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Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

This Notice is a Request for Information (RFI) inviting comments and suggestions on enhancing scientific rigor in biomedical research involving animal models.

It is important to read this entire RFI notice to ensure an adequate response is prepared and to have a full understanding of how your response will be utilized.

Background

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. The NIH seeks comments on any or all, but not limited to, the following topics:

Rigor and Transparency

• The challenges of rigor and transparency in animal research and actions NIH can take to improve the quality of animal research including rigor and transparency.
• How preregistration, the process of specifying the research plan in advance of the study and submitting it to a registry, would impact animal research including improving the quality of scientific research.
• While preregistration is often considered in the context of hypothesis-testing and confirmatory experiments, would it be useful at other stages of the research process, such as the exploratory and hypothesis generating.
• How to address the complexity and expense related to use of large animals, including nonhuman primates, that may provide biologically more relevant models.
• How NIH can partner with the academic community, professional societies, and the private sector to enhance animal research quality though scientific rigor and transparency.

Optimizing the Relevance to Human Biology and Disease

• Actions NIH can take to facilitate the translatability of animal research to human biology and disease.
• How to encourage researchers to select or develop animal models with high utility and design experiments that have external validity to the clinical populations.
• How NIH can partner with the academic community, professional societies, and the private sector to enhance animal research translatability.

Research Culture

• How research culture drives the choice of animal models.
• How incentives/disincentives in the research enterprise influence research using animals
• How all researchers, including trainees, are educated in rigorous research design, statistical considerations, transparent research practices, and the role of NIH in this training.

How to Submit a Response

All comments must be submitted electronically on the submission website: https://grants.nih.gov/grants/rfi/rfi.cfm?ID=108.

Responses must be received by 11:59:59 pm (ET) on August 21, 2020. You will see an electronic confirmation acknowledging receipt of your response.

Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in responses. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information.

We look forward to your input and hope that you will share this RFI document with your colleagues.

Inquiries

Please direct all inquiries to: [email protected]