Surely, I know that I did travel for work and conferences before we all had iPads and smart phones. Still, I can’t understand how I survived it all. Especially not when my husband can now placate my homesickness with adorable stuff like this…
April and May are incredibly busy months for me. This is when all of our major scientific meetings happen. At the end of April is the Experimental Biology meeting. There, I get to get my geek on and learn about new and exciting physiology, but really from a “basic science” perspective. (I put “basic science” in scare quotes, because I think it’s not a relevant term in physiology, especially given how many of are doing applied research. Still, my clinician friends love it, so onward we march.) Then, at the beginning of May I attend the Pediatric Academic Societies(PAS) meeting. This meeting tends to be more clinically-oriented, with focuses on model-based research, patient population research, and clinical practice. I like this mix and I almost always leave with more questions than I could ever answer in a lifetime.
I’m at PAS now and one of the major themes, as it was last year, is stem cell therapy to treat pediatric diseases. Diseases like bronchopulmonary dysplasia, type 1 diabetes, acute respiratory distress syndrome in the intensive care unit, etc. One of the statements that I’ve heard repeatedly is that stem cells traffic to the damaged/affected/diseased tissue, do that thing they do, someone usually says “inflammation”, and then the cells “disappear.” Some of the theories commonly thrown around are that they either differentiate or undergo apoptosis when their work is done (a programmed cell death).
That would be very noble of those little cells, either fading away into the background or throwing themselves on their proverbial caspase swords after their the job is done. Wouldn’t it?
(Image and quote sources here, here and here)
I don’t think it’s that simple and, every time I hear someone suggest that stem cells just “go away”, I want to grab them and yell, “BUT HAVEN’T YOU SEEN THIS???!?! OMFG, IT’S THE MOST AMAZING THING I’VE EVER SEEN! EVER!!1!!11!!!!ELEVENTY!1!”
The “THIS” I refer to is work done by my colleague, respiratory physiologist Dr. Jahar Bhattacharya and his group at Columbia University. At the last two Experimental Biology meetings, Jahar presented his findings that the reparative prowess of bone marrow derived stromal cells comes from their ability to transfer their mitochondria. That is, in a mouse model of experimentally-induced lung injury, BMSCs create channels to the damaged alveolar epithelium and send their mitochondria over to repair the injury. The mitochondria transfer restores the normal metabolic function of the damaged cell. To demonstrate this, the group stained the cells green and mitochondria red. Then, using intravital microscopy, the group observed the transfer of mitochondria between the BMSCs and alveoli and the associated increase in ATP production.
This is part of Figure 1 from the paper. Note the cells in green and mitochondria in red. License for non-profit use granted by Nature Publishing Group.
As I mentioned, I’ve heard Jahar speak about this work on a couple of occasions. Most recently, he showed video of the mitochondrial transfer during a banquet in which he was talking about serendipity in science. It’s still the coolest damned thing I have ever seen. He noted that his group only noted this phenomenon because they had originally grown their BMSCs too densely. When they examined the cells, they found all of these projections. Each time I’ve heard about his work, I have wondered what other organelles these cells might be transferring.
I think this organellar transfer hypothesis might be important in explaining some inconsistent results in the literature. In a paper last year in Pediatrics Research, Sutsko, et al. examined the efficacy of MSCs versus their growth media in a rat model of bronchopulmonary dysplasia, also called chronic lung disease of prematurity. Several groups have investigated the use of growth media because 1) it seems to be at least partially efficacious and 2) people are still concerned about the long-term safety of stem cell injection. Especially in the lung. These authors followed the rats for 100 days after treatment and found that both media and MSCs improved lung development, but the MSCs were more effective. They tracked MSCs engraftment by instilling MSCs whose nuclear DNA had been transfected with green fluorescent protein (GFP, or that stuff that people use to make glow-in-the-dark sheep). This should cause the MSCs to make GFP and glow green. They instilled the stem cells into the trachea and, after 100 days, stained for GFP and found little remaining fluorescent signal. These authors concluded that the cells had not engrafted into the lung and, thus, the cells and media must be working by releasing mediators (a so-called paracrine mechanism). This puzzled me though. What mediators would the cells release that wouldn’t be in the media? Perhaps, as Jahar’s work would suggest, the effects aren’t paracrine at all. Perhaps in this case the MSCs were more effective because they could transfer their mitochondria. Because the GFP gene wouldn’t be in the mitochondrial DNA, they’d never find them using this technique.
