Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water?
Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water?
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DOI：
10.1111/jlme.12054
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发表时间：
2013-06-01
影响因子：
2.1
通讯作者：
Wolf, Leslie E.
中科院分区：
文献类型：
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作者：
Williams, Brett A.;Wolf, Leslie E.
美国卫生与公众服务部在其拟议规则制定预先通知 (ANPRM) 中提议对人类受试者研究法规下处理生物样本研究的方式进行重大改变。目前，大部分研究可以在未经同意的情况下进行，因为它可能不被视为人类受试者研究，被认为是豁免的，或者可以放弃同意。针对科学变革导致生物样本研究风险比上次修订共同规则时预期的风险更大的批评，ANPRM 提议要求生物样本研究获得书面同意，即使它们已被剥夺标识符或最初出于非研究目的而收集。 ANPRM 对这些风险的认识与 NIH 最近的建议是一致的，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，以便为参与者提供额外的保护，而违反保密性通常是主要风险。讽刺的是，ANPRM 提案可能会使提供这些保护变得更加困难。我们的论文探讨了证书和 ANPRM 提案的冲突要求的影响，并为实现适当同意和充分保密保护的双重目标提出了建议。
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.