IBC Protocol Page 1 of 5

07/23/2018

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 (PDF)with signatures of the declaration form, BSL Checklist (if applicable) and any related materials toMichele Smith at .

Questions?

Please call theGrants and Sponsored Research Development Office at 803-323-2460.

#B

To be completed by GSRD

Biohazardous Materials Declaration Form

Instructions: Complete this form using Microsoft WORD. Print a copy and obtain all necessary signatures. Submit a PDF of the signed copy and any attachments to Michele Smith at . Keep the original signed copy with your files.

APPLICANT INFORMATION

PRINCIPAL INVESTIGATOR: / EMAIL ADDRESS:
OFFICE PHONE: HOME PHONE: CELL PHONE:
TITLE: / DEPARTMENT:

CO-INVESTIGATORS

NAME / TITLE/DEPARTMENT / EMAIL ADDRESS / OFFICE PHONE

RESEARCH PROJECT

TITLE OF PROJECT:
ANTICIPATED START DATE: EXPECTED DURATION(Indicate if months or years):
YES NO / 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

Laboratory or Classroom
(On-Campus) / Room Number and Building:
Complete the appropriate BSL Checklist and attached to Declaration form
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:

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 / Risk Group (See Below)
Viral Fungal Bacterial
Toxin Plant
Other (specify) / RG1 RG2
RG3 RG4
Viral Fungal Bacterial
Toxin Plant
Other (specify) / RG1 RG2
RG3 RG4
Viral Fungal Bacterial
Toxin Plant
Other (specify) / RG1 RG2
RG3 RG4
Risk Groups:
RG1 / Agents that are not associated with disease in health adult humans
RG2 / Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available
RG3 / 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)
RG4 / 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 risksin laboratory and/or field work:

A-4. Summarize safety practices, including procedures, equipment, and/or 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 materialsin laboratory and/or field work.

A-6. Describe plans for handling spills and for waste disposal in laboratory and/or field work.

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.

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;

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 InvestigatorDate

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I have reviewed this protocol and concur with the research project.

______

Signature of Department Chair or DeanDate