What is a Certificate of Confidentiality(CoC)?

A Certificate of Confidentiality protects participants in research from the disclosure of identifying or otherwise private information about their health or participation in research.

Those acting on behalf of or on behalf of any component of HHS (e.g., OD TPPRC) are restricted from using, disclosing, and disseminating the data under the Certificate of Confidentiality. Sensitive personal information is protected from unauthorized use, disclosure, and dissemination for commercial purposes by this restriction.

The primary purpose of a certificate of confidentiality is to

A certificate of confidentiality prohibits researchers from disclosing private information about participants to other researchers. The primary purpose of a certificate of confidentiality is to protect the participants’ health and personal health and personal information of participants from being shared with others information from being shared with other companies or individuals for marketing purposes, as well as from becoming public knowledge through the media.

How does Certificate of Confidentiality work?

A Certificate of Confidentiality imposes a legal obligation on anyone who possesses or may gain access to any record containing sensitive information 

Individually identifiable health information. Covered records include case report forms, research participant records and other administrative materials. These individuals are required to protect such records from disclosures that could identify or reveal the identity of research participants in biomedical and behavioral studies conducted or supported by HHS.

Who is eligible for Certificate of Confidentiality?

The following people are eligible to receive a certificate of Confidentiality:

Participants in NIH-sponsored research;

Inmates, detainees, or wards of state or federal correctional institutions;

– Research participants who are minors or otherwise legally incompetent;

Participants whose authorization to use protected health information has not been obtained from them.

Also Read: Primary Function of Dynamic Study Modules