International direct-to-participant (DTP) genomics research involves the use of mobile technology to recruit, consent, and study participants remotely. This model can facilitate research across broad geographies and many countries, but must also comply with the norms of multiple recruitment jurisdictions, with each jurisdiction typically requiring at least one local research ethics review. Each additional research ethics review increases bureaucratic hurdles without necessarily strengthening the protection of participants’ rights and interests. For DTP genomic research, obtaining a review may in fact be impossible in the absence of a local research partner. This paper proposes an “adequacy” approach, inspired by data protection law, to coordinate the regulation and oversight of international DTP genomics research. This involves one country voluntarily assessing whether another country’s research ethics reviews are equivalent to its own, in terms of objectives and effectiveness. Ethics-approved projects led by researchers from countries recognized as adequate are deemed to comply with local norms, eliminating the need for a duplicative local review. Adequacy preserves the sovereignty of countries to determine their own regulatory aims and which other countries to trust. It therefore provides a voluntary, incremental path towards greater global coordination of health research oversight.

中文翻译：

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研究伦理审查的国际协调：充分模型

国际直接参与 (DTP) 基因组学研究涉及使用移动技术远程招募、同意和研究参与者。这种模式可以促进跨地域和许多国家的研究，但也必须遵守多个招聘管辖区的规范，每个管辖区通常需要至少进行一次本地研究伦理审查。每一次额外的研究伦理审查都会增加官僚主义的障碍，但不一定会加强对参与者权益的保护。对于 DTP 基因组研究，如果没有当地研究合作伙伴，实际上可能无法获得审查。本文提出了一种受数据保护法启发的“充分性”方法，以协调国际 DTP 基因组学研究的监管和监督。这涉及一国自愿评估另一国的研究伦理审查在目标和有效性方面是否与本国相同。由来自被认为足够的国家的研究人员领导的伦理批准项目被视为符合当地规范，无需重复进行当地审查。充足性保护了各国的主权，以确定它们自己的监管目标以及信任哪些其他国家。因此，它为加强全球卫生研究监督协调提供了一条自愿的、渐进的途径。无需进行重复的本地审查。充足性保护了各国的主权，以确定它们自己的监管目标以及信任哪些其他国家。因此，它为加强全球卫生研究监督协调提供了一条自愿的、渐进的途径。无需进行重复的本地审查。充足性保护了各国的主权，以确定它们自己的监管目标以及信任哪些其他国家。因此，它为加强全球卫生研究监督协调提供了一条自愿的、渐进的途径。