Conflicts Of Interest In Clinical Practice And Research

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Conflict of Interest in Medical Research, Education, and Practice

Institute of Medicine,Board on Health Sciences Policy,Committee on Conflict of Interest in Medical Research, Education, and Practice
Conflict of Interest in Medical Research Education and Practice Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Conflict of Interest in Medical Research, Education, and Practice
Publisher : National Academies Press
Page : 436 pages
File Size : 40,7 Mb
Release : 2009-09-16
Category : Medical
ISBN : 9780309145442

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Conflict of Interest in Medical Research, Education, and Practice by Institute of Medicine,Board on Health Sciences Policy,Committee on Conflict of Interest in Medical Research, Education, and Practice Pdf

Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

Conflict of Interest in Medical Research, Education, and Practice

Institute of Medicine,Board on Health Sciences Policy,Committee on Conflict of Interest in Medical Research, Education, and Practice
Conflict of Interest in Medical Research Education and Practice Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Conflict of Interest in Medical Research, Education, and Practice
Publisher : National Academies Press
Page : 436 pages
File Size : 47,6 Mb
Release : 2009-10-16
Category : Medical
ISBN : 9780309131889

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Conflict of Interest in Medical Research, Education, and Practice by Institute of Medicine,Board on Health Sciences Policy,Committee on Conflict of Interest in Medical Research, Education, and Practice Pdf

Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

Clinical Practice Guidelines We Can Trust

Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines
Clinical Practice Guidelines We Can Trust Book PDF

Author : Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines
Publisher : National Academies Press
Page : 217 pages
File Size : 46,9 Mb
Release : 2011-06-16
Category : Medical
ISBN : 9780309216463

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Clinical Practice Guidelines We Can Trust by Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines Pdf

Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest ; systematic review-guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating. Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers.

Conflicts of Interest in Clinical Practice and Research

Roy G. Spece,David S. Shimm,Allen E. Buchanan
Conflicts of Interest in Clinical Practice and Research Book PDF

Author : Roy G. Spece,David S. Shimm,Allen E. Buchanan
Publisher : Unknown
Page : 480 pages
File Size : 46,6 Mb
Release : 1996
Category : Law
ISBN : UOM:39015037462796

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Conflicts of Interest in Clinical Practice and Research by Roy G. Spece,David S. Shimm,Allen E. Buchanan Pdf

Our society has long sanctioned, at least tacitly, a conflict of interest in medical practice and research as an unavoidable consequence of the different interests of the participants in health care: the physician or clinical researcher, the patient or research subject, insurance companies or research sponsors, the government, and society as a whole. This multidisciplinary effort draws from philosophy, medicine, law, economics and public policy to identify and categorize conflicts of interest in medical practice and clinical research, and, where possible, to offer a mechanism for resolving them. Part I reviews the theoretical background, including basic concepts and analytical frameworks. The second part discusses two topics prominent in current health care policy debates--self-referral and financial incentives to limit care. Part III examines conflicts of interest generated by pharmaceutical industry involvement in clinical practice and research. The final section deals with clinical research in several contexts, including institutional review boards, clinical trials, research agreements between the government and private researchers, brokerage of research subjects by contract research organizations, and cost-effectiveness studies.

Conflict of Interest and Medicine

Boris Hauray,Henri Boullier,Jean-Paul Gaudillière,Hélène Michel
Conflict of Interest and Medicine Book PDF

Author : Boris Hauray,Henri Boullier,Jean-Paul Gaudillière,Hélène Michel
Publisher : Routledge
Page : 270 pages
File Size : 49,9 Mb
Release : 2021-09-05
Category : Social Science
ISBN : 9781000432367

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Conflict of Interest and Medicine by Boris Hauray,Henri Boullier,Jean-Paul Gaudillière,Hélène Michel Pdf

