John, It is reassuring that we share sensitivity to the issues researchers would face if they had to individualize consents to meet each patient's unique requirements. We appear to part ways (at least for purposes of this discussion) on the best ways to compose and memorialize medical research consents. Regarding consent composition, perhaps, it is best addressed by developing a few model consents that afford different levels of control to data subjects. In this way, review boards might then challenge researchers on why they didn't use the model with the most user control and the researcher would be obliged to justify his selection from among the models. I don't know that allowing subjects full ability to tailor their consent won't raise the objections you cite of sample size and cost. And I don't know that giving subjects such power has much impact on the doctor who recommends participation in the wrong study for the wrong reasons. Regarding memorializing the consents, I could be persuaded that merely giving a subject a copy of a signed consent may be too burdensome on the subject. Storing and tracking the document (in hard copy of digital form) is such a rare event for most subject that they are unlikely to have a good system for doing so that allows for ready retrieval when an issue arises. But I also suspect that adding such a consent to a blockchain may be unnecessarily costly. It could just as easily be stored in a standard database by some independent administrator of such research consents that would operated like a library. The funding for the administrator could come from the same source as funding for a blockchain. I also suspect that giving individuals additional consent opportunities with regard to re-use of research in which they were a subject could dramatically reduce the opportunity to re-use the data. If a large study has 10,000 subjects and the data from it could be used for another study, the new researchers have merely to show that their reuse is consistent with the original consent. If they have to go to each subject to obtain a new, separate consent, the database could well become unusable. Subjects may have new addresses (physical or digital) and tracking them down too costly. I had a similar experience when I wrote a musical several years ago. The entire point of the musical was to re-use existing rock songs that told a story. I assumed that a theater could just pay ASCAP or BMI their licensing fees and be free to have the songs performed in the context of the musical. Not so. Bands can play copyrighted songs under ASCAP and BMI. But a musical requires obtaining unique consent from every publisher. No theater would consider my musical until I first obtained consent from each publisher. I began contacting the publishers. After a few replies such as, "Mr. Morrison needs to know how many seats are in the theater and what is the price per seat," I abandoned the effort. I see individualized consents causing the same problem. I suppose it could be argued that if we can't obtain such individualized consents, perhaps the research is not in the public interest. Perhaps that current practices is tilted too strongly towards the researchers. But I would not want to be the spokesperson representing individualized consents -- even though I am a strong adherent of the rights of the individual. Jef --------------------------------- Jeff Stollman stollman.j@gmail.com 1 202.683.8699 Truth never triumphs — its opponents just die out. Science advances one funeral at a time. Max Planck On Sat, Jul 30, 2016 at 10:13 PM, John Wunderlich <john@wunderlich.ca> wrote:

Jeff;

I’ll not disagree that at first blush the value add for smart contracts and blockchain doesn’t leap off the page. You may recall me trying to argue against a health research/consent use case in the DG. That being said, the basic use case can be used throughout Kantara - once elaborated and validated since there is a lot of work in Kantara that could touch health research.

I agree with your assessment of how clinical trials and the YES/NO decision is made. From sitting on REBs I believe that a study sponsor, especially in an RCT (randomized controlled trial) literally can’t let in too much variability how subjects participate in a drug trial. It would essentially add another independent variable and balloon the sample size and cost requirements.

But here’s the issue arising out of that that may make this worth addressing. Public ledgers can be tools for better governance and transparency to address power imbalances between the information ‘elites’ and the information ‘masses’. And I don’t there that there is an imbalance greater that between a patient that has just been told that the 5 year survival rate for Stage 3 exocrine pancreatic cancer is 3% (ref. here <http://www.cancer.org/cancer/pancreaticcancer/detailedguide/pancreatic-cancer-survival-rates>) and the doctor that is offering an ‘experimental treatment’. How meaningful is consent (which is supposed to be ‘free of coercion’ and ‘informed’) at this point? The circumstances are inherently coercive. This is not to blame the study team or the doctor. It is what it is.

The vast majority, but not all physicians and researchers will make the best choices they can in what they believe to be the patient’s best interests. But even then, once consent has been obtained, some researchers see data as proprietary and something over which the patient has no right to a say. (After all, do rocks have any rights to seismological data?) Consents are often written to enable that proprietary view, and some countries’ laws agree. Research ethics boards are generally self policing, with some governance, and some lay input. But the fact remains that they are mainly researchers approving other researchers’ work. Quis custodiet ipsos custodes?

If it is the case that a doctor recommends certain studies over others based on bad medical judgement, or her relationship with the investigators, or for rewards and recognition (either academic or cash) what tools can a patient or her estate use? A public ledger could protect patient privacy and still provide regulators, auditors and investigators something more to go on that self reports from the investigated. But until such tools are available, it is hard to advocate for them.

As an aside I would argue that consent receipts, if developed and implemented create a whole new potential for consent based big data type recruitment and data mining (thinking of thinks like some of the studies that the Apple Health Kit is starting to make possible). These would be voluntary, so the consent would be real, and real benefits could accrue from such large scale studies. More robust and accurate wearable hardware and software could have large implications, but not for drug trials.

Sincerely, John Wunderlich @PrivacyCDN

Call: +1 (647) 669-4749 eMail: john@wunderlich.ca

On 30 July 2016 at 16:52, j stollman <stollman.j@gmail.com> wrote:

...

John, et al,

I agree that this is a real-world use case. But I am not certain how blockchain has much value add. Perhaps I am too rigid in my thinking, but I see this as a classic example of a use case that is well served by consent consent processes.

If I were conducting a clinical trial, I will need consent from all participants. But consent will be on my terms and will be a YES/NO decision. Ideally, it would be nice to allow some give and take and allow for customized consents for each user. But practically speaking this could become a management nightmare and there is likely too much risk in violating HIPAA for researchers to tolerate anything beyond a traditional consent. Why couldn't this just be stored in a file cabinet.

If, subsequent to the consent, another researcher desires to re-purpose data developed in the first clinical trial, the new researcher would have to obtain separate consents from the users, unless the original consent included consent for using subject data to support other research efforts.

Am I missing something?

If not, what benefit do we expect to get from using the blockchain to track this simple logging of consent receipts?

Thank you.

Jeff

--------------------------------- Jeff Stollman stollman.j@gmail.com 1 202.683.8699

Truth never triumphs — its opponents just die out. Science advances one funeral at a time. Max Planck

On Fri, Jul 29, 2016 at 3:45 PM, John Wunderlich <john@wunderlich.ca> wrote:

...

I've renamed the use case and put in a basic narrative and use case diagram. I've tried to put forward the simplest case. Please review and comment if you have a chance, before I move on and fill in the rest of the use case.

http://kantarainitiative.org/confluence/display/BSC/Trust+and+verification+i...

Sincerely, John Wunderlich @PrivacyCDN

Call: +1 (647) 669-4749 eMail: john@wunderlich.ca

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