Provide a risk assessment justification for the biosafety level selected. Reference agent characteristics and routes of transmission.

1. MILWAUKEE SCHOOL OF ENGINEERING
PROTOCOL SUBMISSION FORM TRAINING
MARIAN DOWNING, RBP, CBSP, SM(NRCM)

2. Objectives of this course
• By the end of this course, you will:
– Understand the fundamentals of the NIH Guidelines for
Research Involving Recombinant DNA Molecules (NIH
Guidelines)
– Understand the importance of properly submitting a protocol
form
– How to successfully complete a protocol form
– Know what additional documentation you will need to provide
– Know what happens if your protocol is not approved
– Know how to submit an amended protocol

3. REVIEW OF THE NIH GUIDELINES

4. The Scope of the NIH Guidelines—Section I
• NIH Guidelines for Research Involving Recombinant DNA
Molecules
• Specifies practices for construction and handling
– rDNA molecules
– Organisms and viruses containing rDNA molecules
• Definition
– Constructed outside living cells by joining natural or
synthetic DNA segments to DNA molecules that can
replicate in a living cell
– Molecules resulting from the replication of those described
above

5. NIH Guidelines
• Apply to rDNA research that is
– Funded by NIH
– Performed at or sponsored by an institution
that receives any NIH funding for rDNA
research
• Are the NIH Guidelines optional?
– Potential consequences for non-compliance:
• Suspension, limitation or termination of
NIH funds for rDNA research at the
institution (and not just for the offending
researcher!) NIH
• A requirement for prior NIH approval of
any or all rDNA projects at the institution

6. Non-compliance Consequences
• UW fined $40K (by NIH) 2010
• ―Major Action Violation‖
– UW Madison professor
barred from lab for 5 years
(by University)
– Research involved a Select
Agent (Brucella)
• Graduate students
working with antibiotic-
resistant strains
• One case of Brucella in
laboratory staff
– PI claimed inadequate
Biosafety training and
support

7. Alphabet Soup
• NIH = National Institutes of Health
• RAC = Recombinant DNA Advisory Committee
• OBA = Office of Biotechnology Activities
• IBC = Institutional Biosafety Committee*
– >5 members of experts who review rDNA proposals, may
include a BSO and must have > 2 community members
• IRB = Institutional Review Board*
– Reviews all human subject trials/experiments, required by
FDA
• BSO = Biosafety Officer*
*affiliated with your institution

8. Guidelines – Section III
Levels Of Review
Relevant
Example of Recombinant DNA Sections of
Level of Review
Research Involving Animals the NIH
Guidelines
IBC, RAC review, & Experiments that compromise control of
NIH Director review disease agents in medicine through deliberate III-A
& approval transfer of a drug resistance trait
IBC approval &
NIH/OBA review for Experiments conducted with a recombinant
III-B
containment DNA modified restricted agent in a whole animal
determinations
IBC & IRB approval
& NIH review before
Not applicable III-C
research participant
enrollment
Continued on next slide

9. Guidelines – Section III
Levels Of Review
Relevant
Example of Recombinant DNA Sections of
Level of Review
Research Involving Animals the NIH
Guidelines
Creating stable germline alterations of an
IBC approval before animal’s genome, or testing viable rDNA
III-D
initiation modified microorganisms on whole animals,
where BL-2 containment or greater is necessary
IBC notice at
Creating stable germline alterations of rodents
initiation. (Not
using recombinant DNA when these III-E
covered in III-A, -B,
experiments require only BL-1 containment
-C, -D, -F)
Exempt from NIH
Guidelines. IBC
Purchase or transfer of transgenic rodents III-F
registration not
required.

10. Review Of Biological Materials and Infectious Agents (Not
Recombinant)
• Important to keep an accurate inventory of the types
of biological materials on site
– Risk assessment of all materials will be
performed by EHS
• This non-recombinant information does not have to
be supplied to NIH
• Select agents/toxins must follow the Select Agent
Law
– requires review by an institutional body, often
referred to as the IBC
• Review of protocols is by Committee for BSL-2/3/4
agents (usually institutional policy).
10

11. PROTOCOL SUBMISSION FORM

12. OVERVIEW OF FORM
• Section A—Project Summary
• Section B—Microorganisms
• Section C—Biosafety Levels
• Section D—Risk Assessment Justification
• Section E—Exposure Control
– Personal Protective Equipment (PPE)
– Laboratory Equipment
• Section F—Disinfection and Biological Waste Disposal
• Section G—Documentation*
• Section H—Faculty Member Assurance
*This section will require additional data sheets to be submitted with the protocol form

13. SECTION A—Project Summary
Provide basic
information about the
protocol: is it
new, seeking
renewal, what is the
project title?
What is the contact
information for the
responsible faculty
member, and in
case of an
emergency?

