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.
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.
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.
Meaningful participant engagement has been identified as a key contributor to the success of efforts to share data via a “Medical Information Commons”. We present findings from expert stakeholder interviews aimed at understanding barriers to engagement and the appropriate role of MIC participants. Although most interviewees supported engagement, they distinguished between individual versus collective forms. They also noted challenges including representation and perceived inefficiency, prompting reflection on political aspects of engagement and efficiency concerns.
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.
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.
Background Citizen science is increasingly prevalent in the biomedical sciences, including the field of human genomics. Genomic citizen science initiatives present new opportunities to engage individuals in scientific discovery, but they also are provoking new questions regarding who owns the outputs of the research, including intangible ideas and discoveries and tangible writings, tools, technologies, and products. The legal and ethical claims of participants to research outputs become stronger—and also more likely to conflict with those of institution-based researchers and other stakeholders—as (...) participants become more involved, quantitatively and qualitatively, in the research process. It is not yet known, however, how genomic citizen science initiatives are managing the interests of their participants in accessing and controlling research outputs in practice. To help fill this gap, we conducted an in-depth review of relevant policies and practices of U.S.-based genomic citizen science initiatives. Methods We queried the peer-reviewed literature and grey literature to identify 22 genomic citizen science initiatives that satisfied six inclusion criteria. A data collection form was used to capture initiative features, policies, and practices relevant to participants’ access to and control over research outputs. Results This analysis revealed that the genomic citizen science landscape is diverse and includes many initiatives that do not have institutional affiliations. Two trends that are in apparent tension were identified: commercialization and operationalization of a philosophy of openness. While most initiatives supported participants’ access to research outputs, including datasets and published findings, none supported participants’ control over results via intellectual property, licensing, or commercialization rights. However, several initiatives disclaimed their own rights to profit from outputs. Conclusions There are opportunities for citizen science initiatives to incorporate more features that support participants’ access to and control over research outputs, consistent with their specific objectives, operations, and technical capabilities. (shrink)
As citizen science expands, questions arise regarding the applicability of norms and policies created in the context of conventional science. This article focuses on data sharing in the conduct of health-related citizen science, asking whether citizen scientists have obligations to share data and publish findings on par with the obligations of professional scientists. We conclude that there are good reasons for supporting citizen scientists in sharing data and publishing findings, and we applaud recent efforts to facilitate data sharing. At the (...) same time, we believe it is problematic to treat data sharing and publication as ethical requirements for citizen scientists, especially where there is the potential for burden and harm without compensating benefit. (shrink)
While valuable work has been done addressing clinical ethics within established healthcare systems, we anticipate that the projected growth in acquisitions of community hospitals and facilities by large tertiary hospitals will impact the field of clinical ethics and the day-to-day responsibilities of clinical ethicists in ways that have yet to be explored. Toward the goal of providing clinical ethicists guidance on a range of issues that they may encounter in the systematization process, we discuss key considerations and potential challenges in (...) implementing system-wide ethics consultation services. Specifically, we identify four models for organizing, developing, and enhancing ethics consultation activities within a system created through acquisitions: train-the-trainer, local capacity-building, circuit-riding, and consolidated accountability. We note each model’s benefits and challenges. To our knowledge, this is the first paper to consider the broader landscape of issues affected by consolidation. We anticipate that clinical ethicists, volunteer consultants, and hospital administrators will benefit from our recommendations. (shrink)
How should clinical ethicists be trained? Scholars have stated that clinical ethics fellowships create well-trained, competent ethicists. While this appears intuitive, few features of fellowship programs have been publicly discussed, let alone debated. In this paper, we examine how fellowships can foster effective mentoring relationships. These relationships provide the foundation for the fellow’s transition from novice to competent professional. In this essay, we begin by discussing our pedagogical commitments. Next, we describe the structures our program has created to assist our (...) fellows in becoming competent ethicists. We then outline the kinds of knowledge, skills, and professional attributes mentors should possess. Following this, we focus on the knowledge, skills, and professional attributes that fellows develop as they co-create effective mentoring relationships. We will not prescribe a single approach to fellowship training; instead, our perspective will, we hope, become a catalyst for further conversation on training and mentoring clinical ethics fellows. (shrink)
