The Secretary of Health and Human Services may issue Certificates of Confidentiality under Section 301(d) of the Public Health Service Act (42 USC 241(d)). These Certificates are intended to protect researchers from compelled disclosure of the identities of research subjects. The Secretary has delegated the authority to issue these Certificates to all Public Health Service agencies.
The Health Resources and Services Administration issues Certificates for research that is supported by HRSA funds or related to HRSA programs.
To apply for a HRSA Certificate, the investigators should first consult with the Certificate of Confidentiality Coordinator. The Coordinator, Jessica Preusch, can be reached at firstname.lastname@example.org or (301) 443-8474. The investigators should submit an application letter electronically to the Coordinator, on the host research institution’s letterhead. The letter should be numbered according to the scheme shown below. Please write in complete sentences, concisely providing each item of information required in narrative format in the body of the letter. Portions of this narrative will be used verbatim to describe the research project in the Certificate that might be issued.
Please include the following in your application letter:
If the applicant institution does not receive DHHS funding for this research involving human subjects but has an IRB that complies with the requirements for IRB’s imposed by another Federal agency, that IRB must approve the research. If the applicant institution does not have an IRB, the project should be reviewed by an IRB in accordance with 45 CFR Part 46.
Documentation of IRB Approval: Attach a formal letter or form signed by an authorized IRB representative. Approval must be current and unconditional, or conditioned only upon the issuance of a Certificate of Confidentiality and documented by a letter or form signed by an authorized IRB representative. If this is a multi-site project, only the lead site IRB approval needs to be submitted; however, the lead site must maintain a copy of the IRB approval from each site, which must be made available to the HRSA upon request.
If the project is exempt from IRB oversight and approval, the applicant should attach justification. If such an exempt project is supported by HRSA funds, please attach a statement demonstrating compliance with Program Protection of Human Subjects Participating in Research Programs Conducted or Supported by HRSA policy.
Documentation of IRB Qualifications: For all projects, submit the Federal Wide Assurance (FWA) number assigned by OHRP for the IRB that reviewed the project or statement of qualifications that the IRB complies with the applicable Federal regulations governing research involving human subjects and the appropriate IRB number associated with the FWA number.
If this is a multi-site project, the lead site must maintain the OHRP assurance number for the reviewing IRB at each site, which must be made available to the HRSA upon request.
Attach copies of the informed consent forms to be used in the study, as approved by the IRB. The informed consent form must include a description of the protections and limitations of the Certificate of Confidentiality, including the circumstances in which the investigators plan to disclose voluntarily identifying information about research participants (e.g. child abuse, harm to self or others, etc.).
Sample language is provided below.
If significant changes are made to the informed consent form, the applicant should contact the Certificate of Confidentiality Coordinator who issued the Certificate and submit a copy of the revised consent form.
Please include verbatim assurances that the investigators, the responsible institution, and all collaborating institutions (if applicable) will ensure:
This letter request must be signed by the individual primarily responsible for the conduct of the research and by an appropriate institutional official authorized to bind the host institution. In doing so, they are agreeing to the assurances as stated in the application letter.
If the research project will not be completed by the expiration date and/or an amendment is necessary, the Certificate holder should submit an email request for an amendment of the Certificate 3 months prior to the expiration date. Any such request should include the justification for the amendment/extension, documentation of the most recent IRB approval, and the expected date for completion of the research project.
Any request will be processed as rapidly as possible. However, if all of the items of information requested above are not provided in the letter, issuance of your certificate will be delayed.
Note to Applicant:
Once your application has been reviewed by the Coordinator, please send your letter to:
HRSA Office of Planning, Analysis and Evaluation
Parklawn Building 10-49
5600 Fishers Lane
Rockville, MD 20857
NOTE: When a researcher obtains a Certificate of Confidentiality, the research subjects must be told about the protections afforded by the certificate and any exceptions to that protection. That information should be included in the informed consent form. Examples of appropriate language follow. Researchers may adapt the language to the needs of the research participants and to the subject matter of the study. However, the language used must cover the basic points.
Researchers should also review the language about confidentiality and data security that is routinely included consent forms to be certain that it is consistent with the protections of the Certificate of Confidentiality.
The Office for Human Research Protections provides guidance on the content of informed consent documents.
A Certificate of Confidentiality has been obtained from the Federal Government for this study to help insure your privacy. This Certificate means that the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative or other proceedings. But, if you request disclosure, we can release the information.
The Certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).
[The researchers should include language such as the following if they intend to make voluntary disclosure about things such as child abuse, intent to hurt self or others, or other voluntary disclosures.] The Certificate of Confidentiality does not prevent the researchers from disclosing voluntarily, without your consent, information that would identify your as a participant in the research project under the following circumstances. [The researchers should state here the conditions under which voluntary disclosure would be made. If no voluntary disclosures will be made, the researchers should so state.]