OMB No.
0990-0278
Approved for use through 01/31/2008
[ ] New Filing [X] Update or Renewal for FWA Number: FWA00004513
1. Institution Filing Assurance
Legal Name:
City:
HHS Institution Profile File (IPF) code, if known: 1514802
Federal Entity Identification Number (EIN), if known: 1150532082A4
If this Assurance replaces an MPA or CPA, please provide the "M" or "T" number:
2. Institutional Components
List below all components over which the Institution has legal authority that operate under a different name. Also list with an asterisk (*) any alternate names under which the Institution operates. The Institution should have available for review by the Office for Human Research Protections (OHRP) upon request a brief description and line diagram explaining the interrelationships among the Assurance Signatory Official, the Institutional Review Board(s) (IRB), IRB support staff, and investigators in these various components.
NOTE: The Signatory Official signing this Assurance must be legally authorized to represent the Institution providing this Assurance and all components listed below. Entities that the Signatory Official is not legally authorized to represent may not be listed here without the prior approval of OHRP.
[X] Please check here if there are no such components or alternate names.
3. Statement of Principles
This Institution assures that all of its activities related to human subjects research, regardless of the source of support, will be guided by the ethical principles in the following document(s): (indicate below )
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[X] The |
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[ ] Other: (Please submit copy to OHRP with this Assurance) |
4. Applicability
(a) This Institution assures that whenever it engages in human subjects research conducted or supported by any federal department or agency that has adopted the Federal Policy for the Protection of Human Subjects, known as the Common Rule, the Institution will comply with the Terms of the Federalwide Assurance for Institutions Within the United States (contained in a separate document on the OHRP website), unless the research is otherwise exempt from the requirements of the Common Rule or a department or agency conducting or supporting the research has determined that the research shall be covered by a separate assurance.
(b) Optional: This Institution elects to apply the following to all of its human subjects research regardless of the source of support, except for research that is covered by a separate assurance:
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[X] The Common Rule (see section 3 of the Terms of the
FWA for Institutions Within the |
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[ ] The Common Rule and subparts B, C, and D of the HHS regulations at 45 CFR part 46 |
5. Designation of Institutional Review Boards (IRBs)
This Institution designates the following IRB(s) for review of research under this Assurance (if the IRB has not previously registered with HHS or has not provided a membership roster to HHS, please submit to OHRP the appropriate IRB registration materials which are available on the OHRP website).
NOTE: Reliance on the IRB of another institution or organization or an independent IRB must be documented by a written agreement that is available for review by OHRP upon request. OHRP’s sample IRB Authorization Agreement may be used for this purpose, or the parties involved may develop their own agreement. Future designation of other IRBs requires an update of the FWA.
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HHS IRB |
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IRB00000340 IRB00000952 IRB00000200 IRB00000758 IRB00000204 IRB00000295 IRB00000463 |
CORNELL
U IRB #1 Mary Imogene Bassett Hosp Johns
U
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6. Human Protections Administrator (e.g., Human Subjects Administrator or Human Subjects Contact Person)
First Name: E. Middle Initial: Ray Last Name: Stinson
Degrees or
Suffix: Ph.D.
Institutional Title: Assistant Vice President for Research Compliance;
Director, Office for Research Integrity and Assurance
Institution:
Telephone: (607) 255-5398 FAX: (607) 255-0758
E-Mail: ers39@cornell.edu
Address:
City:
7. Signatory Official (i.e., Official Legally Authorized to Represent the Institution -- Cannot be IRB Chairperson or IRB Member)
I understand that the Assurance Training Modules on the OHRP website describe the responsibilities of the Signatory Official, the IRB Chair(s), and the Human Protections Administrator under this Assurance. Additionally, I recognize that providing research investigators, IRB members and staff, and other relevant personnel with appropriate initial and continuing education about human subject protections will help ensure that the requirements of this Assurance are satisfied.
Acting officially in an authorized capacity on behalf of this Institution and with an understanding of the Institution’s responsibilities under this Assurance, I assure protections for human subjects as specified above. The IRB(s) designated above are to provide review for all research to which this Assurance applies. The designated IRB(s) will comply with the Terms of the Federalwide Assurance for Institutions Within the United States and possess appropriate knowledge of the local context in which this Institution’s research will be conducted.
All information provided with this Assurance is up-to-date and accurate. I am aware that false statements could be cause for invalidating this Assurance and may lead to other administrative or legal action.
Signature ____________________________________________ Date: ________________
First Name: Charles Middle Initial: R. Last Name: Fay
Degrees or
Suffix:
Institutional Title: Vice Provost for Research Administration
Institution:
Telephone: (607) 255-2946 FAX: (607) 255-9030
E-Mail: crf1@cornell.edu
Address: 222 Day Hall
City:
NOTE: Institutions operated by the U.S. Government may need to obtain department or agency clearance prior to submission of the FWA to OHRP. Please contact the relevant department or agency Human Subject Protections Officer before forwarding this Assurance to OHRP.
8. FWA Approval
The Federalwide Assurance for the Protection of Human Subjects for Institutions Within the United States submitted to HHS by the above Institution is hereby approved.
Assurance Number: Expiration Date:
Signature of HHS Approving Official: Date: