Biosafety Research Protocol / IBC protocol #:
BSL:
Date Submitted:
Date Approved:
The UNCC Institutional Biosafety Committee (IBC) is responsible for oversight of all research and teaching activities involved with potentially hazardous biological materials including but not limited to: infectious agents, human and non-human primate materials (including established cell lines and whole blood), Select Agents, biological toxins, commercial viral vector kits, recombinant DNA (rDNA hereafter referring to both recombinant and synthetic nucleic acids) and studies involving human gene transfer.
ALL RESEARCHERS working with ANYPOTENTIALly hazardous BIOlogical MATERIAL
complete and submit this formfor IBC reviewand approval.
Submit via email to . If you have any questions, contact:
Dr. Angelica N. Martins, Biosafety Officer,Office of Research Compliance (704) 687-1825
Instructions: To ‘check’ a box (), double click on the box and select “Checked” in the Default Value section!
SECTION I: General Information
- Application Status:New Application Three Year Renewal Amendment
- Title of Protocol:
- Principal Investigator:
- Department:
- Mailing Address:
- Telephone:
- Co-Investigator/s:
- Lab Supervisor/Manager:
- Protocol Funded? YES NO If “YES”, provide NORM Proposal #:
- List Research Location(s):
1) Building & room(s):
2)Date of last laboratory(s) inspection(s):
b)Other UNCC site(s) including leased space:
c)Non-UNCC Facility(ies) being used for biohazard use? YES NO
1)If YES, building & room(s):
2)Did this facility grant approval for this study? YES NO Pending Not Required
(NOTE: If YES, attach a copy of IBC approval letter or equivalent to this protocol.)
SECTION II: Identification of Materials or Agent(s), and Biosafety Level based on that
11.Materials used in this protocol
Check all that apply.
(Please fill out the correct Addendum that applies for each option marked below, Section IX)
A. Microorganisms (e.g. Bacteria, Virus, Fungus, Parasitic Agents)
B. Human Blood, Blood Components, Fluids, Unfixed Organs, Tissues and Cells(including established cell lines)C. Non-human Primate Derived Materials (including established cell lines)
D. Recombinant Nucleic Acids
E. Synthetic Nucleic Acids (e.g. PCR, siRNA, cDNA)
F. Plants
G. Animals ( Vertebrates or Invertebrates )
H. Environment Sample. Specify:
I. Biological Toxins
J. Select agents (CDC Select Agent List:
K. Other. Specify:
12.Risk Group and Biosafety Level
Use the links to the resources listed below to:
1) Classify the risk group (Risk Group 1-3*) for the biological agentsbeing used in this protocoland
2)Determine the level of containment and procedures for this protocol (BSL-1-3*).
NOTE:Risk group (RG) must be assigned when applicable. Not all agents may be listed in the guidelines or on the websites listed below. Assign highest level if declaring multiple agents. Biosafety level(BSL) must be assigned.
BMBL:
CDC Select Agents List:
NIH Guidelines:
ABSA Risk Group Database:
A.Risk Group*
RG-1 RG-2 RG-3*B.Biosafety Level
BSL-1 BSL-2 BSL-3**Work with RG-3 agents or in the BSL-3laboratory requires IBC review and prior consultation with the BSO
Work with RG-4 agents is prohibited by University Policy 714. The University does not have a BSL-4
Laboratory.
Contact Biosafety Officer at (704) 687-1825 for work with agents in NIH RG-3 or with Select Agents.
13.Special Containment Considerations – Animal and Plant Use
If you will be working with animals or plants involving rDNA or for plant use, your protocolrequires permitting for transport of USDA regulated articles (genetically modified plants, soil containing plant pests, noxious weeds or pests, etc.), use the following resources to determine the appropriate containment level for the intended use of such categories.
NIH Guidelines: OR
USDA/APHIS:
Indicate below the appropriate containment level for the intended use of such categories of animals or plants.
