Research Oversight through New Lenses: The Consortium to Examine Clinical Research

Introduction

Given widespread media attention to the deaths of research participants, the potential for financial and other conflicts of interest, and concerns about whether adverse events are reported consistently and completely, as well as studies suggesting that institutional review boards are overworked and undersupported, questions are being raised about the adequacy of research oversight. We lack data on the effectiveness of ethical review; indeed, there isn’t agreement on appropriate metrics for measuring the ability of IRBs to protect research participants. Additionally, there is concern that some groups are abundantly, perhaps even overly, protected (in selected survey research for instance), while inadequate protection is in place for others.

Lisa Eckenwiler, Jeremy Sugarman and Ezekiel Emanuel, “Research Oversight through New Lenses: The Consortium to Examine Clinical Research,” IRB: A Review of Human Subjects Research vol. 25, no. 1 (January-February 2003): 9-10

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