14. SECTION A—Project Summary
Where will the
microorganisms be
stored? What BSL
is the room?
Is there an
alternate
POC?

15. SECTION A—Project Summary
Provide everyone
that will be working
on the research Special provisions
project, their are needed if minors
responsibilities and will be working in the
training (with dates of laboratory.
completion)

16. SECTION A—Project Summary Providing
objectives will
provide the basis
for the risk
assessment.

17. SECTION B—Microorganisms
List ALL
microorganisms,
including non-
pathogenic ones
List ALL Cell
lines, including
human, insect
and animal
Select Agents
and toxins are
not used at
MSOE

18. SECTION C—Biosafety Level
What BSL does
your biological
material require?
Reference the
BMBL
MSOE does NOT
have facilities
Given the nature of that can support
the biological material BSL-3 or BSL-3
and info in BMBL, enhanced
what BSL are you research.
suggesting?

19. SECTION D—Risk Assessment
Reference data
sheets from
Product manufacturer or
specification the supplier.
sheets for cell
lines. ATCC, for
example.
Reference
the CDC or
Aerosols, mucous
membranes, ingestio PBSDS
n, cuts/scrapes? If
available, the PBSDS
will have agent
specific routes of 105/mL?
transmission. 106/mL?
0.5 ml?

20. SECTION D—Risk Assessment
What is available if
there is an exposure?
Antibiotic, antiviral, int
erferon?
Some examples are
bleach, dry heat, moist
heat. Reference
PBSDS for your agent
in question.

21. SECTION D—Risk Assessment List all items that
could potentially
puncture the
skin, including glass
tubes, cover
slips, slides, etc.

22. SECTION D—Risk Assessment
Most rDNA work at
MSOE will either be
under Section III-E
or Section III-F
(exempt)

23. SECTION E—Exposure Control: PPE
What specific
laboratory
procedures need the
PPE required for
BSL-1 or BSL-2?
Are there certain
steps in the
experiment, that
need additional
PPE? List and
describe here.
The BMBL and MSOE
policies state gloves, lab
coat, and safety glasses
are standard PPE for
BSL1 and BSL2
procedures.

24. SECTION E—Exposure Control: Equipment How will you eliminate
aerosols? This is the
foundation of your
risk assessment.
What specific
equipment will you
use in your
experiment? For
which procedures?

25. SECTION F—Disinfection & Biological Waste Disposal
Disposables soaked in
disinfectant and discarded*
Add full strength
bleach to a final
dilution of ~10% in
waste, let sit for > 15
minutes and sewer*
List disinfectants to be
If mixed waste is present, usually will used . Alcohol will
inactivate the biohazard first and treat generally only be used
as chemical waste only* for cleaning*
*See the Biosafety Manual for more
detailed procedures

26. SECTION G—Documentation
MSDS are
essential for all
kits and hazardous
materials used in
your protocol
To ensure you
know
manufacturer's or
supplier’s
recommended
handling
instructions
PBSDS sheets will
If PBSDS sheets are not contribute to a
available, CDCse also have
may proper risk
risk assessment information assessment and
available online implementation of
safe laboratory
operations

27. SECTION H—Faculty Member Assurance
These are your
responsibilities
as a faculty
member.
Make sure you
have read and
understand
MSOE’s Biosafety
policies.
Are you familiar
with the NIH
Guidelines and
the BMBL, and
how they impact
your research?

28. SUBMITTING YOUR PROTOCOL

29. Submitting your Protocol
• Where is the electronic protocol form found?
– https://inside.msoe.edu/ehs (under Biosafety)
• How do you submit your protocol?
– E-mail the completed form to Julie LaRose at:
larose@msoe.edu
• Who reviews your protocol?
• How is your protocol evaluated/reviewed?
• What happens once your protocol is reviewed?

30. Thank you for your
attention. Please be
sure to complete the
on line quiz for this
module.