Tomorrow, my dad will be honored at Trinity University in San Antonio as a distinguished alumnus. We’re flying the whole family down to celebrate with him, but I wanted to take a moment to celebrate him here. Since I live on the web most of the time, and few of you know his story, I wanted to tell it. The Trinity blurb is remarkably apt and pithy: His occupation is hard to describe: mainly a scientist - at the intersections of the social and environmental sciences - but also a research program manager, provider of technical assistance, and institution-builder - with one foot in the world of research and one foot in the world of practice. That’s about right. I remember learning the words “sustainable development” from him around the time he taught me to swing a baseball bat, which means late 1970s. My dad drew me into libraries in the 1980s, where I made first contact with networked computer systems, as I helped him find books and images for speeches he gave. His work picnics were places where I stepped on the feet of people who dated back to the Manhattan Project, which is part of being a national labs kid at a place like Oak Ridge. My dad has gotten a lot of notice in his own fields, but the biggest thing, the thing that makes others realize that he’s a pretty towering guy, is when the Nobel committee formally recognized him as a co-laureate in the 2007 Peace Prize shared by the IPCC and Vice President Gore. Hiscareer is remarkable, and he’s not showing any signs of stopping.

I’m sitting in the Vancouver airport winging home from TED 2014. It’s still going on, but I only had a day pass for yesterday as we gathered DNA samples for the soft launch of the Resilience Project(a collaboration between Sage Bionetoworks and Mount Sinai).

The Synapse software we run at Sage Bionetworks is open source software. That’s a statement that has a certain set of expectations that we provide you, the user, with some serious powers: you can download the code from github under the Apache 2.0 License, you can grab our bug tracker. We’ve invested in developer documentation. That’s what “open source” means. You can get our code. You can change our code. You can redistribute those changes. You can sell our software and never tell us or send us a check. There is an Open Source Definition that spells this all out clearly, arrived at via community consensus, and long used to adjudicate claims of open source-ness. There’s a rub, though. The definition is based on the distribution terms of the software - the legal tools that wrap around the code and govern its use and reuse. And we comply with all those terms. But Synapse has been built from the bottom up as a cloud-based service, Our users love that aspect. Our developers develop for that. And that creates a very interesting conundrum. We run a product that is clearly, legally, technically open source. But the definitions that govern our ability to make that claim about a piece of software don’t reach anywhere into the operations of that software - the way that we run it. This has big long-term implications. It’s thus possible to market an organization as an open source software organization, yet to architect a radically closed service built on it. It’s not what we do at Sage, or where we’re going, but it’s something that we have learned, almost by accident, that’s entirely doable. The Free Software Foundation has written about some elements of the relation between services and freedoms. But there’s not a roadmap for an organization that wants to run an open service for free. We need to watch out for for Fauxpen Source here. Not everyone can stand up an Amazon instance and run a cloud service, even if they’ve got the license rights to do so. Not everyone has steady internet. Not everyone will pay attention to the details when they see an open source stamp. Not everyone will pay for open services. And costs are a big part of the rub. Open source in the old technology model is inherently scalable at a fairly low cost other than the costs of development, which can be either paid or volunteer. The usage of the software doesn’t add much cost. If everyone is downloading and running code locally, then you don’t need a big budget for users and their usage. In a service context, our costs scale with our users - maybe linearly, but given that we store genomes and genome sequencing is cheaper every day, maybe exponentially. Open as a service is where we’re going. But no one has a map yet. If anyone’s got ideas, please get in touch.

