Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection's Books

Protecting Data Privacy in Health Services Research

By: Institute of Medicine,Division of Health Care Services,Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection

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Protecting Data Privacy in Health Services Research

By: Institute of Medicine,Division of Health Care Services,Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection

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.

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208

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National Academies Press

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ISBN 10

0309071879

ISBN 13

9780309071871

Beyond the HIPAA Privacy Rule

Enhancing Privacy, Improving Health Through Research

By: Institute of Medicine,Board on Health Care Services,Board on Health Sciences Policy,Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule

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Beyond the HIPAA Privacy Rule

Enhancing Privacy, Improving Health Through Research

By: Institute of Medicine,Board on Health Care Services,Board on Health Sciences Policy,Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule

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.

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334

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National Academies Press

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ISBN 10

0309124999

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9780309124997

Responsible Research

A Systems Approach to Protecting Research Participants

By: Institute of Medicine,Committee on Assessing the System for Protecting Human Research Participants

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Responsible Research

A Systems Approach to Protecting Research Participants

By: Institute of Medicine,Committee on Assessing the System for Protecting Human Research Participants

When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants' safety and their capacity to safeguard the well-being of those who volunteer for research studies. Responsible Research outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes: Improved research review processes, Recognition and integration of research participants' contributions to the system, and Vigilant maintenance of HRPPP performance. Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards. Responsible Research will be important to anyone interested in the issues that are relevant to the practice of using human subjects as research participants, but especially so to policy makers, research administrators, investigators, and research sponsorsâ€"but also including volunteers who may agree to serve as research participants.

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313

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National Academies Press

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ISBN 10

0309084881

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9780309084888

Proposed Revisions to the Common Rule

Perspectives of Social and Behavioral Scientists: Workshop Summary

By: National Research Council,Division of Behavioral and Social Sciences and Education,Board on Behavioral, Cognitive, and Sensory Sciences,Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences

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Proposed Revisions to the Common Rule

Perspectives of Social and Behavioral Scientists: Workshop Summary

On July 26, 2011, the U.S. Department of Health and Human Services issued an advance notice of proposed rulemaking (ANPRM) with the purpose of soliciting comments on how current regulations for protecting research participants could be modernized and revised. The rationale for revising the regulations was as follows: this ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multisite clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary focuses on six broad topic areas: 1. Evidence on the functioning of the Common Rule and of institutional review boards (IRBs), to provide context for the proposed revisions. 2. The types and levels of risks and harms encountered in social and behavioral sciences, and issues related to the severity and probability of harm, because the ANPRM asks for input on calibration of levels of review to levels of risk. 3. The consent process and special populations, because new rules have been proposed to improve informed consent (e.g., standard consent form, consent for future uses of biospecimens, and re-consenting for further use of existing research data). 4. Issues related to the protection of research participants in studies that involve use of existing data and data sharing, because the ANPRM proposed applying standards for protecting the privacy of healthcare data to research data. 5. Multidisciplinary and multisite studies, because the ANPRM proposed a revision to the regulations that would allow multisite studies to be covered by a single IRB. 6. The purview and roles of IRBs, because the ANPRM included possible revisions to categories of research that could entail changes in IRB oversight.

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111

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National Academies Press

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ISBN 10

0309288266

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9780309288262

Protecting Data Privacy in Health Services Research

By: Institute of Medicine,Division of Health Care Services,Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection

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Protecting Data Privacy in Health Services Research

By: Institute of Medicine,Division of Health Care Services,Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection

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208

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National Academies Press

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ISBN 10

0309071879

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9780309071871

Ethical Conduct of Clinical Research Involving Children

By: Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children

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Ethical Conduct of Clinical Research Involving Children

By: Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

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445

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National Academies Press

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ISBN 10

0309133386

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9780309133388

Ethical Conduct of Clinical Research Involving Children

By: Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children

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Ethical Conduct of Clinical Research Involving Children

By: Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children

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445

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National Academies Press

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ISBN 10

0309133386

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9780309133388

Multiple Sclerosis

Current Status and Strategies for the Future

By: Institute of Medicine,Board on Neuroscience and Behavioral Health,Committee on Multiple Sclerosis: Current Status and Strategies for the Future

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Multiple Sclerosis

Current Status and Strategies for the Future

By: Institute of Medicine,Board on Neuroscience and Behavioral Health,Committee on Multiple Sclerosis: Current Status and Strategies for the Future

