Subject: Certificate of Confidentiality

Procedure:

1. Investigator Responsibilities.
   1. The Investigator shall consider applying for a Certificate of Confidentiality when the results of research participation would yield information in one or more of the following categories:
      1. HIV status, AIDS related complications, or other sexually transmitted diseases (STDs),
      2. Information relating to sexual attitudes, preferences, or practices,
      3. Information relating to the use of alcohol, drugs or other addictive products,
      4. Information pertaining to illegal conduct,
      5. Information that if released could reasonably be damaging to an individual's financial standing, employability, or reputation within the community,
      6. 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,
      7. Information pertaining to an individual's psychological well-being or mental health,
      8. Information collected that may be considered sensitive in connection with behavioral interventions and epidemiologic studies; and
      9. Genetic information.
   2. How to apply for the Certificate of Confidentiality.
   3. The Investigator shall notify the IRB that a Certificate of Confidentiality has been requested in the initial IRB submission.
   4. The Investigator shall include language describing the Certificate of Confidentiality, as well as any voluntary disclosures, in Section 12a of the informed consent document template.
2. IRB Committee Responsibilities.
   1. The IRB will assure that the proposed research meets regulatory requirements for approval under 45 CFR 46.111^[1], which includes provisions to protect the privacy of participants and confidentiality of data. This IRB determination will include the recommendation of a Certificate of Confidentiality when the proposed research includes sensitive information that may cause harm to the participant as a result of compelling disclosure.
   2. The IRB will review the consent documents to assure that a description of the Certificate of Confidentiality and any voluntarily, disclosure plans by the Investigator are appropriately described.
   3. The IRB may recommend that an Investigator apply for a Certificate of Confidentiality.
3. IRB Specialist Responsibilities.
   1. Upon receipt, the Specialist will review the submission within two working days.
   2. The Specialist will ensure that the certificate of confidentiality (if applicable to the research proposal) is included in the IRB submission and the appropriate language is included in the consent form template.
   3. The Specialist will ensure that all relevant research information has been entered into the IRB database in an accurate and timely manner.
   4. The Specialist will ensure that all IRB approved documents are provided to the Investigator in an accurate and timely manner.

^[1] 45 CFR 46.111