Policy and Procedures
Florida A&M University
Institutional Biosafety Committee
Table of Contents
I.
Introduction
II.
Principal Investigators
III.
Preparing the Protocol
A.
Is IBC Review Required?
B.
Protocol Submission
1.
Protocol Submission Form
IV.
Risk Group Determination
A.
Risk Group 1
B.
Risk Group 2
V.
Biosafety Levels
A.
Biosafety Levels for Infectious Agents
B.
Biosafety Levels for Vertebrate Animal
VI.
Select Agents
VII.
IBC Procedures for the Review of Protocols and Amendments
A.
Committee Review of New Protocols
Types of Review
B.
Review of Amendments
C.
Protocol/Amendments Status
VIII.
Protocol Renewals
IX.
Termination of a Protocol
X.
Transferring a Protocol to Another Investigator
XI.
Other Committees Related to the IBC
A.
Institutional Animal Care and Use Committee (IACUC)
B.
Institutional Review Board (IRB)
XII.
Relationship Between the Greenhouse and the IBC
XIII.
Responsibilities of the Principle Investigator
XIV.
Responsibilities of the Participants
XV.
Adverse Events
POLICY AND PROCEDURES FOR
THE INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)
I.
Introduction
The IBC is charged with the responsibility for review, approval and surveillance of all
research protocols at Florida A&M University involving the use of biohazards
including recombinant DNA, agents infectious to humans, animals or plants, and
other genetically altered organisms and agents. All research at the University
involving biohazards, regardless of its source of financial support, must be approved
by the IBC and must conform to IBC policies and principles.
The Vice President for Research has the responsibility for enforcing IBC decisions
and recommendations based on federal and institutional policies and procedures.
The IBC membership is comprised of: faculty members selected that they collectively
have experience and expertise in recombinant DNA technology, biological safety, and
physical containment; and at least one community member who represents the
interest of the surrounding community.
Membership reflects basic federal
requirements for expertise and advocacy; additional members are added as
necessary or appropriate.
The Vice President for Research appoints all IBC members, including the Chair. The
term of membership is three years. All terms are renewable upon mutual agreement
between the Vice President, the IBC Chair and the IBC member. The IBC has a
Vice-Chair who is called upon to serve in the Chair's absence. A current membership
roster is available from the Office of Animal Care and Research and their website
(http://research.famu.edu). The Office of Animal Care and Research Compliance is the
administrative office responsible for coordinating IBC activity. The Office is located in
Room 130 Dyson Building. The Director for Animal Care and Research Compliance
for Laboratory is Tanise L. Jackson, DVM, who is responsible for the committee and
can be reached at (850) 599-3214. If there are questions or concerns related to IBC
activities, the IBC staff can be reached at (850) 412-5246.
II.
Principal Investigators
The Principal Investigator (PI) is responsible for the overall conduct of the study,
including modifications to the original submission. In addition, the PI receives all
correspondence from the IBC including the continuing review material. Individuals
who are eligible to serve as PIs on proposals for external funding may also serve as
principal investigators on protocols. In general, these individuals have faculty
appointments at Florida A&M University. The faculty member’s name must appear
as PI on the Protocol Submission Form, and his/her signature must appear on the
signature page. The faculty sponsor will be designated as PI for the protocol; all
others are listed as participants. Any investigator other than the PI must be
designated as a participant on the Protocol Submission Form. The IBC must be
notified in writing when participants are added to or removed from the protocol. Only
the named and approved principal investigator and participant(s) may carry out any
procedure outlined in the IBC protocol.
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III.
Preparing the Protocol
A.
Is IBC Review Required?
