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PROTOCOL SUBMISSION AND OTHER FORMS (Updated 6/1/15)

 

All protocol submissions must now be done in ARIES, excluding Form F (salary support) and Amendments or Continuing Reviews for a paper version of Form D (which will need to be resubmitted as an Offsite Application in ARIES once it is up for 3-year renewal).

 

See the information below for details about each type of submission.  Additionally, see Preparing and Submitting a Protocol for further information.

 

Please note that for all protocols originally submitted online through ARIES, all subsequent submissions (e.g., amendments, exemptions, continuing reviews, 3-year renewals) for that protocol must be created in ARIES, as well.



Form A / Privately Owned Animal Protocol (POAP)

Form A and POAPs must be submitted for projects involving live vertebrate animals for which work will be performed at the University of Pennsylvania (a POAP is for protocols using privately-owned animals, usually those of veterinary clients; these must be reviewed and approved by the Hospital Protocol Review Committees (VHUP) before approval by the IACUC).  Form A and POAPs may be accessed in ARIES by navigating to ‘My submissions > Create > Initial review’, and answering the questions appropriately.  Once submitted, the protocol will be reviewed by designated member review, but any member of the IACUC may call it for full committee review (performed during the monthly IACUC meeting) if they feel that is needed.  Final review category and submission requirements will be determined by the IACUC.  No animal work may begin until the protocol has received IACUC approval, which may take 3 weeks or more.  For further guidance, see Common Problems and Omissions in Preparing Form A.

 

 

Offsite Application (formerly Form D)

Offsite Applications must be submitted by investigators for animal work being done at non-Penn facilities with funds that will be administered by Penn.  An approval letter from the collaborating institution’s IACUC (or equivalent body) and a copy of their animal protocol is required with this submission (see link below).  Offsite Applications may be accessed in ARIES by navigating to ‘My submissions > Create > Initial reivew’ and answering the questions appropriately.  Note, if the collaborating entity is not AAALAC-accredited and 1) is a vendor or 2) Penn will retain ownership of the animals at the other location, please contact the Assistant Director for IACUC Administration in the Office of Animal Welfare ( This e-mail address is being protected from spam bots, you need JavaScript enabled to view it , 215-573-4982).

 

Offsite Application Checklist

Click this link for a letter that can be sent to the IACUC Office/Ethics Committee of the collaborating institution requesting the items needed to complete a new ARIES Offsite Application.

 

 

Continuing Review for Work at Penn (formerly Form B)

A Continuing Review is an annual review mandated by the Animal Welfare Act & Regulations and must be completed for all approved protocols utilizing species covered by the USDA. The application for Continuing Review should be submitted in ARIES, by navigating to ‘My submissions > Create > Continuing review’, no later than three weeks prior to the protocol expiration date.  Failure to have this form submitted and approved by the anniversary date of the initial approval will result in the expiration of the protocol.  A new initial review protocol will then have to be submitted.

 

 

Continuing Review for an Offsite Application (formerly Form D)

A Continuing Review is needed for Offsite Applications when required by the collaborating institution.  This will always be the case for work with USDA-covered species within the continental United States, but may also apply to other species if the collaborating institution requires annual review of their protocols.


ARIES submissions

The application for Continuing Review should be submitted in ARIES, by navigating to ‘My submissions > Create > Continuing review’ to upload the continuing review approval from the other institution.  This can be created when you receive the approval letter, even if the Offsite Application has an “expired” status, since the approval letter from the collaborator is usually not available prior to current approval period.

 

Paper Form Ds

The only exception for submitting a Continuing Review in ARIES is for existing paper Form Ds, in which case the new annual approval letter for the protocol from the collaborating institution should be sent to This e-mail address is being protected from spam bots, you need JavaScript enabled to view it to process the Continuing Review (no other form is needed).  Please note that current paper Form Ds will need to be resubmitted as an Offsite Application within ARIES when their 3-year renewal is due.

 

 

Form F - Salary Support Protocol

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.  In these cases where no grant funds will be used directly for animal work, a separate protocol with a new protocol number is not required, but the salary support grant needs to be linked to an approved animal protocol, which can be accomplished by submitting this form.

 

 

Amendment for Work at Penn

An amendment to a protocol may include changes in animal use procedures, species, animal numbers, hazardous materials, study locations, personnel, or funding.  Changes in approved research cannot be initiated without prior review and approval of the amended change(s).  Amendments were previously separated into either administrative or significant amendment forms but these designations are no longer used for submissions.  These should now be submitted online in ARIES by navigating to ‘My submissions > Create > Amendment’.  Please note that only one amendment can be submitted and reviewed at a one time within ARIES.

