Textbook of Research Ethics: Theory and Practice [Hardcover]

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. It includes case examples and exercises and is of interest to students and experienced researchers.

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.Preface. Acknowledgements. 1: Human Experimentation: A Brief Historical Overview. The Tuskegee Experiment. The Nazi Experiments. The Cold War Experimel£Í