Washington Update

NIH Working Group Presents Final Recommendations on Animal Research

By: Naomi Charalambakis
Thursday, June 17, 2021

On June 11, the Working Group on Enhancing Rigor, Transparency, and Translatability in Animal Research presented its final report and recommendations to the National Institutes of Health (NIH) Advisory Committee to the Director (ACD). For the past two years, the Working Group has worked to develop recommendations to strengthen rigor, reproducibility, and transparency of animal studies through improved experimental design, enhanced training, and streamlined data reporting. Additional details about the report are included in the Working Group’s ACD presentation, and recommendations now move forward for consideration by the NIH Director.

The Working Group’s final report is organized into five themes:

  • Theme 1: Improve Study Design and Data Analysis
  • Theme 2: Address Incomplete Reporting and Questionable Research Practices
  • Theme 3: Improve Selection, Design, and Relevance of Animal Models
  • Theme 4: Improve Methodological Documentation and Results Reporting
  • Theme 5: Measure the Costs and Effectiveness of Efforts to Improve Rigor, Transparency, Reproducibility, and Translatability

Several recommendations aligned with FASEB’s previously proposed actions on the topic, including the 2016 report, Enhancing Research Reproducibility. For example, while established reporting checklists are effective tools to improve vague methodology reporting, such guidelines are commonly incorporated only at the end of a study when researchers plan to publish results. To enhance experimental design and scientific rigor at the outset, the Working Group recommended NIH add an additional page to the Research Strategy section of grant applications for investigators to specifically address research elements such as sample size estimation, blinding, and randomization, echoing FASEB’s previous comments to include a dedicated section on research rigor in NIH grants.

Regarding strategies to enhance translatability of animal studies, the Working Group emphasized the importance of large animal models such as nonhuman primates. Specifically, the Working Group recommended NIH implement policies that accommodate the budget, time, and space constraints associated with large animal research, including animal colony maintenance and retention of relevant veterinary expertise. This recommendation is consistent with President Biden’s recently released budget request, which seeks $30 million to support a 27 percent infrastructure expansion of the National Primate Research Centers. Furthermore, the Working Group suggested NIH educate the public on the value of animal research, and actively express its support for large animal research, highlighting its translational relevance to human physiology.

To strengthen animal research transparency, the Working Group provided recommendations about preregistration of animal studies, a method that requires researchers to describe and submit their study methodologies prior to data collection. Although this approach could improve data quality by preventing selective reporting and other forms of biases, the Working Group reiterated concerns raised by FASEB, including increased administrative burden and delayed completion of research. Given these concerns, the Working Group proposed NIH launch an education program to raise awareness about preregistration and explain the possible benefits for animal research reproducibility, particularly for late-stage preclinical animals prior to clinical trials. The Working Group also advised NIH to implement a pilot program in parallel with the education campaign to generate and evaluate data about the impact of preregistration on experimental design and reproducibility.