Life as an Extreme Sport

Month: April 2015

Apple Updates HealthKit’s Ethics Requirements—But Don’t Celebrate Just Yet

Bioethics

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,”1 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.

ResearchKit-HSR-April302015The 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:

  • Who will have the capability to request to see this paperwork?
  • Can end users say “I want to see the ethics board approval?”
  • What is going to trigger Apple wanting to see this paperwork?
  • Who’s going to make sure that there was actually approval, rather than just submission? It’s not like it’s unusual for companies to try to fly under regulatory radar and sell products or services that haven’t been approved for their specific use (see: 23andMe, LuSys Labs).
  • Who at Apple is qualified to know that the ethics approval was granted by a legitimate, registered institutional review board (IRB)? (Does Apple even know how to check this information?)
  • Is Apple’s use of “independent ethics review board” an acknowledgement of outside-the-US names (where “Research Ethics Committee” or “Independent Ethics Committee” are more frequently used), or is this a way to dodge the requirement of use of an IRB, which does have specific and legal meaning within the USA?
  • What level of paperwork is Apple expecting app submitters to have for IRB approval? (Will they need to show the full paperwork filed? Will Apple be policing that paperwork to make sure it was what was necessary for the app’s purpose? Will they require meeting minutes? A one-page sign-off from an IRB?)
  • Precisely what qualifies an ethics review board as “indepdenent”?
  • Uh, what is “health-related” research, anyhow?
  • If the ethics review board says “this isn’t something that needs our approval, so here’s a waiver,” will Apple accept that as “approval”? (Because technically, that’s not approval.)

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.” ResearchKitHealthKitAppleI’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.

Human Beings are Cruel Things—The Internet Didn’t Create That

...and everything else, life and living

There seems to be a new, public wave of hand-wringing over technology changing us, making us mean or cruel. People cry out that the only reason women receive rape and death threats online is because of anonymity; there’s belief that bullied kids would never kill themselves before the internet; there’s a panic over the shaming that many (especially white men) face for revealing their racism, privilege, bigotry. But as Tabatha Southey points out, we—we humans—are cruel. We have always been cruel. We almost certainly always will be cruel.

Lately, humanity has been flattering itself that it was better and kinder before the Internet — as though we never slipped anonymous notes through locker doors in high-school hallways that were echo chambers in themselves, as if we never wrote on actual walls.

I had a growth spurt at 10; by 11 I’d reached menarche and developed breasts—the first out of my school and friend group. By the time I was 12, I was referred to as “Bazoonga Breasts” by everyone in junior high school, because most other girls—and certainly not any other 6th graders—had not developed to the extent I had.

I didn’t hear anyone, except teachers and family, refer to me by my given name for almost two years.

To hear us now, you’d think no one ever ever crank-called late at night, dialled up even before dial-up to offer abuse, stared into other people’s windows through our own twitching curtains.

When I was 13, everyone I ate lunch with, spent time with on the weekends, socialized with, and thought was my friend decided they liked another guy better than they liked me. molg-butterfly-wings-stickerThat guy was mad at me, so convinced everyone to send me letters telling me how worthless I was, how much they hated me, how much everyone wished I would just kill myself.

I took a decent swing at it.

We were never bitches before BBS. We never took our children to public hangings. The way it’s told now, we never publicly shamed anyone, put them in the stocks, or hurled rotten vegetables at them in the street. We never quietly dropped anyone off the guest list at a time when, new social spheres being difficult to access, a true precipice might well lie below.

When I was 20, the people I thought were helping me leave an abusive, violent relationship—the people who had helped me orchestrate fleeing in the middle of the night, getting into a motel room, fending for myself for several days—stood me up. We were supposed to meet at someone’s house and then caravan to another state; they purposefully didn’t show up, leaving me to either return to my abuser or make a 700 mile drive I’d never made before on my own. When I called to ask where everyone was, they told me they’d left hours earlier.

They thought it was funny.

They had, in their words, punked me.

We didn’t start the flame war. Scandalous satirical pamphlets were once cranked out by writers and sold at train stations, like so many primordial blog posts. Political cartoons have a long and vicious history. Incivility is our legacy, not our invention. It is part, but only part, of who we are. And have always been.

No, the internet hasn’t made us cruel. The internet has simply made it impossible to deny the reality of our nature, amplifying what was once small and local into a chorus people can no longer ignore, and are forced to confront with eyes that want excuses for the baseness of our very being.

Inclusion is the Core of My “Radical” Feminist Agenda

...and everything else, Philosophy

I’m tall, I’m a natural blonde, and I have green eyes. I’m also anywhere from “pleasantly plump” to “obese whale” depending on your scale of things, and I’m invisibly disabled. Needless to say, I receive a lot of comments about my body, both directly and indirectly, on a daily basis, and am frequently reminded of how I am—or am not—valued on the basis of what my body looks like and what it can or cannot do. I “should” be thinner, healthier, ignore the people who think I should be thinner, healthier; I “should” embrace who I am, change who I am, be a ‘better’ version of who I am, achieve health at any size-the list goes on, and on, and it often seems and feels like everyone has, and feels comfortable, voicing their opinion on what my body should look like and be capable of.

