Making data broadly accessible is essential to creating a medical information commons. Transparency about data-sharing practices can cultivate trust among prospective and existing MIC participants. We present an analysis of 34 initiatives sharing DNA-derived data based on public information. We describe data-sharing practices captured, including practices related to consent, privacy and security, data access, oversight, and participant engagement. Our results reveal that data-sharing initiatives have some distance to go in achieving transparency.

Advances in technologies and biomedical informatics have expanded capacity to generate and share biomedical data. With a lens on genomic data, we present a typology characterizing the data-sharing landscape in biomedical research to advance understanding of the key stakeholders and existing data-sharing practices. The typology highlights the diversity of data-sharing efforts and facilitators and reveals how novel data-sharing efforts are challenging existing norms regarding the role of individuals whom the data describe.

Whether, and to what degree, do patents granted on human genes cast a shadow of uncertainty over genomics and its applications? Will owners of patents on individual genes or clusters of genes sue those performing whole-genome analyses on human samples for patent infringement? These are related questions that have haunted molecular diagnostics companies and services, coloring scientific, clinical, and business decisions. Can the profusion of whole-genome analysis methods proceed without fear of patent infringement liability?Whole-genome sequencing is proceeding apace. Academic centers (...) have been performing whole-genome and -exome sequencing in research for at least five years, and academic clinical laboratories with national reach have been doing sequencing for clinical applications for almost as long. Companies have also been offering WGS and WES as a clinical service for a few years now. So far as we know, no one has been sued for infringement of “gene patents” for performing WGS. (shrink)

Edwin Southern developed a blotting technique for DNA in 1973, thereby creating a staple of molecular biology laboratory procedures still used after several decades. It became a seminal technology for studying the structure of DNA. The story of the creation and dissemination of this technology, which was not patented and was freely distributed throughout the scientific community, stands as a case study in open science. The Southern blot was developed at a time when attitudes about commercial intrusion into health research (...) were beginning to change and the practical value of molecular genetics was becoming apparent to industry. Interest from industry in fundamental molecular biological techniques meant that scientists began to think about commercial uses of their work even in otherwise "basic" research. The unpatented Southern blot is contrasted with later patented technologies, particularly microarray methods, which were created in the same environment by many of the same people, but which followed significant changes to UK policies encouraging commercialization of academic research and a norm shift friendlier to such commercialization within academic molecular biology. Professor Southern's personal experience illuminates how the technologies evolved, and his views provide insight into how scientists' attitudes about commercialization have changed. (shrink)

Hastings Center Report, Volume 51, Issue 5, Page 3-3, September‐October 2021.

LeRoy Walters was a central figure in debates about federal policy regarding genetics and biotechnology—a neutral, publicly engaged philosopher and religious studies academic who put his skills to work in national service. His career spanned the emergence of biotechnology as a field in the 1970s until his retirement. His interests reached from moral philosophical theory to Holocaust studies to practical concerns about public policy in genetics. We focus here on the role of bioethics in policy related to the advent of (...) human gene transfer, the Human Genome Project, and the emergence of biotechnology as a commercial enterprise. We focus on his role as an academic influencing the government strand of the “triple helix”... (shrink)

In the forty‐year history of U.S. bioethics commissions, these government‐sanctioned forums have often demonstrated their power to address pressing problems and to enable policy change. For example, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, established in 1974, left a legacy of reports that were translated into regulations and had an enormous practical impact. And the 1982 report Splicing Life, by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and (...) Behavioral Research, became the basis for the National Institutes of Health's Recombinant DNA Advisory Committee as well as for the Food and Drug Administration's developing “Points to Consider” when contemplating the introduction of recombinant DNA into human beings. Some efforts of bioethics commissions, however, are not tightly connected to policy change or to outcomes directly linked to a specific report. While direct policy impact is indeed a useful metric for government bioethics commissions, it is not their only legitimate utility. For instance, bioethics commissions can also be incubators for deliberation on a hot topic, giving policy‐makers time to think through options while the political heat has some time to dissipate. Or a bioethics commission may stake out a position that enables a politician to take action while not necessarily following its recommendations. (shrink)

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...) range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons. We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes.

