Investigator Responsibilities and Study Personnel Training

Individuals with a CWRU faculty position may be the PI on a CWRU IBC submission. 

The PI shall:

Determine whether or not activities under his/her direction involve experiments covered by the NIH Guidelines (described in the Recombinant/Synthetic Nucleic Acid Categories below).  

Submit the experiment(s) to the CWRU IBC and obtain approval prior to initiation of the proposed experiment(s).  Those experiments covered under Section III-E can begin at the time of IBC submission.

Comply with federal, state, local, and institutional guidelines for safe handling of biohazardous materials; appropriate safeguards against environmental release should remain in place during the condition of the proposed experiments. 

Educate and inform personnel of the risk potential and provide them with adequate training to minimize their exposure.

Report any significant problems, violations of the NIH Guidelines, or any significant research related accidents and illnesses to the Institutional Biosafety Committee within 30 days of discovery of the problem, violation, or accident.

  • All significant adverse events that occur during the course of a human clinical study registered with the IBC must be reported to the IBC. Study-related serious adverse events (SAEs) must be reported to the IBC within 7 calendar days if fatal or life threatening. Other SAEs should be reported to the IBC as part of the principal investigator’s annual report.

Click here to access the NIH brochure on Investigator Responsibilities under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

The NIH Guidelines describe experiments that require IBC oversight, as well as experiments that are considered exempt from the guidelines.  The PI should be familiar with the NIH Guidelines, and have an understanding of what sections of the guidelines their proposed research falls under.  Below are short descriptions, however the complete descriptions can be found using the link on the right.

Section III-A:  Experiments that Require NIH Director Approval and IBC Approval Before Initiation (Major Action)

  • Transfer of a drug resistance trait to microorganisms that do not naturally acquire that trait.

Section III-B:  Experiments that Require NIH Office of Science Policy (OSP) and IBC Approval Before Initiation

  • Cloning of DNA encoding molecules toxic to vertebrates within LD50 < 100ng/kg body weight.
  • Experiments previously approved as Major Actions.

Section III-C:  Experiments Involving Human Gene Transfer that require IBC Approval Prior to Initiation

  • Deliberate transfer of recombinant or synthetic nucleic acid molecules, or DNA or RNA derived from recombinant or synthetic nucleic acid molecules into human research participants.

Section III-D:  Experiments that Require Institutional Biosafety Committee Approval Before Initiation

  • Using Risk Group 2, 3, 4, or restricted agents as host-vector systems (eg, use of lentivirus, retrovirus, adenovirus).
  • Cloning DNA from Risk Group 2, 3, 4, or restricted agents into nonpathogenic prokaryotic or lower eukaryotic host vector systems (eg, cloning of viral DNA into bacteria).
  • Experiments using as vectors more than two-thirds of the genome of infectious animal or plant viruses or defective recombinant viruses grown in the presence of a helper virus in culture.
  • Experiments involving whole animals and recombinant or synthetic nucleic acid molecules.  
    • The creation of transgenic animals, with the exception of transgenic rodents that require BL1 containment
    • Use of recombinant or synthetic nucleic acid molecule-modified microorganisms on animals
    • Use of recombinant or synthetic nucleic acid molecules involving whole animals (eg, introduction of cells carrying recombinant DNA sequences)
  • Experiments involving whole plants and recombinant or synthetic nucleic acid molecules.
  • Use of greater than 10L of Culture (in one vessel)
  • Experiments involving Influenza Viruses

Section III-E:  Experiments that Require IBC Notice Simultaneous with Initiation

  • Experiments using as vectors less than two-thirds of the genome of defective animal or plant viruses, free of helper virus.
  • Experiments involving recombinant or synthetic nucleic acids that are not covered under III-A, B, C, D or F.
  • All experiments that may generate transgenic animals requiring BL-1 containment.

Section III-F:  Exempt Experiments

  • Synthetic nucleic acids that do not replicate, integrate, or produce a toxin.
  • Recombinant or synthetic nucleic acids that are not in a cell or modified so they can enter a cell.
  • Re-creating a plasmid from a single source.
  • Nucleic acids from a prokaryotic host.
  • Nucleic acids from a eukaryotic host when propagated in that host.
  • DNA segments from different species that are natural exchangers.
  • Genomic DNA molecules that have acquired a transposable element.
  • All experiments that make use of constructed, purchased, or transferred transgenic rodents at BL-1 containment.
  • Recombinant or synthetic nucleic acid molecules containing less than one-half of any eukaryotic viral genome in tissue culture, unless DNA from risk group 3, 4, or restricted agents are involved. 
  • Experiments utilizing the following host-vector systems:  Escherichia coli K-12, Saccharomyces, Kluyveromyces, Bacillus subtilis or Bacillus licheniformis.
    • Note:  BL21 cells are not an E. coli K-12 derivative, so would not be exempt

 

Required Training for those listed on an IBC protocol

 
Research in a Laboratory Space

CWRU and MetroHealth:  Researchers working in labs at CWRU or Metro will need to complete CWRU EHS training in Lab Safety and Biohazardous Materials.  Information on training can be found at the EHS Website.  Following completion of the initial training, yearly online retraining must be completed.

University Hospitals:  UH employees working in UH laboratory spaces will need to complete annual training in bloodborne pathogens.

VA:  Individuals working in laboratories at the VA must complete yearly research safety training.  Questions regarding training can be sent to John.Schaffer@va.gov.

 

Research in a Clinical Setting

Researchers listed on an IBC protocol for a clinical study must complete the Human Gene Transfer (2 CREC) course every year and the NIH Recombinant DNA Guidelines (1 CREC) course every 3-years through the Collaborative Institutional Training Initiative (CITI).    

CITI Instructions: