IBC Protocol Instructions
Approved 5/13/02
CLEMSON UNIVERSITY
RESEARCH and TEACHING INVOLVING HAZARDOUS AGENTS
INSTRUCTIONS, CHECKLISTS and FORMS FOR COMPLETION
OVERVIEW:
Clemson University aims to provide a safe and healthful work environment for employees,
students and visitors. It is the intent to minimize to the extent practicable all recognizable hazards
and to comply with all federal and State laws and regulations. In accordance with federal
regulations, the Institutional Biosafety Committee (IBC) was established to provide review of all
protocols that involve the use of hazardous or potentially hazardous agents. By providing the
following information, you assist our committee in meeting the standards set by the federal
government and Clemson University. The Chief Environmental Health and Safety Officer
(CEHSO) serves as the University Biosafety Officer (BSO) and must be consulted regarding any
proposed use of potentially hazardous agents. EHS is responsible for the maintenance of a
biosafe environment at Clemson, and they work with the principal investigator (PI) who is directly
responsible for adherence to biosafety regulations in his/her laboratory. This includes the actions
of all students and technicians. Upon request, Chief Environmental Health and Safety Officer
(656-1806) will assist investigators in developing protocols.
REVIEW PROCESS:
To expedite the review process the IBC utilizes three levels of review based on the nature of the
hazard(s) involved; Exempt, Designated and Full Committee.
EXEMPT PROTOCOLS are those that present only minor hazards with very low risk that may be
addressed in a short form that is reviewed by the BSO and IBC chair to validate the Exempt
status. Exempt protocols may be validated immediately upon review by the BSO and IBC
chair and require continuing review on an annual basis.
DESIGNATED REVIEW is used for protocols that present a moderate risk and require review by
the BSO, IBC chair and usually at least one other IBC member with the appropriate expertise
(designated by the IBC chair). Protocols involving chemicals that are highly toxic, carcinogenic,
mutagenic or teratogenic may be reviewed as designated at the discretion of the chair and BSO.
Recombinant DNA Protocols assigned designated review must be reviewed by five IBC members
in compliance with federal guidelines for the use of recombinant DNA. Designated Review
requires 5 to 10 working days and approval may be granted once concerns, if any, have
been adequately addressed by the PI. These protocols require continuing review on at least
an annual basis.
FULL COMMITTEE REVIEW is used for protocols that may present significant hazards to
humans, animals or the environment. Examples of significant hazards would be work with
biological agents requiring greater than BSL2 containment facilities or practices or release of
genetically altered organisms. All members of the IBC participate in a Full Committee Review,
which may require up to 10 - 15 working days depending on the complexity of the proposed
work. In some cases, the IBC chair may request a meeting of the IBC to discuss concerns related
to a full committee review. Protocols requiring Full Committee Review may be approved as
soon as all concerns have been adequately addressed by the PI. These protocols require
continuing review on at least an annual basis and more frequently if indicated.
IBC Protocol Instructions
Approved 5/13/02
Any proposed changes in the protocol for the use of hazardous agents must be submitted and
approved as an update prior to initiation. An annual review of the hazardous agent use must be
completed and approved at least every twelve (12) months for the study to continue.
INSTRUCTIONS:
The following Protocol should be completed and signed by the Principal Investigator and
Department Chair. Please submit original signature page and hazard acknowledgement signature
sheet to the Office of Research Compliance, E308 Martin Hall. This form will not be considered
complete until all of the items have been addressed (requested information that is not available
should be noted). Please note specific instructions for each type of biohazard (biological,
chemical, and recombinant DNA). Incomplete forms will not be approved. Should you have
any questions, please do not hesitate to contact the Office of Research Compliance at 656-6460.
