Process Updates for Certificates of Confidentiality for NIH-Funded Research

October 27th, 2017

NIH recently issued an updated policy so that Certificates of Confidentiality (CoCs) are now automatically issued for all NIH-funded research that collects or uses identifiable, sensitive information. As a result, Schulman will now insert language describing the CoC into consent forms for all NIH-funded studies at the time of initial IRB review.

This change impacts both new studies and studies ongoing on or after December 13, 2016.

If you have an ongoing study open to enrollment that did not previously have a CoC but now does, you will need to submit a revised consent form for prospective participants to sign. The CoC information should be included in the consent form along with other confidentiality information. NIH has developed suggested consent form language describing the CoC protections.

CoCs help to protect the private information of research subjects by prohibiting researchers from disclosing identifiable, sensitive information except in limited situations. For detailed information about this policy change and the impact on NIH-funded research, please see our blog post Changes to NIH Policy for Issuing Certificates of Confidentiality: What You Need to Know.

NIH has advised that when a researcher is issued a CoC and will be obtaining informed consent from participants, the participants should be told about the protections afforded by the CoC and any exceptions to those protections. Additionally, consent forms must include a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained (45 CFR 46.116).

If you have any questions or would like additional information, please contact your Study Manager.