IRB: Federally Funded Research: Environmental Protection Agency
Policy number: 416 C
Date: 06/13/2014
References:
Policy Owner:
Executive Director, HRPP
45CFR46.103 (f)
OHRP Guidance, IRB Review of Application for HHS Support, 5/31/00
AAHRPP I.1.D, II.4.A
EPA: 40 CFR 26, 40 CFR 26:201-203, 40 CFR 26:304, 404-405, 40 CFR
26:1101-1125, 40 CFR 26.12.01-1204, EPA Order 1000.17 Change A1
Cross References:
101 B Federalwide Assurance and Registration
409 Reporting Requirements
416 ,Federally Funded Research: DHHS
603 Transfer of IRB Review Authority
Appendix A: Sponsored Projects
Definitions:
None
1.0 Reason for Policy
To ensure Environmental Protection Agency requirements are met for IRB review and documentation.
2.0 Scope of Policy
This policy covers all University of Minnesota researchers and healthcare components receiving funding
from EPA.
3.0 Policy Statement
Guidance for Specific Federally Funded Projects:
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Federal Agencies, when funding or overseeing research involving human subjects, may impose
additional requirements above those articulated in the Common Rule, even if that agency is a signatory
to the Common Rule. The EPA is an agency that has imposed additional requirements for research
subject to its purview. When reviewing research subject to the EPA’s additional requirements, the IRB
will meet the Essential Requirements for the Common Rule and, when applicable, for FDA regulations.
In addition, EPA supported research that includes protected populations shall meet the protections of
45CFR46, Subparts B, C and D.
No research may be initiated until conditions have been met and documented as applicable.
When additional agency permission is required, no research procedures will be undertaken until such
approvals are secured and documented.
Additional Requirements for Research Involving any EPA component:
For research involving any EPA component, additional requirements listed in 40 CFR 26 and EPA
Order 1000.17 Change A1 will be confirmed by HRPP Staff and the IRB primary reviewer.
Designated IRB staff will review the most recent version of guidance on the agency’s website and verify
the additional requirements of the agency are met. Review will follow normally per IRB policies.
U.S. Environmental Protection Agency
http://www.epa.gov/osa/phre/pdf/epa-order-1000_17 a1.pdf
4.0 Required approvals for this document
Title
Executive Director
5.0 Revision History
Revision
06/13/14
12/23/10
Reason for change
AAHRPP updates
Reorganization from 416
Date of release
09/02/14
12/23/10
To obtain a copy of a historical policy, e-mail IRB at irb@umn.edu or call 612-626-5654
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