ANIMALS:
REQUIRED INFORMATION:
 Complete an Animal Use Protocol and submit it to the ARC
 Complete the relevant parts of the Hazardous Agent Protocol
 Include an abstract and flow sheet of the proposed research; and
BIOLOGICAL HAZARDS:
A biohazard is a potentially dangerous infectious agent or material (tissue, blood, etc.) that is
suspected to contain an infectious agent or whose hazard status is unknown. For our purposes, a
biohazard is any BSL2 agent or above, or human or animal blood, tissue, or waste specimen
known to harbor infectious agents or whose biohazard status is unknown; human or non-human
primate derived cell lines or similar are also considered biohazards (per OSHA definition).
Infectious organisms includes all agents (including prions) capable of causing disease in healthy
humans or animals, whether these occur commonly in the environment or not.
The Center for Disease Control-NIH Biosafety in Microbiological and Biomedical Laboratories
http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm manual should be used for guidelines in
completing the Biohazards Protocol section. It is a requirement that all personnel be offered
appropriate inoculations against any pathogenic for any occupational health purposes before any
lab work can be done. If inoculations are not received, a waiver must be signed. Regardless of
the source, if using human or non-human primate tissue or body fluid(s), a protocol will be
required.
REQUIRED INFORMATION:
 If the Protocol will Qualify as Exempt:
 Completed Signature Page
 The Exempt Certification Form
 General Information: Protocol Qualifying as Exempt; and
 All individuals working on the project must sign the Hazard
Acknowledgement Signature Sheet (or a document in your own
wording, if necessary) indicating they are aware of the potential
hazards of the protocol.
 If the Protocol Does Not Qualify as Exempt:
 Completed Signature Page
 General Information: Protocol Not Qualifying as Exempt
 Part B; and
IBC Protocol Instructions
Approved 5/13/02
 All individuals working on the project must sign the Hazard
Acknowledgement Signature Sheet (or a document in your own
wording, if necessary) indicating they are aware of the potential
hazards of the protocol.
CHEMICAL HAZARDS:
Any chemical listed as highly toxic, carcinogenic (confirmed or suspected), mutagenic, teratogenic
or explosive on its MSDS must be covered by an approved protocol; if undergraduates are
involved in the research, any chemical listed as toxic, carcinogenic (confirmed or suspected),
teratogenic or explosive on its MSDS must be covered and the protocol will not qualify as Exempt.
Highly toxic is defined as: 1) having an oral LD50 of 50 mg/kg body weight when
administered orally to albino rats weighing between 200 and 300 g each. 2) LD50 (200
mg/kg body weight when administered by continuous contact for 24 hours (or less if death
occurs within 24 hours) with bare skin of albino rabbits weighing between 2 and 3 kg each.
3) LC50 in air of 200 ppm by volume or less of gas or vapor, or 2 mg/l or less of mist, fume
or dust, when administered by continuous inhalation for one hour (or less if death occurs
within one hour) to albino rats weighing between 200 and 300 g each.
Toxic is defined as: 1) having an oral LD50 (500 mg/kg 2) a contact LD50 of (1000 mg/kg
for 24 hour exposure or 3) LC50 of 2000 ppm with one hour exposure. If this information is
not listed for rats (or rabbits for contact), and any test animal listed has an LD50 lower than
the amounts listed above; the chemical must be covered by an approved protocol. Also,
chemicals having an LD50 for humans listed at amounts below those listed above must be
covered by an approved protocol.
REQUIRED INFORMATION:
 If the Protocol will Qualify as Exempt:
 Completed Signature Page
 The Exempt Certification Form
 General Information: Protocol Qualifying as Exempt
 Manufacturer’s Material Safety Data Sheets (MSDS) for each
chemical listed (only attach paper copy if not submitting
electronically or the chemical is not listed in the CCINFO MSDS
database (accessible from the EHS website). It allows you to search
and print chemical data from six databases; and
 All individuals working on the project must sign the Hazard
Acknowledgement Signature Sheet (or a document in your own
wording, if necessary) indicating they are aware of the potential
hazards of the protocol.
