Pub-Style Science discussion about how (if at all) philosophy can (or should) inform scientific knowledge-building. Leading up to this part of the conversation, we were considering the possibility that the idealization of the scientific method left out a lot of the details of how real humans actually interact to build scientific knowledge.
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I’ve been doing human research for better than a decade now (and, yes, I did just appeal to authority). Every study that I have ever done has at some point touched an Institutional Review Board and every study has involved some consideration of how to obtain informed consent.
IRBs can do a couple of things when they consider a study. They can approve or deny approval for a study’s conduct. They can exempt the study from review, meaning that the investigators may press on without IRB involvement. They can approve an informed consent process and document, or they can waive the requirement for informed consent.
Every paper that I have subsequently written has been published in a journal that requires two statements be made – 1) What is the study’s status vis-à-vis the IRB and 2) how was informed consent obtained?
I’ve been very fortunate because my studies have been straight forward. I’ve been able to state simply “This study was approved by the Institutional Review Board of the MRU School of Tomfoolery. All participants provided written informed consent.” Done. Moving on…
But what if your study was deemed exempt or you got a waiver to either not need to get consent or get verbal consent or some other such fuckery?
Well, then you say that. You don’t say your protocol was approved if it was exempted from review. That’s not the same. And you don’t say anything about informed consent except the actual way you obtained it.
The last Pub Style Science on patient blogs was a blast, as usual, but there was something more I wanted to say about medicine and interweb communication. Still thinking about what social media can do for medicine because I’ve been on service recently spending hours and hours working with leukemia (and lymphoma and myeloma) patients, fighting a myriad of problems with them. Mostly, of course, it’s their diagnosis, a horrible disease that is the enemy. But a fight against cancer can be a long battle and there are countless small issues that are much of the day-to-day work. With a cold, statistical eye, I don’t know how significant the “little things” are to someone’s overall survival, but I feel they matter, at the very least for a person’s quality of life, and also for the patients’ families who have a strong desire to care for their loved ones in the best possible way.
The simple mechanics of patient care–did the nurse have the items she needed when she needed them? Was a problem dealt with promptly or did wait until after the weekend?– can cause significant anxiety for patients and their families. These days, when there is drama, my first instinct is, “I should tweet that,” I should make some noise, get some attention to the issue, maybe putting a spotlight on the problem will help fix it. But I must not.
Does the on-line community realize that this simple act is not acceptable in the hospital, I wonder? Sure, there are privacy issues, HIPAA concerns (which are distinct IMO), but I feel the greatest damper on speaking openly, the over-arching concern, is a culture of fear based on concerns of liability and lawsuits. The hospital has “patient liaisons” that hear complaints. What these folks do is, in fact, risk management. Will a patient sue? Will a federal regulator impose a hefty penalty? The sad reality is that in 2014 the financial risks involved with open communication supersede any potential benefits.
This means that there are untapped potential benefits to be had. Brilliant people with investor backing are working overtime to develop internet-based technologies for a new era of medicine. Big data. Genome sequencing. Quantified selves. Eric Topol is right that the medical industrial complex is ripe for “creative destruction.” The old ways of delivering medical care are going to change significantly in the next 10 years, many predict. Established players and start-ups are putting resources into ideas that they hope will get them a piece of the huge healthcare money pie.
The Pub Style philosophy is that science should have an open-door accessibility. It reminds me that the tech needed for Schumpeter’s gale in medicine might be relatively low tech. Simplification is likely to be a critical element in a transformative process, especially now that are (finally) enormous pressures to reduce costs. Giving voice to frustrated health care customers is a simple idea that could be a growth industry. What will seem in retrospect as a simple solution is waiting to be invented, and it may just as likely come from a college dropout working in his basement as it is to come from a university or large corporation.