Patent Publication Number: US-2022223238-A1

Title: Management and tracking solution for specific patient consent attributes and permissions

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a continuation of U.S. Ser. No. 16/280,750, filed Feb. 20, 2019, entitled “MANAGEMENT AND TRACKING SOLUTION FOR SPECIFIC: PATIENT CONSENT ATTRIBUTES AND PERMISSION”, now U.S. Pat. No. 11,309,065, which is incorporated by reference herein in its entirety. 
    
    
     FIELD OF INVENTION 
     The present system relates to management of patient consent. 
     BACKGROUND OF INVENTION 
     At present, it is impossible to determine for large datasets, i.e., at scale, and without extreme manual effort, high error rates, and unnecessary access to Patient Identifying Information, which patients and subjects of a clinical research or study have consented to which procedures, granted which permissions, offered which biological samples/specimens, etc. This task may involve reading the patients&#39;/subjects&#39; Informed Consent Forms (ICF) document that include the patients&#39;/subjects&#39; signatures. Such ICF document may include, e.g., 30-pages. 
     Moreover, biological samples/specimens that may be gained through specific clinical research or study, currently have a limited value. This is because such biological samples/specimens are collected for a specific context of that clinical research or study. Reuse of the biological samples/specimens, which increases their value and lowers the cost of the clinical research or studies is limited because of existing difficulties in
     a. identifying the patients or subjects from whom the biological samples/specimens were taken and to whom they belong;   b. determining permissions granted by the patients or subjects and pertaining to the biological samples/specimens;   c. asking the patients or subjects for additional permissions to their biological samples/specimens, if and when the additional permissions become necessary;   d. failure to ask the patients or subjects to grant proper use permissions of the biological samples/specimens in the first place; and   e. inconsistencies in what the permissions for the additional use of the biological samples/specimens have been granted in the text of the ICF document.   

     Manual tracking of patients&#39; or subjects&#39; consent permissions on a document-level, sometimes occurs, but it is inconsistent, unreliable, and labor-intensive. When information regarding the patients&#39; or subjects&#39; consent permissions is required, medical staff often refers to, and reads a full, signed ICF document to discern specific permissions for specific biological samples/specimens and/or procedures. Phrased differently, reading and discerning of a full, signed ICF document by a person is required for different medical clinical research or studies at different sites, and in different languages. This makes computer based pattern analysis difficult and sometimes impossible. 
     Worse, where biological samples/specimens collected through the clinical research or studies are concerned, sponsors of such studies and medical personnel often have no way of understanding annotations on the signed ICF documents. This causes the biological samples/specimens to be misidentified, or at least not clearly identified or not being associated with the patient or subject. Importantly, use of the biological samples/specimens, without clearly identifying the patient or subject who granted the consent is not permissible in the clinical research or studies. At present, verifying patient or subject consent is not possible other than by manually reading the signed ICF 
     DOCUMENTS 
     Some existing approaches address tracking of the patient consent through the use of manual data tracking in spreadsheets. Also cross-referencing biological samples/specimens with subjects IDs with their signed consents at medical and clinical research sites. However, such attempts are inadequate. They rely on re-identification of the subjects to understand their consent. These approaches lack structured data and do not provide scalability, which leads to a loss of the biological samples/specimens to destruction due to insufficient documentation. Further, these approaches are usually restricted to the document level, and do not encompass interactions with the medical and clinical research sites and patients. 
     SUMMARY OF INVENTION 
     It is an object of the present inventive system to overcome disadvantages and/or make improvements in the prior art; 
     It is an object of the inventive system to enable controls for defining of consent attributes as structured and quantifiable data at medical and clinical research site-level, Informed Consent Forms document-level, and patient-level; 
     It is still another object of the present inventive system to enable storage of these attributes as metadata in variable contexts, e.g., studies, documents, and patients; 
     It is another object of the present inventive system to make this information available to other systems; and 
     It is yet another object of the present inventive system to enable the concatenation/continual updating of these metadata over time for easy reliable access. As will be described below, the inventive system enables (a) direct and seamless consent document-authoring; (b) patient electronic consent (e-consent) processes/lifecycles; (c) progressive updating of e-consent data responsive to withdrawal of consent, re-consent, etc.; (d) capturing patient related attribute information at the moment of consent that is not based on later manual data repatriation; (e) user-driven declaration/configuration of form by administrators and content engineers; and (f) exhaustive query ability of subject/sample consent attributes at enterprise scale, i.e., hundreds of thousands of samples/subjects. 
     Provided is a method of managing consent using a computing device, the consent is given by a subject of a plurality of subjects to one or more events in one or more studies, wherein the consent and the plurality of activities are changeable, the method including: authoring one or more first data forms describing the one or more events and one or more selections responsive to the one or more events; authoring, for each of the plurality of subjects, one or more second data forms including description of a plurality of preferences; forming, for a first of the plurality of subjects, an Informed Consent Forms document by combining the one or more first data forms of a first of the one or more studies and one or more second data forms for the first subject; and generating a manifest indicating the one or more events in the first study to which the first subject has granted consent. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
       The invention is explained in further detail, and by way of example, with reference to the accompanying drawings wherein: 
         FIG. 1  is a diagram illustrating workflow of the present inventive system from inception to generation of the manifest on a computing device in accordance with an embodiment of the present inventive system; 
         FIG. 2  is a diagram illustrating a user interface used on the computing device to create data forms that describe the attributes of the study in accordance with art embodiment of the present inventive system; 
         FIG. 3  is a flowchart illustrating creation of an executed manifest in accordance with an embodiment of the present inventive system; and 
         FIG. 4  is a diagram illustrating an example of a digital communication device in accordance with the embodiment of the present inventive system. 
     
