A correction and a summary of the ethical debate/conversation that I had with one person who is involved with a study that uses informed disconsent.
First, I need to run a correction. Though Hopkins is the administrator of the trauma study that uses the concept of informed disconsent, the study is not actually taking place at Hopkins. So the people of Baltimore are, at least for the moment, safe.
I had a few e-mail conversations with some people involved with the study. They were thoughtful enough to engage in a conversation. They believe that informed disconsent is the only way to do the study. They claim that people in shock can't give consent--and having had shock after my surgery, I agree with that claim. However, we disagree on whether there are viable alternatives to informed disconsent.
When presented with the idea of using a driver's license number to check for informed consent, they were on the fence. First, they claimed that they wouldn't have enough time to check for the ID in the ER. That's possible, but I don't see how it'd be longer than checking for bracelets.
Then I suggested employing somebody to ride along with the paramedics. That person's sole job would be to find the license and run it against the database of people that have granted their informed consent. The person involved with the study that I conversed with admitted that such an approach had the potential to work. But they were worried about the fact that driver's licenses were good for 10 years (if they're building a database with driver's license numbers, I don't see how this is a problem), so they settled on informed disconsent as the approach.
Our disagreement comes down to a fundamental point. People involved with the study believe that public health has always trampled on individual's rights, and therefore they see nothing wrong with conducting a study that disregards the rights of individuals. They cite the fact that patients with drug resistant TB apparently are supposed to lose their right to fly, and the fact that AIDS patients sometimes lose their privacy as examples of the public health interest trumping the rights of individuals. In their minds, the public health benefit is potentially so high, that it exceeds our own individual rights.
People involved with the study also note that all 1,000 members of the various institutional review boards will be experimented on too if trauma strikes them. I understand the ethical concept of this--it's meant to say we believe in the concept and think it's safe. However, I would be more comfortable if there were a minority of members who didn't participate and didn't approve. I feel like they'd be more likely to look out for problems and speak up when they happen. Plus, it would ensure that people involved with the study would hear the other side of things (always important from an ethical perspective).
I believe that the "placing public health before individual's rights approach" brought lobotomies and other infamous experimentation in the early 20th century. I think we've rejected that approach for good reason. The concept of informed consent has allowed medicine to progress to truly astounding levels.
Simply put, there isn't a reason to revive the dead "public health trumps individual rights" argument. New studies like the consentless Polyheme study--which probably killed several patients without their consent--show us that informed disconsent is very dangerous. If it is morally and ethically justifiable to take a human life (without consent and without disclosure of what could go wrong), we're headed towards a very, very dark and dangerous place.
Cross-Posted on my blog.