I offer the caveat, though, that this is all probably pretty speculative.
So, where have all the stem cells gone? And how do they repair damaged tissue? I have a feeling the answer is even more amazing than we think…
My son and I are huge fans of the Big Bang Theory. While I will admit to feeling conflicted about the stereotypical portrayal of geeky, awkward, unattractive scientists a la Amy Farrah Fowler, this is far outweighed by how darned loveable I find Sheldon Cooper. Any time I am feeling down, I watch the Rock, Scissors, Paper, Lizard, Spock bit and my mood is instantly improved.
Last week’s episode in which the ladies attempt to play hooky to go to Disneyland but end up having to talk to a group of girls about being “women scientists” left me with a lot to think about. You see, part of being a woman and a scientist (at least if you happen to be me) is that you get asked to talk ~20% of the time about your science. ~80% of the time, you get asked to talk to people more junior about being a woman with a family who happens to be a scientist. A lot of the time, these end up being really meaningful conversations. But, some of the time, it ends up going like it did on the Big Bang Theory…
…where you get asked to give what I would call a “pep talk” to girls. To tell them that they can be anything they want to be.
And, you always get asked to give these sorts of talks in your free time when you really just want to be playing hooky with your friends.
I find these sorts of talks trite and out of touch and I don’t think it’s the sort of information young women really want. I don’t think that girls believe they couldn’t be scientists, per se. The question is, why would they want to be scientists? And, why would they want to stay scientists after all the years of training they endure. That’s a hard question to answer and, I’ll be honest, I don’t know that I necessarily know the answer. No single woman scientist can really be expected to espouse on the enormity of “women in science.”
I’ve come to realize that the only thing I can do that feels truthful when I’m asked to give these sorts of talks is to speak honestly about the experiences that I’ve had and the strategies that I use to survive my life. I once felt bad for not being able to fully discuss the totality of the problem, but I also don’t believe that’s what people really want to hear.
Mostly, they just want to hear about how we “balance” work and family. I don’t know how other women answer that question, but for me there really is no “balance.” I heard an analogy a few years ago that I now use when I answer this question. My life is most like an endless game of Whac-a-Mole. I just whack whatever’s sticking up and try to pretend the other stuff doesn’t exist for the moment. Good enough.
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As I think I have mentioned, I work in a department where I am largely surrounded by clinicians. As a result, I try especially hard to make sure that our graduate students are indoctrinated into all of the cultural hilarity associated with being a scientist.
Today is the greatest nerd holiday of them all – Pi Day. As part of our annual celebration, I kindly requested that each of the students bake a pi(e). Tests, papers and experiments be damned!! Pie is more important on 3/14.
Those are the pie offering from my group. From left to right: chocolate mint pie, macaroni and cheese pie, strawberry rhubarb pie, brandy alexander pie, and banana cream pie.
Here’s what I learned this Pi(e) Day…
1) The people in my group (myself included) clearly have a problem. Today’s offerings included beer, vodka, brandy, creme de cacao, rum…a lot of rum.
2) Most physicians will express a desire to switch teams and become scientists when they find out that there is pie. Pie is the universal bringer-together-er of peoples. Apparently physicians don’t get a holiday that involves pie. I find that sad.
3) Pi(e) Day is the perfect metaphor for an experiment. Everyone is excited by the prospect of preparing their pie and enjoying the pies. Eating your first slice of pie is a glorious event, with a palpable thrill in the air as everyone digs in. By the time you’re on your sixth piece of pie, all you can do is to lie on the ground, swearing and cursing the existence of pie and promising that after you’re done you will never eat pie again. Several hours later, when the sugar coma and stomach fullness have subsided, you sit around and laugh at the memory of what a glorious event Pi(e) Day was and begin to make a mental list of all the people you’re going to tell about its glory…
Yesterday DNLee posted a very thoughtful discussion of research ethics and why above the line behavior is so important. So that you are aware of my possible bias, I will fully disclose that I am a total DNLee fangirl. In her post, she reminds us that there are populations of people that, historically, have been subjected to human subjects abuse, often at the hands of well-intentioned people. This didn’t happen 70 years ago in a foreign country. It happened here, and recently enough that the victims are still alive and suffering the results of what happened to them. Furthermore, many of these people come from cultures with strong oral traditions. We must recognize why we owe them (and the rest of society) complete transparency in our ethics.
