Enabling Posthumous Medical Data Donation: An Appeal for the Ethical Utilisation of Personal Health Data.

This article argues that personal medical data should be made available for scientific research, by enabling and encouraging individuals to donate their medical records once deceased, similar to the way in which they can already donate organs or bodies. This research is part of a project on posthumous medical data donation developed by the Digital Ethics Lab at the Oxford Internet Institute at the University of Oxford. Ten arguments are provided to support the need to foster posthumous medical data donation. Two major risks are also identified-harm to others, and lack of control over the use of data-which could follow from unregulated donation of medical data. The argument that record-based medical research should proceed without the need to secure informed consent is rejected, and instead a voluntary and participatory approach to using personal medical data should be followed. The analysis concludes by stressing the need to develop an ethical code for data donation to minimise the risks, and offers five foundational principles for ethical medical data donation suggested as a draft code.

The Ethics of Big Data and Nursing Science.

Big data is a scientific, social, and technological trend referring to the process and size of datasets available for analysis. Ethical implications arise as healthcare disciplines, including nursing, struggle over questions of informed consent, privacy, ownership of data, and its possible use in epistemology. The author offers straight-thinking possibilities for the use of big data in nursing science.

Internet-based brain training games, citizen scientists, and big data: ethical issues in unprecedented virtual territories.

Internet brain training programs, where consumers serve as both subjects and funders of the research, represent the closest engagement many individuals have with neuroscience. Safeguards are needed to protect participants' privacy and the evolving scientific enterprise of big data.

Ethical aspects of participation in the database of genotypes and phenotypes of the National Center for Biotechnology Information: the Cancer and Leukemia Group B Experience.

BACKGROUND: The rapid pace of genetics research, coupled with evolving standards for informed consent, can create ethical challenges regarding future use of tissue or information from completed clinical trials. The Cancer and Leukemia Group B (CALGB) Oncology Cooperative Group was faced with an ethical dilemma regarding sharing genetic data from a completed genome-wide association study (GWAS) that was conducted as part of a large, multicenter breast cancer clinical trial with a national database: the Database of Genotypes and Phenotypes National Center for Biotechnology Information (dbGaP). METHODS: The CALGB Ethics Committee conducted a series of multidisciplinary meetings and teleconferences involving patient advocates, bioethicists, clinical researchers, and clinical oncologists to evaluate the ethical issues raised by this case and to identify lessons for improving informed consent to future genetics research in oncology trials. RESULTS: The Ethics Committee recommended that GWAS data be provided to dbGaP consistent with documented consent for future use of tissue among trial participants. Ethical issues, including adequacy of informed consent to future research, limitations of privacy in modern genetics research, the potential impact of population-based genetics research on health disparities, and recontact of research participants for clinical care or further research, were identified as major ethical considerations in this area. CONCLUSIONS: Although modern standards for informed consent should not prohibit research or sharing of data consistent with participant's intent and the public interest, there is an urgent need for national consensus on the appropriate use of archived tissue and standardized informed consent for future research among cancer clinical trial participants.

Regulatory and ethical considerations for linking clinical and administrative databases.

Clinical data registries are valuable tools that support evidence development, performance assessment, comparative effectiveness studies, and the adoption of new treatments into routine clinical practice. Although these registries do not have important information on long-term therapies or clinical events, administrative claims databases offer a potentially valuable complement. This article focuses on the regulatory and ethical considerations that arise from the use of registry data for research, including linkage of clinical and administrative data sets. (1) Are such activities primarily designed for quality assessment and improvement, research, or both, as this determines the appropriate ethical and regulatory standards? (2) Does the submission of data to a central registry, which may subsequently be linked to other data sources, require review by the institutional review board (IRB) of each participating organization? (3) What levels and mechanisms of IRB oversight are appropriate for the existence of a linked central data repository and the specific studies that may subsequently be developed using it? (4) Under what circumstances are waivers of informed consent and Health Insurance Portability and Accountability Act authorization required? (5) What are the requirements for a limited data set that would qualify a research activity as not involving human subjects and thus not subject to further IRB review? The approaches outlined in this article represent a local interpretation of the regulations in the context of several clinical data registry projects and focuses on a specific case study of the Society of Thoracic Surgeons National Database.

