Apple has added a clause in its App Store guidelines for developers noting that apps doing health-related human subject research are required to obtain approvals from an independent ethics review board.
Apple previously recommended that developers utilizing its new open-source ResearchKit framework for medical research in apps consult with an “institutional review board or ethics committee” to ensure safety requirements are met, but the new guidelines make approvals from a review board and proof of the approval a requirement for all apps conducting human subject medical research.
The new guideline reads:
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27.10 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 new guideline is in addition to others related to health research data that Apple added last month following the introduction of ResearchKit. The guidelines added in March require developers to obtain consent from users before doing any human subject health research.
Apple added another App Store guideline, as we reported earlier today, that prevents developers from creating Apple Watch apps that only tell time.