IACUC Memo to Investigators - Nov 2016

Dear investigator,

At the suggestion of the USDA, the IUP Institutional Animal Care and Use Committee (IACUC) has developed several new resources and initiatives. In this memo, we describe several updates, including SOP documents and a new post-approval monitoring process.

1) Animal husbandry/breeding Standard Operating Procedure (SOP) documents

The research use of animals requires, in some cases, that animals be held in captivity under standardized and humane conditions. In addition to housing/husbandry, some animal users breed their animals in captivity as a source of animals for their protocol uses.

When animals are held or bred for protocol purposes, the conditions under which they are held/bred are subject to IACUC review. It is sometimes difficult to include these husbandry/breeding details within the context of an IACUC research or teaching protocol submission. For this reason, the IACUC is making available to our users the option of using a husbandry and/or breeding Standard Operating Procedure (SOP) document in which to describe these details.

The purpose of an SOP document is to allow a user to describe the characteristics of animal husbandry and/or breeding, outside of an animal use protocol. SOP documents can then simply be cited within a regular IACUC protocol as a way to document animal housing and husbandry. SOP documents do not require annual review, but can remain on file until changes are required (either by the investigator, or by the IACUC in response to regulation changes). Another advantage is that multiple investigators may collaborate on a single SOP document if their husbandry practices are uniform.

The USDA endorses the use of SOP documents as a way to ensure that animal husbandry/breeding methods are known to the IACUC. The IUP IACUC has developed and tested an SOP document template, which users may modify and use to describe their animal husbandry practices in a manner that best suits them. This template is available on the IACUC website under Forms.

There is no requirement that any user employ an SOP document for their husbandry practices. There is, however, a USDA requirement that animal husbandry be documented in some form, be it within an SOP document, or within a regular IACUC protocol. As such, the IACUC will begin to expect that husbandry details be provided in some manner for animals held in captivity.

2) Protocol post-approval monitoring (PAM)

In response to USDA suggestion, the IUP IACUC has been testing a post-approval monitoring (PAM) program. The goal of PAM is to ensure that animal uses are consistent with approved protocols, and to provide a mechanism by which the IACUC and animal users may communicate directly over animal use practices. PAM is considered to be a tool within an overall compliance framework, a "best practice" to help the university meet its regulatory and ethical requirements.

Ideally, all approved protocols will be subject to PAM. In practice, PAM will focus upon protocols which utilize methods involving higher levels of animal pain or distress. Our goal is to perform PAM at least once during a protocol's possible three years of continued approval.

PAM visits will be arranged with investigators in advance and investigators will have access to all of the PAM documents, to ensure that an open dialog regarding animal use expectations and actual practices will be possible.

For more information on PAM, please examine the PAM guidelines and inspection checklist available on the IACUC website under Forms.

3) Protocol form and pain category updates

We've recently overhauled our primary protocol form, with an eye toward reducing redundancy and streamlining its use. Recent updates also include the addition of questions addressing the conservation status of the animal species involved, as well as details of animal housing/breeding.

When you first use the newly-revised protocol form, you will see that our animal use pain categories (historically, "a," "b," and "c") have been renamed to match those used by the USDA ("c," "d," and "e"). This change was necessary to reduce confusion associated with our annual reporting to the USDA of our animal uses.

As always, when submitting a protocol, be sure to download a copy of the most recent version of the protocol submission form from theIACUC website under Forms.

4) Animal user contact information template

Our IACUC is now being served by a new veterinarian. In order to allow our IACUC veterinarian quick access to animal user contact information, we have developed a contact information template form that can be posted on the exterior door of animal housing areas. Please use this form to identify the primary and secondary contacts for your housed animals, in case there is a need for emergency communication from the veterinarian or other University personnel. You can find this template on theIACUC website under Forms.

As always, the IACUC is here to serve our IUP research community. Please do not hesitate to contact us with any questions or concerns.