Implementing Human Research Regulations
Author | : |
Publisher | : |
Total Pages | : 232 |
Release | : 1983 |
Genre | : Human experimentation in medicine |
ISBN | : |
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Author | : |
Publisher | : |
Total Pages | : 232 |
Release | : 1983 |
Genre | : Human experimentation in medicine |
ISBN | : |
Author | : United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research |
Publisher | : |
Total Pages | : 232 |
Release | : 1983 |
Genre | : Ethics committees |
ISBN | : |
Author | : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research |
Publisher | : |
Total Pages | : 614 |
Release | : 1978 |
Genre | : Ethics, Medical |
ISBN | : |
Author | : |
Publisher | : |
Total Pages | : 219 |
Release | : 1983 |
Genre | : |
ISBN | : |
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 445 |
Release | : 2004-07-09 |
Genre | : Medical |
ISBN | : 0309133386 |
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 | : UNITED STATES. PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAVIORAL RESEARCH. |
Publisher | : |
Total Pages | : 100 |
Release | : 1983 |
Genre | : |
ISBN | : |
Author | : Ezekiel J. Emanuel |
Publisher | : |
Total Pages | : 532 |
Release | : 2003 |
Genre | : Medical |
ISBN | : |
Professionals in need of such training and bioethicists will be interested.
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Total Pages | : |
Release | : 1983 |
Genre | : |
ISBN | : |
Author | : National Research Council |
Publisher | : National Academies Press |
Total Pages | : 226 |
Release | : 2004-06-04 |
Genre | : Science |
ISBN | : 0309166411 |
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.
Author | : National Academies of Sciences, Engineering, and Medicine |
Publisher | : National Academies Press |
Total Pages | : 283 |
Release | : 2016-06-29 |
Genre | : Science |
ISBN | : 0309379512 |
Research universities are critical contributors to our national research enterprise. They are the principal source of a world-class labor force and fundamental discoveries that enhance our lives and the lives of others around the world. These institutions help to create an educated citizenry capable of making informed and crucial choices as participants in a democratic society. However many are concerned that the unintended cumulative effect of federal regulations undercuts the productivity of the research enterprise and diminishes the return on the federal investment in research. Optimizing the Nation's Investment in Academic Research reviews the regulatory framework as it currently exists, considers specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and reassesses the process by which these regulations are created, reviewed, and retired. This review is critical to strengthen the partnership between the federal government and research institutions, to maximize the creation of new knowledge and products, to provide for the effective training and education of the next generation of scholars and workers, and to optimize the return on the federal investment in research for the benefit of the American people.