Occasionally, it may not be apparent that IBC review is required for a particular
research project. This will typically happen when a protocol is being submitted to the
Institutional Animal Care and Use Committee (IACUC) or the Institutional Review
Board (IRB). During their review, these Committees may question whether the
protocol should also be submitted to the IBC. In this event, the PI is requested to
submit an abstract or summary of the proposed work to the IBC staff, which will be
forwarded to the IBC Chair or his/her designee for review. The Chair or his/her
designee will determine whether IBC review is required. The PI will be notified of the
Chair’s determination and the IACUC or IRB will be notified if applicable. If IBC
review is not required, documentation will be kept in file folder “Research Not
Requiring IBC” in the IBC office. If IBC review is required, the PI will be contacted
and requested to submit the required submission forms. Any documentation related
to this will be included in the protocol file.
B.
Protocol Submission
All research involving biohazards conducted at Florida A&M University must be
submitted to the IBC for approval prior to initiation. IBC forms, policies, and
procedures are periodically revised to ensure that the information meets current
regulatory requirements and that the IBC has information needed for a complete
review of the research. Review of a protocol could be delayed if further information is
required. All protocol applications must use the current approved submission form.
The most up-to-date version of the IBC forms are available on the OACRC website at
http://research.famu.edu. or by hard copy in the IBC office in Room 130 Dyson Building.
The principal investigator must submit the original and any other relevant materials to
the IBC.
1.
Protocol Submission Form
The Submission Form is designed to highlight areas of IBC concern. Therefore, the
form should provide an accurate and complete summary of the research project. The
principal investigator must sign the original. Most current IBC protocols at The
University of Chicago fall under Risk Group 1 or 2. The following section describes
the difference in submission requirements for Risk Group 1 and 2. Refer to the NIH
Guidelines for Research Involving Recombinant DNA Molecules, January 2001 or
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html to determine risk group.
IV.
Risk Group Determination
A.
Risk Group 1
Risk Group 1 agents are not associated with disease in healthy adult humans;
typically recombinant DNA (rDNA) work with E. coli is RG1. Protocols that fall under
Risk Group 1 must complete sections I-VI of the protocol submission form. All
laboratories must have a biosafety manual. Laboratories, other than those using
a Risk Group 2 agent, may adopt the CDC/NIH Biosafety in Microbiological and
Biomedical Laboratories (4th Edition) as their principle biosafety laboratory manual,
http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm . The applicable sections of the manual
for the risk group and biosafety level of the protocol must be available in the
laboratory and to the personnel listed on the protocol. Generally, Risk Group 1
research also falls under Biosafety Level 1.
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B.
Risk Group 2
Risk Group 2 agents are associated with human disease which are rarely serious and
for which preventive or therapeutic interventions are often available. For protocols
who fall under Risk Group 2, the entire submission form including section VII must be
completed along with developing a supplemental biosafety manual. The manual
must identify the hazards that will or may be encountered and must specify practices
and procedures, designed to minimize or eliminate risks. The manual must be
submitted to the IBC with the protocol for review. Personnel listed on the protocol
must be advised of special hazards and are required to read and to follow the
required practices and procedures described in the manual. Typical topics for the
manual include but are not limited to: overview of agent, general safety procedures
for laboratory, disposal procedures, biosafety level requirements, procedures for
handling animals in the laboratory, procedures for handling the agent,
decontamination procedures, spill/accident procedures, personal protective
equipment required, and procedures to take in the event of an exposure to the agent,
(include concentrations, length of time bleach needs to sit, efficacy). Generally, Risk
Group 2 research falls under Biosafety Level 2.
V.
Biosafety Levels
The CDC and NIH have established four levels of protection for research involving
infectious microorganisms and laboratory animals. The levels are designated in
ascending order, by degree of protection provided to personnel, the environment, and
the community. Biosafety levels were created to represent the conditions under
which the agent ordinarily can be safely handled. The four biosafety levels are
described below. Occasionally, protocols may be approved with biosafety level 2
with biosafety level 3 practices. Generally, biological safety cabinets are not required
for Risk Group 1 research.
A.
Biosafety Levels for Infectious Agents
The following tables are from the CDC/NIH Biosafety in Microbiological and
Biomedical Laboratories (4th Edition); http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4s3t.htm.