In the context of a growing criticism on the influence of the pharmaceutical industry on physicians, scientists, or politicians, Conflict of Interest and Medicine offers a comprehensive analysis of the conflict of interest in medicine anchored in the social sciences, with perspectives from sociology, history, political science, and law. Based on in-depth empirical investigations conducted within different territories (France, the European Union, and the United States) the contributions analyze the development of conflict of interest as a social issue and how it impacts the production of medical knowledge and expertise, physicians’ work and their prescriptions, and also the framing of health crises and controversies. In doing so, they bring a new understanding of the transformations in the political economy of pharmaceutical knowledge, the politicization of public health risks, and the promotion of transparency in science and public life. Complementing the more normative and quantitative understandings of conflict of interest issues that dominate today, this book will be of interest to researchers in a broad range of areas including social studies of sciences and technology, sociology of health and illness, and political sociology and ethics. It will be also a valuable resource for health professionals, medical scientists, or regulators facing the question of corporate influence.

Optimizing the Process for Establishing the Dietary Guidelines for Americans

National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Food and Nutrition Board,Committee to Review the Process to Update the Dietary Guidelines for Americans
Optimizing the Process for Establishing the Dietary Guidelines for Americans Book PDF

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Food and Nutrition Board,Committee to Review the Process to Update the Dietary Guidelines for Americans
Publisher : National Academies Press
Page : 137 pages
File Size : 46,9 Mb
Release : 2017-12-16
Category : Medical
ISBN : 9780309453608

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Optimizing the Process for Establishing the Dietary Guidelines for Americans by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Food and Nutrition Board,Committee to Review the Process to Update the Dietary Guidelines for Americans Pdf

Federal guidance on nutrition and diet is intended to reflect the state of the science and deliver the most reliable recommendations possible according to the best available evidence. This guidance, updated and presented every 5 years in the Dietary Guidelines for Americans (DGA), serves as the basis for all federal nutrition policies and nutrition assistance programs, as well as nutrition education programs. Despite the use of the guidelines over the past 30 years, recent challenges prompted Congress to question the process by which food and nutrition guidance is developed. This report assesses the process used to develop the guidelines; it does not evaluate the substance or use of the guidelines. As part of an overall, comprehensive review of the process to update the DGA, this first report seeks to discover how the advisory committee selection process can be improved to provide more transparency, eliminate bias, and include committee members with a range of viewpoints for the purpose of informing the 2020 cycle.

Conflict of Interest and Medical Innovation

Sarah H. Beachy,Institute of Medicine,Adam C. Berger,Board on Health Sciences Policy,Steve Olson
Conflict of Interest and Medical Innovation Book PDF

Author : Sarah H. Beachy,Institute of Medicine,Adam C. Berger,Board on Health Sciences Policy,Steve Olson
Publisher : Unknown
Page : 0 pages
File Size : 49,7 Mb
Release : 2014
Category : Medical
ISBN : 0309301688

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Conflict of Interest and Medical Innovation by Sarah H. Beachy,Institute of Medicine,Adam C. Berger,Board on Health Sciences Policy,Steve Olson Pdf

Scientific advances such as the sequencing of the human genome have created great promise for improving human health by providing a greater understanding of disease biology and enabling the development of new drugs, diagnostics, and preventive services. However, the translation of research advances into clinical applications has so far been slower than anticipated. This is due in part to the complexity of the underlying biology as well as the cost and time it takes to develop a product. Pharmaceutical companies are adapting their business models to this new reality for product development by placing increasing emphasis on leveraging alliances, joint development efforts, early-phase research partnerships, and public-private partnerships. These collaborative efforts make it possible to identify new drug targets, enhance the understanding of the underlying basis of disease, discover novel indications for the use of already approved products, and develop biomarkers for disease outcomes or directed drug use. While the potential benefits of collaboration are significant, the fact that the relationships among development partners are often financial means that it is vital to ensure trust by identifying, disclosing, and managing any potential sources of conflict that could create bias in the research being performed together. Conflict of Interest and Medical Innovation is the summary of a workshop convened by the Institute of Medicine Roundtable on Translating Genomic-Based Research for Health in June 2013 to explore the appropriate balance between identifying and managing conflicts of interest and advancing medical innovation. A wide range of stakeholders, including government officials, pharmaceutical company representatives, academic administrators and researchers, health care providers, medical ethicists, patient advocates, and consumers, were invited to present their perspectives and participate in discussions during the workshop. This report focuses on current conflict of interest policies and their effect on medical innovation in an effort to identify best practices and potential solutions for facilitating innovation while still ensuring scientific integrity and public trust.

