Methods and systems for managing informed consent processes
US7801747B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | May 22, 2006 |
| Grant date | Sep 21, 2010 |
| Priority date | — |
| Expiry date | May 14, 2027 |
Classification
- Technology area (CPC G)Physics
- CPC primaryG16B50/00
- WIPO fieldMedical technology
- WIPO sectorInstruments
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.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.