Parsing Words About IRB Statuses Pisses Me The Fuck Off..

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.

If your loved one is sick, you need to tweet about 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.

Is science a polytheistic religion?

“The experimental method is concerned only with the search for objective truths, not with any search for subjective truths…An anticipative idea or an hypothesis is, then, the necessary starting point for all experimental reasoning. Without it, we could not make any investigation at all nor learn anything; we could only pile up sterile observation.”

–Claude Bernard, An Introduction to the Study of Experimental Medicine

Claude Bernard: “Oui, I’m dead…but do I look naive to you?”

The other day, I told Dr. Isis I wanted to do a PubStyleScience on epistemology, and she said, “I don’t get it… what’s so hilarious about that?” Or words to that effect. Imagine my shock and surprise! A bunch of scientists, sitting around, drinking and arguing about the meaning of everything? It’s the *perfect* topic for PSS!! So, let me explain my interest in the topic…

I like to share science and the culture of science with anyone who’s interested, especially to show a relaxed side of science to younger people who may be put off by narrow-minded cultural attitudes. PubStyleScience is a science culture experiment along these lines. Let’s open the doors and windows of the scientific enterprise! I see many sci’s on Twitter motivated to expose and correct sexism and racism in the scientific enterprise, to promote fairness and transparency. We can agree that there is some bullshit cultural baggage with science community, but I’m more interested in the subtle baggage that keeps us from doing the best science. I am often surprised at how scientists embrace groupthink. In the abstract, the NIH (for one) declares a love for radical departures and fresh interdisciplinary ideas. And yet, as a scientists love to run in a herd, and in evaluating others, demand conformity. Professional science should be open to a diversity of participants. This is a moral principle, and a conviction that the progress of science will benefit from the participation of a wider range of voices.

So what I’m interested in is the *positive* side of scientific cultural evolution. My tweeps rail against what they don’t like about the old culture…but what are we *for?* For most of the scientists I interact with, we can easily agree on the extreme ends of “unacceptable,” e.g.sexim and racism. But there are softer cultural values that are not clear-cut, but messy. How should we define the differences between “good culture” and bad? An example of the changing mores of science is the idea of “Kerning,” a word which was coined several years ago after an earnest but tone-deaf opinion piece by cancer biologist Scott Kern.

In it, Kern lamented the erosion of a lab culture that valued working through the weekends. His “where’s the passion?” lamentation was lambasted by Drugmonkey and Dr. Isis. While I agree with some criticisms of Dr. Kern’s piece, e.g. science should not be closed to people with families that need to work 9-to-5, I sincerely believe that intense, clock-ignoring passion is a critical ingredient for good science. Can we revisit the passion and hard work debate?

As the culture of science evolves, I want to understand and communicate to the next generation two pillars: a new, open and diverse culture of science, as well as the essentials of the scientific method. And here’s the question that I would like to discuss: are these two pillars utterly distinct, or does diversity in science require being open to different views of the scientific method? This is where the philosophy comes in:. How do we separate conjecture from reality? How can we know what is true? Science is not set of sciencey facts or topics, it’s a philosophy, a way of thinking, an approach to understanding the universe. I worship the scientific method, I admit. But if science is inherently human process, Is Claude Bernard search for objective truths naive? If the process of science is inherently human activity, one that may not lay claim to objective truth, I start to wonder: is there a clean line between the method and the culture?

Then, my mind was blown when I stumbled on to the existence of a Feminist Theory of Science. Being the interweb, I should have known this has been discussed before. But it’s a radically new idea to me. And the next obvious question: if there is a feminist science, is there an Irish theory of science and a jewish theory of science and a South American theory of science? Does everyone get their own science? Hmm…not sure, but I don’t think so. I think there should be a core set of values. Where do we draw the lines? This is a question of epistemology.

Is there any real-world relevance to this philosophizing? I just got back from a new investigator meeting at the National Cancer Institute (NCI) where we were deluged with data and information about the byzantine workings of the NIH. The NIH recognizes that URMs (under-represented minorities) are under-represented among NIH grant awardees, and that this problem is getting worse given the changing demographics of the USA. The NCI is working to try and fix this problem , but as I was being intensely immersed in the bizarre culture of US science funding at the NIH, I couldn’t help but wonder if our narrow view of “proper” science culture is part of the problem. The NIH also seems to have mixed feelings about “big science.” Big versus small science deserves it’s own post, but briefly, the NIH pays lip service to the importance of individual investigator grants, and yet, they sacrifice many R01s for big science projects. Let’s have a whiskey and discuss.

“This ad­ven­ture is made possible by generations of searchers strictly adhering to a simple set of rules. Test ideas by experiment and observation; build on those ideas that pass the test, reject the ones that fail; follow the evidence wherever it leads and question everything. Accept these terms and the cosmos is yours.” –Neil deGrasse Tyson, on Cosmos

A Brand New #PubScience!! Tonight at 8pm CT!!

Tonight we’ll be talking about the culture and philosophy of how we do science. In outlining the topic, Michael Tomasson had this to say on his blog:

I like to share science and the culture of science with anyone who’s interested, especially to show a relaxed side of science to younger people who may be put off by narrow-minded cultural attitudes. PubStyleScience is a science culture experiment along these lines. Let’s open the doors and windows of the scientific enterprise! I see many sci’s on Twitter motivated to expose and correct sexism and racism in the scientific enterprise, to promote fairness and transparency. We can agree that there is some bullshit cultural baggage with science community, but I’m more interested in the subtle baggage that keeps us from doing the best science. I am often surprised at how scientists embrace groupthink. In the abstract, the NIH (for one) declares a love for radical departures and fresh interdisciplinary ideas. And yet, as a scientists love to run in a herd, and in evaluating others, demand conformity. Professional science should be open to a diversity of participants. This is a moral principle, and a conviction that the progress of science will benefit from the participation of a wider range of voices.

So what I’m interested in is the *positive* side of scientific cultural evolution. My tweeps rail against what they don’t like about the old culture…but what are we *for?* For most of the scientists I interact with, we can easily agree on the extreme ends of “unacceptable,” e.g.sexim and racism. But there are softer cultural values that are not clear-cut, but messy. How should we define the differences between “good culture” and bad?
Joining us will be the esteemed Dr. Free-Ride, Dr. Rubidium, and Andrew Brandel. Dr.Free-Ride has already, as is typical, been prolific on the topic. Go read “Is a scientist without philosophy like a fish without a bicycle?“

Here’s a link to the YouTube page where you can watch our hangout as it’s happening, or catch it later in the archive. We look forward to hearing from everyone!

Fuck “Passion”

Your bestmonktress was reading Michael Tomasson’s recent post setting the stage for the next pubscience (Are you listening to that shit? Because if you aren’t, you should be). And one part, which I sure was meant innocuously, set me the fuck off. So let’s embrace this opportunity for an attention whoring blog post, shall we?

“While I agree with some criticisms of Dr. Kern’s piece, e.g. science should not be closed to people with families that need to work 9-to-5, I sincerely believe that intense, clock-ignoring passion is a critical ingredient for good science. Can we revisit the passion and hard work debate?”

I immediately bristle at the notion of “passion” being brought up as a critical skillset to be emphasized, because it somehow implies there’s some cache of scientists who Don’t Give a Shit. Especially as Kern’s piece is the definition of a ‘kids these days just don’t have…

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