NIH ’s Certificates of Confidentiality Policy Enhances Confidentiality of Participants Enrolled in Clinical Research Studies

A few months ago we blogged about our plan to release an updated Certificate of Confidentiality (CoC) policy. Today, we are pleased to announce that we have published the new policy (NOT-OD-17-109), which will go into effect on October 1, 2017. The new policy both enhances the privacy protections of individuals participating in NIH funded research studies and eliminates the need for NIH funded investigators to apply for a CoC. To help protect the privacy of research participants, NIH has for many years issued CoCs, upon request, to researchers collecting sensitive information about research participants. The CoCs protect researchers and institutions from being compelled to disclose information in response to legal demands that would identify their research subjects.  Section 2012 of the 21st Century Cures Act authorized new provisions governing the authority of HHS to protect the privacy of research subjects.  The new policy implements the new CoC statutory requirements. Under the new policy, as of October 1, 2017, NIH funded researchers will no longer have to request a CoC, nor will they receive an actual certificate. The CoC will be issued automatically to NIH funded grants, cooperative agreements, contracts and intramural research projects research funded wholly or in part by the NIH that collects or uses identifiable, sensitive information. Compliance with the requirements of the law will become a term and condition of award. All research that was commenced or ongoing o...
Source: NIH Extramural Nexus - Category: Research Authors: Tags: blog Open Mike certificates of confidentiality cocs Grants policy grants policy statement Source Type: funding