Conflicts of Interest and the Future of Medicine

Marc A. Rodwin
Conflicts of Interest and the Future of Medicine Book PDF

Author : Marc A. Rodwin
Publisher : Oxford University Press
Page : 392 pages
File Size : 54,8 Mb
Release : 2013-10-03
Category : Health & Fitness
ISBN : 9780199330430

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Conflicts of Interest and the Future of Medicine by Marc A. Rodwin Pdf

Offers a comparison of medical practices in the United States, Japan, and France and the variations of type and prevalence of physcians' conficts of interest.

Principles and Practice of Clinical Research

John I. Gallin,Frederick P Ognibene
Principles and Practice of Clinical Research Book PDF

Author : John I. Gallin,Frederick P Ognibene
Publisher : Elsevier
Page : 448 pages
File Size : 55,6 Mb
Release : 2011-04-28
Category : Medical
ISBN : 0080489567

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Principles and Practice of Clinical Research by John I. Gallin,Frederick P Ognibene Pdf

The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research *Delves into data management and addresses how to collect data and use it for discovery *Contains valuable, up-to-date information on how to obtain funding from the federal government

A Guide to the Scientific Career

Mohammadali M. Shoja,Anastasia Arynchyna,Marios Loukas,Anthony V. D'Antoni,Sandra M. Buerger,Marion Karl,R. Shane Tubbs
A Guide to the Scientific Career Book PDF

Author : Mohammadali M. Shoja,Anastasia Arynchyna,Marios Loukas,Anthony V. D'Antoni,Sandra M. Buerger,Marion Karl,R. Shane Tubbs
Publisher : John Wiley & Sons
Page : 786 pages
File Size : 46,7 Mb
Release : 2020-01-09
Category : Science
ISBN : 9781118907429

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A Guide to the Scientific Career by Mohammadali M. Shoja,Anastasia Arynchyna,Marios Loukas,Anthony V. D'Antoni,Sandra M. Buerger,Marion Karl,R. Shane Tubbs Pdf

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.

Responsible Research

Institute of Medicine,Committee on Assessing the System for Protecting Human Research Participants
Responsible Research Book PDF

Author : Institute of Medicine,Committee on Assessing the System for Protecting Human Research Participants
Publisher : National Academies Press
Page : 313 pages
File Size : 46,7 Mb
Release : 2003-02-06
Category : Medical
ISBN : 9780309084888

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Responsible Research by Institute of Medicine,Committee on Assessing the System for Protecting Human Research Participants Pdf

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.

Clinical Trials

Timothy M. Pawlik,Julie A. Sosa
Clinical Trials Book PDF

Author : Timothy M. Pawlik,Julie A. Sosa
Publisher : Springer Nature
Page : 254 pages
File Size : 46,9 Mb
Release : 2020-03-10
Category : Medical
ISBN : 9783030354886

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Clinical Trials by Timothy M. Pawlik,Julie A. Sosa Pdf

This extensively revised second edition is a unique and portable handbook focusing on clinical trials in surgery. It includes new educational materials addressing the rapid evolution of novel research methodologies in basic science, clinical and educational research. The underlying principles of clinical trials, trial design, the development of a study cohort, statistics, data safety, data monitoring, and trial publication for device and drug trials are also discussed. Clinical Trials provides a comprehensive resource on clinical trials in surgery and describes all the stages of a clinical trial from generating a hypothesis through to trial publication and is a valuable resource for all practicing and trainee academic surgeons.

