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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: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133386
Category : Medical
Languages : en
Pages : 445
Get Book Here
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: Bernard Lo
Publisher: Lippincott Williams & Wilkins
ISBN: 1451152779
Category : Medical
Languages : en
Pages : 302
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Book Description
This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major National Institutes of Health grants in academic health centers.
Author: Anna C. Mastroianni
Publisher:
ISBN:
Category : Human experimentation in medicine
Languages : en
Pages : 268
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Book Description
Author: Gerd Hanekamp
Publisher: Springer
ISBN: 9783642091407
Category : Philosophy
Languages : en
Pages : 0
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Book Description
Firms generally depend upon innovations in order to achieve advantages on competitive markets, thus also raising societal questions. Business ethics provides a normative framework for balancing the different perspectives, values, and interests at stake. This balance must be achieved both at relevant firm and regulatory levels. Business Ethics of Innovation is thus necessarily an interdisciplinary endeavour. This volume assesses general questions of how business ethics may contribute to adequate innovations and specifically discusses respective case studies in pharmaceutical and IT sectors.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309183642
Category : Medical
Languages : en
Pages : 135
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Book Description
The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.
Author: Franklin G. Miller
Publisher: Oxford University Press
ISBN: 0199896208
Category : Law
Languages : en
Pages : 347
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Book Description
This book contains 22 essays on the ethics of research involving human subjects written over a 15-year period. Topics addressed include the ethics of clinical trials, controversial study designs, and informed consent.
Author: H.P. Wolff
Publisher: Springer Science & Business Media
ISBN: 3642746152
Category : Medical
Languages : en
Pages : 319
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Book Description
Distinguished scientists and members of the medical profession discuss the research and development of safe and suitable drugs for the long-term treatment of chronic diseases. The book provides an up-to-date survey on new insights and technologies - as well as ethical considerations - , since traditional means and methods of drug research and drug development may no longer suffice to meet the challenges of the next century.
Author: Doris Schroeder
Publisher: Springer
ISBN: 3319647318
Category : Philosophy
Languages : en
Pages : 144
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Book Description
This open access book provides original, up-to-date case studies of “ethics dumping” that were largely facilitated by loopholes in the ethics governance of low and middle-income countries. It is instructive even to experienced researchers since it provides a voice to vulnerable populations from the fore mentioned countries. Ensuring the ethical conduct of North-South collaborations in research is a process fraught with difficulties. The background conditions under which such collaborations take place include extreme differentials in available income and power, as well as a past history of colonialism, while differences in culture can add a new layer of complications. In this context, up-to-date case studies of unethical conduct are essential for research ethics training.
Author: Michael J. Parnham
Publisher: IOS Press
ISBN: 9789051992793
Category : Medical
Languages : en
Pages : 176
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Book Description
Tuina or Chinese Therapeutic Massage has made a major contribution over thousands of years to the health of the people of China and neighboring countries. It is an important component of Traditional Chinese Medicine (TCM). As a manual therapy, Tuina is easy to perform, convenient, inexpensive, safe and effective, so it has become more and more popular not only with medical practitioners, but with the patients themselves, both in and out of China. The seventh volume focuses on practical applications of Tuina therapy. It is a broad introduction to the art of Tuina. It gives amongst others a general overview of Tuina including its theory, characteristics, indications, contradictions, and the locations and indications of commonly used points.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904992X
Category : Medical
Languages : en
Pages : 286
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Book Description
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.