Page 3 of 14
Table 1. Summary of Recommended Biosafety Levels for Infectious Agents
Biosafety
Level
Agents
Practices
Safety Equipment
(Primary Barriers)
1
Not known to
consistently cause
disease in healthy
adults
Associated with
human disease,
hazard =
percutaneous injury,
ingestion, mucous
membrane exposure
Standard
Microbiological
Practices
None required
BSL-1 practice plus:
Primary barriers =
Class I or II Biological
Safety Cabinets (BSCs)
or other physical
containment devices
used for all
manipulations of agents
that cause splashes or
aerosols of infectious
materials; PPEs:
laboratory coats; gloves;
face
protection as
needed
BSL-1 plus:
Autoclave available
Primary barriers =
Class I or II BCSs
or other physical
containment devices
used for all open
manipulation of agents;
PPEs: protective lab
clothing; gloves;
respiratory protection as
needed
BSL-2 facility plus:
2
Limited access
Biohazard warning
signs
"Sharps" precautions
3
Indigenous or exotic
agents with potential
for aerosol
transmission; disease
may have serious or
lethal consequences
Biosafety manual
defining any needed
waste
decontamination or
medical surveillance
policies
BSL-2 practice plus:
Controlled access
Decontamination of
all waste
Decontamination of
lab clothing before
laundering
Dangerous/exotic
agents which pose
high risk of lifethreatening disease,
aerosol-transmitted
lab infections; or
related agents with
unknown risk of
transmission
BSL-3 practices plus:
Clothing change before
entering
Shower on exit
All material
decontaminated on
exit from facility
Physical separation
from access
corridors
Self-closing, doubledoor access
Exhausted air not
recirculated
Baseline serum
4
Facilities
(Secondary
Barriers)
Open bench top sink
required
Primary Barriers = All
procedures
conducted in Class III
BSCs or Class I or II
BSCs in combination
with full-body,
air-supplied,
positive pressure
personnel suit
Negative airflow into
laboratory
BSL-3 plus:
Separate building or
isolated zone
Dedicated supply
and exhaust,
vacuum, and decon
systems
Other requirements
outlined in the text
B.
Biosafety Levels for Vertebrate Animal
For protocols proposing work with animals and infectious agents, the IACUC, must be
completed and submitted. Protocol form must be completed and signatures by
Biosafety Committee must be in place before review by IACUC.
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Table 2. Summary of Recommended Biosafety Levels for Activities in Which
Experimentally or Naturally Infected Vertebrate Animals Are Used
Biosafety
Level
Agents
Practices
Safety Equipment
(Primary Barriers)
1
Not known to
consistently cause
disease in healthy
human adults.
Standard animal care
and management
practices, including
appropriate medical
surveillance programs
As required for normal
care of each species.
Facilities
(Secondary
Barriers)
Standard animal
facility
No recirculation of
exhaust air
Directional air flow
recommended
2
Associated with
human disease.
ABSL-1 practices plus:
Limited access
Hazard:
percutaneous
exposure, ingestion,
mucous membrane
exposure.
Biohazard warning
signs
Sharps precautions
Biosafety manual
3
Indigenous or exotic
agents with potential
for aerosol
transmission; disease
may have serious
health effects.
Decontamination of all
infectious wastes
and of animal cages
prior to washing
ABSL-2 practices plus:
Decontamination of
clothing before
laundering
Disinfectant foot
bath as needed
Dangerous/exotic
agents that pose
high risk of life
threatening disease;
aerosol transmission,
or related agents with
unknown risk of
transmission.
ABSL-3 practices
plus:
Entrance through
change room where
personal clothing is
removed and laboratory
clothing is
put on; shower on
exiting
All wastes are
decontaminated
before removal from
the facility
Page 5 of 14
PPE: laboratory coats,
gloves, face and
respiratory protection as
needed.
ABSL-2 equipment
plus:
Controlled access
Cages decontaminated
before bedding
removed
4
ABSL-1 equipment plus
primary barriers:
containment equipment
appropriate for animal
species;
Containment equipment
for housing animals and
cage dumping activities
Class I or II BSCs
available for
manipulative procedures
(inoculation, necropsy)
that may create
infectious aerosols.
