Policies, Guidelines and Standard Operating Procedures

PHS Assurance

The Animal Welfare Assurance to (the United States) Public Health Service A4076, also commonly called the “PHS Assurance” or just “Assurance”, is a document describing the CMU Program for animal care and use and how it complies with PHS Policy. At CMU the Assurance document is the equivalent of a University Policy from which the Institutional Official (IO). Institutional Animal Care and Use Committee (IACUC), and The Attending Veterinarian (AV) derive their respective responsibility and authority over the care and use of animals by agents of the University (including faculty, staff, students and contractors).


Policies

A policy is a high level “guiding principle” that defines high level management instructions on how an organization is to be run and is generally driven by legal concerns (e.g. laws and regulations and the due diligence needed to show compliance with laws and regulations). Policies may also reflect the organizations goals, objectives and culture and are intended to be broad.

For example, an institution may have a policy that addresses what types of projects must be submitted by employees to an oversight committee (establishing that committees authority and responsibility), the policy is intended to be a very high-level, non-specific document that says “we will comply with the relevant laws and regulations by doing this”. How a policy will be carried out operationally is typically addressed by accompanying guidelines or standard operating procedures. At CMU, IACUC Policies define how we will comply with applicable regulations regarding animal use, including Public Health Service (PHS) Policy (including the Guide for the Care and Use of Laboratory Animals), and The Animal Welfare Act and Regulations (USDA).


The following policies apply to the inclusion of animal subjects in research:


Guidelines

Guidelines are generally more specific than policies and are intended to offer instructions regarding best practices or acceptable practices for complying with policies, laws or regulations. IACUC Guidelines carry the same weight as a policy and are intended as documents that should be followed unless sufficient justification is provided for departures in an approved animal use protocol.

For example, an institution may have a guideline that addresses acceptable use of non-pharmaceutical grade compounds and acceptable dose ranges that comply with AVMA guidelines, in this case AVMA Guidelines, being a document recognized in federal Regulation, have the weight of policy or regulation and an institution may have its own guidelines on acceptable ways to meet the standards outlined within the AVMA Guidelines.



Standard Operating Procedure

A Standard Operating procedure (SOP) is a written procedure prescribed for repetitive use as a practice, in accordance with agreed upon specifications aimed at obtaining a desired outcome.

For the IACUC at CMU, SOPs are the most specific of the three types of management/oversight document. An SOP describes, in some detail, specific procedures to be carried out that are in compliance with a policy and/or guideline. SOPs may vary greatly so long as they comply with all relevant laws, regulations, policies and guidelines. Justification for departures from SOPs generally does not need to be provided so long as the PI describes an alternative to the SOP in their protocol. IACUC approved SOPs may be referenced in an IACUC protocol to avoid writing out the entire procedure



Guidance

Guidance documents are similar to SOPs in that they provide details or specific procedures that can be followed to comply with a policy, guideline or regulation. Documents labeled "sample" or "example" are suggestions that meet regulatory requirements but can be altered to meet facility or laboratory specific needs.


Other Useful Links and Documents (non CMU)


Updated 4/17/2019

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