- Human rights
The clinical trials enterprise has expanded globally, involving research developed and owned by research institutions in wealthy countries but conducted with participants in low- and middle-income countries (LMICs). These LMICs commonly provide ready access to large pools of subjects who have never received a particular drug and have—at least historically—a more permissive regulatory environment, raising important questions about the rights of vulnerable participants. The unequal power dynamic and imbalances between researchers and human subjects require specific norms and procedures to respect and protect the human rights of trial participants. Complementing bioethics norms, human rights law offers a lens for understanding participant and public health interests, recognizing the unequal dynamic between the researcher and the individual subject, and furthering the participants’ autonomy and decision-making power. Framing these issues in human rights obligations additionally offers new forms of governance and accountability mechanisms, raising new opportunities for legally enforceable claims.
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