Environmental Protection Agency

POLICY

Research funded or supported by the Environmental Protection Agency (EPA), must comply with EPA specific regulations on human subjects research.

PROCEDURE

Research Involving Intentional Exposure of Any Human Subject -  Under 40 CFR 26.203, EPA prohibits research involving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or child.

Research involving intentional exposure of a human subject means 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. Other adults who voluntarily choose to participate are protected under the EPA’s rule, “Protections for Subjects in Human Research”, which requires proposed protocols describing intentional exposures be reviewed by EPA and its Human Studies Review Board.

Observational research involving pregnant women or fetuses is allowable if the IRB determines that all criteria for approval are met as per the Initial Review policy.

Observational research with children not involving greater than minimal risk is allowable only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians.

Observational research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects is allowable only if the IRB finds that (see policy on Research Involving Children):

1. The intervention or procedure holds out the prospect of direct benefit to the individual subject or is likely to contribute to the subject's well-being;
2. The risk is justified by the anticipated benefit to the subjects;
3. The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and
4. Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians.

Final Review by EPA - PIs must submit IRB determinations and approval to the EPA Human Subjects Research Review official for final review and approval before the research can begin.

Research Not Conducted or Supported By Any Federal Agency - For research not conducted or supported by any federal agency that has regulations for protecting human research participants and for which the intention of the research is submission to the EPA, the EPA regulations protecting human research participants apply, including:

1. EPA extends the provisions of the 40 CFR 26 to human research involving the intentional exposure of non-pregnant, non-nursing adults to any substance.
2. EPA prohibits the intentional exposure of pregnant women, nursing women, or children to any substance.

REGULATIONS

1. EPA - Human Subjects Research

REFERENCE TO OTHER POLICIES

1. Initial Review

ATTACHMENTS

1. None

If you find errors in this document, contact [email protected] 

CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)

IRB OFFICE HOURS Thursdays from 1 to 4pm, via the Teams Room at this link

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