(disclosure: This post is about Jane McGonigal. I’ve met Jane in person twice, and we follow each other on twitter. we have spent about 10 minutes total in each others’ company - we are friendly, though we don’t know each other well.) Jane McGonigal, a well-known gamer and advocate for the good that games can bring to people’s health, put up a webpage recently. It’s titled “Play, don’t replay!” and it’s intended to broadcast the existence of a study that established a small, but statistically significant, connection between playing games like Tetris and easing post-traumatic stress disorder. It’s a neat theory. I spent some time in treatment for traumatic stress disorder and looked into eye-movement desensitization and reprocessing as a therapeutic intervention, and there is some real evidence that EMDR works. It makes intuitive sense to me that games, especially ones that inspire a visual twitch like Tetris, could trigger some of the same effects. Jane came under some withering criticism for putting up the page. Much of it is gaslighting and I won’t link to it. The criticism that interests me comes from Brendan Keogh, who lists himself as a PhD Candidate in Game Studies at RMIT University in Australia, and who called the page “shockingly unethical and irresponsible.” Here’s the thing. What’s ethical or responsible depends on where you live, where you work, and what your goals are. What’s ethical is changing on us, in real time, thanks to social media. And charging that someone is shockingly unethical and irresponsible, as Brendan did, is serious stuff. It’s about the worst thing you can say in academia (perhaps only plagiarism is worse). But here’s the thing. It’s not clear to me that the page constitutes research under U.S. law. I can’t see anything on the page that says the point of the page is “a systematic investigation … designed to develop or contribute to generalizable knowledge” - which is what our laws define as research. It’s not systematic. It’s not promising to publish results. So the law’s ambiguous to me here. And it’s really important, this definition. Because the whole point of the criticism seems to be about research ethics (as opposed to, say, Aristotle’s Ethics). So whether or not this is research is really relevant to its ethics. Besides governing law, institutions control for their own liability, which means that Game Studies researchers would probably have to get institutional review for something like this even if it’s not research under the law. But Jane doesn’t work at a research institution, which means she’s not subject to institutional review. If this had been a Huffington Post piece promoting the article and asking for people to leave their experience in the comments, it wouldn’t be much different. Now it’s entirely fair to question that Jane should have taken some more time to think about whether or not she’s covered, if this is human subjects research, if she should get independent review. If her internet stature imposes an obligation. I think that would have been smart, and I’ll come back to that later in this post. But that’s the thing. It’s arguable. And arguable is a long way from “shockingly unethical.” Reading the piece it feels like there was a pre-existing allergic reaction to the “games evangelism industry” that colored the reaction to the page in question. The first version of the piece even added an Upworthy twist to the page’s description of “one simple technique” by converting it to “one simple trick” (this may be an example of priming). I have run into this allergic reaction for years in the “harder” sciences (biology especially). There is a real distaste for connecting directly to people via social media, a distaste that I believe has at least some origins in ethics training. I’d imagine Brendan has had ethics drummed into him by his university (likely the Australian version of research ethics, which does seem to have a larger idea of research than US law). Research ethics require us to get informed consent, assess risks and benefits, and perform selection of subjects - none of which are explicit in Play, don’t replay. And as someone who works nearly full time on informed consent, that does nag at my senses. I’d like to see more of those elements drawn in, more of a sense of responsibility incorporated. But I can’t get past the idea that this isn’t clearly research. It’s talking to people. And the internet has changed the way we talk to people. Talking to people over twitter reaches more people than a clinical trial if you’re Jane. When Amanda Palmer has a twitter chat about sexual violence, it reaches several orders of magnitude more people than a sexual violence research study. That reach itself doesn’t make it a study. I also can’t get past the idea that this isn’t clearly not-research either. There’s enough dancing near the creation of knowledge that, with the right eyes, one could say this is a page that should have been reviewed by an ethics committee. I would love to have seen both parties do something different here. I think Brendan’s accusation of shocking unethical irresponsible behavior ignores local context about what is research and where research ethics kick in. If you’re going to criticize someone’s ethics, you must first attempt to understand their context. I see no evidence of that in the criticism, and that bothers me. I also think Jane’s page brushes close enough to research that she should have run it past someone (not me, someone who does social science and social media) to get an ethical review. I do not think it’s unethical, though. The real reason I think she should run it by ethical review is because of her reach. I think that reach imposes an obligation, an obligation that has never existed the way it now exists. There is a real possibility for abuse in this space by those who have social reach. Indeed I think this possibility is part of the  criticism leveled by Brendan, as he repeatedly notes that he believes in her good intentions. The shockingness here is not attributed to intention, which is an interesting point of intersection. Jane could be a leader in how to use social reach ethically. I would love to see her do it - there’s not a lot of candidates who could do it better than she could. But in the general context…the line between “just talking to people” and “doing research” is dissolving. We never had to even deal with that line. It was there because only credentialed researchers could hit scale in talking to people. They could raise money, they had structures to recruit. Now Jane’s got the structures to recruit, and it’s costless to contact. Now talking-to-people can brush right up against the edge of doing-research, with all the attendant ethical questions swept up into the engine, with none of the systems functioning and none of the people talking to each other about the real problem. We need to have a serious conversation about what the dissolution of that line between research and conversation means. Research has much to teach conversation. But - and this is essential - conversations at scale have much to teach research. I would submit that conversations at scale are simultaneously the most powerful form of research that we have yet invented and a form of research that is totally outside our ethics, because it is so new. This needs to be a two-way street if traditional, university-oriented research wants to survive. Because conversations at scale are going to eat it alive if the academy tries to pick the wrong fight.

