Category Archives: Biomedical Engineering

Appendix

AppendixThe Role of Professional Societies in Biomedical Engineering

Swamy Laxminarayan

New Jersey Institute of Technology

Joseph D. Bronzino

Trinity College/Biomedical Engineering Alliance for Connecticut (BEACON)

Jan E. W. Beneken

Eindhoven University of Technology

Shiro Usai

Toyohashi University of Technology

Richard D. Jones

Christchurch Hospital

A.1 Biomedical Engineering Societies in the World

American Institute for Medical and Biological Engineering (AIMBE) • IEEE Engineering in Medicine and Biology Society (EMBS) • Canadian Medical and Biological Engineering Society • European Society for Engineering in Medicine (ESEM) • French Groups for Medical and Biological Engineering • International Federation for Medical and Biological Engineering (IFMBE) • International Union for Physics and Engineering Sciences in Medicine (IUPESM) • International Council of Scientific Unions (ICSU) • Biomedical Engineering Societies in Japan • BME Activities in Australia and New Zealand • Bioengineering in Latin America

A.2 Summary

Professionals have been defined as an aggregate of people finding identity in sharing values and skills absorbed during a common course of intensive training. Parsons [1954] stated that one determines whether or not individuals are professionals by examining whether or not they have internalized certain given professional values. Friedson [1971] redefined Parson’s definition by noting that a professional is someone who has internalized professional values and is to be recruited and licensed on the basis of his or her technical competence. Furthermore, he pointed out that professionals generally accept scientific standards in their work, restrict their work activities to areas in which they are technically competent, avoid emotional involvement, cultivate objectivity in their work, and put their clients’ interests before their own.

The concept of a profession that manages technology encompasses three occupational models: science, business, and profession. Of particular interest in the contrast between science and profession. Science is seen as the pursuit of knowledge, its value hinging on providing evidence and communicating with colleagues. Profession, on the other hand, is viewed as providing a service to clients who have problems they cannot handle themselves. Science and profession have in common the exercise of some knowledge, skill, or expertise. However, while scientists practice their skills and report their results to knowledgeable colleagues, professionals—such as lawyers, physicians, and engineers—serve lay clients. To protect both the professional and the client from the consequences of the layperson’s lack of knowledge, the practice of the profession is regulated through such formal institutions as state licensing. Both professionals and scientists must persuade their clients to accept their findings. Professionals endorse and follow a specific
code of ethics to serve society. On the other hand, scientists move their colleagues to accept their findings through persuasion [Goodman, 1989].

Consider, for example, the medical profession. Its members are trained in caring for the sick, with the primary goal of healing them. These professionals not only have a responsibility of the creation, devel­opment, and implementation of that tradition, they also are expected to provide a service to the public, within limits, without regard of self-interest. To ensure proper service, the profession itself closely monitors licensing and certification. Thus medical professionals themselves may be regarded as a mech­anism of social control. However, this does not mean that other facets of society are not involved in exercising oversight and control over physicians in their practice of medicine.

Professional Development. One can determine the status of professionalization by noting the occur­rence of six crucial events: (1) the first training school, (2) the first university school, (3) the first local professional association, (4) the first national professional association, (5) the first state license law, and (6) the first formal code of ethics [Wilensky, 1964; Goodman, 1989; Bronzino, 1992].

The early appearances of training school and the university affiliation underscore the importance of the cultivation of a knowledge base. The strategic innovative role of the universities and early teachers lies in linking knowledge to practice and creating a rational for exclusive jurisdiction. Those practitioners pushing for prescribed training then form a professional association. The association defines the task of the profession: raising the quality of recruits, redefining their function to permit the use of less technically skilled people to perform the more routine, less involved tasks, and managing internal and external conflicts. In the process, internal conflict may arise between those committed to established procedures and newcomers committed to change and innovation. At this stage, some form of professional regulation, such as licensing or certification, surfaces because of a belief that it will ensure minimum standards for the profession, enhance status, and protect the layperson in the process.

The latest area of professional development is the establishment of a formal code of ethics, which usually includes rules to exclude the unqualified and unscrupulous practitioners, rules to reduce internal competition, and rules to protect clients and emphasize the ideal service to society. A code of ethics usually comes at the end of the professionalization process.

