Day One Project: Re-envisioning Reporting of Scientific Methods

“The information contained in the methods section of the overwhelming majority of research publications is insufficient to definitively evaluate research practices, let alone reproduce the work. Publication—and subsequent reuse—of detailed scientific methodologies can save researchers time and money, and can accelerate the pace of research overall. However, there is no existing mechanism for collective action to improve reporting of scientific methods. The Biden-Harris Administration should direct research-funding agencies to support development of new standards for reporting scientific methods. These standards would (1) address ongoing challenges in scientific reproducibility, and (2) benefit our nation’s scientific enterprise by improving research quality, reliability, and efficiency. …

Common standards are already proving invaluable for the recognition and reuse of open data. The same principles could be applied to open methods….

Compliance could be achieved through a combination of “push” incentives from publishers and “pull” incentives from funders. As is already happening for open-data standards, federal agencies can require researchers to adhere to open-methods standards in order to receive federal funding, and scientific journals can require researchers to adhere to open-methods standards in order to be eligible for publication….”  

Opinion | Joe Biden Made a Promise to Scientists. He Can Still Keep It. – The New York Times

“Researchers who receive federal help consistently fail to report their results to the public. The government should hold them accountable….

Researchers using federal funds to conduct cancer trials — experiments involving drugs or medical devices that rely on volunteer subjects — were sometimes taking more than a year to report their results to the N.I.H., as required. “If you don’t report, the law says you shouldn’t get any funding,” he said, citing an investigation I had published in Stat with my colleague Talia Bronshtein. “Doc, I’m going to find out if it’s true, and if it’s true, I’m going to cut funding. That’s a promise.”

It was true then. It’s true now. More than 150 trials completed since 2017 by the N.I.H’s National Cancer Institute, which leads the $1.8 billion Moonshot effort, should have reported results by now. About two-thirds reported after their deadlines or not at all, according to a University of Oxford website that tracks clinical trials regulated by the Food and Drug Administration and National Institutes of Health. Some trial results are nearly two years overdue. Over all, government-sponsored scientists have complied less than half the time for trial results due since 2018. (A spokeswoman for the N.I.H. said, “We are willing to do all measures to ensure compliance with ClinicalTrials.gov results reporting.”)…

In 2016, Dr. Francis Collins, the director of the National Institutes of Health, announced that the agency would begin penalizing researchers for failing to comply with its reporting requirements. “We are serious about this,” he said at the time. Yet in the years since, neither the F.D.A. nor N.I.H. has enforced the law. …”

Trump EPA’s Fast Track for ‘Secret Science’ Rule Nixed (1)

“The Trump administration’s EPA broke the law when it finalized a “science transparency” rule and made it effective immediately, a federal court ruled Wednesday in a decision that could help the Biden administration scrap the rule.

The U.S. District Court for the District of Montana said the Environmental Protection Agency failed to justify its decision to make the controversial rule take effect right after its publication in the Federal Register, instead of after 30 days, as is typical….”

Court rules against fast-track of Trump EPA’s ‘secret science’ rule | TheHill

“A federal judge in Montana late Wednesday ruled against the Trump administration’s attempt to fast-track a controversial rule about how the Environmental Protection Agency (EPA) considers scientific evidence, endangering its future under the Biden administration. 

The Trump EPA had characterized the rule, which would restrict the use of studies that don’t make their underlying data publicly available, as procedural, allowing it to go into effect immediately.

Judge Brian Morris, an Obama appointee, disagreed, determining that the rule was substantive and ordering that it can’t go into effect until Feb. 5.

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Delaying the rule could jeopardize it, as it would now be subject to a new White House memo that freezes pending regulations for 60 days….”

Elsevier Chairman Y.S. Chi’s letter to President-elect Joe Biden

“Congratulations on your election as the 46th President of the United States. We also extend our enthusiastic congratulations to Senator Kamala Harris on her historic election as our next Vice President.

My congratulatory letter is also a letter of our commitment to act with open and transparent evidence-based solutions to help your administration to meet the challenges and opportunities of our time….

For example, in January 2020, Elsevier launched a Coronavirus Info Center that made all relevant journal articles, clinical insights and data analytics freely available; and shortly afterwards, added a series of freely accessible resource hubs for healthcare workers and researchers, including a global Healthcare Hub; a Research Hub; and a Mental Health Hub. We are also partnering with OSTP, NIH, and the WHO to support COVID-19 research solutions. And lastly, we launched Elsevier’s The Lancet COVID-19 Commission—an interdisciplinary initiative led by Jeff Sachs, alongside leaders in health sciences, business, finance, and policy—focused on helping to speed up equitable and lasting solutions to the pandemic….”