Apple to require ethics review for all ResearchKit apps

CEO says 60,000 iPhone users are enrolled in app-based clinical trials

Apple has amended its developer guidelines to require that any app using ResearchKit—the company's open-source software platform designed to facilitate clinical trials—get approval from an independent ethics review board.

Currently, all five ResearchKit applications available for the iPhone have been reviewed by an Institutional Review Board (IRB), which is the standard practice for research that involves human subjects. But prior to the latest update to Apple's developer guidelines, the tech company did not require such a review for participating apps.  

Is Apple already changing health care? Thousands sign up for trials through ResearchKit

The update is the second ethics-related change that Apple has made to its guidelines since ResearchKit was made available to all developers in March. The first change required that all ResearchKit applications obtain "consent from participants or, in the case of minors, their parent or guardian."

Strong interest

So far, interest in ResearchKit has been strong. In a second quarter conference call, Apple CEO Tim Cook said, "The response so far has been simply amazing, far exceeding our expectations." He noted that over 60,000 iPhone users have enrolled in a ResearchKit-based study.

Requiring IRB approval is an important step in addressing some of the ethical concerns with ResearchKit, Arielle Duhaime-Ross writes in The Verge. However she notes that there are still lingering questions around issues of consent and the participation of minors in clinical trials (Duhaime-Ross, The Verge, 4/29; Comstock, mobi health news, 4/29).

The takeaway: Apple has updated its developer guidelines to require that all apps using ResearchKit to conduct clinical trials get approval from an independent ethics review board.

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