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...
View Full Document
- Fall '08
- Clinical trial, Clinical Trials Patient Protection Phases, Human Clinical Studies, Cancer Clinical Trials Education Series