Emanual & Menikoff


Reviewed by Raffaella Ravinetto

This article gives an interesting overview about how regulation on medical and clinical research could evolve in the United States. It is not something you can read very quickly, but there are some interesting parallel with reflection ongoing in Europe and in the field on non-commercial research.

Noteworthy, the Authors of the paper have participated in a working group charged to consider revisions to the so called US “Common Rule”, which has remained almost unchanged since 1991, even if meanwhile research with humans has substantially increased in volume (more international and multisite studies, more health services research and more research with bio-specimens) and even if there are complaints that the current regulations impose a variety of burdensome bureaucratic procedures that seem to do little to protect research participants. We can note that there is a parallel with WHO and ICH GCP Guidelines, which have not been updated since 1995 and 1996 respectively!

The working group has drafted an Advance Notice of Proposed Rulemaking (ANPRM) that was circulated for comment by all the concerned US departments and agencies. Taking into account that in 2002 the Institute of Medicine called for a more risk-based review process, several changes to the current rules regarding IRB review are being considered, including in what concerns the distinction between different kinds of risk, the data concerning adverse events, the use of bio-specimens, the informed consent and confidentiality issues, etc.


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