Centers for Disease Control and Prevention.
J Law Med Ethics. 2013 Summer;41(2):440-53. doi: 10.1111/jlme.12054.
In its Advanced Notice of Proposed Rule Making (ANPRM), the U.S. Department of Health and Human Services proposed substantial changes to how biospecimen research is treated under the regulations governing human subjects research. Currently, much of this research can be conducted without consent because it may not be considered "human subjects" research, is considered exempt, or consent may be waived. Responding to criticisms that scientific changes have made biospecimen research riskier than contemplated when the Common Rule was last amended, the ANPRM proposes to require written consent for biospecimen research, even if they have been stripped of identifiers or initially collected for a non-research purpose. The ANPRM's recognition of these risks is consistent with relatively recent NIH recommendations that research projects involving genetics, genomics, or biospecimen repositories should consider getting a Certificate of Confidentiality to provide additional protections to participants where breach of confidentiality is typically the primary risk. Ironically, the ANPRM proposals may make it more difficult to provide these protections. Our paper explores the implications of the conflicting requirements of the Certificate and the ANPRM proposals and makes recommendations for achieving the dual goals of appropriate consent and adequate confidentiality protections.
美国卫生与公众服务部在其预先通知拟议规则制定（ANPRM）中提议对管理人类研究对象的法规中如何处理生物样本研究进行重大修改。目前，由于这项研究可能不被视为“人类研究对象”，因此无需同意，就可以进行许多此类研究，或者认为它是豁免的，或者可以放弃同意。为了回应科学界批评，称自上次修改《常见规则》以来，生物样本研究的风险比预期的要大，ANPRM 提议即使生物样本已被剥夺识别码或最初是为非研究目的而收集的，也需要书面同意进行生物样本研究。ANPRM 对这些风险的认识与 NIH 的最新建议是一致的，即涉及遗传学、基因组学或生物样本库的研究项目应考虑获得保密证书，以便在违反保密通常是主要风险的情况下，为参与者提供额外的保护。具有讽刺意味的是，ANPRM 提案可能会使提供这些保护变得更加困难。我们的论文探讨了保密证书和 ANPRM 提案的相互冲突的要求所带来的影响，并提出了实现适当同意和充分保密保护这双重目标的建议。
