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Preface | ||
Acknowledgments and Permissions | ||
Commonly Used Acronyms | ||
Frequently Cited Research Regulations, Guidelines, and Reports | ||
List of Contributors | ||
Pt. I | Scandals and Tragedies of Research with Human Participants: Nuremberg, the Jewish Chronic Disease Hospital, Beecher, and Tuskegee | 1 |
1 | U.S. Medical Researchers, the Nuremberg Doctors Trial, and the Nuremberg Code: A Review of Findings of the Advisory Committee on Human Radiation Experiments | 7 |
2 | The Jewish Chronic Disease Hospital Case | 11 |
3 | Ethics and Clinical Research | 16 |
4 | Racism and Research: The Case of the Tuskegee Syphilis Study | 20 |
Pt. II | Ethical and Regulatory Guidance for Research with Humans | 25 |
5 | The Nuremberg Code | 29 |
6 | The Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects | 30 |
7 | The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research | 33 |
8 | The Common Rule, Title 45 (Public Welfare), Code of Federal Regulations, Part 46 (Protection of Human Subjects), Subparts A-D | 39 |
9 | The International Ethical Guidelines for Biomedical Research Involving Human Subjects | 56 |
10 | The ICH Harmonised Tripartite Guideline - Guideline for Good Clinical Practice (ICH-GCP Guideline) | 80 |
Pt. III | The Ethics of Clinical Trial Design | 95 |
Sect. 1 | The Distinction between Research and Treatment | 103 |
11 | Research and Practice | 103 |
12 | Demarcating Research and Treatment: A Systematic Approach for the Analysis of the Ethics of Clinical Research | 107 |
Sect. 2 | The Ethics of Randomized Clinical Trials: Clinical Equipoise | 113 |
13 | Of Mice but Not Men: Problems of the Randomized Clinical Trial | 113 |
14 | Equipoise and the Ethics of Clinical Research | 117 |
15 | Randomized Controlled Trials: Lessons from ECMO | 121 |
Sect. 3 | The Role of Placebos in Clinical Research | |
16 | The Continuing Unethical Use of Placebo Controls | 127 |
17 | Placebo-Controlled Trials and the Logic of Clinical Purpose | 130 |
18 | Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments, Part 1: Ethical and Scientific Issues | 137 |
19 | The Ethics of Placebo-Controlled Trials: A Middle Ground | 140 |
Sect. 4 | The Ethics of Phase I Research | 144 |
20 | On the Nature and Ethics of Phase I Clinical Trials of Cancer Chemotherapies | 144 |
21 | The Changing Landscape of Human Experimentation: Nuremberg, Helsinki, and Beyond | 146 |
Pt. IV | The Ethics of Research Participant Recruitment | 151 |
Sect. 1 | Justifications for the Recruitment of Research Participants | 155 |
22 | Philosophical Reflections on Experimenting with Human Subjects | 155 |
23 | Experimentation on Trial: Why Should One Take Part in Medical Research? | 161 |
Sect. 2 | Access to Research | 166 |
24 | Wanted: Single, White Male for Medical Research | 166 |
25 | Why Should We Include Women and Minorities in Randomized Controlled Trials? | 171 |
26 | The Duty to Exlude: Excluding People at Undue Risk from Research | 175 |
Sect. 3 | Payment of Research Participants | 179 |
27 | What's the Price of a Research Subject? Approaches to Payment for Research Participation | 179 |
28 | Justice for the Professional Guinea Pig | 183 |
29 | Paying People to Participate in Research: Why Not? | 185 |
Pt. V | Informed Consent in Research | 189 |
30 | Consent Issues in Human Research | 197 |
31 | Informed (But Uneducated) Consent | 202 |
32 | A Moral Theory of Informed Consent | 203 |
33 | Is Informed Consent Always Necessary for Randomized, Controlled Trials? | 207 |
34 | Human Experimentation and Human Rights | 210 |
35 | Subject Interview Study | 213 |
36 | False Hopes and Best Data: Consent to Research and the Therapeutic Misconception | 216 |
37 | "Therapeutic Misconception" and "Recruiting Doublespeak" in the Informed Consent Process | 221 |
Pt. VI | Clinical Research with Special Populations | 225 |
Sect. 1 | People with Cognitive Impairments | 229 |
38 | Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity | 229 |
39 | Are Research Ethics Bad for Our Mental Health? | 234 |
40 | Caring about Risks: Are Severely Depressed Patients Competent to Consent to Research? | 237 |
Sect. 2 | Children | 240 |
41 | The NIH Trials of Growth Hormone for Short Stature | 240 |
42 | In loco parentis: Minimal Risk as an Ethical Threshold for Research upon Children | 247 |
43 | Minors' Assent, Consent, or Dissent to Medical Research | 252 |
Sect. 3 | Captive Populations: Soldiers, Prisoners, Students | 258 |
44 | Convenient and Captive Populations | 258 |
45 | Medical Experimentation on Prisoners | 262 |
46 | Students, Grades, and Informed Consent | 266 |
47 | Against Special Protections for Medical Students | 270 |
Pt. VII | Special Topics in Research Ethics | 273 |
Sect. 1 | Genetics Research | 285 |
48 | Structuring the Review of Human Genetics Protocols: Gene Localization and Identification Studies | 285 |
49 | Structuring the Review of Human Genetics Protocols, Part II: Diagnostic and Screening Studies | 291 |
