A Scoping Review of Toolkits Addressing Ethical Issues in Health Registry and Clinical Research Participation Among African Americans With Chronic Kidney Disease

ABSTRACT Chronic kidney disease (CKD) disproportionately affects African Americans, yet they remain underrepresented in health registries and clinical research enrolment. This scoping review maps and describes existing toolkits designed to address the ethical challenges that contribute to this disparity. We conducted a scoping review following the Joanna Briggs Institute methodology. We systematically searched Ovid MEDLINE, EMBASE, Scopus, and Cochrane Central for English-language studies (2000-2024) describing tools, strategies, or frameworks to improve the ethical recruitment and retention of African American patients in CKD health registries and clinical research. Of 149 records screened, 14 U.S.-based studies met inclusion criteria. We identified several toolkit strategies: community engagement and educational materials (e.g., for APOL1 testing), educational programs (e.g., for living donor transplantation), participant experience surveys, virtual recruitment tools, and enhanced genetic testing panels. While these toolkits aimed to mitigate challenges like mistrust and complex informed consent, significant gaps in design, evaluation, and scalability were identified. Most toolkits were not rigorously evaluated for effectiveness, were often context-specific (e.g., limited to transplantation), and rarely addressed structural drivers of inequity. Few provided scalable, culturally tailored solutions for the digital divide or offered sustainable models for community partnership. While several promising toolkits exist to address ethical challenges in CKD research with African Americans, they remain nascent. Future work must focus on developing rigorously evaluated, scalable, and co-developed toolkits that move beyond describing barriers to providing actionable, ethical solutions for inclusive registry enrolment and research participation.