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Making data broadly accessible is essential to creating a medical information commons (MIC). 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The article discusses bioethics developments and a potential reboot of "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research" which was released by the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979. America's Office for Human Research Protections (OHRP), a right to privacy in the U.S., and oversight of research involving human subjects are assessed.

Precision medicine research is rapidly taking a lead role in the pursuit of new ways to improve health and prevent disease, but also presents new challenges for protecting human subjects. The extent to which the current "web" of legal protections, including technical data security measures, as well as measures to restrict access or prevent misuse of research data, will protect participants in this context remains largely unknown. Understanding the strength, usefulness, and limitations of this constellation of laws, regulations, and procedures is critical to ensuring not only that participants are protected, but also that their participation decisions are accurately informed. To address these gaps, we conducted in-depth interviews with a diverse group of 60 thought-leaders to explore their perspectives on the protections associated with precision medicine research. [ABSTRACT FROM AUTHOR]

We explore how principles predicting the success of a medical information commons (MIC) advantaged or disadvantaged three MIC initiatives in three Canadian provinces. Our MIC case examples demonstrate that practices and policies to promote access to and use of health information can help improve individual healthcare and inform a learning health system. MICs were constrained by heterogenous health information protection laws across jurisdictions and risk-averse institutional cultures. A networked approach to MICs would unlock even more potential for national and international data collaborations to improve health and healthcare. [ABSTRACT FROM AUTHOR]

A medical information commons (MIC) 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Meaningful participant engagement has been identified as a key contributor to the success of efforts to share data via a "Medical Information Commons" (MIC). 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. [ABSTRACT FROM AUTHOR]

A review of the article "Thought Leader Perspectives on Participant Protections in Precision Medicine Research" by C.M. Hammack, K.M. Brelsford, and L.M. Beskow, which appears in the same issue of the journal, is presented, and it mentions human genetics research.

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 (NIH) 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 timely topic. [ABSTRACT FROM AUTHOR]

David Karp and colleagues discuss the ethical and practical concerns that arise when data are shared in aggregated databases. [ABSTRACT FROM AUTHOR]

Studies that involve getting information from people about other people, including pedigree studies, create obligations to those other people. Defining them as "human subjects," however, does not solve the ethical problems and will, in some cases, make important lines of study impractical or even impossible. The more important task is to define what the ethical obligations are and how to ensure that they are carried out. Some heuristics based on the study of families with inherited Alzheimer's disease suggest that consultation with family members and attention to confidentiality should more directly address the ethical problems than try to treat families merely as collections of people with individual rights. The individual-based approach will necessarily fail when different family members differ in their judgments about the risks and benefits of disclosing information, which will, in turn, lead to the most restrictive individual controlling what others in the family can disclose. This solution is unlikely to be supported in practice by families or researchers or to be sanctioned by the courts. The current policy of the federal Office for Human Research Protections, based on an interpretation of the definition "human subject," is incoherent and will need to be changed, preferably through a process that involves broad debate among all stakeholders but most particularly involving members of families being studied. [ABSTRACT FROM AUTHOR]