Methods and systems for managing informed consent processes

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.

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.    
     
     
         2 . A process according to  claim 1 , further comprising having a trusted third party control access to the stored medical and biological data.  
     
     
         3 . A process according to  claim 1 , wherein allowing the contacting of the human subject includes having a trusted third party to contact the human subjects.  
     
     
         4 . A process according to  claim 1  or  2 , further including encrypting the medical and genetic data stored in the data memory.  
     
     
         5 . A process according to  claim 1 , wherein allowing a human subject to store medical and biological record data includes allowing the human subject to store portions of the medical and biological record data as clear text and portions in an encrypted format.  
     
     
         6 . A process according to  claim 4 , wherein allowing queries of the stored data includes allowing queries on encrypted medical and genetic data.  
     
     
         7 . A process according to  claim 1 , further including storing with the medical and biological contact data for recontacting the human subject.  
     
     
         8 . A process according to  claim 7 , wherein the address is of the type selected from the group consisting of an e-mail address, a post address, patient code assigned to the human subject, an address for the human subject's physician, and identity information for the human subject patient.  
     
     
         9 . A process according to  claim 1 , wherein contacting the human subject to request the human subject to change the associated grant of informed consent includes contacting the human subject by a method selected from the group consisting of e-mail, mail, putting a notice on a bulletin board, contacting the human subject's physician, telephone, and using a portal the human subject is authorized to access.  
     
     
         10 . A process according to  claim 1 , further including providing a form representative of the required grant of consent.  
     
     
         11 . A process according to  claim 1 , wherein a plurality of human subjects have stored data within the data memory, further comprising 
 determining which of the human subjects identified by the query require a different grant of consent, and    contacting the identified human subjects with a request to change the granted level of consent.    
     
     
         12 . A process according to  claim 11 , wherein contacting the identified human subjects includes delivering a form for changing the granted level of consent.  
     
     
         13 . A process according to  claim 1 , further including allowing a human subject to change the consent data stored in the data memory.  
     
     
         14 . A process according to  claim 13 , wherein changing the consent data includes any one of expanding the granted level of access, reducing the granted level of access, and eliminating access.  
     
     
         15 . A process according to  claim 1 , further comprising posting for review by the human subject a notice identifying new actions that the human subject may want to be part of.  
     
     
         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.    
     
     
         17 . A system according to  claim 14 , having storage for medical record and biological data representative of previously collected biological samples, medical and genetic data.  
     
     
         18 . A system according to  claim 14 , having a network web server for providing access over a data network.  
     
     
         19 . A system according to  claim 14 , further including an encryption mechanism for encrypting the medical record data.  
     
     
         20 . A system according to  claim 17 , wherein the query mechanism includes means for performing a query on encrypted data.  
     
     
         21 . A system according to  claim 14 , wherein the contact means includes an e-mail process, a bulletin board process, and a process for delivering information in an electronic data folder.  
     
     
         22 . A system according to  claim 14 , including enrollment means for receiving communications from individuals and determining, as a function of the granted level of consent, whether to enroll the individual in an action or study.  
     
     
         23 . A system according to  claim 14  further comprising a query process having a process for sorting data records in a database as a function of consent data stored in the database and associated with data records stored therein  
     
     
         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.