Methods and systems for managing informed consent processes
First Claim
1. A process for obtaining informed consent from a human subject for an action, comprising having the human subject store data representative of medical and genetic information into a data memory, having the human subject indicate a grant of informed consent to be associated with the stored data, allowing querying the stored data to determine the grant of informed consent associated with the stored data, allowing the determination whether the provided grant of consent is sufficient for the action and includes a grant of consent to re-contact the human subject, and allowing, in response to the determined grant of consent, to contact the human subject to request the human subject to change the associated grant of informed consent.
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Accused Products
Abstract
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.
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Citations
24 Claims
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1. A process for obtaining informed consent from a human subject for an action, comprising having the human subject store data representative of medical and genetic information into a data memory,
having the human subject indicate a grant of informed consent to be associated with the stored data, allowing querying the stored data to determine the grant of informed consent associated with the stored data, allowing the determination whether the provided grant of consent is sufficient for the action and includes a grant of consent to re-contact the human subject, and allowing, in response to the determined grant of consent, to contact the human subject to request the human subject to change the associated grant of informed consent.
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16. A system for managing access to medical record and genetic information of an individual to allow
a biomedical professional to find participants for a study, comprising a database having storage for medical record data of an individual and having storage for consent data representative of a limited grant of informed consent provided by the individual for the data, a query tool that allows a researcher to query the medical record data to identify an individual of interest to the study and that returns to the biomedical professional the consent data associated with medical record and biological data that matches the query, a re-contact mechanism for allowing the biomedical professional to indicate a required grant of consent for the study and to contact the individual and request the individual to alter the provided grant of informed consent to comply with the required grant of informed consent, and a consent mechanism for allowing the individual to participate in the study by granting a new consent.
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24. A computer readable medium having stored thereon instructions for implementing a process for obtaining informed consent from a human subject for an action, comprising having the human subject store data representative of medical and genetic information into a data memory,
having the human subject indicate a grant of informed consent to be associated with the stored data, allowing querying the stored data to determine the grant of informed consent associated with the stored data, allowing the determination whether the provided grant of consent is sufficient for the action and includes a grant of consent to re-contact the human subject, and allowing, in response to the determined grant of consent, to contact the human subject to request the human subject to change the associated grant of informed consent.
Specification