June 11, 2021

Statement on enhancing rigor, transparency, and translatability in animal research

The ability to reproduce biomedical research findings is foundational to the advancement of science and relies on rigorously designed and performed research studies. When a scientific finding can be reproduced by multiple scientists, it validates the accuracy of the data and ensures the study is ready to progress to the next phase of research. NIH has takenÌýnumerous stepsÌýover the past several years to improve the rigor, transparency, and reproducibility of the research we support to ensure that our stewardship of NIH resources is held to the highest standards. This is especially important for clinical trials in humans, but also applies to biomedical research involving animal models, which often serves as the foundation for human clinical trials. Believing that research using animal models required additional attention,Ìýin September 2019, I created a newÌýÌýof myÌýÌý(ACD). I charged the working group with theÌýcomplex and multipronged task ofÌýassessing and submittingÌýrecommendations to the ACD on enhancingÌýthe rigor, transparency, and translatability of animal research by improving experimental design, optimizing translational validity, enhancing training, and increasing the transparency of research studies involving animal models. Additionally, the working group was asked to consider the impact their recommendations would have on the larger biomedical research ecosystem.ÌýToday, the ACD presented me with aÌý. I want to thank the ACD, and particularly the ACD working group which worked tirelessly over the past year and a half to develop this robust set of findings. By their endorsement today, the ACD has provided a clear roadmap for NIH to enhance rigor and transparency in animal research. Given the complexity of these recommendations andÌýtheir potential impact on theÌýlarger biomedical research ecosystem, my leadership team and I will take these recommendations under advisement to determine the best path forward.

Francis S. Collins, M.D., Ph.D.
Director, ľ¹ÏÖ±²¥