Test substances




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Form #: IACUC 007/05

American University of Beirut

Institutional Animal Care and Use Committee
TEST SUBSTANCES
Name of Principal Investigator:
Proposal Title:

1. Toxic Agents. Will toxic chemicals, toxic pharmacologic agents, known or suspected mutagens, carcinogens, teratogens, DNA-binding, or other similar agents be used in animals?

 NO. Proceed to item 2.

 YES. Complete items 1.a, 1.b, and 1.c.

a. Table of toxic agents:

Agent


Diluent

Route of admin.

Dose (e.g. mg/kg) and Volume (ml)

Frequency and duration of administration

Reason for admin., and expected effects

























































  1. Indicate which of the above agents, if any, are known or suspected mutagens, carcinogens, or teratogens:

Form #: IACUC 007/05

c. Will animals be anesthetized or sedated when these agents are administered?

 NO. Proceed to item 2.

 YES. Detail the method of anesthetic, sedative, or tranquilizer administration including agent, dose and volume, and route.

2. Infectious Agents. Will bacteria (including rickettsia), viruses, fungi, protozoa, prions, or other infectious agents be used in animals? If the agent will have a radioactive label added, also complete item 4 below. Likewise, if the infectious agent contains recombinant nucleic acid, fill out item 6 below for the agent as well.

 NO.

 YES. Complete items 2.a, 2.b, 2.c, and 2.d.



a. Complete the table below:


Agent and strain or construct

CDC Biosafety Level of agent (BSL1, 2, 3, 4)

Route of admin.

Dose (e.g. CFU, PFU) and volume administered (ml)

Frequency of administration














































b. Has an antibiogram, anti-viral drug sensitivity screen, or other appropriate drug sensitivity panel been determined for the agent(s) listed to assist physicians in selecting proper therapy if an inadvertent human infection occurs?

c. Will the animals be anesthetized or sedated when these agents are administered?

 NO.


 YES. Detail the method of anesthetic, sedative, or tranquilizer administration including agent, dose and volume, and route.

Form #: IACUC 007/05

3. Biological Materials. Will serum, cell lines, tissue, nucleic acid or other biological materials be administered to animals? If any of the agents are radioactive or will have a radioactive label added, also complete item 4 for that agent.

 NO.


 YES. Complete items 3.a., 3.b., and 3.c

a. Table of biological materials:





Material (e.g. fluid, cells, tissues)

Diluent

Source

(e.g. vendor, other animals, colleague)



Route of admin.

Dose (e.g. ml/kg, mg/kg, cells/kg) and volume (ml)

Freq. and duration of admin.

Reason for admin., and expected effects































































b. Will the animals be anesthetized or sedated when these agents are administered?

 NO

 YES. Detail the method of anesthetic, sedative, or tranquilizer administration including agent, dose and volume, and route.


c. How will these materials be screened to make sure they do not harbor infectious agents that could infect other laboratory animals or people?

4. Radioactive Agents. Will radioactive compounds or agents be administered to animals?

 NO. Proceed to item 5.

 YES. Complete items 4.a., 4.b., and 4.c.; then proceed to item 5.

Form #: IACUC 007/05

a. Table of radioactive agents:


Radioactive Agent (include isotope)



Reason for admin., and expected effects

Diluent

Agent dose (mg/kg) and Vol. (ml)

Activity (e.g. mCi/kg)

Route of admin.

Frequency and duration of admin



































































  1. Which investigator has been given permission by the Radiation Safety Committee to utilize the isotope(s) indicated above?

c. Will the animals be anesthetized or sedated when these agents are administered?

 NO.

 YES. Detail the method of anesthetic, sedative, or tranquilizer administration including agent, dose and volume, and route.



5. Other Agents. Will other substances not listed previously in this appendix be administered to animals? Do not include anesthetics/analgesics/sedatives you will describe elsewhere in the PROTOCOL as part of surgery and postoperative care.

 No.


 Yes. Complete items 5.a. and 5.b.
a. Table of other agents:


Agent

Reason for admin., and expected effects

Diluent

Agent dose (e.g. mg/kg) and Vol. (ml)

Route of admin.

Frequency and duration of admin.























































Form #: IACUC 007/05
b. Will the animals be anesthetized or sedated when these agents are administered?

 NO.


 YES. Detail the method of anesthetic, sedative, or tranquilizer administration including agent, dose and volume, and route.
6. Recombinant nucleic acid and recombinant infectious agents.

a. Do any of the agents noted above in items 1-5 above have recombinant nucleic acid in them?

 NO.

 YES. Answer item 6.b.



b. Are the recombinant constructs exempt from the animal research guidelines included in the latest version of the NIH Guidelines for Research Involving Recombinant DNA Molecules publication?

 NO. You must conduct the animal experiments involving recombinant nucleic acid according to the NIH Guidelines for Research Involving Recombinant DNA Molecules. Consult with the Biosafety Committee and the Veterinarian to make sure you comply.

 YES.

7. Pain or Distress. Will animals potentially experience pain and/or distress as a result of the administration of agents listed above in items 1, 2, 3, 4, 5, or 6?



 NO.

 YES. Describe the nature of the pain and/or distress that animals might experience and describe measures that will be taken to alleviate any pain and/or distress here.


Form #: IACUC 007/05


8. Hazardous/Toxic Agents. Are any of the agents listed above in items 1-6 hazardous or toxic to humans or animals, or covered by the NIH Guidelines for Recombinant DNA and Gene Transfer?

 No. You have completed this appendix; no further information is required in this appendix. YOU DO NOT NEED TO GET SIGNATURES IN ITEM 9. BELOW!

 Yes. Complete items 8.a., 8.b., and 9;

a. Table of hazardous agents, committee approvals, and personnel exposed:





Toxic or hazardous agent(s) from items 1-5 above, or non-exempt agent(s) from item 6.

Safety, biosafety, or radiation safety committee that has approved the use of this hazardous agent

Indicate whether VA or affiliate committee

List all animal facility staff who will come in contact with animals given these agents or with contaminated bedding, cages, or other items.







































  1. Detail how the individuals listed in the table above (item 8.a.) have been (or will be) informed of the possible risks of exposure, and have been (or will be) trained to avoid exposure to these agents:

Form #: IACUC 007/05
9. Signatures. By our signatures, we certify that:

a. Before any animal experiments involving the agents listed in item 8.a. are performed, SOPs designed to protect all animal facility staff as well as non-study animals will be developed and approved by the appropriate affiliated university safety committee and the IACUC; and

b. All staff that might be exposed to these agents will be informed of possible risks and will be properly trained to follow the SOPs to minimize the risk of exposure. As is appropriate, concurrence signatures from biosafety or radiation safety personnel are also required as shown.



Principal Investigator

Signature

Date










Institutional Veterinarian

Signature

Date










Biosafety Officer or Chair,

Safety or Biosafety Committee (typed)



Signature

Date










Radiation Safety Officer, or Chair, Radiation Safety or Isotope Committee (typed)

Signature

Date










IACUC Chair (typed)

Signature

Date
















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