Independent Review, Data Safety Monitoring, and Research Oversight
Independent review, data monitoring, and general oversight of human subjects research provide systematic mechanisms for ensuring that investigators implement best practices to minimize risks, maximize benefits, and ensure justice in the conduct of research. This chapter describes how successful partnerships between research teams and oversight groups have focused on the shared goals and commitments of the research enterprise and how each constitutive piece combines with structure, function, and purpose to facilitate the conduct of ethical research. The author argues that collaborative work toward ensuring not just fidelity to rules and regulations but also attention to the underlying ethical foundations for these mechanisms will foster meaningful conversations about how to ensure high-quality research that places the safety of human subjects at its core.