Certificates of Confidentiality

Certificates of Confidentiality provide protection to research investigators against the involuntary release of information which could lead to the individual identification of research subjects.  The Certificates protect against compelled disclosure of identifying information about subjects of biomedical, clinical and other research, and are issued for individual projects when the research is of a sensitive nature and where the protection is judged necessary to achieve the research objectives.  Research including, but not limited to, the following categories may be considered sensitive:

• Information relating to sexual attitudes, preferences or practices;
• Information relating to the use of alcohol, drugs, or other addictive products;
• Information pertaining to illegal conduct;
• Information that if released could reasonably be damaging to an individual’s financial standing, employability, or reputation within the community;
• Information that would normally be recorded in a patient’s medical record, and the disclosure of which could reasonably lead to social stigmatization or discrimination;
• Information pertaining to an individual’s psychological well being or mental health;
  
• Genetic information
  
  

The protection provided by a Certificate of Confidentiality applies to the research investigators and anyone else who has access to research records, and protects them from having to disclose information in any civil, criminal, administrative, legislative or other proceedings whether federal, state or local.  The Certificate does not prohibit the voluntary disclosure of information which may identify subjects (e.g. disclosure of information regarding child abuse, communicable diseases, threats of violence, etc.) as long as the consent form discusses the potential for such disclosure.  (This could be a risk or a benefit, depending on the disclosure.  For instance, the mandatory reporting of a communicable disease or child abuse would be considered a risk, but a referral to a psychiatrist for a person in need of therapy for a particular problem could be considered a benefit).  An investigator may not use a Certificate as a reason not to disclose information which the subject consents to, or to refuse information which is requested under DHHS regulations by federal officials for use in audits or program evaluations.

The consent form should indicate when a Certificate has been granted for a particular project, along with a brief description, as this may have an impact on an individual’s willingness to participate in the study.  The limitations of the Certificate should be clearly outlined (i.e. audits, FDA, subject request).

Each Certificate application must include documentation of IRB approval along with a justification regarding the need for the protection of the research information.  Certificates are issued by various federal agencies, but are not limited to federally funded projects.  The appropriate agency to contact will vary depending on the nature of the research.  For general information regarding Certificates of Confidentiality contact:

 Ms. Olga Boikess
 Office of Research Management
 National Institutes of Mental Health
 6001 Executive Boulevard, Room 8102
 Mail Stop: MSC 9653
 Bethesda, MD 20892-9653
 Telephone: (301) 443-2578
 E-Mail: oboikess@mail.nih.gov

Additional guidance is available at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/certconpriv.htm