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Monitoring research with human subjects
  1. Jeremy Sugarman
  1. Correspondence to Dr Jeremy Sugarman, Harvey M Meyerhoff Professor of Bioethics and Medicine, Johns Hopkins Berman Institute of Bioethics, 1809 Ashland Ave., Deering Hall, Room 203, Baltimore, MD 21205, USA; jsugarman{at}jhu.edu

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Active monitoring of research with human subjects is no longer reserved for especially complex research or investigating research alleged to be problematic. Rather, many human research subjects’ protection programmes now engage in routine monitoring. Although limited data concerning such monitoring are available, the Association for the Accreditation of Human Research Protection Programs (AAHRP), reports that in 2011 its accredited organisations (except those that are independent institutional review boards) conducted many routine audits (mean=40; median=11).1 While accredited organisations currently represent a small subset of human subjects’ research programmes, these data are consistent with AAHRP's standard (I.5): ‘The Organization measures and improves, when necessary, compliance with organizational policies and procedures and applicable laws, regulations, codes, and guidance. The Organization also measures and improves, when necessary, the quality, effectiveness, and efficiency of the Human Research Protection Program.’2

In this issue of Journal of Medical Ethics …

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