CONSENT PROCESS SPECIAL POPULATIONS CONSENT Com m on Rule ANPRM - PowerPoint PPT Presentation

S E S S I O N 3 CONSENT PROCESS SPECIAL POPULATIONS

CONSENT Com m on Rule ANPRM � Current provisions of the � The regulations would be revised to provide greater specificity Common Rule provide only about how consent forms should basic information about the be written and what information elements of informed they should contain. The goal consent and how consent would be consent forms that are shorter, more readily documents should be understood, less confusing, that written. Many consent contain all of the key forms are too long and information, and that can serve hard to understand, and as an excellent aid to help fail to include some of the someone make a good decision about whether to participate in a most important study information.

BIOSPECIMENS AND RICH DATA SOURCES Com m on Rule ANPRM � Reforms would require written � Research using existing consent for research use of biospecimens, even those that biospecimens (clinical have been stripped of or from prior research) identifiers. Consent could be obtained using a standard, short can be done without form by which a person could provide open-ended consent for consent by stripping most research uses of a variety of biospecimens (such as all clinical the specimens of specimens that might be collected at a particular hospital). identifiers This change would only apply to biospecimens collected after the effective date of the new rules