Methods and systems for managing informed consent processes

摘要

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.

主权项

1. One or more computer-storage media having computer-executable instructions embodied thereon that, when executed, perform a method for managing an informed consent from a subject, the method comprising:
receiving, utilizing a first computer process, data representative of medical and genetic information of the subject; receiving, utilizing a second computer process, a first grant of consent associated with the data representative of medical and genetic information of the subject; receiving, utilizing a third computer process, an indication from the subject identifying a restriction for at least a portion of the data, wherein the restriction indicates one or more parties approved to search the portion of the data and one or more parties that are not approved to search the portion of the data; and storing the received data into a data memory in association with the restriction for the at least a portion of the data, wherein the first, second, and third computer processes are performed on one or more computing devices.