Bloomberg Law
Oct. 19, 2017, 8:13 PM

NIH Confirms Automatic Confidentiality for Study Subjects

Jeannie Baumann
Jeannie Baumann

Research institutions won’t have to repeat the consent process with study volunteers after a legal change automatically protected their confidentiality, an NIH policy analyst confirmed Oct. 18.

The clarification from the National Institutes of Health on privacy protections known as Certificates of Confidentiality (CoCs) relieves institutional review boards (IRBs) of a potentially daunting task of combing through studies, determining who enrolled in research before the new policy took effect Oct. 1 but after the provision took effect last December, and asking them again for consent to continue participating in a study. The NIH automatically issued certificates for those NIH-funded studies, ...

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