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

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.


CRISPR and the Amoral Othering of Chinese Researchers

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.”1 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.


Screening vs Diagnostic – Differentiating Difficulties Lead to Tragedies

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 thisWell, possibly second-most. I did receive a lot of “it’s my DNA and I’ll do what I want with it” retorts, too. was that no one would actually use an OTC, DTC, or otherwise unregulated test to make decisions.

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,...

OutbreakChat: A Livetweet of a Movie That Gives People Nightmares,…

Outbreak-ForBlog…and probably not for the reason you think. Outbreak is one of those movies people seem to either love or hate (or possibly love to hate); almost everyone I know who has anything to do with public health, infectious diseases, or virology tends to swear up a blue storm when the movie comes up.

So naturally, a group of us are going to watch it in real-time tonight, drinking and live-tweeting our thoughts on Twitter. This will include fact-checks, snark, and almost certainly questions and answers from the crowd-at-large. Who is doing this? Well, you might remember David Shiffman (@whysharksmatter) from my Virtually Speaking Science interview a few months ago; while he might seem like an odd choice to organize this, remember he has significant experience with pop culture/movie portrayals of sharks, mermaids, and other scientifically incorrect portrayals of the ocean.

Tara Haelle (@tarahaelle) is a freelance journalist probably best known for her excellent article that debunks flu myths. She’s written extensively on science and the need for accuracy in media imagery and discussion.

Nicholas Evans (@neva9257) is a post-doctoral bioethicist at the University of Pennsylvania’s Department of Medical Ethics and Health Policy, based in the Perelman School of Medicine. He specializes in biosecurity, bioterrorism, and the ethics of pandemic preparedness, and recently wrote a piece for Slate explaining why Ebola is not a bioweapon, despite media myths. (He’s also my husband.)

And what am I (@rocza) doing involved in this? Well, aside from spending much of the last couple of months educating Twitter about Ebola, blogging extensively about Ebola, and doing Justice Putnam’s “The Morning After” radio show to talk about the ethics of science journalism and Ebola coverage, I once upon a time was pursuing a PhD in bioethics and philosophy, looking at how popular media portrayals of medical issues affects our medical-decision-making (a continuation of my undergraduate thesis on autonomy and medical ethics). I’ve taught courses through pop culture (Stargate and Applied Ethics), and one of my most popular and invited lectures was on why we watch reality TV. I also have a weird affinity for Ebola; I once intended to become a virus hunter, and I’ve been studying Ebola, outbreaks, and the research for going on 20 years.

We are, of course, hoping more people will join in the viewing party-both experts and lay people alike. So pop up some popcorn, grab your favourite beverage of choice, and join us at 8pm ET tonight (#OutbreakChat) to see firsthand what set the foundations for the Ebolanoia that has raced through the world these past few months.

Edited to add: Bingo cards are available on Twitter.

If I’m Gonna Drop Anything, It’ll be Bricks, Not Names

I really hate having to justify myself. I hate having to roll out “credentials” and be constantly challenged on whether or not I have the “right” to discuss philosophy or ethics, or why I am actually offering a bit more than an “opinion,” or the recent favourite, that I’m not just talking about these things because my husband is a postdoc at Penn.

I hate it even more when I see how people treat Nick – even before his affiliations were made public, no one asked him to justify his credentials. No one asked if he had the right to offer opinions, and in fact, few took what he said as opinions. Oh sure, he gets the MY SCIENCE FACTS crowd, but that’s the crowd that’s arguing the validity of ethics as a field, not the validity of Nick discussing ethics.

sexistandabsurdNo one has suggested that he writes about ethics, or thinks he’s able to do so, because of who he is married to.

Some people have suggested that it’s because I don’t specifically call myself an ethicist or bioethicist in my Twitter profile, which is true. I have some issues there, and in particular I don’t want people to make the mistake of assuming I have a PhD, because I don’t.Look at my CV. Look at Google. Piece it together.

