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Author :
Publisher :
ISBN 13 :
Total Pages : 282 pages
Book Rating : 4.F/5 ( download)
Download or read book Federal regulation of human experimentation, 1975 written by and published by . This book was released on 1975 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher :
ISBN 13 :
Total Pages : 614 pages
Book Rating : 4.:/5 (327 download)
Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309166411
Total Pages : 226 pages
Book Rating : 4.3/5 (91 download)
Download or read book Intentional Human Dosing Studies for EPA Regulatory Purposes written by National Research Council and published by National Academies Press. This book was released on 2004-06-04 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research
Publisher : National Academies Press
ISBN 13 : 0309164605
Total Pages : 284 pages
Book Rating : 4.3/5 (91 download)
Download or read book Ethical Considerations for Research Involving Prisoners written by Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research and published by National Academies Press. This book was released on 2007-01-22 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past 30 years, the population of prisoners in the United States has expanded almost 5-fold, correctional facilities are increasingly overcrowded, and more of the country's disadvantaged populations—racial minorities, women, people with mental illness, and people with communicable diseases such as HIV/AIDS, hepatitis C, and tuberculosis—are under correctional supervision. Because prisoners face restrictions on liberty and autonomy, have limited privacy, and often receive inadequate health care, they require specific protections when involved in research, particularly in today's correctional settings. Given these issues, the Department of Health and Human Services' Office for Human Research Protections commissioned the Institute of Medicine to review the ethical considerations regarding research involving prisoners. The resulting analysis contained in this book, Ethical Considerations for Research Involving Prisoners, emphasizes five broad actions to provide prisoners involved in research with critically important protections: • expand the definition of "prisoner"; • ensure universally and consistently applied standards of protection; • shift from a category-based to a risk-benefit approach to research review; • update the ethical framework to include collaborative responsibility; and • enhance systematic oversight of research involving prisoners.
Author :
Publisher :
ISBN 13 :
Total Pages : 268 pages
Book Rating : 4.3/5 (91 download)
Download or read book Federal Regulation of Human Experimentation, 1975 written by and published by . This book was released on 1975 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Eileen Welsome
Publisher : Delta
ISBN 13 : 0307767337
Total Pages : 724 pages
Book Rating : 4.3/5 (77 download)
Download or read book The Plutonium Files written by Eileen Welsome and published by Delta. This book was released on 2010-10-20 with total page 724 pages. Available in PDF, EPUB and Kindle. Book excerpt: When the vast wartime factories of the Manhattan Project began producing plutonium in quantities never before seen on earth, scientists working on the top-secret bomb-building program grew apprehensive. Fearful that plutonium might cause a cancer epidemic among workers and desperate to learn more about what it could do to the human body, the Manhattan Project's medical doctors embarked upon an experiment in which eighteen unsuspecting patients in hospital wards throughout the country were secretly injected with the cancer-causing substance. Most of these patients would go to their graves without ever knowing what had been done to them. Now, in The Plutonium Files, Pulitzer Prize-winning reporter Eileen Welsome reveals for the first time the breadth of the extraordinary fifty-year cover-up surrounding the plutonium injections, as well as the deceitful nature of thousands of other experiments conducted on American citizens in the postwar years. Welsome's remarkable investigation spans the 1930s to the 1990s and draws upon hundreds of newly declassified documents and other primary sources to disclose this shadowy chapter in American history. She gives a voice to such innocents as Helen Hutchison, a young woman who entered a prenatal clinic in Nashville for a routine checkup and was instead given a radioactive "cocktail" to drink; Gordon Shattuck, one of several boys at a state school for the developmentally disabled in Massachusetts who was fed radioactive oatmeal for breakfast; and Maude Jacobs, a Cincinnati woman suffering from cancer and subjected to an experimental radiation treatment designed to help military planners learn how to win a nuclear war. Welsome also tells the stories of the scientists themselves, many of whom learned the ways of secrecy on the Manhattan Project. Among them are Stafford Warren, a grand figure whose bravado masked a cunning intelligence; Joseph Hamilton, who felt he was immune to the dangers of radiation only to suffer later from a fatal leukemia; and physician Louis Hempelmann, one of the most enthusiastic supporters of the plan to inject humans with potentially carcinogenic doses of plutonium. Hidden discussions of fifty years past are reconstructed here, wherein trusted government officials debated the ethical and legal implications of the experiments, demolishing forever the argument that these studies took place in a less enlightened era. Powered by her groundbreaking reportage and singular narrative gifts, Eileen Welsome has created a work of profound humanity as well as major historical significance. From the Hardcover edition.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309133386
Total Pages : 445 pages
Book Rating : 4.3/5 (91 download)
Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Jonathan D. Moreno
Publisher : Routledge
ISBN 13 : 1136605568
Total Pages : 394 pages
Book Rating : 4.1/5 (366 download)
Download or read book Undue Risk written by Jonathan D. Moreno and published by Routledge. This book was released on 2013-05-13 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: From the courtrooms of Nuremberg to the battlefields of the Gulf War, Undue Risk exposes a variety of government policies and specific cases, includingplutonium injections to unwilling hospital patients, and even the attempted recruitment of Nazi medical scientists bythe U.S. government after World War II.
