Policies & Procedures - Emory IRB - Emory University

Emory University IRB P&Ps Revised 1/18/2013
committee that advises the HHS Secretary, the HHS Assistant Secretary for Health, and
the NIH Director concerning recombinant DNA research. Specifications for Research
that must undergo RAC review are set forth in the NIH Guidelines for Research Involving
Recombinant DNA Molecules (referred to herein as the “NIH Guidelines”) found at the
following website: http://oba.od.nih.gov/rdna/nih_guidelines_oba.html, as well as in
the policies and procedures of the IHBC found at
http://www.ehso.emory.edu/programs/research/research-policies.cfm. When RAC
review is required, documentation of RAC review and approval/disapproval must be
provided to the IRB upon issuance.
Conflict of Interest (COI) Committee: The Emory University Conflict of Interest Office
has its own review process for Research that involves a COI on the part of the PI or key
study personnel. Resources for requirements regarding disclosure and review of COIs
involving Research and contact persons for schools can be found at the following web
page: http://www.coi.emory.edu/office/contactus.cfm. The Conflict of Interest Office is
responsible for providing the Emory IRB with documentation of review and
approval/disapproval upon issuance.
Assessment of Research Protocol by PI to Determine What Committee Review is
Required: The PI is responsible for reviewing his/her Research protocol and the review
requirements of the Emory IRB and the Other Research Review Committees in order to
determine to which committees the protocol must be submitted for review. The
ultimate decision as to whether review of a protocol falls within a committee’s
jurisdiction shall be with that committee, but any committee may send a protocol to
another committee for a decision as to whether review by the recipient committee is
required (e.g., the Emory IRB may send a protocol for which it believes the PI may have
a COI to the COI committee for review, even if the PI on the protocol did not initiate
such review). The PI is prohibited from beginning activities on a Human Subjects
Research protocol until all required committee approvals have been obtained.
Procedure for Review of Human Subjects Research that Requires Submission to the Emory IRB
and to the Other Research Review Committees:
If a protocol involves activities that must be reviewed by the Emory IRB and by one or
more of the Other Research Review Committees, the PI may simultaneously submit the
protocol for review to the Emory IRB and the Other Research Review Committee(s), but
the Emory IRB’s approval shall be pending unless and until it receives notice of approval
from the Other Research Review Committee(s).
In addition, the Emory IRB may, on its own initiative, send a protocol to one or more of
the Other Research Review Committees or direct the submitting PI to do so. The Emory
IRB also may receive a protocol for review from one of the Other Research Review
Committees.
Protocol Analysts, in consultation with the IRB Director, shall be responsible for making
an initial assessment as to which of the Other Research Review Committees, if any, the
protocol should be routed, and whether that routing has taken place. Confirmation as
to appropriate routing shall be obtained from the IRB Chair/Vice-Chair before routing
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