consent to research

Change The Game.

Fri, 01 Jun 2012 13:38:00 -0400

Just a quick note about the 23andme announcement that it has been granted its first gene patent. Read Dan Vorhaus, who provided us with pro bono advice, with the definitive piece on the topic so far.

23andme is a business. Their business is selling the anonymized data to those who wish to use it for research purposes and in doing their own research on the data. They tell you this up front, as they note in the comments on the blog post:

“We make reference to our intent to pursue intellectual property rights for discoveries made from our research in both Terms of Service (in section 13) and in our Consent document (sections 3 and 5).”

Companies exist not just to provide you with neat services, but to make money. And patenting genes is part of how companies in the drug and health space make money.

One of the reasons we have built Portable Legal Consent, and Sage Bionetworks, and the Synapse compute environment, is to provide competition to these companies from the open side. Open systems matter because the core of the system is a shared set of norms, not a single company or set of companies.

Competition from the open is healthy. It’s why browsers have “Do Not Track” features. It’s what we don’t have in social media (if Facebook buys Opera, as is rumored, I doubt do not track will be part of the next release).

Don’t get mad at 23andme. As @shwu pointed out, haters gonna hate.

23andme does something very important. Something they don’t have to do. They let you download your genotype, pretty easily, from their “Browse Raw Data” feature.

You can get mad at 23andme - which is, in the parlance of our times, hating the player. Or you can hate the game. Not only that, you can change the game. Download your data, and upload it into a common research environment like the one we’re building here.

You’ll be able to do that, very soon, here at Consent to Research. Our clinical research study has been fully approved by the Western Institutional Review Board. We’re finalizing testing of our software (I’ve already uploaded lipids and my own 23andme profile). And we’ll be throwing the doors wide open soon.

(picture from Know Your Meme and not ours, thus not CC0 licensed)

Translators Needed!

Thu, 10 May 2012 13:32:00 -0400

We are rapidly moving to explore making Portable Legal Consent international. We’re starting by translating the core documents into Dutch, French, and German - and we’re happy to pay for the translations. Please pass the word.

PLC Approved - Sign Up To Be Notified

Thu, 26 Apr 2012 10:20:00 -0400

We received formal notification today that the PLC clinical study protocol and consent were approved on 4/23, and we look forward to advertising for participant enrollment in May once we have completed a few requested modifications to study documents and partner websites.

If you want to be notified when PLC launches and begins enrolling patients, make sure to sign up for our mailing list. It’s an incredibly low volume list so don’t worry about us flooding your inbox.

Update, 4/27/2012, 12:56PM US Pacific time: Please note that there is no study underway yet! There are still some tweaks to be made before we can begin advertising for participation. Signing up for the mailing list above is the best way to find out when you can start going through the process and uploading your data.

Your data are not a product

Fri, 30 Mar 2012 01:34:00 -0400

Another Nature editorial talking about our work here, this time in Nature Genetics. Another strong endorsement of the idea that patients are entitled to copies of data about their own health, and of building infrastructure that can route that data to researchers.

The title of this post was the title of the editorial. Couldn’t have put it better myself.

Our data are far too often products. Certainly when I use Facebook, my data is a product. When I use a loyalty card to get half off diapers at the grocery store, my data is a product. But my health data can do more than lower my tab - my health data can drive a revolution in health care.

All it takes is enough of us. We don’t know how many, but we’ll be finding out as soon as the PLC-CGR study launches.

For those wishing the formal citation: Nature Genetics 44, 357 (2012) doi:10.1038/ng.2244Published online 28 March 2012

Nature News Editorial Profiles CtR

Fri, 23 Mar 2012 13:34:32 -0400

Nature News ran an editorial called “Incidental Benefits” this week.

There’s a lot of good stuff in there but the conclusion is the kicker.

In this free market, how sure can researchers be that they are truly doing no harm to their study participants when they take a cheek swab? People thinking of entering a study will assess the risks of how their volunteered genetic information might be used, and this might make them more reluctant to participate. Researchers could help to counter this by offering them medically relevant information back in exchange.

Yup. Now that’s going to require a change in the way that researchers and participants interact. Consent to Research is a part of that change, and I was glad to see my testimony to the US Presidential Commission on Bioethics (my part starts about 15 minutes in) quoted in the editorial as well.

Alpha Testing Closed

Thu, 09 Feb 2012 12:04:51 -0500

Thanks to everyone who signed up. We’ve completed our alpha testing project and didn’t even need to burden all of the volunteers.

Consent to Research is submitting its work to an Institutional Review Board for approval in the coming weeks. We look forward to enrolling our first cohort members thereafter. Keep your eye on this space for news as it comes.

And there’ll be lots of exciting news related to this project at the 2012 Sage Commons Congress, so be sure to apply for a slot there - there is no charge, but there is a review process. Investigator travel awards are open for applications now as well.

Also, if you’re new here, check out our About page and FAQ for more information.

Post-launch chat on Consent to Research with John Wilbanks and...

Fri, 18 Nov 2011 14:18:25 -0500

Post-launch chat on Consent to Research with John Wilbanks and Stephen Friend.

Alpha Testing Launched

Mon, 07 Nov 2011 21:42:00 -0500

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.

Timeline for Portable Legal Consent.

Mon, 07 Nov 2011 21:37:54 -0500

Timeline for Portable Legal Consent.

A 12-minute slidecast explaining the benefits and risks of...

Mon, 07 Nov 2011 21:35:45 -0500

A 12-minute slidecast explaining the benefits and risks of Portable Legal Consent. Embedded into the alpha Consent process.

Illustration of how data flows inside the Portable Legal Consent...

Mon, 07 Nov 2011 21:33:00 -0500

Illustration of how data flows inside the Portable Legal Consent system. Patients upload their data to Common Genomic Research Entities - organizations that want to provide the consent service to their members - and then researchers can harvest only the “common” parts of the data. Personal information data will not be made available (red = stop) but data like genotype, health record, and more will be made available (green = go).

"The time has come for patients to take control of their own data, and participate in research..."

Fri, 28 Oct 2011 23:51:00 -0400

“The time has come for patients to take control of their own data, and participate in research directly.”

- Stephen Friend.

background reading

Fri, 28 Oct 2011 17:32:00 -0400

Wireframe public oct 2011 View more presentations from john wilbanks