Ethics for Bioengineering Scientists

Treating Data as Clients

Howard Winet

• Publisher: CRC Press
• Year: 2021
• ISBN:
  9781000488111
• Edition: 1
• Topic: Business
• Subtopic: Industria dei servizi
• Index: Business

This book introduces bioengineers and students who must generate and/or report scientific data to the ethical challenges they will face in preserving the integrity of their data. It provides the perspective of reaching ethical decisions via pathways that treat data as clients, to whom bioengineering scientists owe a responsibility that is an existential component of their professional identity. The initial chapters lay a historical, biological and philosophical foundation for ethics as a human activity, and data as a foundation of science. The middle chapters explore ethical challenges in lay, engineering, medical and bioengineering scientist settings. These chapters focus on micro-ethics, individual behavior, and cases that showcase the consequences of violating data integrity. Macro-ethics, policy, is dealt with in the Enrichment sections at the end of the chapters, with essay problems and subjects for debates (in a classroom setting). The book can be used for individual study, using links in the Enrichment sections to access cases and media presentations, like PBS' "Ethics in America". The final chapters explore the impact of bioengineering science ethics on patients, via medical product development, its regulation by the FDA, and the contribution of data integrity violation to product failure. The book was developed for advanced undergraduate and graduate students in bioengineering. It also contains much needed material that researchers and academics would find valuable (e.g., FDA survey, and lab animal research justification).

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• Introduces an approach to ethical decision making based on treating data as clients
• Compares the ethics of three professions; engineering, medicine and bioengineering
• Provides five moral theories to choose from for evaluating ethical decisions, and includes a procedure for applying them to moral analysis, and application of the procedure to example cases.
• Examines core concepts, like autonomy, confidentiality, conflict of interest and justice
• Explains the process of developing a medical product under FDA regulation
• Explores the role of lawyers and the judiciary in product development, including intellectual property protection
• Examines a range of ethical cases, from the historical Tuskegee autonomy case to the modern CRISPR-Cas9 patent case.

Howard Winet, PhD is an Adjunct Professor recall, Orthopaedic Surgery and Bioengineering at University of California, Los Angeles.

1 Bioengineering and Ethics

DOI: 10.1201/9781003197218-1

1.1 Bioengineering as an Interdisciplinary Profession

The term “bioengineer” (BE) is used in this text for all engineers trained to work on biological/medical problems. By definition, a BE is both a biologist and an engineer. Biologists are scientists who study organisms. Engineers, traditionally, are empiricists; people rooted in trial-and-error. Prior to the 1960s, BE did not exist as a specialty. The process of a biologist working with an engineer either to maintain lab equipment or build models of a biological phenomenon was coined as bioengineering. The engineer was uninvolved in the scientific aspects of the biological investigation (Britannica 2016). However, when collaboration between biologists and engineers became more frequent and complex, the discipline of bioengineering grew, and sub-groups, such as fields like biomaterials, emerged. As is common in growing professions, a need arose to incorporate an ethical component in bioengineering. The need became more acute as its “bio” component spread into medicine and agriculture. Today, bioengineering ethics (BEE) spans three professions: biology, engineering, and medicine. Accordingly, the ethical problems it addresses cover a broad range.

1.2 What BEs MAY DO

The BE neither designs bridges nor bandages a wound. However, a BE may develop a neurologically controlled device that would allow an engineer to construct a bridge robotically. As a health scientist, he/she may develop a controlled-release “bandage” that directs wound healing. As a biologist, a BE may develop implantable transmitters that allow researchers to monitor behavior of an animal in nature. Since these are all forms of intervention in the life of a living being, they raise general concerns about the welfare of that being, and the ethical problems associated with invading its life. As a scientist, a BE is typically involved in research that produces data, which leads to a different kind of concern—the integrity of those data. If the data result in production of a medical product that fails, the government agency that approved it, the Food and Drug Administration (FDA), will ask “why?” If the answer includes a violation of data integrity, the FDA will assign the Department of Justice (DOJ) to investigate. What follows would be a nightmare for the company, and, by extension, the responsible BE. In parallel, data integrity may be compromised in a noncommercial setting. In these cases, investigations rarely lead to formal trials. But, careers may be ended by the institute involved.

1.3 Basis for Value Conflict Between Bio and Engineering

When you became curious about the world outside your crib, you began to investigate it. A couple of pokes with a pin taught you painfully to avoid sharp things. When you touched a lighted bulb, you learned that there is a heat threshold, which, when crossed, leads to pain. You were learning empirically about the natural world, and the facts, evidence, or data you gathered led you to empirical conclusions we call “truths”. If the truths that attracted you as you matured were solutions to problems, you were leaning toward an interest in a profession, like engineering or medicine, that solved problems. We refer to members of such professions as “truth professionals” because each solution to a problem ends their quest for its truth.

But isn’t science also based on drawing conclusions from facts, data? Yes, it is, but the ultimate goal of a scientist is not to stop at solving problems. It is to understand the natural world. A truth professional may discover the longest lasting implant by empirically testing many candidates. A scientist would try to understand how the tissue needing the implant works, and how it became compromised so as to need the implant. A scientist may solve a problem, but understanding the mechanism or cause underlying the problem opens the door to solutions for similar problems. If the implant failed, a scientist would want to understand the pathophysiological and biomaterial mechanisms underlying that implant’s failure. In fact, failure is a scientist’s best teacher. To a truth professional, failure is often a catastrophe.

