The University of Toledo Institutional
Biosafety Committee (IBC)
The following slides are presented as
frequently asked questions regarding the
role of the IBC and what types of research
require UT personnel to submit research
protocols for approval by the IBC
Last updated 22 Feb. 2016
1
What is the purpose/mission of the IBC?
• The primary mission of the IBC is to ensure the safety of staff,
students, and patients involved in biological research at our
university, and also to protect the general public and the
environment from adverse consequences related to that
research
• This includes meeting all required standards set by federal,
state and local governments, and as necessary, development
of University of Toledo-specific policies to make any research
conducted with hazardous, or potentially hazardous, biologic
agents (either naturally occurring or synthetically created) “as
safe as possible”
Last updated 22 Feb. 2016
2
What are the edicts that guides the activities of
the IBC?
• NIH Requirements for IBCs
• NIH Guidelines for Research Involving Recombinant and
Synthetic Nucleic Acids, issued by the NIH Office of
Biotechnology Activities (NIH OBA)
• Biosafety in Microbiological and Biomedical Laboratories
(BMBL), issued by CDC/NIH
• OSHA Blood-borne Pathogens Standard
• CDC/USDA Select Agent regulations: 42 CFR 73, 7 CFR 331
Last updated 22 Feb. 2016
3
What types of research need an IBC-approved
research protocol?
Any research utilizing the following need IBC approval before
performing research on or receiving biological materials at UT:
• Recombinant DNA
• Synthetic nucleic acids UNLESS they pass all 3 criteria below:
– Can neither replicate nor generate nucleic acids that can replicate in any living cell (e.g.,
oligonucleotides or other synthetic nucleic acids that do not contain an origin of replication or
contain elements known to interact with either DNA or RNA polymerase)
– Are not designed to integrate into DNA
– Do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms per
kilogram body weight
•
•
•
•
•
Microbial agents (BSL1 level and higher)
Biological toxins
Animal (including human) tissues and cell lines
Nanomaterials with biological properties
Select agents and toxins
Last updated 22 Feb. 2016
4
Diagram showing information regarding work within
the different categories of the NIH Guidelines*
External
Authority
Internal
Oversight
BSL2
BSL1
NIH Section III-F
and App C
Exempt
rDNA/SNA,
NIH Guidelines
Sections III-F-1
thru III-F-8;
Appendix C
UT requires IBC
protocol
NIH Section III-E
Non-pathogenic
prokaryotes and
non-pathogenic
eukaryotes
rDNA with <2/3
eukaryotic viral
genome and no
helper, in tissue
culture only
NIH Section III-D
RG2 or RG3
agents used in
host-vector
systems including
pathogenic
bacteria; viral
vectors; rDNA
administered to
whole animals
(fish, worms, flies,
rodents)
Rodents,
III-F-8,
App C
Rodents,
III-E-3
Exempt per NIH
NIH-OBA
NIH-OBA
IBC, (EHRS)
IBC, (EHRS))
IBC, EHRS)
Animals,
III-D
Non-recomb.
pathogens
(isolated for
study)
Human blood,
body fluids, or
tissues used in
research
Non-recomb.
biological
toxins include
belowthreshold
SATs.
Some types of
animal
tissues,
blood, fluids
(define) used
in research
Animals
BMBL (CDC)
Human
cell lines?
(define)
TBD
TBD
Human Gene Transfer or
infectious agents administered to
humans
Type of Work
BSL
Section III-A, Section III-B:
NIH and IBC approval and before initiation
Nanomaterials are not represented on this diagram
BBP (MIOSHA) NIH-OBA
IBC, EHRS)
NIHOBA/
RAC,
FDA
IBC, IRB
BSL3
Select Agent or Toxin
Animals
rDNA
Non-SAT BSL3
CDC
R.O.; IBC
*NIH Section: NIH Guidelines for Research Involving Recombinant & Synthetic Nucleic Acids
EHRS: Environmental Health and Radiation Safety (University of Toledo)
OBA: Office of Biotechnology Activities
SNA: synthetic nucleic acids
Last updated 22 Feb. 2016
5
How do I initiate an IBC protocol?
