Method and system for systematization, tracking and use of information based consent data for human sample study

摘要

The subject matter described herein includes methods, systems, and computer program products for organizing, tracking, and using informed consent data for human specimen studies. According to one method, an informed consent document is organized and an agreement agreement is attached to the specimen. Consent terms and any changes to consent terms are tracked. Authorized use analysis of specimens and associated data is performed to provide a regulatory information knowledge base (RIK) that includes global regulatory data derived from private and public sources. The consent form is automatically generated using the consent document and RIK based on the structured information.