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INTRODUCTION

Chapter Objectives

When you have completed this chapter, you will be able to understand:

  • What medical ethics is, as well as its fundamental principles

  • What the ethical issues in medical research are

  • The historical background necessitating ethics in medical research

  • The principles guiding the conduct of ethical research

  • The institute review board and its functioning

  • The need for independent ethics review

  • Ethical issues in special situations

  • Ethical issues in research publication

Research is an integral part of medical science, both for the advancement of scientific knowledge and for the better utilization of services for evidence-based patient care. Doctors and other health care professionals are uniquely placed in society to look after the general well-being of patients and develop a strong doctor–patient relationship. At the same time, doctors may have to act as researcher and undertake various studies involving their patients, leading to certain conflicts of interest. The essential components of patient care and a good doctor–patient relationship depend on the broad principles of medical ethics, which advocate doing good to the patient without causing any unnecessary harm while treating them, along with providing justice and autonomy to the patients to either accept or refuse any form of treatment. As a researcher, the doctors may have to carry out some form of intervention, like testing a new drug, medical device, or surgical procedure, for the advancement of scientific knowledge and good for the community. At the same time, these procedures may be potentially harmful to the patients on whom these are tested; this, thus, raises the issue of conflict in the doctor–patient relationship. Over the past century, in different countries, various types of “research” were carried out on human subjects without their voluntary consent, leading to significant harm to those exposed. This led the global scientific community to formulate various codes and treaties to safeguard the autonomy and well-being of the subjects who are being exposed to any form of research. This has formed the foundation of the basic codes of medical ethics that guides all researchers in undertaking any form of research in human subjects. Throughout this book, we will use the term doctor (or physician) to include all health care professionals involved in patient care and research.

WHAT ARE ETHICS AND MEDICAL ETHICS

What Is Ethics?

The term ethics is derived from the Greek ethos, meaning “custom,” “habit,” “character,” or “disposition;” and it is based on the moral values of an individual that governs human behavior.”1 Ethics is the study of morality and a careful and systematic reflection on and analysis of moral decisions and behavior, principles that govern a person's behavior or the performance of an activity. Morality, on the other hand, is the value dimension of human decision making and behavior, and includes nouns such as rights, responsibilities, and virtues and adjectives such as good and bad, right...

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