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Strengthened regulatory structures in North America have resulted in clinical trials being moved even more often to middle- or low-income countries, where recruitment and other research-related costs are cheaper, where regulations either do not exist or may not be adequately enforced, and where research participants are even more vulnerable [58]. These developments are a real cause for concern. Our recommendations for a more stringent regulatory review in the North American context will hopefully inspire others to look at strengthening the national regulatory regimes in other countries and at developing and enforcing international standards for recruitment in clinical trials.

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