Clinical researchers can now share initial versions of their manuscripts through a free preprint server modeled after websites where physicists and biologists post papers before they appear in a peer-reviewed journal. Today, its organizers announced that medRxiv is taking submissions and will begin to post papers later this month. Co-sponsored by Cold Spring Harbor Laboratory (CSHL) in New York, which created the bioRxiv preprint server in 2013, Yale University, and publisher The BMJ, the site aims to address concerns about posting draft papers on health science research involving human subjects by screening them carefully for select criteria and prominently labeling the papers as unreviewed.
Preprint advocates say they are a way to get findings out to the research community quickly and gather feedback before the work is published in a journal. Physicists have shared preprints online for decades, and many biologists have joined them since bioRxiv launched in 2013. But clinical researchers have been reluctant to embrace preprints, in part because of the harm that could result if doctors change clinical care or patients try treatments on their own based on findings that haven’t been vetted by peer reviewers.
But Yale cardiologist Harlan Krumholz, who first announced plans for medRxiv nearly 2 years ago, argues that clinical researchers already share their unreviewed findings at scientific meetings. With conference talks, he says, “There’s no opportunity to present the kind of detail” that appears in a paper.
All the same, medRxiv’s organizers will employ three “guardrails,” Krumholz says. First, authors will have to “declare,” or certify, that their preprints include ethics reviews, clinical trial registration, patient consent, funding sources, and conflict of interest information. Second, the papers will be screened for general legitimacy by volunteer researchers, known as “affiliates,” and a professional medical editor who—at least at first—will be the only person who can post the preprint. Finally, prominent labels will describe manuscripts as not yet peer reviewed and caution medical journalists to keep that in mind if they write about the paper.
MedRxiv’s organizers won’t check the declared information they’re requiring, for instance by asking for paperwork from the ethics review, says CSHL’s John Inglis, co-founder of bioRxiv. But if any ethics problems come to light, there will be a “withdraw process,” he says. Those screening submissions will also be on the lookout for sensitive papers with public health implications, such as findings questioning vaccine safety, or “dual use” research, such as studies on pathogens that could be used to cause harm. “We would almost certainly not post” a paper on those topics, Inglis says.
The site is now taking submissions and an initial batch of papers should debut publicly on 25 June. It is launching with seed money from CSHL, but may eventually seek support from foundations, Inglis says. (In 2017, bioRxiv received a grant for an undisclosed amount, from the Chan Zuckerberg Foundation, that now pays for two full-time staff members, he notes.) But fundraising will depend on how many manuscripts medRxiv attracts, he adds. “It may take off slowly.” One barrier is that some major medical journals, such as The New England Journal of Medicine and those published by the JAMA Network, caution that if a submitted paper has been shared as a preprint, that could influence whether the paper is accepted.
*Correction, 7 June, 3:55 p.m.: An earlier version of this story incorrectly stated that the JAMA Network and The New England Journal of Medicine (NEJM) do not allow authors to submit papers that have been shared as preprints. NEJM does not have a written policy on preprints, but a journal spokesperson wrote to ScienceInsider in an email: “NEJM does not object to the publication of an article on a preprint server prior to submission. As for all articles, the editors consider novelty when making manuscript decisions. If substantial publicity for a study occurs before or during the peer-review process, priority for publication could be affected.”