Advance Notice of Proposed Rulemaking (Department of Health & Human Services)

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Tue, July 26, 2011
The Department of Health and Human Services published an Advance Notice of Proposed Rulemaking to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective.  Changes are proposed to seven aspects of the current regulatory framework:
 
  • refinement of the existing risk-based regulatory framework;
  • utilization of a single IRB review of record for domestic sites of multi-site studies;
  • improvement of consent forms and the consent process;
  • establishment of mandatory data security and information protection standards for all studies involving identifiable data;
  • establishment of an improved, more systematic approach for the collection and analysis of data on unanticipated problems and adverse events;
  • extension of Federal regulatory protections to all research, regardless of funding source, conducted at institutions in the U.S. receiving some Federal funding from a Common Rule agency for research with human subjects; and
  • improvement in the harmonization of regulations and related agency guidance

The paper, "Pruning the regulatory tree: For human subjects research, maximum regulation does not mean maximum protection," authored by CBSSM faculty Scott Kim, Peter Ubel, and Ray De Vries, was cited in the ANPRM.