Would there be any less pressure if I wasn’t fat? After all, some people might want to argue that the comments come because of my weight, and the fact that I am so close to “the ideal” for a woman (tall, blonde, fair) that if I could get get thin, it’d all be fine.

Well, Cassey Ho’s recent “The ‘Perfect’ Body” video should put that idea to rest:

And if I were thin, I think it’s safe to say that the so-called “radical feminists” would simply say that being a thin, tall, blonde, fair woman is merely contorting myself to a body approved by a patriarchal/porn culture, and criticize me for that, as well. I suppose I might get “points back” for being disabled, but who knows.

Are you getting the idea that I can’t win? Because if I can’t win—if I can’t be my normal hair colour, my normal eye colour, my normal skin colour, all of which are considered damned near ideal for way too much of the world, and thin or fat or anywhere in between-then how is anyone else supposed to win?

Playboy (yes, really) takes this on in their post on Laverne Cox’s nude photo for Allure and the frankly ugly response from “radical feminist” Megan Murphy. To quote Noah Berlatsky, author of the Playboy piece,

Murphy reacted to the photo just as Cox suggests that people often react to black and trans women ”” with disgust, prejudice and horror. In a short but impressively cruel post, Murphy sneers at Cox for attempting to achieve a “‘perfect’ body as defined by a patriarchal/porn culture, through plastic surgery, and then presenting it as a sexualized object for public consumption.”

She scoffs at the idea that trans women who take hormones or have surgery are accepting themselves. Murphy suggests that trans women are “spending thousands and thousands of dollars sculpting their bodies in order to look like some cartoonish version of ‘woman,’ as defined by the porn industry and pop culture.

My first thought, reading both Berlatsky and Murphy, is that this comes down to a question of how we define self. Berlatsky, along with most who support trans folks, seems to accept the idea that “who we are” can be a mismatch; your internal notion of self doesn’t match your external representation. For Murphy, it appears that you’re supposed to merely integrate the internal and external, and that if your internal notion of self doesn’t match your external being, that’s the fault of society for placing unrealistic notions on the external being.

Now, this notion of social expectation shaping external being is definitely accurate—if the mismatch you experience is what society tells you your external self should be and what your external self actually is. But where Murphy and most “radical feminists” seem to fall down is comprehending that there’s another option here, the one that trans folk fall in to, where your internal notion of self doesn’t match the assigned external self. When that happens, it’s not enough to say “ignore society” because the dissonance isn’t coming from society; there can, after all, be strong, physical differences between genders that have nothing to do with society and everything to do with biology.2 emp_v_obj-finalSociety might embrace fashion that emphasizes child-bearing hips, for example, but society doesn’t create those child-bearing hips. That’s biology.

But my first thought was a bit too shallow, on reflection. While this is all certainly true-Murphy and her ilk are simply not capable of dealing with the nuance of what it means on a base level to be trans-what it actually comes down to isn’t that, at all. What it comes down to is “radical feminists” not understanding the difference between sexual empowerment and sexual objectification. Which, to be fair, is a difficult concept to understand—but I don’t think I’m totally out of line to say “if you’re going to write critiques about bodies and empowerment, you’d best know what you’re talking about, first.”

I find that the cartoon by Ronnie Ritchie, posted by Everyday Feminism, really nicely captures the necessary nuance of power dichotomies (see right).

My problem with the “radical feminists” is pretty simple, and it’s neatly illustrated by the above response to Cox and a lack of understanding agency and consent: they’re drawing such a tiny, tight boundary around what it means to be feminist, that most people fail. Perhaps even more damning, that tight boundary contains body policing—something that most feminists, one hopes, would tell you is decidedly anti-feminist.

I place “radical feminist” in quotation marks because I don’t actually think they’re radical or feminist. I think that, for the most part, they’re scared women who are trying to define themselves in a way that maximizes their own power, and they do that by trying to keep it to themselves rather than share it liberally—another hallmark of what I think feminism should be about. In fact, I think that along with trusting adults to their own agency, about the most radical thing any feminist can do is include everyone.

CRISPR and the Amoral Othering of Chinese Researchers

Bioethics, BioScary

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.

Claim
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?”

Claim
OH MY GOD THE CHINESE ARE MAKING GENETICALLY MODIFIED HUMAN BEINGS!

Fu_ManchuReally? 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,…

Claim
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.

  1. CRISPR isn’t 100% accurate, and sometimes “missed,” inserting DNA in the wrong place. This is problematic, because instead of offering a cure for $Whatever, it can actually create a new problem. So, not a benign “oops.”
  2. Even the embryos that were edited correctly by CRISPR ended up as mosaics-in other words, it wasn’t a universal fix. This, as Carl Zimmer explains, means that it’s a lot harder to take a single cell from an embryo and “verify” that it’s been fixed, and it’s hard to know whether or not the fix will manifest, pass down in the germline, etc.

In other words, as Zhou, Huang, et al say themselves: their “study underscores the challenges facing clinical applications of CRISPR/Cas9.”

Claim
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,…

Conclusion

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?Gattaca 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.