Sample Questionnaire (NOT FOR OFFICIAL USE) The Hong Kong

Sample Questionnaire (NOT FOR OFFICIAL USE)

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The Hong Kong University of Science & Technology

Safety Protocol

Personnel Please provide the names of all personnel who will oversee or conduct work under this protocol.

Principal investigator

The Principal Investigator is responsible for all work conducted under this protocol and can edit the information. Click “Edit Selection” and select the user. If the desired user is not available, see the “Request the Addition of a New User” section below.

Last name First name

Co-Investigators

The Co-Investigator is responsible for all assisting the PI in writing, the protocol and preparing modifications and continuation reviews. Click “Edit Selection” and select the user. If the desired user is not available, see the “Request the Addition of a New User” section below.


Research Personnel (Staff)

Staff who perform procedures under this protocol. Click “Edit Selection” and select the user. If the desired user is not available, see the “Request the Addition of a New User” section below.


Research Personnel (Student)

Students who perform procedures under this protocol. Click “Edit Selection” and select the user. If the desired user is not available, see the “Request the Addition of a New User” section below.



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Signers

Individuals listed here are required to sign the protocol. In addition to the PI, the Head of the Department must be one of the signers.


Request Addition of a New User

If you are unable to locate a user by using the “Edit Selection“ button above, list that user‘s name, e-mail address and which personnel group they belong to in the box below.

ITSC username Email address First name, last name

Department Personnel Group (Co-I/Research Personnel/Student Research Personnel)


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General Information Please upload the proposal in this tab by clicking the 'Attachments' button on top.

Project Title

Lay Description of Research Project

Please include a brief summary of the procedures used in your studies. (*) This description should be written in lay terms so that it can be understood by the general public. The specific details of these materials and techniques will be described in additional sections of this protocol, as necessary.

Minimum Biosafety Level Required for Research

Please describe the minimum BSL level required for work conducted under this protocol. For information about the BSL levels, please see section 'D. Description of Biosafety Levels' at https://hseo.ust.hk/sm_09_p1.

BSL 1

BSL 2

BSL 3

BSL 4

Research Locations Please specify the research location(s) and its current Safety Level e.g. Site, building, floor, section, room, Safety Level.

If work in the room listed requires a higher BSL rating, please list the room number and desired BSL rating. If a room is not listed, provide the room number and BSL level needed. For information about BSL levels, contact the Health, Safety and Environment Office.

Funding

Please provide the funding source information.


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Training Required Safety Training

Select the required Safety Training for the research being conducted on this protocol.

Safety Training Courses

☐ Electrical Safety (DC04) ☐ Radiation Safety with Unsealed Radioactive Materials (MC01) ☐ Radiation Safety with Sealed Radioactive Materials and Irradiating Apparatus (MC02) ☐ Chemical Safety I / Chemical Safety for Laboratory Users (MC07) ☐ Chemical Safety II / Hazardous Waste Management (MC03) ☐ Laser Safety (MC04) ☐ Pressure Safety (MC05) ☐ Biological Safety (MC06) ☐ Respiratory Protection (MC09)

Safety Training and Responsibilities for Study Personnel

Refresh

Safety Training Courses Personnel

Additional General Training Details

For each of the Study Personnel, list their responsibilities under this protocol and describe any additional information and SOP regarding the training and qualifications of Study Personnel that may be relevant.


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Protocol/Forms Links On this tab, record any links to another protocol/form that is appropriate.

Links to other Protocols or Forms

If this Safety Protocol is linked to another Human, COI, Safety or Animal Protocols, please select the appropriate item. If you are unable to find the protocol to link, please contact Help Desk at ext. 5985.

Edit selection

Number Protocol Title Type of Protocol

Additional details for linked protocols and forms Safety Protocol Links Details

If additional details need to be discussed regarding any of the Human, COI, Safety or Animal Protocol above, describe them below.


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Chemical Hazards Chemical Hazards

Does this protocol contain procedures that involve chemical hazards? (*)

No

Yes

If yes , answer the following questions.

