IBC #:
IBC Registration Form
Please refer to instructions for completing this form7. This form is for new research, renewals and amendments involving rDNA 1,
pathogens (infectious agents) or select agents 2. This form must be submitted along with; 1) the specific aims of the research and 2) the
research design and methods. Documents must be submitted via email to Greg.Colores@cmich.edu and thomas.e.schultz@cmich by
the responsible PI for the lab and the dept. chair must be copied. Sending forms from an email account constitutes a signature from that
person. If work involves a select agent toxin ONLY and no other covered agents (rDNA or pathogens) are used, then only complete
section 2c.
1. PRIMARY INFORMATION
Name of PI for this project:
Ph:
Name of responsible PI for lab (submitter):
Date:
Dept:
Title of proposal / grant:
Seeking (or have) external funding for work?
Y
N Source:
Title of grant(s) if different than proposal:
Period:
to
Submission type:
Location for proposed work (rooms):
new IBC project
amendment to existing work
2. TYPE OF AGENT / RESEARCH
a. Please fill in all information in the following table keeping source, vector and hosts used together on the same line. Since boxes
expand, multiple entries may go in each box. Use the highest RG 3 for each line. For infectious agents with no rDNA associated with
them, fill in the “host / infectious agent” section and the “Risk Group (RG)” section only. If whole, live animals are involved (higher
eukaryotes), enter them into the “host / infectious agents” section with the agents used with them and put “live” next to the name.
Table 1
DNA source(s): organism,
gene name
Nature of sequence(s)
(ie: coding, regulatory)
Vector(s): type, source,
name
List All hosts and/or
infectious agents
1
2
3
4
Risk group (RG) 3
1
1
1
1
b. Will you attempt to express a foreign gene?
Y
N
NA (if no rDNA)
2
2
2
2
3
3
3
3
If so, please indicate the cellular function (ie. Protein
produced) for the appropriate agent(s) above:
c. Will you use a select agent 2?
Y
N
If so, please list names and maximum amounts:
d. FOR rDNA WORK ONLY: please indicate the type of research you will conduct below (refer to National Institutes of Health (NIH)
guidelines section III 4 for more details). Choose the highest rating for your work (III-A is highest).
Table 2
†
§
Level
III-A
III-B
III-C
III-D
Approval/Review
NIH Dir, RAC, IBC†
NIH/OBA, IBC†
RAC, IRB, IBC†
IBC†
III-E
IBC§ - most common
III-F
IBC§ - specific
exemptions
Requirements
A drug resistant gene transferred into a (new) microorganism.
The cloning of toxin molecules with LD50 < 100 ng/kg of body weight.
rDNA (or DNA or rDNA derived from rDNA) transferred into humans.
rDNA transferred to or from: whole animals, whole plants (high risk work) and associated small
animals, experiments involving >10 Liters of culture, agents listed in Risk Groups 2, 3, or 4, or
infective eukaryotic viruses in cell culture.
rDNA involving: eukaryotic viruses (not more than 2/3 genome) in cell culture, whole plants (low
risk work) and associated small animals, arthropods, or generation of transgenic rodents
(BSL1), any work not covered in the other categories (most non-pathogenic rDNA work)
rDNA not in organisms or viruses, single non-chromosomal or viral DNA sources, or host DNA
transferred to the same host or related species (not viruses), natural exchangers from appendix
A, eukaryotic viruses (<1/2 genome) in cell culture, host vector systems from appendix C or E,
rDNA entirely from extrachromosomal elements taken from and used in agents listed in
appendix C-V.
Approval required before initiation.
Notify IBC (register) when project is initiated. IBC approval is still required.
IBC Registration Form
Revised 03/2011
IBC #:
3. RISK ASSESSMENT
Y N
Is there any reason to believe any of the following things would be different in your work from the RG level identified in Table
1? (ie: virulence, pathogenicity, infectious dose, environmental stability, host range, cell cycle, replication capacity).
NA (not a pathogen) Are there biological barrier options available (ie: attenuation) that would limit any of the above
characteristics?
NA (no rDNA) Will the insertion encode for an oncogene, integrate into the genome of any host or generate replicationcompetent viruses?
NA (not a pathogen) Is an effective prophylaxis and/or treatment available?
Will work involve large volumes (>10 Liters) or high concentrations?
Is there the potential for aerosols to be generated?
Please explain any yes answers and give any reasons for raising or lowering the original RG level:
4. CONTAINMENT
Each line in Table 3 corresponds to the same number in Table 1. Section III (Table 1) 5 of the publication Biosafety in Microbial and
Biomedical Laboratories (BMBL) defines biosafety Levels (BSL) for working with biologicals. Please check the appropriate containment
level for the work proposed. Work involving mammalian cells must be BSL2 or higher. Check animal biosafety level (ABSL) only if
working with whole, live, vertebrates.
Table 3 – row numbers correspond to agents in table 1
1
Biosafety level (BSL)
1
2
3
Animal biosafety level (ABSL)
NA
1
2
3
2
1
2
3
NA
1
2
3
3
1
2
3
NA
1
2
3
4
1
2
3
NA
1
2
3
IACUC #s (if applicable)
5. SAFETY PROTOCOLS
a.
Special provisions or practices for this work:
b.
If a pathogen is used a written safety protocol is required that explains how all infectious materials are handled safely in each step
of the process including: procurement and storage of agents, protective equipment, biosafety cabinet use, how solid and liquid
waste is handled, training, other equipment used (ie: centrifuge, sonication) and sharps handling.
c.
If a pathogen is used with live vertebrates, please submit the IACUC safety form (last page of the IACUC A form) for each
protocol.
IBC
Chair: __________________________________ _________
signature
date
Biosafety
Officer: __________________________________ _________
References links:
1. The definition of recombinant DNA
2. http://www.selectagents.gov/Select Agents and Toxins List.html
3. http://oba.od.nih.gov/oba/rac/Guidelines/APPENDIX_B.htm - AppxB_Tbl1
4. Classification of rDNA research
5. http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm
6. http://www.cdc.gov/biosafety/publications/bmbl5/index.htm
7. IBC registration form guide
IBC Registration Form
signature
date
Revised 03/2011