Análisis de la producción científica española sobre abuso de sustancias en función de la colaboración entre disciplinas / No disponible

Objetivos: Se analiza la productividad y colaboración de disciplinas y especialidades en el área del Abuso de Sustancias en las publicaciones científicas firmadas por instituciones españolas (2001-2005). Metodología: A partir de las afiliaciones institucionales, en las que se hace constar habitualmente el departamento, servicio o unidad, se ha identificado y cuantificado la participación de las diferentes áreas del conocimiento en los trabajos recogidos en las bases de datos IME/Índice Médico Español, ISOC/Índice Español de Ciencias Sociales y Humanidades, SCI-Expanded/Science Citation Index-Expandedy SSCI/Social Sciences Citation Index. Resultados: En ISOC se han identificado 31 disciplinas y especialidades, con un 8,6% de documentos en colaboración entre las mismas. En IME 55 especialidades médicas, con un 10,89% de documentos en colaboración y en SCI-Expanded 62 especialidades y un 41,68% de documentos en colaboración. Conclusiones: a) El Abuso de Sustancias, Psicología, Psiquiatría, Epidemiología-Medicina Preventiva y Salud Pública y Farmacología son las disciplinas y especialidades que presentan el mayor índice de productividad,a las que se suman, en el caso de los trabajos publicados en revistas extranjeras Bioquímica-Biología Molecular, Neurología y Neurociencia; b) los trabajos publicados en las revistas españolas recogidas en SCI-Expanded y en revistas extranjeras presentan índices de colaboración entre disciplinas mucho más elevados; c) las principales colaboraciones son las establecidas entre Abuso de Sustancias, Psiquiatría y Psicología, a las que se suman, en el caso de las revistas recogidas en SCI-Expanded las colaboraciones que establecen estas disciplinas con la Farmacología, Neurología y Neurociencia

Objectives: The analysis of productivity and disciplinary collaboration patterns for Spanish published scientific researchin the field of Substance Abuse (2001-2005). Methodology: From institutional affiliations we identified and quantified disciplinary participation in papers indexed in the IME / Índice Médico Español, ISOC/Índice Español de Ciencias Sociales y Humanidades, SCI-Expanded/Science Citation Index-Expanded and SSCI/Social Sciences Citation Index databases. Results: A total of 31 disciplines and specialities were identified in ISOC, with 8.6% of documents in collaboration between them; 55 medical specialities were identified in IME, with 10.89% of documents in collaboration between them; and 62 specialities were identified in SCI-Expanded, with 41.68% of documents in collaboration between them. Conclusions: a) Substance Abuse, Psychology, Psychiatry, Epidemiology-Preventive Medicine and Public Health and Pharmacology are the disciplines and specialities that present the highest productivity. To these can be added, in papers published in foreign journals, specialities such as Biochemistry-Molecular Biology, Neurology and Neuroscience; b) Papers published in Spanish journals indexed in SCI-Expanded and in papers published in foreign journals present much higher collaboration indexes between disciplines and specialities; c) The main collaborations between specialities are those between Substance Abuse, Psychiatry and Psychology. To these can be added, in the case of journals indexed in SCI-Expanded, those between these specialities and Pharmacology, Neurology and Neuroscience

Clinical trials registries: towards improved access to therapeutic data.

(1) On July 1, 2005, several leading biomedical journals decided to publish only the results of clinical trials that had been listed in approved registries; (2) More and more clinical trials are now being recorded in a variety of national and international registries by an increasing number of private and public institutions; (3) The international network of WHO-approved registries, operational since 2007, provides access to more than 60 000 trials (in April 2008), but there is still no single comprehensive international registry of clinical trials; (4) The US registry (ClinicalTrials.gov) is publicly accessible, but the public does not have online access to the European registry (EudraCT); (5) These registries would be more useful if registration were transparent and mandatory in all countries where clinical trials are conducted; (6) Patients who agree to participate in a clinical trial should first verify that the study is listed in a WHO-approved registry and that the authors have committed to publish the results.

