Patent Application: US-201113242964-A

Abstract:
a system and methods for creating electronic informed consent documents regarding a healthcare - related research study . such informed consent documents can include multimedia content to help the prospective participants make an informed decision as to whether or not to participate in the study . in addition to providing easy to understand information about the study , the system can allow prospective participants to store questions and notes , to take one or more tests to assess their understanding of the study , and to walk through a set of psychological , physical , and environmental issues that can help them better assess whether to participate in the study .

Description:
reference will now be made in detail to the preferred embodiments of the present invention , examples of which are illustrated in the accompanying drawings . fig1 is a block diagram illustrating the transformation of a clinical trial consent into a multimedia consent document . in a preferred embodiment , the pi first drafts an informed consent document based on a standardized information collection template or form by adding trial specific information ( block 100 ). in the embodiment illustrated in fig1 , all information in the system is created and stored in a relational database with the capability of exporting information into at least one standardized computer language , such as , but not limited to , extensible markup language (“ xml ”), hypertext markup language (“ html ”), or other language derived from or similar to the standardized generalized markup language (“ sgml ”); microsoft &# 39 ; s rich text format (“ rtf ”); adobe &# 39 ; s portable document format (“ pdf ”), or the like . such an arrangement can allow the information to be easily accessed through assigned personal identifiers . in one embodiment , the prospective participant &# 39 ; s personal identifier is keyed to appropriate clinical trials . when the prospective participant signs on with the identifier , the information in the database for that trial is unlocked and displayed as a web page . this architecture also increases the scalability of the product and allows elements , including graphic elements for definitions , to be redisplayed and repurposed throughout a plurality of research projects . the system is preferably designed using a client / server architecture . as should be appreciated by one skilled in the art , the system may be designed as a single - tier architecture or an n - tier architecture , depending on anticipated rates of change for a variety of factors , including , but not limited to , data storage , bandwidth , and computational processing . the system preferably uses at least one http - based front - end server to allow clients to interface with one or more back - end servers . although described herein as separate servers , it should be apparent to one skilled in the art that the back - end server ( s ) and the front - end server can be implemented on the same computer , or distributed across a computer grid . in one embodiment , the back - end servers are responsible for the majority of system - related information storage , processing , and presentation functions . by way of example , without intending to limit the present invention , the back - end servers may include a database server for storing packaged consent documents to be provided to candidates who are considering participating in a particular research program . the back - end servers may also perform candidate and other user identification based on information obtained by the client . the back - end servers can perform such identification using a variety of means , including without limitation assigning a personal identifier and password to each prospective participant or other user , using one or more biometric identifiers to positively identify each user , or combinations thereof . once a user has been properly identified and authenticated , the back - end servers can provide the user with an appropriate level of access to the information and resources provided by the system . clients can be software and / or hardware devices used by a pi , prospective or active participant , or other user involved in the research project . by way of example , such clients may include , but are not limited to , web browser software , such as internet explorer , distributed by microsoft corporation of redmond , wash . ; and netscape navigator , distributed by netscape corporation of mountain view , calif ., running on a personal computer , cellular telephones , portable digital assistants (“ pda &# 39 ; s ”), or pagers , or custom software for interfacing with the back - end servers . the pi &# 39 ; s document is preferably uploaded or otherwise electronically submitted to the system &# 39 ; s back - end servers via client 101 . although electronic submission is preferred for efficiency purposes , one skilled in the art would appreciate that re - keying a paper document , transcribing dictated information , or other data entry means are also effective means for submitting the information to the back - end servers . for clarity purposes , the system will be described as though the information was uploaded in electronic form . the system analyzes the uploaded document and inserts links to more detailed information about known words or phrases into the document ( block 103 ). a glossary is also created which contains definitions of the technical , medical , or other terms not frequently encountered by the general public that are in the document ( block 106 ). the system then preferably inserts links throughout the document for each of the terms in the glossary ( block 110 ). when the system is finished inserting the appropriate auto - generated content , a draft consent document is preferably made available for review by one or more technical (“ cs ”) staff members ( block 113 ). for workflow purposes , the draft consent document is preferably assigned to one or more cs staff , who may be advised that the document exists ( block 116 ). the cs staff can review the draft consent document ( block 120 ) and make any necessary changes ( block 123 ). in some cases , the cs staff may identify portions of the draft consent document for which additional content should be created . the cs staff can request creation of appropriate content , and such content requests may be logged as part of a consent document review process ( block 126 ). the cs staff may also ensure that only a limited amount of technical and / or scientific language is used in the draft consent document , and can request that some portions be rewritten if necessary ( block 130 ). when the cs staff has finished reviewing and