Policies & Procedures - Emory IRB - Emory University

Emory University IRB P&Ps Revised 1/18/2013
Adoption of P&Ps and Effective Date: In conformance with the requirements of the
HHS, FDA VA Regulations, and DOD Regulations/Requirements set forth above, the
Emory IRB has adopted these P&Ps as of the effective date shown on the cover sheet for
these P&Ps.
Maintenance of P&Ps: The current version of these P&Ps shall be maintained by the IRB
Director on the Emory IRB’s official website at: http://www.irb.emory.edu
P&P Compliance with HHS, FDA, VA HIPAA Regulations, and the DOD
Regulations/Requirements: These P&Ps are subject to the HHS, FDA, VA HIPAA
Regulations, the DOD Regulations/Requirements, as well as any other applicable
governmental laws and regulations. In the event of any conflict between these P&Ps and
such applicable laws and regulations, the applicable laws and regulations shall control,
and these P&Ps shall be conformed to such laws and regulations.
P&Ps Review and Revision Procedure: Set forth below, are the procedures to be
followed for the review and adoption of new P&Ps and the review and revision of
existing P&Ps:
Annual Review of P&Ps and Appointment of P&P Subcommittee: On at least an annual
basis the IRB Chair shall appoint at least three IRB voting members to serve on a
subcommittee to participate in the review and revision of the P&Ps to ensure
compliance with all applicable rules and regulations and to incorporate any new
modifications to these P&Ps.. This subcommittee shall be called the “P&P
Subcommittee” and shall meet at least once a year. IRB voting members appointed to
this subcommittee may be re-appointed in subsequent years for an unlimited number of
terms.
In addition to these IRB voting members, the following persons by virtue of their
position shall serve as members of the P&P Subcommittee: the IRB Chair; the IRB
Director, a Protocol Analyst or other person involved in the administration of the Emory
IRB, as designated by the IRB Director in his/her discretion; and a representative from
the Emory University Office of Research Compliance.
Initial Review of P&Ps by IRB Director: The IRB Director and his/her designee shall
perform a periodic review of the P&Ps and bring forward to the P&P Subcommittee
suggested or required modifications or additions to the P&Ps. This process shall occur
on an as needed basis when changes in applicable laws and regulations occur or as
suggestions for modifications or additions are received from interested parties. This
periodic review shall occur at least once per year. As a part of this review process, the
IRB Director shall solicit suggested additions and modifications to the P&Ps from all IRB
Committee members. Any reasonable suggested modifications or additions shall be
provided to the P&P Subcommittee for review and discussion.
Meeting of P&P Subcommittee: The IRB Director shall convene a meeting(s) of the P&P
Subcommittee in order to review and consider P&P additions and modifications that are
brought forward. The IRB Director shall convene meetings as necessary, and at least on an
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