(Stepping back down from soap box…moving forward with the science I have been ignoring this morning…)
Yesterday morning I was driving to work at the hospital and heard a song I haven’t heard in almost twenty years. When I was in college this was “my jam.” I refer, of course, to lyrical poet Skee-Lo’s smash hit “I Wish.”
I spent many an afternoon dancing around my dorm room with my roommates to this song. I think I could empathize with Skee-Lo because I was at a point in my life where I was looking forward to what I might be, seeing professionals more senior than me with the career I wanted. Looking forward to a time in my life when I might achieve full baller status.
baller (noun) meaning: 1. One who exhibits a consistent proficency at-, or exuberant love for the game of basketball. 2. One whose person has been fully and successfully established in numerous social circles (esp. one who is extremely popular with both the male and female members of any given social group) 3. One whose status in society has been earned by one’s possession of “game” (that is, proficiency at the game of life)
And, like Skee-Lo, I drove a hooptie around Southern California. My 1989 Mustang had no air conditioning and doors that didn’t always open. It’s hard to strut after you’ve had to crawl out of the window to escape your car, but the fuzzy dice, window tint, and stereo saved it. (And it was a Mustang! That’s a cool car no matter the condition.)
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Back to now.
“I Wish” was stuck in my head all day. Walking down the hall to meet a colleague. Sitting in a meeting. Reading a paper. All the while, bobbing my head and thinking “I wish I was a little bit taller…” Now, I must confess to always being about 5 (ok, 15) years behind the times and this led me to contact my dear friend, hip hop maven, and scientist chic “cooler than me”, DNLee to ask the question, “Are people still aspiring to be ‘ballers’ these days?
Yup. That’s a sentence written by a fellow human being. I’m not proud.
DNLee informed me that the term “baller” has evolved and that “Baller implies one who has and spends a lot of money. Boss implies just a bad ass, you can’t mess with my science game.” She provided me with some educational material that I found very helpful, leading me to reframe the subsequent part of this. I am in her debt.
Spending the afternoon with some students, working on new research project, made me think that we spend much of our training trying to learn to operate “like a boss.” While I have certainly not attained the full boss status of many of my scientific colleagues, I have learned some valuable lessons that I think have helped me along the way and I thought I would start sharing them here in what, thanks to DNLee’s guidance, I shall dub “Like a Boss Lessons.”
The hardest thing I learned in graduate school was how to write a hypothesis. It’s funny that this was once so hard for me because, in our lab meetings now, I am known for always asking “What is your hypothesis?” I can’t tell you why this was so hard, being one of the most basic things we do as scientists, but I know that there were times my poor labmates had to almost shake a hypothesis out of me. I’d write completely unhelpful hypotheses like “Antioxidants will be different in smokers.” Oh, the shame. The shame of it all.
I think I tended to get bogged down in the details of the background or methods and would lose sight clearly telling people what motivated the experiment in the first place. Then, thankfully, one of my mentors offered me a very simple lesson in forming a good hypothesis that I still use.
A good hypothesis should always have four key components:
1) Identification of the subject or model (red)
2) Identification of the condition or stressor (green)
3) Directionality (brown)
4) Outcome measure (blue)
If you include these components, the basic experimental design falls out of the hypothesis.
Here are a few examples from the literature with these four components highlighted:
“…We hypothesized that…HAPE-susceptible people with higher vascular pressures would develop more exercise-induced VA/Q mismatch…” (Source)
“We hypothesized…that eNOS-mediated vasodilation would be attenuated in healthy, middle-aged humans.” (Source)
“…we hypothesized that women would exhibit enhanced sympatholysis during the early luteal phase compared with the early follicular phase of the menstrual cycle…(Source)
I still got back to that basic lesson every time I write a hypothesis and hope you all find it helpful.
