9to5Mac revealed that Apple has recently issued additional guidelines to its ResearchKit: secure an ethics board approval.
Apple's ResearchKit is an open-source platform that intends to help scientists run clinical trials using apps available in the Apple app store. The additional guidelines regarding the mandatory independent ethics board approval comes two weeks after the company made the platform accessible to developers and medical researchers around the world.
Apple launched ResearchKit in early March - with access given to only a number of institutions. Questions regarding the ethics of running clinical trials solely via mobile phones were raised soon after. At this time, it was unclear whether apps that made it to the Apple apps store would require an Independent Review Board (IRB) approval. An IRB approved the five apps that were released through the apps store on the same day of the launch. However, the app store guidelines do not exactly specify the need for an IRB approval for these apps.
According to The Verge, Apple released new developer guidelines for ResearchKit-made apps a few days later. This required all apps to "obtain consent from participants or, in the case of minors, their parent or guardian."
Now, Apple further added another set of guidelines that make IRB approval mandatory, and it comes just two weeks after ResearchKit was made available to developers. The new guidelines state that: "Apps conducting health-related human subject research must secure approval from an independent ethics review board;" and that "Proof of such approval must be provided upon request."
