Examples
Worked examples
- Is an instance
An NIH R01 application addressing sex as a biological variable and providing an authentication plan for the cell lines used.
- Is an instance
A progress report attesting to mid-grant compliance with the authentication plan.
Counter-examples
Looks similar, but isn't
- Not an instance
An NSF Data Management Plan (different policy).
- Not an instance
A journal reporting standard.
Editorial commentary
The NIH Rigor and Reproducibility policy is the set of US National Institutes of Health policies, effective from 2016, requiring applicants and grantees to address scientific premise, scientific rigour, biological variables (including sex as a biological variable), and authentication of key biological and chemical resources in grant applications. Unlike the other terms in this cluster, it is a funder compliance requirement, not a type or measure of reproducibility itself — it is the policy mechanism NIH uses to make applicants demonstrate attention to the reproducibility problems those other terms describe.
What it requires, concretely
NIH SF424 application instructions require four specific elements across most institutes and centers: a stated scientific premise (the strength of prior data the proposal builds on, and any known weaknesses); a plan for scientific rigour (adequate sample size, appropriate controls, blinding, and statistical approach); explicit consideration of relevant biological variables, most notably sex as a biological variable in vertebrate animal and human studies unless a strong justification for single-sex study is given; and a plan for authentication of key biological and/or chemical resources (cell lines, antibodies, and other reagents whose identity or purity can drift or be mislabelled). These are now built into standard review criteria at the application stage and are followed up in progress reporting, not just requested once.
Why it exists
The policy was NIH’s direct response to a body of preclinical-reproducibility literature — most prominently Begley & Ellis (2012), which reported that Amgen scientists could not replicate the majority of a sample of “landmark” preclinical cancer studies they attempted to build on, and Freedman et al. (2015), which estimated the cumulative cost of irreproducible preclinical research in the US. The policy targets the empirical and methodological weaknesses (underpowered studies, unblinded scoring, unauthenticated cell lines) that literature identified as recurring causes, rather than mandating any specific reproducibility check on the resulting publication.
Sources
NIH Notice NOT-OD-15-103, “Enhancing Reproducibility through Rigor and Transparency”; Begley & Ellis, Nature (2012); Freedman et al., PLOS Biology (2015).
Also known as
NIH R&R policy · NIH Rigor policy
Machine-readable encodings
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