Writing clinical research protocols : ethical considerations /
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| Author / Creator: | DeRenzo, Evan. |
|---|---|
| Imprint: | Burlington, MA : San Diego : Elsevier Academic Press, 2006. |
| Description: | xix, 300 p. ; 23 cm. |
| Language: | English |
| Subject: | |
| Format: | Print Book |
| URL for this record: | http://pi.lib.uchicago.edu/1001/cat/bib/5784945 |
Table of Contents:
- Preface
- Section I. The Basics: What You Need to Know Before Starting Human Subjects Research
- 1. Introduction to the Art and Science of Clinical Research
- I. Clinical Research Defined
- II. Clinical Research Ethics Defined
- III. Oversight: Origins, Relevance, and Future Role
- IV. How to Use This Book
- 2. What You Need to Know About Clinical Research Ethics
- I. Intersections of Scientific Goals and Ethical Concerns: How Study Design Influences Evaluation of Ethical Aspects
- II. Landmark Documents in the Codification of Clinical Research Ethics: National and International
- III. The Basic Principles and Theories of Clinical Research Ethics: Learning How to Justify Study Design
- IV. Balancing Scientific Efficiency Against Subject Protection: Ensuring That the Balance Is Always Weighted in the Right Direction
- 3. What You Need to Know About the Regulation of Clinical Research
- I. U.S. and International Regulatory Oversight Bodies
- II. Radiation Safety Committees
- III. Institutional Review Boards and Other Ethics Research Review Bodies and Committees
- IV. Variability Across IRBs and Other Reviewing Bodies: Those That Exist and Those of the Future
- V. Project Assurances
- VI. Initial Approval and Continuing Reviews
- VII. Data and Safety Monitoring Boards
- VIII. Disclosure and Minimization of Conflicts of Interest: Personal and Institutional
- Section II. Preparing the Protocol
- 4. Designing a Clinical Research Study
- I. Shaping the Study Question or Hypothesis
- II. Selecting the Study Design
- III. General Design Characteristics
- IV. Beginning to Write the Protocol
- 5. Selecting Subjects for Clinical Studies
- I. Study Volunteers: Healthy Subjects or Patient Subjects?
- II. Vulnerable Subject Populations: Who Is Classified as Vulnerable and How This Decision Is Made
- III. Special Populations and Additional Protections
- IV. Writing the Protocol Section on Subject Selection
- 6. Risks and Benefits in Clinical Research
- I. Weighing Risk of Harm Against Potential for Benefits
- II. Regulatory Requirements for Minimization of Risk
- III. Study Procedures for Minimization of Risk
- IV. Completion of a Study
- V. Research-Related Injuries
- VI. Maximizing Benefits
- VII. Writing the Protocol Section on Risk, Burden, and Discomfort
- VIII. Writing the Protocol Section on Benefits
- 7. Recruiting Subjects
- I. Who Is Responsible for Recruiting Subjects?
- II. When Does the Recruitment Process Begin and End?
- III. Recruiting Subjects for Multiple Studies
- IV. The Professional Research Subject
- V. Writing the Protocol Section on Recruitment
- 8. Informed Consent
- I. Traditions and Purpose of Informed Consent
- II. When Does the Informed Consent Process Begin?
- III. The Difference Between Process and Product
- IV. Required Elements
- V. Obtaining Valid Informed Consent
- VI. Writing the Protocol Section on Consent, Assent, and Surrogacy Permissions
- VII. Writing Consent, Assent, and Surrogacy Permission Documents
- 9. Privacy and Confidentiality
- I. Traditions and Expectations
- II. Management of Subject Privacy and Protection of Confidential Information
- III. Provision to the Subject of Clinically Relevant Private Research Information
- IV. Withholding Personal Information from a Study Subject
- V. Provision of Information at Study Conclusion
- VI. Release of Research Information to Others
- VII. Certificate of Confidentiality
- VIII. Writing the Protocol Section on Privacy and Confidentiality
- IX. Writing Privacy and Confidentiality Statements in Consent Forms
- 10. The "Ethics" Section
- I. The Difference Between an Ethics Section and a Compliance with Ethics Regulations Section
- II. An Existing Model of a Substantive Ethics Section
- III. Writing a Substantive Ethics Section
- Section III. Procedures, Methods, Statistics, Data Management, and Record Keeping
- 11. Procedures and Methods
- I. Randomization
- II. Blinding
- III. Drug Testing
- IV. Surgical Trials
- V. Device testing
- VI. Assessments
- VII. Laboratory Studies
- VIII. Observational Methodologies
- IX. Video and/or Audio Taping
- X. Quality-of-Life Measurements
- XI. Follow-up Procedures
- XII. Adverse Reactions and Adverse Events
- 12. Statistics, Data Collection and Management, and Record Keeping
- I. Statistics
- II. Data Collection and Management
- III. Record Keeping
- Section IV. Special Issues
- 13. Use of Human Biological Materials
- I. Anonymous, Anonymized, Coded, and Identifiable Specimens
- II. Anticipated Present and Future Use(s) of Tissue
- III. Tissue Samples from Those Who Are Deceased
- IV. Writing the Protocol Sections on the Use and Storage of Human Biological Materials
- 14. Special Issues Raised by Evolving Areas of Clinical Research
- I. Genetics Research
- II. Psychiatric Research
- III. Recruitment and Retention of Women and Minority Populations
- IV. Involvement of Pregnant Women or Fetuses
- V. Emergency Medicine Research
- VI. Community-Based Research
- VII. Quality Improvement and Quality Assurance Research
- VIII. Translational Research
- IX. Epidemiological Research
- X. Surgical Research
- XI. Biologics
- XII. Prisoners
- XIII. Clinical Research and Bioterrorism
- 15. Case Histories: Learning from Experience
- I. Classical Cases in Clinical Research Ethics
- II. Contemporary Cases in Clinical Research Ethics
- Appendix. Web Resources
- References
- Glossary
- Index
