Because there’s nothing the media likes more than a good look at all these teeny genius stories (except maybe catching a politician with their pants down, figuratively or literally), the primary non-Supreme-Court-ruling-on-Obamacare story making the rounds right now is the S.T.EYE condom, developed by three teenage boys from the Isaac Newton Academy in London. The S.T.EYE changes colour* when it comes in contact with a sexually transmitted infection (hence the name), which is being heralded as ground-breaking, revolutionary, disruptive technology—of course, since this was a TeenTech entry and winner. One of the young inventors, Daanyaal Ali, 14, says that they created the S.T.EYE because they wanted “to make something that made detecting harmful STIs safer than ever before, so that people can take immediate action in the privacy of their own homes without the often-scary procedures at the doctors.” (And as an aside, I find it fascinating that the teenagers want to reduce the embarrassment of going to clinics and emphasize “the privacy of your own home” line so frequently used by DTC advocates without stopping to consider the major hurdle of: if you’re putting the condom on to have sex with someone(s) else, then you’re not alone and we’re right back to the embarrassment-only this time it’s in the privacy of your own home while you’re naked in front of someone you want to have sex with. Which kind of sounds like it should be the beginning of an 80s movie starring Jon Cryer.)
This is an ambitious goal, and it’s laudable that teenagers are behind the idea; a validated, direct-to-consumer, at-home STI test that is inexpensive and accurate would be a great addition to public health. I’m not sure anyone can disagrees with that. The problem here is in implementation: the teens envision their test being wrapped up in a condom, which means that at least one person’s STI test will be revealed after-the-act, rather than before. While you may think “great, post-exposure notice,” it’s not that simple. What happens, for example, to informed consent? You’re talking about revealing whether or not someone has an STI to not just themselves but their partner(s)-at-the-moment; is there something that clearly identifies these as S.T.EYE condoms? Will it be impossible to miss that this condom your partner is providing (or that you provide a partner) will glow in the presence of an STI, regardless of who is infected? Will all parties need to sign a contract honoring the privacy of all participants before opening the condom? Will it come with a EULA-disguised-as-informed-consent? Remember, informed consent can’t be coercive-is right before having sex the bestest time in the world to assure non-coerced consent?
And other difficulties: how do you know who “triggered” the glow? Presumably it glows the same “uh-oh” colour regardless of which side of the condom the exposure occurred on. What if there are multiple partners? Are they considering impregnating dental dams with the same technology to include lesbians, or is this only for penis-based sex? Will the antibodies in the condom react to antigens in saliva? Can you still use lube? But, with exception of exactly who this condom is being created for, those issues are largely technical issues, and they’ve been well-deconstructed elsewhere.
Autonomy to make decisions, ability to consent after given full information, privacy of medical information; these are all pretty basic medical ethics 101 concepts, and they’ve been ignored here. I certainly don’t fault a trio of teenagers for that-but I can and do fault the teachers who encouraged them to pursue this line of thought, as well as the people who awarded it as innovative (not to mention the non-critical journalists breathlessly reporting it).
Innovation is the lifeblood of the technology industry; I understand that. My father had his own technology business when I was a kid. I was part of the technology innovation industry for a decade, and played a role in disruptive medical technologies.1 I was raised in Silicon Valley before it was Silicon Valley; I do understand, and I have no real interest or desire to stifle creativity, innovation, or even disruption. The problem is that in the pursuit of “can” at all costs, “should” is being left in the dust. Should we develop condoms that glow on exposure to STIs? Maybe not. Why? Well, how about the scenario where someone is killed for exposing someone to an STI? How about the person who is too embarrassed or ashamed to get help and kills themselves? What about the person who is shamed across their community, online, for having an STI, with a glowing condom as “proof”? And why do I even have to reach for such dramatic examples of “maybe we shouldn’t do this,” when “how do you manage consent” is such a present and problematic issue?
