Other Review Items

Amendments:

Amendments - Significant

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.
Extensive modifications (ie. production of monoclonal antibody production in mice; 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).

Amendments - Administrative Modifications

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

All changes or amendments in protocols involving radioisotopes or biological/chemical hazards must also be submitted in writing to the Office of Environmental Health and Radiation Safety (OEHRS), in addition to the IACUC. Final approval will not be given until approval is received from OEHRS.

The IACUC has provided the following as examples of changes that are considered significant and may require Full IACUC Review or submission of a new protocol.

• Changes the objectives of the study
• Changes in surgery from non-survival to survival, or from survival to multiple survival surgery
• A change in the invasiveness of a procedure or one that increases animal pain or distress
• Changes in the species used or a request for additional animals exceeding 10% of that approved by the IACUC for the protocol.
• Changes in the principal investigator or changes in personnel involved in recovery surgery procedures
• Changes in anesthetic agent, or use of analgesics unless required to relieve immediate animal pain or discomfort
• Use of a non-standard method of euthanasia
• A change in the duration, frequency or number of procedures performed on the animal.

Animal By-Products
Studies that will use slaughterhouse material or animal tissue or animals utilized on other IACUC approved protocols and then euthanatized, must forward one copy of Form C for review. If the by-products are obtained from another institution one copy of an approval letter from the Animal Care Committee at the cooperating institution must accompany the Form C. This type of protocol can be reviewed by designated review.

Program, Center, Instrumentation, Salary Support and Training Grants
These grants that intend to use vertebrate animals under approved protocols may be reviewed by designated review. The responsible investigator must submit a Form G and attach a listing of the projects, investigators and their IACUC numbers of the individually approved protocols. Animals can only be ordered under the individually approved protocols and not under the IACUC number assigned to the overall application. The ORA requires a complete copy of the grant proposal for review prior to final approval. This type of protocol can be reviewed by designated review.

For Testing Vertebrate Animals at Non-University of Pennsylvania Sites
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. This type of protocol can be reviewed by designated review.