I’ve been devouring The Remedy by Thomas Goetz since it came out last week and finished it on a series of long flights this week. It’s a lucid, accessible popular science book. It’s primarily about two men - Robert Koch and Arthur Conan Doyle - engaged in a debate over whether a tuberculosis cure was indeed a cure or not. If you’re even a little interested in the late 1800s, popular science, the origins of Sherlock Holmes, or the emergence of medicine as a science you’ll probably enjoy it. For me though, I was most struck by the first few chapters and the remarkably clear unfolding of how certain moments in scientific time can be moments of massive and rapid change. Goetz traces how Koch, a country doctor in Germany with big dreams, integrated theoretical, methodological, and technological breakthroughs to become one of the most famous scientists in the world. This integration of breakthroughs fascinated me. The theoretical breakthrough was germ theory, and Koch didn’t invent it. It had spent decades burbling from the fringes of science towards the mainstream but was still well on the outside. It threatened the theories of the famous, eminence-based scientific system. And it hadn’t been demonstrably proven. But it was a powerful enough theory that despite the shutout, it continued to develop, quietly, on the edges. The methodological breakthrough was Koch’s. He figured out how to use pure cultures (the Four Postulates) to determine the cause of infectious disease. In so doing he helped cement germ theory as a cornerstone of modern science and medicine. The technological breakthroughs laid out in the book may be my favorite part. I knew about the emergence of germ theory, I knew vaguely of the four postulates, but I had no idea of the kind of rapid, on-the-fly invention that the emergence of the culture-based methodology spurred. It is straight out of Eric Von Hippel. The example that sticks with me from the book is such a simple one on the surface: the petri dish full of agar. But it arrived after Koch began culturing anthrax in the aqueous humor of a cow’s eye between glass, moving to gelatin on plates, moving to agar on the advice of a jam-savvy scientist’s wife, finally to round plates with upraised edges. This kind of evolution of technology to support methodology to support theory is packed onto most every page of the first few chapters and just blew me away. I’m fairly convinced that this is a pattern we’re in the middle of right now.  What struck me reading The Remedy was that I think we can identify the methods and the technologies - sequencing, causal statistical analysis, self-tracking, all the stuff that is on the bingo card of a “Big Data” conference attendee. But I wonder what the theory is. Goetz clearly makes the point that scientific progress is only obvious in retrospect. In the moment, it’s messy, competitive, sometimes downright personally nasty (the Pasteur-Koch animosity is epic!). The methods can seem so much more obvious in the moment than the theory. I do what I do in the belief, naive though it may be, that the breakthrough methods and technologies of the last 20 years are on the edge of allowing us to prove or disprove new theories about the causation of chronic disease, as Koch’s time did about infectious disease. And it seems obvious in retrospect that germs would emerge as the causative theory. But at the time, it wasn’t. Just like it wasn’t obvious that ulcers were caused by infection. So what are the theories of chronic disease that are going to be embarrassingly obvious? What are even the candidates? I wonder.

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. \tightlist 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.

Coming soon, stay tuned… The participant centered consent (PCC) toolkit is just about ready for its first release next month at Sage Bionetworks. The goal of the PCC toolkit is to transform the concept of consent from a signature on a legal form to a process that engages participants, and to allow as many people as possible to engage in consented studies. We’ll be providing several elements in the toolkit. a visual dictionary for informed consent - icons that represent the ways that data might be gathered or used; workflows for visual informed consent - a set of designs and patterns that can map an informed consent document to the visual dictionary, for use in various consent interactions; sample clinical documents - a template informed consent form and instances of toolkit as implemented in a successful IRB filing for an observational clinical study; implementation support - step by step instructions on how to use the toolkit, a sample piece of workflow softare, detailed FAQs, and more. \tightlist The PCC toolkit will be licensed to the commons and will be usable in any context, by any user, for any purpose, as long as attribution is provided back to Sage Bionetworks. The EDM Forum was a key supporter of the toolkit, and essential to its development. More to come. We’re excited. You can check out a recent presentation to see an example of the toolkit in action - start on slide 21.