adding the appropriate links and content to the draft consent document , the draft consent document may be converted into a simplified display format ( block 133 ). the cs staff also preferably completes other informational ( block 136 ) and assessment templates ( block 140 ) associated with the consent document . such informational and assessment templates may include , but are not limited to , a patient self test and a decision tool . these informational and assessment templates are described in more detail below . a section review list may also be auto - generated based on information present in the draft consent document . the draft consent document , the related content , and other informational and assessment templates are then combined into a packaged consent document using the pi &# 39 ; s preferred template ( block 143 ). once the package is created , the institutional review board (“ irb ”) is invited ( block 146 ) to review the packaged consent document ( block 150 ) to ensure that it meets the irb &# 39 ; s requirements . if the irb does not feel that the packaged consent document is acceptable , the irb &# 39 ; s concerns and requested changes may be addressed by the pi . the revised packaged consent document can be resubmitted to the cs staff for additional modification ( block 136 ). if the irb approves the packaged consent document , the cs staff may perform another quality assurance check on the packaged consent document ( block 156 ), and then the packaged consent document can be made available to the pi for the pi &# 39 ; s final review and approval ( block 160 ). upon final approval by the pi , cs staff can create a set of patient numbers or other user identifiers , together with associated passwords , for that particular packaged consent document . in one embodiment , the number of user identifiers created is in excess of the number of desired patients for the study . this study - specific list can then be transmitted or otherwise distributed to the pi . unique “ patient access cards ” may also be created for each user identifier and delivered to the pi . the pi can then “ prescribe ” the packaged consent document to a prospective study participant ( block 163 ) by providing a patient access card to the prospective participant registering biometric information about the prospective participant , or otherwise facilitating access . a prospective participant can then review the packaged consent document and elect whether or not to participate in the study based on information provided to them . if the prospective participant meets the study &# 39 ; s requirements and elects to participate ( block 170 ), their information is stored in the system ( block 173 ) and the pi is advised that the prospective participant has completed the consent document ( block 176 ). fig2 is a screen capture illustrating a sample login screen . this screen can be used to identify individual participants as they navigate through the packaged consent module . entry of the assigned user identifier on this screen ensures that the prospective participant accesses the recommended clinical trial if more than one trial is available from a given pi or institution . by identifying individual active and prospective participants , the system can also monitor behavior , monitor performance on assessment questions , save notes , and perform other , individual - specific tasks . although a participant login screen is presently preferred , in an alternative embodiment , anyone wishing to find out more about a particular research study may be able to access the study - related information without logging in . fig3 is a screen capture illustrating a sample welcome page and consent document layout . as fig3 illustrates , a consent document can allow a prospective participant to select from a variety of information about the study , and to go through the information at their own pace . to help participants who are visually impaired , the system may include a recording of a person reading the information contained on a given page , or a text reader may be used to read the information to the participant . in an alternative embodiment , participants may also choose their preferred written and / or spoken language . as a participant moves through the consent document , the participant may wish to take certain notes , and may have questions be asked of the pi or their own physician . the system preferably includes a participant note and question screen such as that illustrated in fig4 . the participant &# 39 ; s questions and notes are preferably stored in the system , and the participant may print them , e - mail them to the pi , a study coordinator , or other entity , or otherwise make use of the stored notes and questions . fig5 is a screen capture illustrating a sample participant self test . participants can test their understanding of the research program by taking the participant self test . the self tests can point participants to specific information about the trial whenever the participant provides an incorrect answer . in one embodiment , multiple self tests are created for each research program , thereby allowing participants to take multiple tests and further enhance their understanding of the research program . fig6 is a screen capture illustrating a sample decision tool . the decision tool can help a participant determine whether to participate in the research program . in one embodiment , the decision tool may present the participant with a series of psychological , physical , and environmental related questions or issues , and the participant can choose between two or more options . based on the participant &# 39 ; s answers , the system can then provide feedback to the participant as to whether the participant should or should not participate in the research program . fig7 is a screen capture illustrating a sample section review screen . in a preferred embodiment , a section review screen allows participants to easily access content included in a consent document , without having to scroll through the entire document . such a review screen may also include some or all of the glossary or dictionary definitions from a given section . in one embodiment , the system includes a separate glossary or dictionary screen , such as that illustrated in the screen capture of fig8 . agard a , hermeren g , herlitz j . patients &# 39 ; experiences of intervention trials on the treatment of myocardial infarction : is it time to adjust the informed consent process to the patient &# 39 ; s capacity ? heart 2001 ; 86 ( 6 ): 623 - 7 . berry d l , dodd m j , et al . informed consent : process and clinical issues . onf 1996 ; 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