Multiple sclerosis is a chronic and often disabling disease of the nervous system, affecting about 1 million people worldwide. Even though it has been known for over a hundred years, no cause or cure has yet been discovered-but now there is hope. New therapies have been shown to slow the disease progress in some patients, and the pace of discoveries about the cellular machinery of the brain and spinal cord has accelerated. This book presents a comprehensive overview of multiple sclerosis today, as researchers seek to understand its processes, develop therapies that will slow or halt the disease and perhaps repair damage, offer relief for specific symptoms, and improve the abilities of MS patients to function in their daily lives. The panel reviews existing knowledge and identifies key research questions, focusing on: Research strategies that have the greatest potential to understand the biological mechanisms of recovery and to translate findings into specific strategies for therapy. How people adapt to MS and the research needed to improve the lives of people with MS. Management of disease symptoms (cognitive impairment, depression, spasticity, vision problems, and others). The committee also discusses ways to build and financially support the MS research enterprise, including a look at challenges inherent in designing clinical trials. This book will be important to MS researchers, research funders, health care advocates for MS research and treatment, and interested patients and their families.

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456

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National Academies Press

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ISBN 10

030917130X

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9780309171304

Intentional Human Dosing Studies for EPA Regulatory Purposes

Scientific and Ethical Issues

By: National Research Council,Policy and Global Affairs,Science, Technology, and Law Program,Committee on the Use of Third Party Toxicity Research with Human Research Participants

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Intentional Human Dosing Studies for EPA Regulatory Purposes

Scientific and Ethical Issues

By: National Research Council,Policy and Global Affairs,Science, Technology, and Law Program,Committee on the Use of Third Party Toxicity Research with Human Research Participants

The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can't be answered with animal studies or nondosing human studies; The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and All recognized ethical standards and procedures for protecting the interests of study participants are observed. In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studiesâ€"both at the beginning and upon completion of the experimentsâ€"if they are carried out with the intent of affecting the agency's policy-making.

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226

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National Academies Press

Published Date

ISBN 10

0309091721

ISBN 13

9780309091725

Protecting Participants and Facilitating Social and Behavioral Sciences Research

By: National Research Council,Division on Behavioral and Social Sciences and Education,Board on Behavioral, Cognitive, and Sensory Sciences,Committee on National Statistics,Panel on Institutional Review Boards, Surveys, and Social Science Research

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Protecting Participants and Facilitating Social and Behavioral Sciences Research

Institutional review boards (IRBs) are the linchpins of the protection systems that govern human participation in research. In recent years, high-profile cases have focused attention on the weaknesses of the procedures for protecting participants in medical research. The issues surrounding participants protection in the social, behavioral, and economic sciences may be less visible to the public eye, but they are no less important in ensuring ethical and responsible research. This report examines three key issues related to human participation in social, behavioral, and economic sciences research: (1) obtaining informed, voluntary consent from prospective participants: (2) guaranteeing the confidentiality of information collected from participants, which is a particularly challenging problem in social sciences research; and (3) using appropriate review procedures for "minimal-risk" research. Protecting Participants and Facilitating Social and Behavioral Sciences Research will be important to policy makers, research administrators, research sponsors, IRB members, and investigators. More generally, it contains important information for all who want to ensure the best protectionâ€"for participants and researchers alikeâ€"in the social, behavioral, and economic sciences.

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277

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National Academies Press

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ISBN 10

0309088526

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9780309088527

Beyond the HIPAA Privacy Rule

Enhancing Privacy, Improving Health Through Research

By: Institute of Medicine,Board on Health Care Services,Board on Health Sciences Policy,Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule

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Beyond the HIPAA Privacy Rule

Enhancing Privacy, Improving Health Through Research

By: Institute of Medicine,Board on Health Care Services,Board on Health Sciences Policy,Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule

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334

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National Academies Press

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ISBN 10

0309124999

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9780309124997

Conducting Biosocial Surveys

Collecting, Storing, Accessing, and Protecting Biospecimens and Biodata

By: National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Population,Committee on National Statistics,Panel on Collecting, Storing, Accessing, and Protecting Biological Specimens and Biodata in Social Surveys

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Conducting Biosocial Surveys