We blew our chance to build a data world that truly empowers individuals already with consumer data and surveillance. We screwed it up well and good. We let the argument be that functionality - features, free stuff - is a solid, ethical, and most of all, normal trade for data that describes us in intimate detail. We let the companies that create that functionality use that intimate detail to sift our mail for us, to recommend sweaters to us, to share with the surveillance state and watch us. But we haven’t yet blown that chance with health. Health data is frustratingly illiquid, a truth that frustrates so many attempts to bring consumer level functionality to the health care system, especially here in the USA. But the same structural barriers to data liquidity that are so frustrating have given us a gift, the gift of time. Time has revealed exactly how abusive “data liquidity” can be when it’s controlled completely by large corporations, by an app economy that uses design to make us think as little as possible about the tradeoffs involved with our data. If we already had it in health, do you think it’d be any more individually empowering? We have a chance to do it right. We have a chance to build a health system from the inside out around mobile devices, around commodity prices for clinical data, around cheap DNA sequences, around electronic health records owned by the individual rather than the health care Borg. It’s no small irony that we can use the very same devices that have been revealed to relentlessly surveil us without agency to relentlessly surveil ourselves for health and pool that data to advance our collective understanding of health. And it’s going to happen, one way or another. There’s too much money at stake. But the choices that get made in what we measure, and how we measure, encode our politics. We can measure depression with the secondary measure of movement, for example. Do we take in GPS data? If we do, do we measure the latitude and longitude all the time, or the percentage change from a single point over the course of the day, which in turn is deleted every day? One of those choices is more exploitative than the other. Choosing one is a clear proof of how we think about the individual’s rights. Doing research this way involves risks. Some of those risks we know: disclosure, loss of privacy, risk of re-identification, discrimination, bullying. Some of them we don’t. But clinical study has never been without risk. Informed consent exists because we believe that “normal” people are capable of balancing the risks of a study against its benefits, and exercising their agency to decide to join or not. We can’t transition to a new kind of science based on individual engagement if we don’t agitate for people’s rights to share their data. We won’t be able to do that until we start to loudly and regularly proclaim, basically, that people can - should - must - be trusted to process complex concepts about research and make an informed choice to participate. Right now we run informed consent as a zero sum choice, a form written by a doctor, edited by a lawyer and a committee, no agency at all besides yes or no. The forms are typically long, filled with boilerplate that limits the liability of the organizations involved, and ban re-use of the data. Generally, we allow clinical research to treat the individual involved like a piece of land on which valuable oil sits waiting to be extracted and piped away. That’s what the participant gets to slog through, and it has a predictable impact. That’s unacceptable. We have an entire industry devoted to making complex things engaging, as long as those complex things make it easier to purchase goods and services. We need apply the same design tools towards the illustration of complex concepts like de-identification, risks of data disclosure, and benefits of data sharing and collaborative analysis. We need a visual language for the concepts of informed consent and research. We need technical frameworks that encode the agency of the individual: return results to participants, allow them to connect with the researchers, to connect with other participants. We need new norms and structures that impose obligations on data users: to be good stewards, to respect clinical study as partnership with real people, to be trustable. We can do much of this with good informed consent. Informed consent is a vector into the entire engagement of people in research, and it’s uniquely a vector that helps the open society world compared to the corporate world. And that’s another reason to do not just act on this chance, but to act quickly: if we wait until the health care behemoths get to it, we can expect informed consent to get road-graded down to a one-click. And that’d be a damn shame. (derived in part from a talk given at the Broad Institute yesterday)

