Frequently Asked Questions

IACUC FAQs

• Why does UTMB have a PAM program?
  This program was instituted at UTMB to fulfill the obligation of the Institutional Animal Care and Use Committee (IACUC) to perform post approval monitoring of animal protocols for regulatory agencies, United States Department of Agriculture (USDA) and the Office of Laboratory Animal Welfare (OLAW). The PAM program will also assess the Animal Resource Center (ARC) husbandry practices.
  
  In addition, the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) recommended increased monitoring of animal use activities and improvements in personnel training. Since 99 of the top 100 NIH-funded institutions are accredited by AAALAC, UTMB took note. UTMB must demonstrate to regulatory agencies, sponsors, legislative bodies and the public that its animal research program has sufficient oversight and integrity. The PAM program is designed to provide these assurances.
• Why is the program important to my lab?
  When scientific research involves animals, reliable results depend on proper and consistent animal care. Animal protocols are approved with the principles of humane care and use of animals in mind. These principles are promulgated by regulatory bodies, and compliance is mandatory.
• How does the PAM program protect my research?
  The PAM program wants to correct protocol issues internally so that regulatory agency inspectors are less likely to find problems. Should PAM find that animals are harmed due to major deviation from protocol, IACUC or ARC may suspend that lab’s animal work until the practice is corrected. This is one of the responsibilities of IACUC and ARC, as mandated by federal regulations. If a regulatory agency identifies the non-compliant situation, it may revoke research privileges for the entire campus. It is better for IACUC to suspend research in a single non-compliant lab than for a regulatory body to stop research in the entire institution due to the disregard for compliance in a single lab. IACUC suspensions of lab work are infrequent occurrences and the result of egregious non-compliance.
• What are UTMB's obligations to regulatory bodies?
  UTMB’s Institutional Official must sign an Animal Welfare Assurance Statement for OLAW, promising that UTMB will conduct animal research in accordance with federal policy, the Guide for the Care and Use of Laboratory Animals and other applicable regulations. In addition, UTMB must send a yearly record of its acquisition and disposal of animals by December 1st to the USDA. The USDA conducts unannounced inspections of animal care facilities and has the authority to stop research if it determines that investigators do not treat animals in accordance with the law. The records of USDA inspections are available to the public.
• What are UTMB's obligations to regulatory bodies?
  UTMB’s Institutional Official must sign an Animal Welfare Assurance Statement for OLAW, promising that UTMB will conduct animal research in accordance with federal policy, the Guide for the Care and Use of Laboratory Animals and other applicable regulations. In addition, UTMB must send a yearly record of its acquisition and disposal of animals by December 1st to the USDA. The USDA conducts unannounced inspections of animal care facilities and has the authority to stop research if it determines that investigators do not treat animals in accordance with the law. The records of USDA inspections are available to the public.
• Why do we need AAALAC certification?
  Many private funding sources strongly recommend that grantees receiving support have animal programs with AAALAC accreditation. The NIH, NSF, NASA, DOD, and VA consider AAALAC accreditation a commitment to excellence. More than 980 institutions in 44 countries have earned AAALAC accreditation, thus it is an international symbol of quality. AAALAC accreditation requires that we demonstrate not only that we meet the minimum standards required by law, but also that we take extra steps to achieve excellence in animal care and use and thus, promote scientific validity.
• What are the goals of the PAM program?
  The primary goals of the PAM program are to ensure animal well being and to maintain regulatory compliance. Concomitant with this, PAM will facilitate the science by serving as a resource to the research community. PAM personnel are positioned to convey IACUC policies on matters of animal care and to identify education and training needs of laboratory staff. Ultimately, the PAM program will confirm that the manner in which the IACUC understood and approved an animal protocol is consistent with the way its procedures are being performed.
• How will PAM achieve these goals?
  Post Approval Monitors, known as Protocol Advisors & Liaisons (PALs), are consultants for the IACUC and are conduits between laboratory staff and the IACUC. The PALs are unbiased observers and do not have independent enforcement authority. The PALs will observe protocol related activity, prepare reports on their observations, and recommend steps for maintaining compliance, including referrals to campus and online training programs. Laboratory staff discussions with liaisons are a valuable part of the process.
• In which UTMB department do the PAM program, IACUC and ARC reside?
  All three entities are part of the UTMB Department of Research Services but are in separate divisions. The PAM program is part of the Monitoring & Quality Assurance section of the Research Administration division of Research Services. IACUC is part of the Research Subject Protection division of Research Services. ARC is a third division of Research Services. PALs act as consultants to IACUC and ARC.
• Who will interact with the PALs?
  The PALs will communicate with the PIs and their lab staffs, animal technicians, veterinary staff, IACUC members, and the Research Services’ Quality Assurance and Research Education groups.
• Who will be selected for assessment?
  All active protocols are assessed on a regularly scheduled basis, but may also selected by request of IACUC or by the Monitoring and Quality Assurance office of Research Services. Studies classified as pain category E, studies using socially sensitive species such as dogs, cats, rabbits and non-human primates, and groups that have had past compliance issues, will be assessed more frequently.
• Does the Principal Investigator need to be present for the entire process?
  Initial contact from the PAM program will be with the PI; however other laboratory staff members can work with the PALs during laboratory observations.
• What happens when my lab is selected?
  The PI listed on the protocol will be initially contacted with information regarding the PAM visit. The PI can designate a lab member to manage the visits which consist of a short protocol discussion, observation(s) of the protocol procedures and a debriefing meeting. The protocol discussion and debriefing meetings will be scheduled at a convenient time for the laboratory. Observations will take place during the normal course of the laboratory’s protocol work.
• What will be observed?

  Observations will include, but are not limited to, determining whether:

  • procedures being performed are in accordance with IACUC approved protocols;
  • the personnel performing these procedures are listed on the protocol;
  • anesthetics, analgesics, antibiotics and other medications are being used in accordance with the protocol;
  • survival surgery is aseptic;
  • euthanasia procedures and the method for ensuring death are protocol compliant;
  • training records for laboratory personnel are complete;
  • drug use is documented and animal medical records are kept;
  • all substances and sterile supplies used are within expiration dates.
• What if the nature of my experiment changes after protocol approval?
  We realize that procedures may drift from the original protocol, since the creative and investigational actions are part of research. If the procedure has become unintentionally discordant from the original protocol, the procedure must either return to the original protocol or be postponed until a protocol amendment has been approved by IACUC.
• Why do the PALs ask so many questions?
  Questions do not mean that things are wrong or there is a problem. PALs simply are working to collect as much information as possible. They want to understand all aspects of the protocol and how things are done. This allows them to be advocates for the researchers.
• Will this replace the IACUC semiannual lab visits?
  No. The PAM program does not replace the IACUC’s semi-annual lab visit and facility review, but its visits may be considered a “dress rehearsal” for the IACUC assessments. PALs would like to resolve any non-compliance issues before the IACUC reviews or regulatory agency inspections.