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IRB-HSR > Special Issues > Certificates of Confidentiality







Certificates of Confidentiality

Data collection about sensitive issues (such as illegal behavior, alcohol or drug use, or sexual practices or preferences) requires the protection of confidentiality beyond preventing accidental disclosures.

Under Federal law, researchers can obtain an advance grant of confidentiality, known as a Certificate of Confidentiality that will provide protection against compulsory disclosure, such as subpoena, for research data.

The Certificates of Confidentiality were developed to encourage participation in research by granting certain protections to a subject divulging possible compromising information.

The Certificates, however, do not exempt investigators from performing ethical research nor do they allow investigators to abdicate the responsibility to act in the public good.

Therefore, investigators are required to include a statement in the consent form that alerts potential subjects of the legal and ethical mandate compelling researchers to report certain criteria.

The investigator should delineate in the IRB protocol any conditions under which confidential information might be disclosed and create an informed consent document that accurately reflects those conditions, including any voluntary disclosure by the researcher.

The IRB is required to determine whether the risks to subjects are minimized, informed consent is appropriate, and privacy and confidentiality protections are adequate.

Certificates are issued only "when the research is of a sensitive nature where the protection is judged necessary to achieve the research objectives."

The Public Health Service policy defines "sensitive" research as involving the collection of information falling into any of the following categories:

  • 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 subject'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.
  • Information in other categories not listed may also be considered sensitive because of specific cultural or other factors, and protection can be granted in such cases upon appropriate justification and explanation.

Additional policy considerations apply to research that involves the collection of data that relates to communicable diseases. The Assistant Secretary of the Department of Health and Human Services has issued a policy granting certificates of confidentiality to projects that "intend routinely to determine whether its subjects have communicable diseases and that are required to report them under State law." Certificates will be issued:

  • where the referring and/or treating physician assures the project director that they have complied with reporting requirements; or
  • where there is no referring and/or treating physician, the investigator has reached an agreement with the health department about how s/he will cooperate with the department to help serve the purposes of the reporting requirements (Unless the investigator can show why such cooperation is precluded; and
  • only where disclosures of identifiable information about subjects comply with regulations on subject protection and are explained clearly to subjects prior to their participation.

How do I apply for a Certificate of Confidentiality?