The Franklin and Marshall College
Annual Renewal and Revision to BSL2 Biosafety Review Form
1. Instructions
This form may be used for the annual renewal for IBC approved research registrations. Any changes (such as the addition or removal of infectious agents, viral vectors, human cell lines, etc.) to your research registration should be indicated on this form. You do not need to complete this entire form: complete Table 1 and provide only updated information in the appropriate yellow shaded boxes. If you reply ‘Yes’ to a question, you need to provide additional details in the table associated with that question.
If you are reporting substantial change to the currently approved protocol, such as an increase in the biosafety containment level, you may be required to submit a new BSL2 Biosafety Review form for IBC review and approval. Additional SOPs for your lab may need to be developed depending on the revisions that are being reported on this form.
If there are no changes to your research registration, you may complete Table 1 and use Table 18 to indicate that there are no changes.
You must also electronically sign (that is, type your signature) this Renewal and Revision Form, which includes the Acknowledgement of Your Responsibilities, prior to submission.
Table 1. PI InformationPI name / e-mail address / Department / Previous IBC protocol no.
2. Project Title and Description of Work
Provide a brief title describing the work encompassed by the biohazards being registered and a short (usually less than 150 words) summary in lay terminology of 1) the overall goal of the research and 2) the planned research activities to assist Committee members to understand how the registered materials will be manipulated. Since the IBC includes Institutional and community members from a variety of backgrounds, it is essential to provide information in a manner that is understandable to readers who are scientifically educated but not specialists.
Table 2. Project Title and Description of Work2A: Project Title (maximum; 70 characters)
2B: Summary including overall goal(s) and description of research activities (in lay scientific terminology)
3. Unfixed Materials from Humans or Non-Human Primates
3-i. Does this work for research or education involve work with any unfixed materials derived from humans or non-human primates? These materials include established cell lines, blood, other fluids, tissues, and primary cells.
Yes / NoIf no, go to item 4.
If yes,
3a. Specify unfixed human or non-human primate material(s) employed including specific name(s) or description(s) and Institutional Review Board (IRB) approval number as appropriate in Table 3. (Note that work with any unfixed human-derived material is at least BSL2.)
3b. If additions to this table will result in a change in the Biosafety Level of your lab or require the development of new SOPs, contact the Biosafety Officer. It may be necessary to submit a new BSL2 Biosafety Review Form for IBC review.
Table 3. Unfixed Human or Non-Human Primate MaterialsHuman or primate materials / Comments (e.g. primary tissue, established cell line, known pathogens) / BL / IRB # / SOP ID#
Examples / Human cell lines / HEK293 cell line and BxPC-3 pancreatic adenocarcinoma cell line / BL2 / NA / RLK #1
Human body fluids / Including, but not limited to, blood and saliva collected from volunteers / BL2 / 78901EP / Infection Control Policy V-1; Standard Body Substance Precautions (SBSP)
(Add additional rows as necessary to the table above.)
3-ii. Will any federally funded work with human embryonic stem cells (hESC) and/or human induced pluripotent stem cells (hiPSC) be conducted?
Yes / NoIf no, go to item 4.
If yes, contact the Biosafety Officer; additional information will be required.
4. Biological Toxins or Carcinogens
4-i. Does this work involve toxins of biological origin?
Yes / NoIf no, go to item 4-ii.
If yes,
4a. specify these toxin(s) in Table 4 below.
4b. If additions to this table will result in a change in the Biosafety Level of your lab or require the development of new SOPs, contact the Biosafety Officer. It may be necessary to submit a new BSL2 Biosafety Review Form for IBC review.
Table 4. Toxins of Biological OriginToxin / Comments (include dose, LD50, route of administration,
safety precautions, etc.) / SOP ID#
Example / Diphtheria toxin / 25 ng/kg mouse body weight (human LD50 = 100 ng/kg); IP injection; All personnel handling the toxin have received booster vaccinations. Rooms will be posted while DT is administered and animal cages will be marked accordingly. / RLK #2
(Add additional rows as necessary to the table above.)
4-ii. Will toxins, carcinogens, or hazardous chemicals be used in animals?
Yes / NoIf no, go to item 5.
If yes, contact the Biosafety Officer and IACUC; additional forms will be required.
5. Infectious Agents that do not contain recombinant DNA (recombinant infectious agents should be listed in Item 6)
5. Does your work involve any non-recombinant agents that are potentially infectious, including viruses, bacteria, or parasites? Note: recombinant infectious agents (that is, containing recombinant DNA) belong in Item 6 and Table 6 rather than in Item 5.
