07.04.2013 Views

Policies & Procedures - Emory IRB - Emory University

Policies & Procedures - Emory IRB - Emory University

Policies & Procedures - Emory IRB - Emory University

SHOW MORE
SHOW LESS

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

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

POLICY:<br />

15 EMORY <strong>IRB</strong> RELATIONSHIPS WITH OTHER INSTITUTIONS;<br />

RELIANCE ARRANGEMENTS FOR <strong>IRB</strong> REVIEW<br />

<strong>Emory</strong> <strong>University</strong> acknowledges that each institution that is Engaged in multi-institutional,<br />

collaborative Research is responsible for safeguarding the rights and welfare of Human Subjects<br />

and for complying with applicable federal regulations. With respect to such collaborative<br />

Research, <strong>Emory</strong> and the other institutions may choose to provide concurrent review within<br />

their own jurisdictions. Alternatively, the <strong>Emory</strong> <strong>IRB</strong> may enter into a written agreement per<br />

which the <strong>Emory</strong> <strong>IRB</strong> relies on the review of another qualified <strong>IRB</strong> or vice versa.<br />

In addition, when multi-site Research subject to a DOD Addendum is being conducted, <strong>Emory</strong><br />

and the other Research sites shall enter into formal written agreements that specify the roles<br />

and responsibilities of each party.<br />

PROCEDURES:<br />

Concurrent <strong>IRB</strong> Review: If <strong>Emory</strong> provides <strong>IRB</strong> review of Research concurrently with the <strong>IRB</strong><br />

review of the collaborative institutions’ <strong>IRB</strong>s, all of the P&Ps, rules, regulations and laws<br />

described in these P&Ps shall apply to <strong>Emory</strong>’s review just as they would in non-collaborative<br />

Research <strong>IRB</strong> reviews.<br />

<strong>Emory</strong> <strong>IRB</strong> Reliance on Another <strong>IRB</strong>: With regard to any cooperative Research projects that fall<br />

within the jurisdiction of the <strong>Emory</strong> <strong>IRB</strong>, <strong>Emory</strong> may rely on another appropriately constituted<br />

<strong>IRB</strong> for the review of the Research.<br />

The IO has the sole authority to make the decision whether or not to rely on another <strong>IRB</strong>. The<br />

IO is authorized to execute IAAs on <strong>Emory</strong>’s behalf and may delegate this authority provided the<br />

delegation of authority is recorded in writing.<br />

In deciding whether or not to rely on another <strong>IRB</strong>, the IO shall consider the following criteria:<br />

Whether other <strong>IRB</strong>’s policies and procedures meet <strong>Emory</strong> <strong>University</strong> standards. If the<br />

other <strong>IRB</strong> is part of an AAHRPP-accredited HRPP, then it will be presumed that <strong>Emory</strong><br />

<strong>University</strong> standards are being met; however, accredited status does not in itself<br />

necessarily suffice as a basis for the IO’s decision.<br />

Where the Human Subjects Research activities would take place.<br />

Which institution’s facilities and personnel would be involved.<br />

The capacity of the other institution and its <strong>IRB</strong> to sufficiently informed about the <strong>Emory</strong><br />

local research context and applicable laws and regulations.<br />

Page 42 of 370

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!