The legal, governance and ethical implications of involving service users and carers in research.

Abstract

Purpose: Service user and carer involvement in all aspects of the health and care research process, from co-applicant on funding applications to active engagement in a research study, is now a requirement for most research funders. However, as co-production increases and service users and carers take on more responsibilities, this involvement has legal, governance and ethical implications. The purpose of this paper is to raise awareness of the issues and consider potential solutions.

Design/methodology/approach: Experiences of engagement as co-applicants in research funding applications, of involvement as research study team members, and as co-researchers were gathered from a range of service user and carer experts. Consultation and a workshop gathered further evidence from a range of stakeholders across the research management community.

Findings: Service users and carers, who contribute to the research protocol and process, feel a strong sense of responsibility to ensure the high quality of a research study. However, they may be new to their roles, status and key responsibilities when acting as project team members, co-researchers or co-applicants engaging in funding applications. The responsibility of sponsors, grant holding organisations, funders and other members of the research community is to communicate with and support service users and carers in those roles. More needs to be done to understand the contractual, a legal and governance issues and responsibilities that are specific to service user and carer co-applicants, project team members and co-researchers, from both an organisational and individual service user and carer perspective.

Practical implications: The implications of the findings are to raise awareness of the practical, legal and ethical issues arising from this type of involvement and the potential risks arising from lack of cohesion or understanding. The review also highlights the concerns and barriers service users and carers may find in becoming involved.

Originality/value: The findings highlight a range of issues for research regulators, sponsors and investigators to consider to ensure service users and carers can fulfil their responsibilities and be supported in doing so.