Submit the protocol by the last Friday of the month prior to the review meeting (for example, if you
want the protocol reviewed at the 12/17/15 meeting, the deadline for submitting would be 11/27/15.
• The IBC encourages all Primary Investigators (PIs) to consult with any member of the committee
during the planning phases of their IBC protocol
• The PI must be a salaried UT faculty member OR other salaried contract personnel
• IMPORTANT: If your IBC will be linked to an animal protocol (IACUC), the IBC protocol must be
approved first before the animal protocol will be approved
• All new protocols must be submitted on the most current template, which can be found at
www.utoledo.edu/research/forms
• Protocols must be sent electronically from the PI’s mailbox to Monika DeGregorio
(Monika.DeGregorio@utoledo.edu). Please do not send hard copies!
• IBC meets the 3rd Thursday of each month. PI’s are invited and encouraged to attend the meeting
• Required training must be completed by the PI and all personnel on the protocol before final
approval; otherwise, they cannot begin the proposed studies. Training must be repeated annually.
– For BSL1 protocols, Laboratory Safety is required. Training is done through EHRS
– For BSL2 protocols, Laboratory Safety & Biosafety training is required. Training is done through EHRS
– For BSL3 protocols, Laboratory Safety, Biosafety, and BSL3 training is required, along with mandatory federal
training and clearance
Last updated 22 Feb. 2016
6
What are the possible outcomes of the IBC review?
•
Approved
– IBC Administrator will send a final electronic copy to the PI to be printed twice, signed, and
returned to the IACUC office via campus mail or personal drop off.
– Committee chair signs the approved protocol, original is returned to the PI, and work can begin.
•
Modifications are required to secure approval
– A memo will be emailed to the PI indicating the modifications that need to be performed before
the protocol can be approved.
– The revised protocol will be re-reviewed via designated member review (typically the Chairman
and/or reviewer #1 and/or reviewer #2).
– Protocol will be approved after all requested revisions have been made (see above).
•
Deferred or tabled review
– If the committee feels that substantial information is lacking and/or insufficient to clearly
understand the critical aspects of the protocol, then the protocol will be deferred.
– Memo is emailed to the PI describing the issues that need to be changed or clarified.
– Because the revised protocol will contain a significant amount of additional information, the
committee is likely to require additional modifications that were not part of the initial review.
– If deferred, the PI must attend all the follow-up IBC meetings to directly answer any questions the
committee may have; however, they will not be able to remain in the room when the committee
takes the final discussions/voting. If the PI does not attend, the protocol will not be reviewed.
Last updated 22 Feb. 2016
7
What happens after my protocol is approved?
•
A successful IBC Protocol is approved for 5 years, minus one day, from the date of the
IBC Chairman’s signature
– Every 5 years, resubmission of the protocol is required for a complete review
– This resubmitted protocol will contain all amended materials since the last submission
– Annual electronic updates are required from PIs regarding whether the protocol remains
active; these will be received and completed via email
•
As a courtesy, the IBC office will send out a notice via email or interoffice mail prior to
the 5 year expiration date
– This will both remind you to resubmit the protocol and provide the deadline for resubmission
– If for some reason, the PI has not received this reminder, it is the PI’s responsibility to know
his/her expiration date of the protocol and to resubmit in time for review before the
termination date
•
BSL1 renewals can be reviewed by the Committee Chairman. The form for BSL1
renewals will be obtained from the IBC administrator
•
BSL2 (or higher) renewals are reviewed by the full IBC committee and must be
submitted on form RSP601
Last updated 22 Feb. 2016
8
What if I need to add new materials/procedures to
my protocol?
