Enhancing research ethics and protections for uninsured and underinsured research participants in clinical trials in the USA.

ABSTRACT: Inclusion of uninsured and underinsured (UUI) individuals in clinical research (CR) is necessary to ensure data quality, diversity, generalizability and fairness. Yet, in the USA, UUI persons tend to be excluded from CR. We conducted an ethical analysis of: the regulatory and ethics literature related to protections of, and duty to care for, research participants from vulnerable groups; the nature and scope of the ancillary health care obligations of researchers, and the applicable laws, regulations and practices concerning the care for UUI participants. We consider six examples illustrating the challenges of including UUI persons in CR. We note that addressing fully the challenges of UUI participation in CR requires comprehensive legal and health care reforms. We maintain that even in the

SUBMITTER: Pascalev A 

PROVIDER: S-EPMC12780799 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature