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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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This note was uploaded on 07/08/2009 for the course ME 128 taught by Professor Laguette,s during the Fall '08 term at UCSB.

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