Are there any lessons that you’ve learned that have helped you in forming a hypothesis?
If you have been following the discussion of uBiome on Twitter, you may have noticed that others have weighed in and the conversation has exponentially unfolded. There are some great posts from scientist bloggers pondering ethics, including “citizen-journalist” Comradde Physioprof (here and here), Drugmonkey (here), Janet Stemwedel (here), and evidence-minded physician Peter Lipson (here).
Over the last twelve hours, the folks from uBiome have been commenting on what I can now confirm is a lack of IRB oversight. On my own blog, company founder Jessica writes the following, which I have annotated with numbers so that I can organize my subsequent comments:
These are very important issues and I’m glad that you’ve raised them in such a thoughtful way on your blog. Our response is not “how dare you criticize us” — not at all. We are glad to have these issues brought to public awareness and believe as strongly as you do in ethical safeguards for research. (Comparing us to Nazis, though, is not a great way to start a dialog — just sayin’. [1])
Our point in requesting that you talk with us first was not to oppose transparency, but just to get the facts straight. Your previous post called our actions “ethical shenanigans” without verifying any of your assumptions about our project. We agree with transparency, but also appreciate having a chance to get the facts right before publication [2].
That said, we’re happy to respond here (and elsewhere) and to address your concerns and those of the rest of the public. We want citizen science to become a viable new way to fund and perform research, and unverified rumors of ethical issues will tarnish that ability unjustly.
Also — please remember that we’re a small team trying to do a big thing [3]. Attacking us publicly before giving us an opportunity to respond and set the facts straight is really hard on us [4]. We don’t have a huge PR staff (well, any PR staff at all), or even a lot of time to keep up on Twitter [5]. We’re not some huge monolith of moneymaking. We’re three people who want to empower people to get involved in science, and to ensure that this field can grow in an sustainable, inclusive, and ethical manner.
We can now safely say based on statements left here and at Comradde Physioprof’s blog that uBiome has not received IRB approval for their project, despite having made what I believe to be grossly over-stated claims about the applicability of their data to human disease and the fact that they have already collected money from their subjects and are in possession of potentially identifying data from their future subjects. That makes this “ethical shenanigans.” I believe that this is made more egregious by the fact that they used their university affiliations to “sell” their donors/subjects on the fact that they could complete their study as they described. Indeed, on their newly updated FAQs they state [with my comments in the text]:
However, IRB approval is not required for us to provide our primary service of microbiome compositional analysis and interpretation for private parties [Yup, that's true - MLB]. Thus, our sample collection is part of a service and our research study is a meta-analysis of de-identified data, which is technically exempt from IRB [This is not true when you are the people who collected the data to begin with. It is only true when you receive de-identified data from another investigator who already went through the IRB process - MLB]. That said, we are doing full Board review to insure that every aspect of the project is ethically safe and sound [That's good. - MLB].
If uBiome accepted any federal funding or was a university research laboratory instead of a citizen science startup, the IRB review would indeed be mandatory [This is where I disagree most vehemently. This is not a citizen start up. It is a start up founded by people affiliated with a university whose status as a start up allows them to skate the rules. This is my greatest concern, as stated in my original post - that university and industry affiliates will brand themselves "citizen scientists" to skate ethical obligations when they should know better. - MLB] As it is, this review should only strengthen uBiome as a research study and as a community [Yeah, maybe. - MLB].
This may all be a moot point, given that the dollars are already out of the wallets, but I still want to return to Jessica’s original comment, which believe warrants addressing.
[1] I want to be clear that I in no way compared uBiome to a bunch of Nazis. Indeed, Jessica’s tactic over the last 12 hours has been to paint the scientists who have questioned uBiome’s ethics as a bunch of big ole meanie pants-es who don’t understand that they just LOVE SCIENCE!!! I can imagine that criticism of the project must have been difficult for a group that was receiving essentially unquestioning praise from the popular media, but them’s the breaks. If Jessica intends to take the Fox News approach and claim that I called her a Nazi, so be it. I know that readers of the original post will remember that I simply offered the context for why we have IRBs. We have IRBs specifically because of Nazi physician experiments and the Tuskegee syphilis incident. I didn’t make up history. There’s a reason we have IRBs and it has nothing to do with whether we are “good people.” It’s because we are a better community when we all agree to abide by particular ethical standards. Calling your critics “combative” is a distraction from the discussion at best and disingenuous at worst.