In biomedical engineering, all six critical steps mentioned above have been clearly taken. Therefore, biomedical engineering is definitely a profession. It is important here to note the professional associations across the globe that represent the interest of professionals in the field.

A.1 Biomedical Engineering Societies in the World

Globalization of biomedical engineering (BME) activities is underscored by the fact that there are several major professional BME societies currently operational throughout the world. The various countries and continents to have provided concerted “action” groups in biomedical engineering are Europe, the Amer­icas, Canada, and the Far East, including Japan and Australia. while all these organizations share in the common pursuit of promoting biomedical engineering, all national societies are geared to serving the needs of their “local” memberships. The activities of some of the major professional organizations are described below.

American Institute for Medical and Biological Engineering (AIMBE)

The United States has the largest biomedical engineering community in the world. Major professional organizations that address various cross sections of the field and serve over 20,000 biomedical engineers include (1) the American College of Clinical Engineering, (2) the American Institute of Chemical Engi­neers, (3) The American Medical Informatics Association, (4) the American Society of Agricultural Engineers, (5) the American Society for Artificial Internal Organs, (6) the American Society of Mechanical Engineers, (7) the Association for the Advancement of Medical Instrumentation, (8) the Biomedical Engineering Society, (9) the IEEE Engineering in Medicine and Biology Society, (10) an interdisciplinary

Association for the Advancement of Rehabilitation and Assistive Technologies, (11) the Society for Biomaterials, (12) Orthopedic Research Society, (13) American Society of Biomechanics, and (14) Amer­ican Association of Physicist in Medicine. In an effort to unify all the disparate components of the biomedical engineering community in the United States as represented by these various societies, the American Institute for Medical and Biological Engineers (AIMBE) was created in 1992. The AIMBE is the result of a 3-year effort funded by the National Science Foundation and led by a joint steering committee established by the Alliance of Engineering in Medicine and Biology and the U. S. National Committee on Biomechanics. The primary goal of AIMBE is to serve as an umbrella organization “for the purpose of unifying the bioengineering community, addressing public policy issues, identifying common themes of reflection and proposals for action, and promoting the engineering approach in society” s effort to enhance health and quality of life through the judicious use of technology” [Galletti, 1994].

AIMBE serves its role through four working divisions: (1) the Council of Societies, consisting of the 11 constituent organizations mentioned above, (2) the Academic Programs Council, currently consisting of 46 institutional charter members, (3) the Industry Council, and (4) the College Fellows. In addition to these councils, there are four commissions, Education, Public Awareness, Public Policy, and Liaisons. With its inception in 1992, AIMBE is a relatively young institution trying to establish its identity as an umbrella organization for medical and biologic engineering in the United States. As summarized by two of the founding officials of the AIMBE, Profs Nerem and Galletti:

What we are all doing, collectively, is defining a focus for biological and medical engineering. In a society often confused by technophobic tendencies, we will try to assert what engineering can do for biology, for medicine, for health care and for industrial development, We should be neither shy, nor arrogant, nor self-centered. The public has great expectations from engineering and technology in terms of their own health and welfare. They are also concerned about side effects, unpredictable consequences and the economic costs. Many object to science for the sake of science, resent exaggerated or empty promises of benefit to society, and are shocked by sluggish or misdirected flow from basic research to useful applications. These issues must be addressed by the engineering and medical com­munities. For more information, contact the Executive Office, AIMBE, 1901 Pennsylvania Avenue, N. W., Suite 401, Washington DC 20006-3405 (Tel: 202-496-9660; fax: 202-466-8489; email: AIMBE@aol. com).

IEEE Engineering in Medicine and Biology Society (EMBS)

