Ethics and Regulation of Clinical Research |
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Page 8
... judgments . A judgment is a decision , verdict or con- clusion about a particular action . Particular judgments , if challenged , may be justified ethically by showing that they conform to one or more rules or norms . A rule is a more ...
... judgments . A judgment is a decision , verdict or con- clusion about a particular action . Particular judgments , if challenged , may be justified ethically by showing that they conform to one or more rules or norms . A rule is a more ...
Page 9
... judgments are provided in most other sections . In this section we shall concentrate on the fundamental ethical principles . The Commission defined a " basic ethical principle " as a " general judgment that serves as a basic ...
... judgments are provided in most other sections . In this section we shall concentrate on the fundamental ethical principles . The Commission defined a " basic ethical principle " as a " general judgment that serves as a basic ...
Page 65
... judgment and it is always possible that the value judgments of the patients might differ from those of investigators and IRB members . At an assembly of prospective subjects , investigators can learn whether these patients consider the ...
... judgment and it is always possible that the value judgments of the patients might differ from those of investigators and IRB members . At an assembly of prospective subjects , investigators can learn whether these patients consider the ...
Contents
Selection of Subjects | 49 |
Balance of Harms and Benefits | 66 |
Informed Consent | 69 |
Copyright | |
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addition adequate application appropriate approval behavior benefits biomedical Chairperson Chapter Clini Clinical Research clinical trials Commission Commission's committee competent conducted consent form considered deception Declaration of Helsinki determine develop DHEW DHHS diagnostic discussed documentation elements of informed example expedited review Experimentation Federal Register Fetal Research fetoscopy fetus fetuses Food and Drug harm Human Subjects Research identified individual informed consent injury Institutional Review Board institutionalized as mentally involving human subjects IRB members IRB review IRB's jects Lebacqz Levine Medicine mentally infirm minimal risk Nuremberg Code participation in research patients persons Pharmacology physician practice pregnant presented problems procedures prospective subject protocol purpose reasons Recommendation regulations requirements research activities research involving human research involving prisoners research subjects responsibility Review of Human rights and welfare Secretary social standard study section subpart therapeutic therapy tion treatment Tuskegee Syphilis Study utero vitro fertilization vulnerable