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| Preface | |
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| The Basics: What You Need to Know Before Starting Human Subjects Research | |
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| Introduction to the Art and Science of Clinical Research | |
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| Clinical Research Defined | |
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| Clinical Research Ethics Defined | |
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| Oversight: Origins, Relevance, and Future Role | |
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| How to Use This Book | |
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| What You Need to Know About Clinical Research Ethics | |
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| Intersections of Scientific Goals and Ethical Concerns: How Study Design Influences Evaluation of Ethical Aspects | |
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| Landmark Documents in the Codification of Clinical Research Ethics: National and International | |
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| The Basic Principles and Theories of Clinical Research Ethics: Learning How to Justify Study Design | |
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| Balancing Scientific Efficiency Against Subject Protection: Ensuring That the Balance Is Always Weighted in the Right Direction | |
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| What You Need to Know About the Regulation of Clinical Research | |
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| U.S. and International Regulatory Oversight Bodies | |
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| Radiation Safety Committees | |
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| Institutional Review Boards and Other Ethics Research Review Bodies and Committees | |
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| Variability Across IRBs and Other Reviewing Bodies: Those That Exist and Those of the Future | |
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| Project Assurances | |
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| Initial Approval and Continuing Reviews | |
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| Data and Safety Monitoring Boards | |
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| Disclosure and Minimization of Conflicts of Interest: Personal and Institutional | |
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| Preparing the Protocol | |
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| Designing a Clinical Research Study | |
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| Shaping the Study Question or Hypothesis | |
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| Selecting the Study Design | |
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| General Design Characteristics | |
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| Beginning to Write the Protocol | |
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| Selecting Subjects for Clinical Studies | |
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| Study Volunteers: Healthy Subjects or Patient Subjects? | |
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| Vulnerable Subject Populations: Who Is Classified as Vulnerable and How This Decision Is Made | |
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| Special Populations and Additional Protections | |
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| Writing the Protocol Section on Subject Selection | |
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| Risks and Benefits in Clinical Research | |
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| Weighing Risk of Harm Against Potential for Benefits | |
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| Regulatory Requirements for Minimization of Risk | |
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| Study Procedures for Minimization of Risk | |
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| Completion of a Study | |
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| Research-Related Injuries | |
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| Maximizing Benefits | |
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| Writing the Protocol Section on Risk, Burden, and Discomfort | |
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| Writing the Protocol Section on Benefits | |
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| Recruiting Subjects | |
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| Who Is Responsible for Recruiting Subjects? | |
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| When Does the Recruitment Process Begin and End? | |
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| Recruiting Subjects for Multiple Studies | |
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| The Professional Research Subject | |
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| Writing the Protocol Section on Recruitment | |
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| Informed Consent | |
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| Traditions and Purpose of Informed Consent | |
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| When Does the Informed Consent Process Begin? | |
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| The Difference Between Process and Product | |
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| Required Elements | |
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| Obtaining Valid Informed Consent | |
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| Writing the Protocol Section on Consent, Assent, and Surrogacy Permissions | |
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| Writing Consent, Assent, and Surrogacy Permission Documents | |
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| Privacy and Confidentiality | |
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| Traditions and Expectations | |
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| Management of Subject Privacy and Protection of Confidential Information | |
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| Provision to the Subject of Clinically Relevant Private Research Information | |
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| Withholding Personal Information from a Study Subject | |
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| Provision of Information at Study Conclusion | |
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| Release of Research Information to Others | |
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| Certificate of Confidentiality | |
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| Writing the Protocol Section on Privacy and Confidentiality | |
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| Writing Privacy and Confidentiality Statements in Consent Forms | |
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| The "Ethics" Section | |
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| The Difference Between an Ethics Section and a Compliance with Ethics Regulations Section | |
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| An Existing Model of a Substantive Ethics Section | |
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| Writing a Substantive Ethics Section | |
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| Procedures, Methods, Statistics, Data Management, and Record Keeping | |
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| Procedures and Methods | |
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| Randomization | |
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| Blinding | |
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| Drug Testing | |
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| Surgical Trials | |
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| Device testing | |
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| Assessments | |
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| Laboratory Studies | |
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| Observational Methodologies | |
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| Video and/or Audio Taping | |
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| Quality-of-Life Measurements | |
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| Follow-up Procedures | |
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| Adverse Reactions and Adverse Events | |
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| Statistics, Data Collection and Management, and Record Keeping | |
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| Statistics | |
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| Data Collection and Management | |
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| Record Keeping | |
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| Special Issues | |
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| Use of Human Biological Materials | |
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| Anonymous, Anonymized, Coded, and Identifiable Specimens | |
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| Anticipated Present and Future Use(s) of Tissue | |
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| Tissue Samples from Those Who Are Deceased | |
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| Writing the Protocol Sections on the Use and Storage of Human Biological Materials | |
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| Special Issues Raised by Evolving Areas of Clinical Research | |
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| Genetics Research | |
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| Psychiatric Research | |
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| Recruitment and Retention of Women and Minority Populations | |
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| Involvement of Pregnant Women or Fetuses | |
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| Emergency Medicine Research | |
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| Community-Based Research | |
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| Quality Improvement and Quality Assurance Research | |
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| Translational Research | |
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| Epidemiological Research | |
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| Surgical Research | |
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| Biologics | |
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| Prisoners | |
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| Clinical Research and Bioterrorism | |
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| Case Histories: Learning from Experience | |
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| Classical Cases in Clinical Research Ethics | |
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| Contemporary Cases in Clinical Research Ethics | |
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| Web Resources | |
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| References | |
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| Glossary | |
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| Index | |