    
    
     DETAILED DESCRIPTION OF INVENTION 
     The following are descriptions of illustrative embodiments that when taken in conjunction with the following drawings will demonstrate the above noted features and advantages, as well as further ones. In the following description, for purposes of explanation rather than limitation, illustrative details are set forth such as architecture, interfaces, techniques, element attributes, etc. However, it will be apparent to those of ordinary skill in the art that other embodiments that depart from these details would still be understood to be within the scope of the appended claims. Moreover, for the purpose of clarity, detailed descriptions of well-known devices, tools, techniques, and methods are omitted so as not to obscure the description of the present inventive system. It should be expressly understood that the drawings are included for illustrative purposes and do not represent the scope of the present inventive system. In the accompanying drawings, like reference numbers in different drawings may designate similar elements. 
     The present inventive system introduces a top-level Informed Consent Form (ICF) document having a configuration that allows for standardization of fields across many documents relating to handling and utilization of biological samples/specimens for various clinical research or studies. A sponsor of each clinical research or study may design a standard form to describe attributes that will be included in each ICF document. The attributes are structured data describing various aspects of the clinical research or studies and the meaning of consent, precisely to what the consent is being given. Thus, the ICF document-level attributes may be declared during the ICF document-authoring lifecycle, rather than retrospectively. 
     The attributes may be stored in context of software objects, e.g., ICF documents&#39; attributes and a patients&#39; data document attributes, rather than in manually managed, disassociated spreadsheets. Concatenation of the ICF document and the patient data document may allow for generation of a manifest of attributes, i.e., permissions, that is not achievable outside of consent without duplicate data entry. 
     The inventive system provides reliable metadata in the ICF document, accommodates explicit requests for permissions given in the ICF document, and enables a novel tracking of answers given in the context of an original patient consent. This results in empowerment of known and potential users of the biological samples/specimens to determine both the specifics and patterns of consent in a quantifiable way with low error, minimal effort, and no unnecessary access to Patient Identification Information (PII). This greatly increases the research value of the biological samples/specimens because the inventive system enables their reuse while providing reliable bookkeeping of patient consent information. This ability to reuse the biological samples/specimens and reliability of the patient consent information will lower barriers to entry for research. 
       FIG. 1  illustrates inventive e-consent system  100  that aims to define structured attribute describing data forms describing individual clinical research or studies for which the biological samples/specimens are being procured. The data forms define the attributes of the clinical research or studies. 
     Thus, the purpose of the inventive e-consent system  100  may be achieved in about four stages. In the first stage, a system configuration stage, at step S 102  someone in a position of responsibility, e.g., an administrator of the e-consent system  100 , defines or structures the data forms of the ICF document that describe the attributes of the clinical research or study. These attributes may include type, purpose and descriptions of the biological samples/specimens; intended retention or duration for storage of the biological samples/specimens; intent to reuse of the biological samples/specimens and etc. The values of the attributes can be static, e.g. expire at end of study, or dynamic, e.g. 3 years+date of consent. 
