I.ADMINISTERED SUBSTANCES

  1. Will you administer any substances to your animals during the course of the life of the animal(s)? Yes☐ No☐

If "NO", proceed to Section J

  1. If “YES”, list all administered substances here and categorize (refer to http://toxnet.nlm.nih.gov/):

Do NOT include analgesia/anesthesia here, include as appropriate in Section B or Section J

Specify each substance:
  1. Chemical carcinogen:

  1. DEA Controlled substance:

  1. Toxic substance:

  1. Radioisotope:
/ license #:
  1. Microbiological agent*:

  1. Human or animal cell lines** (including tumor cell lines):

  1. Human embryonic stem cells (hESC)***

  1. Diluents or carriers:

  1. Other (Including monoclonal antibodies and serum-derived products. Do not include anesthestics or analgesics):

☐ I certify that BOTH animal-derived tumor or tissue cell lines and passaged human tumor or cell lines will be tested for biological contaminants prior to use, to prevent introduction of adventitious or zoonotic disease according to the following guideline:

https://hccm.med.harvard.edu/getting-started/cell-lines-and-biological-materials:

HCCM must be contacted if you will be using substances potentially harmful to humans in the animal facilities, see the Mandatory Risk Disclosure page.

  1. For substances potentially harmful to either animal subjects or staff:
  1. The use of *microbiological agents must be approved by the Committee on Microbiological Safety (COMS) or Partners Institutional Biosafety Committee (PIBC). Contact a Biosafety Officer at EH&S at 617-432-1720 (HMS) or 800-825-5343 (BWH) for the necessary forms. BWH investigators must obtain approval from the Partners IBC; registrations can be completed online: or contact the PIBC for assistance at

Provide the COMS/PIBC Registration #

  1. The use of**human or NHP tissues or cells must be approved by COMS or PIBC. Contact a Biosafety Officer at EH&S at 617-432-1720 (HMS) or 800-825-5343 (BWH) for the necessary forms. BWH/MGH investigators must obtain approval from the Partners IBC; registrations can be completed online: or contact the PIBC for assistance at

Provide the COMS/PIBC Registration #

  1. Protocols involving the use of ***hESC must also be sent to the Harvard University Embryonic Stem Cell Research (ESCRO) Committee for review and approval (617-495-9829) and the Office of Research Compliance must be notified (617-432-3884).

BWH PI’s – Contact the Partner’s ESCRO Committee (617-424-4171).
Children’s PI’s – Contact the Children’s ESCRO Committee

  1. IACUC approval CANNOT be granted until ESCRO approval is in place.
    Have you submitted an ESCRO protocol application? Yes☐ No☐

List your ESCRO Protocol Number here: ______

  1. Specify the following for each substance listed above
    (copy this table and complete separately for each substance):

AGENT:
VERTEBRATE SPECIES to which agent will be administered:
  1. Volume, Concentration, Route of administration:

  1. Anatomic Site of injection(s) (e.g. tail vein, thigh muscle) (if applicable):

  1. Number of Injection(s) (if applicable):

  1. Frequency of injection(s) (if applicable):

  1. Effects of the agent or substance on research animal:

  1. Length of survival time after initial administration:

  1. Will the animal experience pain, distress or illness as a result of the substance administered? Yes ☐ No ☐
If "YES", describe the procedures to alleviate the pain, distress or illness:
  1. Is this compound pharmaceutical grade (USP)? Yes ☐ No ☐ N/A ☐
If NO, the following standards should be followed for all non-pharmaceutical grade agents:
  • pH: Agents will be made pH appropriate for the route of administration.
  • Purity: The highest available purity grade will be used.
  • Stability: If stability information is unavailable, the agent will be prepared immediately prior to use.
  • Sterility: The agent and equipment will be sterilized (e.g. filtered, autoclaved, etc.) prior to parenteral administration.
  • Labeling/Storage: Agents will be labeled with the name, concentration, and preparation date.
  • Expiration: Agents will be used within the expiration date. Compounds will be used within 30 days of preparation.
☐I agree to abide by the above standards.
☐I will deviate from the above standards in the following way(s):
  1. Specify the following for all HAZARDOUS/INFECTIOUS agents:

You must complete the following section for all studies involving HAZARDOUS/INFECTIOUS agents:
Agent Used
Chemical Carcinogen:
Agent Used
Toxic Substance:
Agent Used
Microbiological Agent: / Existing COMS or PIBC #: / Biosafety level:
Agent Used
Radioisotope: / License #: / Half-life:
Route of Administration or Delivery Method
Shed in: / Blood☐ / Saliva☐ / Urine☐ / Feces☐
Location where agent will be administered:
Building:
Room: / Duration of Animal Survival Post treatment: / Animal Housing Location Post-treatment:
Special Housing Request:
Has contact with HCCM and EH&S been established for use of hazardous agents?
Yes ☐ No ☐
State the terms of, or describe the agreement with HCCM and EH&S on procedures and precautions for use of hazardous agents:
  1. Pharmaceutical-grade compounds
  1. Will you be using compounds, including diluents, that are not pharmaceutical-grade? Yes ☐ No ☐

In keeping with the USDA and OLAW guidance, it is the policy of the IACUC that pharmaceutical-grade compounds, including diluents and carriers, must be used in experiments instead of non-USP drugs or reagents, even in acute procedures. Non-pharmaceutical-grade chemical compounds, diluents and carriers may only be used after specific review and approval by the IACUC. The IACUC may consider scientific necessity or non-availability of an acceptable veterinary or human pharmaceutical-grade product as sufficient reasons for accepting the use of non-pharmaceutical grade drugs or diluents in animal experiments. Cost savings alone is not a sufficiently compelling reason to justify use of a potentially ineffective or toxic non-pharmaceutical-grade substance.

  1. If you are administering ANY non-pharmaceutical grade substances, list each in the table below and check appropriate box a., b., or c. Microbiological agents need not be listed in this section.

Compound / Identify need for non-USP substance
☐ /
  1. Non-commercially available experimental compound

☐ /
  1. Only non-USP grade is commercially available and no other alternatives exist

☐ /
  1. USP grade drug or alternative is available, but a non-USP grade is requested

  1. If pharmaceutical-grade compounds are available and you are NOT administering pharmaceutical-grade compound(s) to your animal(s), (c is checked) you must also complete the detailed scientific justification column below.

The IACUC expects researchers to justify the use of a non-pharmaceutical grade drug, compound, diluent, or carrier and to demonstrate consideration (and rejection) of pharmaceutical grade alternatives for experimental reasons. Reasons related to the cost of USP grade products are generally deemed insufficient on those grounds alone to justify substitution of non-pharmaceutical grade alternatives for USP drugs and reagents. Provide sufficient detail and present the respective advantages and disadvantages of the pharmaceutical and non-pharmaceutical-grade compound/chemicals.

  • Describe how rejected alternatives will negatively impact outcomes or measurements.
  • Describe how experimental logistics have influenced the choice of the chosen agent.
  • Address any issues of animal or human safety, compound efficacy related to the experimental aim, and address the possibility of inadvertent introduction of research-complicating variables.

Provide detailed scientific justification

Page 1 of 5