[2] I am glad that uBiome is now seeking IRB oversight, but the study is still problematic in that they took money and information before-hand and have engaged in what I believe to be coercive advertising. I’ll leave it to their IRB to deal with that and only hope they seek the guidance of a real IRB and not a commercial rubberstamper. I hope that this is a lesson for real citizen scientists in the future. Your career scientist colleagues take ethics seriously as a community. But, I believe that many of us would be willing to help if you asked…
[3], [4], [5] Your obligation to do the right thing is the same whether you are one person or one hundred people. This isn’t the PR problem that Jessica paints it as. Ethics are not a mater of public relations. What I think this is, is an example of is a situation where having a mentor with experience in this sort of thing would have prevented this. it is irrelevant whether your ethical obligation is hard on you or makes you feel bad. It’s a shame that receiving well-intentioned criticism makes anyone feel bad, but that is the nature of science. We believe that review and criticism from our peers ultimately makes us better. Sometimes that criticism stings, but I believe that open funding and open science warrants what Drugmonkey genius-ly termed “open peer review.” I refuse to engage in this privately by email when it is a public project, especially given their propensity for threatening legal action when these communications are discussed openly.
And now, if you’ll allow me a Nazi reference, which I assure you is not akin to calling Jessica a Nazi…
I bet that the Nazi scientists who committed atrocities felt bad that their peers pointed out they had been unethical. They may even have believe they were doing “good work” or “important work.” But, you know who I bet felt a lot worse? Their victims.
Reasonable and responsible ethical oversight is not about us as scientists. It’s about protecting the safety and well-being of our subjects in a transparent way. If “citizen scientists” cannot realize this, then that should serve as an enormous red flag.
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My sincerest thanks to all who have stopped by in the last 24 hours to discuss my recent post on ethics and citizen science.
I am a little dismayed that the major response from the officials at ubiome has amounted to “we’re sad you didn’t contact us directly instead of talking about this on the internet.” I thought that a major tenant of the open science movement was transparency. As a scientist, I have concerns about this citizen science movement and I would think the appropriate move would be to crowdsource my concern. For what it’s worth, I know that officials at the project have been contact directly and the response has been…
I’ll say, though, that I am still concerned. This is a study that has enrolled it’s participants without a clear and transparent plan for ethics. I think that this should be of concern to anyone who has given money to this project, especially given the explicit statement of the projects goals:
“We will involve the public in not just collecting the samples, but in analyzing the data, generating and testing hypotheses, and doing as much official “science” as possible.”
It’s clear that the study investigators hope that the data they collect will be beneficial to the scientific and medical community and I worry that the lack of a clear, transparent ethical plan will be a hindrance to them.
If you’ve given money to the project, or considered giving money to the project, it’s worth asking whether these data will ever translate into meaningful information that a physician will use to treat disease. Given how many physicians make decisions, I’m not sure. One of the primary sources of information for scientists and physicians is the peer-reviewed scientific literature. Publishing a paper nearly universally requires a statement that a study has been reviewed by an IRB, that it was conducted in accordance with the Declaration of Helsinki, and that there is informed consent. It’s a very simple statement, but one whose omission generally precludes the publication of any work. It’s very black or white. It doesn’t matter how much you’ve thought about it, or whether ethics are important to you. You either did it, or you didn’t. If you can’t include that statement, most journals won’t publish you’re study. If scientists and physicians can’t use the work, the likelihood that it will ever influence global health (beyond one person swabbing their toilet paper to investigate the effects of white vs wheat bread on his gut flora) is negligible.
It’s such a simple statement that I find myself troubled that the ubiome investigators won’t make it despite having collected a lot of money. To put this in perspective, university scientists receiving funds have to give assurances of human subjects’ protection before our money is released to us.
