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Hogan Lovells Issues Sponsored Research Alert on Proposed Changes to Federal Policy for Protection of Human Subjects

22 September 2015
Hogan Lovells has issued a Sponsored Research Alert outlining a Notice of Proposed Rulemaking (NPRM) issued by the U.S. Department of Health and Human Services (HHS) that seeks to amend the U.S. Government's policy on protection of human research subjects.  As the Alert describes:

The NPRM would substantially change, in several respects, the regulatory framework with which universities and research institutions have had years of experience. For example, if an institution receives federal funding for human subjects research, all clinical trials at the institution would become subject to the Common Rule. New rules would govern research use of biospecimens, and new elements of informed consent would prompt substantive and procedural modifications to current practice. The NPRM also implicates questions such as how institutions manage risk in multi-site studies if such studies are to be reviewed, as the proposal suggests, by a single Institutional Review Board (IRB).

To view the alert, please click here.

EMA to Revise Herbal Medicines Guideline

On 1 September 2016, the European Medicines Agency ("EMA") opened for public consultation a Draft revision to its Guideline on the assessment of clinical safety and efficacy in the...

08 September 2016
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