Medicine, Money, and Morals

Marc A. Rodwin
Medicine Money and Morals Book PDF

Author : Marc A. Rodwin
Publisher : Oxford University Press
Page : 432 pages
File Size : 49,5 Mb
Release : 1995-04-20
Category : Medical
ISBN : 9780198024262

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Medicine, Money, and Morals by Marc A. Rodwin Pdf

Marc A. Rodwin draws on his own experience as a health lawyer--and his research in health ethics, law, and policy--to reveal how financial conflicts of interest can and do negatively affect the quality of patient care. He shows that the problem has become worse over the last century and provides many actual examples of how doctors' decisions are influenced by financial considerations. We learn how two California physicians, for example, resumed referrals to Pasadena General Hospital only after the hospital started paying $70 per patient (their referrals grew from 14 in one month to 82 in the next). As Rodwin writes, incentives such as this can inhibit a doctor from taking action when a hospital fails to provide proper service, and may also lead to the unnecessary hospitalization of patients. We also learn of a Wyeth-Ayerst Labs promotion in which physicians who started patients on INDERAL (a drug for high blood pressure, angina, and migraines) received 1000 mileage points on American Airlines for each patient (studies show that promotions such as this have a direct effect on a doctor's choice of drug). Rodwin reveals why the medical community has failed to regulate conflicts of interest: peer review has little authority, state licensing boards are usually ignorant of abuses, and the AMA code of ethics has historically been recommended rather than required. He examines what can be learned from the way society has coped with the conflicts of interest of other professionals --lawyers, government officials, and businessmen--all of which are held to higher standards of accountability than doctors. And he recommends that efforts be made to prohibit and regulate certain kinds of activity (such as kickbacks and self-referrals), to monitor and regulate conduct, and to provide penalties for improper conduct. Our failure to face physicians' conflicts of interest has distorted the way medicine is practiced, compromised the loyalty of doctors to patients, and harmed society, the integrity of the medical profession, and patients. For those concerned with the quality of health care or medical ethics, Medicine, Money and Morals is a provocative look into the current health care crisis and a powerful prescription for change.

Evidence-biased Antidepressant Prescription

Michael P. Hengartner
Evidence biased Antidepressant Prescription Book PDF

Author : Michael P. Hengartner
Publisher : Springer Nature
Page : 355 pages
File Size : 42,5 Mb
Release : 2021-12-09
Category : Psychology
ISBN : 9783030825874

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Evidence-biased Antidepressant Prescription by Michael P. Hengartner Pdf

This book addresses the over-prescribing of antidepressants in people with mostly mild and subthreshold depression. It outlines the steep increase in antidepressant prescription and critically examines the current scientific evidence on the efficacy and safety of antidepressants in depression. The book is not only concerned with the conflicting views as to whether antidepressants are useful or ineffective in various forms of depression, but also aims at detailing how flaws in the conduct and reporting of antidepressant trials have led to an overestimation of benefits and underestimation of harms. The transformation of the diagnostic concept of depression from a rare but serious disorder to an over-inclusive, highly prevalent but predominantly mild and self-limiting disorder is central to the books argument. It maintains that biological reductionism in psychiatry and pharmaceutical marketing reframed depression as a brain disorder, corroborating the overemphasis on drug treatment in both research and practice. Finally, the author goes on to explore how pharmaceutical companies have distorted the scientific literature on the efficacy and safety of antidepressants and how patient advocacy groups, leading academics, and medical organisations with pervasive financial ties to the industry helped to promote systematically biased benefit-harm evaluations, affecting public attitudes towards antidepressants as well as medical education, training, and practice.

Ethical Conduct of Clinical Research Involving Children

Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Ethical Conduct of Clinical Research Involving Children Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publisher : National Academies Press
Page : 445 pages
File Size : 52,9 Mb
Release : 2004-07-09
Category : Medical
ISBN : 9780309133388

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Ethical Conduct of Clinical Research Involving Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children Pdf

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.