Request for Information (RFI): Enhancing Rigor, Transparency, and Translatability to Improve Biomedical Research Involving Animal Models
This is a time-sensitive Request for Information (RFI) inviting comments and suggestions on enhancing scientific rigor in biomedical research involving animal models. Comments must be submitted electronically in the comment boxes below and are due by August 21, 2020.
NOTE: It is important to read the entire RFI notice (NOT-OD-20-130) to ensure an adequate response is prepared and to have a full understanding of how your response will be acknowledged and utilized.
Scientific rigor is the strict application of the scientific method to ensure unbiased and well-controlled experimental design, methodology, analysis, interpretation and reporting of results. In conducting biomedical research this is key to the successful application of knowledge towards improving health outcomes. NIH has taken several steps in recent years, including establishment of an ACD working group in response to the 21st Century Cures Act, to improve the scientific rigor of the research it supports. In this way NIH upholds the highest standards of scientific integrity, public accountability, and social responsibility in the conduct of science. As highlighted at a 2014 National Academies workshop, biomedical research involving animal models continues to face issues regarding scientific rigor, including selection of poorly validated animal models for the human disease under study, as well as additional problems with suboptimal study design, misapplication of statistical analyses and lack of transparency.
In 2016 the NIH’s Office of Portfolio Analysis and Office of Extramural Research/Office of Research Information Systems examined trends in research using animals. Research using rodents and other model organisms account for a significant portion of the NIH research portfolio, creating a substantial opportunity cost. However, some models poorly represent the corresponding human disease or are not used in a rigorous manner. It is therefore critical that the agency focus on ways to ensure the value, rigor, and transparency of animal studies, while considering the impact on the overall funding landscape, especially those studies designed to translate to human biology, to ensure the best use of NIH resources.
Information Requested/Request for Comment
This RFI solicits input from stakeholders throughout the scientific research, advocacy, and professional societies, as well as the general public, regarding the above proposed research plan. The NIH seeks comments on any or all, but not limited to the following themes: (1) Rigor and Transparency; (2) Optimizing the relevance of animal model research to human biology and disease; (3) and the effects of research culture on research involving animal models.
The focus areas listed above are not exhaustive, and suggested additions are welcome.
NIH invites input from stakeholders throughout the scientific research, advocacy, and clinical practice communities, as well as the general public on the above proposed research plan. Your input is a valuable component in developing the ACD Working groups recommendations, and your time and consideration are appreciated.
Comment fields are limited to 500 words each. NIH encourages organizations (e.g., patient advocacy groups, professional organizations) to submit a single response reflective of the views of the organization/membership as a whole when possible. We look forward to your input and hope you will share this RFI with your colleagues.
See Guide Notice NOT-OD-20-130 for more information.
To ensure consideration, responses must be submitted by: August 21, 2020 11:59:59 PM EDT
( * = Required fields)