After discussions with the National Cancer Institute and the Department of Energy the Board on Biology of the National Research Council agreed to run a workshop under the auspices of its Forum on Biotechnology entitled "Privacy Issues in Biomedical and Clinical Research" on November 1, 1997. The organizers want to stress the forum was not intended to cover the full gauntlet of issues concerning Genomics and the Privacy of Medical Records. The emphasis of this forum was to look at pending legislation in Congress (Fall, 1997) and consider, if enacted as written, how this would affect genetic research. The broad language of this legislation written to protect the individual could inadvertently restrict research intended to help these same individuals. Scientific progress requires the sharing of information for the validation of results and the dissemination of gained knowledge to be effective. Other issues which were touched upon in this forum but not fully explored include; the trust of individuals involved in genetic studies in the manner their genetic information could be used, the practice of the generalized "linking" of particular ethnic groups with specific genetic traits, and the potential for positive and negative impact on the quality of life by having knowledge of one's genetic potential. These and other issues which have come upon us in the age of genomics require separate, focused efforts to explore their potential effect on society.

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

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.

After discussions with the National Cancer Institute and the Department of Energy the Board on Biology of the National Research Council agreed to run a workshop under the auspices of its Forum on Biotechnology entitled "Privacy Issues in Biomedical and Clinical Research" on November 1, 1997. The organizers want to stress the forum was not intended to cover the full gauntlet of issues concerning Genomics and the Privacy of Medical Records. The emphasis of this forum was to look at pending legislation in Congress (Fall, 1997) and consider, if enacted as written, how this would affect genetic research. The broad language of this legislation written to protect the individual could inadvertently restrict research intended to help these same individuals. Scientific progress requires the sharing of information for the validation of results and the dissemination of gained knowledge to be effective. Other issues which were touched upon in this forum but not fully explored include; the trust of individuals involved in genetic studies in the manner their genetic information could be used, the practice of the generalized "linking" of particular ethnic groups with specific genetic traits, and the potential for positive and negative impact on the quality of life by having knowledge of one's genetic potential. These and other issues which have come upon us in the age of genomics require separate, focused efforts to explore their potential effect on society.