PPEs: appropriate
respiratory protection
ABSL-3 equipment
plus:
Maximum containment
equipment (i.e., Class III
BSC or partial
containment
equipment in
combination with full
body, air-supplied
positive-pressure
personnel suit) used
for all procedures
and activities
Handwashing sink
recommended
ABSL-1 facility plus:
Autoclave available
Handwashing sink
available in the
animal room.
Mechanical cage
washer used
ABSL-2 facility plus:
Physical separation
from access
corridors
Self-closing, doubledoor access
Sealed penetrations
Sealed windows
Autoclave available
in facility
ABSL-3 facility plus:
Separate building or
isolated zone
Dedicated supply
and exhaust,
vacuum and
decontamination
systems
Other requirements
outlined in the text
VI.
Select Agents
42 CFR Part 72 RIN 0905-AE70 “Interstate Shipment of Etiologic Agents” regulates
the transfer of select agents. This rule places shipping and handling requirements on
facilities that transfer or receive select agents listed in the rule that are capable of
causing substantial harm to human health. Prior to transferring or receiving a select
agent listed, a facility must register with the CDC through the IBC Office. The
following is the CDC list of select agents:
Viruses - Crimean-Congo haemorrhagic fever virus, Eastern Equine Encephalitis virus, Ebola
viruses, Equine Morbillivirus, Lassa fever virus, Marburg virus, Rift Valley fever virus, South
American Haemorrhagic fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito), Tick-borne
encephalitis complex viruses, Variola major virus (Smallpox virus), Venezuelan Equine
Encephalitis virus, Viruses causing hantavirus pulmonary syndrome, Yellow fever virus
Bacteria - Bacillus anthracis, Brucella abortus, B. melitensis, B. suis, Burkholderia
(Pseudomonas) mallei, Burkholderia (Pseudomonas) pseudomallei, Clostridium botulinum,
Francisella tularensis, Yersinia pestis
Rickettsiae - Coxiella burnetii, Rickettsia prowazekii, Rickettsia rickettsii
Fungi - Coccidioides immitis
Toxins - Abrin, Aflatoxins, Botulinum toxins, Clostridium perfringens epsilon toxin, Conotoxins,
Diacetoxyscirpenol, Ricin, Saxitoxin, Shigatoxin, Staphylococcal enterotoxins, Tetrodotoxin, T-2
toxin
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The following must be submitted to the IBC Office when proposing work with a
Select Agent, then the IBC will submit the material to the CDC:
a cover letter from the College Dean
completed applicable form “Information on Select Agents…”
completed applicable Laboratory Assessment Instruments Form
curriculum vitae for Principle Investigator
indication of the source of DNA/organism
indicate assurance that there are no spores or living material present
discussion of Biosecurity procedures (i.e., inventory, security) - found in Appendix
I of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, 4th
ed.
sketch/floor plan (not blueprints) of the lab where work will be performed. The
plan should show entry, location of biosafety cabinet, incubators, freezers,
autoclaves, other equipment and the location of air intake and exhaust vents.
Also, a description of the air-handling system for the lab is required, (e.g., single
pass or re-circulation, type of filters, method for handling safety cabinet exhaust.)
The CDC may inspect the facility using a Select Agent. Once a registration number
has been provided from the CDC to the University, Form EA-101 must be filled out
prior to the actual transfer of agent. The form must be provided to the CDC and be
retained for five years after the shipment or after the agents are consumed or
properly disposed, whichever is longer.
VII. IBC Procedures for the Review of Protocols and Amendments
Upon receipt of a protocol, the IBC staff reviews it for completeness and notifies the
investigator of any apparent problems. Each protocol is then assigned a protocol
number by which the protocol will be tracked. Amendments for each protocol will be
numbered sequentially upon receipt. Each new protocol and amendment is reviewed
upon receipt by the IBC staff. See Appendix B for the flow of protocol and
amendment reviews.
