Northwestern University – Institutional Review Board Office
Supplement for the Environmental Protection Agency (EPA)
Research and Research Intended to Be Submitted to the Environmental
Protection Agency
Please use this form only when:
o The study is under the purview of the Environmental Protection Agency (EPA) and/or the
research will be submitted to the EPA http://www.epa.gov/phre/
1. Principal Investigator Name:
2. Project Title:
3. IRB Study Number: STU
4. This form is an attachment to a
new study or
existing study (select one)
Instructions:
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

Handwritten or incomplete forms will not be accepted
Complete all applicable sections of this form and do not leave any blanks unless directed
Within eIRB, upload a copy of the completed form in the protocol section of the study
application.
A. Does the research involve the intentional exposure of a human subject?
Check “yes” or indicate the question is not applicable. Provide a response for all items listed below.
The 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. Research involving intentional
exposure of a human subjects 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”.
Examples include the following:
 Intentional dosing studies in which a study substance is administered directly to participants or
introduced into their environment by a researcher under controlled conditions
 Other environmental exposure studies which do not entail intentional dosing but in which
some aspect of the exposure under study is determined or influenced by the research.
Version date 04/05/2012
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Northwestern University – Institutional Review Board Office
Yes
N/A – The research does not involve the intentional exposure of pregnant women,
nursing women or children to any substance
Note: Pregnant women, nursing women and children are not permitted to participate in studies
that involve the intentional exposure to substances
B. Is this an observational study which will enroll minors?
Observational Research means any research with human subjects that does not meet the
definition of research involving intentional exposure of a human subject in 40 CFR 26.202(a).
This includes studies that measure only naturally occurring environmental exposures that are not
controlled or influenced by the research in any way.
1.
Yes
N/A – Is this an observational study?
2. Does the study involve minors?
Yes
N/A
3. If the research involves minors, indicate the risk level to minors:
Minimal risk
Greater than minimal risk
If minimal risk, please describe here and in the protocol, how children assent and
parental permission will be obtained.
b. If greater than minimal risk, address each item below. The information should also be
added to the protocol.
i. Explain how 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.
ii. Are risk is justified by the anticipated benefit to the subjects. Please explain:
iii. Clarify if the relation of the anticipated benefit to the risk is at least as favorable
to the subjects as that presented by available alternative approaches.
iv. Were adequate provisions made for soliciting the assent of the children and
permission of their parents or guardians? Please describe:
C. Prior to initiating research which involves intentional exposure, confirm the following:
Yes
N/A – If the results of research involving an intentional exposure of human
subjects are intended to be submitted to or held for inspection by the Environmental
Protection Agency (EPA), the IRB’s determinations and approval will be submitted by the PI
to the EPA Human Subjects Research Review Official for final review and approval before
the research can begin.
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