The Health Research Authority (HRA) welcomes the publication by the European Patients’ Academy on Therapeutic Interventions, EUPATI, of guidance on the involvement of patients in the ethical review of clinical trials.
EUPATI is a consortium from the pharmaceutical industry, academia, not-for-profit and patient organisations, and focuses on education and training for patients contributing to medicines research and development. The organisation also works to improve the availability of information for the public.
The new guidance describes four different time points in the
research process where patients can be involved in designing and conducting
clinical trials that are ethically sound. Three of these are the responsibility
of researchers and research funders and sponsors: trial concept where the
research questions and design concepts are developed; trial design where the
details of what will be done to participants are developed; and after the end
of the trial where the results are communicated to different audiences. The
fourth area covers the role of patients in the review of study proposals by
research ethics committees.
The HRA published
new guidance this year for applicants for ethical review. This includes the
three time points in the EUPATI guidance that are the responsibility of
researchers, funders and sponsors. The EUPATI guidance is entirely consistent
with our own publication, and welcome in reinforcing the importance of
involving patients in the design and conduct of high quality clinical trials
that will best meet patients’ needs.
The HRA believes that research ethics committees play a crucial role in ensuring that there is relevant patient input into the three time points. At least a third of the members of HRA RECs are lay, a higher proportion than in other countries, though lay members are not expected to act as representatives of specific patient groups. Instead these members look for evidence of patient input into each application, and we encourage researchers and patient representatives to attend REC meetings together to explain how they have worked together. Our members, lay and expert alike, receive training and support consistent with that set out in the EUPATI guidance to enable them to fully contribute to the independent review of any type of study in any health or social care context.
Jim Elliott, Public Involvement Lead
The HRA continues to be enormously grateful to our volunteer members for the valuable part they play in protecting and promoting the interests of patients and the public, ensuring that study design is acceptable to patients, that patients will be treated with dignity and respect and that findings from research will be communicated to patients and more widely