Enhancing communication among data monitoring committees and institutional review boards.
Data Monitoring Committees (DMC) and Institutional Review Boards (IRB) each can play important roles in protecting the rights and interests of research participants and ensuring the integrity of research. While both IRBs and DMCs have unique responsibilities, promoting a robust human research participant protection program requires integration of these efforts. Communication about DMC actions and considerations to IRBs is arguably an important component of integration. We sought to explore whether and how DMCs actions are currently communicated to IRBs as a basis for recommendations to improve such communications. Evidence of communication was sought in files related to research conducted by faculty, staff, and students affiliated with the Johns Hopkins Medical Institutions and the Johns Hopkins Bloomberg School of Public Health. Overall, we found a lack of consistency in the way that DMC actions are communicated to IRBs. While national policy encourages that actions taken by DMCs be communicated to IRBs and there is not a clear consensus about either who should be responsible for disseminating the information to the IRB or what information ought to be considered standard. Such standards promise to enhance the quality of ethics oversight of research.
Department of Health Policy and Management, Bloomberg School of Public Health and Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD 21205, USA. htaylor@jhsph.edu
Holly A
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Taylor
Lelia
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Chaisson
Jeremy
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Sugarman
D026661:Clinical Trials Data Monitoring Committees; D003142:Communication; D028744:Ethics Committees, Research; D006805:Human Experimentation / Q000592:standards*; D006801:Humans; D014481:United States