ARIES will be required as of April 1, 2011 for all Form A and POAP submissions.
The investigator in charge of a project or procedure involving animals or animal tissues shall prepare Form E and one of the protocols "A" -"D". Form F is for salary support only. Preparing and Submitting a Protocol
- Submissions and revisions should include one signed copy and an electronic copy
- Send submission to the IACUC Office, which will then send the protocol to any other offices (EHRS, HUP, ULAR, etc.)
- Many hyperlinks fixed, updated, or added
- Addition of "core facilities" for production of transgenics (#13)
- Animal identification includes ALL species (#14)
- Clarification on use of analgesics in surgical procedures (#17)
- Inclusion of pilot study data for use of neuromuscular blocking agents (#20)
- Clarification of chronic catheterization (#26)
- Wire-bottom caging for rodents requires scientific justification (#27)
EHRS section (#5) was updated in December 2008.
Note: The 2005 Forms will no longer be accepted. Protocol Review Form. Form A must be prepared carefully and completely in accordance with the requested information on the forms and within these Guidelines. If possible, the study title should not exceed two lines of 50 characters each. Projects involving live vertebrate animals shall be submitted to the IACUC for approval. The completed form is forwarded to the Office of Regulatory Affairs as part of the pre-submission campus review process. An IACUC number will be issued for each protocol and will be used for review, procurement and animal housing. The Protocol Review Form will be used as an official University record and must receive full IACUC approval before initiating any activity involving all vertebrate animals at this institution.
Form B- Annual Review Form (USDA species only) Updated Dec 2005 Continuation of Applications to PHS using USDA covered species. Non-competing continuation applications to PHS are no longer afforded a 60-day grace period for submitting IACUC certification of approval to the sponsor. These protocols must have a current status prior to processing through Research Services. All IACUC protocols must reflect the exact experimental work proposed in any submission to a sponsoring agency and presented in a timely manner for Committee review.
Form C - Animal By-products Protocol Form 2 pages Updated March 2005 The Animal By-Products protocol form (Form C). Form C should be used by principal investigators who use animal by-products (fresh or frozen) in their research. If embryonic eggs are to be used and they are used 72 hours prior to the expected hatching date, Form C can be used in lieu of the longer protocol. It is not necessary to fill out the long protocol for these type experiments if live animals will not be used. The original form must be forwarded to the Director of Regulatory Affairs. Other investigators may use tissues or individual organs of euthanized animals, which were not exposed to infectious agents or chemical contaminants. Form C is used for this propose. No activity may commence until approval has been given by the IACUC.
Form D - For Testing Vertebrate Animals at Non-University of Pennsylvania Sites Updated March 2005 Collaborating Institution Form D. Form D must be used by investigators doing work at a collaborating institution (off-campus facility), but with funds administered by the University. An approval letter from the collaborating institutions IACUC and a copy of the animal protocol/assurance from the collaborating institution is required for submission with Form D. Note, if the collaborating institution does not have a PHS approved Assurance of Compliance for animal welfare on file with OLAW the investigator must contact the Director, ORA.
Form E - The attached form is ONLY for visitors to the University. All Penn employees must use the Knowledge Link training modules noted below.
Form-E has been replaced with the Knowledge Link training modules: Occupational Health - Animal Users Risk Assessment (all animal users) and Occupational Health - NHP Users Risk Assessment (nonhuman primate users). Please log-on to Knowledge Link and complete the appropriate course based on the species used. These modules will be found in your "Optional Training" section under Course Master ID: UNIV_ALL_IACUC_OCCHEALTHALL (all animal users) and UNIV_ALL_IACUC_OCCHEALTHNHP (nonhuman primate users).
Please Note: The Occupational Health - NHP Users Risk Assessment (nonhuman primate users) must be re-taken annually and The Occupational Health - Animal Users Risk Assessment (all animal users) must be re-taken every three years.
Form F - Salary Support Protocol Updated July 2004
Many grants are only for salary support in which the investigator will be working on an animal protocol that may be approved under a different grant or investigator. The salary support grant does not require a separate protocol with a new protocol number but needs to be linked to an approved animal protocol. This SOP will describe the procedures necessary to link a proposal to a protocol
To be used by investigators submitting these types of grant applications that use vertebrate animals under approved protocols. They may be reviewed by designated review. Animals can only be ordered under the individually approved protocols and not under the IACUC number assigned to this overall application. The ORA requires a complete copy of the grant proposal for review.
Any modifications to a protocol (ie. any changes in surgical or non-surgical methods; changes in method of euthanasia; modifications in time points; or revisions to the purpose or aim of the study) require approval by the IACUC prior to implementation. A principle investigator may request these changes by completing and submitting the IACUC amendment form.
Changes in the pain/distress category from A to B, or B to C; or any changes which deviate considerably from the original procedures described by the investigator) may be referred to the full IACUC for review, and may require submission of a new or revised protocol (Form A).
Any administrative changes to a protocol (ie. change of funding source or grant title; addition of personnel or change of location for procedures and/or satellite housing) may be completed by submitting the administrative modification form. Please note that although these modifications do not have to go through the complete review process, all documentation and training must be completed and submitted before approval will be granted
EHRS ANIMAL PROTOCOL REVIEW PROCESS
Investigators intending to administer or treat live animals with hazardous materials must submit a copy of their Institutional Animal Care and Use Committee (IACUC) animal protocol review form (Form A) to the Office of Environmental Health and Radiation Safety (EHRS) for review and approval before the IACUC will give its full approval to the protocol. For details, see the EHRS Web site.
If you need to amend the material submitted to EHRS, please use the Appendix 2: EHRS . Updated March 2011
Final Disposition Form - This form should be used for each USDA covered animal upon final disposition (e.g. death, euthanasia, adoption).
Request for Housing of Animals Within a Study AreaUpdated January 2006 -This form may be used for protocols which were submitted on paper. If you are submitting or have submitted your protocol via ARIES, please use the Housing Request form available in ARIES. This can be found by going to: My Submissions - Create - Housing Request.
Exemption Form To be used if, due to specifications/ requirements of the research protocol, an exemption from the standards, federal regulations, and/or U Penn policies are required. (i.e. space requirement [including innovative enclosures and metabolic cages], use of an animal in more than one major survival surgery, etc.). If you are submitting or have submitted your protocol via ARIES, please use the Exemption Request form available in ARIES. This can be found by going to: My Submissions - Create - Exemption Request.