A.Animal Containment
ABSL-1 ABSL-2B.Plant/Pest Containment
BL1-P BL2-P14.Classification Determination
Indicate below the relevant section(s) of the BMBL and/or NIH Guidelines you used in making your determinations in Question 12 Aabove: (e.g., “BMBL: Section IV - RG classification and Section VIII – Agent Summary Statements” or “NIH Guidelines: Appendix B - BSL classification”)
OR, if the agent(s) you are using are not referenced in these documents, provide scientific rationale for your classification determinations:
SECTION III: Protocol Description
15.Protocol Description:Please give a non-technical description of the protocol (appropriate for lay public), focusing on the use of biohazardous agents.(250 words or less)
16.Procedures and Occupational Hazards
Summarize methods/procedures and list associated occupational hazards for each procedure involving use of biohazardous material. Include a description of any risk-reducing devices (e.g. wear safety glasses, gloves, lab coat, etc.).
SECTION IV:PPE / Disinfection-Decontamination / Engineering Controls
17.Personal Protection Equipment (PPE)Indicate which PPE and processes will be used while handling agents. Check all that apply based on your determination of the biosafety and/or risk-group level of biohazardous agent/s use.
Lab Coat/ Overalls
Disposable gloves
Eye protection
Mask
Full face shield / Fitted respirator(For fit-testing: call EHS 704-687-1111)
Shoe covers
Head cover
Other:
18.Decontamination (Describe how biohazardous material and wastewill be decontaminated)
Check all that apply.
Autoclave
For biohazard decontamination follow the instruction below:
-Use autoclavable clear bags
-Use an autoclave that have been validated within the last 7 days (NC requirement)
-Use dry cycle for at least 1h 121oC-123oC)
-Dispose autoclaved clear bag in regular trash bins
SteriCycle pick-up (Use biohazardred bags)
SteriCycle pick-up for pathological waste (Use biohazardyellow bags)
Ethanol or isopropanol 70%
Disinfectant Specify:
Bleach(NOTE: Usinghousehold bleachdiluted 1:10 or 1:5 (5,000 to 10,000 ppm): prepared fresh on theday
of use (within 24 hours). Contact time: 10-15 minutes on the surface.Liquidinfectious waste:Using fresh
household bleach in a final concentration of 10%: 100ml of household bleach (50,000-82,500 ppm) for each
liter of liquid waste for a minimum of30 minutes prior to drain disposal.
19.Waste produced
Solid waste Infected animal carcasses (Requires Stericycle pick-up.)
Liquid waste Pathological waste (Note: Human tissue requiresspecial Stericycle pick-up.)
Sharps waste
20.Autoclave: / Location(s):
21.Biosafety cabinet(s): / Type/s:
Location(s):
Certification date(s):
SECTION V: Transportation / Shipping
Transporting materials to off-campus locations: Containers used to transport materials between UNC Charlotte and off-campus/off-site locations must meet applicable Department of Transportation (DOT) requirements and be properly labeled, sealed, leak-proof and puncture resistant. For more information, go to:DOT Regulations [49 CFR]:
Air Transport Authority [IATA] Guidance on Shipping Infectious Substances:
US Department of Agriculture [USDA], Animal and Plant Health Inspection Service [APHIS]
For guidance on importation/interstate transport of regulated biological organisms, plants and plant pests:
22.Indicate how materials may/will be transported under this protocol
Check all that apply.
Will NOT be transported outside of the laboratory where used.
Will be carried within the building to separate research areas.
Will be carried outside between buildings: from: to:
Will be transported to campus from the following off site location/s:
List all individuals who will transport materials from off-site:
Will be shipped off campus (e.g. FedEx and UPS).
Material Transfer Agreement (MTA) Forms can be obtained from UNC Charlotte Office of Technology Transfer Contact Brad Fach EM: PH: 704-687-8018
TRAINING REQUIREMENTS FOR PACKAGING AND SHIPPING OF “DANGEROUS GOODS” (e.g. dry ice, most laboratory samples and infectious materials): Any person who prepares packaging for shipment, fills out paperwork, handles shipment, transports and/or sends the shipmentMUST have current DOT/ IATA Shipper Training Certificationthat is valid for two years. Some exclusions for dry-ice shipments may apply. Non-compliance is also subject to large fines (up to $37,000 per violation) and, in egregious cases, imprisonment.Contact BSO for information or training: EM: PH: 704-687-1825
23.Description of packaging to be used for transport:
Briefly describe how you will package biohazardous materials for transport to ensure appropriate containment and protection of handlers based on the guidance resources noted above (NOTE: Intra- and inter-building movement of biohazardous materials on campus may use the minimal packaging standard required to contain the material and protect handlers):
SECTION VI: Personnel / Training
24.Describe the Principal Investigator(s)’s previous experience using the biohazardous agents described in this form or using similar procedures. If the Principal Investigator does not have relevant experience, explain how the required expertise will be provided/acquired.25.List ALL personnel working under this protocol.
