Complying With the National Institutes of Health Guidelines and Principles for Rigor and Reproducibility: Refutations.

Abstract

In 2014, the National Institutes of Health (NIH) delivered a document that described the principles and guidelines for reporting preclinical research (https://www.nih.gov/research-training/rigor-reproducibility/principles-guidelines-reporting-preclinical-research). These principles and guidelines were developed in a workshop that addressed the concern of reproducibility of preclinical research and were built on previous NIH recommendations for transparency in reporting data.1 A major driving force behind this effort stemmed from concerns voiced by the pharmaceutical industry that described their failure to replicate studies performed in academic laboratories2,3 These issues have also attracted attention through commentaries in both scientific journals4 and the lay press.5 As guardians of a large investment of public funds, the NIH aspires to promote confidence in science through enhanced reporting of protocols and data in journals, focusing in particular on reproducibility of results of similar experiments performed in different laboratories. A wide spectrum of scientific leaders, including many journal editors, attended the meeting at which this document was developed. The consequent report emphasized the need for journals to modify their editorial processes in several respects. These included requirement that authors document a detailed description of statistical analyses and data reporting with the aim of increasing transparency, sharing of data and materials, and establishing best practices for reagent verification. An additional requirement was for journals to establish a standard mechanism for the reporting …