 If the Protocol Does Not Qualify as Exempt:
 Completed Signature Page
 General Information: Protocol Not Qualifying as Exempt
 Part C
 Manufacturer’s Material Safety Data Sheets (MSDS) for each
chemical listed (only attach paper copy if not submitting
electronically or the chemical is not listed in the CCINFO MSDS
database (accessible from the EHS website). It allows you to search
and print chemical data from six databases; and
 All individuals working on the project must sign the Hazard
Acknowledgement Signature Sheet (or a document in your own
IBC Protocol Instructions
Approved 5/13/02
wording, if necessary) indicating they are aware of the potential
hazards of the protocol.
See the following websites for copies of MSDS:
http://ehs.clemson.edu/
RECOMBINANT DNA:
By definition (Federal Register 51 (88) page 16959 I-D-2), the CU IBC reviews and oversees
projects which deal with recombinant DNA (rDNA) technologies. Clemson University must have
such a committee made up of faculty, staff, and community members, for review of protocols and
compliance in rDNA matters. While the most scrutinized protocols are those dealing with the
environmental release of genetically engineered organisms, all protocols including those using
only laboratory contained experiments are closely examined. CU has a policy of requesting that
all investigators file a protocol when using rDNA molecules or organisms, although certain types of
experiments will qualify as "Exempt". This process guarantees our compliance with Federal
regulations and allows us to assure the public that we are safeguarding the public interest.
If you work with recombinant DNA, (see Section I-B of the NIH Guidelines: Definition of
Recombinant DNA Molecules), a component of the protocol form will require you to identify the
section(s) and appendices of the NIH Guidelines appropriate for your experiments. A copy of the
Guidelines for Research Involving Recombinant DNA Molecules is available on the Internet at
http://www.nih.gov/od/oba/. A hard copy is available in the Office of Research Compliance.
If you plan at any time to introduce genetically engineered organisms into the environment,
additional information must be filed. For this component, you will need to complete Steps 1-4 in
Part D of the protocol. You also will need to reference the USDA publication entitled Guidelines
for Research Involving Planned Introduction into the Environment of Genetically Modified
Organisms (December 3-4, 1991 or most current version).
REQUIRED INFORMATION:
 If the Protocol will Qualify as Exempt:
 Completed Signature Page
 The Exempt Certification Form
 General Information: Protocol Qualifying as Exempt; and
 All individuals working on the project must sign the Hazard
Acknowledgement Signature Sheet (or a document in your own
wording, if necessary) indicating they are aware of the potential
hazards of the protocol.
 If the Protocol Does Not Qualify as Exempt:
 Completed Signature Page
 General Information: Protocol Not Qualifying as Exempt
 Part D; and
 All individuals working on the project must sign the Hazard
Acknowledgement Signature Sheet (or a document in your own
wording, if necessary) indicating they are aware of the potential
hazards of the protocol.
IBC Protocol Exempt Certification Form
INSTITUTIONAL BIOSAFETY COMMITTEE:
Approved 5/13/02
EXEMPT CERTIFICATION FORM
Protocols that present only minor hazards with very low risk to humans, animals or the environment may be exempt
from full review of the IBC. Exempt protocols may be validated immediately upon review of the CHESO
and IBC chair and require continuing review on an annual basis. Please complete the following
checklist to determine if your study may be validated as exempt. Use of any non-exempt agent requires
the submission of a non-exempt protocol application for all agents.
Hazard Categories Check List (Check all that apply):
Animal Use: This proposal involves the use of live animals.
An Animal Use Protocol must be submitted to the ARC, and any research or teaching involving a
hazardous agent will require approval by the IBC.
Biological Hazard [Refer to Center for Disease Control-NIH Biosafety in Microbiological
and Biomedical Laboratories (Current Edition)
Does this protocol involve biological agents that require containment levels of:
 Biosafety Level 4 (BSL4)/(ABSL4)
YES
NO
 Biosafety Level 3 (BSL3))/(ABSL3)
YES
NO
 Biosafety Level 2 (BSL2))/(ABSL2)
YES
NO
 Biosafety Level 1 (BSL1))/(ABSL1)
YES
NO
 CDC select agents
YES
NO
Complete Section B if this proposal requires levels 2, 3 or 4.
