A couple of weeks ago I visited UCSC as part of a workshop titled “Are you my Data?” organized by Jenny Reardon of UCSC Office of Research. UCSC is becoming the major center in the US for hosting cancer-related genomics data, and organized the workshop to help inform policies governing distribution of this data to the public. This was a bit of a departure from my usual audience and role, as the event was targeted more at the social and ethical issues around sharing human health data than the more technical issues with which I am normally faced.
The central issue we faced was how to manage data collected from people in clinical trials or other medical settings: in particular, data which have broad utility to seed future medical advances though research. There’s been a pretty dismal history of medical research in this country, ranging from the cases of directly harmful experiments in the Tuskegee syphilis experiment to the much more common type of neglect and dehumanizing treatment described in Rebecca Skloot’s book The Immortal Life Henrietta Lacks. This history resulted in the development of ethical rules and procedures to govern clinical trials, including a strong emphasis on patient privacy that greatly limits access to the data generated by those trials. As part of enrolling in a clinical trial, patients sign an “informed consent” agreement in which they agree to participate in the research and are informed about the potential dangers and side effects of their participation, and give their consent for the trial to be conducted and data used in certain pre-defined ways.
However, many at this meeting felt that while the concerns around patient privacy and rights are real, many of the current rules do not serve the public well. Current consent agreements typically limit who can access the data to ensure patient privacy and protect patients against those who might use the data against them. Unfortunately, this arrangement also prevents widespread distribution of the data among researchers who could use that information to better advance treatments for diseases. In fact, in many cases the researchers running trials use narrowly-framed consents as a shield to prevent data from being distributed to their scientific or corporate competitors. Having a monopoly on data is good for individual scientific careers, but bad for future patients.
If you’re wondering why you should care about something that seems rather abstract and academic, just remember that that odds are very high that you or someone you love will someday come down with one of these sorts of diseases. People usually get involved with groups like Army of Women or Michael J Fox Foundation when they or someone they love is touched by a particular disease. These groups are great, and the specifics of targeting a particular disease gives them incredible focus and energy. However, we also think there’s a lot of general purpose infrastructure that doesn’t need to be reinvented in every disease area, and hope to partner with these sorts of groups to build it. It’s a founding belief of Sage Bionetworks that open research will be faster and more effective research, and it’s our job to find ways to make open systems work with human health data.
An example of this infrastructure is an attempt to create a standard legal clause that can be dropped into informed consent agreements, giving patients the ability to opt in to broad sharing of their data for research purposes. The Portable Legal Consent will act much like an open source software license: it will provide a standard way for patients to choose to place their data into the public domain for research purposes under terms that ensure the data will be easily and broadly shared among all researchers, not just those conducting the trial.
Of course, we don’t advocate changing clinical trials without the informed understanding and cooperation of patients. As people at the meeting discussed the issue, the topic moved from issues of privacy to issues of respect. Fundamentally, the problem with previous ethical lapses is that researchers stopped thinking of the people in the trials as actual people, and started thinking of them more like any other object of scientific scrutiny. While it’s probably not feasible or productive to have researchers completely engaged in continuous dialog with patients, we feel the research community would benefit from more active engagement of the community they are ostensibly trying to help. It’s not enough to simply ask patients to submit to research; we must find new ways to encourage patients to increase their involvement in medical research, and make that research as open and transparent as possible.