Application Review & Approval Process

IBC approval of recombinant or synthetic nucleic acid molesules and biohazardous research protocols is effective for three years. PIs must complete an IBC Annual Renewal each year to continue work for up to three years after the initial approval. After three years, the application must be resubmitted and reviewed by the committee.

What Needs IBC Approval?

  • Recombinant or synthetic nucleic acid molecules
  • Hazardous biological agents (virus, bacteria, fungi, parasite, prion, rickettsia etc.)
  • Other potentially infectious materials (human or non-human primate blood, serum, plasma, body fluids, unfixed tissue, organ and cells)
  • Biological toxins including select agent toxins
  • Inactivated Biological Samples derived from BSL-3 or BSL-4 agents
  • Attenuated pathogens derived from BSL-3 or BSL-4 agents
  • Human gene transfer
  • Transgenic animals or plants
  • Sheep and any tissues derived from them (these tissues can transmit Coxiella burnetii, the causative agent of Q-fever)
  • Field studies with wild animals and their tissues inherently infected or would be experimentally infected with BSL-2 or higher agents

What Does IBC Review?

  • Recombinant or synthetic nucleic acid molecule research for conformity with the NIH Guidlines
  • Potential risk to the environment and public health
  • Containment levels per NIH Guidlines
  • Adequacy of facilities, procedures, practices, and training and expertise of personnel
  • Adverse event report

Note:

  • BU considers Human Cell Lines to be BSL-2.
  • E.coli K-12 strains are BSL-1 and as such do not require IBC approval.
  • Because the Boston Public Health Commission (BPHC) requires registration of BSL-1 rDNA projects, rDNA studies designated BSL-1 and considered “exempt” by the NIH Guidlines must be reviewed and approved by the IBC.

Research Involving the Following May Require Additional Requirements

  • Select Agents
  • Biological Agents with Potential to Cause Laboratory Acquired Infection (LAI)