Policies & Procedures - Emory IRB - Emory University

Emory University IRB P&Ps Revised 1/18/2013
under the auspices of Emory University. These P&Ps are made available to all Emory University
investigators, staff, and the general public at the Emory IRB website:
http://www.irb.emory.edu.
Governing Laws, Regulations and Principles: The Emory HRPP is established pursuant to and in
accordance with the laws, regulations and principles listed below regarding the protection of
Human Subjects. Emory University will adhere to these laws, regulations and principles with
regard to Research conducted by or under its auspices:
The Department of Health and Human Services (HHS) policy and regulations at 45 CFR
Part 46, also known as the Federal Policy for the Protection of Human Subjects or the
“Common Rule” (collectively referred to in this document as the “HHS Regulations,”
found at http://www.hhs.gov/ohrp/policy/common.html;
Food and Drug Administration (FDA) regulations at 21 CFR Parts 51 and 56 (collectively
referred to in this document as the “FDA Regulations,” found at
http://www.cfsan.fda.gov/~dms/reg-2.html;
The principles (i.e., respect for persons, beneficence and justice) set forth in the Ethical
Principles and Guidelines for the Protection of Human Subjects of Research (collectively
referred to in this document as the “Belmont Report,” found at
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm;
The Department of Veterans Affairs policies for Human Subjects Research protection,
including the regulations at 38 CFR Part 16 and the VHA Handbook Section 1200.5
(collectively referred to in this document as the “VA Regulations,” found at
http://www.access.gpo.gov/nara/cfr/waisidx_98/38cfr16_98.html and
http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1727respectively)
for Research involving the Atlanta Veterans Administration Medical Center (AVAMC) or
Atlanta Research & Education Foundation (AREF);
For projects subject to a DOD Addendum, any DOD Requirements.
All other applicable federal, state and local laws and regulations.
Agreement to Abide by Principles and Regulations:
Emory University agrees to uphold the ethical principles of the Belmont Report and to abide by
all requirements of the applicable HHS, FDA, DOD and VA Regulations. In this regard, Emory
University has charged the Emory IRB with carrying out all responsibilities of a duly constituted
Institutional Review Board as set forth in these governing regulations and principles. Emory
University agrees to provide the Emory IRB with meeting space and sufficient staff and
resources to support its review, oversight, record-keeping and other duties.
Provision of Resources: Emory University is committed to providing adequate staff, physical
space, and resources to adequately maintain and operate the Emory HRPP, including the IRB.
The IO is tasked with evaluating the needs of the Emory HRPP, including the IRB and the IRB
Office, and ensuring that they are provided with adequate resources, including staff, meeting
and office space, equipment and supplies (e.g., copiers, office supplies, computers, internet
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