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Writing Clinical Research Protocols Ethical Considerations

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ISBN-10: 0122107519

ISBN-13: 9780122107511

Edition: 2006

Authors: Joel Moss, Evan DeRenzo

List price: $76.95
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Description:

A practical guide for clinical researchers that aims to improve their skills in the understanding of the ethical requirements for the design and conduct of clinical research. Includes information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. Appendices include internet resources, grant writing tips, as well as advice on subject recruitment and budget considerations. * Contains information on conducting clinical research within the pharmaceutical industry * An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations * Numerous flowcharts summarize good work practice * Includes a chapter containing Case Histories * Excellent internet resources are included in the appendix * Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations explicitly address biostatistical considerations
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Book details

List price: $76.95
Copyright year: 2006
Publisher: Elsevier Science & Technology Books
Publication date: 9/8/2005
Binding: Paperback
Pages: 320
Size: 5.98" wide x 9.02" long x 0.29" tall
Weight: 0.990
Language: English

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