Yes / NoIf no, go to item 6.
If yes,
5a. specify agent(s) employed and indicate the BL and/or Risk Group (RG) of each if applicable in Table 5 (a useful web link for help in determining BL and/or RG is http://www.absa.org/riskgroups/index.html).
5b. If additions to this table will result in a change in the Biosafety Level of your lab or require the development of new SOPs, contact the Biosafety Officer. It may be necessary to submit a new BSL2 Biosafety Review Form for IBC review.
Table 5. Infectious AgentsInfectious agent / Comments (e.g. strain, modifications) / BL / RG / SOP ID #
Example / Vaccinia virus
/ Western Reserve strain / BL2+ / 2 / EXAMPLE RLK #3
(Add additional rows as necessary to the table above.)
6. Recombinant Infectious Agents
6. Does this work involve recombinant infectious agents including viruses, bacteria, or parasites?
Yes / NoIf no, go to item 7.
If yes,
6a. In Table 6a list recombinant pathogens including bacteria, parasites, and viruses (including recombinant retroviruses). Include the type, specific strain, or name as applicable, and nature of the pathogen.
6b. In Table 6b list information about recombinant retroviral vectors (including lentiviral vectors).
6c. In Table 6c list recombinant inserts (including genes, cDNAs, microRNA or shRNA cassettes, etc.) expressed in the pathogens described in Tables 6a and 6b. Provide any additional comments that will assist Committee members in assessing biosafety concerns.
6d. If additions to this table will result in a change in the Biosafety Level of your lab or require the development of new SOPs, contact the Biosafety Officer. It may be necessary to submit a new BSL2 Biosafety Review Form for IBC review.
Table 6a. Recombinant Infectious AgentsPathogen type, strain, or name / Is this a retrovirus?
If YES, fill out Table 6B / Is this replication competent? / If this is replication defective, is helper virus(es) used? / If this is replication defective, is a packaging cell line or replication-defective packaging plasmids used? / Does this encode a product that increases expression of an oncogene or decrease expression of a tumor suppressor? / Comments (e. g., oncogene name, tumor suppressor targeted by insert, means used to make virus replication defective, helper virus ID) / SOP ID # / BL
Yes/No / Yes/No / Yes/No / Yes/No / Yes/No
Examples / Adenovirus Cre recombinase (Ad-CMV-Cre) / No / No / No / Yes / No / Deleted for the essential E1 gene as well as the E3 gene; thus, this agent is non-replicative / RLK#1 / BL2
pLenti6-myc lentiviral vector / Yes / No / No / Yes / Yes / Human c-myc oncogene; lentiviral particles produced are replication defective & only contain the c-myc gene / RLK#3 / BL2+
(Add additional rows as necessary to the table above.)
Table 6b. Recombinant RetrovirusesName of vector or system / Source (e.g., company, or scientist) / ‘Generation’ or number of plasmids in system / Envelope gene(s) encoded / Tropism / Can the expression vector infect human cells? / SOP ID#
Yes/No
Example / ViraPower System / Invitrogen / 3rd generation;
4 plasmids / VSV-G / Pantropic / Yes / EXAMPLE RLK #3
(Add additional rows as necessary to the table above.)
Table 6c. Recombinant DNA in Infectious Agent(s) that are Listed in Tables 6a and 6bExamples
Insert / Insert / Insert 1 / Insert 2 / Insert 3 / Insert 4
Nature of insert (e.g., gene, cDNA, microRNA, shRNA cassette) / Gene / Gene
Gene or product name (or class of product) / c-Myc / Cre
Source/species / Human / Phage P1
Biological role of rDNA / Encodes transcription factor / Site-specific recombination
Biologically active protein(s) or product(s) / c-myc protein / Cre
Does product potentially initiate or promote oncogenesis?
Yes/No / Yes / No
Recombinant pathogen (from Tables 6a and 6b) in which this will be present / ViraPower lentivirus vector / Ad-CMV-Cre
Cells to receive rDNA during experiment (e.g. HeLa, human, mouse) / Human HEK293 / Human HEK293
NIH category (III-A to III-F) / III-D / III-D
BL / BL2+ / BL2
SOP ID # / RLK #3 / RLK #2
(If more genes need to be listed, duplicate this table and paste it below this original table.)
