Protecting data privacy in health services research

Abstract

Protecting Data Privacy in Health Services Research -- Copyright -- Preface -- Acknowledgments -- REVIEWERS -- Contents -- Executive Summary -- HEALTH SERVICES RESEARCH AND QUALITY ASSURANCE OR IMPROVEMENT -- PROTECTION OF HUMAN SUBJECTS -- GOOD PRACTICES -- PROJECT AND SCOPE -- RECOMMENDATIONS -- Best Practices for IRB Review of HSR Subject to Federal Regulations (Chapter 3) -- Best Practices for Review of HSR Not Necessarily Subject to Federal Regulation (Chapter 4) -- Recommendations for Next Steps (Chapter 5) -- 1 Introduction -- PRIVACY AND RESEARCH -- Privacy and Confidentiality -- Benefits and Risks of Harm in Research -- Federal Regulations -- HEALTH SERVICES RESEARCH -- BENEFITS OF HSR -- RISKS OF HARM FROM HSR -- BACKGROUND AND POLICY CONTEXT -- PROJECT AND SCOPE -- OUTLINE OF REPORT -- 2 Human Subjects Protection and Health Services Research in Federal Regulations -- IRBS AND HUMAN SUBJECTS PROTECTION -- Background of Federal Regulations -- IRB Review -- What Research Is Subject to Federal Regulations? -- What Establishes a Project as Research? -- What Establishes a Research Study as Involving Human Subjects? -- What HSR May Be Exempt from IRB Review? -- What HSR May Qualify for Expedited Review? -- May Informed Consent Be Waived? -- What Is Minimal Risk? -- PREVIOUS STUDIES OF IRBS -- HUMAN SUBJECTS PROTECTION IN HSR -- PRINCIPLES AND PRACTICES -- 3 Best Practices for IRB Review of Health Services Research Subject to Federal Regulations -- RECOMMENDATIONS -- 4 Best Practices for IRB or Other Review Board Oversight of Health Services Research Not Necessarily Subject to Federal... -- RECOMMENDATIONS -- 5 Recommendations for Next Steps -- RECOMMENDATIONS -- References -- Acronyms and Abbreviations -- APPENDIX A Study Activities -- WORKSHOP ON INSTITUTIONAL REVIEW BOARDS.