50 | Structuring the Review of Human Genetics Protocols, Part III: Gene Therapy Studies | 297 |
51 | Protecting the Privacy of Family Members in Survey and Pedigree Research | 302 |
Sect. 2 | Stored Human Biological Specimens | 305 |
52 | Statement on Informed Consent for Genetic Research | 305 |
53 | Informed Consent for Genetic Research on Stored Tissue Samples | 308 |
54 | Use of Human Tissues in Research: Clarifying Clinician and Researcher Roles and Information Flows | 311 |
Sect. 3 | Human Embryos and Stem Cells | 313 |
55 | Report of the Human Embryo Research Panel, Volume 1 | 313 |
56 | The Inhuman Use of Human Beings: A Statement on Embryo Research | 317 |
57 | Ethical Issues in Human Stem Cell Research | 319 |
58 | Creating Embryos for Research: On Weighing Symbolic Costs | 325 |
Sect. 4 | Drug Challenge and Drug Washout Studies | 329 |
59 | Drug-Free Research in Schizophrenia: An Overview of the Controversy | 329 |
60 | Psychiatric Symptom-Provoking Studies: An Ethical Appraisal | 332 |
Sect. 5 | Research with Communities | 335 |
61 | A Model Agreement for Genetic Research in Socially Identifiable Populations | 335 |
62 | Groups as Gatekeepers to Genomic Research: Conceptually Confusing, Morally Hazardous, and Practically Useless | 337 |
63 | Protecting Communities in Research: Current Guidelines and Limits of Extrapolation | 340 |
64 | Protecting Communities in Biomedical Research | 342 |
Sect. 6 | International Research | 343 |
65 | Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries | 343 |
66 | Human Rights and Maternal-Fetal HIV Transmission Prevention Trials in Africa | 346 |
67 | AZT Trials and Tribulations | 348 |
68 | Fair Benefits for Research in Developing Countries | 354 |
69 | Ethical Imperialism? Ethics in International Collaborative Clinical Research | 356 |
70 | Ethics Are Local: Engaging Cross-Cultural Variation in the Ethics for Clinical Research | 358 |
71 | Ethical and Regulatory Challenges in a Randomized Control Trial of Adjuvant Treatment for Breast Cancer in Vietnam | 363 |
Pt. VIII | The Behavior of Clinical Investigators: Conflicts of Interest | 369 |
72 | Understanding Financial Conflicts of Interest | 375 |
73 | Finder's Fees for Research Subjects | 377 |
74 | Conflicts of Interests and the Validity of Clinical Trials | 378 |
75 | In Whose Best Interest? Breaching the Academic-Industrial Wall | 382 |
Pt. IX | Scientific Misconduct | 385 |
Sect. 1 | Altering Data: Fraud, Fabrication, and Falsification | 393 |
76 | Pressure to Publish and Fraud in Science | 393 |
77 | Science, Statistics, and Deception | 395 |
78 | Data Torturing | 397 |
79 | Preventing Scientific Misconduct | 399 |
Sect. 2 | Rules of Authorship | 403 |
80 | When Authorship Fails: A Proposal to Make Contributors Accountable | 403 |
Sect. 3 | Problems in the Publication of Research Methods and Findings | 411 |
81 | Underreporting Research Is Scientific Misconduct | 411 |
82 | The CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials | 414 |
Pt. X | Challenges to the Institutional Review Board System | 419 |
83 | Monitoring Clinical Research: An Obligation Unfulfilled | 425 |
84 | Ethics Review for Sale? Conflict of Interest and Commercial Research Review Boards | 429 |
85 | The Institutional Review Board and Beyond: Future Challenges to the Ethics of Human Experimentation | 436 |
86 | A Central Institutional Review Board for Multi-institutional Trials | 441 |
Appendixes: Informed Consent Forms | 445 | |
App. A | Phase I Treatment of Adults with Recurrent Supratentorial High-Grade Glioma with Gliadel Wafers Plus Temodar | 447 |
App. B | A Phase I Study of Intra-arterial Onyx-015 for Squamous Cell Cancer of the Head and Neck | 451 |
App. C | Cohort-Varying Information Insert for Form for Consent to Participate in a Phase I Study | 459 |
App. D | Nitric Oxide Inhalation Therapy for Myocardial Ischemia in Patients with Coronary Artery Disease | 460 |
App. E | Double-Blind Drug Crossover and Withdrawal Project | 468 |
App. F | Information and Consent Letter for Hemochromatosis Study | 471 |
App. G | National Action Plan on Breast Cancer (NAPBC) Consent Form for Use of Tissue for Research | 474 |
App. H | Patient Written Consent Form for Review of Medical Records | 476 |
App. I | A Descriptive Study of the Views and Experiences of Persons Involved in a Measles Vaccine Study | 478 |
Index | 479 |
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Add Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary, All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the fir, Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary to the inventory that you are selling on WonderClubX
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Add Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary, All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the fir, Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary to your collection on WonderClub |