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Ethical and regulatory aspects of clinical research. Risks and benefits and research with children-2010 / Dave Wendler and Robert Nelson.
Wendler, David. National Institutes of Health (U.S.)
(CIT): Course Objectives: By the end of this course, participants will be able to: Utilize a systematic framework for evaluating the ethics of a clinical research protocol. Apply appropriate codes, regulations, and other documents governing the ethical conduct of human subject research to their own research. Discuss controversial issues relating to human subject research, including Phase 1 research, randomization, children in research, international research, etc. Identify the critical elements of informed consent and strategies for implementing informed consent for clinical research. Describe the purpose, function, and challenges of IRBs. Appreciate the experience of human subjects who have participated in research protocols.
Child Human Experimentation--ethics Research Subjects Risk Assessment Risk Factors Safety Management--ethics