Scott Burris and Abraham Gutman on ‘The Week in Health Law’ Podcast

By Nicolas Terry

Special guest host Wendy Mariner from Boston University and I welcome Scott Burris and Abraham Gutman from Temple University’s Center for Public Health Law Research. We discuss the failures associated with the Fair Housing Act, including the delayed implementation of the Affirmatively Furthering Fair Housing rule, the eviction epidemic highlighted in Matthew Desmond’s book Evicted: Poverty and Profit in the American City, the tragedy of the silos in public health interventions, and the application of the concept of “health in all policies” to the housing crisis. Read More

Introducing Blogger Nicholas Diamond

Nicholas J. Diamond, J.D., LL.M., M.B.E. is joining Bill of Health as a regular contributor.

Nick is an advisor and educator, focused on the intersection of public health, policy, and ethics. He works at an advisory firm in Washington, DC, where he helps biopharmaceutical companies, health insurers, and advocacy organizations better understand and respond to changes in the healthcare landscape. He also teaches part-time at Georgetown Law and George Washington, and holds (non-teaching) academic affiliations at the Perelman School of Medicine at the University of Pennsylvania. Read More

Introducing Blogger Tara Sklar

The Petrie-Flom Center is pleased to welcome Tara Sklar to Bill of Health as our newest contributor!

Tara is a Professor of Health Law and Director of the Graduate Health Sciences Programs at the University of Arizona James E. Rogers College of Law. She also holds an appointment as a Health Law Fellow in the Law and Public Health Group at the University of Melbourne, School of Population and Global Health. Prior to this she was the Founding Director of Aging Programs at the University of Melbourne, and in 2016 was awarded University of Melbourne’s Teaching Excellence in Innovation Award. She has particular interests in laws and regulations that impact population well-being, with a focus on older adults. Read More

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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Patient Safety, Health Quality and Learning Disability

By John Tingle

Tragic stories of mental health care failings leading to injury and in some cases death have featured strongly in the English media in recent years. The reports reveal common threads such as poor resources, inadequate staffing levels, limited service availability, poor inter-agency cooperation, poor patient engagement, poor understanding of the Mental Capacity Act 2005 and so on. This care area seems to largely remain a Cinderella health care service provision, existing in the shadows, with the focus being predominantly on physical acute care. There are however now welcome and firm Government commitments to drive improvement into mental health care supported by a raft of promising initiatives.

When patient stories of learning disability and autism care failings are read from several reference sources a picture emerges. Care for people with learning disability and autism can be seen to share many of the patient safety and health quality problems that beset patients who are classified as being mentally ill: Read More