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Introduction.1766 I. The Critique of Choice.1771 A. Inaccessibility.1771 B. Inadequate to Motivate Action.1772 C. The Absence of Choice.1772 D. The Illusion of Choice.1773 E. Inadequate Privacy Protection.1773 F. False Dichotomy.1775 G. Burden on the Individual.1775 H. The Cost of Providing Choice.1776 I. Government Access to Personal Data Unaffected.1776 J. Choice As a Disservice to Individuals.1777 II. Health Research and Its Regulation.1778 A. The Role of Personal Data in Health Research.1778 1. Information-Based Health Research.1778 2. Personalized Medicine and Genetic Analysis.1779 3. Data-Based Health Research.1781 B. Autonomy and Informed Consent.1783 C. The Common Rule.1784 III. The Privacy Rule.1786 A. Basic Requirements.1786
Fred H. Cate (Fri,) studied this question.