DETERMINATION OF EXEMPT STATUS ..... 13 6.1 Exempt Categories ..... 13 6.2 Procedures for Reviewing Exempt Research ..... 17

IRB REVIEW CONSIDERATIONS ..... 18 7.1 Criteria for IRB Approval ..... 18 7.2 Informed Consent ..... 19 General Requirements ..... 19 Basic Elements ..... 20 Documentation of Informed Consent ..... 21 7.3 Other Considerations ..... 22 Study Design ..... 22 Risks and Benefits ..... 22 Selection of Subjects ..... 23 Confidentiality ..... 23 Subject Safety ..... 23 Frequency of Review ..... 23 Surveys and Other Instruments ..... 24 Coercion and Undue Influence ..... 24 Payments to Subjects ..... 25 Deception in Research ..... 26 Financial Conflicts of Interest ..... 26

INITIAL FULL BOARD REVIEW ..... 26 8.1 Procedures ..... 26 8.2 Primary/Secondary Reviewers ..... 27 8.3 Assistance from Consultants ..... 27 8.4 Avoiding Conflicts of Interest ..... 28 8.5 Outcomes of Review ..... 28 8.6 Approval Periods ..... 29 8.7 Appeal Process ..... 29

INITIAL EXPEDITED REVIEW ..... 29 9.1 Procedures ..... 30 9.2 HHS Guidelines for Expedited Review ..... 30 Applicability ..... 31 Research Categories ..... 31 9.3 Outcomes of Review ..... 33