Collecting, Storing, Accessing, and Protecting Biospecimens and Biodata

Recent years have seen a growing tendency for social scientists to collect biological specimens such as blood, urine, and saliva as part of large-scale household surveys. By combining biological and social data, scientists are opening up new fields of inquiry and are able for the first time to address many new questions and connections. But including biospecimens in social surveys also adds a great deal of complexity and cost to the investigator's task. Along with the usual concerns about informed consent, privacy issues, and the best ways to collect, store, and share data, researchers now face a variety of issues that are much less familiar or that appear in a new light. In particular, collecting and storing human biological materials for use in social science research raises additional legal, ethical, and social issues, as well as practical issues related to the storage, retrieval, and sharing of data. For example, acquiring biological data and linking them to social science databases requires a more complex informed consent process, the development of a biorepository, the establishment of data sharing policies, and the creation of a process for deciding how the data are going to be shared and used for secondary analysis-all of which add cost to a survey and require additional time and attention from the investigators. These issues also are likely to be unfamiliar to social scientists who have not worked with biological specimens in the past. Adding to the attraction of collecting biospecimens but also to the complexity of sharing and protecting the data is the fact that this is an era of incredibly rapid gains in our understanding of complex biological and physiological phenomena. Thus the tradeoffs between the risks and opportunities of expanding access to research data are constantly changing. Conducting Biosocial Surveys offers findings and recommendations concerning the best approaches to the collection, storage, use, and sharing of biospecimens gathered in social science surveys and the digital representations of biological data derived therefrom. It is aimed at researchers interested in carrying out such surveys, their institutions, and their funding agencies.

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125

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National Academies Press

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ISBN 10

0309161371

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9780309161374

Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences

By: National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Population,Committee on National Statistics,Board on Behavioral, Cognitive, and Sensory Sciences,Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences

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Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences

Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences examines how to update human subjects protections regulations so that they effectively respond to current research contexts and methods. With a specific focus on social and behavioral sciences, this consensus report aims to address the dramatic alterations in the research landscapes that institutional review boards (IRBs) have come to inhabit during the past 40 years. The report aims to balance respect for the individual persons whose consent to participate makes research possible and respect for the social benefits that productive research communities make possible. The ethics of human subjects research has captured scientific and regulatory attention for half a century. To keep abreast of the universe of changes that factor into the ethical conduct of research today, the Department of Health and Human Services published an Advance Notice of Proposed Rulemaking (ANPRM) in July 2011. Recognizing that widespread technological and societal transformations have occurred in the contexts for and conduct of human research since the passage of the National Research Act of 1974, the ANPRM revisits the regulations mandated by the Act in a correspondingly comprehensive manner. Its proposals aim to modernize the Common Rule and to improve the efficiency of the work conducted under its auspices. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences identifies issues raised in the ANPRM that are critical and feasible for the federal government to address for the protection of participants and for the advancement of the social and behavioral sciences. For each identified issue, this report provides guidance for IRBs on techniques to address it, with specific examples and best practice models to illustrate how the techniques would be applied to different behavioral and social sciences research procedures.

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204

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National Academies Press

Published Date

ISBN 10

0309298091

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9780309298094

Protecting Student Records and Facilitating Education Research

A Workshop Summary

By: National Research Council,Division of Behavioral and Social Sciences and Education,Center for Education,Committee on National Statistics

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Protecting Student Records and Facilitating Education Research

A Workshop Summary

By: National Research Council,Division of Behavioral and Social Sciences and Education,Center for Education,Committee on National Statistics

Designed to protect the privacy of individual student test scores, grades, and other education records, the Family Educational Rights and Privacy Act (FERPA) of 1974 places limits the access of educational researches, and slows research not only in education but also in related fields, such as child welfare and health. Recent trends have converged to greatly increase the supply of data on student performance in public schools. Education policies now emphasize education standards and testing to measure progress toward those standards, as well as rigorous education research. At the same time, private firms and public agencies, including schools, have replaced most paper records with electronic data systems. Although these databases represent a rich source of longitudinal data, researchers' access to the individually identifiable data they contain is limited by the privacy protections of FERPA. To explore possibilities for data access and confidentiality in compliance with FERPA and with the Common Rule for the Protection of Human Subjects, the National Academies and the American Educational Research Association convened the Workshop on Protecting Student Records and Facilitating Education Research in April 2008.