•
Protocols need to be amended for a variety of reasons
–
–
–
–
–
–
–
–
•
Changes in personnel
Addition of new project(s) under current protocol
Changes in containment procedures to a lower biosafety level
Changes to the source of DNA, host or vector
The use of more than 10 liters of material containing rDNA
Changes in the organism studied or increase in biohazard level (mammalian, human or plant)
Changes in location of research
Changes in procedures
The PI should complete form RSP605, mail a signed, hard copy to the IBC administrator
(Monika DeGregorio MS 1020)
– If the changes do not entail a change in BSL level, the Chairman can review and approve the
amendment without it being discussed in the full IBC meeting
– However, if the amendment requires a change in BSL level, the amendment will need to be
discussed in the next IBC meeting
•
Approved changes are recorded in the IBC meeting minutes, and the PI will receive the
Chairman-endorsed amendment via campus mail
Last updated 22 Feb. 2016
9
What other departments/officials provide lab
safety oversight?
•
Members from the Department of Environmental Health and Radiation Safety (EHRS)
are responsible for inspecting the labs where research covered by an IBC protocol is
performed
– Will consult with the PI to ensure that the lab environment and equipment meet the biosafety
standards required for the work described in the IBC protocol
– Will ensure the PI performs annual certification of Biosafety Cabinets for BSL2 protocols
•
One or more members from the Department of EHRS serve on the IBC to allow timely
incorporation of their input
– The Institutional Biosafety Officer and the Responsible Official are permanent members of the
IBC committee
•
Approval of an IBC protocol is contingent on:
– Satisfactory completion of a biohazard lab inspection
– Appropriate training of personnel on the protocol
– Completing all corrective action items identified by EHRS
Last updated 22 Feb. 2016
10
Helpful hints for completing an IBC protocol?
There are certain issues in a research protocol that the IBC scrutinizes closely to ensure that
research is being performed safely and within the IBC guidelines. These include:
•
Confirmation of biosafety containment level (BSL) needed to complete the work
–
•
•
•
Through Department of EHRS, assessment of lab space, equipment, and lab practices
Through Department of EHRS, confirming that all personnel have completed all
necessary laboratory safety and biosafety training
Assessment of the risks posed by the work described, including
–
–
•
If viral vectors are being used, ensure they are replication deficient
If infectious materials and/or tissues are being assessed, are the materials being inactivated/killed before
taking outside the biological safety cabinet for further analyses?
Transport of biological materials between different lab spaces, buildings, or institutions
must be clearly defined and performed by trained personnel
–
•
Thus, it is important to clearly list the microbes and cell lines to be used
EHRS also provides shipping training
An IBC protocol will be reviewed more expeditiously if the above issues are clearly
explained in the protocol
Last updated 22 Feb. 2016
11
Overview for submitting and gaining approval of an IBC
protocol
Protocol BSL
BSL1
BSL1
BSL2
BSL2
BSL2
TBD
TBD
BSL3
Type of Work or
Category
NIH Guidelines
Section III-F
NIH Guidelines
Section III-E
(transfer synthetic
DNA >67% viral
genome, transgenic
mice)
NIH Guidelines
Section III-D
NIH Guidelines
Non-recombinant
infectious agents;
biological toxins
NIH Guidelines
Blood-borne
pathogens (BBP);
human blood,
tissues, etc.
NIH Guidelines
Section III-A & III-B
(Transfer antibiotic
resistance or toxin
genes)
NIH Guidelines
Section III-C
(Transfer of nucleic
acids into humans)
NIH Guidelines
Section III-D; select
agents & toxins,
non-select agent
BSL3 agents
External
NIH/EHRS
NIH/EHRS
NIH/EHRS
BMBL/CDC
BMBL/CDC
NIH/OBA
NIH/OBA
CDC
Internal
IBC/EHRS
IBC/EHRS
IBC/EHRS
IBC/EHRS
IBC/EHRS
IBC/EHRS
IBC/IRB
IBC/RO
Submit What to
Whom
Protocol to IBC
Protocol to IBC
Protocol to IBC
Protocol to IBC
Protocol to IBC
Protocol to IBC
Appendix M, etc. to
NIH OBA and IBC/IRB
Coordinated by RO.
