University of-Alabama-Birmingham-AAALAC-Complaint-8-12-21

Kathryn A Bayne, M.S., Ph.D., D.V.M AAALAC International Chief Executive Officer 5205 Chairman’s Court, Suite 300 Frederick, MD 21730 Via email: accredit@aaalac.org 8/12/21 CEO Bayne, I am writing to you today because multiple serious issues of non-compliance within the animal laboratories of the University of Alabama, Birmingham (UAB), have been documented in correspondence/reports obtained by SAEN These situations demonstrate excessively faulty science, contempt for federal regulations, and contempt for the lives and well-being of animals A 3/2/21 USDA/APHIS/AC inspection issued a CRITICAL citation against UAB for violating 2.31(e) (4) Institutional Animal Care and Use Committee (IACUC) This citation followed a federal complaint filed by SAEN in January of 2021 (see: https://saenonline.org/University-of-Alabama-BirminghamFederal-complaint-1-12-21.html ) relevant to a cigarette smoke experiment on ferrets which resulted in several deaths (see attached USDA report) SAEN has filed a second federal complaint with the USDA against UAB based on an internal whistleblower report regarding:
 “*Inadequate restraint of animals for minor experimental and/or diagnostic procedures *Recording specific values in animal records, without performing the corresponding necessary measurements, e.g., pulse rate, blood pressure, weight, fluid input/output *Recording inaccurate time of drug administration in animal records.” Evidently the UAB Institutional Animal Care & Use Committee (IACUC) considered these issues to be very serious because the IACUC suspended animal use privileges for the offending staff: “For 1year, all UAB animal use privileges revoked for the two staff/faculty involved.” These incidents clearly involve violations of federal regulations under the Animal Welfare Act, as well as the Guide for the Care and use of Laboratory Animals However, since these incidents involve falsification of research documents, and recording of inaccurate information, we have also filed a federal complaint with the Office of Research Integrity, which is available here: https://saenonline.org/news-media-news-2021/University-of-Alabama-Birmingham,President-Letter-and-Office-of-Research-Integrity-Complaint.html 1081-B State Route 28 #280 Milford, OH 45150 513-575-5517 www.SAENonline.org This is NOT the first time that UAB has dealt with the Office of Research Integrity (ORI) (see attached Case Summary) In fact, ORI previously issued a finding of Research Misconduct against a UAB researcher relevant to falsifying/fabricating the data in to the information contained in ten publications and five grant applications UAB has a history of Research Misconduct However, these are by no means the only serious animal experimentation problems which have occurred at UAB UAB correspondence dated 7/5/19 discloses that 100 animals did not receive adequate pain relief following a surgical procedure (see attached report) Similarly, UAB correspondence dated 6/17/19 discloses the suspension of an experimental project because over 200 animals were denied protocol required pain relief (see attached report) It is also worth noting that the University of Alabama, Birmingham previously retracted a journal involving primate experimentation (see attached PubMed screenshot) Collectively these incidents demonstrate a USDA finding of a CRITICAL violation of the Animal Welfare Act, an Office of Research Integrity finding of Research Misconduct which included falsification of research multiple research publications and grants in connection to a federal finding of Research misconduct, an additional article retraction, an incident of falsification of research documentation, multiple failures to provide pain relief to hundreds of animals, involving the suspension of one protocol, and multiple failure to follow multiple research protocols Collectively these incidents demonstrate widespread programmatic misconduct and non-compliance issues within the University of Alabama, Birmingham Therefore, to effectively address these issues, I am calling upon the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) to launch an immediate investigation of the University of Alabama animal care program CEO Bayne, what Principal Investigator doesn’t understand the importance of accurately recording experimental measurements (or actually performing those measurements)? What lab staff doesn’t understand the necessity of following a protocol and providing approved pain relief? How is it that UAB lab staff think they are not required to follow research protocols that have been approved by the UAB Institutional Animal Care & Use Committee, keep records? None of this should even be possible in a program of research that is even remotely scientific or that meets even basic animal care standards The fact that all of the incidents have occurred in UAB facilities within the last several years is an indictment of the UAB system and clearly demonstrates that UAB lab staff is quite simply out of control Sincerely, ! Michael A Budkie, A.H.T., Co-Founder, SAEN Attachments: USDA Inspection report, ORI Case summary, UAB OLAW reports, Article Retraction ! ! ! ! ! ! ! ! ! ! ! ! ... were denied protocol required pain relief (see attached report) It is also worth noting that the University of Alabama, Birmingham previously retracted a journal involving primate experimentation... these incidents demonstrate widespread programmatic misconduct and non-compliance issues within the University of Alabama, Birmingham Therefore, to effectively address these issues, I am calling upon... and Accreditation of Laboratory Animal Care (AAALAC) to launch an immediate investigation of the University of Alabama animal care program CEO Bayne, what Principal Investigator doesn’t understand