The other thing, related to their goal of doing ‘official science’ that I found myself pondering is the source of the money in crowdsourced science. Let’s assume that the IRB questions resolve themselves. When I write a paper, I typically include a financial disclosure telling the journal all of the sources of funding that contributed to my work. I also usually acknowledge it in the paper. This sort of thing is very important to clinicians. They’re very sensitive to conflict of interest in data that guides their treatment decision.
I wonder how journals will handle crowdsourced funding. Will we get a supplemental table with 30,000 listed donors and all of their assorted conflicts of interest? Will we know if a drug or device company, or a political group, gave a large donation to a project? I suppose that’s the advantage of the structure of the current government-based model. The money is pooled and divided among the recipients in a way that no individual’s contribution is a primary source of funding.
The disadvantage, of course, is that the pool is small compared to the number of mouths at the trough. From that standpoint, I will give the crowdsourcing folks credit. They’ve gotten some people excited about the idea of giving money to research. Now, if only we could figure out how to do it without all of these messy ethical issues. Expanding that enthusiasm would be, most assuredly, a good thing.
I was sitting up in the middle of the night last night, pondering (ok, stressing about) the enormity of work that lies ahead of me for the upcoming week when an email arrived in my work email box and caught my interest.
Now, normally I would never have opened an email like this. Spammy-looking emails generally go right to the trash. Maybe it was the fact that it was 2 am. Maybe it was the vodka martini I’d had earlier in the evening. Maybe it was the fact that it was sitting alone in a list of read messages. Something inspired me to open it and, thus, we have inspiration for today’s post.
The sender of the email was the “Citizen Science Newsletter” and the title read “Only Hours Left to Sequence your Microbiome with Citizen Science”. I have pdf-ed the uBiome email if you’d like to read it in its entirety yourself.
The group soliciting me to sequence my microbiome is called “uBiome” and they look pretty excited about people doing science.
I’m pretty excited about regular folks doing science too, so I explored their website a bit. This group has been featured by a lot of media outlets and it seems that folks are pretty excited about their work. Even the NIH is excited about them.
The link in their email takes you to a website to donate to their cause and they have more than surpassed their funding goal.
But, why I am concerned about this project?
I should preface the rest of this post by telling you that I have been doing research with human subjects and patients for a long time. About 12 years, to be more precise. I take the privilege of being able to do human research very seriously. It is important to me to do research that protects the safety and dignity of my participants. More importantly, it is important to me that participants in my studies be informed about what their participation in my studies entails. What are the risks? What will be done to them? How will their information be used? What safeguards are in place to protect their rights?
And this brings me to what I believe to be the potentially dubious ethics of this citizen science project. One of the first questions I ask when I see any scientific project involving collecting data from humans is, “What institutional review board (IRB) is monitoring this project?” An IRB is a group that is specifically charged with protecting the rights of human research participants. The legal framework that dictates the necessary use of an IRB for any project receiving federal funding or affiliated with an investigational new drug application stems from the major abuses perpetrated by Nazi physicians during Word War II and scientists and physicians affiliated with the Tuskegee experiments. The work that I have conducted while affiliated with universities and with pharmaceutical companies has all been overseen by an IRB. I will certainly concede to all of you that the IRB process is not perfect, but I do believe that it is a necessary and largely beneficial process.
From their website, the uBiome project does not appear to be affiliated with an IRB and I find no mention of an informed consent process.
Why is informed consent process important? Informed consent assures that human research participants are fully aware of what their participation entails. It also makes participants aware of any relationships the investigators have that might influence their conduct. With both of these considerations in mind, I can see several places in which the uBiome project might be ethically dubious in a way that would be have been picked up on and probably prevented by an IRB.
1) Participation in the uBiome project requires the payment of a fee.
The coupling of payment with participation is problematic. It biases your data by limiting participation to people who can afford to participate. uBiome appears to have donated 150 kits, but that’s a trivial portion of their sample size. When I conduct research, our informed consent notifies participants that they will not be charged for participation in research. In no way will their revocation of consent influence their relationship with our institution and they are free to revoke their consent at any time. Participants in the uBiome project do not appear to have that right.
Now, let’s be clear that I am not necessarily saying that uBiome shouldn’t crowdsource their funding. I am saying that data collection and crowdsourcing should be separated, even if that limits the efficacy of the crowdsourcing.
2) There is no clear statement about what will be done with the data or samples.
