Preface. Acknowledgements. 1: Human Experimentation: A Brief Historical Overview. The Tuskegee Experiment. The Nazi Experiments. The Cold War Experiments. The Prison Experiments. The Development of Diethylstilbesterol (DES).

The Willowbrook Hepatitis Experiments. The Tearoom Trade. The Development of International Codes and Guidelines. The Development of United States Guidelines and Regulations. Chapter Summary. Exercise. References. 2: Approaches to Ethical Analysis.

Casuistry. Communitarianism. Feminist Ethics. Principlism. Deontology. Utilitarianism. Contract-Based Ethics. Virtue Ethics.

Pragmatism. Chapter Summary. Exercise. References. 3: Ethical Issues Before the Study Begins. Study Design. Ethical Review Committees. Conflicts of Interest.

Chapter Summary. Exercise. References. 4: Ethical Issues During and After the Study. The Informed Consent Process. Confidentiality and Privacy Concerns. Monitoring the Study. Issues Relating to Confidentiality and Disclosure.

Chapter Summary. References. 5: Legal Issues in Research. Introduction. Misuse of Human Participants in Research. Scientific Misconduct.Misconduct in Regulated Research. Legal Responses to Misuse of Human Participants, Scientific Misconduct, and Misconduct in Regulated Research.

Releasing Data in a Legal Context. Chapter Summary. References. Appendix 1: Principles of Research Design. Appendix 2: Basic Legal Concepts. Index.