Human Subjects Research

Certificates of Confidentiality

Application Instructions

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, investigators should send a letter containing the following information, organized into paragraphs according to the numbering scheme shown. Please write in complete sentences, concisely providing each item of information required in narrative format in the body of the letter. Except for Items 4 and 5, attachments are not necessary. Portions of this narrative will be used verbatim to describe the research project in any Certificate that might be issued.

1. Title of the project.
2. Source and number of any Federal grant or contract that supports the research directly or indirectly (e.g. "This research is supported by SPNS Grant BRH-xxxxxx from the Health Resources and Services Administration;" if none, state "This study is not supported by Federal funds").
3. Name and location of the host institution(s) that will sponsor and oversee the study.
4. Brief explanation of how the study complies with HHS requirements for Institutional Review Board (IRB) approval (attach letter or form signed by authorized IRB representative). If the project is claimed to be exempt from IRB oversight, 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 (this is not necessary if the study has been approved by an IRB).
5. Brief explanation of how the study complies with requirements for informed consent from all subjects. Attach copies of the informed consent forms to be used in the study, as approved by Institutional Review Board or other appropriate authority (specify).
6. Name, business address and phone number of the Principal Investigator. Briefly summarize relevant training and experience.
7. Beginning and expected end dates of the project.
8. Concise description (one or two paragraphs) of the project aims and research methods. Please state the number, source and description of the human subjects.
9. Reasons for requiring confidentiality.
10. Concise description of the means used to protect subjects' identities (e.g., coded identifiers, record access restricted to trusted staff, locked files and secured computer data storage, etc.).
11. Assurances of compliance with HHS requirements. Please give specific assurances that the investigators, the responsible institution, and all collaborating institutions (if applicable) will ensure:

    (a) that all personnel involved in the conduct of the research will comply with all the requirements of 45 CFR Part 46, "Protection of Human Subjects." (Projects not supported by DHHS must certify compliance with 45 CFR 46.103(c) and document legally informed consent in a manner consistent with the principles stated in 45 CFR 46.111);

    (b) that the Certificate of Confidentiality will not be represented as an endorsement of the project by the Secretary of HHS or be used to coerce individuals to participate in the research project;

    (c) that the recipient of the Confidentiality Certificate will use its authority to protect the identity of research subjects;

    (d) that all subjects will be informed that a certificate has been issued and that subjects will be provided with a description of the protection covered by the certificate; and

    (e) that subjects who enter the project after termination of the certificate will be informed of the termination.

This letter request must be signed by the individual primarily responsible for the conduct of the research and by an appropriate management or administrative official authorized to bind the host institution.

The Confidentiality Certificate does not prevent the voluntary disclosure of identifying characteristics of research subjects, but only protects subjects from compelled disclosure of identifying characteristics. The Certificate thus does not forbid a researcher voluntarily disclosing matters such as child abuse or a subject's threatened violence to self or others. However, if a researcher intends to make such voluntary disclosures, the consent form should clearly indicate this.

If the research project will not be completed by the expiration date and/or an amendment is necessary, the Certificate holder should submit a written 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.

Send letter to:

Amber Berrian
HRSA Center for Quality
Parklawn Building 7-100
5600 Fishers Lane
Rockville, MD 20857
aberrian@hrsa.gov
301-443-0845