Includes CDC, DOJ,
Dean, IBC, DURC
Begin Work or Wait
for Approval
Begin concurrent
with submission
Begin concurrent with
submission
Wait until IBC
approval is issued
Wait until IBC
approval is issued
Wait until IBC
approval is issued
Wait for NIH & IBC
approval
Wait for
NIH/OBA/RAC, IBC, IRB
approval
Wait until all
aspects of review
are complete and
RO issues approved
Approval Criteria
Satisfactory protocol
content; BSL1appropriate work
Satisfactory protocol
content; BSL1appropriate work
Satisfactory protocol
content, personnel
training, lab
inspections
Satisfactory
protocol content,
personnel training,
lab inspections
Satisfactory
protocol content,
personnel training,
lab inspections
TBD
OBA/RAC outcome;
satisfactory Appendix
M, etc.
Multiple
considerations
depending on
agents used
Review Process
Administrative
review with option
of more committee
member; no vote
Two designated
reviewers; full
committee vote at
meeting
Two designated
reviewers; full
committee vote at
meeting
Two designated
reviewers; full
committee vote at
meeting
Two designated
reviewers; full
committee vote at
meeting
IBC submits
information from
PI/registration to
NIH
See Appendix M; IBC
waits for OBA; IRB
waits for IBC
Multi-step,
external & internal,
coordinated by RO
Outcome
Notification
Approval letter
issued stating BSL &
criteria for protocol
or amendment
Approval letter issued
stating BSL & criteria
for protocol or
amendment
Approval letter issued
stating BSL, ABSL,
vectors & criteria for
protocol or
amendment
Approval letter
issued stating BSL,
ABSL, vectors &
criteria for protocol
or amendment
Approval letter
issued stating BSL &
criteria for protocol
or amendment
NIH emails outcome
to IBC & PI
Letter indicating BSL &
other requirements,
including reporting
Different review
bodies depending
on agent; RO
compiles before
work can begin
Duration of
Approval
5 years
5 years
5 years
5 years
5 years
TBD
Open with annual
reports to IRB & OBA
3 years (CDC); 5
year (IBC); annual
by RO
Amendment
Needed?
Any non-exempt
work or new
categories of exempt
Any change in
systems; work with
pathogens, including
viral vectors
Any changes in viral
vectors, genes
cloned, organism
studied, etc.
Any new
pathogens, modify
pathogens, animal
model, etc.
TBD
TBD
Per clinical trial
sponsor or DSMB
Defined in
regulations and
EHRS guidance
Last updated 22 Feb. 2016
EHRS (Environmental Health & Radiation Safety)
IRB (Institutional Review Board)
OBA (Office of Biotechnology Activities)
RAC (Recombinant DNA Advisory Committee)
RO (Responsible Official – University of Toledo)
DAMB (Data and Safety Monitoring Board)
12
Flow chart for IBC protocol review
PI submits
protocol
staff
IBCIBC
staff
pre-review
pre-review
protocol
registration
Are
changes
needed?
no
IBC
reviewers
consider
protocol
IBC staff
assign
reviewers
yes
Are there
questions for
PI?
no
yes
IBC staff
requests
changes
EHRS performs
inspection
IBC reviewers
submit
comments
and/or
outcome
Protocol
discussed at
IBC meeting
Research protocols
cannot be performed
at this institution
Approve
conditionally
Committee
votes
EHRS
inspection
complete?
yes
Corrective
actions
completed
(PI)?
yes
IBC approval
Table/Defer
PI notified
that changes
or additional
information
requested
PI notified of
disapproval
Last updated 22 Feb. 2016
13
Important numbers for IBC-related issues
• IBC Administrative Assistant: Monika DeGregorio
– Monika.Degregorio@utoledo.edu
– 419-383-4252
• IBC Chairman: R. Mark Wooten, Ph.D.
– r.mark.wooten@utoledo.edu
• EHRA Biosafety Officer: Skylar Rohrs
– Skylar.Rohrs@UToledo.Edu
• EHRA Director: Heather Lorenz
–
Heather.Lorenz@utoledo.edu
• Website: https://www.utoledo.edu/research/RC/biosafety.html
Last updated 22 Feb. 2016
14