
We know that people have more confidence in research when they know that safeguards exist. For example, almost seven in ten people told us that they'd feel more confident in taking part in a health and social care study if they knew that it had been reviewed by a Research Ethics Committee.
And research can only produce findings that benefit everyone if everyone feels confident to take part.
The workshop following the Infected Blood Inquiry identified areas where further work would be valuable to help earn that confidence and we are taking forward one of these recommendations.
Recommendations from the inquiry
We need to make the protections that are in place across the research system more visible. This includes making it clear how the different organisations and individuals who are part of health and social care research protect the rights of participants, and the responsibilities of the people and organisations involved in running research.
We want people to know that research has gone through appropriate scrutiny before they agree to take part, so they can be reassured by this. We also want them to know what to do if they are not being treated as they should be.
This will help everyone make better-informed decisions about whether to take part in research.
It will also lay the foundations for a better public debate about how these rights and responsibilities might evolve.
The checks and balances currently in place seek to prevent mistakes and poor practice, but they may be able to do more to help us continuously improve the way research is carried out.
We can continue to develop the UK’s research governance system to better consider the needs of both participants and researchers.
In doing so we will make sure that research is an equitable partnership, with a shared objective of producing better findings that can improve care in a way people can trust.
Next steps
We will explore what information people want and need about their rights and responsibilities, and those of others in the system, when deciding whether to take part in research.
In particular, we’ll focus on how they would like to access this information.
We will use these findings to develop new resources, working with a diverse group of people to ensure they work for everyone who needs them.
The project will bring together insights from people with relevant lived experience, researchers, research organisations, Research Ethics Committees, Confidentiality Advisory Group members, charities, industry representatives and academics.
These diverse perspectives will help us identify existing resources, gaps and opportunities to better support informed decision-making and meaningful participation in research.
Our ambition is simple: to help ensure that anyone considering taking part in health and social care research can access information about what to expect in a way they can understand and trust.
Establishing an advisory group
To help us to do this project well, and consider different needs and perspectives, we will establish an advisory group who will play a central role in guiding this work. The group will include people with relevant lived experience as well as representatives from organisations that support and do health and social care research.
They will help us ensure that future recommendations are informed by a broad range of expertise and lived experience.
They will:
- provide independent advice and constructive challenge
- help identify existing resources, evidence and good practice
- highlight the needs of different audiences and communities
- advise on opportunities to improve accessibility, inclusivity and relevance
- help shape the project's recommendations and outputs
We will share more about the group as it is established. We're excited to work with them to explore how we can support people to be informed and feel confident to take part in health and social care research if they choose to do so.