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Protection Of Human Research Subjects
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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)
Book Synopsis The Belmont Report by : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
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:
Book Synopsis Responsible Research by : Institute of Medicine
Download or read book Responsible Research written by Institute of Medicine and published by National Academies Press. This book was released on 2003-02-06 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Protecting Data Privacy in Health Services Research by : Institute of Medicine
Download or read book Protecting Data Privacy in Health Services Research written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-13 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Ethical Conduct of Clinical Research Involving Children by : Institute of Medicine
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 :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)
Book Synopsis Ethical Considerations for Research Involving Prisoners by : Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research
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.
Book Synopsis The Ethics of Research with Human Subjects by : David B. Resnik
Download or read book The Ethics of Research with Human Subjects written by David B. Resnik and published by Springer. This book was released on 2018-01-09 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Intentional Human Dosing Studies for EPA Regulatory Purposes by : National Research Council
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.
Book Synopsis Institutional Review Board Member Handbook by : Robert J. Amdur
Download or read book Institutional Review Board Member Handbook written by Robert J. Amdur and published by Jones & Bartlett Publishers. This book was released on 2010-10-22 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Essential Resource for All IRB Members! Designed to give Institutional Review Board (IRB) members the information they need to protect the rights and welfare of research subjects in a way that is both effective and efficient, the chapters of the Institutional Review Board Member Handbook are short and to the point. Topic-specific chapters list the criteria IRB members should use to determine how to vote on specific kinds of studies and offer practical advice on what IRB members should do before and during full-committee meetings. NEW CHAPTERS in this Edition Include: * Definition of Human Subject Research, Exempt & Expedited Review Categories * IRB Member Conflict of Interest All chapters are completely updated for 2010 practice! This handbook is an excellent accompaniment to Institutional Review Board: Management and Function, Second Edition and the Study Guide that IRB members can access and refer to quickly and easily.
Book Synopsis The Ethics and Regulation of Research with Human Subjects by : Carl H. Coleman
Download or read book The Ethics and Regulation of Research with Human Subjects written by Carl H. Coleman and published by . This book was released on 2015 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309379512 Total Pages :283 pages Book Rating :4.3/5 (93 download)
Book Synopsis Optimizing the Nation's Investment in Academic Research by : National Academies of Sciences, Engineering, and Medicine
Download or read book Optimizing the Nation's Investment in Academic Research written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-06-29 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Ethics in Research with Human Participants by : Bruce Dennis Sales
Download or read book Ethics in Research with Human Participants written by Bruce Dennis Sales and published by Amer Psychological Assn. This book was released on 2000-01-01 with total page 215 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Protection of Human Research Subjects by : D.M. Maloney
Download or read book Protection of Human Research Subjects written by D.M. Maloney and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulations on human subjects research have evolved over a 20-year period and now provide a formal set of requirements for the conduct of federally sponsored studies. Over time, government regulations, like taboos in primitive societies, develop a life of their own, seemingly dissociated from their origins and justifica tions. When the investigator suffers the burdens of trying to comply with com plex rules, it is easy for him or her to lapse into a frustration that can be eased by being informed or reminded of why the rules were created in the first place and what they were designed to accomplish. Dennis Maloney's work provides a handy historical record of the processes by which the regulations were created and modified. He also recounts his own experience with research at Boys Town and provides instructions on how to cope with the system. It is difficult to find in one place the current status and appropriate citations for regulations as well as the contacts and know-how to obtain more information on the subject. In this respect, by providing a history and guide to interpretation and compliance, "Protection of Human Subjects" is a reference of importance and utility to the investigator entering into or working in the field of biomedical or behavioral research involving human subjects.
Book Synopsis Women and Health Research by : Institute of Medicine
Download or read book Women and Health Research written by Institute of Medicine and published by National Academies Press. This book was released on 1994-02-01 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues. Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies. Leading experts present general principles for the ethical conduct of research on womenâ€"principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research. Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research. The book addresses present-day challenges to equity in four areas: Scientificâ€"Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics. Social and Ethicalâ€"The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants. Legalâ€"Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases. Riskâ€"The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed. This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.
Book Synopsis Responsible Conduct of Research by : Adil E. Shamoo
Download or read book Responsible Conduct of Research written by Adil E. Shamoo and published by Oxford University Press. This book was released on 2009-02-12 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today.
