Confidentiality Certificates: A False Sense of Security?
First, for those who don't know what a Confidentiality Certificate is (and if you didn't, why would you be reading this?), let me just briefly explain. A Confidentiality Certificate is issued by the federal government to researchers who ask for it and who are conducting research involving information about participants which, if disclosed, could put the research participant at risk financially, socially, criminally, or otherwise. For example, just knowing someone was enrolled in a study of a sexually transmitted disease, such as syphilis, would potentially be harmful to a participant. For this reason, and to enable researchers to enroll otherwise unwilling participants, all information collected during the research covered by a Confidentiality Certificate is protected from disclosure. That means the investigators can withhold the information, even if a court orders its release.
For years, researchers in psychiatric disorders, substance and behavioral addiction, and other fields have relied on the protection afforded by Confidentiality Certificates to offer participants assurance that information collected about them would not be shared. Researchers at Duke University have just published a paper in Science suggesting that this reliance may be far from secure.
In the case described in the November 14 Science article, the authors describe how, when they objected and Duke appealed a judge's order that information about a research participant be released in a criminal case, it became apparent that the judge was not even aware of the protections afforded by Confidentiality Certificates. Further, even when he was made aware, he ultimately ordered the information be released, under seal, to those involved in the case over which he was presiding. The information never actually saw the light of day only because it was ultimately deemed irrelevant to the case.
Laura Beskow and her colleagues at Duke, Lauren Dame and E Jane Costello, have done the biomedical and social science community a great service by bringing their experience in this matter to the public's attention and by highlighting the need for research into the incidence of breaches of confidentiality. Meanwhile, researchers and clinical trial participants alike should be aware that information collected during a clinical trial, while maintained as confidential under normal circumstances, may be exposed in a court of law.
-Joe
For years, researchers in psychiatric disorders, substance and behavioral addiction, and other fields have relied on the protection afforded by Confidentiality Certificates to offer participants assurance that information collected about them would not be shared. Researchers at Duke University have just published a paper in Science suggesting that this reliance may be far from secure.
In the case described in the November 14 Science article, the authors describe how, when they objected and Duke appealed a judge's order that information about a research participant be released in a criminal case, it became apparent that the judge was not even aware of the protections afforded by Confidentiality Certificates. Further, even when he was made aware, he ultimately ordered the information be released, under seal, to those involved in the case over which he was presiding. The information never actually saw the light of day only because it was ultimately deemed irrelevant to the case.
Laura Beskow and her colleagues at Duke, Lauren Dame and E Jane Costello, have done the biomedical and social science community a great service by bringing their experience in this matter to the public's attention and by highlighting the need for research into the incidence of breaches of confidentiality. Meanwhile, researchers and clinical trial participants alike should be aware that information collected during a clinical trial, while maintained as confidential under normal circumstances, may be exposed in a court of law.
-Joe


