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NIH Certificate of Confidentiality

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What is a Certificate of Confidentiality (CoC)?

CoCs provide additional privacy protections to research participant by protecting investigators and institutions from being compelled to release information that could be used to identify subjects with a research project.  Certificates are issued by NIH and other Department of Health and Human Services (HHS) agencies to institutions or universities where the research is conducted. They allow the investigator and others who have access to research records to refuse to disclose identifying information in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. Learn more about CoCs.



Which projects are eligible for CoCs?

Certificates of confidentiality are ONLY issued for research projects that are:

  • Collecting subject names or other identifying characteristics, on a sensitive research topic
  • Approved by an Institutional Review Board (IRB) operating under a Federalwide assurance (FWA) issued by the DHHS Office of Human Research Protections (OHRP) or with the approval of the FDA
  • On a topic that is within the HHS health related research mission
  • Storing research data in the United States
  • Allowable under federal regulations
  • Federal funding is not required but issuance is at the discretion of the issuing agency.

 

The following is an illustrative but not exhaustive list of research areas eligible for a CoC:

  • Research on HIV, AIDS, and other STDs;
  • Studies that collect information on sexual attitudes, preferences, or practices;
  • Studies on the use of alcohol, drugs, or other addictive products;
  • Studies that collect information on illegal conduct;
  • Studies that gather information that if released could be damaging to a participant's financial standing, employability, or reputation within the community;
  • Research involving information that might lead to social stigmatization or discrimination if it were disclosed;
  • Research on participants' psychological well-being or mental health;
  • Genetic studies, including those that collect and store biological samples for future use;
  • Research on behavioral interventions and epidemiologic studies.



In what situations may personally identifiable information protected by a CoC be disclosed?

Disclosure is permitted only when:
  • Required by Federal, State, or local laws (e.g., as required by the Federal Food, Drug, and Cosmetic Act, or state laws requiring the reporting of communicable diseases to State and local health departments), excluding instances of disclosure in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding;
  • Necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;
  • Made with the consent of the individual to whom the information, document, or biospecimen pertains; or
  • Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.



NIH Funded Research - Procedures for when a CoC is automatically issued

  1. The IRB application (or modification application) must address the CoC in the confidentiality sections of both the protocol narrative and the informed consent document(s)
  2. Ensure that the informed consent document(s) contain appropriate language about the protections and limitations of the CoC. Please see the UCI biomedical and social/behavioral/educational consent form template(s) for CoC language.



Non-NIH Funded Research - Procedures for when a CoC is not obtained prior to IRB Submission (i.e. CoC application is pending)

Generally, a CoC application is submitted after the IRB approval, as approval is required as a pre-requisite for issuance of the Certificate.

  1. If an Investigator wants to apply for a CoC, submit an IRB application (or modification application) that addresses the intent to apply for a CoC in the confidentiality sections of both the protocol narrative and the informed consent document(s).
  2. Ensure the informed consent document(s) contain appropriate language about the protections and limitations of the CoC. Please see the UCI biomedical and social/behavioral/educational consent form template(s) for CoC language.
  3. Complete the CoC application via the NIH on-line application system. For further instruction, visit the CoC Kiosk.
  4. Provide a copy of the CoC application and CoC assurance page, signed by the Investigator, with the IRB application.
  5. The IRB application, protocol documents, and CoC application will be administratively reviewed by the HRP staff to confirm completeness and accuracy. If revisions to the IRB documents or CoC application are required, the Investigator will be notified.   
  6. Once the CoC application has been verified by HRP staff, the requisite signature will be obtained. After it is signed, the HRP staff will forward the CoC assurance to the Investigator to include with their CoC application on-line.
  7. Immediately upon receiving the CoC Approval letter, forward a copy to the HRP office for documentation in the protocol record.
  8. If the research project will extend beyond the expiration date on the CoC, the Investigator may submit a written request to NIH for extension of the date. If the request is approved, an amended Certificate will be issued.  The amended CoC Approval letter must be forwarded to the IRB immediately upon receipt.



Non-NIH Funded Research - Procedures for when CoC Approval has been obtained prior to IRB Submission

For multi-site projects, a coordinating center, lead institution, or Sponsor can apply for and receive a CoC Approval on behalf of all member institutions.

  1. The IRB application (or modification application) must address the CoC Approval in the confidentiality sections of both the protocol narrative and the informed consent document(s).
  2. Ensure that the informed consent document(s) contain appropriate language about the protections and limitations of the CoC. Please see the UCI biomedical and social/behavioral/educational consent form template(s) for CoC language.
  3. Provide a copy of the CoC Approval letter with the IRB application. 
  4. The IRB application, protocol documents, and CoC Approval letter will be administratively reviewed by the HRP staff to confirm completeness and accuracy. If revisions to the IRB documents are required, the Investigator will be notified.  
  5. If the research project will extend beyond the expiration date on the CoC, the Investigator must forward the amended CoC Approval to the IRB immediately upon receipt.



Additional requirements

  1. Informed Consent Process - When an Investigator obtains a CoC, the subjects must be told about protections afforded by the CoC and any exceptions to those protections. In addition, researchers may not represent the CoC as an endorsement of the research project by the DHHS or use it in a coercive manner when recruiting subjects.
  2. Significant Changes - If a significant change in the research project is proposed after a CoC is issued, the Investigator must inform the Certificate Coordinator of the Institute issuing the certificate by submitting an amended application for a CoC (in the same form and manner as the original application for a Certificate). Significant changes include: major changes in the scope or direction of the research protocol, changes in personnel having major responsibilities in the project, or changes in the drugs to be administered (if any) and the persons who will administer them.
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