Page 6 of 14
A.
Committee Review of New Protocols
IBC members who are involved in the protocol being reviewed will not be counted
toward a quorum. Reviewers are guaranteed anonymity, which they themselves may
waive. The IBC office will not disclose the name of protocol reviewers. Following
each IBC review, the principal investigator is informed of the protocol status in writing.
Types of Review
 Risk Group 1 Review - Risk Group 1 agents are not associated with disease in
healthy adult human, typically DNA work with E. coli is RG1. Will be reviewed by
the committee at a convened meeting.
 Risk Group 2 or higher Review - Risk Group 2 agents are associated with human
disease which are rarely serious and for which preventive or therapeutic
interventions are often available. The full committee will review these protocols.
B.
Review of Amendments
When any revision to an approved research protocol is desired, the investigator must
submit an Amendment Form. The form must be completed indicating the changes.
The form should explain what changes have been made and the rationale for those
changes. A revised copy of the pertinent original should also be submitted with the
changes identified. A cover letter or additional information may be attached as
necessary. Amendments to approved protocols may not be initiated until IBC
approval has been obtained. For staff or location changes, an acknowledgementminor change letter signed by the IBC Administrator will be sent to the PI. For other
changes, the amendment will be reviewed by the full IBC or the subcommittee per the
procedure that the original protocol was reviewed. Once approved, the IBC Chair will
sign the approval letter, with the original letter going to the PI and a copy kept in the
IBC file.
When adding a risk group 2 or higher agent to an approved protocol, the PI must
submit with the amendment.
C.
Protocol/Amendment Status
As part of its review of a protocol or amendment, the committee will assign a status to
each protocol. A letter indicating the status will be signed by the IBC Chair and sent
to the PI. That status will be one of the following:
Approved - If full approval is granted, the investigator may begin the research
outlined in the protocol. Protocols are approved for 5 years.
Approved with stipulations - Protocol is approved as long as PI follows any
stipulations the Committee indicates on the letter. The PI is NOT required to respond
to this letter in writing. Examples of stipulations may include reinforcing a point to the
PI, i.e., work is approved as BL1 with BL2 practices, which will include gloves, no
mouth pipetting, etc.
Pending - conditions (Formerly Approved with Conditions) - This status indicates that
there are questions or issues, which the investigator must resolve before the protocol
can receive full approval. No research may be initiated until all conditions have been
met and full approval has been obtained. The PI MUST respond to all conditions
within 60 days of notification. After 60 days with no response, another letter is sent
by the IBC to the PI requesting a response, after an additional 30 days with no
Page 7 of 14
response, the protocol or amendment is withdrawn. The PI’s response to the
conditions goes back to reviewer, who will confirm the response is satisfactory and
the protocol will be given full approval. All time periods are pending no unforeseen
circumstances.
Pending - Deferred - Protocols receiving a deferred status contain concerns of a
more substantive nature such that once the investigator responds the protocol must
be reviewed by the full Committee. No research can be done at this time until a
satisfactory response is received and full approval has been granted. The PI MUST
respond to all conditions within 60 days of. After 60 days with no response, another
letter is sent by the IBC to the PI requesting a response. After an additional 30 days
with no response, protocol or amendment is withdrawn. All time periods are pending
no unforeseen circumstances.
Reject - The Committee has major concerns with the protocol. The protocol is not
justified and poses severe or unnecessary risk; protocol may have been deferred
several times; the problems with the proposed protocol have not been adequately
addressed. Further revisions to a rejected protocol will not be accepted. The PI may
re-write the protocol with substantial changes for submission as a new protocol.
Withdrawn – This designation applies to protocols or amendments that have been
removed from further consideration by the IBC. This may occur because the PI failed
to respond to Committee questions in the allotted time or because the PI has
withdrawn the protocol or amendment for their own reasons.
Terminated – The protocol is no longer active and research outlined in the protocol
must not be conducted. The PI may terminate the protocol at any time by contacting
the IBC Administrator. The PI may also indicate to terminate the protocol during the
renewal process. If the PI fails to respond to renewal survey within the allotted time,
the IBC may terminate the protocol.