Author :Council for International Organizations of Medical Sciences Publisher :World Health Organization ISBN 13 : Total Pages :116 pages Book Rating :4.3/5 (91 download)
Book Synopsis International Ethical Guidelines for Biomedical Research Involving Human Subjects by : Council for International Organizations of Medical Sciences
Download or read book International Ethical Guidelines for Biomedical Research Involving Human Subjects written by Council for International Organizations of Medical Sciences and published by World Health Organization. This book was released on 2002 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt: The present text is the revised/updated version of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. It consists of 21 guidelines with commentaries. A prefatory section outlines the historical background and the revision process and includes an introduction an account of earlier instruments and guidelines a statement of ethical principles and a preamble. An Appendix lists the items to be included in the research protocol to be submitted for scientific and ethical review and clearance. The Guidelines relate mainly to ethical justification and scientific validity of research; ethical review; informed consent; vulnerability - of individuals groups communities and populations; women as research subjects; equity regarding burdens and benefits; choice of control in clinical trials; confidentiality; compensation for injury; strengthening of national or local capacity for ethical review; and obligations of sponsors to provide health-care services. They are designed to be of use to countries in defining national policies on the ethics of biomedical research involving human subjects applying ethical standards in local circumstances and establishing or improving ethical review mechanisms. A particular aim is to reflect the conditions and the needs of low-resource countries and the implications for multinational or transnational research in which they may be partners.
Book Synopsis Human Subjects Research Regulation by : I. Glenn Cohen
Download or read book Human Subjects Research Regulation written by I. Glenn Cohen and published by MIT Press. This book was released on 2014-07-25 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects. The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee syphilis study, conducted by U.S. government researchers from 1932 to 1972. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws—including its potential to burden important research, overprotect some subjects and inadequately protect others, generate inconsistent results, and lag behind developments in how research is conducted. Invigorated by the U.S. government's first steps toward change in over twenty years, Human Subjects Research Regulation brings together the leading thinkers in this field from ethics, law, medicine, and public policy to discuss how to make the system better. The result is a collection of novel ideas—some incremental, some radical—for the future of research oversight and human subject protection. After reviewing the history of U.S. research regulations, the contributors consider such topics as risk-based regulation; research involving vulnerable populations (including military personnel, children, and prisoners); the relationships among subjects, investigators, sponsors, and institutional review boards; privacy, especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigm shifts. Contributors Adam Braddock, Alexander Morgan Capron, Ellen Wright Clayton, I. Glenn Cohen, Susan Cox, Amy L. Davis, Hilary Eckert, Barbara J. Evans, Nir Eyal, Heidi Li Feldman, Benjamin Fombonne, Elisa A. Hurley, Ana S. Iltis, Gail H. Javitt, Greg Koski, Nicole Lockhart, Holly Fernandez Lynch, Michael McDonald, Michelle N. Meyer, Osagie K. Obasogie, Efthimios Parasidis, Govind Persad, Rosamond Rhodes, Suzanne M. Rivera, Zachary M. Schrag, Seema K. Shah, Jeffrey Skopek, Laura Stark, Patrick Taylor, Anne Townsend, Carol Weil, Brett A. Williams, Leslie E. Wolf
Book Synopsis A Guide to the Scientific Career by : Mohammadali M. Shoja
Download or read book A Guide to the Scientific Career written by Mohammadali M. Shoja and published by John Wiley & Sons. This book was released on 2020-01-09 with total page 786 pages. Available in PDF, EPUB and Kindle. Book excerpt: A concise, easy-to-read source of essential tips and skills for writing research papers and career management In order to be truly successful in the biomedical professions, one must have excellent communication skills and networking abilities. Of equal importance is the possession of sufficient clinical knowledge, as well as a proficiency in conducting research and writing scientific papers. This unique and important book provides medical students and residents with the most commonly encountered topics in the academic and professional lifestyle, teaching them all of the practical nuances that are often only learned through experience. Written by a team of experienced professionals to help guide younger researchers, A Guide to the Scientific Career: Virtues, Communication, Research and Academic Writing features ten sections composed of seventy-four chapters that cover: qualities of research scientists; career satisfaction and its determinants; publishing in academic medicine; assessing a researcher’s scientific productivity and scholarly impact; manners in academics; communication skills; essence of collaborative research; dealing with manipulative people; writing and scientific misconduct: ethical and legal aspects; plagiarism; research regulations, proposals, grants, and practice; publication and resources; tips on writing every type of paper and report; and much more. An easy-to-read source of essential tips and skills for scientific research Emphasizes good communication skills, sound clinical judgment, knowledge of research methodology, and good writing skills Offers comprehensive guidelines that address every aspect of the medical student/resident academic and professional lifestyle Combines elements of a career-management guide and publication guide in one comprehensive reference source Includes selected personal stories by great researchers, fascinating writers, inspiring mentors, and extraordinary clinicians/scientists A Guide to the Scientific Career: Virtues, Communication, Research and Academic Writing is an excellent interdisciplinary text that will appeal to all medical students and scientists who seek to improve their writing and communication skills in order to make the most of their chosen career.
