Bill of Health Blog Symposium: Research Integrity and Trustworthy Science: Challenges & Solutions

We are pleased to host this symposium featuring commentary from participants in the University of Minnesota’s Consortium on Law and Values in Health, Environment & the Life Sciences event, “Research Integrity and Trustworthy Science: Challenges and Solutions.”  Below, Susan M. Wolf tees up the issues.  All posts in the series will be available here.

By Susan M. Wolf, JD (Chair, Consortium on Law and Values in Health, Environment & the Life Sciences; McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; Professor of Medicine, University of Minnesota)

Trustworthy science is crucial to progress in scientific understanding, patient care, and product development. Yet threats to the integrity of science and to public confidence loom large. Researcher misconduct, inadequate education of new researchers, concerns over the reproducibility and rigor of scientific research, predatory journals that fail to perform thorough peer review, and oversight lapses all constitute significant threats to sound science and public trust.

A 2017 report from the National Academies on Fostering Integrity in Research carefully analyzed “detrimental research practices.” The report called for significant changes in the policies and practices of journals, research institutions, and researchers. Among the proposals was creation of a Research Integrity Advisory Board (RIAB) as an independent nonprofit. Further recommendations called for changes to allow researchers to reproduce results, including archiving datasets and code.

In March 2018, the University of Minnesota responded to the emerging research challenges and solutions by sponsoring a conference on “Research Integrity and Trustworthy Science: Challenges and Solutions.” We invited leading analysts to address the challenges for researchers, journals, and research institutions. In this blog symposium, plenary speakers from the conference examine three foundational elements of credible research:

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Challenges for Investigators—Generating Reproducible Research Results

This post is part of a series on emerging research challenges and solutions. The introduction to the series is available here, and all posts in the series are available here.

By John P.A. Ioannidis, MD, DSc, C.F. Rehnborg Chair in Disease Prevention, Professor of Medicine, of Health Research and Policy, of Biomedical Data Science, and of Statistics, and Co-Director, Meta-Research Innovation Center at Stanford (METRICS), Stanford University

Generating reproducible research results is not an easy task. As discussions about a reproducibility crisis become more common and occasionally heated, investigators may feel intimidated or even threatened, caught in the middle of the reproducibility wars. Some feel that the mounting pressure to deliver (both quantity and quality) may be threatening the joy of doing science and even the momentum to explore bold ideas. However, this is a gross misunderstanding. The effort to understand the shortcomings of reproducibility in our work and to find ways to improve our research standards is not some sort of externally imposed police auditing. It is a grassroots movement that stems from scientists themselves who want to improve their work, including its validity, relevance, and utility.

As it has been clarified before, reproducibility of results is just one of many aspects of reproducibility. It is difficult to deal with it in isolation, without also considering reproducibility of methods and reproducibility of inferences. Reproducibility of methods is usually impossible to assess, because unfortunately the triplet of software, script/code, and complete raw data is hardly ever available in a complete functional form. Lack of reproducibility of inferences leads to debates, even when the evidence seems strong and well-rounded. Reproducibility of results, when considered in the context of these other two reproducibility components, is unevenly pursued across disciplines. Some fields like genetic epidemiology have long understood the importance of routinely incorporating replication as a sine qua non in their efforts. Others still consider replication as second-class, “me too” research. Nevertheless, it can be shown (see Ioannidis, Behavioral and Brain Sciences, in press), that in most circumstances replication has at least the same value—and often more value—than original discovery. However, this leads to the question: how do we reward and incentivize investigators to follow a reproducible research path?

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Challenges for Journals—Encouraging Sound Science

This post is part of a series on emerging research challenges and solutions. The introduction to the series is available here, and all posts in the series are available here.

By Barbara A. Spellman, Professor of Law and Professor of Psychology, University of Virginia School of Law

Journals and scientists should be BFFs. But currently they are frenemies. Or, in adult-speak:

Journals play an important role in ensuring that the scientific enterprise is sound. Their most obvious function is to publish science—good science, science that has been peer-reviewed by experts and is of interest to a journal’s readership. But in fulfilling that mission, journals may provide incentives to scientists that undermine the quality of published science and distort the scientific record.

Journal policies certainly contributed to the replication crisis. As businesses, publishers (appropriately) want to make money; to do so they need people to buy, read, and cite their journals. To make that happen, editors seek articles that are novel, that confirm some new hypothesis, and that have clear results. Scientists know that editors want articles with these qualities. Accordingly, scientists may (knowingly or not) bias the scientific process to produce that type of result.

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Systems Matter: Research Environments and Institutional Integrity

This post is part of a series on emerging research challenges and solutions. The introduction to the series is available here, and all posts in the series are available here.