VIII. Protocol Renewals
In accordance with federal regulations, the IBC is required to periodically review
recombinant DNA research conducted at the University to ensure compliance with
the NIH Guidelines. The protocol renewal process will include a cover letter and an
IBC Protocol Renewal Survey, for each approved protocol assigned to the
investigator. Protocol Renewal Surveys for all protocols assigned to an investigator
must be completed in full and received by the IBC Office in room 130 Dyson within
three weeks. Once the IBC is satisfied that the survey is complete, a renewal letter
will be sent to the investigator. All time periods are pending no unforeseen
circumstances.
If the survey has not been submitted to the IBC Office, the IBC may send a follow-up
notice for delinquent surveys. Failure to provide an adequate and timely
response to the survey will result in an AUTOMATIC TERMINATION of the
protocol. The IBC will send a “Notice of Termination”. In this case, if future
research conducted under the protocol is requested, a new submission and approval
of the protocol is required. Keep in mind that the IBC may find that additional
information or revisions are needed while reviewing a new submission.
Page 8 of 14
IX.
Termination of a Protocol
Investigators should terminate a protocol when biohazards are no longer being used.
Investigators are encouraged to notify the IBC as soon as a study should be
terminated. However, another mechanism for terminating a study is through the
continuing review process. When a faculty member leaves the University, he or she
should terminate his/her protocol(s), or notify the IBC in writing that the protocol(s)
should be transferred to another investigator who will take responsibility for the
research. See section on transferring a protocol to another investigator.
X.
Transferring a Protocol to Another Investigator
When an investigator chooses to transfer his status as principal investigator on an
approved protocol to another investigator, the IBC must be notified. The new
investigator must be eligible to serve as Principal Investigator (See Section II). To
effect this transfer, an Amendment Form should be submitted to the IBC with a
statement that the protocol should be transferred to another investigator who will take
responsibility for the research. Section V, Staff Group, of the Protocol Submission
Form must also be completed and submitted. This amendment should be co-signed
by the existing investigator and the new investigator recognizing that he/she is now
responsible for the study. If the former investigator is no longer at the University, a
simple statement to this effect, rather than his/her signature is sufficient. IBC staff will
inform the investigator when the amendment is approved.
If the IBC is notified that a PI is no longer at the University, all PI-eligible participants
listed on the protocol will be contacted by email, to inquire whether they would like
the protocol transferred. At this point, the protocol is suspended and the work
outlined on the protocol cannot be conducted. The PI-eligible participants have 30
days to submit an amendment requesting a transfer. After 30 days, if no
amendments were received, the protocol will be terminated. All time periods are
pending no unforeseen circumstances.
XI.
Other Committees Related to the IBC
Often research will require review by other committees in addition to the IBC. In
these cases, copies of each Committee's approval must be cross-referenced in the
other Committee's files and approval of one Committee will be contingent upon the
other. Coordination of review by these committees will be done through the Office of
Animal Care & Research Compliance.
A.
Institutional Animal Care and Use Committee (IACUC)
The IACUC is charged with the responsibility for review, approval and surveillance of
all research and teaching protocols involving the use of animals at Florida A&M
University. This review and surveillance is conducted to assure the humane care and
use of animals in these protocols.
B.
Institutional Review Board (IRB)
The IRB is charged with the responsibility for review, approval and surveillance of all
research involving human subjects carried out at Florida A&M University. This review
and surveillance is conducted to assure the protection of the rights and welfare of all
research subjects, including volunteers and patients.
