Current Issues In Human Subject Protection

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Assessing the System for Protecting Human Research Subjects
Publisher : National Academies Press
Page : 232 pages
File Size : 49,9 Mb
Release : 2001-07-02
Category : Medical
ISBN : 9780309171090

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Preserving Public Trust by Institute of Medicine,Board on Health Sciences Policy,Committee on Assessing the System for Protecting Human Research Subjects Pdf

Amid increasing concern for patient safety and the shutdown of prominent research operations, the need to improve protections for individuals who volunteer to participate in research has become critical. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs considers the possible impact of creating an accreditation system to raise the performance of local protection mechanisms. In the United States, the system for human research participant protections has centered on the Institutional Review Board (IRB); however, this report envisions a broader system with multiple functional elements. In this context, two draft sets of accreditation standards are reviewed (authored by Public Responsibility in Medicine & Research and the National Committee for Quality Assurance) for their specific content in core areas, as well as their objectivity and validity as measurement tools. The recommendations in the report support the concept of accreditation as a quality improvement strategy, suggesting that the model should be initially pursued through pilot testing of the proposed accreditation programs.

Author : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher : Unknown
Page : 128 pages
File Size : 41,5 Mb
Release : 1978
Category : Human experimentation in medicine
ISBN : LCCN:79601661

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The Belmont Report by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Pdf

Author : David B. Resnik
Publisher : Springer
Page : 316 pages
File Size : 55,7 Mb
Release : 2018-01-09
Category : Philosophy
ISBN : 9783319687568

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The Ethics of Research with Human Subjects by David B. Resnik Pdf

This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust.

Author : Institute of Medicine,Division of Health Care Services,Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection
Publisher : National Academies Press
Page : 208 pages
File Size : 45,8 Mb
Release : 2001-01-13
Category : Computers
ISBN : 9780309071871

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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 Pdf

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.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publisher : National Academies Press
Page : 445 pages
File Size : 53,6 Mb
Release : 2004-07-09
Category : Medical
ISBN : 9780309133388

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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 Pdf

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.

Author : United States. Food and Drug Administration
Publisher : Unknown
Page : 288 pages
File Size : 55,8 Mb
Release : 1996
Category : Clinical trials
ISBN : MINN:31951D02465636D

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Current Issues in Human Subject Protection by United States. Food and Drug Administration Pdf

Author : Institute of Medicine,Committee on Assessing the System for Protecting Human Research Participants
Publisher : National Academies Press
Page : 313 pages
File Size : 55,6 Mb
Release : 2003-02-06
Category : Medical
ISBN : 9780309084888

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Responsible Research by Institute of Medicine,Committee on Assessing the System for Protecting Human Research Participants Pdf

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.

Author : National Academies of Sciences, Engineering, and Medicine,Policy and Global Affairs,Board on Higher Education and Workforce,Committee on Science, Technology, and Law,Committee on Federal Research Regulations and Reporting Requirements: A New Framework for Research Universities in the 21st Century
Publisher : National Academies Press
Page : 283 pages
File Size : 51,7 Mb
Release : 2016-06-29
Category : Science
ISBN : 9780309379519

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Optimizing the Nation's Investment in Academic Research by National Academies of Sciences, Engineering, and Medicine,Policy and Global Affairs,Board on Higher Education and Workforce,Committee on Science, Technology, and Law,Committee on Federal Research Regulations and Reporting Requirements: A New Framework for Research Universities in the 21st Century Pdf

Research universities are critical contributors to our national research enterprise. They are the principal source of a world-class labor force and fundamental discoveries that enhance our lives and the lives of others around the world. These institutions help to create an educated citizenry capable of making informed and crucial choices as participants in a democratic society. However many are concerned that the unintended cumulative effect of federal regulations undercuts the productivity of the research enterprise and diminishes the return on the federal investment in research. Optimizing the Nation's Investment in Academic Research reviews the regulatory framework as it currently exists, considers specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and reassesses the process by which these regulations are created, reviewed, and retired. This review is critical to strengthen the partnership between the federal government and research institutions, to maximize the creation of new knowledge and products, to provide for the effective training and education of the next generation of scholars and workers, and to optimize the return on the federal investment in research for the benefit of the American people.

Author : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions. Subcommittee on Public Health
Publisher : Unknown
Page : 64 pages
File Size : 53,9 Mb
Release : 2002
Category : Medical
ISBN : STANFORD:36105063299700

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Protecting Human Subjects in Research by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions. Subcommittee on Public Health Pdf

Author : 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
Publisher : National Academies Press
Page : 226 pages
File Size : 42,8 Mb
Release : 2004-06-04
Category : Science
ISBN : 9780309166416

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Intentional Human Dosing Studies for EPA Regulatory Purposes 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 Pdf

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.

