Health care partner Mark Barnes (Boston) is quoted extensively in the Nov. 18 issue of Bloomberg BNA’s Medical Research Law & Policy Report. Mr. Barnes offers his perspectives on industry-shaping issues in three articles in the issue, which cover a debate over a proposed requirement that would make informed consent documents relating to clinical trials publicly available; the ramifications of a proposal to exclude research activities regulated under HIPAA from the Common Rule, which has regulated research activities since 1991; and a proposed update to the Common Rule that would classify biospecimens as “human subjects” and require researchers to seek approval for their use in studies.
Additionally, Mr. Barnes, along with life sciences partner Greg Levine (Washington, D.C.) and health care associate David Peloquin (Boston) co-authored an article titled “Impact of Proposed Federal Research Regulation Amendments (the Common Rule NPRM) on Life Sciences Companies,” appearing in both the Medical Research Law & Policy Report as well as Bloomberg BNA’s Life Sciences Law & Industry Report. The article analyzes changes to the Common Rule proposed by the U.S. Department of Health and Human Services with ramifications affecting research consent procedures, data security protocol and the study of biospecimens.
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