Let’s imagine I collect blood. I am required to disclose to our participants exactly what I am analyzing the sample for. I have to disclose whether I will share the sample with anyone and whether an individual’s identity will be tied to the sample. I also have to have a plan for destroying samples. None of this appears to be disclosed by the uBiome folks. It could be that the particularly unique chlamydia sequence they find in your vaginal swab (that you didn’t know you had) would be shared with hundreds of other researchers, ultimately ending up incorporated into some GMO tomato somewhere that your mother adds to her spaghetti sauce. Maybe you’re ok with being the person that changes the face of chlamydia research and tomato growing, but you should have to right to make that decision. It’s not enough to know that people can go to their database, but will they actively send your information to people?
3) There is no apparent plan for how your identity will be protected.
The site states “Your data is open to the world… if you choose. Your data is yours — you can download it, share it, do whatever you want with it. We encourage you to opt-in to share your data with our scientists, but we respect your privacy and will not force you to do so. The data is also anonymized and private.” It’s not clear to me how this process works. Do you have the choice to “opt out” before or after you find out you have science-changing chlamydia? This is the sort of question an IRB would ask.
They also state “uBiome will never release any of your personal identifying data. We will never even store your data in such a way that anyone could figure out who you are from it.”
I suspect, if they are directly linking your ability to access your results either through email or a website that this is not true. If it is true, I would certainly like to hear more about it…
With my projects, we have a very rigorous data protection plan. We disclose all of the potentially identifying information that we collect. Birth dates. Medical history. Everything. We disclose both to the participant and to the IRB the locations where their name is linked to their data. We disclose how long we will keep those materials and how we will destroy them. We disclose the encryption on our computers, phones, and other devices that prevents people from accessing identifying information about our participants. The uBiome project’s data protection plan appears to amount to “Trust us! We love science!”
4) It’s not clear what conflicts the major players in the project might have.
The site states “our team will analyze the results to explore scientific research questions such as how the microbiome influences human health and disease”. The major players in the project appear to be a graduate student, an entrepreneur, a postdoc, a couple of pharmaceutical company employees, a physician, and a couple of independent investigators. How are their relationships influencing their work on this project? Will any of the university-affiliated staff be using your data for publication or will the pharmaceutical companies be using your information for drug development? That may be difficult without IRB approval. Are either of these groups either funding the project or receiving money from it? You should know about the financial relationships that surround a project that might influence your participation. There’s not guarantee that a citizen science project has to tell you any of that.
5) The benefits you’ll receive are grossly over-stated
These are the statements on the site that bother me the most:
“uBiome is not a diagnostic test. However, we can give you valuable information about your microbiome that you can use to learn more about your health. You and your doctor can discuss the results of the test and determine the best way to proceed.”
And…
“First, you can use it to understand what is going on in your body. If you have a tricky health condition and would like more information about your body, your uBiome profile might add useful additional data points. If you are going on a diet, experiencing a bowel flare-up, or changing your lifestyle, we can help you see how your microbiome is before and after. If you would like to know how your microbiome compares to others or to yourself over time (or both), we can help with that too.
Also, the information you contribute allows all of us to learn more about the microbiome, and, going forward, to better understand and possibly cure disease.”
Granted, the investigators do state that uBiome is not a diagnostic test, but they couple it with statements that the results should be discussed with the participant’s doctor and that this information may be useful data in treating difficult disease. It gives the participant hope that their doctor will be able to decode some information from the data. I’ve posed this to a few of my physician colleagues this morning and they agree that they are not sure how they would use this data, if at all. They would probably treat their patient according to evidence based guidelines.
This is especially troubling when an individual has to pay for their data. It’s not hard to make the leap to the scenario where people pay $1337 for the kit with the hope that they will learn something that helps them treat their difficult illness only to find themselves none the wiser and about a thousand dollars poorer.
To the best of my knowledge, there are no medical guidelines for the use of microbiome data and uBiome does not have a medical pathology-grade laboratory. The project should tell people that the uBiome is not a diagnostic test. End of story.
6) There is no statement as to what your risks of participation are.