Protocols requiring containment levels of BSL2 or above and/or undergraduate students will not
qualify for exempt.
Chemical Hazard (Consult Material Safety Data Sheets (MSDS) for this information)
This proposal does involve chemicals that are:
 highly toxic
 mutagenic
 teratogenic
 carcinogenic (confirmed or suspected)
 explosive
YES
YES
YES
YES
YES
NO
NO
NO
NO
NO
Complete Section C if this proposal does involve any of the above categories.
Protocols involving any of the above categories will not qualify as exempt.
Protocols involving undergraduate students will not qualify for exempt.
Recombinant DNA (Refer to NIH Guidelines for Research Involving Recombinant DNA
Molecules for more information)
This protocol does involve:
the planned release of an experimental genetically modified/engineered (transgenic) organism
into the environment (excluding contained areas such as greenhouse, growth chamber or
laboratory)
the direct transfer of a gene or DNA derived from any source (or RNA derived from recombinant
DNA) into a human
genes encoding animal/human toxins (or their toxic subunits) (e.g., those on the CDC’s Select
Agent List or listed in Appendix A of the NIH Guidelines)
the cloning of a gene or factor associated with an animal/human disease
recombinant molecules that contain the majority of a pathogen's genome (e.g., those on the
CDC’s Select Agent List, or in the NIH’s Risk Group 2, 3 or 4)
the use of organisms from the CDC’s Select Agent List, or in NIH Risk Groups 2, 3 or 4, as hosts
for the propagation or expression of recombinant DNA molecules
Complete Section D if this proposal does involve any of the above categories.
If you checked any of the above categories, your proposal does not qualify as exempt.
CLEMSON UNIVERSITY
HAZARDOUS AGENTS PROTOCOL - EXEMPT
SIGNATURE PAGE
Protocol #:_________________________
AUP or IRB #:__________________
Date Approved: _____________________
Signature IBC Chair: _______________________________________________________
Signature CEHSO: ____________________________________________________________
(For Office of Research Compliance use Only)
This is a:
New Protocol
Revised Protocol
Amendment
Hazard Category:
(check all that apply):
Biological
Chemical
rDNA
Animals will be involved in this protocol:
Human subjects or tissue(s) will be involved in this protocol:
Yes
Yes
No
No
If you answered Yes to either of these questions, please submit the appropriate IRB or ARC Protocol
Application. ARC or IRB Protocol Number if known:
)
Principal Investigator:
Co-Investigator:
Full Name of Principal Investigator
Full Name of Co-Investigator
E-Mail Address
Department
Telephone Number
Fax Number
Mailing Address
Sponsor Information
Sponsored Programs Proposal #
Project or CourseTitle:
(must match the title submitted to the funding agency, departmental course coordinator or any other CU committee)
Source of Funding:
Anticipated Start Date of Project:
Expected Duration of Project (indicate if months, years, etc.):
Signature of Principal Investigator: _________________________
Signature of Co-Investigator: ______________________________
Date: _________
Date: _________
Signature of the principal investigator certifies that the information in this protocol is accurate and complete, that the
PI is familiar with federal and institutional regulations and guidelines and agrees to abide by such regulations and
guidelines. Signature also certifies that the PI is responsible for assuring that all personnel working with the project
are properly trained and informed of the hazards involved and have signed a statement indicating that they have been
informed of such hazards.
Signature of Department Chair: ____________________________
Date: __________
Signature of the department chair certifies that he/she is familiar with the project, is aware of the hazards involved
and that the project has been given his/her approval
Part A- General Information
Approved 5/13/02
PART A - GENERAL INFORMATION
HAZARDOUS AGENTS PROTOCOL FORM
To be filled out for:
PROTOCOLS QUALIFYING AS EXEMPT
1.
AGENTS UTILIZED
A.
Names of Agent(s):
Biological
Chemical
rDNA
B.
