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Protecting data privacy in health services research / Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection, Division of Health Care Services, Institute of Medicine.
- Format:
- Book
- Author/Creator:
- Institute of Medicine (U.S.). Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection.
- Language:
- English
- Subjects (All):
- Medical records--Access control.
- Medical records.
- Public health records--Access control.
- Public health records.
- Medicine--Research--Moral and ethical aspects.
- Medicine.
- Privacy, Right of.
- Confidential communications.
- Institutional review boards (Medicine).
- Physical Description:
- 1 online resource (208 p.)
- Edition:
- 1st ed.
- Place of Publication:
- Washington, D.C. : National Academy Press, c2000.
- Language Note:
- English
- Contents:
- 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
- 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
- 4 Best Practices for IRB or Other Review Board Oversight of Health Services Research Not Necessarily Subject to Federal...
- 5 Recommendations for Next Steps
- 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
- 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
- Research Institute IRB Chairs
- Determining Which HSR Qualify Studies as Exempt
- 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
- Intermountain Health Care
- Additional Recommendations by Presenter
- Pharmacy Benefit Management Company
- 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
- APPENDIX D Confidentiality of Health Information: International Comparative Approaches
- INTERNATIONAL
- NATIONAL
- United Kingdom
- Australia
- France
- Canada.
- Quebec
- Iceland
- CONCLUSION
- APPENDIX E Biographical Sketches.
- Notes:
- Bibliographic Level Mode of Issuance: Monograph
- Includes bibliographical references.
- ISBN:
- 9786612083853
- 9780309183598
- 0309183596
- 9781282083851
- 1282083856
- 9780309564861
- 0309564867
- OCLC:
- 70755720
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