The Belmont Report

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Publisher :
ISBN 13 :
Total Pages : 614 pages
Book Rating : 4.:/5 (327 download)

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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:

The Protection of Human Subjects in Research Conducted Or Supported by Federal Agencies

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Publisher :
ISBN 13 :
Total Pages : 104 pages
Book Rating : 4.E/5 ( download)

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Book Synopsis The Protection of Human Subjects in Research Conducted Or Supported by Federal Agencies by : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Download or read book The Protection of Human Subjects in Research Conducted Or Supported by Federal Agencies 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 104 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Protecting Data Privacy in Health Services Research

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Publisher : National Academies Press
ISBN 13 : 0309071879
Total Pages : 208 pages
Book Rating : 4.3/5 (9 download)

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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.

Ethical Conduct of Clinical Research Involving Children

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Publisher : National Academies Press
ISBN 13 : 0309133386
Total Pages : 445 pages
Book Rating : 4.3/5 (91 download)

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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.

Ethical Considerations for Research Involving Prisoners

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Publisher : National Academies Press
ISBN 13 : 0309164605
Total Pages : 284 pages
Book Rating : 4.3/5 (91 download)

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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.

The Protection of Human Subjects in Research Conducted Or Supported by Federal Agencies

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Publisher : Forgotten Books
ISBN 13 : 9780656534920
Total Pages : 102 pages
Book Rating : 4.5/5 (349 download)

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Book Synopsis The Protection of Human Subjects in Research Conducted Or Supported by Federal Agencies by : U. S. National Commission for Research

Download or read book The Protection of Human Subjects in Research Conducted Or Supported by Federal Agencies written by U. S. National Commission for Research and published by Forgotten Books. This book was released on 2018-02-14 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt: Excerpt from The Protection of Human Subjects in Research Conducted or Supported by Federal Agencies: February 10, 1978 It is c1ear that dhew has been preeminent in the area of protection of human subjects of research. Aimost a11 the other agencies that have forma1 po1icies or regulations governing such activities f0110w (to a greater or 1esser extent) the standards and procedures of dhew; rough1y ha of these agencies impose additiona1 requirements. The degree to which the other federa1 agencies monitor imp1ementation and comptiance varies, however; and nine agencies conducting or supporting research with human subjects have no forma1 po1icies to assure the protection of human subjects. Thus, the degree of protection afforded subjects of federa11y funded research varies from non existent to standards that exceed those imposed by dhew. The norm, however. About the Publisher Forgotten Books publishes hundreds of thousands of rare and classic books. Find more at www.forgottenbooks.com This book is a reproduction of an important historical work. Forgotten Books uses state-of-the-art technology to digitally reconstruct the work, preserving the original format whilst repairing imperfections present in the aged copy. In rare cases, an imperfection in the original, such as a blemish or missing page, may be replicated in our edition. We do, however, repair the vast majority of imperfections successfully; any imperfections that remain are intentionally left to preserve the state of such historical works.

Optimizing the Nation's Investment in Academic Research

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Publisher : National Academies Press
ISBN 13 : 0309379512
Total Pages : 283 pages
Book Rating : 4.3/5 (93 download)

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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.

Federal Protection for Human Research Subjects

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Publisher : Nova Publishers
ISBN 13 : 9781594547256
Total Pages : 120 pages
Book Rating : 4.5/5 (472 download)

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Book Synopsis Federal Protection for Human Research Subjects by : Lee O. Jastone

Download or read book Federal Protection for Human Research Subjects written by Lee O. Jastone and published by Nova Publishers. This book was released on 2006 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Common Rule (45 CFR 46, Subpart A) governs research that is conducted on human beings if it is funded by one of 18 federal agencies. It requires a review of proposed research by an Institutional Review Board (IRB), the informed consent of research subjects, and institutional assurances of compliance with the regulations. In 1974, 45 CFR 46 was published following some cases of harm to human subjects, such as those caused by thalidomide drug trials and the United States Public Health Service syphilis study in Tuskeegee, Alabama. The regulations had their roots in numerous international agreements, such as the Nuremberg Code and the Declaration of Helsinki, and domestic policies, such as those put forth by the Department of Health, Education and Welfare (DHEW; now the Department of Health and Human Services, HHS). In 1991, 16 federal agencies adopted 45 CFR 46, Subpart A, which then became known as the Common Rule. Since the Common Rule took effect, events like the death of Jesse Gelsinger in 1999 due to his participation a clinical trial have prompted scrutiny of the Rule and its ability to protect research subjects. In order to help enhance research subject protections, in 2000 HHS removed the Office for Protection from Research Risks (OPRR) from the National Institutes of Health (NIH), and created a new office -- the Office for Human Research Protections (OHRP) -- in an elevated position in HHS. In addition, groups like the National Bioethics Advisory Commission and the National Academies raised the following policy questions: (1) Should the Common Rule be applied to non-federally funded research, social and behavioural research, international clinical trials, and research with human biological materials? (2) Do existing provisions ensure the participation and protection of children, prisoners, minorities, those with diminished capacity, pregnant women, foetuses, neonates, and people in emergency situations? (3) What should be the requirements regarding IRBs' membership, responsibilities, training, and registration? (4) How should conflicts of interest, accreditation, ongoing research, and adverse event reporting be handled? (5) How should basic and research-related medical care's cost, and IRB liability for harm be handled? (6) How should the human subjects protection system be reassessed, adequate resources ensured, and the burdens and benefits of amending regulations appropriately weighed? (7) How does 45 CFR 46 interact with the Food and Drug Administration (FDA) regulations for the protection of human subjects (21 CFR 50 and 56), and the Privacy Rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (45 CFR 146)?

Responsible Research

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Publisher : National Academies Press
ISBN 13 : 0309084881
Total Pages : 313 pages
Book Rating : 4.3/5 (9 download)

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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.

Protecting Human Subjects

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Publisher :
ISBN 13 :
Total Pages : 286 pages
Book Rating : 4.:/5 (44 download)

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Book Synopsis Protecting Human Subjects by : United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research

Download or read book Protecting Human Subjects written by United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research and published by . This book was released on 1981 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Intentional Human Dosing Studies for EPA Regulatory Purposes

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Publisher : National Academies Press
ISBN 13 : 0309166411
Total Pages : 226 pages
Book Rating : 4.3/5 (91 download)

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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.

Institutional Review Board Member Handbook

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Publisher : Jones & Bartlett Publishers
ISBN 13 : 1449609929
Total Pages : 224 pages
Book Rating : 4.4/5 (496 download)

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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.

Human Subjects Research Regulation

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Publisher : MIT Press
ISBN 13 : 0262320835
Total Pages : 393 pages
Book Rating : 4.2/5 (623 download)

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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

Protection of Human Research Subjects

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Publisher : Springer Science & Business Media
ISBN 13 : 1461327032
Total Pages : 422 pages
Book Rating : 4.4/5 (613 download)

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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.

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children

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Publisher : National Academies Press
ISBN 13 : 0309164923
Total Pages : 216 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ethical Considerations for Research on Housing-Related Health Hazards Involving Children by : Institute of Medicine

Download or read book Ethical Considerations for Research on Housing-Related Health Hazards Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2005-11-10 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Beyond the HIPAA Privacy Rule

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Publisher : National Academies Press
ISBN 13 : 0309124999
Total Pages : 334 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Beyond the HIPAA Privacy Rule by : Institute of Medicine

Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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

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Publisher : National Academies Press
ISBN 13 : 0309298091
Total Pages : 204 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences by : National Research Council

Download or read book Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences written by National Research Council and published by National Academies Press. This book was released on 2014-03-31 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.