Getting approval from an independent ethics board is now mandatory for all apps made using Apple's Researchkit — an open-source software platform meant to help scientists run clinical trials through apps available in the Apple app store. The additional guidelines, spotted by 9to5Mac, come two weeks after Apple opened up the platform to developers and medical researchers around the world.
What prompted the change is unclear
Apple announced ResearchKit in early March to great fanfare. At the time, only a handful of institutions had been given access to the platform. Almost immediately questions about the ethics of running clinical trials exclusively through mobile phones were raised. When The Verge reported on the story in March, it was unclear whether IRB approval would become mandatory for apps that made it to the Apple apps store. The five apps that were released through the app store on the day of the announcement had all been approved by an independent ethics review board, but the app store guidelines lacked specific wording about the need for Institutional Review Board (IRB) approval for these apps.
A few days later, Apple released new developer guidelines for ResearchKit-made apps. They demanded that all research apps "obtain consent from participants or, in the case of minors, their parent or guardian." As noted in The Verge's ResearchKit ethics story, the first set of apps made through ResearchKit made it very easy for minors to lie about their age in order to gain access to clinical trials aimed at people over 18.
"Proof of such approval must be provided upon request."
Now, two weeks after making ResearchKit available to all developers, Apple has added another set of guidelines that make IRB approval mandatory. "Apps conducting health-related human subject research must secure approval from an independent ethics review board," the new guidelines read. "Proof of such approval must be provided upon request." It's unclear what might have prompted the addition. The Verge has reached out to Apple for comment on this issue.
Overall, the change is a welcome step. IRBs are designed to approve, monitor, and review scientific trials involving humans. This process often involves a risk-benefit analysis that's aimed at determining whether the research should be conducted at all.
Still, some questions remain about how scientists will use ResearchKit moving forward. As researchers become comfortable with the idea of running a trial exclusively through an app, studies might become riskier. If that happens, developers will likely have to make some changes — changes that may include coming up with more secure ways of keeping minors from participating in these trials, for instance. In the meantime, however, mandatory IRB approval should help protect users from taking part in dubious trials.
Correction: An earlier version of this article defined IRB as an "Independent Review Board." That is incorrect. IRB stands for "Institutional Review Board." We regret the error.