We’re opening up for alpha testing today. But first, a bit on why we’re here at all.
Systematic clinical studies are the way we make progress in medicine. Despite all the new technologies which allow us to learn about biology and diseases through animals, cell lines, or molecular experiments, at some point a new treatment has to be tested in humans for the first time. This is inherently risky, and there’s no way around the fact that somebody (or really somebodies) has to go first. Informed consent documents were developed to make sure patients understood both the potential risks and benefits before entering a clinical trial. Mostly this has covered what the particular medical benefits and risks were of a particular new therapy for a particular disease, and this aspect of informed consent continues to provide valuable protection to patients.
This system has worked well for decades, but it is now becoming apparent that another aspect of informed consents is preventing scientific progress from occurring as well as it could. The problem is that people running clinical trials have tended to create informed consent documents that narrowly defined the types of research that could be done on the data, and the researchers who could do it.
This was ostensibly done to protect patient privacy, and didn’t hamper the people running the clinical trial because they mostly care about one thing: can those particular researchers or company prove the treatment works better than the existing standard of care. In fact, it actually benefited the companies and scientists running the trial because it gave them exclusive access to data that could give them an advantage over their academic and industrial competitors. However, given the wealth of clinical and genetic information now collected in a clinical trial it is becoming apparent that there are a variety of secondary uses of clinical trial data that could greatly enhance the rate of scientific progress in a variety of ways not forseen by the original study developers.
This was actually always the case. A good example of this is the Framingham Heart Study, from which more than 1000 papers have come - including new research on how obesity can travel through social networks, something that was far from the minds of the study’s designers in 1949. But it’s even more evident now that the downstream uses of data are more powerful than we can imagine, and that we need systems that enable that downstream use of data.
Currently, the terms of most existing informed consents greatly limit the ability of the study authors to share data with colleagues, even when they want to, as it’s not usually possible to go back and ask patients about a new use for their data after the study has completed. We believe that in many cases this situation is not in the patient’s interest. What is in the patient’s best interest is for their data to be exposed to as many researchers as possible, as this minimizes the amount of time and money needed for medical break-throughs to occur.
Portable Legal Consent is being developed as a tool to allow patients to tell the doctors, researchers, and companies that are experimenting on them, that they, the patients own the rights to the data generated from their bodies. When a patient chooses PLC, it’s a statement that what the patient desires is for the data to be shared broadly in the public domain, to serve scientific progress as a whole, regardless of the particular individual or institution that makes the breakthrough.
PLC is voluntary. If you don’t want to share your data, you don’t have to.
We’re looking for alpha testers. Alpha testers are people who are willing to sit down for 20-30 minutes and go through our first version of the PLC process - and then to fill out a survey about the process so we can know what’s working and what isn’t. You don’t get a monetary reward for testing. But you will be part, the very first part, of a process that will eventually lead to patient control over data, direct engagement of patients in research, and the long term social benefits that come from getting data into the research system.
