I’ve been quiet on the Portable Legal Consent front for a bit, but there’s enough going on that it feels like time to make a public update on where we’ve been, where we are, and where we’re going.
First, the study we’ve been running at Sage Bionetworks - the Self-Contributed Cohort - has yielded a lot of data. I’ve got a chapter in the Privacy, Big Data, and the Public Good book coming out later this year that goes into some detail, and we’ll be preparing a paper for peer-review later in the year as well. The short version is:
- Deploying interaction design is incredibly effective at increasing informedness in an e-consent context. We can get levels of informedness, even on complex concepts, that can outstrip traditional methods of consent. That’s the good news.
- Most people do not yet have enough data about themselves, or good enough data, to feed computational modeling processes that generate insights. Despite all the advances of patient-centered research, direct-to-consumer genomics, electronic medical records, and more, the data simply aren’t yet rich and clean enough to make the big data analytics tools really sing in a citizen-contributed cohort. That’s the bad news.
- If we want the kind of prediction engines in use by Amazon or Facebook or Google, which we use to figure out why drugs work in arthritis, generate insights for personalized cancer therapy, predict Alzheimers progression, and more…we need the kind of rich, clean data that comes out of structured study.
- Clinical studies are the best structured place at the moment to get rich, clean data about individuals to feed computational reuse.
Given these results, we have turned the revision of PLC towards the study itself. We have been working in partnership with the Electronic Data Methods (EDM) Forum as a Collaborative Methods Project. The EDM Forum is funded by the Alliance for Healthcare Research and Quality and is a multi-year project to build capacity for networks of actors working in health care.
We conducted a series of interviews under the EDM’s guidance earlier this year as part of an in-depth interaction design process. We talked to giant clinical systems, hospital surgical centers, patient-powered networks, clinical data networks, patient advocates, and more. And to get to the million patients I’ve always wanted under PLC and make their data actionable for computation, we need to infuse PLC into clinical studies. This creates a requirement for decentralized approaches, which fits nicely with most of my underlying beliefs about networks (they are either dominated by a dictator at the center, or they’re built at the edges by lots of people using standardized tools - take a guess with my preference!).
Clinical studies happen locally, and their protocols and consent forms are approved locally. Think of it as thousands of little pieces of software - legal code - that don’t interoperate. Thus, PLC 2.0 is not “one consent form to rule them all.” It is instead designed to make it easy for those writing the thousands of little pieces of legal code to add on functionality: getting the data from the study into the cloud for secondary reuse, and empowering patients to receive and transmit a copy of the data about them to other parties. It’s akin to a software developer’s kit, but for legal code.
The beta of PLC 2.0 (which we’re calling the PLC toolkit) will be released in the fall of 2014. The toolkit isn’t going to contain any technology in this release. It’s instead a set of text documents containing consent language for various classes of data, wireframes for those classes of data, implementation guidelines for investigators running studies, and educational materials for institutional review boards. Supported data modules include mobile devices, wearable sensors, electronic medical records, labs data, and genetic sequences. All the files will be available under the CC-BY 4.0 license, so they’ll be infinitely reusable by all parties for all uses as long as we get attribution.
I expect to see a few mobile applications using the toolkit as part of Sage’s BRIDGE project and partnerships coming out this fall. And we are conducting private alpha testing now and welcome anyone who wants to get involved and review - email me for details.
In the interim, here’s a teaser that I showed publicly at the last EDM forum meeting. It’s the dashboard that sits inside mobile applications and manages a participant’s ongoing consent inside a clinical study. This is the kind of wireframe we’re designing.