2.
Provide a short synopsis in non-technical language of how the agent
(chemical, biologic and/or rDNA) is to be used. An abstract or means and
methods may be attached. This is to help IBC members and non-specialists
understand the nature of the project and its significance.
HANDLING OF AGENT
A.
Personnel Conducting Research (faculty, staff and students):
Name
B.
Title/Status
Training & Experience in Research
Designated Work Areas: (building, room, labs, storage areas, etc.)
Building
Room Number
Type of Room
Part A- General Information
3.
Approved 5/13/02
HAZARDOUS AGENT IDENTIFICATION
A.
(1) What hazardous agent signage is being used?
Biohazard
Chemical
Other
(2) Are the hazardous agents identified on these signs?
Yes
No
(3) Where is hazardous agent signage being used?
Lab entrance
Storage areas (refrigerators, freezers, etc.)
Work areas (biosafety cabinet, incubators, etc.)
Other: (please specify)
(4) Contact numbers for emergencies have been posted on the laboratory
doors.
Yes
No
B.
4.
The signs are incompliance with the requirements of "Biosafety in Microbiological
and Biomedical Laboratories" and/or appropriate to your Chemical Hygiene Plan.
Yes
No
(i.e for BSL-2/ABSL-2 or above: a biohazard sign MUST be posted at the entrance
of the laboratory when etiologic agents are in use. The sign will include the name of
the agents in use, the biosafety level and the name and phone number of the
Investigator and any personal protective equipment which must be worn in the
laboratory and any procedures required for exiting the laboratory)
GENERAL LABORATORY INFORMATION
A.
Is there a current Clemson University Chemical Hygiene Plan available for all
laboratory and storage facilities?
YES, Plan is dated
Copies are maintained in
(bldg./room).
YES, Individual laboratory Standard Operating Procedures are
available.
Copies are maintained in
(bldg./room).
NO (Contact EHS for information)


Biological Safety Officer: Mr. Robin Newberry 656-1806 or
wnewber@clemson.edu
Chemical Safety: Ms. Naomi Kelly 656-7554 or
nkelly@clemson.edu
Part A- General Information
Approved 5/13/02
B.
Laboratory Facilities and Procedures are in Compliance with standard
microbiological practices as described in the current edition of "Biosafety in
Microbiological and Biomedical Laboratories"
Yes
No
C.
Safety Equipment and Protective Apparel (Must be consistent with MSD Sheets
and other guidelines): Describe protective equipment (fume hoods, biosafety
cabinets, etc.) and apparel (face shield, goggles, dust/mist mask, NIOSH approved
respirator, etc.). If equipment is such that inspection or training is required, include
date of inspection or training.
D.
Organisms Genetically Modified through Recombinant DNA Methodologies
1.
Are transgenic organisms, other than commercially available strains,
involved?
YES
2.
NO (no further information necessary in this section)
Will the genetically modified micro-organism(s) be grown in quantities
greater than ten (10) liters: (see Appendix K in the NIH Guidelines for
Research Involving Recombinant DNA Molecules)
YES
NO
If Yes, what volume: _____________
3.
Will the genetically modified organism(s) be:
… released into the environment?
YES
NO If yes, be sure to complete all of Section D
… maintained in the laboratory or other controlled environment ?
YES
NO
Explain procedures used to avoid GMO/agent escape (containment).
Hazard Acknowledgement Sheet
Approved 5/13/02
HAZARD ACKNOWLEDGEMENT SIGNATURE SHEET
Protocol #: _________________
Cross-Reference #:____________
Principal Investigator: _________________________________________
Project Title: _________________________________________________
____________________________________________________________
I have read, understand, and agree to abide by the Hazardous Agents Protocol listed above when
working with the hazardous agents described therein. I understand the nature of the hazard
associated with the agents under this protocol. I understand that disregard for the policies and
procedures as outlined in this protocol could result in dismissal from work with the designated
hazardous agents.
Date
Name (Print)
Signature
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