Public Comments on Proposed Regulatory Reforms That Would Impact Biospecimen Research: The Good, the Bad, and the Puzzling.

The article discusses the Advance Notice of Proposed Rule Making (ANPRM) published by U.S. Department of Health and Human Services (DHHS) which identified bio-specimen research as an area in particular need of attention for regulatory change. Topics cited include its proposals for mandated written informed consent from individuals for any use of their biospecimens regardless of the identifiability of the biospecimens and that consent should be obtained through a standardized consent form.