Clinical trials are commonly used during the development of drugs studied for approval by FDA for the use in animals.  Similar use in veterinary medicine has been increasing, but there are a number of interesting issues not considered in human clinical trials, where the individual involved in such trials is able to provide consent for inclusion in the trial.  Clearly, the animals that may be subject to such studies, cannot provide specific consent—their owner would have to do so on their behalf.  Those advocating for a change in status of animals as “property” to “persons” would be expected to object to such clinical trials, even if they benefit animals and people and help save their lives.

This issue was critically analyzed by veterinarians analyzing whether clinical veterinary studies must be reviewed by institutional animal care and use committees pursuant the Animal Welfare Act; the Office of Laboratory Animal Welfare for those studies funded by NIH; and/or reviewed and approved by a Veterinary Clinical Studies Committee established by a research entity, in a JAVMA published study, “Institutional animal care and use committee review of clinical studies.”

The study found

Determining whether activities conducted under the auspices of a clinical study are regulated by the USDA or OLAW, and thus require IACUC oversight, is not always a clear and simple issue. Institutions should develop their own guidance on how the IACUC oversees-or does not oversee-clinical trials.

Whether and to the extent certain clinical trials required review and approval by the IACUC pursuant to the Animal Welfare Act and/or OLAW requirements was dependent on whether the studying entities purchased the animals involved in the clinical trial and whether the proposed procedures would be required for the animal’s care, or were additional procedures only required for the purposes of the clinical trial.

The article presents 6 examples to help determine when USDA or OLAW oversight would be required.

Clearly, clinical trials, as utilized in human medicine, provide critical data related to the final approval of drugs and medical devices that will help prevent, diagnose and/or treat animals affected with life-altering diseases and conditions.

On September 22, 2017, the New Jersey Association for Biomedical Research (NJABR) offered its 24th Annual IACUC Conference,  – “the region’s premier training conference for Institutional Animal Care and Use Committee members, lab animal veterinarians, animal welfare compliance specialists and lab animal research team members.”

As described, the conference focused “focus on opportunities to improve laboratory animal welfare, while reducing regulatory burdens, cutting red tape and creating efficiencies within institutions.”  Toward that end, presenters from NIH and USDA (Patricia Brown, VMD, MS, Director, NIH, OLAW and William S. Stokes, ACLAM, DACAW, BCES, FATS, Assistant Director, Animal Welfare Operations, USDA, APHIS, respectively) requested recommendations from the attendees to reduce unnecessary or redundant regulatory burdens to researchers.

Following morning presentations, discussed further below, the conference included the following workshop selections that attendees could attend:

AAALAC Perspectives on Occupational Health & Safety Programs

Presenter: Richard B. Huneke, DVM, Council Member Emeritus

Animal Care & Use Committee Scenarios: You Make the Call

Presenter: Pam Straeter, RLATG, Asst. Director, Research Integrity and Assurance, Princeton University

Legal Update: USDA, Animals and the Law                               

Presenter: Nancy Halpern, DVM, Esq., Attorney, Fox Rothschild

New IACUC Member – Double Session   

Presenter: Amy Salem, PhD, Associate Director of Operations and Training for Animal Welfare, Merck

Ask the Regulators                                                                    

Presenters:

Patricia Brown, VMD, MS, Director, Office of Laboratory Animal Welfare

Tonya Hadjis, DVM, Supervisory Animal Care Specialist, Northeast Area, USDA, APHIS, Animal Care

John F. Lopinto, DVM, Veterinary Medical Officer, USDA, APHIS, Animal Care

Ashley C. McIntosh, DVM, Veterinary Medical Officer, USDA, APHIS

Animal Reproducibility & Relatability of Animal Research to Human Research

Panelists:

Damir Hamamdzic, DVM, PhD, Research and Regulatory Affairs, Post-Approval Monitoring Compliance Administrator, Rutgers University

Sarah E. Robertson, PhD, Director, Sponsored Projects and Research, University of the Sciences

Laszlo Szabo, Esq., Director, Research and Regulatory Affairs, Rutgers University

Andrew Gow, Ph.D., Professor and IACUC Chair, Rutgers University

Elizabeth Dodemaide, BVSc, MA, MANZCVS, Director Comparative Medicine Resources, Rutgers University

Gregory Reinhard, DVM, Director, Animal Welfare, University of Pennsylvania

Strategies to Enhance Animal Welfare Compliance Monitoring

Presenters:

Pharmaceutical: Lisa Stanislawczyk, Bristol-Myers Squibb, CRO: Mary Ann Jacobs, Envigo

Academic: Greg Reinhard, MBA, DVM, University of Pennsylvania, The Role of the Statistician in Study Design, IACUC Protocol Preparation Data Analysis

Presenter: Alfred Barron, Associate Director, Nonclinical Statistics/TMEDS, Janssen Research & Development

The keynote speaker, Jim Welch, Executive Director of the Elizabeth R. Griffin Research Foundation, presented a phenomenal motivational talk about “the importance of safe work practices, biosecurity, and collaboration among organizations and institutions seeking to advance scientific discovery.”  It does not sound like a topic that would lend itself to a motivational talk, anyone looking for a keynote should consider Jim.

Overall, it was another great conference.