7. Recombinant DNA (not including recombinant viruses and other infectious agents, which were listed in Tables 6a and 6b)
7. Does this work involve recombinant DNA other than recombinant infectious agents (which were addressed in Tables 6a and 6b)?
Yes / NoIf no, go to item 8.
If yes,
7a. list recombinant inserts (including genes, cDNAs, microRNA or shRNA cassettes, etc.) used in Table 7. For assistance, the NIH guidelines are available at http://oba.od.nih.gov/rdna/nih_guidelines_oba.html.
7b. If additions to this table will result in a change in the Biosafety Level of your lab or require the development of new SOPs, contact the Biosafety Officer. It may be necessary to submit a new BSL2 Biosafety Review Form for IBC review.
Table 7. Recombinant DNAExamples
Insert / Insert 1 / Insert 2 / Insert 3 / Insert 4
Nature of insert (e.g., gene, cDNA, microRNA, shRNA cassette) / Gene
Gene or product name (or class of product) / Various amino acid transporter genes
Source/species / Yeast S. cerevisiae
Biological role of rDNA / Encodes amino acid transporters
Biologically active protein(s) or product(s) / Amino acid transporters
Does product potentially initiate or promote oncogenesis?
Yes/No / No
Original host/vector
(e.g. E.coli/pUC; insect cells/baculovirus) / E. coli pBR derivatives that also replicate in yeast
Cells to receive rDNA during experiment (e.g. E. coli, yeast, HeLa) / E. coli and yeast (S. cerevisiae)
NIH category (III-A to III-F) / III-F
BL / BL1
SOP ID # / EXAMPLE
RLK #4
(If more genes need to be listed, duplicate the table above and paste it below this original table.)
8. Biohazards in Animals
8-i. Will any of the biohazards or recombinant DNAs described above (items 3-7; including unfixed human-derived materials) be used in animals?
Yes / NoIf no, go to item 8-ii.
If yes, specify biohazard(s)/recombinant DNAs, animal specie(s) and Institutional Animal Care and Use Committee (IACUC) protocol number(s) in Table 8a. If you have not yet submitted an IACUC protocol, write ‘to be submitted’ in this column.
Table 8a. Biohazards in AnimalsBiohazard/recombinant DNA / Animal Specie(s) and description / Comments / BL / IACUC protocol #
Example / BxPC-3 human cells / Nude mice / Prior to injection in mice, BxPC-3 cells will be transfected with plasmid pLWW, which expresses GFP. / BL2 / 20YY-ZZZ
(Add additional rows as necessary to the table above.)
8-ii. Will any experiments, with or without biohazards, be conducted in genetically manipulated animals (e.g., transgenic or knockout animals)?
Yes / NoIf no, go to item 9.
If yes,
8b. provide appropriate information in Table 8b.
8c. If additions to this table will result in a change in the Biosafety Level of your lab or require the development of new SOPs, contact the Biosafety Officer. It may be necessary to submit a new BSL2 Biosafety Review Form for IBC review.
Table 8b. Genetically Manipulated AnimalsGene altered;
Transgene (TG) or knockout (KO)
and Source / Species of gene/marker / Species and type of genetically altered animal / Biohazard (if used) / Does change initiate or promote oncogenesis?
Yes/No / BL / IACUC protocol #
Example / Simian diptheria toxin receptor (TG) / Monkey / Mouse / Vaccinia virus / No / 2+ / 20YY-ZZZ
(Add additional rows as necessary to the table above.)
9. Biohazards in Humans
9. Will any of the biohazards or recombinant DNAs described above (items 2-6) be used in humans?
Yes / NoIf no, go to item 10-i.
If yes, specify biohazard(s) and IRB protocol number(s) in Table 9. If recombinant DNA is used, the documents pertaining to the review by the NIH RAC must also be sent to .
Table 9. Biohazards or Recombinant DNA in HumansBiohazard or recombinant DNA / Comments / Trial
Phase / IRB protocol # / FDA New drug approval #
(IND) / For protocols with recombinant DNA or derived materials, list NIH category and NIH RAC protocol # and status / Informed consent attached; required
Example / Recombinant adenovirus / 1 x 106 adenovirus with tumor suppressor gene p53 will be injected into hepatic artery feeding hepatoma lesion, as per protocol xx-xxx (attached) / I / 78902 pending / WWW / NIH category III-C; NIH RAC #0311-WWW; public review done; summary attached / Yes
(Add additional rows as necessary to the table above.)