All such employees, including the Principal Investigator, should be trained in the safe use and handling of potentially hazardous materials prior to commencement of this protocol. The IBC may require that training be provided by someone other than the Principal Investigator.
- List additional personnel together in the last row.
- When personnel change, submit the updated information as an amendment.
First and Last Name / 9-digit UNCC
ID # / Degree / Job title / Years of experience / Procedures performed
(Section III – Item 16) / Onlinerequired training completed? (Date last training module completed)
a.
b.
c.
d.
e.
f.
SECTION VII:Occupational Health
All employees who have occupational exposure to potentially hazardous materials must be aware of theirrisk of exposure to these materials as well as control measures that reduce or eliminate the exposure risk.
26.Have all employees working with human material been offered the Hepatitis B vaccine per the OSHA Bloodborne Pathogens Standard?
YES NO N/A
27.Are serological tests or other immunizations required for this protocol?
YES NO N/A If YES, identify each:
SECTION VIII: Included With This Application
28.Indicate which Addendum(s) are applicable to this protocol. Then, download, complete and submit the addendum(s) with this core protocol application.- Downloaded Addendum(s) via the links provided.
- To ‘check’ a box (), double click on the box and select “Checked” in the Default Value section!
PH: 704-687-1825 EM:
Non-Exempt Recombinant or SyntheticNucleic Acids and Host-Vector Systems
(ref: Addendum I and NIH Guidelines (Section III - A—E; includes creation of transgenic or other genetically Modified Plants or Animals) / Addendum I
Biological Materials in Animals / Addendum II
Biological Materials in Human Subjects / Addendum III
Infectious Agents (e.g., Bacteria, Virus, Fungus, Parasitic Agents), CDC/USDA Select Agentsand/or Biological Toxins
(Go to: / Addendum IV
Human/Non-Human Primate Material (Including Established Human Cell Lines) / Addendum V
SECTION IX: Investigator’s Assurance
1.I confirm that all persons involved with this protocol (including my collaborators) have been adequately trained in good microbiological techniques, have received instruction on any specific hazards associated with the protocol and worksite, and are aware of any specific safety equipment, practices and behaviors required while conducting protocol procedures and using these facilities. The IBC may review my records documenting this instruction.
2.I will immediately report to the Biosafety Officer any spill of biohazardous material, equipment or facility failure (i.e., ventilation failure), and /or any breakdown in procedure that could result in potential exposure of laboratory personnel, staff or the public to biohazardous or toxic material.
3.I will immediately report any accident or injury to the Environmental Health and Safety Office PH 704-687-1111.
4.I confirm that any proposed changes to my work that would result in an increased level of biohazard will be reported to the IBC before the change is implemented.
5.I confirm that no work that requires IBC approval will be initiated or modified until approval is received.
6.I will notify the IBC of all personnel changes or additions through the submission of an amendment.
7.I have read and understand my responsibilities as Principal Investigator outlined in Section IV-B-4 of the NIH Guidelines, and agree to comply with these responsibilities.
8.I have read and understand my responsibilities as Principle Investigator as outlined in University Policy 714 “Biosafety” as well as other related policies referenced with that policy.
9.I certify that the information provided within this application is accurate to the best of my knowledge.
10.I understand that, should I use the protocol described in this application as a basis for a funding proposal (either intramural or extramural), I am responsible for ensuring that the description of procedures in the funding proposal is identical in principle to that contained in this application.
11.I confirm that all persons involved with this protocol will comply with all environmental laws and regulations and that this protocol does not significantly impact the environment.
Investigator Name: ______
PLEASE PRINT
Investigator Signature: ______Date: ______
Please submit the protocol to: Office of Research Compliance ATTN: Angelica Martins300 Cameron Hall
Send signed Investigator’s Assurance to:EM: orFX: 704-687-0980.
(Electronic signatures are not acceptable.)
Biosafety Research Protocol Form
v.09.2016 Page 1 of 7