This book presents cutting edge research on the new ethical challenges posed by biomedical Big Data technologies and practices. ‘Biomedical Big Data’ refers to the analysis of aggregated, very large datasets to improve medical knowledge and clinical care. The book describes the ethical problems posed by aggregation of biomedical datasets and re-use/re-purposing of data, in areas such as privacy, consent, professionalism, power relationships, and ethical governance of Big Data platforms. Approaches and methods are discussed that can be used to address these problems to achieve the appropriate balance between the social goods of biomedical Big Data research and the safety and privacy of individuals. Seventeen original contributions analyse the ethical, social and related policy implications of the analysis and curation of biomedical Big Data, written by leading experts in the areas of biomedical research, medical and technology ethics, privacy, governance and data protection. The book advances our understanding of the ethical conundrums posed by biomedical Big Data, and shows how practitioners and policy-makers can address these issues going forward.

Data access is essential for serving the public good. This book provides new frameworks to address the resultant privacy issues.

Informed consent is a central topic in contemporary biomedical ethics. Yet attempts to set defensible and feasible standards for consenting have led to persistent difficulties. In Rethinking Informed Consent in Bioethics, first published in 2007, Neil Manson and Onora O'Neill set debates about informed consent in medicine and research in a fresh light. They show why informed consent cannot be fully specific or fully explicit, and why more specific consent is not always ethically better. They argue that consent needs distinctive communicative transactions, by which other obligations, prohibitions, and rights can be waived or set aside in controlled and specific ways. Their book offers a coherent, wide-ranging and practical account of the role of consent in biomedicine which will be valuable to readers working in a range of areas in bioethics, medicine and law.

Health services research performed over the last three decades has established a body of evidence that undermines a number of the fundamental assumptions of our informed consent laws. Currently there is a divide among the states about what standard prevails in informed consent cases between physician-based states and patient-based states. In physician based states, the courts apply a standard of what information would the reasonable physician disclose to the patient under like or similar circumstances. In patient based states, the courts apply the standard of what information would the objective reasonable patient want under like or similar circumstances. Both standards fail but for different reasons. The physician based standard fails to recognize that there is no true objective standard that physicians follow and in fact there is large practice variation amongst physicians even in the same geographic region. The patient based standard fails to recognize that patient's values and preferences vary widely depending on the individual patient. How a particular patient perceives the medical treatment information based upon their own, lifestyle, values and preferences will dictate what course of treatment to follow. Evidence suggests that informed medical decision making strengthens the therapeutic alliance and improves patient satisfaction. It also reduces in many instances costly surgical interventions. The health services research of Wennberg et al, accompanied with evidence of patient dissatisfaction with current disclosure practices suggests that an overhaul of our current informed consent system is necessary. Shared decision-making, a process that requires both the physician and the patient to engage in a discussion of all relevant information regarding the treatment options, including the risks, benefits and alternatives to treatment, as well as the individual patient's lifestyle, values and preferences, offers a promising alternative to our current system. However, many physicians, lawyers and scholars argue that shared decision-making will consume too much time, money and scarce medical resources in an already overburdened medical system. This article examines these claims and concludes that despite the bureaucratic headaches, the enormous expenditure of financial and human resources, and the need for state by state adoption of new informed consent laws, the long-term benefits of shared decision-making and the use of evidence based decision aids to promote patient understanding of medical information to arrive at informed medical decision making far outweigh the costs for both patients and physicians.

This essential guide to doing social research in this fast-evolving digital age explains how the digital revolution is transforming the way social scientists observe behavior, ask questions, run experiments, and engage in mass collaborations.