Are you from the Department of Chemistry? (*)

No

Yes If Yes, answer the following questions.

Does this proposal involve synthetic chemistry work which operates in accordance with the Chemistry Department Safety Manual requirements and terms and conditions listed in the MOU between SEPO (HSEO) and CHEM, dated February 17, 2005? (*)

Yes

No

The following categories of regular hazardous chemicals will be used in this research project: (*)

Asphyxiant (e.g. inert gases)

Corrosive

Flammable

Irritant

Moisture/Air sensitive

Pyrophoric

Reactive (e.g. oxidizers)

Sensitizer

Toxic/Carcinogenic

Others

PI will ensure that all researchers of this project follow established university-wide and departmental safety policies and requirements when using these regular hazardous chemicals. (*)

Yes


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Location (room) where experiments will be carried out. (*)

Please list out all Hazardous Substances involved. (*) Major Hazard Codes: Asphyxiant (A), Carcinogenic (CA), Corrosive (C), Flammable (F), Irritant (I), Mutagenic (M), Reactive/Explosive (R/E), Sensitizer (S), Teratogenic (T), Toxic (TX), Others (O)

Name of Compound Major Hazard Code(s) Maximum amount

used in each experiment Amount in

storage and location

Description of work processes involving hazardous materials: (*)

Will there be any off-hours hazardous operations at high temperature and pressure or running water supply is required? (*)

Yes

No

Are any of the following thermodynamic reactions anticipated?

Exothermic (gets hot): This can lead to a runaway reaction.

Endothermic (gets cold): This can lead to equipment failures and erratic reaction rates via freezing solvents, decreased solubility, and heterogeneous mixtures.

Induction period (delayed reaction): This can lead to runaway reactions if reactants are added too quickly.

Proposed Engineering controls:

Local exhaust ventilation

Fume cupboard

Minimize quantity

Substitution for less hazardous materials

Blast shield

Glove box

Others

Not applicable


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Proposed Administrative controls:

Safety training

Warning & label

Access control

Approved operating procedures

Proper waste management practice

Others

Not applicable

Proposed personal protection equipment:

Safety glasses

Face shield

Lab coat

Safety goggles

Respirator

Appropriate gloves

Others

Not applicable

Special emergency response plan and procedures for off-hours operations. (*) What action plan will be implemented to prevent the experiment from becoming dangerous if any of these conditions fail to operate as anticipated?


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Nanomaterial

Will nanomaterial be produced or used? (*)

No

Yes If yes , answer the following questions. What kind of nanomaterial is to be produced or used? (*)

What is its chemical formula? (*)

What will be the size and morphology? (*)

Is there any known or suspected surface activity or toxicity that may adversely affect biological systems or the environment? (*)

e.g. radical formation, toxic elements, etc

No

Yes

If Yes, please In what phase will the nanomaterial be produced.

Will the nanomaterial be handled/used in gas phase during the study? (*)

No

Yes

If Yes, please specify what will be the containment or control measures for preventing workers’ inhalation of the nanomaterial or its release into the environment?

Will there be potential fire and explosion hazards related to handling of fine powder material? (*)

No

Yes

If Yes, please specify what will be the control measures.


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What will be the containment or control measures for preventing nanomaterial in non-gas phases from exposure to workers or escaping into the environment? (*)

Will the nanomaterial be intentionally released into the environment? (*)

No

Yes

If Yes, What are the justifications considering the risk and benefit of such activity, and what kind of environmental impact will result? *

How will the used nanomaterial be destroyed or inactivated before it is disposed of? (*)

How will the efficiency of destruction or inactivation be measured/verified? (*)


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Biological Hazards

RECOMBINANT DNA/TRANSGENICS

Instructions: Complete this section if your project involves the use of Recombinant DNA, Transgenic Animals, and/or Transgenic Plants. You may submit multiple versions of form 2 specific to different projects or specific to different DNA technologies, if you find that simpler. Definition of recombinant DNA: 1) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in living cells, or 2) molecules that result from the replication of these defined in 1), including recombinant proteins.

