In February 2023, the government announced an independent review, led by Lord James O’Shaughnessy, into the UK commercial clinical trials landscape. The review aimed to support the life sciences sector to unlock UK growth and investment opportunities and suggest resolutions to the key challenges in conducting commercial clinical trials in the UK. The report made two recommendations relating to identifying and contacting people about research:
- 'agencies responsible for information governance within clinical trials should establish a common approach to contacting patients about research within the current legislative framework.'
- 'a national participatory process should be conducted to examine how to achieve greater data usage for clinical studies in a way that commands public trust. This should seek to establish a publicly supported position around the proactive contacting of patients to take part in clinical trials and studies that could form part of their care.'
The government accepted both recommendations. In May 2023 it tasked the Health Research Authority (HRA) to work closely with its Confidentiality Advisory Group, the National Data Guardian, the Information Commissioner’s Office, DHSC and NHS England to establish measures that streamline the processes to approach patients about research, establish the means by which the public should be consulted and identify whether legislation is needed to establish clinical research as part of direct care, making it easier to provide innovative treatments to patients.
The HRA established a small UK-wide project group including public contributors to oversee this work. The project was undertaken in a short space of time and so mostly drew on previous work and interviews. We are grateful to those who gave time for individual and small group discussions at short notice. We are now finalising the formal report of this work with partners.
We started by drawing on the principles and hallmarks of people-centred research that the HRA has described with patients, members of the public and researchers. This helped us to identify key principles to earn public trust in the use of patient information for identifying and contacting people about research. Those principles have then informed our work.
We have reviewed the existing law, taking account of the original intentions of existing legislation as shown in parliamentary debates, and also academic work on confidentiality, consent and research.
We believe that current legislation strikes the right balance between respecting privacy and enabling research that is in the public interest. However, we have identified areas where we are able to provide clarity and reduce variation in the interpretation of the legislation. We will publish guidance to ensure that there are consistent arrangements across the NHS for identifying and contacting people about research. We have also been making improvements to some of the HRA’s processes to help researchers understand what they need to do.
Current law draws a distinction between use of a patient’s information to support their individual care, and what are called ‘secondary purposes’ including research. An important clarification we make is that research is also care for a patient where the research intervention provides them with a treatment, or a diagnostic procedure, or a preventative measure that is being tested. Our guidance will set out the criteria for when research provides individual care, and how this affects who can access identifiable confidential patient information to identify and contact patients about some research.
We will also publish standards for registers for people to sign up to hear about research, and for digital intermediaries that offer services that can allow potential research participants to be identified. These standards will make sure that these services work in consistent ways so that researchers know how to make best use of them. These consistent standards will also make it easier for people to understand how their information is used, which will help to earn public trust.
Throughout our work we have identified topics where we need more evidence about the views of the public, to make sure that future developments earn public trust. We will remind researchers why it is important to involve patients and members of the public in their research, and draw attention to how researchers need to think and work in people-centred ways when designing how they will identify and contact potential participants.