​Apple says ResearchKit medical apps must get ethics board approval

Now that the first ResearchKit apps have been released, Apple will require future applications to be approved by an independent ethics review board.

Developers that build medical research apps with Apple's ResearchKit will now need to get approval from an ethics board.

The new requirement was outlined in an update to Apple's App Store review guidelines and follows the launch of ResearchKit a fortnight ago.

"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," the guidelines state. The update was first reported by 9to5 Mac.

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ResearchKit allows medical researchers to develop apps for the study of ailments and diseases using data about user activity, motor function, and other measures collected from an iPhone's sensors, without the need for individuals to answer surveys.

An independent ethics review board might weigh up the risk versus benefits of research proposals that involve humans to determine whether they should proceed.

The update from Apple comes after early ResearchKit developers have already enlisted thousands of participants for their human studies. Stanford University researchers in March said 11,000 people signed up its ResearchKit-based cardiovascular study within 24 hours of its launch, Bloomberg reported.

So far ResearchKit only involves iPhone apps - Apple hasn't mentioned whether it will be extended to the Watch, which contains a heart rate sensor not found in the iPhone.

The requirement for users to get ethics board approval adds to an earlier condition which stipulates apps must obtain the explicit consent of participants as well as provide information about the context of research and any risks.

"Apps conducting health-related human subject research must obtain consent from participants or, in the case of minors, their parent or guardian," the guidelines say.

"Such consent must include the (a) nature, purpose, and duration of the research; (b) procedures, risks, and benefits to the participant; (c) information about confidentiality and handling of data (including any sharing with third parties); (d) a point of contact for participant questions; and (e) the withdrawal process".

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