     In the second stage, a study configuration stage, at step S 104 , again someone in a position of responsibility, e.g., the administrator or a content engineer, selects and identifies the characteristics of structured data forms to be filed and signed by patients or study participants. The characteristics indicate the patients&#39; or study participants&#39; consent to various medical procedures, giving of the biological samples/specimens, and use of the biological samples/specimens in specified and/or unspecified studies. The structured data forms with the selected characteristics should be designed to provide transparency, efficiency, and reliability in assuring proper consent. 
     As further illustrated, at step S 106 , forms that require signatures and are to be completed prior to signing are defined. At step S 108 , quality of the forms is examined and approved. Which is followed at step S 110  by the document being activated for use on the clinical research or study website accessible to computer devices via a network, e.g., the Internet. 
     As stated above, once the questions or descriptions are answered and filled in, e.g., by the administrator, they become the properties, i.e., the attributes of the document being authored. Later, when the patient signs the ICF document, that ICF document&#39;s attributes are conferred to the signing patient. And the administrator can look up the attributes of each signing patient&#39;s ICF document. 
     In the third stage, a patient consent stage, at step S 112 , after carefully reading the document information, the patient fills out all the necessary fields in the data form, e.g., date of birth, and signs. After the signature is obtained, at step S 114 , e-consent system  100  generates a manifest using a combination of the document&#39;s attribute data and patient data. 
     As illustrated in  FIG. 2 , the administrator creates the data forms including questions to define the attributes of the clinical research or study. The questions and descriptions, as exemplary and non-exhaustively illustrated in  FIG. 2 , may pertain e.g., to (1) the biological samples/specimens retention policy after withdrawal of consent; (2) the biological samples/specimens destruction policy after withdrawal of consent; (3) usage of data learned about the biological samples/specimens after withdrawal of consent; and (4) the purpose for the biological samples/specimens. Data entry fields, e.g., drop down fields including possible answers pertaining to the particular clinical research or study will be provided by the administrator including, for example, various durations for retention of the biological samples/specimens or their destruction. Also corresponding data entry fields may be provided for typed answers. 
     The data forms, like the one illustrated in  FIG. 2 , are created and published using an inventive form-builder application executing on a general purpose computer. The form-builder application enables the administrator to create the data forms by adding forms&#39; fields and defining the fields&#39; rules. The fields are then filled out and the forms signed. The administrator defines a standard form, which when filled out describes the metadata of a document. The document is filled out to accommodate specific clinical research or studies by the administrator itself or another authority. Then the document is signed by the patient who consents to participate in the clinical research or studies as outlined in the document. Once the document is signed, the form-builder application associates the patient with the metadata of the document. 
     Also, once published, the data forms can be revised and previewed. When the data forms are created and revised the administrator, or another responsible party, chooses which data form is to be applied to the ICF document. Then, before publishing, when all required fields in the data form are fill out the respective attributes may be generated. 
     An example of the generated attributes of the ICF document may look as follows: 
     
       
         
           
               
             
               
                   
               
             
            
               
                 { 
               
               
                  “Attributes”: [{ 
               
               
                   “name”: “Retention policy of samples after withdrawal (ICF Block 
               
               
                   “ 4)”, value”: “Destroy samples” 
               