The line between science and truth professions is not rigid. Empirical and clinical science exist in the world of investigation between the extremes of causal science and trial-and-error empiricism. The nature of clinical science will be discussed in Chapter 11, where we describe the approach of Bradford Hill used epidemiology to causally link smoking and lung cancer. Bioengineering research encompasses all these investigative approaches.

Our first challenge to understanding the roles of empiricism and science in the development of bioengineering is to put the truth and causal fields of endeavor into perspective through their histories. We shall hit only the highlights, to avoid getting sidetracked into historical arguments. It will be necessary to limit the location of cultures for our story to the fertile crescent, because, as Diamond has maintained, technological and scientific advancement had different histories elsewhere (Diamond 1999).

1.4 The Ancient Period and First Western Societies

1.4.1 General

We begin with the first agricultural societies, some 15,000 or so years ago. These have been supposed to have all transitioned from hunter-gatherers. But there is evidence from Göbekli Tepi in Turkey contradicting this conclusion (Harari 2015). Agricultural societies depended on “simply serendipity” (Aslaksen 2013) or trial-and-error experience, empiricism, for solving survival problems (Diamond 1999; Harari 2015). Domestication of plants and animals for food, clothing, and shelter (Diamond 1999); the use of trephines in paleomedicine (Ackerknecht 2016); and by about 10,000 years ago “engineering activities” (Aslaksen 2013) were taking place in some regions. The individuals who performed such “engineering activities” are identified by Aslaksen, as “craftsmen”. Here (Table 1.1) is his timetable with some modification (last two rows replaced by row from Parodi (Parodi et al. 2006)).

Table 1.1 Adjusted Timetable of Historical Periods from One Engineer's Point of View

Period	Approximate Duration
Ancient	13,000 B.C.–500 B.C.
Classical	500 B.C.–400 A.D.
Medieval	400–1400
Renaissance	1400–1650
Enlightenment	1650–1750
Industrial Revolution	1750–1850
Second Industrial Revolution	1850–c.1920

Until the invention of writing, in about 3,500 B.C. (Ackerknecht 2016), accounts of inventions or innovations that solved each problem were passed to succeeding generations by oral tradition alone. For anthropologists, then, evidence for such solutions had to come from resulting constructions and tools, that is, the technology (e.g. flintstones) that craftsmen left behind (Ackerknecht 2016). The segment of time under discussion, from prehistory to about 500 B.C., has been called the “Ancient” Period (Aslaksen 2013). It included, near its end, rise of the Mesopotamian, Egyptian, and early Greek civilizations (Principe 2002).

1.4.2 Medicine

Cuneiform writing from Sumeria and Babylonia 5,300 years ago indicated that illness was caused by spirits and could be cured by sorcery (Parker 2019). The medical practitioners who could perform the sorcery were called “ashipus”. Alternative treaters, who were information reservoirs for practical treatments, such as herbal potions, were called “asus” (Parker 2019). In any group, one man stood out as a healer, shaman, or medicine man. Fractures and skin wounds could be treated. Teeth could be drilled. In Egypt, 2,500 years later, physicians were hailed as priests—one of the most famous being Imhotep who was treated as a demigod (Parker 2019). The Egyptians learned anatomy from their experiences with mummification. Imhotep’s following in Ancient Greece continued to revere him in the form of Asclepios (Parker 2019). In all these societies, medicine was a mixture of spiritualism and empiricism.

1.4.3 Engineering

Near its end, the Ancient Period was characterized by reorganization of craftsmen from members of small groups that fashioned tools for building rafts, boats, and simple houses, bridges, and irrigation canals, to larger workgroups that built government structures requiring designers and managers (Aslaksen 2013). Craftsman skills that were needed included not only the physical ability to process and work with copper, bronze, iron, and glass, but also, starting with the Babylonians (Mesopotamians), mathematics and accounting skills (Principe 2002). The Egyptians further advanced metalworking and glassmaking (Principe 2002).

1.4.4 Science

Judging from surviving documents, attempts to understand the natural world beyond empirical application or religious interpretation were “quite limited” in pre-Greek civilizations (Principe 2002). The acknowledged first philosopher, who moved beyond empiricism toward an understanding of the natural world, was the Greek, Thales of Miletus (whose lifetime fell between the interval 624–545 B.C.; Britannica 2009, Principe 2002). Thales marks the end of Aslaksen’s Ancient Period of craftsmen and the beginning of his Classical Period (500 B.C.–400 A.D.; Aslaksen 2013).

1.5 The Classical Period—Mythos and Logos

1.5.1 General

Intellectual development in the Classical Period was dominated by Greek and Roman philosophers. They built the foundation of the enlightenment that produced science (Principe 2002) and, eventually, bioengineering. We shall not detail their writings. Instead, we shall highlight concepts they developed that are crucial for gaining insight into concepts of truth and causal thinking as it evolved in society.

The first crucial concept is the difference between mythos and 1logos ways of thinking. While a number of Greek philosophers have argued over the meaning of this difference (Bottici 2008), a case can be made (Principe 2002) that Plato (428–347 B.C.), in his Republic (Shorey and Plato 1953), settled on mythos as a belief or “sacred narrative explaining how the world and man came to be” (Orfanos 2006). In contrast to mythos thinking, logos thinking develops a narrative explaining the world, based on reason and following the rules of logic.

What separates the philosophers of the Classical Period from thinkers that preceded them is the way they organized their thoughts to transform reason into logic. The scheme, traceable to Plato (Principe 2002), may be found in a traditional Introduction to Philosophy book (Rosen et al. 2018). The formal thinking that follows this scheme employs the following three kinds of statements:

1. Logical/formal/analytical: Declarations of relationships or states of exis...