So, Nature said a thing about public access tonight. Everything is free to read* they say. But there’s an asterisk, pesky and persistent, next to read. And it’s a big one. The asterisk is that you can’t do anything but read the document, and you have to \soutdownload use their proprietary reader software in order to read the document, and you have to hope that someone who has a subscription or is a journalist is kind enough to share a link to the document that you want to read, and if you try to do anything other than look at the document passively on a screen you’re basically gonna get sued for copyright infringement. I got contacted in advance for my take, and I really did think long and hard on this. I wanted to be impressed. I wanted to believe in it. I wanted to be courteous, to find common ground. And I am certainly pleased they included the backfile of old papers in their strategy, a longtime gripe of mine. But I can’t praise. I just can’t. The ability to beg for a link, to be opened in a closed ecosystem that literally disables core functions on your device like “print” and “screenshot”…that’s not an advance. It’s a canonization of a system that privileges the wealthy academic. It’s a canonization of a system that says it’s ok to pay for documents while simultaneously losing all rights. It’s a canonization of a system that says a small number of companies not only do control the world’s knowledge, but should control all the world’s knowledge. Think about it. The people who are allowed to share the link are people who have paid enormous sums for the literature…yet they can’t send you something you’re even allowed to print on a crappy deskjet. The right to index the literature so we can have scholarly search that doesn’t totally suck? Not here. The right to cross-reference the literature to databases? Absent. The right to start companies that can outdo the famous publishers on both of these fronts? Explicitly forbidden. And we need those rights. As Dave Clifford noted… @wilbanks There’s no reason a computer would ever need to read a pdf instead of a human. *Counts the # of publications last year.* Oh wait. — Dave Clifford (@DCDave) December 2, 2014 So let’s do count that number. How many papers do get published? How long would it take to read them all, with no rights to get help from computers? Jason Priem has a handy chart for us.

I don’t often ask y’all for financial support. But this is important. My employer, Sage Bionetworks, is partnering with Prize4Life and the DREAM project to run a computational challenge in ALS. You may remember ALS from this summer’s insanely viral Ice Bucket Challenge. If you took the challenge but never donated, here’s a good chance to do so. And you’ll know exactly where your money is going, unlike most donations! We are trying to raise $37,000 in prize money. We’ll use the funds to set up prizes to be won in a challenge format. We’ll ask brilliant minds from around the world to develop computational tools that predict why it is some ALS patients live longer than others, and to figure out why symptoms are so different for some patients than others. 100% of your prize money will go to Fund the Prize. This isn’t particularly risky, because we know it works - it’s been done before. In the first ALS DREAM Challenge, a data analyst from a marketing company, who had no life sciences training, shared the lead prize with a lawyer and statistics professor from Stanford University. Their innovative tools were published in Nature Biotechnology and outperformed the estimates of more than 12 expert clinicians of ALS. The first Challenge’s outputs will allow future clinical trials to be run with 20% fewer patients and reduce costs by at least $6 million per trial. If we knew which body parts would be affected and how quickly motor and neurological functions might deteriorate, and the reasons why some people’s progression is different from other ALS patients, families could make clearer decisions about how to live their lives at each stage.  This kind of knowledge would also help to target clinical trials on ALS sub-groups, advancing new treatments or a cure faster and more cheaply.

I spent most of this week at Health Datapalooza, the big annual event that brings the health IT industry and the health IT feds together here in Washington DC. It was as wonky and startupy as ever, and I’m ever-grateful to Academy Health for letting me be a part of it. As is usual, I was going on about informed consent and ethics and the idea that we don’t have to toss those two things over the side to get innovation out of health IT, especially health IT that moves closer and closer to the citizen. But I felt alone a lot. Many folks didn’t even want to use the word citizen, preferring “consumer” or “user” instead. There was a sense among quite a few people I spoke with that privacy was a problem to be gotten rid of, sand in the gears of the soon-to-be-realized brave new health world. And that bugs me a lot. We gave away our shot at an ethical consumer technology world a while ago. We don’t have to give this one away. The failure is evident every time I see a story about an amazing technology. Design a robot that can unfold inside a kid’s stomach to get swallowed batteries out? DONE. Design software that respects privacy? WHOA SLOW DOWN THERE BUDDY. This failure of imagination is the most significant threat to health privacy - the idea that because we threw it away in the software stacks that we have to throw it away in the health stacks. It’s a failure that comes from entrepreneurs, who don’t see the opportunity in treating people like citizens with rights instead of potential customers to be targeted. It’s also a failure that comes from investors who can’t imagine a business model other than “data is oil” - with no thought to the network effects of treating human beings literally as oil wells (without even the grace to share mineral rights - my Texan family would never stand for that). Imagine bigger, folks. Try integrating ethics into your design. Try thinking of participant-centric as meaning “inviolable rights” rather than “targeting for purchase.” You might be surprised to find that ethical designs work really well, and that you don’t have to treat a human being like an oil well to innovate in health IT.

I wrote this two months ago, as my dad died on January 29. but attending yesterday’s climate march pushed me to post it publicly (dad was a co-laureate on the IPCC Nobel for his work on climate adaptation). This one’s for you, Dad.

I was lucky to officiate the wedding of my dear friends Kelsey and Ryan earlier this week. I wrote this little homily for them as part of the ceremony.