Author : American Bar Association. House of Delegates
Publisher : American Bar Association
ISBN 13 : 9781590318737
Total Pages : 216 pages
Book Rating : 4.3/5 (187 download)
Download or read book Model Rules of Professional Conduct written by American Bar Association. House of Delegates and published by American Bar Association. This book was released on 2007 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.
Author : Kathrin Herrmann
Publisher :
ISBN 13 : 9789004356184
Total Pages : 0 pages
Book Rating : 4.3/5 (561 download)
Download or read book Animal Experimentation written by Kathrin Herrmann and published by . This book was released on 2019 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Animal Experimentation: Working Towards a Paradigm Change critically appraises current animal use in science and discusses ways in which we can contribute to a paradigm change towards human-biology based approaches.
Author : Caroline Fournet
Publisher : BRILL
ISBN 13 : 9004364420
Total Pages : 411 pages
Book Rating : 4.0/5 (43 download)
Download or read book Biolaw and International Criminal Law written by Caroline Fournet and published by BRILL. This book was released on 2020-11-30 with total page 411 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biolaw and International Criminal Law: Towards Interdisciplinary Synergies investigates the foundational, conceptual and interdisciplinary aspects of an emerging field: International Criminal Biolaw.
Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309046289
Total Pages : 337 pages
Book Rating : 4.3/5 (9 download)
Download or read book The Social Impact of AIDS in the United States written by National Research Council and published by National Academies Press. This book was released on 1993-02-01 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: Europe's "Black Death" contributed to the rise of nation states, mercantile economies, and even the Reformation. Will the AIDS epidemic have similar dramatic effects on the social and political landscape of the twenty-first century? This readable volume looks at the impact of AIDS since its emergence and suggests its effects in the next decade, when a million or more Americans will likely die of the disease. The Social Impact of AIDS in the United States addresses some of the most sensitive and controversial issues in the public debate over AIDS. This landmark book explores how AIDS has affected fundamental policies and practices in our major institutions, examining: How America's major religious organizations have dealt with sometimes conflicting values: the imperative of care for the sick versus traditional views of homosexuality and drug use. Hotly debated public health measures, such as HIV antibody testing and screening, tracing of sexual contacts, and quarantine. The potential risk of HIV infection to and from health care workers. How AIDS activists have brought about major change in the way new drugs are brought to the marketplace. The impact of AIDS on community-based organizations, from volunteers caring for individuals to the highly political ACT-UP organization. Coping with HIV infection in prisons. Two case studies shed light on HIV and the family relationship. One reports on some efforts to gain legal recognition for nonmarital relationships, and the other examines foster care programs for newborns with the HIV virus. A case study of New York City details how selected institutions interact to give what may be a picture of AIDS in the future. This clear and comprehensive presentation will be of interest to anyone concerned about AIDS and its impact on the country: health professionals, sociologists, psychologists, advocates for at-risk populations, and interested individuals.
Author : United States. Department of Justice. Privacy and Civil Liberties Office
Publisher :
ISBN 13 :
Total Pages : 276 pages
Book Rating : 4.3/5 (91 download)
Download or read book Overview of the Privacy Act of 1974 written by United States. Department of Justice. Privacy and Civil Liberties Office and published by . This book was released on 2010 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: The "Overview of the Privacy Act of 1974," prepared by the Department of Justice's Office of Privacy and Civil Liberties (OPCL), is a discussion of the Privacy Act's disclosure prohibition, its access and amendment provisions, and its agency recordkeeping requirements. Tracking the provisions of the Act itself, the Overview provides reference to, and legal analysis of, court decisions interpreting the Act's provisions.
Author : Anna C. Mastroianni
Publisher :
ISBN 13 :
Total Pages : 268 pages
Book Rating : 4.3/5 (97 download)
Download or read book Women and Health Research written by Anna C. Mastroianni and published by . This book was released on 1994 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309047986
Total Pages : 353 pages
Book Rating : 4.3/5 (9 download)
Download or read book Assessing Genetic Risks written by Institute of Medicine and published by National Academies Press. This book was released on 1994-01-01 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: Raising hopes for disease treatment and prevention, but also the specter of discrimination and "designer genes," genetic testing is potentially one of the most socially explosive developments of our time. This book presents a current assessment of this rapidly evolving field, offering principles for actions and research and recommendations on key issues in genetic testing and screening. Advantages of early genetic knowledge are balanced with issues associated with such knowledge: availability of treatment, privacy and discrimination, personal decision-making, public health objectives, cost, and more. Among the important issues covered: Quality control in genetic testing. Appropriate roles for public agencies, private health practitioners, and laboratories. Value-neutral education and counseling for persons considering testing. Use of test results in insurance, employment, and other settings.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309212421
Total Pages : 318 pages
Book Rating : 4.3/5 (92 download)
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 030929665X
Total Pages : 78 pages
Book Rating : 4.3/5 (92 download)
Download or read book Oversight and Review of Clinical Gene Transfer Protocols written by Institute of Medicine and published by National Academies Press. This book was released on 2014-03-27 with total page 78 pages. Available in PDF, EPUB and Kindle. Book excerpt: Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion. Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes.
