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Making Funding Awards and Other Agreements that Support Human Subjects Research (HSR)

Program in Human
Research Ethics

PHRE Online Tutorial

This page provides information for EPA grants specialists, project officers, and others who participate in the process of making funding awards or entering into other agreements that support projects that may incorporate HSR during the period of support. This includes grants, contracts, cooperative agreements, cooperative research and development agreements (CRADAs), interagency agreements (IAGs), or any other formal agreement involving EPA support for a project that may incorporate HSR.

What Kinds of Projects May Incorporate HSR?

Any project that collects data from or about humans may meet the regulatory definition of research with human subjects and thereby be subject to the requirements of EPA Regulation 40 CFR 26 and EPA Order 1000.17 Change A1. This includes projects conducted under programs that are not considered research for other purposes. For example, some demonstration programs and some public health practice programs may include research activities. Any EPA personnel involved in the development of support agreements for any project that collects data from or about humans should therefore be sure that an accurate HSR/non-HSR determination has been made before proceeding.

Who Makes the HSR/non-HSR Determination?

The EPA component supporting the project is responsible for the HSR/non-HSR determination. Some EPA components have an HSR Officer who is trained to make this determination accurately and to process those projects that meet the regulatory definition of HSR according to the requirements of 40 CFR 26 and Order 1000.17 Change A1. Personnel from EPA components where an HSR Officer is not available may contact the EPA Human Subjects Research Review Official (HSRRO) directly to obtain these services.

If a Supported Project Anticipates Incorporating HSR, What is Required of the Entity Receiving the Support?

Entities that will be engaged in HSR supported by EPA must provide an assurance of compliance to the Agency documenting their agreement to comply with EPA Regulation 40 CFR 26 (Protection of Human Subjects) in order to be able to receive support. EPA does not generally negotiate individual assurances with potential awardees but rather requires that they hold a Federalwide Assurance, which is a document filed with the Office for Human Research Protections of the Department of Health and Human Services that covers all Common Rule agencies, including EPA. In addition, the research must be reviewed and approved by an institutional review board (IRB) listed on the assurance before it can be conducted, unless the research meets the regulatory criteria for exemption.

Approval of the Support Agreement by the EPA Human Subjects Research Review Official (HSRRO):

EPA Order 1000.17 Change A1 requires that all HSR supported by EPA be reviewed and approved by the HSRRO as compliant with 40 CFR 26, or be determined to be exempt research, before any support agreement is entered into. This is not always possible, however, because sufficient detail to do an adequate review may not be available until after support has already been provided, because only then can full protocol development and IRB review occur. Under such circumstances, the HSRRO will provide a conditional approval for the support agreement contingent upon later HSRRO review and approval of the research itself after IRB review and approval have occurred. More detail about HSRRO review of support agreements, and the documents required for that review, can be found on the Project Review page.

Approval of the Research Itself by the HSRRO:

Whether or not a prior conditional approval of a support agreement was provided, all EPA-supported HSR must itself be reviewed and approved by the HSRRO as compliant with 40 CFR 26, or be determined to be exempt research, before the research can begin. This requirement is in addition to IRB review and approval, and it occurs subsequent to it as the final step before the research commences. This step is specific to EPA and may not be known to some supported entities, so it is important to make sure that the supported entity is aware of this requirement in order that EPA-supported HSR not begin before final HSRRO approval is obtained.

Checklists for Use in Processing Support Agreements for Possible HSR:

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