By CK Gunsalus, Director, National Center for Professional and Research Ethics (NCPRE), University of Illinois Urbana-Champaign

We know what it takes for institutions and scholars to produce high-quality, high-integrity research, and yet we do not always act upon that knowledge. As far back as 1988, Paul J. Friedman described both the roots of systemic shortcoming and approaches for conducting trustworthy research. Despite a clear understanding of the issues and steps that would improve our research and educational environments, the academy continues to be dogged by those same systemic issues. A recent National Academies of Sciences, Engineering and Medicine consensus study, Fostering Integrity in Research, in which I participated as a panel member, explores that same disconnect and makes recommendations. The bottom line is this: we must shift our attention and energy away from individual bad actors—though they exist and must be addressed—and toward the highly complex ecosystem within which research is conducted.

An update of an earlier appraisal published 1992, the 2017 NASEM report describes the transformation of research through advances in technology, globalization, increased interdisciplinarity, growing competition, and multiplying policy applications. It identifies six core values underlying research integrity—objectivity, openness, accountability, honesty, fairness and stewardship—and outlines best practices, including checklists, for all aspects of the research enterprise. I encourage you to read it and use these tools in your own work.

All the reports in the world won’t improve research integrity, however, if we don’t do the work in our institutions, departments, and research groups. There are many components to this effort, some of which are discussed in separate posts by my colleagues John P.A. Ioannidis and Barbara A. Spellman elsewhere in this symposium. Let’s focus here on institutional infrastructure.

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Dystopian Memes on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

It’s a stormy healthcare landscape out there, so this show is all lightning round. We cover several areas:

Litigation: Nic provides the Ariadne’s thread through a labyrinthine pharma-tort judgment out of California. The metal on metal hip litigation has resulted in a big judgment, but medical device regulation is still fundamentally broken. Disgruntled Centene enrollees are suing the ACA insurer of last resort for ultra-narrow networks (and Washington state is not happy, either). Washington may lead the way for future narrow network regulation or consent decrees. We followed up on the duodenoscope superbug litigation saga, focusing on duties to translate foreign language emails in discovery.

Regulation: We discussed a crisis in long-term care, following up on last week’s discussion with Paul Osterman. Medicare is not making it any easier for many who qualify for help. We reviewed the new priorities of HHS’s Conscience Rights, er, Civil Rights Division (and potential responses to conscience claims). The rise of Medicaid work requirements is a hot topic, as Kentucky Governor Bevin imposed them last week. Read More

Bioethicist Art Caplan: A New Mind-Body Problem

A new piece by Bill of Health contributor Arthur Caplan, with Lisa Kearns, in The Hastings Center Bioethics Forum:

Not since Rene Descartes gazed from his garret window in early 17th-century Paris and wondered whether those were men or hats and coats covering “automatic machines” he saw roaming the streets has the issue of personal identity and your cranium been of such import. Descartes feared a world that he alone occupied due to deception by the devil. Today we face a different mind-body challenge in the form of a devil we know: Italian neuroscientist Sergio Canavero. He recently announced that the first human head transplant is imminent.

For bioethicists, the moral critiques of this surgery practically write themselves: Are we merely our bodies? How can a person so ill as to wish to trade in his lifelong corporeal companion be considered competent to consent to such a drastic procedure? How can family members consent to donate a body that they could very well run into — and recognize — at the beach or gym? What if a left-handed person received a right-handed body? What if a lifelong Chicago Bears fan woke to find himself attached to the green-and-gold-tattooed torso of a former Packers fan? Would transplant recipients need to buy whole new wardrobes? Who will pay? […]

Read the full article here!

Limited Seats Still Available, Register Now! 12/12: Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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2017’s Word Of The Year In Health Law And Bioethics: Uncertainty

This is the first post by Carmel Shachar and I. Glenn Cohen that appears on the Health Affairs Blog in a series stemming from the Sixth Annual Health Law Year in P/Review event to be held at Harvard Law School on Tuesday, December 12, 2017.

2017 was a year of tremendous uncertainty for many areas of public policy. Health care policy was no exception, most prominently with an almost successful push by Congressional Republicans to radically revise the Affordable Care Act (ACA). Medical research and bioethics also faced uncertainty, with the struggle to ethically engage with new technologies and to better understand the boundaries around self-determination. As we look over the past year and anticipate the coming one, the overarching question remains: Is it possible to run a health law and health care system given this level of flux?

Healthcare Policy in Flux

2017 saw a new presidential administration and Congress. Seeking to capitalize on the Republican control of the White House and both Houses of Congress, Congressional Republicans sought to make good on their campaign promise to “replace and repeal” the ACA. The proposed legislation would have dramatically reshaped our health care landscape, including ending Medicaid’s financial status as an entitlement program, and undercutting the health insurance Marketplaces championed by the Obama administration. Despite the fact that the ACA is not yet a decade old, this would have been a seismic shift in the way many Americans receive their health care. […]

Read the full post here.

We will be discussing these issues and more at the Sixth Annual Health Law Year in P/Review conference, held on December 12, 2017, at Harvard Law School in Cambridge, MA. If you find these issues interesting, we invite you to join us as the event is free and open to the public (registered required). For those unable to join us in Cambridge, some of our conference presenters will participate in a blog series to follow  at the Health Affairs Blog. Stay tuned!

REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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