Protecting Confidentiality in Human Research (original) (raw)
2013, American Journal of Psychiatry
The validity of clinical research relies on accurate and truthful data collected without fear of disclosure of sensitive information. To that end, Congress authorized the Secretary of Health and Human Services to issue certificates giving investigators protection as intended by the statute to refuse to disclose the identity of research subjects, even when required by an order of the court. The Certificate of Confidentiality is intended to guarantee that vulnerable research populations can participate in research without fear of disclosure. Some court cases, however, have raised concerns about whether the Certificate provides the promised protections and whether the application procedure is overly cumbersome (1, 2). In addition, the Patriot Act further clouds the security provided to research information presumably secured by the Certificate. At the same time, the National Institutes of Health (NIH) and local institutional review boards have been encouraging, and sometimes requiring, researchers to obtain a Certificate in order to carry out research. These issues have been the focus of several recent symposia at national conferences (3; unpublished 2012 paper of L. Dame; unpublished 2012 paper of T.
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