Apple just added a new line to its App Store submission guidelines for people interested in doing research via Apple's new ResearchKit platform: All studies conducted via ResearchKit must obtain prior approval from an independent ethics review board. 9to5Mac first spotted the new guideline.
This is at least the second time the guidelines for this particular section have been updated, something Apple does routinely (Apple refers to the App Store submission guidelines as a "living document" where "new apps presenting new questions may result in new rules at any time".) Last month, Apple added new guidelines laying out exactly what sort of consent needs to be obtained from research participants or their legal guardians.
The relevant section of the guidance now reads:
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.
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.
All five ResearchKit apps that are already in operation conform to these guidelines, but Apple hadn't made it clear that they would be a requirement going forward. It's unclear what prompted the changes, but Apple does say it modifies guidelines based on the submissions it receives.
The guideline begins to address, but doesn't fully answer, some of the concerns that have been raised about the rigor of Apple as a research platform
In a second quarter conference call, Apple CEO Tim Cook said the response to ResearchKit since its launch has been favorable, with more than 1,000 researchers reaching out to Apple with potential projects.
"The response so far has been simply amazing, far exceeding our expectations," he said. "The first research apps developed using ResearchKit study asthma, breast cancer, cardiovascular disease, diabetes, and Parkinson’s disease, and have enrolled over 60,000 iPhone users in just the first few weeks of being available on the App Store. Over 1,000 researchers have contacted us expressing interest in performing studies through ResearchKit. We think these types of solutions have the potential to revolutionize medical studies in life-changing ways, and we’re proud that Apple is helping make this possible."