Writing clinical research protocols ethical considerations
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| Format: | Buch |
| Sprache: | English |
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Amsterdam [u.a.]
Elsevier
2006
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| 245 | 1 | 0 | |a Writing clinical research protocols |b ethical considerations |c Evan G. DeRenzo and Joel Moss |
| 264 | 1 | |a Amsterdam [u.a.] |b Elsevier |c 2006 | |
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| 650 | 4 | |a Clinial trials | |
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| 650 | 4 | |a Medizinische Ethik | |
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| 650 | 4 | |a Biomedical Research |x ethics | |
| 650 | 4 | |a Clinical Protocols |x standards | |
| 650 | 4 | |a Human experimentation in medicine |x Moral and ethical aspects | |
| 650 | 4 | |a Proposal writing in medicine | |
| 700 | 1 | |a Moss, Joel |e Verfasser |4 aut | |
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Datensatz im Suchindex
| _version_ | 1819648846738751488 |
|---|---|
| adam_text | Table of Contents
Preface xvii
Section I. The Basics: What You Need to Know
Before Starting Human Subjects Research 1
1. introduction to the art and science of clinical
Research 3
I. Clinical Research Defined 3
II. Clinical Research Ethics Defined 3
III. Oversight: Origins, Relevance, and Future Role 4
IV. How to Use This Book 5
2. What You Need to Know About Clinical Research
Ethics 11
I. Intersections of Scientific Goals and Ethical Concerns:
How Study Design Influences Evaluation of Ethical
Aspects 11
vii
viii Contents A. Distinctions Between Physician and
Investigator Roles 12
B. Conflicts with Recruiting One s Own Patients 13
C. Conflicts of Interest in General 14
n. Landmark Documents in the Codification of Clinical
Research Ethics: National and International 14
A. What Are Landmark Documents and How Are
They Applied? 14
B. Controversies Surrounding Each Document 15
IE. The Basic Principles and Theories of Clinical Research
Ethics: Learning How to Justify Study Design 18
A. Consequentialist Ethical Theory 20
B. Deontology, or Duty Based Ethics 22
C. Virtue Ethics 23
IV. Balancing Scientific Efficiency Against Subject
Protection: Ensuring That the Balance Is Always
Weighted in the Right Direction 24
3. What You Need to Know About the Regulation
of Clinical Research 27
I. U.S. and International Regulatory Oversight Bodies 27
A. U.S. Department of Health and Human Services
and the Food and Drug Administration 27
n. Radiation Safety Committees 30
ID. Institutional Review Boards and Other Ethics
Research Review Bodies and Committees 31
A. The Roles of Review Bodies and Their Purpose 31
B. The Responsibilities of IRBs and Ethical
Requirements 32
C. Helping IRBs Do What They Do Better 34
IV. Variability Across IRBs and Other Reviewing Bodies:
Those That Exist and Those of the Future 34
V. Project Assurances 35
VI. Initial Approval and Continuing Reviews 36
VII. Data and Safety Monitoring Boards 37
Contents ix
VIII. Disclosure and Minimization of Conflicts of Interest:
Personal and Institutional 38
Section II. Preparing the Protocol 41
4. Designing a Clinical Research Study 43
I. Shaping the Study Question or Hypothesis 43
II. Selecting the Study Design 45
A. Distinctions Between Hypothesis Testing and
Hypothesis Generating Clinical Research 45
B. Basic Versus Applied Research 46
III. General Design Characteristics 50
A. Expected Direct Benefit Research Versus
No Direct Benefit Research 50
B. Randomization and Blinding 52
C. Placebo Controls Versus Comparator Arms 54
D. Phases of a Clinical Trial 56
IV. Beginning to Write the Protocol 59
A. Precis 59
B. Introduction: Purpose and Justification for the
Proposed Study 59
C. literature Review 60
D. Objectives, Questions, or Hypotheses 61
5. Selecting Subjects for Clinical Studies 63
I. Study Volunteers: Healthy Subjects or Patient Subjects? 64
II. Vulnerable Subject Populations: Who Is Classified as
Vulnerable and How This Decision Is Made 65
A. What Makes a Subject Vulnerable? 66
B. Distinguishing Between Potentially Vulnerable
and Vulnerable 67
x Contents HI. Special Populations and Additional Protections 67
A. Healthy Adult Volunteers 68
B. Adult Patient Volunteers 71
C. Minors 77
D. Fetal Research 80
E. Special Communities 81
F. Special Protections for Special Populations 83
