Policies & Procedures - Emory IRB - Emory University

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Emory University IRB P&Ps Revised 1/18/2013 38 CFR §16.103(b)(5). 32 CFR Part 219; DOD Addendum. Page 30 of 370
Emory University IRB P&Ps Revised 1/18/2013 POLICY: 11 AUTHORITY AND RESPONSIBILITY OF THE EMORY IRB The Emory IRB is an administrative body established to protect the rights and welfare of Human Subjects recruited to participate in Research activities conducted under the auspices of Emory University. The Emory IRB is the body at Emory University that has the authority to approve, require modifications in, or disapprove all Human Subjects Research activities conducted under the auspices of Emory University. The Emory IRB also has the authority to Suspend, place restrictions on, or Terminate approval of Human Subjects Research activities that fall within its jurisdiction and that are not being conducted in accordance with Emory IRB requirements or that have been associated with unexpected serious harm to subjects. PROCEDURES: Responsibility of the Emory IRB: In order to protect the rights and welfare of persons participating in Research, the Emory IRB is responsible for the Initial Review and continuing oversight of Human Subjects Research under its jurisdiction. Through this review, which includes an initial analysis and on-going monitoring of the risks and benefits associated with the Research, the Emory IRB ensures that the Human Subjects Research is being carried out in accordance with the requirements of the applicable HHS, FDA, VA Regulations, DOD Regulations/Requirements and the Belmont Report ethical principles. In order to ensure that appropriate safeguards exist to protect the rights and welfare of Research subjects, the IRB includes within its review all of the Research documents and activities that bear directly on the rights and welfare of the subjects of the proposed Research, including, but not limited to the following: consent/assent documents, investigational brochure (for studies conducted under the FDA’s Investigational New Drug regulations); tests; surveys; questionnaires;, and recruiting documents. The Emory IRB also performs the functions of an Institutional Privacy Board under the regulations implementing the Health Insurance Portability and Accountability Act. Authority of the Emory IRB: The Emory FWA evidences the Emory IRB’s commitment to protecting the rights and welfare of Human Subjects in accordance with applicable HHS, FDA, VA Regulations, DOD Regulations/Requirements and the Belmont Report principles. In accordance with the FWA, the Emory IRB has the authority to perform the following tasks: Risk/Benefit Evaluation: On an initial and on-going basis, provide evaluation of the risks and potential benefits, if any, of Research protocols and proposed amendments to Research protocols and determine whether the rights and welfare of Human Subjects are adequately protected thereby. Before any Human Subject is involved in Research under the auspices of Emory University, the Emory IRB will give proper consideration to: (a) the risks to the subjects; (b) the anticipated benefits to the subjects and others; (c) the importance of the knowledge that may reasonably be expected to result; and (d) the informed consent process to be employed. Approve or take other voting actions: See P&Ps entitled Exempt Research, Expedited Review, Full Committee Review, IRB Meetings, Continuing Review, Protocol Page 31 of 370
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Policies & Procedures - Emory IRB - Emory University

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