Institutional Review Board for Health Sciences Research (IRB-HSR)

Special Issues

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:

Effective August 2017, the IRB-HSR no longer requires a Certificate of Confidentiality for studies that are testing for HIV, AIDS, HEPATITS and other sexually transmitted diseases.

How do I apply for a Certificate of Confidentiality?


Last Modified: Wednesday, 07-Jun-2017 14:40:55 EDT