The Institute of Electrical and Electronic Engineers (IEEE) is the largest international professional organi­zation in the world and accommodates 37 different societies under its umbrella structure. Of these 37, the Engineering in Medicine and Biology Society represents the foremost international organization serving the needs of nearly 8000 biomedical engineering members around the world. The field of interest of the EMB Society is application of the concepts and methods of the physical and engineering sciences in biology and medicine. Each year, the society sponsors a major international conference while cosponsoring a number of theme-oriented regional conferences throughout the world. A growing number of EMBS chapters and student clubs across the major cities of the world have provided the forum for enhancing local activities through special seminars, symposia, and summer schools on biomedical engineering topics. These are supplemented by EMBS’s special initiatives that provide faculty and financial subsidies to such programs through the society’s distinguished lecturer program as well as the society” s Regional Conference Committee. Other feature achievements of the society include its premier publications in the form of three monthly journals (Transactions on Biomedical Engineering, Transactions on Rehabilitation Engineering, and Transac­tions on Information Technology in Biomedicine) and a bi-monthly EMB Magazine (the IEEE Engineering in Medicine and Biology Magazine). EMBS is a transnational voting member society of the International Federation for Medical and Biological Engineering. For more information, contact the Secretariat, IEEE EMBS, National Research Council of Canada, Room 393, Building M-55, Ottawa, Ontario K1A OR8, Canada. (Tel: 613-993-4005; fax: 613-954-2216; email: Soc. emb@ieee. org).

Canadian Medical and Biological Engineering Society

The Canadian Medical and Biological Engineering Society (CMBES) is an association covering the fields of biomedical engineering, clinical engineering, rehabilitation engineering, and biomechanics and biom­aterials applications. CMBES is affiliated with the International Federation for Medical and Biological Engineering and currently has 272 full members. The society organizes national medical and biological engineering conferences annually in various cities across Canada. In addition, CMBES has sponsored seminars and symposia on specialized topics such as communication aids, computers, and the handi­capped, as well as instructional courses on topics of interest to the membership. To promote the professional development of its members, the society as drafted guidelines on education and certification for clinical engineers and biomedical engineering technologists and technicians. CMBES is committed to bringing together all individuals in Canada who are engaged in interdisciplinary work involving engineering, the life sciences, and medicine. The society communicates to its membership through the publication of a newsletter as well as recently launched academic series to help nonengineering hospital personnel to gain better understanding of biomedical technology. For more information, contact the Secretariat, The Cana­dian Medical and Biological Engineering Society, National Research Council of Canada, Room 393, Building M-55, Ottawa, Ontario K1A OR8, Canada (Tel: 613-993-1686; fax: 613-954-2216).

European Society for Engineering in Medicine (ESEM)

Most European countries are affiliated organizations of the International Federation for Medical and Biological Engineering (IFMBE). The IFMBE activities are described in another section of this chapter. In 1992, a separate organization called the European Society for Engineering in Medicine (ESEM) was created with the objective of providing opportunities for academic centers, research institutes, industry, hospitals and other health care organizations, and various national and international societies to interact and jointly explore BME issues of European significance. These include (1) research and development,

Education and training, (3) communication between and among industry, health care providers, and policymakers, (4) European policy on technology and health care, and (5) collaboration between eastern European countries in transition and the western European countries on health care technology, delivery, and management. To reflect this goal the ESEM membership constitutes representation of all relevant disciplines from all European countries while maintaining active relations with the Commission of the European Community and other supranational bodies and organizations.

The major promotional strategies of the ESEM’s scientific contributions include its quarterly journal Technology and Health Care, ESEM News, the Society’s Newsletter, a biennial European Conference on Engineering and Medicine, and various topic-oriented workshops and courses. ESEM offers two classes of membership: the regular individual (active or student) membership and an associate grade. The latter is granted to those scientific and industrial organizations which satisfy the society guidelines and subject to approval by the Membership and Industrial Committees. The society is administered by an Admin­istrative Council consisting of 13 members elected by the general membership. For more information, contact the Secretary General, European Society for Engineering in Medicine, Institut fьr Biomedizinische Technik, Seidenstrasse 36, D-70174 Stuttgart, Germany. (Fax: 711-121-2371

French Groups for Medical and Biological Engineering

The French National Federation of Bioengineering (Genie Biologique et Medical, GMB) is a multidisci­plinary body aimed at developing methods and processes and new biomedical materials in various fields covering prognosis, diagnosis, therapeutics, and rehabilitation. These goals are achieved through the creation of 10 regional centers of bioengineering, called the poles. The poles are directly involved at all levels, from applied research through the industrialization to the marketing of the product. Some of the actions pursued by these poles include providing financial seed support for innovative biomedical engi­neering projects, providing technological help, advice, and assistance, developing partnerships among universities and industries, and organizing special seminars and conferences. The information dissemi­nation of all scientific progress is done through the Journal of Innovation and Technology in Biology and Medicine. For more information, contact the French National Federation of Bioengineering, Coordinateur de la Federation Francaise des Poles GBM, Pole GBM Aquitaine-Site Bordeaux-Montesquieu, Centre de Resources, 33651 Martillac Cedex, France.

