© 2002

Textbook of Research Ethics

Theory and Practice


Table of contents

About this book


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.


Deontology Ethical Issues Utilitarianism confidentiality ethics

Authors and affiliations

  1. 1.Case Western Reserve UniversityCleveland

Bibliographic information

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"If you want to know more about the historical, theoretical, and legal context of ethical issues in human-subject research, read this new book by Sana Loue. Sana Loue's book provides a valuable set of tools with which to identify, analyze and resolve a range of ethical issues that can arise in human-subject research.......the real strength of her book is that it provides a historical context and a theoretical framework for dealing with new issues as they arise."
(The Journal of Legal Medicine, 22:431-439)