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Purpose of a Certificate of Confidentiality

Certificates of Confidentiality are issued by the National Institute of Health (NIH) to protect the privacy of research participants by protecting investigators and institutions from being compelled to release information that could be used to identify participants within a research project. Certificates of Confidentiality are issued to institutions or universities where the research is conducted. They allow the investigator and others who have access to research records to refuse to disclose identifying information in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.

Identifying information is broadly defined as any item or combination of items in the research data that could lead directly or indirectly to the identification of a research subject.

By protecting researchers and institutions from being compelled to disclose information that would identify research participants, Certificates of Confidentiality help achieve the research objectives and promote participation in studies by assuring privacy to subjects.

Allergan recognizes the importance of your privacy and the confidential nature of the information collected as part of this study and has obtained a Certificate of Confidentiality from the National Institutes of Health covering the BIFS research program. With this Certificate, the BIFS investigators cannot be forced (for example, by a court subpoena) to disclose information that may identify you in any civil, criminal, administrative, legislative, or other proceedings. Identifiable information may be released to federal agencies, however, by request of FDA or the Department of Health and Human Services for auditing or study evaluation purposes or to meet federal research requirements.

A Certificate of Confidentiality does not prevent you from voluntarily releasing information about your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive such information, the BIFS program administrators and/or investigators may not use the Certificate to withhold that information.

Click here to read the Certificate of Confidentiality issued to Allergan Medical covering the BIFS program.

National Institute of HealthNational Institute of Health (NIH) is the nation’s medical research agency - making important medical discoveries that improve health and save lives. The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting medical research.

Helping to lead the way toward important medical discoveries that improve people’s health and save lives, NIH scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases.

Composed of 27 Institutes and Centers, the NIH provides leadership and financial support to researchers in every state and throughout the world.

Click here to learn more about the NIH and its charter http://www.nih.gov/