NIH Certificate of Confidentiality

Certificates of Confidentiality

  • Are issued by the National Institutes of Health (NIH) to protect the privacy of research subjects by protecting investigators and institutions from being compelled to release information that could be used to identify subjects with a research project.
  • Are issued to institutions or universities where the research is conducted.
  • 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 proceedings, whether at the federal, state, or local level. Identifying information in this context 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.
  • Help achieve the research objectives and promote participation in studies by assuring privacy to subjects by protecting researchers and institutions from being compelled to disclose information that would identify research participants.
  • Certificates can be used for biomedical, behavioral, clinical or other types of research that is sensitive. Sensitive means that disclosure of identifying information could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation.

Examples of sensitive research activities include but are not limited to the following:

  • Collecting genetic information;
  • Collecting information on psychological well-being of subjects;
  • Collecting information on subjects' sexual attitudes, preferences or practices;
  • Collecting data on substance abuse or other illegal risk behaviors;
  • Studies where subjects may be involved in litigation related to exposures under study (e.g., breast implants, environmental or occupational exposures).