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NIH Issues Significant Changes to Certificates of Confidentiality (CoC) Policy

In a continuing effort to keep you informed about the many changes that are occurring in the field, we would like to provide you with information about the new NIH policy regarding Certificates of Confidentiality.

NIH Issues Significant Changes to Certificates of Confidentiality (CoC) Policy

Importantly, while the effective date of the policy is October 1, 2017, it will apply retrospectively to all NIH research that was initiated or ongoing on or after December 13, 2016 that falls within the scope of the policy.

Additionally, HRP is pleased to provide a sample CoC Standard Operating Procedure (SOP) for HRPPs and IRBs that addresses both the updated statutory requirements that apply to all CoCs and the NIH policy.  As modeled in the sample SOP, HRP recommends that the analysis of whether a NIH-funded activity falls within the scope of the NIH policy (and the overall policies for CoCs) sit outside of the HRPP/IRB, because the activities covered by a CoC may not be subject to HRPP or IRB review or oversight.

NIH has informed us that they likely will be updating the information that is currently on their CoC website, including the sample consent language, so this is worth monitoring.  We are waiting on responses to a few other questions and will share information as it becomes available.

Please read through the information and feel free to contact us with any questions you may have.