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The literature on the return of individual research results does not always make this distinction. For example, Shalowitz, and Miller, , supra note 4, at 738, imply that research participants have a right to any information about themselves. Lavieri and Garner suggest that “in all cases for which unanticipated, possibly clinically useful genetic data is obtained, investigators have a moral obligation to let the affected persons know that the results are available,” without limiting this information to research results. Lavieri, R. R. and Garner, S. A., “Ethical Considerations in the Communication of Unexpected Information with Clinical Implications,” American Journal of Bioethics 6, no. 6 (2006): 46–48.Google Scholar

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An example of this type of incidental finding is described by Verweij, and Hamel, , supra note 43. A sample from an unaffected person in a study on inherited limb malformation was later used in a second study as a “normal” control. However, that study found that the sample contained a sequence variance in a certain gene, mutations of which may cause a primary cardiac disorder. Id. at 116.Google Scholar

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45 C.F.R. §§ 46.404–06 (2007).CrossRefGoogle Scholar

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