Resource to Evaluate Rigor and Transparency as required by NIH

Rigor and Transparency in Research: To support the highest quality science, public accountability, and social responsibility in the conduct of science, NIH's Rigor and Transparency efforts are intended to clarify expectation and highlight attention to four areas that may need more explicit attention by applicants and reviewers:

  • Scientific premise
  • Scientific rigor
  • Consideration of relevant biological variables, such as sex
  • Authentication of key biological and/or chemical resources

For more information and guidance, click here.

Rigor and Reproducibility in grant applications (OER site)

NIH presentation of background and goals of Rigor and Transparency (Video)

Reviewer Guidance on Rigor and Transparency

Consideration of Sex as a Biological Variable in NIH-funded Research

Questions about the NIH policy should be directed to: 

Understanding NIH Grants and Funding Opportunities

Historical NIH Appropriations and Salary Cap Summary

Definition of Vertebrate Animal Research

The NIH defines animals in research as follows. Any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes. The generation of custom antibodies and animals obtained or euthanized for tissue harvest constitute activities involving vertebrate animals.

Visit the online training module for tips and guidance on completing the Vertebrate Animals Section in NIH grant applications.

Definition of Human Subjects Research

According to 45 CFR 46 , a human subject is "a living individual about whom an investigator is conducting research including the following:

  • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."

NIH: Decision Tool: Am I Doing Human Subjects Research? 

This NIH questionnaire is a tool to assist you with determining whether your project involves non-exempt human subjects research, meets the criteria for exempt human subjects research, or does not involve human subjects research. 

NIH: Human Subjects Research Infographic

This resource summarizes the definition of human subjects research and provides examples of human subjects research projects. It also describes what you will need when you are preparing your NIH application and what is required if you are funded.

NIH: Exempt Human Subjects Research Infographic

This resource is a guide to simplify the understanding of the exemptions from the federal regulations for the protection of human subjects research. It summarizes Exemptions 1, 2, 3, 4, 5, 6, 7 and 8, providing basic definitions, examples of studies that meet and do not meet the criteria of the exemption, and aspects one must consider when engaged in exempt or non-exempt human subjects research. 

NIH: Research Involving Private Information or Biospecimens Flowchart

Studies involving the use of human specimens or data may or may not be considered to be research involving human subjects, depending on the details of the materials to be used. Use this flowchart to help determine if studies involving private information or biospecimens may meet the definition of human subjects research.

NIH: Basic Experimental Studies with Humans and Special Awards

These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research.  See: Guidance for Determining if a Study Falls Within a BESH FOA 

NIH: Decision Tool: Your Human Subjects study may meet the NIH definition of a clinical trial.

Research Forrest