Few things seem more a part of the material world than biological specimens. Yet the processes by which collections of specimens are assembled, translated into information, combined with more information, and distributed are taking research repositories into the virtual realm.The term “virtual” has a number of meanings, and so a research repository can qualify as virtual in a variety of ways. The term would seem to apply, for example, to constructing a repository by forming a network among institutions; using the (...) Internet or the World Wide Web to solicit specimens and information; integrating web-based technology into the operation of the bank; using the Internet or web-based technology to manage relationships with donors or collection sites and recipients; and digitizing specimens. The all-digital repository would seem the most virtual of all possible repositories, a true cyberbank. (shrink)
Patients who enter the health care system for acute care may become “permanent” patients of the hospital when a lack of resources precludes discharge to the next level of post-acute care. Legal, professional, and ethical norms prohibit physician and acute care hospital “dumping” of these patients. However, limitless use of hospital resources for indefinite stays is untenable. In the absence of hospital policy addressing this specific issue, the availability of financial support will be determined by health care professionals' willingness to (...) advocate for the patient and negotiate with hospital administrators and the ability and willingness of administrators to authorize the use of hospital resources. We propose five mid-level ethical principles to guide advocacy and administrative decision-making about provision of financial support for post-acute care for those patients who cannot afford it. We use two actual, de-identified cases to illustrate how these principles can be used to make reasoned, consistent decisions about the provision of post-acute financial support. (shrink)
Patients who enter the health care system for acute care may become “permanent” patients of the hospital when a lack of resources precludes discharge to the next level of post-acute care. The care of these patients contributes to the rising costs of health care and will remain largely unaffected by the Affordable Care Act. For example, some resources may be available for treatment of undocumented persons, but Medicaid enrollment is unavailable for this population. Even where patients have access to Medicaid, (...) it takes up to three months between applying for and actually receiving Medicaid benefits. During that time, patients may be ready for hospital discharge. However, post-acute care facilities have no financial incentive or legal obligation to accept patients with no insurance or only pending Medicaid coverage. (shrink)
Few things seem more a part of the material world than biological specimens. Yet the processes by which collections of specimens are assembled, translated into information, combined with more information, and distributed are taking research repositories into the virtual realm.The term “virtual” has a number of meanings, and so a research repository can qualify as virtual in a variety of ways. The term would seem to apply, for example, to constructing a repository by forming a network among institutions; using the (...) Internet or the World Wide Web to solicit specimens and information; integrating web-based technology into the operation of the bank; using the Internet or web-based technology to manage relationships with donors or collection sites and recipients; and digitizing specimens. The all-digital repository would seem the most virtual of all possible repositories, a true cyberbank. (shrink)
In the lead article in this symposium issue, Edward Imwinkelried follows other scholars in distinguishing among three types of tasks for ethicists serving as expert witnesses: descriptive ; metaethical ; and normative. He finds agreement that the admissibility of descriptive or metaethical evidence rests upon the usual criteria of helpfulness and reliability. He breaks new ground in arguing that normative evidence typically relates to the judge's legislative rather than adjudicative function and therefore need not satisfy the usual standards for admissibility (...) in order to be considered. (shrink)
In the lead article in this symposium issue, Edward Imwinkelried follows other scholars in distinguishing among three types of tasks for ethicists serving as expert witnesses: descriptive ; metaethical ; and normative. He finds agreement that the admissibility of descriptive or metaethical evidence rests upon the usual criteria of helpfulness and reliability. He breaks new ground in arguing that normative evidence typically relates to the judge's legislative rather than adjudicative function and therefore need not satisfy the usual standards for admissibility (...) in order to be considered. (shrink)
There is a national movement supporting the retention and use of bio-specimens from deceased individuals for the purpose of genetic testing. This manuscript discusses the significance of postmortem genetic testing in the context of death determination by medical examiners. We highlight distinctive concerns that are raised in the areas of consent, confidentiality, and return of results when genetic testing is performed as part of a public molecular autopsy. We believe our manuscript will contribute to the development of a robust ethical (...) and legal framework for genetic testing in this context. (shrink)
