Last year, NIH was one of several federal agencies to join the White House Office of Science and Technology Policy in their celebration of 2023 as the Year of Open Science. Let’s break down this definition of open science.
The role of preprints — complete and public draft manuscripts which have not gone through the formal peer review, editing, or journal publishing process – continues to be a hot topic in the biological and medical sciences. In January, three major biomedical research funders – HHMI, the MRC, and the Wellcome Trust, changed their policies to allow preprints to be cited in their progress reports and applications.
Thinking about preprints also raises questions about the broader class of interim research products, and the role they should play in NIH processes. Other interim products include products like preregistration of protocols or research methods, to publicly declare key elements of a research project in advance. While, under current policy, NIH does not restrict items cited in the research plan of an application, applicants cannot claim preprints in biosketches or progress reports.
So, in October, we issued a call for comments to get a fuller understanding of how the NIH-supported research community uses and thinks about interim research products. Today I’d like to follow up with what we’ve learned from your input, and the policy changes this feedback suggests. ….
Many scientific disciplines, like physics and mathematics, routinely communicate research findings through preprints — manuscripts that have not yet gone through the formal peer review, editing, or journal publishing process. However, this is still a relatively novel concept in biology and clinical research. …. we at NIH are interested in feedback from you, to get a fuller understanding of the current use of preprints in the broader NIH-supported research community, accepted preprint standards, whether preprints should be included in NIH applications and reports, and how investigators could report them. …. Not only are we interested in your current use of preprints — and other interim research products — but perhaps most importantly we’d like your feedback on the specific standards that need to be in place for their citation, particularly for citation in NIH applications and reports ….
On September 11, 2015, the National Heart, Lung, and Blood Institute (NHLBI) announced that it was stopping its Systolic Pressure Intervention Trial (“SPRINT”). The Institute’s Data Safety and Monitoring Board (DSMB) had reviewed interim data and concluded that the results demonstrated clear benefit from aggressive blood pressure lowering. The trial enrolled over 9300 adults with systolic hypertension and increased cardiovascular risk and randomized them to standard control (aiming for a target systolic blood pressure of 140 mm Hg) or to aggressive control (aiming for a target blood pressure of 120 mm Hg). ….