The university has a Biological Safety Officer (BSO) in Environmental Health and Safety (EH&S) and a federally mandated Institutional Biosafety Committe (IBC), which includes faculty, the Biosafety Officer, Assistant Director of Research Compliance - IACUC, the consulting veternarian, and community representatives. All research projects involving the use of rDNA or synthetic DNA must be registered with the Office of Research Compliance (ORC) which provides reports to the IBC. The BSO pre-reviews protocols 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 IBC in compliance with the NIH Guidelines for Research Involving Recombinant or Synthetic DNA Molecules. 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 ORC that a protocol covering this research has been submitted for IBC review or is already on file.
- Protocols must be submitted by UMass employees who satisfy the Faculty Senate Policy that defines a PI at UMass (Sen. doc. No. 09-032).
- Each protocol is pre-reviewed by the BSO in EHS to verify that the NIH review level indicated by the PI is correct and to ensure the protocol 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. 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 protocol 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.