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Human Investigation Committee
Yale University
School of Medicine
47 College Street,
Suite 204
New Haven, CT
06520-8010 USA
Phone:
(203) 785-4688
Fax:
(203) 785-2847
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Assurances
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Federalwide Assurance of Protection for Human Subjects: FWA00002571 |
Terms of the Federalwide Assurance Web site. |
Federal regulations require that institutions conducting human subject research, which is supported by or in collaboration with DHHS agencies, provide the Office for Human Research Protections (OHRP) with a Federalwide Assurance (FWA).
The terms of the FWA define the relationship between Yale University and DHHS by outlining the institutional responsibilities and procedures used to protect human subjects. The Assurance also specifies that Yale University will meet all the requirements of Title 45, Part 46, of the Code of Federal Regulations (45 CFR 46) for all federally funded research involving human subjects. The Assurance establishes the Institutional Review Board (IRB) and ensures that research involving human subjects will not be permitted until the IRB has reviewed and approved the research protocol and informed consent process.
FWA affiliates who may rely on Yale IRBs include The APT Foundation, Community Consultation Board, Inc., Connecticut Mental Health Center, Haskins Laboratories, John B. Pierce Laboratory, Inc., Yale-New Haven Hospital and Yale University.
View the Terms of the Federalwide Assurance:
FWA00002571
Please visit the OHRP web site for more information on institutional assurances.
Food and Drug Administration
In addition to the Terms of the Federalwide Assurance, Yale complies with all applicable regulations and policies set forth in 21 CFR Parts 50 and 56 of the DHHS Food and Drug Administration.
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Last modified: Wednesday, 08-Oct-2008 12:09:33 EDT. (VM)