Methods and systems for organizing, tracking, and using informed consent data for human specimen studies

摘要

PROBLEM TO BE SOLVED: To provide a method and a system for systematizing, tracking, and using informed consent data for human specimen research. The subjects described herein include methods, systems, and computer program products for the systematization, tracking, and use of informed consent data for human specimen studies. According to one method, the informed consent document is systematized and the consent agreement is attached to the specimen. The agreement and any changes to the agreement will be tracked. Permit use analysis of samples and associated data is performed to provide a Regulatory Information Knowledge Base (RIK) containing global regulatory data derived from private and public sources. Consent forms are automatically generated using systematic, informed consent documents and RIK. [Selection diagram] Fig. 1