LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER NEW ORLEANS

Components of an Animal Welfare Program 1. Division of Animal Care AAALAC Accreditation 2. Occupational and Health Surveillance 3. Institutional Animal Care and Use Committee ( IACUC) OLAW Assurance

Why so many rules to do research?  It is the law and regulations. - Rules and Regulations Animal Welfare Act [7 USC ; 7 CFR.22,2.80,371.29(g)] “Guide for the Care and Use of Laboratory Animals” Public Health Service Policy on Humane Care and Use of Laboratory Animals - Regulatory agencies: U.S. Department of Agriculture Office of Laboratory Animal Welfare (OLAW) - Third Party Accreditation Association of Assessment and Accreditation of Laboratory Animal Care (AAALAC)

Why so many rules to do research?  Accept NIH, DoD and other federal/state funding.  Accept private and non-profit funding that require same compliance as NIH funding.  Institutional requirements to protect personnel and resources as well as the animals.  Personal and Institutional liabilities.  It is the right thing to do.

Survey on Con vs Pro Animal Research

Animal Activists benefit from their objections!

Institutional Animal Care and Use Committee (IACUC) Purpose To Protect the Welfare of Animals Used as Subjects in Research

How does the IACUC provide protection? By ensuring compliance with all federal, state and local laws and regulations governing the use of animals.  IACUC Policy and Procedure Guidelines  IACUC application – Review and approval by full committee  Annual reviews, amendments, personnel changes  Semi-annual Animal Care Facility Inspection  Includes investigators’ laboratory and any other area where live animals are taken.  Semi-Annual Program Review  Includes IACUC and institutional policies, education and occupation health surveillance  Review concerns and advise the Institutional Official  Suspend PHS-supported activities if necessary

IACUC Applications and Forms  IACUC application is required for the use or breeding of live vertebrate animals.  IACUC Tissue Form is required for animal tissue or materials that will be shared between approved IACUC protocols or for the use of animal tissue or materials that will be taken from an euthanized animal incidental to the original use of the animal.  IACUC Amendment must be submitted for approval PRIOR to initiating a change to the protocol. Use the Change in Personnel Form when adding personnel.  IACUC applications are approved annually for up to three years when a renewal application must be submitted to continue the project.  Change in Personnel Form to add or remove particiapants.

 Not following instructions  Not writing the abstract in lay terms  Not defining acronyms when first used  Inadequate alternative search  Inadequate justification for the number of animals requested  Not consulting with veterinarian on survival surgeries  Not utilizing veterinarian consult where pain or distress may occur. The most common errors

Institutional Biosafety Committee (IBC) Purpose  To protect individuals and research animals from potential dangers in the use of or exposure to such things as pathogens, organs or tissues of biological origin, genetic therapy products, transgenic genes, bacteria, viruses, prions and chemicals and toxins that may affect health.  To assure that the Institution is in compliance with all state and federal regulatory agency bio-safety requirements, e.g. rDNA research as described in the NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT DNA MOLECULES (NIH GUIDELINES)  To review projects for use of “Select Agents” under the Select Agents Program of DHHS and USDA and/or “Dual use items” under export control regulations of the Department of Commerce

IBC Applications  IBC Oversight is required for research with u Physical human contact u Physical animal contact u Use of biological materials, pathogens, toxins or rDNA  IBC Amendment must be submitted for approval PRIOR to initiating a change to the protocol. Use the Change in Personnel Form when adding personnel.  IBC applications are approved annually for up to five years when a renewal application must be submitted to continue the project.  Exemption from IBC Oversight if there is NO human or animal contact u Chart review or data collection u Survey or questionnaire by telephone, mail, web or in person but with NO PHYSICAL CONTACT  Special circumstances upon request  If exempted, no annuals or renewals.  If exemption status changes, a full IBC application must be submitted.

Implications of Noncompliance  Corrective actions & improved systems  Restrict/withdraw approval of Assurance  Special terms/conditions of awards  Cost disallowance  Suspension/termination of award  Disbarment  Criminal prosecution

Best way to navigate through the process  Follow the instructions and to correct address.  Always download forms from the websites for the latest version.  Answer each question completely or enter “N/A” where appropriate.  Submit applications by the last Monday of the month for the next committee meeting. ( IBC Meeting is the 2 nd Wednesday and the IACUC Meeting is the 3 rd Monday of the month)  Check that personnel completes all training for activities to be performed.  Need help with forms or have questions, call or me.  If you have animal care questions, the veterinarians and the animal care technicians and managers are also available to assist you.  Investigators can avoid problems by following all institutional, state and federal policies and regulations.  Reply by when you receive IACUC or IBC annual or expiration notices. A certain person will nag you until you do!