ABSTRACT
OBJECTIVE: To develop and refine a programme theory that explains factors that influence decisions to take part in health research by people of diverse ethnic and cultural backgrounds. DESIGN: Realist review following a sequence of five steps: (a) scoping search and identification of programme theory; (b) evidence searching; (c) critical appraisal and data extraction; (d) organisation of evidence and (e) refinement of programme theory. ELIGIBILITY CRITERIA: Documents (including peer-reviewed articles, grey literature, websites, reports and conference papers) either full text, or a section of relevance to the overarching research question were included. DATA SOURCES: EMBASE, Medline, Web of Science, Psych Info, Google and Google Scholar were searched iteratively between May and August 2020. Search strategy was refined for each database providing a broad enough review for building of programme theory. ANALYSIS: Data from eligible documents was extracted to build understanding of the factors that influence decision-making. Data were mapped to create a data matrix according to context (C), mechanism (M), outcome (O), configurations (C) (CMOCs) for the process of informed consent, to aid interpretation and produce final programme theory. RESULTS: 566 documents were screened and 71 included. Final programme theory was underpinned by CMOCs on processes influencing decisions to take part in research. Key findings indicate the type of infrastructure required, for example, resources, services and policies, to support inclusion in health research, with a greater need to increase the social presence of researchers within communities, improve cultural competency of individuals and organisations, reduce the complexity of participant information, and provide additional resources to support adaptive processes and shared decision making. CONCLUSION: The review indicates the need for a more inclusive research infrastructure that facilitates diverse participation in health research through incorporating adaptive processes that support shared decision making within the informed consent process and in the conduct of research projects.