Expert Perspectives on Oversight for Unregulated mHealth Research: Empirical Data and Commentary

专家对不受监管的移动医疗研究的监管观点:实证数据与评论

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Abstract

In qualitative interviews with a diverse group of experts, the vast majority believed unregulated researchers should seek out independent oversight. Reasons included the need for objectivity, protecting app users from research risks, and consistency in standards for the ethical conduct of research. Concerns included burdening minimal risk research and limitations in current systems of oversight. Literature and analysis supports the use of IRBs even when not required by regulations, and the need for evidence-based improvements in IRB processes.

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