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            "text": "5.6 Distribution of Materials to the IRB ..... 13\nVI. DETERMINATION OF EXEMPT STATUS ..... 13\n6.1 Exempt Categories ..... 13\n6.2 Procedures for Reviewing Exempt Research ..... 17\nVII. IRB REVIEW CONSIDERATIONS ..... 18\n7.1 Criteria for IRB Approval ..... 18\n7.2 Informed Consent ..... 19\nGeneral Requirements ..... 19\nBasic Elements ..... 20\nDocumentation of Informed Consent ..... 21\n7.3 Other Considerations ..... 22\nStudy Design ..... 22\nRisks and Benefits ..... 22\nSelection of Subjects ..... 23\nConfidentiality ..... 23\nSubject Safety ..... 23\nFrequency of Review ..... 23\nSurveys and Other Instruments ..... 24\nCoercion and Undue Influence ..... 24\nPayments to Subjects ..... 25\nDeception in Research ..... 26\nFinancial Conflicts of Interest ..... 26\nVIII. INITIAL FULL BOARD REVIEW ..... 26\n8.1 Procedures ..... 26\n8.2 Primary/Secondary Reviewers ..... 27\n8.3 Assistance from Consultants ..... 27\n8.4 Avoiding Conflicts of Interest ..... 28\n8.5 Outcomes of Review ..... 28\n8.6 Approval Periods ..... 29\n8.7 Appeal Process ..... 29\nIX. INITIAL EXPEDITED REVIEW ..... 29\n9.1 Procedures ..... 30\n9.2 HHS Guidelines for Expedited Review ..... 30\nApplicability ..... 31\nResearch Categories ..... 31\n9.3 Outcomes of Review ..... 33",
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