Tuesday, November 4, 2014

OHRP Claims to Be "Working Very Hard" on NPRM

Writing for the Chronicle of Higher Education, Christopher Shea notes that though two years passed between the 2012 Future of Human Subjects Research Regulation conference at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the publication of the conference volume in July 2014, the delay of the next step in regulatory reform--a notice of proposed rulemaking (NPRM)--means that the book remains timely.

[Shea, Christopher. “New Rules for Human-Subject Research Are Delayed and Debated.” Chronicle of Higher Education, November 3, 2014.]

One also hopes that it won't be timely forever. Shea writes,

A spokesman for the Office for Human Research Protections, which is part of the Department of Health and Human Services, could not provide a timetable but told The Chronicle late last month, "I can assure you that this continues to be an HHS priority, and all the relevant parties are still working very hard on this."

Or, as they might have put it, "We have top men working on it right now."

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