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ASM commented on the Advance Notice of Proposed Rulemaking (ANPRM) for 45 CFR Parts 46, 160, 164, and 21 CFR Parts 50 and 56 "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators."
The proposed additional rules would require informed consent from patients for the use of their "spent" biological specimens in research. These specimens provide an essential, readily available, low-cost source of material for evaluation of laboratory procedures and would otherwise be discarded. Additionally, this would place an undue administrative and financial burden on laboratories to obtain this consent, especially since it offers no advantage to patient protection in a clinical laboratory already operating under HIPAA privacy regulations. ASM also answered several of the 84 questions posed by the ANPRM with specificity to the usage of "spent" biological specimens in clinical laboratories. The entire ASM statement is available online at http://www.asm.org/index.php/policy/ohrp10-26-11.html.
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