               
                  }, { 
               
               
                   “name”: “Samples types that should be destroyed after withdrawal”, 
               
               
                   “value”: “NA” 
               
               
                  }, { 
               
               
                   “name”: “Data usage after withdrawal (ICF Block 8)”, 
               
               
                   “value”: “Data will continue to be used” 
               
               
                  }, { 
               
               
                   “name”: “Sample Purpose”, 
               
               
                   “value”: “Specified” 
               
               
                  }, { 
               
               
                   “name”: “Sample Optional?”, 
               
               
                   “value”: “Yes” 
               
               
                  }, { 
               
               
                   “name”: “Storage duration of samples”, 
               
               
                   “value”: “End of study” 
               
               
                  }] 
               
               
                 } 
               
               
                   
               
            
           
         
       
     
     Importantly, the attribute data of the ICF document may be stored as a property of each medical and clinical research site document-version. The attribute data of the ICF document may be changed with each version or revision of the ICF document. The version is conferred on the ICF document when a patient signs the document thereby conferring consent. Also, when the patient signs, the attribute data for that version of the ICF document is conferred to the patient, thereby forming the manifest of the patient&#39;s consent. 
     To be clear, the ICF document may have many versions, and each version may include changes to the document&#39;s content (e.g. updating risks), version information (e.g. from version 1 to version 2), and other metadata (e.g. attributes). When the patient signs a “main consent form” for a particular study, the inventive system possesses much more information than simply which document was signed. The information includes the version, language, content, and attributes of the form. Change management, i.e., version control for the ICF documents allows for protocol amendments in the clinical research or studies. 
     Where there are multiple ICF documents, each may contain different attributes. The attribute data of the many documents can be quarried to find all ICF documents which attributes do not limit some particular use of the biological samples/specimens in previously unspecified research. Moreover, report may be run to list ICF documents having particular attributes and printed, displayed or exported in various formats, e.g., simple file format CSV where one row per ICF document-version using that form and columns for each value that can be represented tabularly. 
     Table 1 illustrates an example of a report on the patients and their attributes vis a vis the ICF documents the patients signed. In this example, the patients consented to study ABCD1234 in April. Later, some of the patients re-consented to an amended ICF document with changes to attributes. (This is illustrative of how document-versions can contain changes from prior versions.) The specific fields will vary based on how attribute related fields are defined in the forms (i.e., per study sponsor) and how the ICF document attributes are specified (i.e. per study). 
     
       
         
           
               
               
               
               
               
               
               
               
             
               
                 TABLE 1 
               
               
                   
               
               
                   
                   
                 Initial Consent 
                 Most Recent Consent 
                 Current Consent 
                   
                 sample-retention- 
                 sample-reuse- 
               
               
                 Study ID 
                 Subject ID 
                 Date 
                 Date 
                 Status 
                 sample-type 
                 period-years 
                 permissions 
               
               
                   
               
             
            
               
                 ABCD1234 
                 S00001 
                 Apr. 12, 2018 
                 Apr. 12, 2018 
                 Needs to reconsent 
                 blood 
                 3 
                 this-condition 
               
               
                 ABCD1234 
                 S00002 
                 Apr. 13, 2018 
                 Nov. 14, 2018 
                 Consented 
                 blood 
                 2 
                 all-purposes 
               
               
                 ABCD1234 
                 S00003 
                 Apr. 14, 2018 
                 Apr. 14, 2018 
                 Needs to reconsent 
                 blood 
                 2 
                 this-condition 
               
               
                 ABCD1234 
                 S00004 
                 Apr. 15, 2018 
                 Apr. 15, 2018 
                 Needs to reconsent 
                 blood 
                 2 
                 this-condition 
               
               
                 ABCD1234 
                 S00005 
                 Apr. 16, 2018 
                 Apr. 16, 2018 
                 Needs to reconsent 
                 blood 
                 2 
                 this-condition 
               
