Human Subjects Protection

HRSA must protect human subjects under its Federal Wide Assurance with the Department of Health and Human Services (HHS) Office for Human Research Protections (ORHP).

How do we apply the protections?

Specifically we protect people who participate in research programs we conduct or support. The protections apply to studies conducted internally by federal staff and to external studies conducted by grantees and contractors.

What is HRSA’s policy?

Read HRSA’s Human Subjects’ Protection Policy (PDF – 118 KB)

HRSA’s policy:

  • Provides guidance for compliance with federal regulations for the protection of human research subjects participating in research that we conduct, support, and disseminate.
  • Affirms our commitment to protect the rights of all participants in research and delineate various levels of protection applicable to HRSA investigators, supervisors, and other stakeholders.
  • Explains how to determine the appropriate procedures to support the human research protections in each HRSA program involving interventions with human subjects to ensure the safety of participants and the integrity of the data.
  • Defines specific responsibilities and processes for HRSA staff participating in planning, reviewing, executing, or administratively supporting research involving human participants.
  • Explains the exemption process for certain research, which is exempt from human subjects’ research regulatory requirements.

What training opportunities are available?

National Institutes of Health (NIH) Web-based Training Module

Protecting Human Research Participants (PHRP) Online Training - a free online training module.

Note: you must create an account before you can view the module. Continuing Medical Education (CME) credits are available for this training.

Office for Human Research Protections (OHRP) Webinars

View the educational webinars on the Department of Health and Human Services (HHS) regulations requirements for the protection of human subjects.

HHS’s Interactive Training Video

The Research Clinic is an interactive training video educates clinical and social researchers on the importance of appropriately protecting research subjects and avoiding research misconduct. 

What is a Certificate of Confidentiality?

The Secretary of Health and Human Services may issue Certificates of Confidentiality to protect researchers from compelled disclosure of the identities of research subjects.

What are the benefits?

A Certificate of Confidentiality protects all identifiable information for any research subject (i.e., an individual about whom the investigator maintains identifying information) any time the Certificate is in effect.

The protection is permanent; subjects enrolled within the specified study period are protected even after the study ends. However, the Certificate does not cover subjects enrolled in a study outside the specified timeframe of the Certificate.

What are the limitations?

The Certificate protects against the involuntary disclosure of information that could identify subjects. It does not govern the voluntary disclosure of identities of research subjects.

Researchers are not prevented from the voluntary disclosure of 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 informed consent form provided to research subjects should clearly indicate this.

How do you apply for a Certificate of Confidentiality?

To apply for a HRSA Certificate of Confidentiality, complete the following steps:

  1. Download and review the Certificate of Confidentiality Application Instructions
    (PDF – 122 KB)
  2. Contact the HRSA Certificate of Confidentiality Coordinator for an initial consultation:
    Lisa Wright-Solomon
    Email: lwright-solomon@hrsa.gov | Call: 301-443-1984
  3. Email an application letter to the Coordinator, using the host research institution’s letterhead. Number the letter according to the application instructions.
    Note: 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 the Secretary may issue.

Who can submit the application?

Anyone on the study team can apply on behalf of the Principal Investigator (PI) (i.e., the individual primarily responsible for conducting the research).

However, the PI and the authorized Institutional Official must sign the application letter. By signing the application letter, you agree to the assurances in the application letter.

Note: Type the name and title of the Institutional Official below the signature line.

Do you need Institutional Review Board (IRB) approval?

Yes. Approval must be current and unconditional, or conditioned only upon the issuance of a Certificate of Confidentiality.

If this is a multi-site project, you only need to submit the lead site Institutional Review Board (IRB) approval. However, the lead site must maintain a copy of the IRB approval from each site, which must be made available to us upon request.

Can you request an extension on the Certificate?

Yes. You may request an extension if you will not complete the research project by the expiration date indicated on the Certificate and/or if an amendment is necessary. Email the HRSA Certificates of Confidentiality Coordinator at least three months prior to the expiration date.

Note: Your request should include a justification for the extension/amendment, documentation of the most recent IRB approval, and expected date for completion of the research project.

Date Last Reviewed:  March 2019


Contact Us

Certificate of Confidentiality Coordinator
Email Lisa Wright-Solomon
Call: 301-443-1984