Author : Bruce Dennis Sales,Susan Folkman
Publisher : Amer Psychological Assn
Page : 215 pages
File Size : 53,9 Mb
Release : 2000-01-01
Category : Medical
ISBN : 1557986886

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Ethics in Research with Human Participants by Bruce Dennis Sales,Susan Folkman Pdf

The American Psychological Association offers this book to help researchers understand ethical conflicts. The examples and analyses help researchers in identifying conflicts of interest and solving ethical dilemmas, planning research, recruiting participants, training researchers, managing matters of informed consent and confidentiality, dealing with intellectual property issues, working with special populations, and updating protocols for institutional review boards.

Author : Anonim
Publisher : Unknown
Page : 128 pages
File Size : 42,8 Mb
Release : 2004
Category : Medical ethics
ISBN : OCLC:225309868

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World Medical Association Declaration of Helsinki by Anonim Pdf

Author : Institute of Medicine,National Research Council,Division of Behavioral and Social Sciences and Education,Board on Children, Youth, and Families,Committee on Ethical Issues in Housing-Related Health Hazard Research Involving Children, Youth, and Families
Publisher : National Academies Press
Page : 216 pages
File Size : 48,6 Mb
Release : 2005-11-10
Category : Social Science
ISBN : 9780309164924

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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children by Institute of Medicine,National Research Council,Division of Behavioral and Social Sciences and Education,Board on Children, Youth, and Families,Committee on Ethical Issues in Housing-Related Health Hazard Research Involving Children, Youth, and Families Pdf

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children explores the ethical issues posed when conducting research designed to identify, understand, or ameliorate housing-related health hazards among children. Such research involves children as subjects and is conducted in the home and in communities. It is often conducted with children in low-income families given the disproportionate prevalence of housing-related conditions such as lead poisoning, asthma, and fatal injuries among these children. This book emphasizes five key elements to address the particular ethical concerns raised by these characteristics: involving the affected community in the research and responding to their concerns; ensuring that parents understand the essential elements of the research; adopting uniform federal guidelines for such research by all sponsors (Subpart D of 45 CFR 46); providing guidance on key terms in the regulations; and viewing research oversight as a system with important roles for researchers, IRBs and their research institutions, sponsors and regulators of research, and the community.

Author : National Academies of Sciences, Engineering, and Medicine,Policy and Global Affairs,Committee on Science, Engineering, Medicine, and Public Policy,Committee on Responsible Science
Publisher : National Academies Press
Page : 327 pages
File Size : 54,9 Mb
Release : 2018-01-13
Category : Science
ISBN : 9780309391252

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Fostering Integrity in Research by National Academies of Sciences, Engineering, and Medicine,Policy and Global Affairs,Committee on Science, Engineering, Medicine, and Public Policy,Committee on Responsible Science Pdf

The integrity of knowledge that emerges from research is based on individual and collective adherence to core values of objectivity, honesty, openness, fairness, accountability, and stewardship. Integrity in science means that the organizations in which research is conducted encourage those involved to exemplify these values in every step of the research process. Understanding the dynamics that support â€" or distort â€" practices that uphold the integrity of research by all participants ensures that the research enterprise advances knowledge. The 1992 report Responsible Science: Ensuring the Integrity of the Research Process evaluated issues related to scientific responsibility and the conduct of research. It provided a valuable service in describing and analyzing a very complicated set of issues, and has served as a crucial basis for thinking about research integrity for more than two decades. However, as experience has accumulated with various forms of research misconduct, detrimental research practices, and other forms of misconduct, as subsequent empirical research has revealed more about the nature of scientific misconduct, and because technological and social changes have altered the environment in which science is conducted, it is clear that the framework established more than two decades ago needs to be updated. Responsible Science served as a valuable benchmark to set the context for this most recent analysis and to help guide the committee's thought process. Fostering Integrity in Research identifies best practices in research and recommends practical options for discouraging and addressing research misconduct and detrimental research practices.

Author : International Commission on Intervention and State Sovereignty,International Development Research Centre (Canada)
Publisher : IDRC
Page : 432 pages
File Size : 46,8 Mb
Release : 2001
Category : Law
ISBN : 0889369631

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The Responsibility to Protect by International Commission on Intervention and State Sovereignty,International Development Research Centre (Canada) Pdf

Responsibility to Protect: Research, bibliography, background. Supplementary volume to the Report of the International Commission on Intervention and State Sovereignty