Description
We distinguish here between the context of providing health care, which is a highly regulated and complex area, and the specific use case where an individual's information is being sought for use in health care research. The particular case here involves a person whose disease has experimental treatments available. We will assume for this case that the person is both an adult and capable of making decisions for themselves and giving consent. This use case may be extended into the future to account for pediatric research or research involving persons deemed incapable (mental health for example). We also note that there may be a predecessor or stereotypical case - Human Research Consent - that encompasses any research project that has humans as subjects. This could include but is not restricted to areas like human-computer interface research, social sciences research or marketing research.
Narrative
Alice 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 Dan, to participate in the study. We note that this narrative elides over whether or not Dan's use of Alice's health information to determine if she might be a candidate for research raises its own set of consent and use issues. Dan will provide her Alice with 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 study team will seek consent from Alice to participate in the study, using their standard consent form. Alice will be assigned a study number (typically a random number of some kind.) The 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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