Protecting data privacy in health services research [[electronic resource] /] / Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection, Division of Health Care Services, Institute of Medicine

• Pubblicazione: Washington, D.C., : National Academy Press, c2000
• Edizione: 1st ed.
• Descrizione fisica: 1 online resource (208 p.)
• Disciplina: 174/.2
• Soggetto topico: Medical records - Access control; Public health records - Access control; Medicine - Research - Moral and ethical aspects; Privacy, Right of; Confidential communications; Institutional review boards (Medicine)
• Note generali: Bibliographic Level Mode of Issuance: Monograph
• Nota di bibliografia: Includes bibliographical references.
• Nota di contenuto: 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. ; INVITATION TO IRBS TO PROVIDE INFORMATION ON PRACTICES OF REVIEWING HEALTH SERVICES RESEARCH -- Discussion Issues -- Appendix B Institutional Review Boards and Health Services Research Data Privacy: A Workshop Summary -- EXECUTIVE SUMMARY -- POLICY CONTEXT -- SCOPE OF PROJECT -- WORKSHOP -- 1 INTRODUCTION -- BACKGROUND AND POLICY CONTEXT -- PROJECT OBJECTIVES -- SCOPE OF WORKSHOP REPORT -- DEFINITIONS -- 2 WORKSHOP SUMMARY -- INTRODUCTORY PRESENTATIONS -- Comments from Sponsoring Agencies -- Overview of Current Human Subjects Regulations -- IRB FUNCTION -- IRB Administrators -- Identifying Specific Studies as HSR -- Determining Which HSR Studies Qualify as Exempt -- Determining Whether Information Is Identifiable in Assessing Risk of Disclosure -- Weighing Importance of the Research Relative to Risk -- Ensuring That Identifiable Information Is Protected During the Study -- Enforcement of Procedures to Protect Confidentiality -- Additional Recommendations by Presenters -- General Discussion Following Presentations -- Academic IRB Chairs -- Identifying Specific Studies as HSR -- Determining Which HSR Studies Qualify as Exempt -- Weighing Importance of the Research Relative to Risk -- Additional Recommendations by Presenters -- General Discussion Following Presentations -- Research Institute IRB Chairs -- Identifying Specific Studies as HSR -- Determining Which HSR Qualify Studies as Exempt -- Determining Whether Information Is Identifiable in Assessing Risk of Disclosure -- Weighing Importance of the Research Relative to Risk -- Ensuring That Identifiable Information Is Protected During the Study -- Enforcement of Procedures to Protect Confidentiality -- Additional Recommendations by Presenters -- Commercial, Nonaffiliated IRBs -- Determining Which HSR Studies Qualify as Exempt. ; Determining Whether Information Is Identifiable in Assessing Risk of Disclosure -- General Discussion Following Presentation -- HEALTH CARE PRODUCTS AND SERVICES INDUSTRY -- Pharmaceutical Manufacturer's Epidemiological Research -- Identifying Specific Studies as Research under the Regulations -- Ensuring That Identifiable Information Is Protected During the Study -- Enforcement of Procedures to Protect Confidentiality -- Intermountain Health Care -- Identifying Specific Studies as HSR -- Determining Which HSR Studies Qualify as Exempt -- Ensuring That Identifiable Information Is Protected During the Study -- Enforcement of Procedures to Protect Confidentiality -- Additional Recommendations by Presenter -- Pharmacy Benefit Management Company -- Identifying Specific Studies as HSR -- Determining Whether Information Is Identifiable in Assessing Risk of Disclosure -- Ensuring That Identifiable Information Is Protected During the Study -- Health Maintenance Organizations and Research -- SPECIAL CONSIDERATIONS OF DATA PRIVACY AND MINORITY GROUPS -- Levels of Privacy Concerns -- Strategies for Enhancing Both Privacy Protection and Trust -- General Discussion -- TECHNICAL CONSIDERATIONS AND PRODUCTS -- SPECIAL CONSIDERATIONS OF DATA PRIVACY AND MINORS -- INTERNATIONAL COMPARISONS OF DATA PRIVACY STANDARDS -- REFERENCES -- ADDENDUM A WORKSHOP SPEAKERS -- ADDENDUM B WORKSHOP PARTICIPANTS -- APPENDIX C Protecting the Health Services Research Data of Minors -- A CASE ILLUSTRATION -- ISSUES TO CONSIDER -- Children as a Heterogeneous Population -- Children as a Uniquely Vulnerable Population -- Problems in Proxy Consent -- Special Considerations in Biomedical Data -- CONCLUSIONS -- REFERENCES -- APPENDIX D Confidentiality of Health Information: International Comparative Approaches -- INTERNATIONAL -- NATIONAL -- United Kingdom -- Australia -- France -- Canada. ; Quebec -- Iceland -- CONCLUSION -- APPENDIX E Biographical Sketches.
• Titolo autorizzato: Protecting data privacy in health services research
• ISBN: 0-309-18359-6; 1-282-08385-6; 9786612083853; 0-309-56486-7
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910826930603321
• Lo trovi qui: Univ. Federico II