Safe From Subpoena? The Importance of Certificates of Confidentiality to the Viability and Ethics of Research

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Vol: 48, Issue: 2

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Haney-Caron, Emily; Goldstein, Naomi E.; DeMatteo, David
subpeona; Certificates of Confidentiality; National Institutes of Health; NIH; medical ethics; doctor-patient privilege; Legal Ethics and Professional Responsibility
article description
This Article addresses legal issues related to Certificates, recognizes that Certificates face an uncertain future if challenged in court—based on the statutory history and limited relevant case law—and proposes that changes should be made to ensure Certificates actually offer the protection they promise. Part II reviews the background of Certificates of Confidentiality. Part III explores how Certificates fulfill vital functions by encouraging research participation, satisfying ethical obligations of researchers to protect participant data, and promoting the accuracy of data provided by participants in research studies. Part IV observes that the case law relevant to Certificates of Confidentiality, though limited, presents cause for concern. Part V explores the potential threats to Certificates of Confidentiality. Part VI argues that, for legal and public policy reasons, courts and Congress should consider changes in the way they approach Certificates of Confidentiality in order to offer broad protection for participants involved in sensitive research studies. Additionally, this section provides recommendations for researchers to secure sensitive data.