Does this protocol contain procedures that use rDNA as defined on the “General Procedures” tab, including plasmid work, transgenic plants and/or animals? (*)

No

Yes

If Yes, answer the following questions.

Please check the techniques/applications associated with rDNA technology that will be used in your lab: (*)

General subcloning

Plasmid transfections

Promoter analyses

siRNA/shRNA delivery

Viral vectors

Recombinant proteins

Genetically modified animals

Genetically modified plants

Stable cell line creation

Other (please explain):

Please indicate the purpose and provide a detailed description for using rDNA in your research. (*) Ex. 1) We will subclone the Hsp90 promoter from mouse in front of a firefly luciferase gene to determine changes in gene expression regulation. Ex. 2) We will transiently transfect siRNAs against human p53 to reduce p53-dependent gene expression in HeLa cells.


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Will you use viral vectors for rDNA delivery? (*)

No

Yes

If Yes, answer the following question.

If biological source of rDNA is virus, indicate percentage of viral genome present in the vector. (*)

< 1/2

1/2 to 2/3

> 2/3

N/A

Please list the viral vectors indicating species and strain and how they are used in your studies. (*) Ex) We will use replication-defective adenovirus, derived from human adenovirus serotype 5, with E1 and E3 genes deleted, from the Ad Easy system (Agilent). We will subclone genes into the adenoviral vector to infect mammalian cell lines from mouse, rat, and human origins.

Please describe the risks associated with accidental exposure to the rDNA, or gene product. (*) Include the probability and consequences of 1) recombination events leading to restoration of a replication-competent virus, and 2) integration of the viral vector into the host genome leading to insertional mutagenesis. Ex) Because the AdEasy vector lacks E1 and E3 genes, it is incapable of assembling virus particles or evading host immunity. The worst risk would be employees not wearing PPE and infecting their skin cells which theoretically could overexpress the gene inserted.

Please list all cell lines from sources other than humans or primates employed, if applicable. Ex) Madin-Darby Canine Kidney Cells.

Does you rDNA work involve the biosynthesis of a toxic molecule that would be lethal for vertebrates? (*) Ex) cholera toxin or prion protein.

No


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Yes

If Yes, please provide details

Do your experiments involve the use of genetically modified plants? (*)

No

Yes

If Yes, Please provide a list all transgenic plant species used in the study. In your list, please indicate the relative risks associated with the introduction of these modified plants into the wild. In your description, please explain the expected functional outcome of the foreign genetic material being expressed within this species.

Does your work employ the genetic modification of any other organisms that are not covered in these protocols, for example arthropods or sea urchins? (*)

No

Yes

If Yes, Please provide a list these additional genetically modified organisms used in the study. In your list, please indicate the relative risks associated with the introduction of these modified organisms into the wild. In your description, please explain the expected functional outcome of the foreign genetic material being expressed within this species.


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MICROORGANISMS

Instructions: Complete this section for all uses of microorganisms regardless of biosafety level. Definition of microorganism: Any microorganism, regardless of biosafety level, that has the ability to infect plants, cells in tissue culture, and animals, including humans. These microorganisms include viruses and bacteria that are primarily used for propagation and/or delivery of recombinant DNA to cells for expression and/or silencing of gene products. These include typical laboratory bacterial strains, for example E. coli DH5a and viral vectors including Adenoviruses and Lentiviruses.

Does this protocol contain procedures that use microorganisms of any kind, including bacteria or viruses for cloning, as defined on the “General Procedures” tab?

No

Yes


Please provide a detailed description of the use of microorganisms (as defined above) within your lab. (*) Ex) Our lab uses E. coli DH5 to propagate plasmid DNA for transfection of mammalian cells.

Please list the microorganism(s) and strain(s) that will be used in this study. (*) *This includes bacterial strains used for cloning purposes. Ex) E. coli DH5 cells will be transformed with plasmid DNA expressing GFP behind a CMV promoter. The plasmid will be isolated and transfected into HeLa cells. An ampicillin resistance gene incorporated into the plasmid pSPORT6 vector will be used to select positive clones, but the expression of this gene product does not change the biosafety level, which is Biosafety Level 1.