International Federation for Medical and Biological Engineering (IFMBE)

Established in 1959, the International Federation for Medical and Biological Engineering (IFMBE) is an organization made up from an affiliation of national societies including membership of transnational organizations. The current national affiliates are Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Cuba, Cyprus, Slovakia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, South Africa, South Korea, Spain, Sweden, Thailand, United Kingdom, and the United States. The first transnational organization to become a member of the federation is the IEEE Engineering in Medicine and Biology Society. At the present time, the federation has an estimated 25,000 members from all of its constituent societies.

The primary goal of the IFMBE is to recognize the interests and initiatives of its affiliated member organizations and to provide an international forum for the exchange of ideas and dissemination of information. The major IFMBE activities include the publication of the federation’s bimonthly journal, the Journal of Medical and Biological Engineering and Computing, the MBEC News, establishment of close liaisons with developing countries to encourage and promote BME activities, and the organization of a major world conference every 3 years in collaboration with the International Organization for Medical Physics and the International Union for Physical and Engineering Sciences in Medicine. The IFMBE also serves as a consultant to the United Nations Industrial Development Organization and has nongovern­mental organization status with the World Health Organization, the United Nations, and the Economic Commission for Europe. For more information, contact the Secretary General, International Federation for Medical and Biological Engineering, AMC, University of Amsterdam, Meibergdreef 15, 1105 AZ Amsterdam, the Netherlands. (Tel: 20-566-5200, ext. 5179; fax 20-691-7233; email: Ifmbe@amc. uva. nl)

International Union for Physics and Engineering Sciences in Medicine (IUPESM)

The IUPESM resulted from the IFMBE’s collaboration with the International Organization of Medical Physics (IOMP), culminating into the joint organization of the triennial World Congress on Medical Physics and Biomedical Engineering. Traditionally, these two organizations held their conferences back to back from each other for a number of years. Since both organizations were involved in the research, development, and utilization of medical devices, they were combined to form IUPESM. Consequently, all members of the IFMBE’s national and transnational societies are also automatically members of the IUPESM. The statutes of the IUPESM have been recently changed to allow other organizations to become members in addition to the founding members, the IOMP and the IFMBE.

International Council of Scientific Unions (ICSU)

The International Council of Scientific Unions is nongovernmental organization created to promote inter­national scientific activity in the various scientific branches and their applications for the benefit of human­ity. ICSU has two categories of membership: scientific academies or research councils, which are national, multidisciplinary bodies, and scientific unions, which are international disciplinary organizations. Currently, there are 92 members in the first category and 23 in the second. ICSU maintains close working relations with a number of intergovernmental and nongovernmental organizations, in particular with UNESCO. In the past, a number of international programs have been launched and are being run in cooperation with UNESCO. ICSU is particularly involved in serving the interests of developing countries.

Membership in the ICSU implies recognition of the particular field of activity as a field of science. Although ICSU is heralded as a body of pure scientific unions to the exclusion of cross and multidisci­plinary organizations and those of an engineering nature, IUPESM, attained its associate membership in the ICSU in the mid-1980s. The various other international scientific unions that are members of the ICSU include the International Union of Biochemistry and Molecular Biology (IUBMB), the Interna­tional Union of Biological Sciences (IUBS), the International Brain Research Organization (IBRO), and the International Union of Pure and Applied Biophysics (IUPAB). The IEEE is an affiliated commission of the IUPAB and is represented through the Engineering in Medicine and Biology Society [ICSU Year Book, 1994]. For more information, contact the Secretariat, International Council of Scientific Unions, 51 Boulevard de Montmorency, 75016 Paris, France. (Tel: 1-4525-0329; fax: 1-4288-9431; email: Icsu@paris7.jussieu. fr)