The Bermuda Principles for DNA sequence data sharing are an enduring legacy of the Human Genome Project. They were adopted by the HGP at a strategy meeting in Bermuda in February of 1996 and implemented in formal policies by early 1998, mandating daily release of HGP-funded DNA sequences into the public domain. The idea of daily sharing, we argue, emanated directly from strategies for large, goal-directed molecular biology projects first tested within the “community” of C. elegans researchers, and were introduced (...) and defended for the HGP by the nematode biologists John Sulston and Robert Waterston. In the C. elegans community, and subsequently in the HGP, daily sharing served the pragmatic goals of quality control and project coordination. Yet in the HGP human genome, we also argue, the Bermuda Principles addressed concerns about gene patents impeding scientific advancement, and were aspirational and flexible in implementation and justification. They endured as an archetype for how rapid data sharing could be realized and rationalized, and permitted adaptation to the needs of various scientific communities. Yet in addition to the support of Sulston and Waterston, their adoption also depended on the clout of administrators at the US National Institutes of Health and the UK nonprofit charity the Wellcome Trust, which together funded 90% of the HGP human sequencing effort. The other nations wishing to remain in the HGP consortium had to accommodate to the Bermuda Principles, requiring exceptions from incompatible existing or pending data access policies for publicly funded research in Germany, Japan, and France. We begin this story in 1963, with the biologist Sydney Brenner’s proposal for a nematode research program at the Laboratory of Molecular Biology at the University of Cambridge. We continue through 2003, with the completion of the HGP human reference genome, and conclude with observations about policy and the historiography of molecular biology. (shrink)

A medical information commons is a networked data environment utilized for research and clinical applications. At three deliberations across the U.S., we engaged 75 adults in two-day facilitated discussions on the ethical and social issues inherent to sharing data with an MIC. Deliberants made recommendations regarding opt-in consent, transparent data policies, public representation on MIC governing boards, and strict data security and privacy protection. Community engagement is critical to earning the public's trust.

A 2011 National Academies of Sciences report called for an “Information Commons” and a “Knowledge Network” to revolutionize biomedical research and clinical care. We interviewed 41 expert stakeholders to examine governance, access, data collection, and privacy in the context of a medical information commons. Stakeholders' attitudes about MICs align with the NAS vision of an Information Commons; however, differences of opinion regarding clinical use and access warrant further research to explore policy and technological solutions.

Accessing BRCA1/2 data facilitates the detection of disease-associated variants, which is critical to informing clinical management of risks. BRCA1/2 data sharing is complex and many practices exist. We describe current BRCA1/2 data-sharing practices, in the United States and globally, and discuss obstacles and incentives to sharing, based on 28 interviews with personnel at U.S. and non-U.S. clinical laboratories and databases. Our examination of the BRCA1/2 data-sharing landscape demonstrates strong support for and robust sharing of BRCA1/2 data around the world, increasing (...) global accesses to diverse data sets. (shrink)

Understanding the clinical significance of variants associated with hereditary cancer risk requires access to a pooled data resource or network of resources—a “cancer gene variant commons”—incorporating representative, well-characterized genetic data, metadata, and, for some purposes, pathways to case-level data. Several initiatives have invested significant resources into collecting and sharing cancer gene variant data, but further progress hinges on identifying and addressing unresolved policy issues. This commentary provides insights from a modified policy Delphi process involving experts from a range of stakeholder (...) groups involved in the data-sharing ecosystem. In particular, we describe policy issues and options generated by Delphi participants in five domains critical to the development of an effective cancer gene variant commons: incentives, financial sustainability, privacy and security, equity, and data quality. Our intention is to stimulate wider discussion and lay a foundation for further work evaluating policy options more in-depth and mapping them to those who have the power to bring about change. Addressing issues in these five domains will contribute to a cancer gene variant commons that supports better care for at-risk and affected patients, empowers patient communities, and advances research on hereditary cancers. (shrink)

Early last year, the GenEthics Consortium (GEC) of the Washington Metropolitan Area convened at George Washington University to consider a complex case about genetic testing for Alzheimer disease (AD). The GEC consists of scientists, bioethicists, lawyers, genetic counselors, and consumers from a variety of institutions and affiliations. Four of the 8 co-authors of this paper delivered presentations on the case. Supplemented by additional ethical and legal observations, these presentations form the basis for the following discussion.

