Monitoring research with human subjects

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...

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Bibliographic Details
Main Author: Sugarman, Jeremy (Author)
Format: Electronic Article
Language:English
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Published: BMJ Publ. 2013
In: Journal of medical ethics
Year: 2013, Volume: 39, Issue: 4, Pages: 242
Online Access: Volltext (JSTOR)
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520 |a 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.’2In this issue of Journal of Medical Ethics … 
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