But that doesn’t mean I don’t have an education, because I do. I started off studying human psychology and comparative religions, and got about halfway through a dual degree when I had to relocate to another state, putting my education on hold. When I went back to school, it was with an eye towards either communication or epidemiology; I ended up in a strange interdisciplinary department at the University of Washington, the Comparative History of Ideas. My mentor had a degree in the History and Philosophy of Science, and I studied that, with a heavy emphasis in continental philosophy and anthropology, as well as medical history and ethics, in what was, at the time, the Department of Medical History and Ethics. They only offered a minor for undergraduates, but because of my major and my interest, I was allowed to take as many courses as I could, which ended up being equivalent the Master’s students.

During that time, I also started writing about pop culture and ethics for “the school newspaper” – which happened to be the third largest paper in Seattle at the time. I started guest blogging and then actually writing for other bioethics-related blogs, and I started giving invited talks on subjects I’d written on.

My thesis, which neared the length of a dissertation, was required for graduating with honors (which I did, both department and university). Relying heavily on continental philosophers you’ve never heard of, I made an argument against the primacy of autonomy and proposed an affect-centered ethic to take its place.

I went to graduate school, where I ended up writing for yet another bioethics blog. I worked in a bioethics research institute as a research assistant. I learned how to edit academic papers while working at an academic journal, where I also learned how to run an academic journal. I learned how to talk to the media, how to give interviews, how to evaluate timely and relevant topics. I learned how to write about complicated and serious issues in an accessible manner.

I also taught; I started teaching as an undergraduate, and into my graduate years. I taught basic general topics, I taught applied ethics, I taught bioethics. I taught Merleau-Ponty to freshmen and I taught medical ethics to graduate students.

Is that enough hitting over the head, or do I need to start name-dropping? After all, I learned a lot, from a lot of people, many of whom were, or are, considered the best in what they work in.

No, through circumstances, most out of my control, I don’t have a PhD to hit you over the head with when you question my credentials or my ability to talk about ethics in 140 characters. And that’s why, if you want to talk to “an ethicist” for a paper or publication, I’m happy to give you suggestions on who I think is accessible and able to talk on the subject at hand; I do understand the power of a PhD and the ability to cite an institutional affiliation. Do I wish I had that? Of course. But I also understand reality.

It's not just academia where you find this "treat a couple in the same field differently" bias; Emma Stone has spoken quite pointedly on it.

It’s not just academia where you find this “treat a couple in the same field differently” bias; Emma Stone has spoken quite pointedly on it.

Just like I understand the reality of why you question me and my ability to talk about ethics when it doesn’t even cross your mind to do the same with Nick. And it has nothing to do with his PhD, or my lack of.

Unfortunately, the fact that I even had to write that tells me that too many people don’t understand this, or the dynamics we’re working in, at all. Too many people don’t see that they will automatically accept a man as an authority, while automatically suspect that a woman can have any knowledge at all. So a situation is created where women have to be on constant defense, constantly justifying their ability to have more than an opinion.And yes, my irritation and my experience is a small fraction of what minorities, both male and female, have to deal with in academic and professional fields.

There is a difference between “let’s discuss” and “prove it,” one that rests not on tone or language, but on the implicit assumption that discussions happen between people with differing understandings, ideas, and knowledge, whereas someone being told to “prove it” has to meet some unknown, hidden bar of justification just to move on in to the possibility of discussion, and that the person making the demand has the qualifications to make such a determination.

And while there are situations in which “prove it” is appropriate, they are not “when the topic is about ethics and your background, degree, career are nowhere near ethics,” because you don’t have the ability to accurately judge my knowledge of my field.

You know who does?

The people I’ve never once been challenged by,Which is not to say there have never been loud and feisty disagreements. But see the difference between “let’s discuss” and “prove it.” I have never once felt as though I’ve had to prove my right or otherwise justify my ability to discuss ethics with other people in philosophy, ethics, and bioethics–and we’re not talking a giant happy-go-lucky field here, but one where civility is often strained, at best. in my last decade and change of being publicly involved in philosophical, biomedical ethical issues: other ethicists.