Please indicate how the microorganism will be obtained.

Please specify its biosafety level.

Please provide details if any genetic modifications to the microorganism will occur.

What is the natural host for this microorganism? (*) Ex) E. coli DH5 cells are laboratory-derived cells that were created for the purpose of cloning. These cells do not exist in nature, and have no natural host. Ex) Streptococcus pyogenes is a Gram-positive bacterial species that naturally infects humans.


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The organism known to be pathogenic to:

Humans

Other Animals

Plants

Where will the microorganism(s) be stored? (Building and Room No.) (*)

Do any of your procedures have the potential to generate aerosols?

No

Yes.

If Yes, please list the procedures.

Does the study involve the infection of animals?

No

Yes.

If Yes, please answer the following questions.

• Please list the AUP protocols referenced on the “Protocols/Forms Links” Tab that are relevant to microorganism activities conducted under this protocol. (*)

• List the species to be infected: (*)

• Can infected animals release this microorganism into the environment? (*)

No

Yes.

If Yes, please describe safety precautions like proper handling of cages, disposables, excreta and animal carcasses. Include training requirements and attach any applicable standard operating procedures.


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Please describe the risks associated with accidental exposure of lab personnel to these microorganisms. (*)

Describe the procedures required to destroy and dispose of the microorganism. (*)


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BIOLOGICAL TOXINS

Instructions: Complete this section if you are working with a biological toxin or select agent. This will also include microorganisms which synthesize a toxic molecule lethal for vertebrates, or the biosynthesis of toxic molecules.

Does this protocol contain procedures that use biological toxins? (*)

No

Yes


Please name the biological toxins (*)

Is the biological toxin supplied by others or created on-site ?

Yes

No

Will the toxin be genetically modified within your lab ?

Yes

No

Please specify the BSL level applicable to the toxin.

Will this toxin be harvested in your lab? (*)

No

Yes If Yes, answer the following question. How will this toxin be harvested?

Unfractionated mix

Purified conjugate

Microbial culture

Do you know the LD50 of the toxin? (*)

No


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Yes If Yes, please specify what is the LD50 of the toxin.

Where will the toxin be produced and/or stored? (Building and Room) (*)

What is the maximum amount of toxin produced in any single experiment or purchased in any single order? (*)

What is the maximum amount of toxin that will be stored in the lab at any given time? (*)

Do experiments involve the administration of toxin to animals?

No

Yes If Yes, answer the following question. • Please list the AUP protocols referenced on the

“Protocol/Forms Links” Tab that are relevant to biological toxin use activities conducted under this protocol.

• List the species to be used

• Please describe the necessary safety considerations to protect staff during animal housing

• Please describe how toxin-containing materials will be inactivated

Please describe the risks associated with accidental exposure of lab personnel to these toxins (*)

Please identify the method of disposal/deactivation of contaminated materials and remaining toxic agent (*)


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Is there an antidote available for persons exposed to the toxin? (*)

No

Yes If Yes, please specify where the antidote is located.

Has the toxin been modified to make it safer to use? (*)

No

Yes If Yes, Provide the information and describe the modification. You may attach files to this tab if desired (indicate this has been done).

Human / Non-Human Primate

Instructions: Complete this section if you are working with human or non-human primate blood, body fluids, tissues and/or cultured human cell lines and/or cell lines immortalized using human or non-human primate viruses.

Does this protocol contain procedures that use Human or Non-Human Primate Blood, Tissue, Fluid, or cell lines (includes primary and immortalized)? (*)

No

Yes


Please describe in detail the purpose for using human and non-human primate blood, fluids, tissues, cell strains, and cell lines used in your research. (*)

Please indicate the material to be used (check all that may apply). (*)

Blood

Cell Lines

Fluid

Primary culture or explant

Tissues


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Please indicate origin of the material. (*)

Human

If Human, please answer the following question.

