rDNA or Synthetic DNA

Institutional Biosafety Committee (IBC) protocols are now submitted through Kuali.

The University has a Biological Safety Officer in Environmental Health and Safety and a federally mandated Institutional Biosafety Committe (IBC), which includes faculty, the Biosafety Officer, the Compliance Coordinator, the Director of Animal Care, and community representatives. All research projects involving the use of rDNA  or synthetic DNA must be registered with the Office of Research Compliance which provides reports to the IBC. The Biological Safety Officer pre-reviews registrations and determines the level of IBC review required.  The review process is briefly summarized here:

Conducting IBC reviews of use of rDNA and synthetic DNA at UMass Amherst

Umass Amherst is required by the NIH to ensure appropriate review of research involving the use of rDNA or synthetic DNA by the Institutional Biosafety Committee (IBC) in compliance with the NIH Guidelines for Research Involving Recombinant or Synthetic DNA Molecules (NIH Guidelines (https://osp.od.nih.gov/biotechnology/biosafety-and-recombinant-dna-activities).  OPAM post-award staff may hold back release of funding for research involving use of rDNA or synthetic DNA until they get confirmation from the Office of Research Compliance that a registration covering this research has been submitted for IBC review or is already on file.

Registrations must be submitted by UMass employees who satisfy the Faculty Senate Policy that defines a PI at UMass (Sen. doc. No. 09-032).

Each registration is pre-reviewed by the Biosafety Officer in EH&S to verify that the NIH review level indicated by the PI is correct and to ensure the registration is complete.  The IBC review process follows NIH Guidelines.    For review level IIIE the IBC is notified of the registration as soon as the pre-review is completed and the research may start prior to the PI receiving notice of formal IBC approval.  For higher NIH review levels (IIID to IIA) the work cannot start until the PI receives an approval letter signed by the IBC Chair.   Approval is for 5 years after which  time a new registration must be submitted if the use of rDNA or synthetic DNA is to continue.

Synthetic DNA in PCR products that are not clones is exempt from registration with the IBC.  However, use of commercially available nucleic acid molecules is not a determinant of exemption.