NIH policies on experimental studies with humans

Riley, William T.; Riddle, Melissa; Lauer, Michael S.

doi:10.1038/s41562-017-0265-4

Cited by 11 publications

(10 citation statements)

References 10 publications

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“…To the Editor -There is shared support from Riley et al 1 and Wolfe and Kanwisher 2 for the principles of increasing the transparency, rigour and reproducibility of science and "[fulfilling] an inherent commitment to study participants and the public" 1 . These principles are motivating the expansion of the National Institutes of Health (NIH) guidelines to include study registration and outcome reporting for basic science.…”

Section: Easy Preregistration Will Benefit Any Researchmentioning

confidence: 99%

Easy preregistration will benefit any research

Mellor

Nosek

2018

Nat Hum Behav

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Section: Easy Preregistration Will Benefit Any Researchmentioning

confidence: 99%

Easy preregistration will benefit any research

Mellor

Nosek

2018

Nat Hum Behav

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“…The Declaration of Helsinki notes that all researchers have an ethical obligation to disseminate research results [ 26 ]. Funders have highlighted the importance of ensuring that research outputs, including negative results, are published [ 7 , 27 , 28 ]. Funding agencies such as the National Institutes of Health in the United States allow researchers to cite preprints in grant applications [ 29 ].…”

Section: New Solutionsmentioning

confidence: 99%

fiddle: a tool to combat publication bias by getting research out of the file drawer and into the scientific community

et al. 2020

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Statistically significant findings are more likely to be published than non-significant or null findings, leaving scientists and healthcare personnel to make decisions based on distorted scientific evidence. Continuously expanding ´file drawers’ of unpublished data from well-designed experiments waste resources creates problems for researchers, the scientific community and the public. There is limited awareness of the negative impact that publication bias and selective reporting have on the scientific literature. Alternative publication formats have recently been introduced that make it easier to publish research that is difficult to publish in traditional peer reviewed journals. These include micropublications, data repositories, data journals, preprints, publishing platforms, and journals focusing on null or neutral results. While these alternative formats have the potential to reduce publication bias, many scientists are unaware that these formats exist and don’t know how to use them. Our open source file drawer data liberation effort (fiddle) tool (RRID:SCR_017327 available at: http://s-quest.bihealth.org/fiddle/) is a match-making Shiny app designed to help biomedical researchers to identify the most appropriate publication format for their data. Users can search for a publication format that meets their needs, compare and contrast different publication formats, and find links to publishing platforms. This tool will assist scientists in getting otherwise inaccessible, hidden data out of the file drawer into the scientific community and literature. We briefly highlight essential details that should be included to ensure reporting quality, which will allow others to use and benefit from research published in these new formats.

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“…In April 2017, the New England Journal of Medicine ( NEJM ) hosted a summit on ‘Aligning Incentives for Sharing Clinical Trial Data’, with the aim of providing a demonstration of the benefits of clinical trial data sharing. 1 In the months leading up to the summit, NEJM launched the Systolic Blood Pressure Intervention Trial (SPRINT) Data Analysis Challenge, which offered researchers access to the SPRINT clinical trial database in order to provide a real-world demonstration of the benefits of clinical trial data sharing. Investigators from around the world used the SPRINT data to produce novel research abstracts that were shared publicly.…”

Section: Introductionmentioning

confidence: 99%

“…SPRINT, a randomised clinical trial sponsored by the National Institutes of Health, compared a more intensive systolic blood pressure target (<120 mm Hg) with a standard target (<140 mm Hg) among non-diabetic patients aged 50 or older with hypertension and with known cardiovascular disease or known elevated risk for cardiovascular disease. 1 After observing significantly fewer cardiovascular events among patients allocated to the more intense treatment regimen, the Data Safety and Monitoring Board stopped the trial early, and the primary results were published in NEJM on 26 November 2015.…”

Section: Introductionmentioning

confidence: 99%

Accurate estimation of cardiovascular risk in a non-diabetic adult: detecting and correcting the error in the reported Framingham Risk Score for the Systolic Blood Pressure Intervention Trial population

et al. 2018

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ObjectivesTo understand the discrepancy between the published 10-year cardiovascular risk and 10-year cardiovascular risk generated from raw data using the Framingham Risk Score for participants in the Systolic Blood Pressure Intervention Trial (SPRINT).DesignSecondary analysis of SPRINT data published in The New England Journal of Medicine (NEJM) and made available to researchers in late 2016.SettingSPRINT clinical trial sites.ParticipantsStudy participants enrolled into SPRINT.ResultsThe number of SPRINT study participants identified as having ≥15% 10-year cardiovascular risk was not consistent with what was reported in the original publication. Using the data from the trial, the Framingham Risk Score indicated ≥15% 10-year cardiovascular risk for 7089 participants compared with 5737 reported in the paper, a change from 61% to 76% of the total study population.ConclusionsThe analysis of the clinical trial data by independent investigators identified an error in the reporting of the risk of the study population. The SPRINT trial enrolled a higher risk population than was reported in the initial publication, which was brought to light by data sharing.

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NIH policies on experimental studies with humans

Cited by 11 publications

References 10 publications

Easy preregistration will benefit any research

Easy preregistration will benefit any research

fiddle: a tool to combat publication bias by getting research out of the file drawer and into the scientific community

Accurate estimation of cardiovascular risk in a non-diabetic adult: detecting and correcting the error in the reported Framingham Risk Score for the Systolic Blood Pressure Intervention Trial population

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