Ethical Conduct of Clinical Research Involving Children (2004) / Chapter Skim
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Appendix D: Glossary, Acronyms, and Laws and Regulations
Appendix D: Glossary, Acronyms, and Laws and Regulations
Pages 394-401
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Regulations related to the protection of human subjects focus on serious and unexpected adverse events. Age of majority.
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Certificates issued by the National Institutes of Health to research institutions to protect the privacy of research participants involved in sensitive research by protecting investigators and institutions from being compelled to release identifying informa tion in any federal, state, or local civil, criminal, administrative, legisla tive, or other proceeding. Clinical research.
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Data and safety monitoring board. An independent committee charged with periodically reviewing and comparing safety and outcome data collected during a study to determine whether a trial should continue as originally designed, should be altered, or should be terminated.
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Minimal risk. A risk associated with research in which the probability and magnitude of harm or discomfort anticipated are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical psychological examinations or tests of normal, average, healthy children.
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Federal regulations providing for general protections of human subjects in research (the basic policy of the U.S. Department of Health and Human Services for the protection of human research subjects)
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DSMB data and safety monitoring board FDA Food and Drug Administration GAO General Accounting Office HIV human immunodeficiency virus ICH International Conference on Harmonisation IND Investigational New Drug IOM Institute of Medicine IRB institutional review board NAS National Academy of Sciences NBAC National Bioethics Advisory Committee NCHS National Center for Health Statistics NCI National Cancer Institute NHRPAC National Human Research Protections Advisory Committee NICHD National Institute for Child Health and Human Development NIH National Institutes of Health NRC National Research Council OHRP Office for Human Research Protections (formerly Office for Protection from Research Risk) OIG Office of Inspector General OMH Office of Mental Health OPRR Office for Protection from Research Risk PPRA Protection of Pupil Rights Amendment SACHRP Secretary's Advisory Committee on Human Research Protections STD sexually transmitted disease TDN Therapeutic Development Network USDA U.S.
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21 CFR 56. The Food and Drug Administration policy on institutional review boards.
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APPENDIX D 401 prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition. Section 407.
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