A white hospital hallway

The ‘Nazi Problem’ in Human Subject Research Regulation

As Holocaust Martyrs’ and Heroes’ Remembrance Day draws near, it is heartening to note that our collective horror against Nazis and Nazism is still sufficiently strong as to make them the archetype evil villains in movies, TV, and dystopian literature. The evil doctor conducting fiendish experiments lives on in fiction because we recall the all-too-real horrific acts of torture conducted by Nazi physicians against children held captive and killed in the millions.

(Here are the Personal Statements of people who survived to tell their stories.)

Yet, as important as it is to never forget these crimes, we should resist the temptation of letting these memories lead us to a false story about the origin of human subject research regulation in the United States. Read More

Zoom in of a dashboard focusing on the "App Store" widget

Nobody Reads the Terms and Conditions: A Digital Advanced Directive Might Be Our Solution

Could Facebook know your menstruation cycle?

In a recent Op-ed Piece, “You Just Clicked Yes. But, Do you Know Terms and Conditions of that Health App?,” I proposed that a mix of factors have given rise to the need to regulate web-based health services and apps. Since most of these applications do not fall under the Health Insurance Portability and Accountability Act (HIPAA), few people actually read through the Terms and Conditions, and also, the explosive growth of web-based health applications, the need for solutions is dire. Read More

Image of Normal blood cells next to a sickle blood cell, colored scanning electron microscope image.

Recharting the Course of Sickle Cell Disease – Who will Benefit?

By Vence L. Bonham and Anitra Persaud

Scientific advancements in gene therapy and the implications of leveraging this technology to develop new curative therapies are at the forefront of medical research. Sickle cell disease (SCD), the most common genetic blood disorder, stands center stage. Last month, 60 Minutes aired a segment showcasing the story of a patient at the NIH Clinical Center who is on her journey to a cure of sickle cell disease (SCD) with the help of an experimental gene therapy.

Preliminary clinical trial findings suggest that gene therapy has an acceptable level of safety and can help individuals with the disease produce normal red blood cells instead of the sickle-shaped ones that underlie the physiological basis of the disease and its complications. Given these promising results, there is hope that gene therapy may catalyze a turning point for the SCD population, a community that has long suffered the debilitating effects of not only their disease, but of longstanding neglect within the medical system and research enterprise. Read More

Image from the movie Groundhog Day where man is looking at a groundhog

Regulating Human Subject Research: Like Being an Unwilling Participant in a Very Nerdy Version of Groundhog Day

This is the first in a series of blog posts highlighting how I am developing an overview of some of the significant gaps in regulation of human subject research. I will be looking at the use of living human beings as participants in experiments conducted by academics to advance knowledge, as well as by biomedical companies to test new products.

My goal is two-fold: I hope to develop the first Nutshell in Human Subject Regulation as a valuable handbook for those studying and working in this field. In addition, I hope to bring together two issues that are often separate: providing greater protection to people who participate in research as subjects, and increasing the quality of the information generated. Read More

Healthcare professional walking down a hospital hallway

An Urgent Need to Improve Mental Health Care in the National Health Service

Mental Health Care in the National Health Service in England has always existed in the shadow of physical care in terms of funding and NHS-government health policy priorities.

Many in the past have termed it the “Cinderella” part of the NHS. This neglect has been chronicled in numerous reports over the years pointing to many problems which include chronic under funding, poor patient safety, abuses of patient rights, poor complaint handling, unnecessary restrictive care regimes, poor patient, health carer communication, and poor patient satisfaction. Read More

US servicemembers pictured from behind, saluting

“Homecoming” to a History of Servicemember Experimentation

Much ado has been made about Amazon’s new hit, “Homecoming,” which recently received three Golden Globe nominations, including one for best drama series. The psychological thriller, directed by “Mr. Robot” creator Sam Esmail and starring Julia Roberts, has been characterized as “an irresistible mystery-box drama” and “the good kind of ‘what the hell is going on here?’ TV.” Tim Goodman described the show, which was adopted from Eli Horowitz and Micah Bloomberg’s Gimlet Mediacult hit” podcast of the same moniker, as a “dazzling” play “on memory, the military industrial complex, conspiracy and unchecked government privilege.”

The series revolves around novice caseworker Heidi Bergman’s (Roberts) experiences administering the Tampa, Florida-based Homecoming Transitional Support Center (HTSC). HTSC is a privately-run, Department of Defense (DoD) contract facility, which purports to assist combat-traumatized servicemembers readjust from the battlefield and reintegrate to civilian life. Indeed, Bergman opens the drama’s aptly-titled pilot, “Mandatory,” by explaining to her “client,” three-tour-combat-veteran Walter Cruz (Stephan James), that the treatment facility is “a safe space for you to process your military experience and re-familiarize yourself with civilian life in a monitored environment, which, just means getting you situated now that you’re back home, rear-wise, health-wise, basically, I just work for you.” 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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