I. IACUC Operations

PURPOSE

This SOP specifies activities that involve the use of vertebrate animals that require submission to and review of protocols to the Institutional Animal Care & Use Committee (IACUC).  The role of the IACUC is to facilitate all activities conducted by the College of Charleston involving animals and is intended to assist investigators in meeting their obligations to plan and conduct animal studies in accordance with scientific and human principles.

IACUC approval is required for all animal activity at the College of Charleston facilities and for all field studies conducted by College of Charleston investigators. Investigators shall submit their protocols to and receive approval from the IACUC before any animal activity begins.  Investigators, as defined below, who engage in activity at Ft. Johnson research facilities (Grice Marine Laboratory [GML], Department of Natural Resources ([DNR], National Oceanic & Atmospheric Administration [NOAA], National Institute of Standards & Technology [NST], Hollings Marine Laboratory [HML] and associated research vessels and facilities) must submit protocols and receive approval from the College of Charleston IACUC.

DEFINITIONS & REFERENCES

Activity- An element of research, testing, or teaching procedures that involves the care and/or use of animals.  IACUC approval must be obtained prior to any activity involving the use of animals.  Excluded under this definition are activities involving only observation that do not interfere or interact with the animals. For example, using feeders or providing animals with shelter would not be excluded.

ACUPRA- Animal Care & Use Program Research Application.

Animal- Any living non-human vertebrate animal used or intended for use in research, training, experimentation, testing, propagation, or related purpose, with the exception of embryos, tissue, and other biological samples.

• For embryos, the point in development at which oviparous, ovoviviparous and viviparous species become regulated animals is specified by the Animal Welfare Act (AWA) and the Office of Laboratory Animal Welfare (OLAW).  Viviparous and ovoviviparous species become regulated at parturition from the maternal animal.  Oviparous species become regulated when they hatch from the egg.  For fish, the College of Charleston has determined a similar stage in development as the “buttoned-up” stage (when the embryo has fully absorbed the yolk sac and must forage on its own).
• For tissues and other biological samples, only those that have been collected from a live animal by a College of Charleston investigator are regulated.

Animal Facility- Any building, room, area, enclosure, or vehicle, including field stations and associated structures, in which animals are housed for more than 12 hours, that is assigned for confinement, transportation, maintenance, breeding, or experiments inclusive of surgical manipulation.  This also includes similar areas assigned for animal food preparation and storage.  Animal areas containing free-living wild animals in their natural habitat are not included in this definition. 

Field Study- A study conducted on free-living animals in their natural habitat or outside of a designated animal facility. An application to the IACUC is required. 

Field Observation Study- Animal research that involves passive observation of animals without interfering with any aspect of their normal behavior. This term excludes any study that involves an invasive procedure, harms, or materially alters the behavior of an animal under study. No ACUPRA is required.

Investigator- Any faculty or staff member employed by or a student enrolled in the College of Charleston who is involved in any activity with animals.  External researchers involved in an activity with animals on the College of Charleston campus who agree to operate under the auspices of the College IACUC are also included in this definition but must operate under an approved protocol of a Principle Investigator.

Principle Investigator- Faculty or staff member employed by the College of Charleston who bears administrative responsibility for animal research and animal research protocol reporting.

Surgical Manipulation- Includes but is not limited to, penetration or exposure of a body cavity, placement of an indwelling catheter, and amputation or excision of tissues. Routine injections and blood sampling are not considered surgical manipulations. 

AREA OF APPLICABILITY

The SOP is meant to clarify the College of Charleston Policy in the Faculty Administration Manual on Care & Use of vertebrate animals in Research and Instruction. This Policy is applicable to all activity conducted at the College of Charleston, associated satellite facilities, and field stations that involves the use of animals.  The IACUC has adopted the NRC Guide as the operating procedure manual.  The IACUC has agreed to the principles of the Guide.  These principles cover all vertebrate animals. Departures from these guidelines will be permitted only when it is deemed by the IACUC to be in the animal’s best interest, and then only on a case by case basis. Individuals or organizations conducting animal activities supported by the College or utilizing animals supplied by the College must satisfy the IACUC that their animal care & use procedures are in compliance with the Guide.   

REFERENCES

Animal Welfare Act- Public Law 89-544, 1966 as amended, (P.L. 91-579, P.L. 94-279, and P.L. 99-188) 7 U.S.C. 2131 et. Seq.  Implementing regulations are in the Code of Federal Regulations (CFR), Title 9, Subchapter A, Parts 1,2,3, and 4. 

National Research Council (NRC) Guide for the Care and Use of Laboratory Animals, Eighth edition or succeeding editions.  Referred to as the NRC Guide in other documents. May be accessed here:  https://grants.nih.gov/grants/.../guide-for-the-care-and-use-of-laboratory-animals.pdf

CofC IACUC- October 24, 2000

Revisions: 12/12/2000; 4/16/2001; 9/11/2001; 10/9/2001; 5/12/2004; 8/2018