Certificate of Confidentiality

This is a document issued by the National Institutes of Health (NIH) to certain IRB approved research studies. A Certificate of Confidentiality helps researchers protect the privacy of individuals who have chosen to participate in studies that could potentially affect an individual’s financial standing, employability, insurability, or reputation. Studies involving genetic research could possibly provide this type of information. This certificate protects a research study from "forced disclosure", such as court orders or subpoenas that request releasing identifying information or characteristics about a research participant.

A research study is eligible for a Certificate of Confidentiality if the study is collecting “personally identifiable information”. Personally identifiable information is any information that could possibly identify directly or indirectly a research participant. Information such as name, address, social security number, fingerprints, photographs, genetic information, tissue samples or any other information that can be linked to a specific individual falls under the category of personally identifiable information. Furthermore, if a research project involves sensitive information or information that might harm research participants; those studies are also eligible for a Certificate of Confidentiality.

The NUgene Project, since it collects identifying information about each participant (for example: name, medical record number, blood, and genetic information), is eligible for a Certificate of Confidentiality. The NIH granted a Certificate of Confidentiality to the NUgene Project in July of 2002. Therefore, by choosing to participate in the NUgene Project, any identifying information you provide us will be protected and kept confidential.