Of course, this isn’t just about innovation-it’s also about disruption. And the disruption here isn’t the idea of color-changing-upon-STI-detection condoms, but who is having the idea: teenagers. These teens are envisioning medical devices that are conveying diagnostic information, and they’re doing so outside of the normal channel that we expect medical devices to be developed in. That means the typical standards that are in place for medical device development (specificity, standards, quality control, labeling requirements, documented risks, etc) haven’t been addressed (or likely even thought about). To quote Nick, “In the world of distributed technology, these things are increasingly up to the individual, and we need to start adopting an “ethics of design” into our disruptive tech scene.” In other words, this project shouldn’t have made it to a technology competition without serious consideration given to plausibly, specificity, testing standards, and the other things that, presumably, the condom manufacturing company that has partnered with these teen boys will now take on.
It’s fantastic that there are challenges like TeenTech to encourage teenagers to pursue STEM-related careers. However, we need to make sure that we are setting the foundations to good research by teaching all aspects of research and development, including ethics, and make sure that our enthusiasm for encouragement doesn’t overshadow the necessity of ethical oversight.
*26 June 2015: Just a quick clarification, based in Maggie’s nice comment below: I want to stress that the idea the teens presented at TeenTech are conceptual ideas, not actual prototypes or working models. I do think that this stage is definitely where the “ethics of design” needs to be built in, but presumably—hopefully—that dialog will continue happening as the teenagers partner with a company to see what happens in science after you have that initial “oh hey” idea.
In the on-going drama of Apple’s ResearchKit and its lack of conforming to modern expectations regarding human subjects research, Apple has updated the guidelines for apps “using the HealthKit framework or conducting human subject research for health purposes, such as through the use of ResearchKit,”2 requiring “approval from an independent ethics review board.” At first blush, this seems great—one of the bigger problems raised when Apple debuted Health/ResearchKit in March was that there didn’t appear to be any nod to or concession towards the necessity of ethical oversight of human subjects research, a conversation that’s been growing louder over the years, especially as Silicon Valley has become more interested in the potential “killer app” money behind health care products.
Unfortunately, a closer read of the actual guidelines shows that there’s still a lot to be desired, and Apple really needs to actually bring in someone familiar with medical ethics and health policy to help them not only with the language of their guidelines for apps, but also to review any app that wants to utilize the HealthKit framework or use ResearchKit for health-related research.
The revised guidelines can be read here; a snapshot of section 27, HealthKit and Human Subject Research, taken on April 30, 2015, can be seen to the right (click to embiggen). The particular language regarding ethics review boards is at the very end:
27.10 Apps conducting health-related human subject research must secure approval from an independent ethics review board. Proof of such approval must be provided upon request.
Obviously, the first and largest problem here is that proof of ethics board approval isn’t required, it merely needs to be available upon request, but a tumble of questions spill forth from that:
And of course, separate from this is the fact that currently, research (at least within America) only requires IRB oversight if money for that research is coming from the federal government. While yes, it’s true that all legitimate academic journals will require that the research was approved by an IRB and followed the conventions of the Declaration of Helsinki, not everyone is doing research with an eye towards publication within a peer-reviewed journal. This means that anyone doing HealthKit or ResearchKit work who is not embedded within an academic institution that has access to an on-site IRB will have to pay a for-profit IRB to review the app design and research goals – will Apple be looking for proof of payment? (And of course, that assumes that Apple will consider a university IRB “independent.” I’m relatively sure Carl Elliott would have some choice words about that particular assumption.)
All in all, this-the entirety of section 27, to be frank-reads as Apple scrambling, post-debut, to mollify the science journalists and media-savvy ethicists who have been honest and critical about Apple’s failures to understand even the most basic aspects of protecting the subject in human subjects research. It doesn’t actually seem to indicate Apple understands what is actually required from those doing human subjects research, only that Apple lawyers seem to be aware that there is a serious potential for a lawsuit here, and thus are trying to figure out how to best cover their corporate asses.
I’ve been under a rock for the last week or so, first at a conference in San Diego, and then fighting off a nasty combination of strep throat, laryngitis, and double ear infections. (So when I say “under a rock,” I mean hiding under the blankets in my bed, spending most of my time sleeping.) So while bits and pieces of the “CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes” paper published in Protein & Cell by researchers from Sun Yat-sen University in Guangzhou, China, made its way to me, it wasn’t until today I felt well enough to say anything about it–mostly because I don’t expect what I have to say will be very popular. So without further adieu, a few unpopular thoughts on Zhou, Huang, et al’s paper.
