发明授权
- 专利标题: Methods and systems for managing informed consent processes
- 专利标题(中): 管理知情同意程序的方法和系统
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申请号: US11438677申请日: 2006-05-22
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公开(公告)号: US07801747B2公开(公告)日: 2010-09-21
- 发明人: Andrea Califano , Aristidis Floratos , David Wang , Peter Young , Arthur Holden
- 申请人: Andrea Califano , Aristidis Floratos , David Wang , Peter Young , Arthur Holden
- 申请人地址: US KS Overland Park
- 专利权人: Cerner Innovation, Inc.
- 当前专利权人: Cerner Innovation, Inc.
- 当前专利权人地址: US KS Overland Park
- 代理机构: Shook, Hardy & Bacon L.L.P.
- 主分类号: G06F19/00
- IPC分类号: G06F19/00
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.
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