Author: United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 286
Book Description
Protecting Human Subjects
Author: United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 286
Book Description
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 286
Book Description
Protecting Human Subjects: Report on the Adequacy and Uniformity of Federal Rules and Policies, and Their Implementation, for the Protection of Human Subjects in Biomedical and Behavioral Research
Author: United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
Publisher:
ISBN:
Category :
Languages : en
Pages : 99
Book Description
Publisher:
ISBN:
Category :
Languages : en
Pages : 99
Book Description
Implementing Human Research Regulations
Author: United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Ethics committees
Languages : en
Pages : 232
Book Description
Publisher:
ISBN:
Category : Ethics committees
Languages : en
Pages : 232
Book Description
Protecting Human Subjects - First Biennial Report on the Adequacy and Uniformity of Federal Rules and Policies, and Their Implementation, for the Protection of Human Subjects in Biomedical and Behavioral Research
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 270
Book Description
Publisher:
ISBN:
Category :
Languages : en
Pages : 270
Book Description
Protecting Human Subjects
Author: United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Human experimentation in medicine
Languages : en
Pages : 271
Book Description
Publisher:
ISBN:
Category : Human experimentation in medicine
Languages : en
Pages : 271
Book Description
Protecting Human Subjects
Author: United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 288
Book Description
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 288
Book Description
Intentional Human Dosing Studies for EPA Regulatory Purposes
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309166411
Category : Science
Languages : en
Pages : 226
Book Description
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.
Publisher: National Academies Press
ISBN: 0309166411
Category : Science
Languages : en
Pages : 226
Book Description
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.
The Oxford Textbook of Clinical Research Ethics
Author: Ezekiel J. Emanuel
Publisher: OUP USA
ISBN: 0199768633
Category : Medical
Languages : en
Pages : 848
Book Description
The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.
Publisher: OUP USA
ISBN: 0199768633
Category : Medical
Languages : en
Pages : 848
Book Description
The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.
Clinical Aspects of Functional Foods and Nutraceuticals
Author: Dilip Ghosh
Publisher: CRC Press
ISBN: 1466569166
Category : Medical
Languages : en
Pages : 470
Book Description
In the last three decades, revolutionary achievements have taken place in nutraceutical and functional food research including the introduction of a number of cutting-edge dietary supplements supported by human clinical trials and strong patents. Novel manufacturing technologies including unique extraction processes, bioavailability improvements th
Publisher: CRC Press
ISBN: 1466569166
Category : Medical
Languages : en
Pages : 470
Book Description
In the last three decades, revolutionary achievements have taken place in nutraceutical and functional food research including the introduction of a number of cutting-edge dietary supplements supported by human clinical trials and strong patents. Novel manufacturing technologies including unique extraction processes, bioavailability improvements th
Regulatory Program of the United States Government
Author: United States. Office of Management and Budget
Publisher:
ISBN:
Category : Administrative agencies
Languages : en
Pages : 624
Book Description
Publisher:
ISBN:
Category : Administrative agencies
Languages : en
Pages : 624
Book Description