Protecting Data Privacy in Health Services Research

Éditeur: National Academies Press
ISBN: 9780309071871
eISBN Pdf: 9780309564861
eISBN Epub: 9780309183598
Lieu de publication: United States
Année de publication électronique: 2000
Mois : Décembre
Pages: 209
Langue: Anglais

Légende

The need for quality improvement and for cost saving are driving both individual choices and health system dynamics. The health services research that we need to support informed choices depends on access to data, but at the same time, individual privacy and patient-health care provider confidentiality must be protected.

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

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