Page 9 of 14
XII. Responsibilities of Investigators
It is the responsibility of the investigator to:
 ensure that all procedures in approved protocols are performed and/or supervised
by the listed investigator or other authorized personnel (not unlisted investigators,
technicians, residents, fellows or students);
 submit an amendment to the IBC if the investigator or other personnel have
changed;
 provide the IBC with the appropriate information on the research protocol
including initial information, notification of subsequent modifications, and
terminations;
 ensure that no research will be initiated until IBC approval is received;
 carry out the protocol as approved, initiating modifications only after the IBC has
approved the amendment;
 ensure all personnel listed on the protocol have been adequately trained in
microbiological techniques and practices required to ensure safety and for
procedures in dealing with accidents;
 enforce federal regulations regarding laboratory safety for all persons who work
under his/her direction;
 correct work errors and conditions that may result in the release of rDNA materials
or infectious agents and ensuring the integrity of the physical containment;
 report any adverse event, such as a work related injury or exposure to the IBC;
 ensure that participants, if any, employ the necessary safeguards to protect
laboratory personnel, students, and the community from potential hazards posed
by the project; and
 ensure the timely completion and submission of the renewal survey; it is the
responsibility of the principal investigator to ensure that review is completed and
approved by the IBC.
The IBC will mail original correspondence only to the principal investigators. It is the
responsibility of the investigator to ensure that copies of IBC letters are distributed to
appropriate individuals (e.g. grant and contract administrators, department
administrators, granting agencies, etc.).
XIII. Responsibilities of the Participants
It is the responsibility of the participant to:
 read and understand the submitted protocol;
 read and understand the applicable sections (for risk group and biosafety level) of
the biosafety manual;
 to abide by the procedures in approved protocols;
 be adequately trained in microbiological techniques and practices; and
 report any adverse event, such as a work related injury or exposure to the PI.
XIV. Adverse Events
Any adverse event, which occurs related to an IBC Protocol, must be reported to the
IBC Administrator or IBC Chair. Examples of adverse events include: work-related
exposures, injuries, illnesses, laboratory accidents, any event of non-compliance,
such as research conducted outside the scope of the approved protocol. If the
protocol in question involves animals, the IACUC will evaluate the adverse event or
handle the non-compliance. If the protocol involves animals and infectious agents,
the IACUC and the IBC will handle the relevant issues jointly.
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The IBC must determine if the problem, research-related accident or illness is
significant to necessitate reporting to the institutional official or NIH/OBA.
A.
IBC requirements:
Section IV-B-2-b-(7) The IBC shall report any significant problems with violations of
the NIH Guidelines and any significant research-related accidents and illnesses to the
appropriate institutional official and NIH/OBA within thirty days, unless the institution
determines that a report has already been filed by the PI or the IBC.
B.
PI requirements:
Section IV-B-7-a-(3) The PI shall report any significant problems, violations of the
NIH Guidelines, or any significant research-related accidents and illnesses to the
Biological Safety Officer (where applicable), Greenhouse/Animal Facility Director
(where applicable), Institutional Biosafety Committee, NIH/OBA, and other
appropriate authorities (if applicable) within 30 days.
Any non-compliance with these procedures may result in the suspension of the
protocol.
Page 11 of 14
Appendix B.
IBC Procedures for Florida A&M University
IBC Protocol or
Amendment is received,
pre-reviewed by the IBC
Administrator
If protocol involves Plants, the
Plant expert ex-officio member
will also review, in addition to
the subcommittee or full
committee reviewers.
If protocol involves Animals, the
animal expert ex-officio member
will also review, in addition to
the subcommittee or full
committee reviewers.
Protocol is
Risk Group 1
Protocol is
Risk Group 2
IBC Subcommittee (two
members, not involved with the
protocol) will review the protocol
Subcommittee has seven
days to review protocol
Full IBC will review the
protocol
Full Committee has 10 days to
review the protocol
Once Subcommittee or the Full
Committee reviews the protocol,
the IBC Administrator will
contact the PI to address any
issues/concerns.
Renewal surveys will be
sent to the PI on a regular
basis. A renewal letter will
be sent to the PI, once the
survey is complete.
Page 12 of 14
Once approved, the IBC
Administrator will update
the database and generate
an approval letter for the
Chair (Vice-Chair if Chair is
not available) to sign.
Original letter will be sent
to PI, and a copy placed in
the protocol file.