The goal of Consent to Research is to play a part in the transformation of health from something we experience passively to something we experience actively. Our health is more than the medical visits we make, or the genomes we carry inside us, or our environments. We can now measure an enormous set of data about an individual, and if there were an enormous pool of publicly available health data, it will be far easier to apply powerful modeling techniques and begin to develop new kinds of hypotheses about the connections between our health, our DNA, and our choices.
Our strategy to achieve this goal is to create a massive pool of openly available, user-contributed data about health and disease. Right now data about people’s health is expensive, complex to access, and the sample sizes are tiny.
The problem is that right now, it’s not easy to donate your data to health research.
Thus, our tactics are to create standard, free tools for managing data donation and personal data, promote the use of open standards, and embed our tools into clinical study. These tools help people not only gather data about themselves and their health, but get that data into the hands of data-driven research scientists. Everything we do is free.
To help potential data donors, we make systems that let data donation happen: informed consent processes, institutional review board protocols, tools to extract data from the systems where it normally lives, and a software system that can receive data and get it to health researchers.
PORTABLE LEGAL CONSENT
The legal system is Portable Legal Consent, so named because it allows data donors to carry their consent with them, and to attach that consent to the data they donate – it’s portable.
PLC is at heart designed as an open standard, inspired by the way that technology protocols such as HTTP and TCP/IP work. That means that we’re building a methodology by which multiple “open consent” projects might use their own consent forms and protocols, but have all the data be legally interoperable and usable as a common pool of information. We’re starting by writing a specific implementation being used in the Self Contributed Cohort for Common Genomics Research study, or SCC-CGR, which has been positively received by the research and patient advocacy communities. SCC-CGR is a study run by Sage Bionetworks and you are welcome to enroll.
Five other projects are underway through the Bridge project, also being run by Sage Bionetworks. We are also developing a process to certifying the other “gold standard” open consent protocol already in use at the Personal Genome Project.
WHO WE ARE
John Wilbanks runs CtR as the Chief Commons Officer at Sage Bionetworks and as a senior fellow in Entrepreneurship at the Ewing Marion Kauffman Foundation. Our work is supported by Sage Bionetworks, Lybba.org, Inspire2Live, and the Ewing Marion Kauffman Foundation.
Pro bono legal support on the first standard consent form (in use in the SGG-CGR sturdy) was provided by Dan Vorhaus and Wilson Sonsini Goodrich & Rosati. Low bono, open source technical services have been provided by Fabricatorz and 5AM Solutions. Inspiration for the work comes from George Church and Jason Bobe and the astronauts who make up the Personal Genome Project, and who first pioneered the “open consent” approach we are standardizing.
By listing these folks, we mean to thank them for their help, but do not imply their endorsement. Any mistakes are ours alone.