Certificate of Confidentiality

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US-APP-4THCIR-45
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Description

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A Certificate of Confidentiality is a document issued by the U.S. Department of Health and Human Services, granting qualified researchers legal protection from any legal or civil action that might arise from the release of confidential study information. The certificate is intended to protect the privacy of research participants by prohibiting the disclosure of their identifiable information without their express permission. It also protects researchers from being compelled to release information about their study participants, even if they are subpoenaed. There are two main types of Certificate of Confidentiality: the Common Rule Certificate, which applies to research conducted under the Common Rule (45 CFR 46), and the HIPAA Certificate, which applies to research conducted under the Health Insurance Portability and Accountability Act (HIPAA).

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FAQ

Certificates of Confidentiality (Certificate or CoC) protect the privacy of research participants by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research except when the participant consents or in a few other specific situations.

Generally, research will be considered "sensitive" and eligible for CoC protection if the study involves the collection of identifying information, which, if revealed, could harm the financial standing, employability, insurability, or reputation of a research subject.

CoCs do not protect research subjects against the voluntary disclosure by the investigator of identifying information. For example, a CoC does not prevent an investigator from notifying the authorities if he or she obtains evidence of child abuse or a subject's threatened violence to self or others.

To be eligible for a CoC issued by the Centers for Disease Control and Prevention (CDC), CDC funding is required. If your research is not supported by CDC funding, you may apply for a Certificate through the NIH. Contact information is available on the NIH website at the Certificates of Confidentiality Kiosk.

The Certificate of Clearance (C O C) is a document issued by the Commission to an individual who has completed the Commission's fingerprint character and identification process, whose moral and professional fitness has been shown to meet the standards as established by law.

What is a Certificate of Confidentiality? A Certificate of Confidentiality (CoC) is issued by the National Institutes of Health (NIH) to safeguard the privacy of research study participants by protecting identifiable research information from forced disclosure.

Certificate of Conformity (CoC)

Certificates of Confidentiality are issued by the National Institutes of Health (NIH) and other HHS agencies to protect identifiable research information from forced or compelled disclosure.

More info

The PI is responsible for submitting the request for a CoC to NIH or other federal agency following IRB approval. 1. A Certificate of Confidentiality can also be issued for non-.NIH funded research. Purpose. Certificates of Confidentiality (CoCs). -COC Application Form (you will complete a draft on the COC website and provide the IRB a PDF copy. Guidance on Certificates of Confidentiality. ➢ See the CoC user guide for details about the application process. Guidance on Certificates of Confidentiality. What is a Certificate of Confidentiality? NIH Policy Change Regarding Certificates of Confidentiality.

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Certificate of Confidentiality