Security and health research databases: the stakeholders and questions to be addressed.

Health research database security issues abound. Issues include subject confidentiality, data ownership, data integrity and data accessibility. There are also various stakeholders in database security. Each of these stakeholders has a different set of concerns and responsibilities when dealing with security issues. There is an obvious need for training in security issues, so that these issues may be addressed and health research will move on without added obstacles based on misunderstanding security methods and technologies.

Human genetic research: emerging trends in ethics.

Genetic research has moved from Mendelian genetics to sequence maps to the study of natural human genetic variation at the level of the genome. This past decade of discovery has been accompanied by a shift in emphasis towards the ethical principles of reciprocity, mutuality, solidarity, citizenry and universality.

Governing UK Biobank: the importance of ensuring public trust.

In the autumn of 2003, UK Biobank published the first draft of its Ethics and Governance Framework. Subsequently, this document has been available for interested parties to comment on and the UK Biobank Board of Directors is expected to adopt the final version in 2004. Here, we aim to contribute to this process and highlight to a wider audience some of the inconsistencies in the issues of consent, governance and right of withdrawal that emerge from the draft of the Framework. These issues will have implications for securing the public trust and long-term support that the success of the project depends on. Therefore, they must be considered carefully because the UK Biobank will be the first ever genetic database of a general population of this size to become operational, and will be used as a model for other projects of this kind.

Limited access data sets from studies funded by the National Heart, Lung, and Blood Institute.

The NHLBI has recently developed standards for protection of subject confidentiality which enable distribution of large data sets collected in completed epidemiological studies and clinical trials. This allows other investigators to pursue research using the data these studies have generated. An ethical commitment to protect the privacy of the research subjects requires careful review and some compromise in data details prior to distribution. To meet the challenge posed by the ethical and legal requirements to protect participants' privacy and making data sets useful for researchers, the NHLBI has devised a policy which seeks to balance these two opposing forces. This paper describes this policy as well as the limited access data sets currently available from NHLBI.

UK Biobank: a project in search of a protocol?

Before it has even begun recruiting participants, the UK Biobank project has raised extraordinary passions among scientists. Some scientists are broadly supportive of the project, and feel that it is a scientifically valid, potentially valuable resource, although they still have reservations over the details of the current protocol. Others see it as an ill-conceived, politically motivated project, in which consultations have only been done to give an appearance of legitimacy and in which the scientific case has not been made for its design. There has been resentment over how the protocol has evolved, and the secrecy and legal constraints that surrounded the process for groups bidding to be involved has had the appearance of attempting to stifle debate. For this article even supporters of the project have been unwilling to be quoted on the record. The only point that everyone seems to agree on is that sufficient debate about the project has not taken place.

Biosamples, genomics, and human rights: context and content of Iceland's Biobanks Act.

In recent years, human DNA sampling and collection has accelerated without the development of enforceable rules protecting the human rights of donors. The need for regulation of biobanking is especially acute in Iceland, whose parliament has granted a for-profit corporation, deCODE Genetics, an exclusive license to create a centralized database of health records for studies on human genetic variation. Until recently, how deCODE Genetics would get genetic material for its genotypic-phenotypic database remained unclear. However, in May 2000, the Icelandic Parliament passed the Icelandic Biobanks Act, the world's earliest attempt to construct binding rules for the use of biobanks in scientific research. Unfortunately, Iceland has lost an opportunity for bringing clear and ethically sound standards to the use of human biological samples in deCODE's database and in other projects: the Biobanks Act has extended a notion of "presumed consent" from the use of medical records to the use of patients' biological samples; worse, the act has made it possible--perhaps likely--that a donor's wish to withdraw his/her sample will be ignored. Inadequacies in the Act's legislative process help account for these deficiencies in the protection of donor autonomy.