               
                 ABCD1234 
                 S00006 
                 Apr. 17, 2018 
                 Nov. 14, 2018 
                 Consented 
                 blood 
                 3 
                 all-purposes 
               
               
                 ABCD1234 
                 S00007 
                 Apr. 18, 2018 
                 Nov. 14, 2018 
                 Consented 
                 blood 
                 3 
                 all-purposes 
               
               
                 ABCD1234 
                 S00008 
                 Apr. 19, 2018 
                 Nov. 14, 2018 
                 Consented 
                 blood 
                 3 
                 all-purposes 
               
               
                   
               
            
           
         
       
     
     It is notable that the report in Table 1 does not include any PII such as names, phone numbers, emails, etc. While the inventive system collects, stores, and encrypts this information it strictly restricts access to it. 
     After patient&#39;s consent, the biological sample/specimen is taken and may be associated with an identifier that uniquely associate the sample with the patient&#39;s ICF document. When the code is read, e.g., by scanning, the inventive system may instantly, without a person having to determine the patient&#39;s identity and read the full-text of their signed ICF documents, return attributes of the patient&#39;s ICF document, even when the patient has updated some or all of the attributes. 
       FIG. 3  offers another look at the creation of an executed manifest  310  using the form-builder application  300  of an embodiment of the present inventive system. To generate manifest  310 , ICF document  304  is created by a user, e.g., an administrator using the application to create consent attribute forms  302  describing the attributes of the biological sample/specimen and the attributes of the envisioned clinical research or studies for which the biological sample/specimen will be taken. 
     Further, the user forms signature forms  306  to be associated with the formed consent attribute forms  302 . The formed consent attribute forms  302  and the signature forms  306  are then combined to build the unexecuted ICF document  304  which can be presented or forwarded via a network to the patient for signature. 
     After verifying, at step  308 , that the patient has approved of the provisions stipulated to in the consent attribute forms  302  by providing the signature or signing signature forms  306 , form builder creates manifest  310  to include the attributes and the metadata associated with the attributes, as well as a version number. The version number is assigned to indicate uniqueness of the attributes. The assigned version number changes when the attributes change, as for example when the patient withdraws consent, gives consent to additional provisions of ICF document  304  or when metadata, i.e., descriptions associated with the clinical research or studies are added or modified. 
     Thus, for example, consent attribute forms  302  may include metadata fields requesting permission to draw blood; to reuse the sample; and what duration to store the sample. The respective attributes may be yes; yes; 15 years. Similarly, signature forms  306  may include metadata fields asking patients&#39; permission to notify primary care physician; to sequence the patient&#39;s genome; and to use the information for reproductive research. The respective attributes may be, no; no; and yes. Manifest  31  based on the described consent attribute forms  302  and signature forms  306 , may be shown as follows: 
     
       
         
           
               
               
             
               
                   
               
             
            
               
                 “attributes”: { 
                   
               
               
                   “sample-reuse”: “true”, 
                 - Sample reuse: yes 
               
               
                   “sample-type”: “blood”, 
                 - Blood draw: yes 
               
               
                   “storage-duration-years”: “15”, 
                 - Storage duration: 15 years 
               
               
                   “notify-primary-care”: “false”, 
                 - Notify primary care: no 
               
               
                   “sequence-genome”: “false”, 
                 - Sequence genome: no 
               
               
                   “reproductive-research”: “true” 
                 - Use for reproductive research: 
               
               
                   
                 yes 
               
               
                  } 
               
               
                   
               
            
           
         
       
     
