The Final Rule includes enhanced patient protections and reduced administrative burden.
A Final Rule released on Jan. 18 by the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies changes the Federal Policy for the Protection of Human Subjects. The rule, known as “the Common Rule,” will go into effect in 2018. HHS stated in a press release that the Department made significant changes to the rule in response to comments, such as those provided by ASCP.
While supportive of the enhanced patient protections, ASCP had raised several concerns about some of the proposals outlined in the proposed rule. In formal comments, ASCP urged the Department to create an exclusion from the rule’s informed consent requirements to shield clinical laboratories that use residual, de-identified biospecimens to validate test instrumentation. Per ASCP’s request, HHS indicated that the final rule removed the proposal that would have required informed consent before non-identified biospecimens could be used. The final rule maintains the current practice with respect to oversight of these specimens.
ASCP also raised concern with a proposal to expand the definition of “human specimen” to include biospecimens, regardless of whether the specimens contain identifiable information. The proposal could have made it difficult to use biospecimens for research unrelated to the purposes for which the specimen was originally obtained. ASCP noted that the continuing expansion of regulatory requirements for investigators could add significantly to the administrative burden and costs on research. HHS has clarified that “researchers will still not have to obtain consent for studies on non-identified stored data or biospecimens.”
ASCP is still reviewing the 126-page rule and will provide additional analysis of the rule in the February issue of ePolicy News.