Ethical and Regulatory Aspects of Clinical Research PDF Download
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Author: Ezekiel J. Emanuel
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 532
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Book Description
Professionals in need of such training and bioethicists will be interested.
Author: Ezekiel J. Emanuel
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 532
Get Book Here
Book Description
Professionals in need of such training and bioethicists will be interested.
Author: Elisa Eiseman
Publisher: Rand Corporation
ISBN: 9780833033642
Category : Business & Economics
Languages : en
Pages : 206
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Book Description
The National Bioethics Advisory Commission (NBAC) was established in 1995 to advise various government entities on issues arising from research on human biology and behavior. During its five-year tenure, NBAC submitted six reports to the White House containing 120 recommendations on several complex bioethical issues including the cloning of human beings and embryonic stem cell research. This study assesses NBAC's contribution to policymaking by tracking the response to NBAC's recommendations from the president, Congress, government, societies and foundations, other countries, and international groups.
Author:
Publisher: UNESCO
ISBN: 9230011118
Category : Bioethics
Languages : en
Pages : 47
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Book Description
Author: United States. National Bioethics Advisory Commission
Publisher:
ISBN:
Category : Bioethics
Languages : en
Pages : 212
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133386
Category : Medical
Languages : en
Pages : 445
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Book Description
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: National Bioethics National Bioethics Advisory Commission
Publisher: CreateSpace
ISBN: 9781508819585
Category :
Languages : en
Pages : 282
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Book Description
Protecting the rights and welfare of those who volunteer to participate in research is a fundamental tenet of ethical research. A great deal of progress has been made in recent decades in changing the culture of research to incorporate more fully this ethical responsibility into protocol design and implementation. In the 1960s and 1970s, a series of scandals concerning social science research and medical research conducted with the sick and the illiterate underlined the need to systematically and rigorously protect individuals in research (Beecher 1966; Faden and Beauchamp 1986; Jones 1981; Katz 1972; Tuskegee Syphilis Study Ad Hoc Advisory Panel 1973). However, the resulting system of protections that evolved out of these rising concerns-although an improvement over past practices-is no longer sufficient. It is a patchwork arrangement associated with the receipt of federal research funding or the regulatory review and approval of new drugs and devices. In addition, it depends on the voluntary cooperation of investigators, research institutions, and professional societies across a wide array of research disciplines. Increasingly, the current system is being viewed as uneven in its ability to simultaneously protect the rights and welfare of research participants and promote ethically responsible research.
Author:
Publisher: Nordic Council of Ministers
ISBN: 9789289306539
Category : Political Science
Languages : en
Pages : 116
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Book Description
Includes the introductory talks and a summary of the general discussion of a workshop arranged by the Nordic Committee on Bioethics and held Oct. 10-11, 2000--Introd.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309452880
Category : Medical
Languages : en
Pages : 329
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Book Description
Genome editing is a powerful new tool for making precise alterations to an organism's genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve human health. The speed at which these technologies are being developed and applied has led many policymakers and stakeholders to express concern about whether appropriate systems are in place to govern these technologies and how and when the public should be engaged in these decisions. Human Genome Editing considers important questions about the human application of genome editing including: balancing potential benefits with unintended risks, governing the use of genome editing, incorporating societal values into clinical applications and policy decisions, and respecting the inevitable differences across nations and cultures that will shape how and whether to use these new technologies. This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309076374
Category : Science
Languages : en
Pages : 295
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Book Description
Human reproductive cloning is an assisted reproductive technology that would be carried out with the goal of creating a newborn genetically identical to another human being. It is currently the subject of much debate around the world, involving a variety of ethical, religious, societal, scientific, and medical issues. Scientific and Medical Aspects of Human Reproductive Cloning considers the scientific and medical sides of this issue, plus ethical issues that pertain to human-subjects research. Based on experience with reproductive cloning in animals, the report concludes that human reproductive cloning would be dangerous for the woman, fetus, and newborn, and is likely to fail. The study panel did not address the issue of whether human reproductive cloning, even if it were found to be medically safe, would beâ€"or would not beâ€"acceptable to individuals or society.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309084881
Category : Medical
Languages : en
Pages : 313
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Book Description
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.