     Finally,  FIG. 4  shows a system  400  which represents an example of computing device  404  utilized to implement the form-builder application  300  (the present inventive system described above as well as any digital communication devices that may be used in conjunction with the computing device. The system  400  includes computing device  404  that has processor  412  operationally coupled to one or more of: units of memory  414 ; rendering devices  408 , such as one or more of a display, speaker, printer, transceiver, etc.; peripheral input devices  406 ; and network  402  operationally coupled to computing device  404 . 
     Any external content may be received by processor  412  and is used to perform operations in accordance with the present inventive system. The operations may include controlling rendering device  408  to render, e.g., a user interface (UI) and/or content in accordance with the present inventive system as illustrated in the Figs. 
     Input device  406  may include one or more computer keyboard, a pointing device, e.g., a computer mouse, a microphone, touch sensitive displays screens, which may be stand alone or be a part of rendering device  408 . User input device  406  is operable to interact with processor  412  including interaction within a paradigm of the UI and/or other elements of the present inventive system, such as to enable web browsing, content selection, such as provided by left and right clicking on a device, a mouse-over, pop-up menu, radio button, etc., such as provided by user interaction with a computer mouse, etc., as may be readily appreciated by a person of ordinary skill in the art. 
     In accordance with an embodiment of the present inventive system, rendering device  408  may operate as a touch sensitive display for communicating with processors  412 , and thereby, rendering device  408  may also operate as input device  406 . In this way, a user may interact with processor  412 . Clearly user device  404 , processor  412 , memory  414 , rendering device  408 , optional disk  410  and/or user input device  406  may all or partly be portions of a computer system or other device, and/or be embedded in a portable device, such as a mobile device, personal computer, tablet, personal digital assistant, converged device such as a smart telephone, etc. 
     The methods of the present inventive system are particularly suited to be carried out by a computer software program, such program containing modules corresponding to one or more of the individual steps or acts described and/or envisioned by the present inventive system. Such program may of course be embodied in a computer-readable medium, such as an integrated chip, a peripheral device or memory, such as memory  414  and/or other memory devices coupled to processor  412 . 
     The computer-readable medium and/or memory  414  may be any recordable medium (e.g., random access memory, read only memory, removable memory, memory cards, compact discs, and digital optical disk storage, hard drives, floppy disks) or may be a transmission medium utilizing one or more of radio frequency coupling, Bluetooth coupling, infrared coupling etc. Any medium known or developed that may store and/or transmit information suitable for use with a computer system may be used as the computer-readable medium and/or memory  414 . 
     Additional memories may also be used. The computer-readable medium, memory  414 , and/or any other memories may be long-term, short-term, or a combination of long-term and short-term memories. These memories configure processor  412  to implement the methods, operational acts, and functions disclosed herein. The operation acts may include controlling rendering device  408  to render elements in a form of the UI and/or controlling rendering device  408  to render other information in accordance with the present inventive system. The memories may be implemented as electrical, magnetic or optical memory, or any combination of these or other types of storage devices. 
     Network  402  should be understood to include further network connections to other user devices, systems (e.g., servers), etc. While not shown for purposes of simplifying the following description, it is readily appreciated that network  402  may include an operable interconnection between processors, memories, displays and user inputs similar as shown for user device  404 , as well as networked servers, such as may host websites, etc. Accordingly, while the description contained herein focuses on details of interaction within components of user device  404  and other user devices and servers, it should be understood to similarly apply to interactions of other devices operably coupled to network  402 . 
     Processor  412  is capable of providing control signals and/or performing operations in response to input signals from the user input device  406  and executing instructions stored in memory  414  or on disk  410 . Processor  412  may be an application-specific or general-use integrated circuit(s). Further, processor  412  may be a dedicated processor for performing in accordance with the present inventive system or may be a general-purpose processor wherein only one of many functions operates for performing in accordance with the present inventive system. Processor  412  may operate utilizing a program portion, multiple program segments, or may be a hardware device utilizing a dedicated or multi-purpose integrated circuit. 
     Thus, while the present inventive system has been described with reference to exemplary embodiments, it should also be appreciated that numerous modifications and alternative embodiments may be devised by those having ordinary skill in the art without departing from the broader and intended spirit and scope of the present inventive system as set forth in the claims that follow. 
     The section headings included herein are intended to facilitate a review but are not intended to limit the scope of the present inventive system. Accordingly, the specification and drawings are to be regarded in an illustrative manner and are not intended to limit the scope of the appended claims.