Textbook of Research Ethics

The International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS and WHO, 1993: 11) defines research as referring to a class of activities designed to develop or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principles or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific techniques of observation and inference. The International Guidelines for the Ethical Review of Epidemiological Studies (CIOMS, 1991) recognizes that it may be difficult to distinguish between research and program evaluation. It offers the following guidance: The defining attribute of research is that it is designed to produce new, generalizable knowledge, as distinct from knowledge pertaining only to a particular individual or programme (CIOMS, 1991, Guideline 52,23). Health research includes both medical and behavioral studies that relate to health. Research can be conducted in conjunction with patient care (clinical research), or it can be conducted outside of the context of clinical care. Research may involve only observation, or it may require, instead or in combination, a physical, chemical, or psychological intervention. Research may generate new records or may rely on already-existing records.

Inhalt
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.

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