Get Started with Recombinant or Synthetic Nucleic Acid Molecules (r/sNA) or Other Biohazardous Agents

• Full time members of the Faculty may serve as Principal Investigators/Project Directors on IBC MUAs. Individuals with certain other titles may serve under special circumstances with the approval of the Office of the Vice President for Research and Innovation. Research Associates, Extension Associates, Lecturers, or Senior Assistant Librarians may be approved to serve as principal investigators for a specific project and its duration. For more information, see the Principal Investigator Eligibility Policy.
• Investigator Responsibilities Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
• Information on reporting of incidents involving recombinant DNA

• All personnel listed on the MUA must complete all training required by the IBC before they can be approved to work with the biohazardous materials.
• Bloodborne pathogen training is required for those individuals who are working with human and non-human primate blood, tissues, fluids, and other potentially infectious materials (including cell lines). Individuals must complete Bloodborne pathogen training prior to working with the material. This training has an annual renewal requirement.
• Register for Bloodborne Pathogen Training
  • Log in
  • Upper right hand select the Magnifying Glass icon
  • Search for the 1070 Blood borne pathogen certification
    • If taking for the first time - Select EHS 1074-Blood borne pathogens and sign up for a training time or web based learning.
    • If renewing - Select EHS 1875 and launch the web based training

Research involving the following require IBC approval:

• Recombinant/synthetic nucleic acid molecules, as covered by NIH Guidelines
• Infectious agents (viruses, bacteria, fungi, parasites, prions, etc.) that can cause disease in healthy humans and/or significant environmental or agricultural impacts, as covered by the Biosafety in Microbiological and Biomedical Laboratories (BMBL) guidelines
• Select agents and select toxins, as covered by the Federal Select Agent regulations 
• Human materials (including all fluids, tissues, excretions, secretions, or cell lines) as covered by the U.S. Occupational Safety and Health Administration (OSHA) Bloodborne pathogens Standard
• Nonhuman primate materials (including live animals, all fluids, tissues, excretions, secretions, or cell lines) as covered by the BMBL and OSHA Bloodborne Pathogen Standard
• Genetically modified animals and whole plants as covered by NIH guidelines
• Regulated Plant Pest of Pathogens as covered by USDA-APHIS

Under the NIH Guidelines, agents are classified into four Risk Groups (RGs) according to their relative pathogenicity for healthy adult humans by the following criteria:

• RG1 – Are not associated with disease in healthy adult humans or animals
• RG2 – Are associated with disease which is rarely serious and for which preventative or therapeutics is often available
• RG3 – Are associated with serious or lethal human disease for which preventative or therapeutics may be available
• RG4 – Are associated with lethal human disease for which preventative or therapeutics are not readily available

Microorganisms and their associate RG designation can be found at  ABSA website

Factors to be considered in determining the level of containment include agent factors such as:

• Virulence, pathogenicity  and infectious dose of the organism
• Mode of transmission and host range
• Availability of effective preventive measures (e.g., vaccines)
• Availability of effective treatment (e.g., antibiotics)
• Other factors

All cell and organ cultures of human and non-human primate origin, including well established cell lines, shall be handled in accordance with the OSHA Bloodborne Pathogens Standard and under BSL-2 containment.

• Bloodborne Pathogen training is required as defined by OSHA 929 CFR 1910.1030. Annual refresher training is required.

• For more information go to the EHS Web site

• Research Lab Exposure Control Plan

• Use of commercially available deregulated transgenic crops

• Activities involving only the in vitro use of nucleic acids (i.e., PCR, synthetic double stranded RNA) and does not involve the cloning and propagation of recombinant or synthetic nucleic acid molecules in cells, organisms or viruses.

• Complete all IBC applications online through RASS-IBC
• For detailed instructions on how to use the RASS-IBC system please see the RASS-IBC guide site. 

PIs must submit to the IBC for review and approval of any changes to their MUA. Unless specified otherwise, the proposed changes must not be implemented until the PI receives an electronic approval notice from the IBC. The types of changes that require an amendment to the MUA are:

• Addition or deletion of individuals on the MUA
• Change in facility or use of facility
• Additional objectives to the research
• New sources of nucleic acids (including RNA and DNA)
• New vectors
• Addition of gene editing techniques (CRISPR)
• Recipient organisms
• New biohazardous materials (ex. biotoxins, viral vectors, etc.)
• Change in procedures or use of biohazardous materials

Please see the RASS-IBC Guide site for instructions on how to complete an amendment. 

• Please see the RASS-IBC guide site for instructions on how to complete the an annual review. 

PIs need to update their MUA and submit it for IBC review and approval before the three year approval lapses, in order to maintain continuity of approval. The IBC office will contact the PI to remind them of the upcoming expiration date and provide a link to the e-MUA application to start work on the renewal. This renewal will require review by the full IBC.

• For instructions on how to complete a 3rd year renewal please see the RASS-IBC guide site. 

When you research activities no longer require the use of r/sNA or biohazards or you are leaving the university, you can request a closure of your IBC MUA application. To do this see the RASS-IBC guide site for instructions.