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,” 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:
- 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.” 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.