Conflict of Interest in Medical Research, Education, and Practice

Conflict of Interest in Medical Research, Education, and Practice

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2009-09-16

Total Pages: 436

ISBN-13: 0309145449

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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.


United States Code

United States Code

Author: United States

Publisher:

Published: 2013

Total Pages: 1146

ISBN-13:

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"The United States Code is the official codification of the general and permanent laws of the United States of America. The Code was first published in 1926, and a new edition of the code has been published every six years since 1934. The 2012 edition of the Code incorporates laws enacted through the One Hundred Twelfth Congress, Second Session, the last of which was signed by the President on January 15, 2013. It does not include laws of the One Hundred Thirteenth Congress, First Session, enacted between January 2, 2013, the date it convened, and January 15, 2013. By statutory authority this edition may be cited "U.S.C. 2012 ed." As adopted in 1926, the Code established prima facie the general and permanent laws of the United States. The underlying statutes reprinted in the Code remained in effect and controlled over the Code in case of any discrepancy. In 1947, Congress began enacting individual titles of the Code into positive law. When a title is enacted into positive law, the underlying statutes are repealed and the title then becomes legal evidence of the law. Currently, 26 of the 51 titles in the Code have been so enacted. These are identified in the table of titles near the beginning of each volume. The Law Revision Counsel of the House of Representatives continues to prepare legislation pursuant to 2 U.S.C. 285b to enact the remainder of the Code, on a title-by-title basis, into positive law. The 2012 edition of the Code was prepared and published under the supervision of Ralph V. Seep, Law Revision Counsel. Grateful acknowledgment is made of the contributions by all who helped in this work, particularly the staffs of the Office of the Law Revision Counsel and the Government Printing Office"--Preface.


Section 1557 of the Affordable Care Act

Section 1557 of the Affordable Care Act

Author: American Dental Association

Publisher: American Dental Association

Published: 2017-05-24

Total Pages: 60

ISBN-13: 1941807712

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Section 1557 is the nondiscrimination provision of the Affordable Care Act (ACA). This brief guide explains Section 1557 in more detail and what your practice needs to do to meet the requirements of this federal law. Includes sample notices of nondiscrimination, as well as taglines translated for the top 15 languages by state.


Women and Health Research

Women and Health Research

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1994-02-01

Total Pages: 286

ISBN-13: 030904992X

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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.


Ethical Considerations for Research Involving Prisoners

Ethical Considerations for Research Involving Prisoners

Author: Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research

Publisher: National Academies Press

Published: 2007-01-22

Total Pages: 284

ISBN-13: 0309164605

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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.


Agriculture Priorities and Allocations System (Us Farm Service Agency Regulation) (Fsa) (2018 Edition)

Agriculture Priorities and Allocations System (Us Farm Service Agency Regulation) (Fsa) (2018 Edition)

Author: The Law The Law Library

Publisher: Createspace Independent Publishing Platform

Published: 2018-10-23

Total Pages: 52

ISBN-13: 9781729565100

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Agriculture Priorities and Allocations System (US Farm Service Agency Regulation) (FSA) (2018 Edition) The Law Library presents the complete text of the Agriculture Priorities and Allocations System (US Farm Service Agency Regulation) (FSA) (2018 Edition). Updated as of May 29, 2018 The Farm Service Agency (FSA) is establishing the regulation for the Agriculture Priorities and Allocations System (APAS). Food is a critical commodity essential to the national defense (including civil emergency preparedness and response). To avoid civilian hardship during national defense emergencies, it may be necessary to regulate the production, processing, storage, and wholesale distribution of food. Through the APAS rule, the U.S. Department of Agriculture (USDA) will respond to requests to place priority ratings on contracts or orders (establishing priority on which contracts or orders are filled first) for agriculture commodities up through the wholesale levels, including agriculture production equipment, and allocate resources, as specified in the Defense Production Act (DPA) of 1950, as amended, if the necessity arises. FSA is implementing this rule as a way to redirect the agriculture commodities and resources to areas of hardship or potential hardship due to national emergencies. In most cases, there is likely to be no economic impact in filling priority orders because it would generally just be changing the timing in which orders are completed. This book contains: - The complete text of the Agriculture Priorities and Allocations System (US Farm Service Agency Regulation) (FSA) (2018 Edition) - A table of contents with the page number of each section