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Policies & Procedures - Emory IRB - Emory University

Policies & Procedures - Emory IRB - Emory University

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<strong>Emory</strong> <strong>University</strong> <strong>IRB</strong> P&Ps Revised 1/18/2013<br />

POLICY:<br />

6 NUMBER OF <strong>IRB</strong>S AND REGISTRATION<br />

<strong>Emory</strong> <strong>University</strong> is committed to allocating sufficient resources, meeting space, and staff to<br />

support <strong>IRB</strong> review, education, quality assurance, and recordkeeping duties. Further, <strong>Emory</strong><br />

<strong>University</strong> ensures that it designates and establishes sufficient numbers of <strong>IRB</strong> committees or<br />

panels to conduct compliant review of research involving human subjects in a timely manner.<br />

The <strong>Emory</strong> <strong>IRB</strong> holds an OHRP-approved Federalwide Assurance, FWA # 5792 and has registered<br />

its <strong>IRB</strong> committees with OHRP. The <strong>Emory</strong> <strong>IRB</strong> is composed of three separate committees: one<br />

social-humanist-behavioral (SHB) and two for biomedical research. Each of the two biomedical<br />

committees has four (4) panels. The SHB committee and each biomedical panel meet monthly.<br />

Thus, in each average month, eight (8) convened <strong>IRB</strong> meetings are held, unless a lack of quorum<br />

or agenda items obviates the need for a convened meeting.<br />

A Chair or Vice Chair presides at each biomedical panel and the SHB committee meetings. Each<br />

committee or panel is referred to in these P&Ps as an “<strong>IRB</strong> Committee” and collectively they are<br />

referred to as the “<strong>IRB</strong> Committees.”<br />

In addition to the aforesaid internal <strong>IRB</strong> Committees, <strong>Emory</strong> <strong>University</strong> has an agreement with<br />

the commercial <strong>IRB</strong>, Western Institutional Review Board (W<strong>IRB</strong>), per which the W<strong>IRB</strong> serves as<br />

an <strong>IRB</strong> for <strong>Emory</strong> for the review of certain Human Subjects Research.<br />

Prohibition of Use of Commercial <strong>IRB</strong> for VA-Sponsored Research: In accordance with VA<br />

Regulations, however, neither the W<strong>IRB</strong>, nor any other commercial <strong>IRB</strong>, shall be used to review<br />

any VA-supported Research.<br />

Moreover, on occasion <strong>Emory</strong> will enter into an <strong>IRB</strong> Authorization Agreement with another<br />

FWA-holding institution, by which <strong>Emory</strong> can rely on the other institution’s <strong>IRB</strong>. (See the P&P<br />

entitled <strong>Emory</strong> <strong>IRB</strong> Relationships with Other Institutions; Reliance Arrangements for <strong>IRB</strong> Review.)<br />

In such cases, the <strong>Emory</strong> FWA lists the reviewing institution’s <strong>IRB</strong> as one of its designated <strong>IRB</strong>s if<br />

that institution’s <strong>IRB</strong> reviews federally supported research for <strong>Emory</strong>. (See below for<br />

procedures for updating the <strong>Emory</strong> FWA.)<br />

PROCEDURES:<br />

Chair and Vice Chairs of <strong>IRB</strong> Committees: A single individual serves as the Chair of all of the <strong>IRB</strong><br />

Committees; however, with the IO’s approval ,two Co-Chairs may share this role and its<br />

responsibilities. One or more individuals from each of the <strong>IRB</strong> Committees shall serve as Vice<br />

Chairs, with one assigned to preside at each panel’s convened meetings. Unless otherwise<br />

specifically indicated throughout these P&Ps, the term “Chair” shall refer to both the <strong>IRB</strong> Chair<br />

or Co-Chairs, and to any Vice Chair, when the Vice Chair is acting for or on behalf of the Chair.<br />

Appointments of Chairs and Vice Chairs of <strong>IRB</strong> Committees by the IO: The IO shall appoint the<br />

<strong>IRB</strong> Chair and any Vice Chairs. The following specifications shall be followed with regard to<br />

appointments:<br />

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