 


Amendment for an Offsite Application (formerly Form D)

An amendment to an Offsite Application would include changes to the title or Principal investigator (PI) of the Penn protocol, changes in Penn personnel performing work at the collaborating institution, changes to funding, a change in strain or species, or an increase in animal numbers for orders placed through POLARIS for delivery at the other institution (i.e., CHOP, Wistar, or the PVMA).  Amendments are not needed to reflect changes in the experimental design, procedures, or non-Penn personnel.


ARIES submissions

The amendment should be submitted in ARIES, by navigating to ‘My submissions > Create > Amendment’.  Please note that only one amendment can be submitted and reviewed at a one time within ARIES.

 

Paper Form Ds

The only exception for submitting an amendment in ARIES is for existing paper Form Ds.  If you need to amend a Form D, please submit one of the appropriate forms below by completing it and emailing it to This e-mail address is being protected from spam bots, you need JavaScript enabled to view it or faxing it to 215-746-6308.  Please note that the “Administrative” and “Significant” designations are for internal form classification only and do not affect the processing of the amendment.

 

Amendment Form - Administrative

Use this form to change any of the following on a paper Form D:

1)    Penn personnel (other than the Principal investigator)

2)    Funding

3)    Protocol or grant title

 

Amendment Form - Significant

Use this form to change any of the following on a paper Form D:

1)    Animal strain

2)    Animal species

3)    Animal numbers

4)    Principal investigator

 

 

Request for Housing of Animals Within a Study Area Form

A satellite housing request is submitted to request the housing of animals outside of animal facility for greater than 12 hours.  All Housing Requests must be submitted in ARIES by navigating to ‘My Submissions > Create > Housing request’Requests are often designated reviews, but may be reviewed at a full board meeting of the IACUC.  Approval is granted to those requests with a strong scientific justification of why the proposed work cannot be performed in the animal facility.  Proposed sites will be inspected prior to approval to ensure they meet University and federal guideline standards.  Prior to submitting a housing request, please review the IACUC policies to determine whether satellite housing is necessary and is a reasonable consideration.  

 

 

Exemption Request

When deviating from the federal regulations and University policies and guidelines regarding the care and use of vertebrate animals in testing, research, and educational activities, a request for an exemption must be submitted to the IACUC for review.  All Exemptions must be submitted in ARIES by navigating to ‘My Submissions > Create > Exemption request’.  Exemption requests must be associated with an IACUC protocol.  The exemption, if granted, may be reported to the USDA and/or OLAW as required by law.  Examples of an exemption could include scientifically-justified single housing, modifications/exceptions to space requirements, light cycles, exercise plan for dogs, food/water restriction, use of an animal in more than one major survival surgery, etc.   

 

 

 

OTHER FORMS

 

Immediate Postoperative Care Record - Used to record observations from the time an animal is extubated until returned to colony housing.  Please note that certain fields of this template may not apply to all species.

 

Postoperative Care During Periods of Analgesic Administration - Used to record observations and medication administration after the animal is returned to colony housing.

 

DEA Controlled Substances Record Templates - Contains templates that can be used for the various required documentations when working with controlled substances.

 

Compliance Checklist - A checklist used by IACUC members and regulatory staff during post-approval monitoring visits, which can be used by laboratory staff to prepare for these visits.

 

Final Disposition Form - This form should be used for each USDA-regulated animal upon final disposition (e.g., death, euthanasia, adoption).

 

 

 

FORMS NO LONGER REQUIRED

 

Form C

The Office of Animal Welfare has decided that Form C protocols are no longer required for research using animal tissues or by-products that are obtained from animals on other protocols or from other sources.

 

Form E

Form E has been replaced with the Knowledge Link training modules: Occupational Health and Safety: Animal Users Orientation (all animal users except those using macaques) and Occupational Health and Safety: Macaque Users Orientation (macaque users).  Please logon 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 (macaque users).

 

Form G

The Office of Animal Welfare has determined that Form G protocols are no longer required for Program, Center, or Training grants.  If your program official is asking for documentation regarding a Program, Center, or Training grant, please contact the Office of Animal Welfare for assistance ( This e-mail address is being protected from spam bots, you need JavaScript enabled to view it ).

 
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