Background: Public and Patient Involvement (PPI) in health research has evolved in the last 30 years. So have the roles and responsibilities of patients and consumers including acting as co-applicants in research funding applications, being co-researchers and project team members.
Whilst research professionals would understand their roles and responsibilities within a research study, it is less clear if PPI representatives understand the full implications of taking on these roles. Becoming a co-applicant or an equal member of a team implies shared responsibilities, yet many patients and consumers do not have the supportive mechanism of an employment contract or environment.
- to ensure patients as project team members, co-researchers or co-applicants engaging in funding applications are aware of their responsibilities and implications of these roles;
- to raise awareness for research funders, sponsors, managers and lead investigators of the ethical and legal implications of PPI;
- to understand the contractual and legal governance issues and responsibilities that are particular to patients in the roles listed above, from both an organisational and patient perspective.
Methods: this is a patient-driven project. To undertake the review, the NHS Research and Development (RD) Forum* Service User and Carer (SUC) Working Group undertook a literature review, ongoing data collection based on their involvement experiences, two workshops, and a consultation exercise across the RD Forum, to identify the issues from the perspective of patients and research managers. The review focused on awareness of responsibilities, communication and support, understanding of the contractual and legal governance issues and responsibilities of involving patients. It also identified areas of effective involvement and good practice.
*The Forum is a professional network for research managers
Results: the review, data collection and consultation led to collaborative working with the National Institute of Health Research Involve and the Health Research Authority to raise awareness, promote good practice and effective co-production in research.
Guidelines for research managers, researchers, and SUC were published in January 2019.
Conclusions: evidence collected by a group of service users and carers actively involved in research activities confirmed that there was a lack of understanding on the part of PPI representatives, and professional researchers, of the legal and governance implications of patients as co-applicants, co-researchers and project team members. This led to a review of current practice aimed at identifying the challenges and issues experienced. New guidelines should contribute to raising awareness and to increasing SUC empowerment in research.
Patient or healthcare consumer involvement: led by patients throughout as a result of concerns highlighted by experts by experience.