Version
1.2
Date Updated
Tuesday, February 14, 2017
Descripton

Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 123
AAHRPP Elements: II.2.D

The purpose of this policy and procedure is to describe the coordination between the IRB/OPRS and the Institutional Biosafety Committee/Office of Animal Care and Institutional Biosafety (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. 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 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.