The lack of black-and-white approaches is not necessarily a problem; in fact, it likely represents the best course given the need for individualization of studies to match individual or local community needs. Such flexibility is also in keeping with the federal government’s emphasis on local review, notably, through the IRB structure. However, this results in a situation of uncertainty for researchers, who are advised to build rapport with local regulators and routinely confer with these regulators—as well as ethics and legal counsel—to ensure that a proper balance is maintained between research needs and the protection of vulnerable children and adolescents.
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Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis ."
The Ethical Conduct of Clinical Research Involving Children . Washington, DC: The National Academies Press,
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