Environmental Protection Agency
Research that is either: 1) conducted by the EPA, 2) supported by the EPA or 3) conducted by any party with the intent that the results will be submitted to the EPA for consideration under the Federal Insecticide, Fungicide, and Rodenticide Act, or under Section 408 of the Food, Drug and Cosmetic Act. 40 C.F.R. § 26.1203, is subject to additional regulations specific to the Environmental Protection Agency (EPA)found at 40 CFR 26. These regulations outline additional protections and prohibitions for children, pregnant women and fetuses, and nursing women.
Research involving intentional exposure of a human subject: a study of a substance in which the exposure to the substance experienced by a human subject participating in the study would not have occurred but for the human subject’s participation in the study.
Observational Research: any human research that does not meet the definition of research involving intentional exposure of a human subject.
Specific EPA Requirements and Restrictions
EPA prohibits research involving the intentional exposure of pregnant women, nursing women, or children to any substance.
While intentional exposure is prohibited in pregnant women and fetuses, in EPA sponsored studies, observational research is permitted provided all of the conditions outlined in 45 CFR 46.204 and 45 CFR 46.206 are met.
Children may also be enrolled in observational studies provided that the study either presents minimal risk, or the study presents greater than minimal risk, but holds out the prospect of direct benefit to the child or “is likely to contribute to the subject’s well-being.” 40 C.F.R. § 26.405(a). In reviewing studies of this nature, the IRB must determine that the risk is justified by the anticipated benefit, and that the relation of the anticipated benefit to the risk is at least as favorable as the available alternative approaches. 40 C.F.R. § 26.405. Appropriate mechanisms must be employed for soliciting the permission of the parents and the assent of the children in such observational studies. 40 C.F.R. § 26.406.
Prior Submission of Proposed Human Subject Research for EPA
All human subject research studies supported by the EPA must either be approved or be determined to be exempt research by the EPA Human Subjects Research Review Official before any contract, grant, or formal agreement involving EPA support is awarded or entered into.
To obtain approval by the EPA Human Subjects Research Review Official (Review Official), the following documents must be submitted by the investigator to the EPA:
- The Primary Awardees Federalwide Assurance (FWA) number
- Copies of:
- the IRB approval (or exemption) letter
- the study protocol(s) as submitted to the IRB (the pre-award document is not sufficient)
- the IRB approved consent forms and subject recruitment materials if applicable
- all supplementary IRB correspondence