Apple is tightening up its guidelines for developing apps for the ResearchKit platform, making it mandatory that developers obtain approval from an independent board before forging ahead with research projects.
"Apps conducting health-related human subject research must secure approval from an independent ethics review board," the new rule stipulates. "Proof of such approval must be provided upon request."
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The new rule isn't earth-shattering. Corey Bridges of LifeMap Solutions, which helped to develop the Asthma Help App – one of the unveiled with ResearchKit two months ago – said at that time most apps used in clinical research are designed on familiar Independent Review Board (IRB) standards. This just ensures that future studies follow that basic framework.
An independent review, analysts say, could also conceivably weigh the risks of a study against its perceived benefits.
The new rule comes just weeks after Apple made the platform open-source, enabling developers and healthcare providers to design their own apps for clinical trials. And it follows another tweaking of the platform's guidelines that mandates app-makers must obtain consent from all participants and disclose any risks involved in the research.
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"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," that amendment stated.
Apple unveiled ResearchKit in late March, along with five apps that had been vetted by an IRB and were being used in clinical research in health systems around the country. Almost immediately questions arose as to whether clinical studies that rely on consumer data reported through an iPhone could be considered valid.
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