What next for US clinical trials? Federal regulations series part 5 of 5

Part 5 of MESM’s series on proposed federal research regulation amendments and the impacts on commercial sponsors and research organisations.

A consultation period inviting comments from industry and other stakeholders was extended to the 6th January 2016 following the publication of the proposed NPRM in September 2015. During that period the OHRP received over 2,100 comments, of which a majority raised concerns over the proposed provisions for the treatment of biospecimens and informed consent. Many comments also offered potential solutions to foreseen problems.

In this final article in the series, we examine some of the comments submitted to the Office for Human Research Protections (OHRP) during the consultation process by a small selection of major stakeholders in the life science industry, and consider what steps companies should take now in preparation for the future publication of the Final Rule.

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