Informed consent scientific review institutional

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Unformatted text preview: rmed consent Scientific review Institutional review boards (IRBs) Data safety and monitoring boards (DSMBs) 11/19/07 ME 128 18 How Are Patients' Rights Protected? Informed Consent: Purpose Procedures Potential risks and benefits Individual rights 11/19/07 ME 128 19 How Are Patients' Rights Protected? Scientific review Institutional review boards (IRBs) are required by federal law for trials that are: --Subject to FDA regulation 11/19/07 ME 128 20 How Are Patients' Rights Protected? Data and safety monitoring boards: Ensure that risks are minimized Ensure data integrity Stop a trial if safety concerns arise or objectives have been met 11/19/07 ME 128 21 Clinical Trial Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a...
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  • Fall '08
  • Laguette,S
  • Clinical trial, Clinical Trials Patient Protection Phases, Human Clinical Studies, Cancer Clinical Trials Education Series

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