Cerner Innovation, Inc.

First Genetic Trust Inc.

Arthur L Holden

Andrea Califano

Aristidis Floratos

Peter Young

David Wang

The systems and methods provide a dynamic process for obtaining and managing informed consent documentation. In general, the dynamic informed consent process (DICP) makes use of an intermediary organization, e.g., a trusted intermediary, which: (a) provides ICFs which have been dynamically generated for a specified trial or medical procedure and based on particular state or federal requirements, if any; and (b) archives copies of signed ICFs. In certain preferred embodiments, there may also be a procedure to provide training materials, such as audio or video presentations, to be viewed by prospective participants. In certain preferred embodiments, the process also includes contacting subjects who have signed ICFs in the event that there is a change of circumstance which the subject may deem material to whether s/he would continue to consent, or whether the participant needs to provide a different type of consent to participate in particular event or trial.

Methods and systems for managing informed consent processes

A method is provided for determining whether a third party is authorized to access information representative of genetic data. This information representative of genetic data is associated with a physical sample and is provided in an accessible format. A set or access rights is received that define which third parties can access the information and how the information can be used. A third party requests to access the information for the purposes of performing a test. The request is compared to the access rights. If the third party is authorized, the test is performed on the information. If, however, the third party is not authorized, access is denied.

Genetic profiling and banking system and method

A method is provided for determining whether a third party is authorized to access information representative of genetic data. This information representative of genetic data is associated with a physical sample and is provided in an accessible format. A set of access rights is received that define which third parties can access the information and how the information can be used. A third party requests to access the information for the purposes of performing a test. The request is compared to the access rights. If the third party is authorized, the test is performed on the information. If, however, the third party is not authorized, access is denied.

A genetic banking system allows the ability to securely store genetic profile data while allowing access to individuals authorized to access the profile for authorized purposes.

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Winnetka, IL, United States of America

Arthur L Holden