Protocol Review Within the Context of a Research Program
Miller, Franklin G.
Rosenstein, Donald L.
IRB: A Review of Human Subjects Research. 1998 Jul-Aug; 20(4): 7-10.
Coercion; Comprehension; Consent Forms; Consent; Disclosure; Education; Ethics; Ethics Committees; Forms; Human Experimentation; Information Dissemination; Informed Consent; Investigators; Motivation; Nontherapeutic Research; Patient Education; Patients; Physicians; Placebos; Research; Research Design; Research Ethics; Research Subjects; Review; Risks and Benefits; Therapeutic Research; Volunteers;
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Chen, Donna T.; Rosenstein, Donald L.; Muthappan, Palaniappan; Hilsenbeck, Susan G.; Miller, Franklin G.; Emanuel, Ezekiel J.; Wendler, David (2005-03-28)BACKGROUND: There is widespread disagreement about the type of consent needed for research with stored biological samples. Many believe consent for each future use is required to respect individuals. Others worry this ...
Miller, Franklin G.; Rosenstein, Donald L.; DeRenzo, Evan G. (1998-10-28)In response to public concern over abuses in human medical experimentation, the dominant approach to the ethics of clinical research during the past 30 years has been regulation, particularly via institutional review board ...
Chen, Donna T.; Miller, Franklin G.; Rosenstein, Donald L. (2003-04-15)All practicing physicians should be prepared to respond to requests from patients for advice about participating in clinical trials research. Even physicians who choose not to conduct clinical trials but rather devote ...