VA Form 10-0398

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RESEARCH PROTOCOL SAFETY SURVEY

PRINCIPAL INVESTIGATOR (PI): __________________________________________

PROJECT TITLE: _________________________________________________________

DATE OF SUBMISSION: ___________________________________________________

LIST VA AND NON-VA LOCATIONS IN WHICH PI CONDUCTS RESEARCH:

1. DOES THE RESEARCH INVOLVE THE USE OF ANY OF THE FOLLOWING?

a. Biological Hazards (Microbiological or viral agents, pathogens, toxins, select agents as

defined in Title 42 Code of Federal Regulations (CFR) 72.6, or animals)

YES ( ) NO ( )

b. Human or non-human cell or tissue samples (including cultures, tissues, blood, other

bodily fluids or cell lines) YES ( ) NO ( )

c. Recombinant deoxyribonucleic acid (DNA) YES ( ) NO ( )

d. Chemicals:

(1) Toxic chemicals (including heavy metals) YES ( ) NO ( )

(2) Flammable, explosive, or corrosive chemicals YES ( ) NO ( )

(3) Carcinogenic, mutagenic, or teratogenic chemicals YES ( ) NO ( )

(4) Toxic compressed gases YES ( ) NO ( )

(5) Acetylcholinesterase inhibitors or neurotoxins YES ( ) NO ( )

e. Controlled Substances YES ( ) NO ( )

f. Ionizing Radiation:

(1) Radioactive materials YES ( ) NO ( )

(2) Radiation generating equipment YES ( ) NO ( )

g. Nonionizing Radiation:

(1) Ultraviolet Light YES ( ) NO ( )

(2) Lasers (class 3b or class 4) YES ( ) NO ( )

(3) Radiofrequency or microwave sources YES ( ) NO ( )

If the answer to any

of these questions is YES, complete all sections of this survey that apply.

If all answers are NO, a documented review by the local Subcommittee on Research Safety is still

required prior to submission. If the research involves the use of human subjects or human tissues,

Institutional Review Board (IRB) review is required. NOTE: Use of animals also requires submission

of an Institutional Animal Care and Use Committee (IACUC)-approved Animal Component.

VA FORM

MAY 2002

10-0398

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2. BIOLOGICAL HAZARDS

a. Does your research involve the use of microbiological or viral agents, pathogens, toxins,

poisons or venom? YES ( ) NO ( )

If NO, skip to the section on Cells and Tissue Samples.

If YES, list all Biosafety Level 2 and 3 agents or toxins used in your laboratory. It is

the responsibility of each PI to:

(1) Consult either:

(a) The National Institutes of Health (NIH)-Center for Disease Control and Prevention

(CDC) publication entitled Biosafety in Microbiological and Biomedical Laboratories or

(b) The CDC online reference (http://www.cdc.gov)

(2) Identify the Biosafety Level (also called Risk Group) for each organism, agent, or toxin.

Enter it into the following table.

Organism, Agent, or Toxin Biosafety Level**

_________________________________________________________________

** For each Biosafety Level 2 or 3 agent or toxin listed, provide the information requested on the following

page(s). (Description of Biosafety Levels 2 and 3 can be found in Appendix A.)

b. Are any of the biohazardous agents listed above classified as a “Select Agent” by the

Centers for Disease Control? YES ( ) NO ( )

3. BIOLOGICAL HAZARDS – Description of Use NOTE: Photocopy this page, as

necessary.

a. Identify the microbiological agent or toxin (name, strain, etc.):

_____________________________________________________________________

b. If this is a Select Agent (42 CFR 72.6), provide the CDC Laboratory Registration # and the

date of the CDC inspection:

_______________ _______________

c. Indicate the largest volume and/or concentration to be used:

_____________________________________________________________________

d. Indicate whether antibiotic resistance will be expressed, and the nature of this antibiotic

resistance:

_____________________________________________________________________

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e. Describe the containment equipment (protective clothing or equipment, biological safety

cabinets, fume hoods, containment centrifuges, etc.) to be used in this research:

_____________________________________________________________________

f. Describe the proposed methods to be employed in monitoring the health and safety of

personnel involved in this research:

_____________________________________________________________________

4. CELLS and TISSUE SAMPLES

a. Will personnel work with animal blood, human or non-human primate blood, body fluids,

organs, tissues, cell lines or cell clones? YES ( ) NO ( )

If yes, specify:

b. Will research studies represent a potential biohazard for lab personnel?

NA ( ) YES ( ) NO ( )

If yes, specify the potential hazard and precautions employed to protect personnel in the

laboratory:

NOTE: If these studies involve animals, the Animal Component of Research Protocol (ACORP)

must be completed.

c. Specify precautions employed to protect personnel working in the laboratory:

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5. RECOMBINANT DNA

a. Are procedures involving recombinant DNA used in your laboratory?

