Chapter 7: Ethical Issues in Clinical Research

Introduction

Ethical issues are of concern in all health professions, with principles delineated in codes of ethics that address all aspects of practice and professional behavior. Clinical research requires special considerations because it involves the participation of people for the purpose of gaining new knowledge that may or may not have a direct impact on their lives or health. We ask them to contribute to our efforts because we seek answers to questions that we believe will eventually be of benefit to society. Because their participation may put them at risk, or at least some inconvenience, it is our responsibility to ensure that they are treated with respect and that we look out for their safety and well-being. We also know that published findings may influence clinical decisions, potentially affecting the lives of patients or the operation of health systems. Therefore, we must be vigilant to ensure the integrity of data.

The purpose of this chapter is to present general principles and practices that have become standards in the planning, implementation, and reporting of research involving human subjects or scientific theory. These principles apply to quantitative and qualitative studies, and they elucidate the ethical obligation of researchers to ensure protection of the participants, to safeguard scientific truth, and to engage in meaningful research.

The Protection of Human Rights

In our society, we recognize a responsibility to research subjects for assuring their rights as individuals. It is unfortunate that our history is replete with examples of unconscionable research practices that have violated ethical and moral tenets.¹ One of the more well-known examples is the Tuskegee syphilis study, begun in the 1930s, in which treatment for syphilis was withheld from rural, black men to observe the natural course of the disease.² This study continued until the early 1970s, long after penicillin had been identified as an effective cure.

One would like to think that most examples of unethical healthcare research have occurred because of misguided intentions and not because of purposeful malice. Nonetheless, the number of instances in which such behavior has been perpetrated in both human and animal research mandates that we pay attention to both direct and indirect consequences of such choices (see Focus on Evidence 7-1).