MIES biblioteka

Naujausi A B C D E F G H I J K L M N O P R S T V W Y Z

Autoriai: SANA LOUE
ISBN: 0-306-46448-9
Brūkšninis kodas: 003075180318
Ieškoti VUB kataloge

     This textbook provides a brief history of human experimentation and reviews various theories of ethics from which the principles and rules that govern this research are derived. All relevant international documents and national regulations,
policies, and memoranda are referred to extensively to assist in addressing issues that regularly arise during the course of research involving human subjects. Extensive case examples and exercises for discussion are presented throughout the text to challenge the reader to devise creative strategies for the integration of science, ethics, where relevant, law. This volume will be of interest to both students and experienced researchers who design, conduct, and disseminate findings using human subjects in then research.

1 Chapter 1. Human Experimentation and Research: A Brief Historical Overview
2The Tuskegee Experiment
2 The Historical and Social Context
6 The Tuskegee Syphilis Study The Nazi Experiments
8 Eugenics and Racial Hygiene
8 The Recruitment of Physicians to the Nazi Cause
11 The "Cleansing" of the Aryan "Body"
13 Regulations Governing Human Experimentation
14 The Medical Experiments The Cold War Experiments
18 The Cold War: How It Began and What It Meant
19 The Vanderbilt Nutrition Study
19 The Fernald State School Experiments
20 Total Body Irradiation at the University of Cincinnati
21 The Aftermath The Prison Experiments
22 The Holmesburg Prison Experiments
23 Malaria, Leukemia, and Pellagra
30 The Development of Diethylstilbesterol (DES)
30 The Willowbrook Hepatitis Experiments
31 The Tearoom Trade
32 The Development of International Codes and Guidelines
32 The Nuremberg Code and Declaration of Helsinki
33 The International Covenant on Civil and Political Rights
34 CIOMS and WHO International Guidelines
35 The Development of United States Guidelines and Regulations
37 Chapter Summary
37 Exercise
38 References
45 Chapter 2. Approaches to Ethical Analysis
45 Casuistry
47 Communitarianism Feminist Ethics
48 Feminine or Feminist?
48 Foundations of Feminine and Feminist Ethics
51 Feminine Approaches to Ethics
51 Feminist Approaches to Ethics
58 Principlism
60 Deontology
61 Utilitarianism
64 Contract-Based Ethics
65 Virtue Ethics
65 Pragmatism
66 Chapter Summary
66 Exercise
71 Chapter 3. Ethical Issues Before the Study Begins
71 Study Design
71 Designing the Study
74 Formulating the Research Team
76 Formulating Inclusion and Exclusion Criteria
77 Working with Vulnerable Participants
83 Selecting a Comparison Treatment or Intervention
86 Balancing the Risks and Benefits Ethical Review Committees
89 The Purpose and Function of the Review Committees
89 Ethical Review in the United States: The Institutional Review Board
91 One Institutional Review Board: An Example
95 Institutional Review and International Research
97 Exercise
99Conflicts of Interest
100 Financial Conflicts
104 Other Conflicts
105 Strategies to Address Conflicts Before the Study Begins
108 Chapter Summary
109 Exercise
113 Chapter 4. Ethical Issues During and After the Study
113 The Informed Consent Process
116 Recruitment
127 Explaining the Study
142 Designing the Informed Consent Process
147 Confidentiality and Privacy Concerns
148 Monitoring the Study
148 The Data Safety Monitoring Board
149 Community Consultation
149 Issues Relating to Confidentiality and Disclosure
149 Authorship
159 Obligation to Inform
162 Advocacy
163 Chapter Summary
164 References
171Chapter 5. Legal Issues in Research
1771 Introduction
171 Misuse of Human Participants in Research
175 Scientific Misconduct
175 Defining Scientific Misconduct
175 Institutional Responses
182 Administrative Responses to Scientific Misconduct
185 Misconduct in Regulated Research
189Legal Responses to Misuse of Human Participants,
Scientific Misconduct, and Misconduct in Regulated Research
189 Civil Proceedings
193 Criminal Proceedings
196 Releasing Data in a Legal Context
196 Limits on Confidentiality
208 Mechanisms to Enhance Confidentiality
212 Chapter Summary
212 References
217 Appendix 1: Principles of Research Design
241 Appendix 2: Basic Legal Concepts
249 Index

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