For EPA Grantees Proposing Human Subjects Research

All human subjects research (HSR) projects, including those proposed by EPA grantees, must be approved by the EPA Human Subjects Research Review Official (HSRRO) before any work involving human subjects can begin. This page provides information for grantees with EPA-funded research projects who are prepared to submit their HSR projects for HSRRO approval. 

On this page:

• Human Subjects Research Approval Process
• Simple Overview of the Human Subjects Research Process
• Human Subjects Research Statement
• Required Documents
• Human Subjects Research Application Portal
• Policies, Regulations, and Guidance

Human Subjects Research Approval Process

The HSRRO is responsible for ensuring that all human subject research studies supported by EPA comply with EPA regulations concerning research involving human subjects. All human subject research studies conducted by, or funded by EPA must be approved by the HSRRO before work can begin. Ordinarily, the HSRRO’s decision is expected in 30 business days or less; however, timelines vary on the complexity of the project and the number of submissions in the queue. Visit the webpage on the approval process for human subjects research at EPA to learn more.

View the diagram below, or read the text of the information contained in the diagram.

Simple Overview of the Human Subjects Research Process

1. Grantee submits research application to EPA with the Human Subjects Research Statement.
2. If the grant application is approved and awarded, the project officer will forward the project to the Human Subjects Officer (HSO).
3. The HSO will triage the project to assess if it meets the HSR regulations.
   1. This triage effectively decides whether your project constitutes HSR per 40 CFR 26. If your project was flagged by PHREO as HSR and you did not intend to conduct HSR, please work with your HSO.
4. If the project contains human subjects research (HSR), EPA Human Subject Research Review Official (HSRRO) approval must be obtained before HSR activities can begin.
5. If the project does not contain HSR as determined by EPA, no further action is required. For projects determined by EPA to be HSR, the Principal Investigator shall submit the project to an Institutional Review Board (IRB) for approval, and then submit the IRB’s documentation of approval, and all documents submitted to the IRB for HSRRO review. Find more information on IRBs under Policies, Regulations, and Guidance.
6. In order to submit to the HSRRO for review, an application must be completed in using EPA’s Human Subjects Research Application Portal (HSRAP). Complete the steps in the Human Subjects Research Application Portal User Guide (pdf) (1.85 MB) to submit a request to gain access to HSRAP.
7. Add required documents to HSRAP and submit. 
   1. The grantee, or the Project Officer (PO) or the HSO may submit the HSRAP on behalf of the grantee. Contact your PO, who will then contact the EPA HSO regarding the HSRAP submission process.
8. EPA’s Policy Order 1000.17A states that the HSRRO review ordinarily is expected in 30 business days or less; however, timelines vary on the complexity of the project and the number of submissions in the queue.
9. HSR activities can begin only AFTER documentation of HSRRO approval is received.

Human Subjects Research Statement

All applications submitted for research solicitations should include a Human Subjects Research Statement (HSRS). Applications being recommended for funding that involve human subjects research will have their HSRS reviewed before the award. The EPA program office or region’s Human Subjects Officer (HSO) will review the information provided in the HSRS and the Research Plan to determine if the ethical treatment of human subjects is described in a manner appropriate for the project to move forward. The HSO may consult with the EPA Human Subject Research Review Official (HSRRO) as appropriate. The HSRRO may determine that an application cannot be funded if it is inconsistent with EPA’s regulations at 40 CFR Part 26.

If the proposed research does not plan to involve human subjects as defined above, provide the following statement in your application package as your HSRS: “The proposed research does not involve human subjects.” Applicants should provide a clear justification about how the proposed research does not meet the definition. EPA retains the final determination authority for whether a project is human subjects research, or not. 

If the proposed research does involve human subjects, then include in your application package an HSRS referencing the specific location of the information in the Research Plan, providing the information in the HSRS, or explaining why the section does not apply to the proposed research. For more information about the HSRS and requirements, access the  Human Subjects Research Statement (pdf) (136.32 KB) or find more information in the funding solicitation.

