Apple makes ethics board approval mandatory for all medical research apps
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 come two weeks after Apple opened up the platform to developers and medical researchers around the world. "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. 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.
Apple makes ethics board approval mandatory for all medical research apps