Biomedical Engineering Societies in Japan

The biomedical engineering activities in Japan are promoted through several major organizations: (1) the Japan Society of Medical Electronics and Biological Engineering (JSMEBE), (2) the Institute of Electron­ics, Information and Communication Engineering (IEICE), (3) the Institute of Electrical Engineers of Japan (IEEJ), (4) the Society of Instrument and Control Engineers (SICE), (5) the Society of Biomech­anisms of Japan (SBJ), (6) the Japanese Neural network Society (JNNS), (7) Japan Ergonomics Research Society (JERS), and (8) the Japan Society of Ultrasonics in Medicine (JSUM). The various special sister societies that are affiliated under the auspicies of these organizations mainly focus on medical electronics, biocybernetics, neurocomputing, medical and biologic engineering, color media and vision system, and biologic and physiologic engineering. The JSMEBE has the most BME concentration, with two confer­ences held each year in biomedic engineering and three international journals that publish original peer- reviewed papers. The IEICE, which is now 77 years old, is one of the largest international societies, constituting about 40,000 members. The aim of the society is to provide a forum for the exchange of knowledge on the science and technology of electronics, information, and communications and the development of appropriate industry in these fields.

BME Activities in Australia and New Zealand

The BME activities in Australia and New Zealand are served by one transnational organization called the Australasian College of Physical Scientists and Engineers in Medicine (ACPSEM) covering Australia and New Zealand and a national organization called the College of Biomedical Engineers of the Institute of Engineers, (CBEIE) serving the Australian member segment.

The Australasian College of Physical Scientists and Engineers in Medicine was founded in 1977 and comprises 6 branches and 339 members. The membership is made up of 76% from Australia, 17% from New Zealand, and the rest from overseas. A majority of members are employed in pubic hospitals, with most of these in departments of medical physics and clinical engineering. The primary objectives of the college are (1) to promote and further the development of the physical sciences and engineering in medicine and to facilitate the exchange of information and ideas among members of the college and others concerned with medicine and related subjects and (2) to promote and encourage education and training in the physical sciences and engineering in medicine. Entry to ordinary membership of the college requires applicants to have an appropriate 4-year bachelor’s degree and at least 5 years of expe­rience as a physical scientist or engineer in a hospital or other approved institution.

Bioengineering in Latin America

Latin American countries have demonstrated in the past decade significant growth in their bioengineering activities. In terms of IEEE statistics, Latin America has the fastest growing membership rate. Currently, there are over 10,000 IEEE members alone in this region, of which about 300 are members of the Engineering in Medicine and Biology Society. In an effort to stimulate this growth and promote active International interactions, the presidents of the IEEE, EMBS, and the IFMBE met with representatives of biomedical engineering societies from Argentina, Brazil, Chile, Columbia, and Mexico in 1991 [Rob­inson, 1991]. This meeting resulted in the formation of an independent Latin American Regional Council of Biomedical Engineering, known by its spanish and portugese acronym as CORAL (Consejo Regional de Ingenieria Biomedica para Americana Latina). Both the EMBS and the IFMBE are the founding sponsoring members of the CORAL. The main objectives of CORAL are (1) to foster, promote and encourage the development of research, student programs, publications, professional activities, and joint efforts and (2) to act as a communication channel for national societies within Latin American region and to improve communication between societies, laboratories, hospitals, industries, universities, and other groups in Latin America and the Caribbean. Since its inception, CORAL has already provided the centerpiece for bioengineering activities in Latin America through special concerted scientific meetings and closer society interactions both in a national and international sense. For more information, contact the Secretary General, CORAL, Centro Investigacion y de Estudios, Avanzados Duel Ipn, Departamento Ingenieria Electrica, Seccion Bioelectronica, Av. Instituto Politecnico Nacional 2508, Esg. Av. Ticoman 07000, Mexico Apartado Postal 14-740, Mexico.

A.2 Summary

The field of biomedical engineering, which originated as a professional group on medical electronics in the late fifties, has grown from a few scattered individuals to very well-established organization. There are approximately 50 national societies throughout the world serving an increasingly growing community of biomedical engineers. The scope of biomedical engineering today is enormously diverse. Over the years, many new disciplines such as molecular biology, genetic engineering, computer-aided drug design, nanotechnology, and so on, which were once considered alien to the field, are now new challenges a biomedical engineer faces. Professional societies play a major role in bringing together members of this diverse community in pursuit of technology applications for improving the health and quality of life of human beings. Intersocietal cooperations and collaborations, both at national and international levels, are more actively fostered today through professional organizations such as the IFMBE, AIMBE, CORAL, and the IEEE. These developments are strategic to the advancement of the professional status of bio­medical engineers. Some of the self-imposed mandates the professional societies should continue to pursue include promoting public awareness, addressing public policy issues that impact research and development of biologic and medical products, establishing close liaisons with developing countries, encouraging educational programs for developing scientific and technical expertise in medical and biologic engineering, providing a management paradigm that ensures efficiency and economy of health care technology [Wald, 1993], and participating in the development of new job opportunities for bio­medical engineers.

