Protecting Research Subjects After Consent: The Case for the "Research Intermediary."
Reiser, Stanley Joel
IRB: A Review of Human Subjects Research. 1993 Mar-Apr; 15(2): 10-11.
Accountability; Communication; Comprehension; Consent Forms; Consent; Disclosure; Ethical Review; Ethics; Ethics Committees; Federal Government; Forms; Government; Government Regulation; Human Experimentation; Informed Consent; Patient Advocacy; Regulation; Research; Research Subjects; Review; Standards;
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Holcomb, John B; Weiskopf, Richard; Champion, Howard; Gould, Steven A; Sauer, R Michelle; Brasel, Karen; Bochicchio, Grant; Bulger, Eileen; Cotton, Bryan A; Davis, Daniel; Dutton, Richard; Hauser, Carl J; Hess, John R; Hides, George A; Knudson, Paula; MacKenzie, Ellen; McGinnis, Robert L; Michalek, Joel; Moore, Frederick A; Omert, Laurel; Pollock, Brad H; Tortella, Bartholomew; Sugarman, Jeremy; Schreiber, Martin A; Wade, Charles E (2011-02)Selection of study endpoints is one of the most important decisions in the design of effective clinical trials. Late mortality (e.g., 28 days) is an unambiguous endpoint, accepted by regulatory agencies, but it is viewed ...