I am sure that swabbing a region of the body is generally harmless, but it’s also not hard to jump to the scenario where people learn something they may not have realized they would learn. For example, it’s not difficult to imagine a scenario where a mother swabs herself, her husband, and her child and learns that the husband and child share a common STD. Or, where someone swabs a partner purposefully, using this information to make a judgement, but receives a contaminated result.
In our research projects, we must disclose any risks of participation and we must give individuals the right to tell us what information they want to know and what they don’t want to know.
7) Children are included, but it’s not apparent how they are protected.
This brings me to my final concern (for now). It’s not apparent how children are treated, other than an answer to a FAQ about whether you can swab your child that essentially says “Sure!” Can you swab someone else’s child? Can you swab your disabled family member? A prisoner?
I note these groups, among others, because they are specially protected groups in research because of their difficulty providing consent. An IRB takes special care in evaluating research using these groups because they, historically, have been subjected to abuse. There is no evidence to me that consideration of these groups has been given by this project in the same way that it would be considered in a classically-conducted research study.
In conclusion, the project investigators state:
“We are funding this project through citizen science for several reasons. First, we want to bring this technology directly to the public as quickly as possible. Second, we want to prove that citizen science is a viable way to do science, and an alternative to slower, more traditional methods. And finally, going directly to the public does not prevent more traditional funding later — we just wanted to get you all involved as soon as possible!”
I want the average citizen to be excited about science. That’s why I do stuff like blogging. I also think it is valuable when people feel invested in science, but I am frightened by the phrase “we want to prove that citizen science is a viable way to do science, and an alternative to slower, more traditional methods.” Faster science shouldn’t be the motivation for citizen science especially when some aspects of the “traditional methods” exist for a reason – to protect human research subjects and guide investigators in the responsible and ethical conduct of research.
I worry that the use of human subjects by citizen scientists has the potential to return us to an era where human subjects abuses were more prevalent. At the extreme, I worry that “citizen science” projects may provide a route for scientists affiliated with universities and pharmaceutical industries (individuals who should know better) to circumvent the IRB process when it is convenient for them.
I worry that, for as much as we think “citizen science” and “crowdsourcing” is the way of the future, we are actually taking a huge step backward.
I just read a really interesting study in the journal Pediatrics that may be helpful to those of us with small children.
This time of year, many young children face one or more bouts with an upper respiratory tract infection. While treating these infections is best done in consult with a child’s pediatrician, the discomfort experienced by a child during an illness can be a major source of anxiety for a parent.
In 2009, 118 deaths in children younger than twelve taking over the counter (OTC) cough and cold medications were reported. Eighty-eight of these deaths were likely due to overdose, potentially as a result of failure to properly measure the dose, accidental use of the adult dose, or accidental doubling in cases where ingredients were present in more than one medication that was given to the child. Because the risks associated with misuse outweigh the benefits of these medications,the Food and Drug Administration recommends that OTC cough and cold remedies are no longer recommended for children less than six years old.
But how does a parent soothe the symptoms of a sick, coughing child? A 2010 study compared the effectiveness of honey in treating cough with the drugs dextromethorphan, and diphenhydramine or a placebo. These drugs are key ingredients in OTC medicines like Nyquil and Benadryl. These authors found that honey was superior to these two common drugs in treating cough. The study has an important limitation, though. Parents knew which treatment their child was receiving, which can introduce a huge bias into the results of a study.
In this new study, 300 children (1-5 years old) with upper respiratory infections were randomly assigned to receive either honey or date syrup at bedtime to treat their cough. The sweet date syrup was used as a placebo control in order to blind the children and their parents to which treatment the child was receiving. This removes the bias that can result from the parent or child knowing which treatment they were receiving. The parents were then asked about their child’s night time symptoms. Here, honey proved to be superior to the date syrup in alleviating the child’s discomfort . Parents reported that the children coughed less frequent, had less severe cough, and the children and parents had improved sleep with the honey treatment.
Honey should not be given to children less than a year old because of the risk of botulism, but these data suggest that honey might be a valuable tool in treating in cough in children.
Honey, like many things found in nature, is a complex substance and it is quite possible that some of its components have anti-tussive (anti-cough) properties.
Maybe Mary Poppins should have been singing about a spoon full of honey.
(Source)
