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As of June 2022, UNC will be utilizing WCG’s IBC services to review human gene transfer research covered under Section III-C of the NIH Guidelines. Please download and fill out IBCS Submission Form – Part B and send your completed application to IBCServices@wcgirb.com.

Research involving human gene transfer is covered under Section III-C of the NIH Guidelines, and requires IBC approval prior to initiation. Applicable studies will involve the deliberate transfer into human research participants of either

  1. Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules, or
  2. Synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules, that meet any one of the following criteria:
    1. Contain more than 100 nucleotides; or
    2. Possess biological properties that enable integration into the genome (e.g., cis elements involved in integration); or
    3. Have the potential to replicate in a cell; or
    4. Can be translated or transcribed.

Per the NIH Guidelines, research covered under Section III-C of the Guidelines cannot be initiated until the study has received:

  1. Institutional Biosafety Committee approval
  2. All other applicable institutional and regulatory authorization(s) (e.g., approval from UNC’s Institutional Review Board)

IBC approval will be considered valid for the duration of the study provided:

  1. No protocol amendments involving changes to the recombinant or synthetic nucleic acids (including vectors, gene of interest, etc.) administered to human subjects have been made.
  2. No protocol amendments involving changes to the handling of the recombinant or synthetic nucleic acids by UNC employees, including waste disposal, personal protective equipment, etc. have been made.

If any such changes are made, an amendment must be submitted for further IBC review. Protocol amendments should not be initiated until they have been approved by the IBC.

For assistance, email ibc@office.unc.edu and IBCServices@wcgirb.com.