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The problem: Changes to the Federal Policy for the Protection of Human Subjects (the Common Rule) as presented in the Notice of Proposed Rulemaking (NPRM) are both logical and necessary. However, the proposed changes continue to focus entirely on the individual and fail to take into account the rapidly emerging types of research that involve patients and communities directly in the research process. Purpose of Article: We propose several changes and amendments that address the interests of communities and underscore the principle of justice, especially social justice.

Key points: Our recommendations seek to revise human subjects’ protections that currently overemphasize individualism and autonomy to reflect a collectivist ethos that would extend protections to communities engaged in medical research.

Conclusion: We believe this is necessary to effectively and efficiently conduct the types of research that will ultimately rectify health inequities that continue to exist in many communities, but particularly communities of color.