Certificate of Confidentiality

A Certificate of Confidentiality

  • is an important tool to protect the privacy of research study participants is issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure allows the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level
  • may be granted for studies collecting information that if disclosed could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation.

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

Statutory Authority of Confidentiality as it Relates to NIH-authorized Research

Under section 301(d) of the Public Health Service Act (42 U.S.C. 241(d)) the Secretary of Health and Human Services may authorize persons engaged in biomedical, behavioral, clinical, or other research to protect the privacy of individuals who are the subjects of that research. This authority has been delegated to the National Institutes of Health (NIH).

Persons authorized by the NIH to protect the privacy of research subjects may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify them by name or other identifying characteristic.

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LUPUS GENETIC STUDIES • OKLAHOMA MEDICAL RESEARCH FOUNDATION • 825 NE 13TH STREET MAILSTOP #5, OKLAHOMA CITY, OK 73104