Certificates of Confidentiality
Certificates of Confidentiality (COCs) are documents issued by the National Institutes of Health (NIH) and other federal agencies (such as DOJ, FDA, CDC) to protect against forced disclosure of identifiable research information. They allow investigators and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. COCs may be granted for studies collecting sensitive information that, if disclosed, could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. NIH will issue a COC for a study that fits the NIH mission regardless if the study has federal funding or not.
Examples of sensitive information that may require a COC include:
- Genetic susceptibility or family pedigree
- Mental illness
- High risk sexual attitudes, preferences, and practices
- Substance abuse or other illegal behaviors
- Participation in exposure effects studies that later become litigious, such as breast implants or environmental or occupational exposures
By protecting investigators and Institutions from being compelled to disclose information that would identify research participants, COCs help the investigator achieve research objectives and promote participation in studies by assuring confidentiality and privacy to participants.
Certificate of Confidentiality Links
How to Obtain a Certificate of Confidentiality
Investigators may choose to apply for a COC, or the IRB may require that an investigator obtain one. The following steps are required to request a COC:
- Investigator indicates in the IRB application that a COC will be requested for the study
- Investigator completes a COC application (online, if available) and drafts and signs a cover letter to be additionally signed by the USC Institutional Official
- Investigator submits a copy of the COC application and the original cover letter to the IRB
- IRB forwards the packet (see below) and IRB cover memo to the USC Office for the Protection of Research Subjects (OPRS)
- OPRS staff verifies packet completion, obtains the signature of the OPRS Executive Director, and forwards the packet to the office of the USC Vice President of Research / Institutional Official (VPR/IO)
- VPR/IO staff obtain VPR/IO signature, distribute electronic copies of signed document(s) to the Principal Investigator, IRB, and OPRS
- Investigator submits the application to NIH (or other agency) according to the agency’s application procedures
A complete USC COC packet will contain these items in the prescribed order:
- Memorandum signed by IRB Chair or Director requesting VPR/IO signature
- Principal Investigator letter to NIH and additional documents submitted by PI, if any
- IRB Study Approval* Letter (may be included in IRB memo – item 1)
Neither the USC IRB nor the VPR/IO will evaluate the content of the Certificate of Confidentiality application. *IRB approval may be granted even though receipt of a COC is pending as long as the consent form(s) indicate the Principal Investigator has applied for a Certificate of Confidentiality from an HHS agency. Once received the PI must upload the certificate of confidentiality into iStar and submit an amendment to update the consent informing participants the data is covered under a COC.