Summary of “NIH Workshop on Optimizing Reproducibility in Nonhuman Primate Research Studies by Enhancing Rigor and Transparency” Now Available

First, I want to take a moment to wish you all well as we collectively weather the unprecedented novel coronavirus pandemic. I hope all readers of this blog, and their loved ones and friends are staying safe and well. As you might imagine, COVID-19 response is occupying a great deal of the bandwidth of NIH right now, as we ensure the safety of our workforce and accelerate scientific solutions to the current crisis. However, even from remote workspaces and amidst the flurry of pandemic response, work to support the ongoing mission of the agency is continuing…

Today, NIH is posting a summary of a workshop held in February which brought together key stakeholders to explore the intersection of optimizing research rigor and research involving non-human primates (NHP). You may recall I blogged about this last fall, and I noted the continuity with other NIH efforts assessing the landscape of NHP research, as well as the agency’s ongoing initiative to enhance research reproducibility through improvements in rigor and transparency. In the interim, a neuroethics working group of the Advisory Committee to the NIH Director (ACD) produced a report in October 2019 “Enabling and Enhancing Neuroscience Advances for Society” which included ethical considerations for NHP research, particularly relative to emerging biotechnologies. Collectively, these presented a terrific backdrop to bring together experts in various scientific disciplines, primatologists, veterinarians, and bioethicists, including representatives from National Primate Research Centers, academic institutions, government, industry and non-profit groups for two days of in-depth discussion.

A number of common themes emerged, including:

• Ethical considerations should extend beyond legal and regulatory requirements.
• It is of critical importance to understand the course of human disease and to understand the strengths and limitations of the animal model proposed for use.
• Rigor and transparency necessitates data sharing yet there are challenges.
• Rigor, welfare, husbandry, environment, and behavior are all interrelated.
• Rigorous and reproducible science is part of a virtuous learning cycle.

However, this concise summary gives short shrift to the rich and thoughtful discussion of the unique opportunities and challenges shared by the NHP research community, and I encourage you to read the full report to get a better sense of the full breath of issues discussed. As one participant noted, even the lunchtime conversations represented exciting exchanges of ideas at the nexus of scientific and clinical opportunities, ethical considerations, ensuring rigor and transparency, and the nuances of animal welfare and husbandry. It highlighted how interdisciplinary engagement – from experts in primatology, statisticians, experimental design, clinicians, ethicists, data scientists, and basic biologists – can be incredibly useful to maximize the knowledge generated by working with these critically important animal models. In addition, it became very clear that lessons learned from NHP can more broadly benefit enhancing rigorous study design in all animal research and that data sharing is key for facilitating rigor and reproducibility.

While the discussion itself was important in fostering those connections, a natural question to ask is: what happens next? The proceedings of the workshop feed into the broader efforts of the ACD Working Group on Enhancing Reproducibility and Rigor in Animal Research (of which I am a member) in its deliberations. This group has been charged with assessing and making recommendations to enhance the reproducibility and rigor of animal research by improving experimental design, optimizing translational validity, enhancing training, and increasing the transparency of research studies involving animal models, and is expected to present an interim report to the ACD in June.