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106

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National Academies Press

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ISBN 10

0309127998

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9780309127998

Evolution of Translational Omics

Lessons Learned and the Path Forward

By: Institute of Medicine,Board on Health Sciences Policy,Board on Health Care Services,Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials

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Evolution of Translational Omics

Lessons Learned and the Path Forward

By: Institute of Medicine,Board on Health Sciences Policy,Board on Health Care Services,Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials

Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.

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354

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National Academies Press

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ISBN 10

0309224187

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9780309224185

Health Data in the Information Age

Use, Disclosure, and Privacy

By: Institute of Medicine,Committee on Regional Health Data Networks

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Health Data in the Information Age

Use, Disclosure, and Privacy

By: Institute of Medicine,Committee on Regional Health Data Networks

Regional health care databases are being established around the country with the goal of providing timely and useful information to policymakers, physicians, and patients. But their emergence is raising important and sometimes controversial questions about the collection, quality, and appropriate use of health care data. Based on experience with databases now in operation and in development, Health Data in the Information Age provides a clear set of guidelines and principles for exploiting the potential benefits of aggregated health dataâ€"without jeopardizing confidentiality. A panel of experts identifies characteristics of emerging health database organizations (HDOs). The committee explores how HDOs can maintain the quality of their data, what policies and practices they should adopt, how they can prepare for linkages with computer-based patient records, and how diverse groups from researchers to health care administrators might use aggregated data. Health Data in the Information Age offers frank analysis and guidelines that will be invaluable to anyone interested in the operation of health care databases.

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272

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National Academies Press

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ISBN 10

0309049954

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9780309049955

Conducting Biosocial Surveys

Collecting, Storing, Accessing, and Protecting Biospecimens and Biodata

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Conducting Biosocial Surveys

Collecting, Storing, Accessing, and Protecting Biospecimens and Biodata

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125

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National Academies Press

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ISBN 10

0309161371

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9780309161374

A National Trauma Care System

Integrating Military and Civilian Trauma Systems to Achieve Zero Preventable Deaths After Injury

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on the Health of Select Populations,Board on Health Sciences Policy,Committee on Military Trauma Care's Learning Health System and Its Translation to the Civilian Sector

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A National Trauma Care System

Integrating Military and Civilian Trauma Systems to Achieve Zero Preventable Deaths After Injury

Advances in trauma care have accelerated over the past decade, spurred by the significant burden of injury from the wars in Afghanistan and Iraq. Between 2005 and 2013, the case fatality rate for United States service members injured in Afghanistan decreased by nearly 50 percent, despite an increase in the severity of injury among U.S. troops during the same period of time. But as the war in Afghanistan ends, knowledge and advances in trauma care developed by the Department of Defense (DoD) over the past decade from experiences in Afghanistan and Iraq may be lost. This would have implications for the quality of trauma care both within the DoD and in the civilian setting, where adoption of military advances in trauma care has become increasingly common and necessary to improve the response to multiple civilian casualty events. Intentional steps to codify and harvest the lessons learned within the military's trauma system are needed to ensure a ready military medical force for future combat and to prevent death from survivable injuries in both military and civilian systems. This will require partnership across military and civilian sectors and a sustained commitment from trauma system leaders at all levels to assure that the necessary knowledge and tools are not lost. A National Trauma Care System defines the components of a learning health system necessary to enable continued improvement in trauma care in both the civilian and the military sectors. This report provides recommendations to ensure that lessons learned over the past decade from the military's experiences in Afghanistan and Iraq are sustained and built upon for future combat operations and translated into the U.S. civilian system.

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531

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National Academies Press

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ISBN 10

0309442885

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9780309442886

Cells and Surveys

Should Biological Measures Be Included in Social Science Research?

By: National Research Council,Commission on Behavioral and Social Sciences and Education,Committee on Population

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Cells and Surveys

Should Biological Measures Be Included in Social Science Research?

By: National Research Council,Commission on Behavioral and Social Sciences and Education,Committee on Population

What can social science, and demography in particular, reasonably expect to learn from biological information? There is increasing pressure for multipurpose household surveys to collect biological data along with the more familiar interviewer-respondent information. Given that recent technical developments have made it more feasible to collect biological information in non-clinical settings, those who fund, design, and analyze survey data need to think through the rationale and potential consequences. This is a concern that transcends national boundaries. Cells and Surveys addresses issues such as which biologic/genetic data should be collected in order to be most useful to a range of social scientists and whether amassing biological data has unintended side effects. The book also takes a look at the various ethical and legal concerns that such data collection entails.

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