Version
1.1
Date Updated
Sunday, June 28, 2009
Descripton

Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 101
AAHRPP Elements: II.2.D

The purpose of this policy and procedure is to describe the coordination between the IRB/OPRS and the IBC/OACIB on protocols involving transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA (human gene transfer), and/or infectious agents into human research participants. For the purposes of this policy and procedure, recombinant DNA molecules are defined as either: (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii) molecules that result from the replication of those described in (i) above and infectious agents are defined as any microorganism or toxin produced by a microorganism that is potentially pathogenic to humans, such as a live vaccine.


POLICY


  1. The UIC IBC reviews all research involving the use of rDNA in compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines). The IBC is also responsible for the safe conduct of research involving infectious agents, including select agents and toxins.
  2. Through an Agreement between the UIC and the JBVAMC, the JBVAMC utilizes the UIC IBC to review research involving rDNA conducted by a UIC-affiliated investigator or supported by funds administered by the University. Research involving human subjects and engaging the JBVAMC that is submitted for UIC IRB and IBC review will follow the policies and procedures outlined below, as well as, the MOU and Operating and Coordinating Procedures for the Administration of the Collaborative JBVAMC/NU/UIC IRB (UIC IRB #4) SOP between UIC and JBVAMC regarding human subject protections.
  3. An investigator must have an UIC affiliation to submit a protocol to the UIC OACIB for review by the UIC IBC. Further, if IBC approval is needed for a research study, the UIC IRBs, including the JBVAMC/NU/UIC Collaborative IRB (UIC IRB#4), will only review research protocols reviewed and approved by the UIC IBC. The IBC approval from other institutions will not be accepted in place of UIC IBC approval.