The paper was rejected by Nature, Science, other top journals, for being unethical.
Hah. Ahem. Look, if Nature, Science, et al, want to make that sort of “it’s unethical we can’t publish it” claim, they might want to do so when the ethics-inclined folks who’ve been around a while are, I don’t know, busy, off tilting at other windmills, at a conference in Bermuda, or something. Because history here isn’t really kind to the so-called “top journals” when it comes to publishing unethical material; see, for just a really short course on it, the Fouchier and Kawaoka H5N1 gain-of-function debacle. “Top journals” were burned by the response to the H5N1 enhancement debacle, and were flat-out caught unaware that such a thing as “bioethics” had enough of a voice to be heard. They don’t want to be caught again, so they’re walking away from anything possibly controversial right now, and the debate over CRISPR/Cas9 has already been going up in the flames of controversy.
In short, any time any “Top Journal” says “we’re concerned about the ethics” you should actually read “we don’t want to be involved in any mainstream media controversy.”2 They learned this with H5N1 GOF issue to the point that these days, any debate over GOF/dual-use research of concern/potential pandemic pathogen research is met with a chorus of “la la la can’t hear you publish what?”
OH MY GOD THE CHINESE ARE MAKING GENETICALLY MODIFIED HUMAN BEINGS!
Really? Is it time for the great Bondsian bad guy freak-out? Do you suppose the folks who are making this claim picture Zhou, Huang, et al, twirling Fu-Manchu moustaches while wearing Zhongshan suit-inspired lab coats as they look upon an army of genetically modified super humans being incubated in chained women who were discarded as babies for being female? How many tropes do you suppose are shoved into this image of evil?
Again, take it from an old-timer: “we have to do it before the Chinese” has been a rallying cry for an awful lot of the science that falls at the intersection of bioethics and transhumanism. Why? Because “the Chinese” stands for “people who don’t have our values and belief systems-they’re DIFFERENT.” We’ve heard it with cloning humans, dual-use research of concern, with just about everything, and now we’re hearing it with CRISPR/Cas9: “we” have to do it before the big scary Not Western people do it!
Except some researchers from China do it and what–it’s suddenly “not ethical” because they’re Chinese? Pundits, scientists and otherwise, are freaking out not because “omg someone edited embryos with CRIPSR!” but because “the Chinese” have. (And do you note how most folks are just saying “the Chinese” as if the paper has no authors? See: creating a big bad menace in your mind.) And unfortunately, this excuse isn’t limited to Top Journals rejecting the paper for claims of it being unethical. The concern shows up in Paul Knoepfler’s blog, as well:
It is worth noting that the current study had institutional ethical approval according to a statement in the paper:
This study conformed to ethical standards of Helsinki Declaration and national legislation and was approved by the Medical Ethical Committee of the First Affiliated Hospital, Sun Yat-sen University. The patients donated their tripronuclear (3PN) zygotes for research and signed informed consent forms.
Would an institutional review board in another country such as the US have given the green light to making GM human embryos? I don’t know.
The emphasis there is mine, and it’s one I dislike making,2 since I do consider Paul a friend. But what this shows is just how pervasive the idea that “the Chinese aren’t moral like us” is: Zhou, Huang, et al, swore to the study conforming by ethical standards required by the Helsinki Declaration as well as their own national legislation, noted it was approved by a MEC–and people are still questioning whether it was ethical enough, because they’re Not Western.
Which ties into the third issue people seem to be having,…
OMG the Chinese did CRISPR/Cas9 editing this is so worrying aren’t you bothered YOU SHOULD BE BOTHERED!
Well, no, I’m not bothered by the paper. I am bothered that Protein & Cell did such a rapid turn-around on peer review for the paper, but I have that concern whenever any journal does such “rapid turn-around” (and you’re kidding yourself if you think this is an isolated event-it’s very much not). Nor am I bothered that “the Chinese” did this particular CRISPR/Cas9 experiment, just like I’m not bothered by human embryonic stem cell research. The researchers (and again, let’s think for a minute about the alienating and Othering going on by insisting on referring to the folks behind this research as “The Chinese”) answered some pretty important questions about the immediate applicable functionality of CRISPR/Cas9 editing–which is especially important given the recent moral panic going on about the technology as a whole.3 In short, they learned two major pieces of information that have direct implications for any conversation about future use in humans–and bans on the technology.
