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Expanding Access to Research Data

Author: Panel on Data Access for Research Purposes

Publisher: National Academies Press

Published: 2005-11-11

Total Pages: 142

ISBN-13: 9780309100120

Policy makers need information about the nation—ranging from trends in the overall economy down to the use by individuals of Medicare—in order to evaluate existing programs and to develop new ones. This information often comes from research based on data about individual people, households, and businesses and other organizations, collected by statistical agencies. The benefit of increasing data accessibility to researchers and analysts is better informed public policy. To realize this benefit, a variety of modes for data access— including restricted access to confidential data and unrestricted access to appropriately altered public-use data—must be used. The risk of expanded access to potentially sensitive data is the increased probability of breaching the confidentiality of the data and, in turn, eroding public confidence in the data collection enterprise. Indeed, the statistical system of the United States ultimately depends on the willingness of the public to provide the information on which research data are based. Expanding Access to Research Data issues guidance on how to more fully exploit these tradeoffs. The panel’s recommendations focus on needs highlighted by legal, social, and technological changes that have occurred during the last decade.

Expanding Access to Research Data

Author: National Research Council

Publisher: National Academies Press

Published: 2005-12-11

Total Pages: 133

ISBN-13: 0309100127

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Policy makers need information about the nationâ€"ranging from trends in the overall economy down to the use by individuals of Medicareâ€"in order to evaluate existing programs and to develop new ones. This information often comes from research based on data about individual people, households, and businesses and other organizations, collected by statistical agencies. The benefit of increasing data accessibility to researchers and analysts is better informed public policy. To realize this benefit, a variety of modes for data accessâ€" including restricted access to confidential data and unrestricted access to appropriately altered public-use dataâ€"must be used. The risk of expanded access to potentially sensitive data is the increased probability of breaching the confidentiality of the data and, in turn, eroding public confidence in the data collection enterprise. Indeed, the statistical system of the United States ultimately depends on the willingness of the public to provide the information on which research data are based. Expanding Access to Research Data issues guidance on how to more fully exploit these tradeoffs. The panel's recommendations focus on needs highlighted by legal, social, and technological changes that have occurred during the last decade.

Beyond the HIPAA Privacy Rule

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2009-03-24

Total Pages: 334

ISBN-13: 0309124999

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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.

Expanding Access to Research Data

Author: National Research Council

Publisher: National Academies Press

Published: 2005-11-11

Total Pages: 132

ISBN-13: 0309164958

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Protecting Data Privacy in Health Services Research

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2001-01-13

Total Pages: 208

ISBN-13: 0309071879

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The need for quality improvement and for cost saving are driving both individual choices and health system dynamics. The health services research that we need to support informed choices depends on access to data, but at the same time, individual privacy and patient-health care provider confidentiality must be protected.

Registries for Evaluating Patient Outcomes

Author: Agency for Healthcare Research and Quality/AHRQ

Publisher: Government Printing Office

Published: 2014-04-01

Total Pages: 396

ISBN-13: 1587634333

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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.

Sharing Clinical Trial Data

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2015-04-20

Total Pages: 236

ISBN-13: 0309316324

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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.

Data Matters

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2019-01-28

Total Pages: 103

ISBN-13: 030948247X

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In an increasingly interconnected world, perhaps it should come as no surprise that international collaboration in science and technology research is growing at a remarkable rate. As science and technology capabilities grow around the world, U.S.-based organizations are finding that international collaborations and partnerships provide unique opportunities to enhance research and training. International research agreements can serve many purposes, but data are always involved in these collaborations. The kinds of data in play within international research agreements varies widely and may range from financial and consumer data, to Earth and space data, to population behavior and health data, to specific project-generated dataâ€"this is just a narrow set of examples of research data but illustrates the breadth of possibilities. The uses of these data are various and require accounting for the effects of data access, use, and sharing on many different parties. Cultural, legal, policy, and technical concerns are also important determinants of what can be done in the realms of maintaining privacy, confidentiality, and security, and ethics is a lens through which the issues of data, data sharing, and research agreements can be viewed as well. A workshop held on March 14-16, 2018, in Washington, DC explored the changing opportunities and risks of data management and use across disciplinary domains. The third workshop in a series, participants gathered to examine advisory principles for consideration when developing international research agreements, in the pursuit of highlighting promising practices for sustaining and enabling international research collaborations at the highest ethical level possible. The intent of the workshop was to explore, through an ethical lens, the changing opportunities and risks associated with data management and use across disciplinary domainsâ€"all within the context of international research agreements. This publication summarizes the presentations and discussions from the workshop.