IBC Protocol
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Biohazardous Materials Declaration Form
Submission Check Sheet
Please check to make sure the following has been completed prior to submitting the Biohazardous Materials
Declaration Form:
Members of the research team or classroom instructors have completed CITI Training module:
“Training for Investigators, Staff and Students Handling Biohazards - Stage 1”
The Biohazardous Materials Declaration Form has been completed in its entirety.
The Biohazardous Material Declaration Form has been signed by the Principal Investigator and the
Department Chair or Dean of the Principal Investigator.
The appropriate BSL1 and/or BSL2 Checklist for Labs has been completed, signed and is attached.
Submission:
Submit electronic copy with signatures of the declaration form, BSL Checklist(if applicable) and any
related materials to Deborah Broome at broomed@winthrop.edu.
OR
Submit a signed paper copy of the declaration form, BSL check list (if applicable) and any related
materials to the Sponsored Programs and Research Office, Rm. 149 McLaurin.
Questions?
Deborah Broome; Sponsored Programs and Research Office – 803-323-2398 or broomed@winthrop.edu
Jason Hurlbert; IBC Chair – 803-323-4928 or hurlbertj@winthrop.edu
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#B
To be completed by SPAR
Biohazardous Materials Declaration Form
Instructions: Complete this form using Microsoft WORD. Print a copy and obtain all necessary signatures
and submit the original form with signatures to Deborah Broome, Sponsored Programs and Research Office.
(Rm.149 McLaurin Bldg). Also send an electronic copy of the form and any attachments to Deborah Broome at
broomed@winthrop.edu. The electronic copy does not need signatures.
APPLICANT INFORMATION
PRINCIPAL INVESTIGATOR:
OFFICE PHONE:
EMAIL ADDRESS:
HOME PHONE:
CELL PHONE:
TITLE:
DEPARTMENT:
CO-INVESTIGATORS
NAME
TITLE/DEPARTMENT
EMAIL ADDRESS
OFFICE PHONE
RESEARCH PROJECT
TITLE OF PROJECT:
ANTICIPATED START DATE:
YES
NO
EXPECTED DURATION(Indicate if months or years):
IS THIS PROJECT FUNDED BY A GRANT OR CONTRACT?
IF YES: SPONSOR NAME:
GRANT/CONTRACT: START DATE:
END DATE:
PURPOSE OF THIS STUDY:
LOCATION OF RESEARCH ACTIVITY – Check all that apply
Room Number and Building:
Complete the appropriate BSL Checklist and attached to Declaration form
Laboratory or Classroom
(On-Campus)
BSL 1; Well-characterized agents not known to consistently cause disease in healthy adults, and of
minimal potential hazard to lab personnel and environment. Appropriate for undergraduate and
secondary training and teaching laboratories. Example: Bacillus subtilis
BSL2: Associated with human disease. Example Bacillus anthracis, Shigella spp., Yersinia pestis.
Field Work
(Off-Campus)
Address or description of location:
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A. BIOHAZARDOUS MATERIALS USED IN BIOLOGICAL RESEARCH
A-1. Identification of Hazardous Biological Materials
INSTRUCTIONS: LIST THE BIOHAZARDOUS MATERIALS AND PROVIDE THE FOLLOWING INFORMATION FOR EACH OF THE MATERIALS LISTED
TO BE USED IN THE STUDY. COMPLETE RELATED CHECK LISTS AS INDICATED.
NAME OF AGENT
SOURCE/IDENTITY
CLASSIFICATION
Viral
Fungal
Toxin
Plant
Other (specify)
Viral
Fungal
Toxin
Plant
Other (specify)
Viral
Fungal
Toxin
Plant
Other (specify)
Bacterial
Risk Group (See Below)
RG1
RG2
RG3
RG4
Bacterial
RG1
RG3
RG2
RG4
Bacterial
RG1
RG3
RG2
RG4
Risk Groups:
RG1
RG2
RG3
RG4
Agents that are not associated with disease in health adult humans
Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic
interventions are often available
Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be
available (high individual risk but low community risk)
Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not
usually available (high individual risk and high community risk)
A-2. Cell Line or Tissue Culture
SOURCE OF CELL LINE OR TISSUE CULTURE:
CLASSIFICATION:
HUMAN
NON-HUMAN PRIMATE
PRIMARY CELL CULTURE
TRANSFORMED / IMMORTAL CELL LINE
OTHER (Specify):
A-3. Identify known risks for occupational exposure and measures taken to minimize risks in laboratory and/or field work :
A-4. Summarize safety practices, including procedures, equipment, apparel, that will be used to minimize exposure of
personnel to hazardous agents in laboratory and/or field work.
A-5. Describe method of storage and location of storage of biohazardous materials in laboratory and/or field work .
A-6. Describe plans for handling spills and for waste disposal in laboratory and/or field work.
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B.RECOMBINANT DNA
B-1. Describe the proposed use of recombinant DNA in this project.
B-2. Describe the nature of the inserted DNA sequences.
B-3. State the host(s) and vector(s) to be used. [Include their selectable marker(s)/reporter gene(s) and the nature of the cloned DNA.]
B-4. State whether an attempt will be made to obtain expression of a foreign gene, and if so, indicate the protein that will be produced.
B-5. Describe the containment conditions that will be implemented.
B-6. Describe the risks and occupational exposures that expect to result from the use of organisms possessing this recombinant DNA.
C. PERSONNEL TRAINING
C-1. Describe the steps that will be taken to ensure that all personnel understand the guidelines to be followed when participating in
the proposed project.
C-2. Describe training to be conducted and method for documenting completion of training.
C-3. Describe the protective apparel requirements for personnel handling the hazardous materials that exceed standard laboratory
practices.
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PRINCIPAL INVESTIGATOR ASSURANCE
By my signature, I certify that I understand and accept the following obligations in this study:
 I recognize that as the Principal Investigator it is my responsibility to ensure that this research and the
actions of all project personnel involved in conducting the study will conform with the Winthrop
Institutional BioSafety Committee (IBC) approved protocol and the provisions of the NIH Guidelines
for Research Involving Recombinant DNA, the CDC/NIH Biosafety in Microbiological and Biomedical
Laboratories Manual, and the Select Agent Rule where appropriate. [A link to each of these documents
is available on the Winthrop University BioSafety Website; http://www.winthrop.edu/spar/biosafety.htm
 I will inform the IBC of any change in an RG-1 protocol.
 I will not initiate any change in an RG-2, RG-3 or RG-4 protocol without prior IBC approval
 I recognize that representatives of the IBC are authorized to inspect records documenting personnel
training.
 I accept responsibility for the safe conduct of the experiments to be conducted and will see that all
associated personnel are trained in the safe laboratory practices required for this work.
 I will oversee the development and implementation of the standard biosafety operating procedures for
the laboratory.
 I accept responsibility that all personnel working in my laboratory will be trained to report any
biological spill to me and that any spills involving the contamination of personnel and/or the
environment that has the potential to cause illness or may cause sufficient concern to the public will be
reported to the Winthrop University Environmental Health and Safety Officer. Contact information will
be posted in the lab.
 I will instruct personnel to report to me or to the Winthrop University Environmental Health and Safety
Officer in my absence, any infection where a potential exists that the infection may have been
occupationally acquired.
 I have completed the training course, Training for Investigators, Staff and Students Handling
Biohazards – Stage 1, CITI on-line training program.
_______________________________________
Signature of Principal Investigator
_________________
Date
----------------------------------------------------------------------------------------------------------------------------------I have reviewed this protocol and concur with the research project.
_______________________________________
Signature of Department Chair or Dean
_________________
Date