References

Fard TB. 1994. International Council of Scientific Unions Year Book, Paris, ICSU.

Friedson E. 1971. Profession of Medicine. New York, Dodd, Mead.

Galletti PM, Nerem RM. 1994. The Role of Bioengineering in Biotechnology. AIMBE Third Annual Event. Goodman G. 1989. The profession of clinical engineering. J Clin Eng 14:27.

Parsons T. 1954. Essays in Sociological Theories. Glencoe, Ill, Free Press.

Robinson CR. 1991. Presidents column. IEEE Eng Med Bio Mag.

Wald A. 1993. Health care: Reform and technology (editors note). IEEE Eng Med Bio Mag 12:3.

The primary purpose of the respiratory system is gas exchange. In the gas-exchange process, gas must diffuse through the alveolar space, across tissue, and through plasma into the red blood cell, where it finally chemically joins to hemoglobin. A similar process occurs for carbon dioxide elimination.

As long as intermolecular interactions are small, most gases of physiologic significance can be consid­ered to obey the ideal gas law:

PV □ nRT

Where p = pressure, N/m2

Control of respiration occurs in many different cerebral structures [Johnson, 1991] and regulates many things [Hornbein, 1981]. Respiration must be controlled to produce the respiratory rhythm, ensure adequate gas exchange, protect against inhalation of poisonous substances, assist in maintenance of body pH, remove irritations, and minimize energy cost. Respiratory control is more complex than cardiac control for at least three reasons:

1. Airways airflow occurs in both directions.

3. Parts of the respiratory system are used for other functions, such as swallowing and speaking.

As a result, respiratory muscular action must be exquisitely coordinated; it must be prepared to protect itself against environmental onslaught, and breathing must be temporarily suspended on demand.

The purpose of a pulmonary function laboratory is to obtain clinically useful data from patients with respiratory dysfunction. The pulmonary function tests (PFTs) within this laboratory fulfill a variety of functions. They permit (1) quantification of a patient’s breathing deficiency, (2) diagnosis of different types of pulmonary diseases, (3) evaluation of a patient’s response to therapy, and (4) preoperative screening to determine whether the presence of lung disease increases the risk of surgery.

One of the most common problems in bioelectric theory is the calculation of the potential distribution,

O (V), throughout a volume conductor. The calculation of O is important in impedance imaging, cardiac pacing and defibrillation, electrocardiogram and electroencephalogram analysis, and functional electrical stimulation. In bioelectric problems, O often changes slowly enough so that we can assume it to be quasistatic [Plonsey, 1969]; that is, we ignore capacitive and inductive effects and the finite speed of electromagnetic radiation. (For bioelectric phenomena, this approximation is usually valid for frequencies roughly below 100 kHz.) Under the quasistatic approximation, the continuity equation states that the divergence, V% of the current density, J (A/m2), is equal to the applied or endogenous source of electrical current, S (A/m3):

V • J = S. (10.1)

In regions where there are no such sources, S is zero. In these cases, the divergenceless of J is equivalent to the law of conservation of current that is often invoked when analyzing electrical circuits. Another fundamental property of a volume conductor is that the current density and the electric field, E (V/m), are related linearly by Ohm’s Law,

J = g E, (10.2)

Where g is the electrical conductivity (S/m). Finally, the relationship between the electric field and the gradient, V, of the potential is

E = – V O. (10.3)

The purpose of this chapter is to characterize the electrical conductivity. This task is not easy, because g is generally a macroscopic parameter (an “effective conductivity”) that represents the electrical prop­erties of the tissue averaged in space over many cells. The effective conductivity can be anisotropic, complex (containing real and imaginary parts), and can depend on both the temporal and spatial frequencies.

I □ ^LA □ Vra

II □ VLL – VRA

HI □ VLL – VLA

Where RA = right arm, LA = left arm, and LL = left leg. Because the body is assumed to be purely resistive at ECG frequencies, the four limbs can be thought of as wires attached to the torso. Hence lead I could be recorded from the respective shoulders without a loss of cardiac information. Note that these are not independent, and the following relationship holds: II = I + III.