Are materials KNOWN to be infected with agents from Risk Group 3 or higher (Hepatitis B, HIV, etc.)?

No

Not known

Yes If Yes, please list all KNOWN agents

Non-Human Primate

Are the human/non-human primate cells immortalized? (*)

No

Yes

If Yes, please answer the following questions.

• Please list the immoralized cell lines that will be used. • Please describe how they are obtained. • Please indicate the biosafety level associated with the

cells.

Are the human/non-human primate cells going to be transfected or infected with rDNA in an effort to create a stable cell line? (*)

No

Yes

If Yes, please provide detailed information in how these cell lines are created.

Please describe the known risks associated with accidental exposure of lab personnel to these blood/fluid/tissue samples. (*)

Please identify the method of disposal/deactivation of these blood/fluid/tissue samples. (*)

Does your laboratory have a blood-borne pathogen exposure procedures in place? (*)


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No

Yes

If Yes, please provide details.

Have all personnel working with human material vaccinated for Hepatitis B? (*)

No

If No, please answer the following question.

Have researchers been enrolled in medical surveillance programme?(*)

No

Yes

Yes

Does the described use of human derived agents, tissues or cell lines have an IRB approval or exemption letter? If it does, please attach the IRB approval or exemption letter to this tab. (*)

No

Yes

If Yes, please list the IRB Protocol number and date of approval. Be sure that any referenced IBC protocol is selected on the "Protocol/Forms Links" tab.


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Physical Hazards PHYSICAL HAZARDS Does this protocol contain procedures that involve physical hazards? (*)

No

Yes


Location (room) where experiments will be carried out: (*)

Hazardous materials/operations involved: (*)

☐ High voltage equipment (> 600V AC or 1.0 KV DC)

☐ High pressure/vacuum condition

☐ High temperature

☐ Laser (Class III or above)

☐ Ionizing radiation (e.g. isotopes, X-ray)

☐ Non-ionizing radiation (e.g. UV, microwave, other EM fields)

☐ Others. Please specify: _______________________________

Description of work processes involving hazardous operations, including the type of operation, operating conditions, maximum quantity, duration, and other relevant information: (*)

Proposed engineering control: (*)

☐ Proper shielding/enclosure

☐ Proper relief devices

☐ Proper guarding

☐ Proper insulation

☐ Proper interlock


☐ Not applicable


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Proposed administrative control: (*)

☐ Safety training

☐ Approved operating procedures Please upload the Operating Procedures in this tab by clicking the 'Attachments' button on top, if appropriate

☐ RUA. Please state the RUA no.: __________________________

☐ Laser hazard control plan. Laser hazard control plan number: _________________

☐ Access control

☐ Proper waste management practice


☐ Not applicable

Proposed personal protective equipment: (*)

☐ Safety glasses

☐ Face shield

☐ Lab coat

☐ Safety goggles

☐ Respirator

☐ Appropriate gloves


☐ Not applicable


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PI Certification

PI Certification

∗ The Principal Investigator certifies:

∗ To the best of my knowledge, I affirm that all information contained herein is accurate and complete.

∗ I agree to comply with the university requirements pertaining to handling, shipment, transfer, and disposal of biological materials.

∗ I agree to accept responsibility for the training of all personnel involved in this research and that all personnel have been trained and made aware of the risks involved.

∗ I affirm that I am aware of the university guidelines and will follow appropriate biosafety level laboratory techniques in the research.

∗ I understand that all significant changes in agents, procedures/practices, and facilities must be reported in writing to the Safety Panel and that Safety Panel approval shall be obtained prior to implementation of these changes.

∗ I understand that unauthorized use of recombinant DNA, microorganisms, select agents, biological toxins, regulated and particularly hazardous chemicals, or deviation from an approved IBC protocol may result in the suspension of research privileges and/or disciplinary action.

☐ I agree with the certification statement above.

Documents

Sample Questionnaire (NOT FOR OFFICIAL USE) The Hong Kong