YES ( ) NO ( )

b. Are recombinant DNA procedures used in your laboratory limited to PCR amplification of

DNA segments (i.e., no subsequent cloning of amplified DNA)? YES ( ) NO ( )

(1) If YES, your recombinant DNA studies are exempt from restrictions described in the NIH

Guidelines for Research Involving Recombinant DNA Molecules.

(2) If NO, it is the responsibility of each PI to:

(a) Consult the current NIH Guidelines for Research Involving Recombinant DNA

Molecules which can be found at the Internet site

http://www4.od.nih.gov/oba/rac/guidelines/guidelines.htm.

(b) Identify the experimental category of their recombinant DNA research.

c. Description of Recombinant DNA Procedures:

(1) Identify the NIH classification (and brief description) for these recombinant DNA studies:

____________________________________________________________________

(2) Biological source of DNA insert or gene:

____________________________________________________________________

(3) Function of the insert or gene:

____________________________________________________________________

(4) Vector(s) used or to be used for cloning (e.g., pUC18, pCR3.1):

____________________________________________________________________

(5) Host cells and/or virus used or to be used for cloning (e.g., bacterial, yeast or viral strain,

cell line): ____________________________________________________________________

6. USE OF CHEMICALS

a. Has the use of chemicals in your laboratory been reviewed by an appropriate committee or

subcommittee in the past 12 months? YES ( ) NO ( )

b. Are personnel knowledgeable about the special hazards posed by:

(1) Carcinogens? NA ( ) YES ( ) NO ( )

(2) Teratogens and Mutagens? NA ( ) YES ( ) NO ( )

(3) Toxic gases? NA ( ) YES ( ) NO ( )

(4) Neurotoxins? NA ( ) YES ( ) NO ( )

(5) Reactive and potentially explosive compounds? NA ( ) YES ( ) NO ( )

NOTE: Submission of the laboratory chemical inventory is required for local review.

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7. CONTROLLED SUBSTANCES

a. Does your research involve the use of any substance regulated by the Drug Enforcement

Agency? YES ( ) NO ( )

If yes, list controlled substances to be used:

(1) ___________________________________________

(2) ___________________________________________

(3) ___________________________________________

(4) ___________________________________________

(5) ___________________________________________

(6) ___________________________________________

b. Are all Schedule II and III drugs stored in a double-locked vault

NA ( ) YES ( ) NO ( )

NOTE: The schedule of controlled substances can be found at the Internet site

http://www.usdoj.gov/dea/pubs/schedule.pdf

8. RADIOACTIVE MATERIALS

Does your research involve the use of radioactive materials? YES ( ) NO ( )

If YES, provide the following:

a. Identity of radioactive source (s): _____________________________________

b. Radiation Safety Committee Approval (date): ___________________________

9. PHYSICAL HAZARDS

a. Are physical hazards addressed in the facility Occupational Safety and Health Plan?

YES ( ) NO ( )

b. Do employees receive annual training addressing physical hazards?

YES ( ) NO ( )

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Acknowledgement of Responsibility and Knowledge

I certify that my research studies will be conducted in compliance with and full knowledge of

Federal, State, and local policies, regulations, and CDC-NIH Guidelines governing the use of,

biohazardous materials, chemicals, radioisotopes, and physical hazards. I further certify that all

technical and incidental workers involved with my research studies will be aware of potential

hazards, the degree of personal risk (if any), and will receive instructions and training on the

proper handling and use of biohazardous materials, chemicals, radioisotopes, and physical

hazards. A chemical inventory of all Occupational Safety and Health Administration (OSHA)

and Environmental Protection Agency (EPA)-regulated hazardous chemicals is attached to this

survey.

____________________________________________________________________

Principal Investigator’s Signature Date

Certification of Safety Officer’s Approval

A complete list of chemicals to be used in the proposal has been reviewed. Appropriate

occupational safety and health, environmental, and emergency response programs will be

implemented on the basis of the list provided.

____________________________________________________________________

Safety Officer’s Signature Date

Certification of Research Approval

The safety information for this application has been reviewed and is in compliance with

Federal, State, and local policies, regulations, and CDC-NIH Guidelines governing the use of

biohazardous materials, chemicals, radioisotopes, and physical hazards. Copies of any additional

surveys used locally are available from the Research and Development (R&D) Office.

_____________________________________________________________________

Chair, Subcommittee on Research Safety Date

_____________________________________________________________________

Chair, Research & Development Committee Date

______________________________________________________________________

Radiation Safety Officer (if applicable) Date

____________________________________________________________________

Facility Safety Officer Date

Fillable Printable VA Form 10-0398

Fillable Printable VA Form 10-0398