The evolution of the ECG proceeded for 30 years when F. N. Wilson added concepts of a “unipolar” recording [3]. He created a reference point by tying the three limbs together and averaging their potentials so that individual recording sites on the limbs or chest surface would be differentially recorded with the same reference point. Wilson extended the biophysical models to include the concept of the cardiac source enclosed within the volume conductor of the body. He erroneously thought that the central terminal was a true zero potential. However, from the mid-1930s until today, the 12 leads composed of the 3 limb

Observe that the Reuss laminate is identical to the Voigt laminate, except for a rotation with respect to the direction of load. Therefore, the stiffness of the laminate is anisotropic, that is, dependent on direction [Agarwal and Broutman, 1980; Nye, 1976; Lekhnitskii, 1963]. Anisotropy is characteristic of composite materials. The relationship between stress aij and strain ekl in anisotropic materials is given by the tensorial form of Hooke’s law as follows:

3 3

^□□□CkA. (40.3)

K=1 l =1

Here is the elastic modulus tensor. It has 34 = 81 elements, however since the stress and strain are represented by symmetric matrices with six independent elements each, the number of independent modulus tensor elements is reduced to 36. An additional reduction to 21 is achieved by considering elastic materials for which a strain energy function exists. Physically, C2323 represents a shear modulus

The Fick method employs oxygen as the indicator and the increase in oxygen content of venous blood as it passes through the lungs, along with the respiratory oxygen uptake, as the quantities that are needed to determine cardiac output, CO = O2 uptake/A – VO2 difference). Oxygen uptake (mL/min) is measured at the airway, usually with an oxygen-filled spirometer containing a CO2 absorber. The A – VO2 difference is determined from the oxygen content (mL/100 mL blood) from any arterial sample and the oxygen content (mL/100 mL) of pulmonary arterial blood. The oxygen content of blood used to be difficult to measure. However, the new blood-gas analyzers that measure, pH, pO2, pCO2, hematocrit, and hemo­globin provide a value for O2 content by computation using the oxygen-dissociation curve.

There is a slight technicality involved in determining the oxygen uptake because oxygen is consumed at body temperature but measured at room temperature in the spirometer. Consequently, the volume of

H = height in inches, A = age in years, L = liters, L/min = liters per minute,

SEE = standard error of estimate, SD = standard deviation *Kory, Callahan, Boren, Syner. 1961. Am J Med 30:243.

*Leiner, Abramowitz, Small, Stenby, Lewis. 1963. Amer Rev Resp Dis 88:644.

Although vaccinology and manufacturing methods have come a considerable distance over the past

40 years, much more development will occur. There will be challenges for biotechnologists to arrive at safer, more effective vaccines for an ever-increasing number of antigen targets. If government interference

114 Fluid Shear Stress Effects on Cellular Function Charles W. Patrick, Jr., Rangarajan Sampath, Larry V. McIntire

Devices and Methodology Used for in Vitro Experiments • Shear Stress-Mediated Cell – Endothelium Interactions • Shear Stress Effects on Cell Morphology and Cytoskeletal Rearrangement • Shear Stress Effects on Signal Transduction and Mass Transfer • Shear Stress Effects on Endothelial Cell Metabolite Secretion • Shear Stress Effects on Gene Regulation • Mechanisms of Shear Stress-Induced Gene Regulation • Gene Therapy and Tissue Engineering in Vascular Biology • Conclusions

In the natural lungs, the factors underlying exchange across the alveolo-capillary barrier and transport by the blood can be grouped into four classes:

1. The ventilation of the lungs (the volume flow rate of gas) and the composition of the gas mixture to which mixed venous (pulmonary artery) blood will be exposed

3. The pattern of pressure and flow through the airways and through the pulmonary vascular bed and the distribution of inspired air and circulating blood among the various zones of the exchange system

4. The gas carrying capacity of the blood as regards oxygen and carbon dioxide (and secondarily nitrogen and anesthetic gases)

