Description
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Alice has been diagnosed with cancer and is being treated by her doctor, Dan. Dan is an oncologist with an active research agenda and is aware of a Phase III trial of a new drug for the type of cancer that Alice has. The trial is a randomized unblinded two-armed study that compares the standard of care (the treatment that Alice is currently receiving) vs standard of care plus the new drug.Two-armed means that the patients in the trial will be divided into two groups randomly (hence randomized). It is an unblinded study, which means that patients will know which arm they are on. While Dan is not an investigator on the study, he feels that Alice should be presented with the option of participating in the study. This use case starts after Alice has made the choice, in discussion with BobDan, to participate in the study. Bob Dan will provide her treatment, including the experimental drug if she ends up on the experimental arm, but will not use the data in her health record for the study. If Alice consents, the study team will be provided with regular data extracts from her health record for the purposes of their research. To enable this data extract Bob from the research study team will seek consent from Alice, using their standard consent form. Alice will be assigned a study number (typically a random number of some kind.) The research study team will regularly extract health data from her record in accordance with the consent until a defined study end-point is reached or Alice withdraws from the study. Each tranche of data collected by the study team will be de-identified (used) and tagged with Alice's study number. The de-identified data will be sent to the drug manufacturer who is the sponsor of the trial. The drug company will use the de-identified data to evaluate the study results and produce any necessary regulatory or research results.
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Alice Authorizes Clinical Research from HEART (talks about an aggregator subsequently sharing with clinical researchers)
Alice Selectively Shares Health-Related Data with Physicians and Others from HEART (talks about deidentified data)
The GA4GH folks have a committee that created a model data sharing consent form in CommonAccord. There's capacity for it to be signed. (This is perhaps where we want to concentrate our efforts.)
Jim shares this link as a resource for helping with the first use case.
Champion / Stakeholder
John Wunderlich
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Actor | Technical Role | Role in the use case |
Alice | A person who sends a message. | The patient who is the subject of health research and whose consent is required to enable the research. |
Bob | A person who receives a message. | The person or entity that seeks consent from Alice |
| Study Sponsor | The organization that receives de-identified data including Alice's data. | |
| Study Team | The individuals who collect Alice's information at the health organization where she receives care. Bob is a member of the study team. | |
| Dan | None | The attending physician who informs Alice about the health research but is not part of it. For this use case, we separate the attending physician and the investigating physician so that there is a clear demarcation between access to health information for treatment and access to health information for research. We recognize that this is a bit of a contrivance but do so nonetheless to clarify the roles and data flows. |
Mal | A person who intercepts a message. | Generic bad actor |
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