There are limited circumstances when an investigator and institution are permitted to release a participant’s identifiable sensitive information that is protected by a Certificate of Confidentiality. Read on for more.
I Am Conducting NIH-funded Research With Humans and Am Obtaining Identifiable Information About the Participants. Is My Research Covered by a Certificate of Confidentiality?
Yes, the research activity that you describe is deemed to be issued a Certificate of Confidentiality (CoC), i.e., your research is covered by a CoC. All NIH-funded research activities in which the investigator collects or uses “covered information” is deemed to be issued a Certificate of Confidentiality.
You likely know that for human-participant research funded wholly or in part by NIH, we automatically issue Certificates of Confidentiality (CoCs) as a term and condition of award. CoCs protect identifiable, sensitive information of people who participate from being disclosed to others not associated with the study. But, for human-participant research funded by an entity other than NIH, did you know that you can reach out to us to request a CoC as well? Read on for more!
Certificates of Confidentiality protect identifiable, sensitive research information from disclosure. While Certificates of Confidentiality are issued automatically for NIH-funded research, non-NIH funded research that collects identifiable, sensitive information can request a certificate. NIH has updated its Certificate of Confidentiality request process for non-NIH funded research through a new online system.
In this next installment of the NIH’s All About Grants podcast series, we delve into what you should know about certificates. Lyndi Lahl, a Human Subjects Officer within the NIH’s Office of Extramural Research, explains exactly what are certificates, when is disclosure of participant data allowed and when it is not, how to know if your study should have a certificate to protect participants, where to find a certificate associated with your study, and much more.
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. …
Earlier this year I wrote a post about the 21st Century Cures Act and its changes that directly affect the NIH. One part of this new legislation contains provisions to improve clinical research and privacy through certificates of confidentiality.
Currently, certificates of confidentiality (or “CoCs”) are provided upon request to researchers collecting sensitive information about research participants. Soon, CoCs will be automatically provided for NIH-supported research, as set forth in the 21st Century Cures Act. ….