Apple has updated its App Store Guidelines to reflect that apps for health-related human subject research are required to obtain approvals from an independent ethics review board.
Apple had previously recommended that developers utilizing ResearchKit 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.
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.
Apple also requires participant consent for health-related human subject research:
27.9 Apps conducting health-related human subject research must obtain consent from participants or, in the case of minors, their parent or guardian. 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
For more information see: