Late last month the Department of Health and Human Services (HHS) and other Federal Departments and Agencies announced an extension until January 6, 2016 to the comment period for the Federal Policy for the Protection of Human Subjects notice of proposed rulemaking (NPRM). The proposed rulemaking is the most sweeping since 1991 when HHS codified The Common Rule, 45 C. F. R. part 46, and recognizes the changed research environment with many multisite studies and the expansion of research with more data accessible through technology. The NPRM seeks to further the principles of autonomy and beneficence by protecting privacy and improving the consent process in the new world of research while creating avenues to lessen the administrative burden and to promote research.
Continue Reading HHS Recognizes Changing Environment of Research: Still Time to Comment
Dawn Crumel
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Reconsideration of Certificate of Need in Virginia
By Dawn Crumel & Robert Magielnicki on
Posted in Antitrust
In a joint statement issued by the Federal Trade Commission and the Antitrust Division of the U.S. Department of Justice (collectively, the “Agencies”) late last month, the Agencies suggested Virginia’s Certificate of Public Need Work Group (“Work Group”), currently convened, consider repealing or retrenching Virginia’s Certificate of Public Need (“COPN”) law.[1]
Continue Reading Reconsideration of Certificate of Need in Virginia