IV. Writing the Protocol Section on Subject Selection 95
A. Characterization and Justification for the Proposed
Population 95
B. Inclusion Criteria 96
C. Exclusion Criteria 96
6. Risks and Benefits in Clinical Research 9?
I. Weighing Risk of Harm Against Potential for Benefits 99
A. Benefits to Society 99
B. Benefits to Participating Subjects 102
II. Regulatory Requirements for Minimization of Risk 105
m. Study Procedures for Minimization of Risk 106
A. Inclusion and Exclusion Criteria 106
B. Rescue End Points 106
C. Premature Withdrawal of Study Subjects 1°7
D. Premature Study Closure HO
IV. Completion of a Study HI
A. Follow Up HI
B. Sponsor Obligations After Study Termination HI
V. Research Related Injuries H3
VI. Maximizing Benefits 113
A. What Constitutes a Benefit? 113
B. Compensation Versus Payment H^
VII. Writing the Protocol Section on Risk, Burden, and
Discomfort 116
Vm. Writing the Protocol Section on Benefits ll7
Contents xi
7. Recruiting Subjects 119
I. Who Is Responsible for Recruiting Subjects? 120
n. When Does the Recruitment Process Begin and End? 122
HI. Recruiting Subjects for Multiple Studies 123
IV. The Professional Research Subject 125
V. Writing the Protocol Section on Recruitment 125
8. Informed Consent 127
I. Traditions and Purpose of Informed Consent 127
II. When Does the Informed Consent Process Begin? 129
A. The First Phase of the Informed Consent Process 129
B. The Second Phase of the Informed Consent Process 130
C. The Third Phase of the Informed Consent Process 130
D. The Fourth Phase of the Informed Consent Process:
When Does it End? 130
HI. The Difference Between Process and Product 131
IV. Required Elements 133
A. What Elements Are Required by Law 133
B. What Additional Elements Are Required by
Good Practice? 134
V. Obtaining Valid Informed Consent 141
A. Assessing Capacity to Provide Valid Informed
Consent for Research 141
B. Assent for Adults and Minors Who Are Unable
to Make Decisions 143
VI. Writing the Protocol Section on Consent,
Assent, and Surrogacy Permissions 146
A. Prospective and On Study Subjects 146
B. Family Members of Index Subjects 147
C. Addressing Assent in the Protocol 148
D. Surrogate Permission 148
E. Consent Alterations or Waivers 150
F. Community Consent 150
xii Contents VII. Writing Consent, Assent, and Surrogacy Permission
Documents 152
A. The Basics 152
B. Debriefing for Altered or Waived Consent Processes 155
C. Written Informed Consent in Health Services
Research and Quality Improvement Projects 156
D. Short Form Documents 157
E. Translations 158
F. Timing 158
9. Privacy and Confidentiality 159
I. Traditions and Expectations 159
II. Management of Subject Privacy and Protection of
Confidential Information 160
III. Provision to the Subject of Clinically Relevant
Private Research Information 163
A. Provision of Information During Study Participation 163
B. Provision of Information at Study Conclusion 164
C. Provision of Information Long After Study Completion 165
D. Counseling Subjects 167
IV. Withholding Personal Information from a Study
Subject 168
A. Withholding Meaningfully Uninterpretable Clinical
Research Information 168
B. Withholding Highly Volatile and Possibly
Destructive Information 170
V. Provision of Information at Study Conclusion 171
VI. Release of Research Information to Others 172
VII. Certificate of Confidentiality 173
VIII. Writing the Protocol Section on Privacy and
Confidentiality 173
IX. Writing Privacy and Confidentiality Statements in
Consent Forms 174
Content* xill
10. The Ethics Section 175
I. The Difference Between an Ethics Section and
a Compliance with Ethics Regulations Section 175
n. An Existing Model of a Substantive Ethics Section 177
HI. Writing a Substantive Ethics Section 178
Section III. Procedures, Methods, Statistics,
Data Management, and Record Keeping 183
11. Procedures and Methods 185
I. Randomization 186
II. Blinding 186
in. Drug Testing 187
A. Drug Information 187
B. Dosing and Administration 188
C. Compliance 191
D. Concomitant Therapies 192
E. Open Label Extensions 192
IV. Surgical Trials 193
V. Device testing 196
VI. Assessments 197
A. The Subject s Standard Physical and Patient History 197
B. Sexual Maturity in Minors 199
C. Capacity to Provide Ethically and Legally
Valid Consent 199
vn. Laboratory Studies 199
Vm. Observational Methodologies 200
DC. Video and/or Audio Taping 201
