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    Final Rule Published Without Biospecimen Provisions

    Over the last year and a half, academic and government researchers have joined to voice their opposition to proposed updates to the Common Rule regarding biomedical and behavioral research involving human subjects in the United States. Specifically, they opposed consent changes that would stifle the progress of science. It seems the U.S. Department of Health and Human Services listened.

    Whether it was a rush to announce prior to the administration transition or serendipity, on the eve of Inauguration Day, the Feds published the Final Rule, minus the biospecimen provisions.

    The spark that ignited 17 months of debate, angst, and uncertainty was a proposal that would have required researchers to obtain written consent before using biospecimens such as DNA, cells, blood, and tumor samples obtained during clinical care or a specific research study. This proposal would have required consent even if the biospecimens were de-identified (stripped of personally identifiable information). As of today, and for the indefinite future, those biospecimens can now be used for government-funded research without the donor’s consent, provided they are de-identified.

    While academic and government researchers may collectively exhale in response to the recently published Final Rule, privately funded programs cannot.  Lobbyists and patient advocates were unsuccessful in their efforts to convince HHS to expand the regulations on human subjects to include Industry (Biotech and Pharmaceutical). The procedures and regulation of industry-sponsored human subject research are more stringent and remain unchanged.

    The key takeaway for any researcher: It is your responsibility to ensure that all biospecimens intended or used in the course of your research were obtained in compliance with the appropriate Federal Regulation.

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