In other words, as Zhou, Huang, et al say themselves: their “study underscores the challenges facing clinical applications of CRISPR/Cas9.”
But what about the embryos?!
Zhou, Huang, et al used tripronuclear (3PN) zygotes for their research. These zygotes occur in upwards of 5% of IVF attempts, and are discarded because, while they might develop into blastocysts in vitro, they absolutely do not develop further in vivo. In other words, these are non-viable creations4 with a built-in suicide switch: they’re never going to develop into bouncing babies, Chinese or otherwise. In fact, it was because of the very specific concerns over CRISPR/Cas9-mediated gene editing in normal embryos that Zhou, Huang, et al used 3PN zygotes: it says so, right there in the paper. (So what was that about ethical concerns, again? You can’t really say they weren’t thinking about it when they put it right there in the paper. Repeatedly.)
If I were to be moved by the creation of these 3PN CRISPR creations as somehow unethical, then wouldn’t I also be obligated to find human embryonic stem cells unethical? I don’t,5 so in practicing a policy of consistency,…
Look, the panic over the CRISPR paper comes down to this: people somehow believe that there’s “moral control” if Westerners do this research. To which all I can really say is, DURC folks? Maybe y’all missed the boat on how to get traction on this issue, and should have run around all a-panic, OMG THE JAPANESE!6
More seriously, the history of science and medicine should underscore and emphasize the fact that “like us” does not mean “moral and ethical.”
As I was pointing out to Razib Khan and others on Twitter, I was around during the OMG DOLLY NOW WE’RE GOING TO CLONE HUMANS AND THE END IS NEAR panic, which as Khan noted, hasn’t happened–or at least, the Raelians haven’t made us believe. Will the same happen to CRISPR/Cas9-mediated gene editing? It’s hard to say, because the technology is so new, and whether or not we’ll be able to overcome random DNA insertions and mosaic, chimeric embryos is down the line enough that it’s speculative.
But whether we’re on our way to a GATTACA-esque future or not, one thing is certain: the first step to any dialog over CRISPR/Cas9-mediated gene editing isn’t going to be an Asilomar-like conference. It’s going to be to stop demonizing “The Chinese” as being a-moral, immoral scientists.
Edited to add: BTW, this was originally a stream-of-conscious Twitter rant that I was goaded to turning into a full blog post. You can read the original, see comments, etc, starting here.
I’ve been a relatively vocal critic of unregulated over-the-counter and direct-to-consumer screening kits for years, and moreso in the last few, as 23andMe flirted with the DTC genetic screening market. I felt (and still believe) that yanking the 23andMe kits was necessary because they’d not been validated and had no overight or FDA approval. Perhaps not surprisingly, the most common pushback I received on this
This Boston Globe story, by Beth Daley at the New England Center for Investigative Reporting, helps to prove my point: people do make life-changing decisions based on the results of screenings and unregulated (or non-regulated) tests, instead of diagnostic tests. Aside from being a very big problem, this can often be incredibly tragic:
Now, evidence is building that some women are terminating pregnancies based on the screening tests alone. A recent study … found that 6.2 percent of women who received test results showing their fetus at high risk for a chromosomal condition terminated pregnancies without getting a diagnostic test such as an amniocentesis.
And at Stanford University, there have been at least three cases of women aborting healthy fetuses that had received a high-risk screen result. …
In one of the three Stanford cases, the woman actually obtained a confirmatory test and was told the fetus was fine, but aborted anyway because of her faith in the screening company’s accuracy claims. “She felt it couldn’t be wrong.”
And no, these screening kits aren’t subject to regulation, because yay, loopholes. Expect them to be closed in oh, nine years, give or take.
It’s always nice to have another point of data to support an argument.
And yes, possibly I’m humming a revised version of a song from West Side Story, as I idly think about sending this link to people who told me there was just no way people’d make life-changing choices without doctor feedback/approval. I feel petty, oh so petty, I feel petty and witty and bright,...