X. Quality of Iife Measurements 201
XI. Follow up Procedures 202
XQ. Adverse Reactions and Adverse Events 203
A. Definitions, Classifications, and Attribution 204
B. Reporting 204
xiv Contents 12. Statistics, Data Collection and Management,
and Record Keeping 207
I. Statistics 207
A. Qualitative and/or Quantitative Data 208
B. Sample Size and Power Calculations 209
C. Variables and End Points 210
D. Pharmacokinetics and Pharmacodynamics 211
E. Placebos 212
F. Modeling 214
n. Data Collection and Management 215
A. Instructions for Subjects, Investigators, and
Other Study Personnel 215
B. Data Entry 216
C. Clinical Research Coordinators and Contract
Research Organizations 217
D. Academic and Pharmaceutical Industry
Collaborations 218
m. Record Keeping 219
Section IV. Special Issues 221
13. Use of Human Biological Materials 223
I. Anonymous, Anonymized, Coded, and
Identifiable Specimens 223
n. Anticipated Present and Future Use(s) of Tissue 225
A. What Is Known and What Is or Can Be Anticipated 225
B. Storage Procedures 227
C. Sharing Samples with Other Investigators 229
HI. Tissue Samples from Those Who Are Deceased 230
IV. Writing the Protocol Sections on the Use and Storage
of Human Biological Materials 232
A. Storing the Samples 233
Contents xv
14. Special Issues Raised by Evolving Areas of
Clinical Research 237
I. Genetics Research 237
A. Risks to Subjects 238
B. Subject and Family Member Conflicts 240
C. Risks to Communities 240
D. Genetics Studies or Genetics Study Add ons? 241
E. Use and Storage of Genetic Samples 243
F. Minors: Participation in Genetics Research 244
G. Variability in Ethical Standards, Vocabulary,
and Regulations 244
II. Psychiatric Research 245
A. Capacity to Give Consent 246
B. Risk of Placebo Arms 247
C. Minors: Participation in Psychiatric Research 248
HI. Recruitment and Retention of Women and
Minority Populations 249
IV. Involvement of Pregnant Women or Fetuses 250
V. Emergency Medicine Research 251
VI. Community Based Research 252
VII. Quality Improvement and Quality Assurance
Research 253
Vm. Translational Research 254
IX. Epidemiological Research 255
X. Surgical Research 256
XI. Biologies 257
XII. Prisoners 257
XIII. Clinical Research and Bioterrorism 258
15. Case Histories: Learning from Experience 261
I. Classical Cases in Clinical Research Ethics 262
A. The Tuskegee Syphilis Study 262
B. The Wichita Jury Study 263
C. The Milgram Obedience Studies 264
xvi Contents n. Contemporary Cases in Clinical Research Ethics 265
A. The Jesse Gelsinger Case 265
B. The FIAU Case 266
C. The Case of Brain Tissue Transplantation in
Parkinson s Disease Studies 267
Appendix: Web Resources 269
References 273
Glossary 281
Index 291
|
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| language | English |
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| spellingShingle | DeRenzo, Evan G. Moss, Joel Writing clinical research protocols ethical considerations Clinial trials Klinisches Experiment Medizinische Ethik Ethik Biomedical Research ethics Clinical Protocols standards Human experimentation in medicine Moral and ethical aspects Proposal writing in medicine |
| title | Writing clinical research protocols ethical considerations |
| title_auth | Writing clinical research protocols ethical considerations |
| title_exact_search | Writing clinical research protocols ethical considerations |
| title_full | Writing clinical research protocols ethical considerations Evan G. DeRenzo and Joel Moss |
| title_fullStr | Writing clinical research protocols ethical considerations Evan G. DeRenzo and Joel Moss |
| title_full_unstemmed | Writing clinical research protocols ethical considerations Evan G. DeRenzo and Joel Moss |
| title_short | Writing clinical research protocols |
| title_sort | writing clinical research protocols ethical considerations |
| title_sub | ethical considerations |
| topic | Clinial trials Klinisches Experiment Medizinische Ethik Ethik Biomedical Research ethics Clinical Protocols standards Human experimentation in medicine Moral and ethical aspects Proposal writing in medicine |
| topic_facet | Clinial trials Klinisches Experiment Medizinische Ethik Ethik Biomedical Research ethics Clinical Protocols standards Human experimentation in medicine Moral and ethical aspects Proposal writing in medicine |
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