This article deals with Alain Badiou’s practical and theoretical engagements with the SONACOTRA rent strike, which ran from 1975 to 1979 and mobilized tens of thousands of immigrant workers across France. Drawing on the work Histoire politique du mouvement des foyers Sonacotra, a retrospective study written collectively by members of Badiou’s Maoist group L’Union des communistes de France marxistes-léninistes, we demonstrate how the practical stakes of the movement were taken up in philosophical form in the contemporaneous text Theory of the (...) Subject. Finally, we suggest that this interweaving of practice and theory is an exemplary instance of Badiou’s conception of politics as the immanent construction of a universal—a conception that links Badiou’s Maoist engagements with his current philosophical and political commitments, from Being and Event to Logics of Worlds. (shrink)

Background: The use of race as a category in medical research is the focus of an intense debate, complicated by the inconsistency of presumed independent variables, race and ethnicity, on which analysis depends. Interpretation is made difficult by inconsistent methods for determining the race or ethnicity of a participant. The failure to specify how race or ethnicity was determined is common in the published literature.Hypothesis: Criteria by which they assign a research participant to racial or ethnic categories are not reported (...) by published articles.Methods: Methods were reviewed for assigning race and ethnicity of research participants in 268 published reports reporting associations among race , health outcome and genotype.Results: Of the 268 published reports reviewed, it was found that 192 did not explain their methods for assigning race or ethnicity as an independent variable. This was despite the fact that 180 of those reports reached conclusions about associations among genetics, health outcome and race or ethnicity.Conclusions: More attention needs to be given to the definition of race and ethnicity in genetic studies, especially in those diseases where health disparities are known to exist. (shrink)

This paper is designed to do three things. First, it discusses some of the key trends in business ethics in the academic and corporate communities. Initiatives like the Arthur Andersen Business Ethics Program are noted. Secondly, the paper examines certain basic misconceptions about the field and concludes that the adage that good ethics is good business is still true. Finally, the paper highlights fourteen business attitudes or practices that may put a firm at ethical risk. For example, the paper discusses (...) the risk of using ethics as simply a public relations initiative.Man's life is not a state of unalloyed happiness. The earth is no paradise. Although this is not the fault of social institutions, people are wont to hold them responsible for it. The foundation of any and every civilization, including our own, is private ownership of the means of production. Whoever wishes to criticize modern civilization, therefore, begins with private property. It is blamed for everything that does not please the critic, especially those evils that have their origin in the fact that private property has been hampered and restrained in various respects so that its full social potentialities cannot be realized.1. (shrink)

As the interest in the quality of work life grows, it becomes increasingly apparent that certain practices within this arena require critical scrutiny. This paper is an examination of one such area, performance appraisal (PA). We examine some of the main conceptual issues in PA, and we sketch some key, practical dilemmas that may arise in the use of PA. We conclude that one can morally justify the use of PA under certain condition, and we suggest possible solutions to key (...) ethical dilemmas that are faced by the manager and the employee. (shrink)

During the last decade, the intensity of interest in the subject of business ethics has surprised even the most ardent defenders of the movement. It is easy to become euphoric over such developments. Yet, we should not be lulled into believing that such growth has no limits. The fact is that the movement stands at a watershed where certain alternative courses of action are available. In this paper, I outline what some of those crossroads are and what the consequences will (...) be if certain actions are or are not taken. The key to success is dependent upon a multidisciplinary approach that relies on dialogue and cooperation among colleagues in the academy and in business. This will ensure a true mix of theory and practice. (shrink)

The solution structures of several small proteins have recently been determined from high‐resolution nuclear magnetic resonance data. The principal features of the methods available to do this are outlined here, together with the advantages, limitations and future prospects of the technique.