University of Pennsylvania, Institutional Review Board

University of Pennsylvania, Institutional Review Board

3800 Spruce St. First Floor Suite 151, Philadelphia PA 19104-6006

ENVIRONMENTAL PROTECTION AGENCY (EPA): ADDITIONAL REGULATIONS CHECKLIST FOR INVESTIGATORS AND IRB STAFF

PI:

The following items/documentation is required for research supported and/or regulated by the Environmental Protection Agency (EPA). For any items that pertain to your research (i.e. marked “yes”), please verify that the appropriate protections are in place. Comments may be provided if necessary.

Please note the following:

ü  EPA prohibits research involving the intentional exposure of pregnant women, nursing women, or children to any substance.

ü  EPA policy requires submission of IRB determinations and approval to the EPA human subjects’ research review official for final review and approval before the research can begin.

ü  If the research targets pregnant women or fetuses for enrollment, the reviewing IRB will apply the regulations under 40 CFR 26 and 46 CFR 46 Subpart B.

General
1. (Yes) (No) / Are you including pregnant women and/or children in observational research?
-If yes, verified that the research follows the requirements of 40 CFR 26 Subparts C and D to provide additional protections to these vulnerable population.
Subpart B worksheet attached (pregnant women)
Subpart D worksheet attached (children)
Comments
2. (Yes) (No) / Are you conducting research that is not supported by any other federal agency or is not being conducted at an Institution which applies the federal regulations for protections of human research participants and for which the only reviewing entity will be the EPA?
-If yes, the following EPA regulations protecting human research participants will apply including:
·  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.
·  EPA prohibits the intentional exposure of pregnant women, nursing women, or children to any substance.
Comments
3. (Yes) (No) / Does the research propose observational activities involving children (which would not qualify as greater than minimal risk)?
If yes, adequate provisions for soliciting assent of the children and permission of their parents or guardians must be present in the protocol, as set forth in 46 CFR 46 Subpart D.
Subpart D worksheet attached
Comments
4. (Yes) (No) / Does the research propose observational activities involving children (which would qualify as greater than minimal risk)?
If yes, please provide justification in the protocol for the following criteria that the IRB must agree to be met:
·  The intervention or procedure holds out the prospect of direct benefit to the individual participant or is likely to contribute to the participant's well-being.
·  The risk is justified by the anticipated benefit to the participants.
·  The relation of the anticipated benefit to the risk is at least as favorable to the participants as that presented by available alternative approaches.
·  Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in 46 CFR 46 Subpart D.
Subpart D worksheet attached
Comments
18. (Yes) (No) / Hold for additional elements
If yes,
Comments
Principal Investigator: / Signature: Date:
IRB ONLY
IRB Administrator / Signature: Date Screening Completed:

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Version: 2017.10