Ethics of the Use of Human Subjects in Research

(Practical Guide)

Adil Shamoo, Felix A. Khin-Maung-Gyi

• Publisher: Garland Science
• Year: 2021
• ISBN:
  9781136276026
• Edition: 1
• Topic: Biological Sciences
• Subtopic: Cell Biology
• Index: Biological Sciences

Media headlines about research misconduct in American Universities have focused public attention on the dramatic ethical problems that can arise during the conductof research. In the current atmosphere of accountability, scientific research on humans is now under increased scrutiny by the media, Congress and the public. Ethics of the Use of Human Subjects in Research fills the need for learning materials and strategies providing support for training programs related to the ethics of the use of human subjects in research. It presents a practical introduction to the ethical issues at stake in the conduct of research with human subjects. Beginning with a chapter on research ethics, a total of 10 chapters range in scope from the deveolopment of a protocol for ethical decision making to how to obtain IRB approval, with an emphasis on ethical factors underpinning the IRB process.

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Chapter 1
Introduction to Research Ethics

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The use of human subjects in research is critical to developing basic and applied knowledge in the biomedical and social sciences. In clinical research, experiments on human beings are essential to testing and developing new treatments to combat disease and promote health.

Human subject involvement through clinical trials has been expanding for well over a decade, as have ethical concerns. The greater research effort has been accompanied by increasing concern with ethical issues owing to a variety of factors:

• An aging population in the developed world and a longer life span in some developing countries

• Public policy focus on health care and health care coverage in North America, the European Community, and Japan, and in the developed world in particular

• Public awareness of research risks, nationally and internationally, as publicized throughout the media, especially the interrelationships between the developed and the developing worlds

• Increasing US federal government funding for health related research

• Increased private funding of clinical research, which, for the last 15 years or so in the USA, has outstripped federal government funding

The use of human research subjects plays a key role in promoting disease treatment and prevention, public health, and social well-being. However, the vulnerability of many participants to potential abuses, especially those with significant diseases (such as chronic conditions or those that impact a person’s decision-making capacities), raises considerable challenges from business, government regulatory, and ethical perspectives.

In this chapter, relevant ethical theories are briefly overviewed, including virtue ethics, Kantianism, and utilitarianism. From these theories, four principles are derived: respect for persons, beneficence (do good), nonmaleficence (do no harm), and justice.

Compliance with ethical principles is not only important for society, it also contributes to maintaining the public confidence that is so essential to the continuance of the development of new and improved treatment strategies. Researchers, as leaders in society, are expected to promote ethical values as well as to provide vision, initiative, and realism.

Learning Objectives

1. The necessity of using human subjects in research

2. The unprecedented growth of research in the past few decades

3. The Nuremberg Code (1947) as a cornerstone of ethics of the use of human subjects in research

4. The basic ethics theories

5. The most commonly used ethical principles

6. The characteristics of a researcher as a leader

Modern science is based on the continuous acquisition of new knowledge. This now occurs primarily through systematic and organized research undertakings involving multiple investigators and, very frequently, large operations.

The importance of research in advances in national defense, the economy, education, the environment, and health care has been well documented for at least the past 100 years. These advances create new technologies and innovations that keep our economies competitive, and new tools and drugs for patient diagnosis and therapy. For example, the total expenditure in the USA for research and development exceeds $170 billion annually, with federal government funds accounting for less than half of this.

The significant growth of public funding for research in the USA started after World War II (STAE, 1989; Shamoo, 1989). The fruits of research were recognized when resulting knowledge made an important and crucial impact on the outcome of the War. Through grants and contracts, the US Government began to fund university scientists to conduct research in numerous fields such as agriculture, medicine, and science in general. This was a new age for biomedical science research and knowledge, emerging from an unprecedented growth in work largely conducted by university scientists and at the federal campus of the National Institutes of Health (NIH) in Bethesda, Maryland. Since the mid-1980s in particular, industry as well as government have increased dramatically their funding for biological research (Beardsley, 1994).

Research is always carried out in a social and political context, whether initiated by individuals or by collaborations. Thus, societal priorities have a direct impact on what kind of research is funded. Even though researchers strive for objectivity, societal ethical issues are intertwined with the purpose and process of their research. They need to earn and then maintain public trust in order to gain support.

There have been high-profile incidences of research aberrations that have shaped modern discussions of research ethics. Examples include concerns over the use of pesticides, air pollution, radiation, and the human atrocities before and during World War II, including, in the USA, the Tuskegee experiments, and, during the war, experimentation by German and Japanese scientists. The rapid growth of industry, especially the biomedical industry after World War II and more recently the growth of biotechnology, have added greater complexities to the conduct of research, particularly with respect to ethics. In turn, even though the industrial funding for research has been welcomed by most researchers, it has added commercial dimensions to ethical issues for consideration.

Intensified research activity in the USA and internationally have also resulted in significant increases in the use of animals and humans as experimental subjects. The use of people in research is necessitated if new drugs are ever to be used by humans. It is critically important for this to be understood by all the parties involved (i.e. patients, families, researchers, and industrial concerns). If public confidence fails, the use of human subjects in research will decrease and drug development will suffer. If new drugs do not reach the market, desperate patients may use untested and unproven chemicals and drugs to the detriment of their health.

All those involved in clinical research must come to the conclusion that the use of human subjects can and must be conducted in an ethical manner in order to serve the health and well-being of our society.

During World War II, Nazi “researchers” used prisoners – mostly Jews, and mentally retarded and mentally ill people – in experiments that shocked the conscience of the world as they came to light during the Nuremberg trials. The Nuremberg military tribunal issued a strong condemnation of such barbaric behavior towards fellow human beings and issued a code of conduct for research with humans, now known as the Nuremberg Code (ACHRE, 1995). Unfortunately, while paling in comparison with the Nazi scale, human research subject abuse was discovered in the USA prior to and, more disturbingly, after World War II.

The Nuremberg Code identified crucial elements for human subjects’ participation in research. The first and most enduring principle is that “The voluntary consent of the human subject is absolutely essential.” The Code further emphasizes the requirement that the subject must be given sufficient knowledge, be free of duress and coercion, and comprehend the associated risks and benefits.

In 1964, the Helsinki Declaration, adopted by the World Medical Assembly meeting in Helsinki, Finland, followed the Nuremberg Code. It has since been revised five times (for general references, see Beauchamp and Childress, 1994; ACHRE, 1995; Veatch, 1989). The Helsinki Declaration provides more detail on regulating the protection of human research subjects and distinguishes between therapeutic and nontherapeutic research.

ETHICAL PRINCIPLES

In our society, there are at least two distinct meanings for the term “ethics”. In the first sense of the term, ethics refers to principles of conduct that distinguish between right and wrong actions. These principles may be embodied in a particular code, creed, or law, such as the Nuremberg Code, or they may exist as social conventions or norms (or morals). Beauchamp and Childress (1994) link ethics and morality by asserting:

“The term morality refers to social conventions about right and wrong human cond...

Table of contents

• Cover
• Half Title
• Title Page
• Copyright Page
• Dedication
• Table of Contents
• Preface
• About the authors
• Acknowledgements
• List of abbreviations
• 1 Introduction to research ethics
• 2 Development of a protocol for ethical decision making
• 3 Current federal regulations, the DHHS, and the FDA
• 4 Informed consent
• 5 Institutional review boards
• 6 Conflict of interest
• 7 The use of decisionally impaired people in research
• 8 The use of children in research
• 9 The use of prisoners in research
• 10 Process of obtaining approval for the use of human subjects in research
• Quiz answers
• Index