IRB: Federally Funded Research: Department of Education (ED)
Policy number: 416 E
Date: 06/12/2014
References:
Policy Owner:
Executive Director, HRPP
45CFR46.103 (f)
OHRP Guidance, IRB Review of Application for HHS Support, 5/31/00
AAHRPP II.1.E, II.3.G, II.4.B, III.2.C
34 CFR 356, 34 CFR 99, 34 CFR 98
Public Law 107-110 Jan. 8, 2002 Part E
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 Department of Education 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 Department of Education.
3.0 Policy Statement
Guidance for Specific Federally Funded Projects:
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
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to the Common Rule. The ED is an agency that has imposed additional requirements for research
subject to its purview. When reviewing research subject to the ED’s additional requirements, the IRB
will meet the Essential Requirements for the Common Rule and, when applicable, for FDA regulations.
In addition, ED 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.
For non-Exempt research involving any ED component, additional requirements listed in 34 CFR 356,
34 CFR 99, 34 CFR 98, and Public Law 107-110 Jan. 8, 2002 Part E (as applicable) 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. Department of Education (ED)
http://www.ed.gov/about/offices/list/ocfo/humansub.html
Public Law 107-110 Jan. 8, 2002 Part E
http://www2.ed.gov/legislation/esea02/107-110.pdf
4.0 Required approvals for this document
Title
Executive Director
5.0 Revision History
Revision
Reason for change
Date of release
06/13/14
12/23/10
Policy update 2014
Reorganization from 416
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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