Required Documents

The EPA Human Subject Research Review Official (HSRRO) reviews specific documents like the protocol and informed consent documents, before approving human subjects research. In complying with 40 CFR 26 and EPA Order 1000.17A, the Principal Investigator, Contractor, or Grantee must include the following documents in their package to EPA:

• All correspondence(s) between the Principal Investigator and the Institutional Review Board (IRB)
• IRB determination letters, to include all approvals or exemption determination memos
  • The date listed on the IRB approval/exempt determination must match or follow the preceding IRB submission date.
• Full IRB package (to include the IRB-approved study protocol and key research personnel descriptions)
• Scientific Data Management Plan (SDMP), if applicable
• Data Sharing Agreement(s), if applicable
•  Subject-facing materials: 
  • Surveys
  • Questionnaires
  • Interview scripts
  • Recruitment materials (including both print and digital communications)
• IRB-approved informed consent form(s)

You may find more details about each required document in the funding solicitation.

Human Subjects Research Application Portal

Are you ready to submit a project for approval?

To submit a project to the EPA Human Subject Research Review Official (HSRRO) for review, please use the Human Subjects Research Application Portal (HSRAP). Research involving human subjects requires approval by the HSRRO. Additional reviewers may be involved before the HSRRO. The HSRAP system will route these reviews automatically, depending on your location and the nature of the research.

We encourage you to use the  Human Subjects Research Application Portal User Guide (pdf) (1.85 MB)  which includes step-by-step screenshots and detailed guidance on completing the form. The grantee, or the Project Officer (PO) or the HSO may submit the HSRAP on behalf of the grantee. Contact your PO, who will then contact the EPA HSO regarding the HSRAP submission process.

For additional support with HSRAP, contact HSR-Support@epa.gov.

Policies, Regulations and Guidance

EPA follows strict safety protocols for all of its studies to protect the health and safety of human subject volunteers, including engineering controls for the facility and protocols for the medical oversight of the exposures. In addition, all EPA human subject research is conducted in compliance with federal regulations and best practices in ethics. Below are the major regulations to protect and guide HSR. View the How EPA Protects Human Subjects page for more information.

EPA Regulation 40 CFR 26

The primary regulation that governs human subjects research at EPA is 40 CFR Part 26 Subpart A. It is known as the "Common Rule" because over 19 federal departments and agencies have agreed to hold this regulation "in common." Subpart B of the regulation is a ban on intentional exposure research involving pregnant women, nursing women, and children. Subparts C and D of 40 CFR Part 26 seek to ensure that vulnerable subjects are protected in observational research. EPA also added special regulations, subparts K-Q, which are related to the review of third-party pesticide research involving human participants.

• Access the EPA Regulation 40 CFR 26, including the Common Rule

EPA Order 1000.17 A

EPA Order 1000.17A establishes EPA procedures and responsibilities for implementing the requirements outlined in 40 CFR 26. The Order requires that all human subjects research conducted or supported by EPA must either be approved or be acknowledged as exempt research by the EPA HSRRO before any work involving human subjects research can begin. The Order describes the requirements for review, as well as the responsibilities of all parties involved in EPA research in protecting the rights and welfare of human research subjects.

• Access EPA Order 1000.17 A

Institutional Review Board

An Institutional Review Board (IRB) is a committee responsible for reviewing, approving, and overseeing studies (research) involving humans. In the United States, there are federal regulations, guidance, and ethical principles that are used to make decisions on whether an HSR project should be approved, disapproved, or changed so that it can be approved. At EPA, HSR is also reviewed by the HSRRO after it is approved by the IRB because EPA has special regulations that need to be followed to make sure the HSR is ethical.

• Access the Ethical Principles and Guidelines for the Protection of Human Subjects of Research - the “Belmont Report”

If you are a non-EPA researcher, contractor, or grantee, you should contact your organization’s IRB office to learn more about their process for submitting HSR. If your organization does not have its own IRB, you may need to find an IRB that is not associated with an institution/organization. These IRBs are often referred to as “independent” or “central” IRBs, and vary in size and cost, but should be IRBs that follow federal HSR regulations. To locate an independent or central IRB, you may use an internet search engine to search for one that could review your HSR project.

Human Subjects Research Triage Fact Sheet

The Human Subjects Research Triage Fact Sheet gives a one-page overview describing the HSR process.

• Access the  EPA Grantee Human Subjects Research Fact Sheet (pdf) (735.63 KB)

To contact the Program in Human Research Ethics and Oversight, email HSRRO@epa.gov.