In an artificial lung, replacing the gas transfer function of the natural organ implies that blood circulation can be sustained by mechanical pumps for extended periods of time to achieve a continuous, rather than a batch process, and that venous blood can be arterialized in that device by exposure to a gas mixture of appropriate composition. The external gas supply to an artificial lung does not pose particular problems, since pressurized gas mixtures are readily available. Similarly the components of blood which provide its gas-carrying capacity are well identified and can be adapted to the task at hand. In clinical practice, it is important to minimize the amount of donor blood needed to fill the extracor – poreal circuit, or priming volume. Therefore a heart-lung machine is generally filled with an electrolyte or plasma expander solution (with or without donor blood), resulting in hemodilution upon mixing of the contents of the extracorporeal and intracorporeal blood circuits. The critical aspects for the operation of an artificial lung are blood distribution to the exchanger, diffusion resistances in the blood mass transfer boundary layer, and stability of the gas exchange process.

Artificial lungs are expected to perform within acceptable limits of safety and effectiveness. The most common clinical situation in which an artificial lung is needed is typically of short duration, with resting or basal metabolism in anesthetized patients. Table 129.3 compares the structures and operating condi­tions of the natural lung and standard hollow fiber artificial membrane lungs with internal blood flow.

An artificial lung designed to replace the gas exchange function of the natural organ during cardiac surgery must meet specifications which are far less demanding than the range of capability of the mammalian lung would suggest. Nonetheless, these specifications must embrace a range of performance to cover all metabolic situations which a patient undergoing cardiopulmonary bypass might present. These conditions range in terms of metabolic rate from the slightly depressed resting metabolism char­acteristic of an anesthetized patient, lightly clad in a cool operating room, to moderate (25-28°C) and occasionally deep (below 20°C) hypothermia. Hypothermia and high blood flow are occasionally encoun­tered in patients with septic shock. In terms of body mass, patients range from 2-5-lb newborn with congenital cardiac malformations to the 250-lb obese, diabetic elderly patient suffering from coronary artery disease and scheduled for aortocoronary bypass surgery.

Whereas it is appropriate to match in advance the size and therefore the transfer capability of the gas exchange unit in the heart-lung machine to the size of the patient (largely out of concern for the volume of fluid needed to fill or “prime” the extracorporeal circuit), each gas exchange unit, once in use, must be capable of covering the patient’s requirement under any circumstances. This is the responsibility of the perfusionist, who controls the system in the light of what is happening to the patient in the operative field. In fact, the perfusionist substitutes his or her own judgment for the natural feedback mechanisms which normally control ventilation and circulation to the natural lungs. The following analysis indicates

‘The Advanced Research Projects Agency of the U. S. Department of Defense, chair of the Defense Technology Conversion Council which administers the Technology Reinvestment Project.

[2]Galen, in turn, based many of his beliefs on those of the hippocratic era scholars—Hippocrates, Aristotle, Polybus, and Diocles (4th century bc).

Regulation of Medical Device Innovation


Introduction

Joseph D. Bronzino

Trinity College/Biomedical Engineering Alliance for Connecticut (BEACON)

подпись: joseph d. bronzino
trinity college/biomedical engineering alliance for connecticut (beacon)
Ethical Issues in Feasibility Studies

Ethical Issues in Emergency Use

Ethical Issues in Treatment Use

The Safe Medical Devices Act

Introduction

Responsibility for regulating medical devices falls to the Food and Drug Administration (FDA) under the Medical Device Amendment of 1976. This statute requires approval from the FDA before new devices are marketed and imposes requirements for the clinical investigation of new medical devices on human subjects. Although the statute makes interstate commerce of an unapproved new medical device generally unlawful, it provides an exception to allow interstate distribution of unapproved devices in order to conduct clinical research on human subjects. This investigational device exemption (IDE) can be obtained by submitting to the FDA “a protocol for the proposed clinical testing of the device, reports of prior investigations of the device, certification that the study has been approved by a local institutional review board, and an assurance that informed consent will be obtained from each human subject” (Bronzino et al., 1990a, b).

With respect to clinical research on humans, the FDA distinguishes devices into two categories: devices that pose significant risk and those that involve insignificant risk. Examples of the former included orthopedic implants, artificial hearts, and infusion pumps. Examples of the latter include various dental devices and daily-wear contact lenses. Clinical research involving a significant risk device cannot begin until an institutional review board (IRB) has approved both the protocol and the informed consent form and the FDA itself has given permission. This requirement to submit an IDE application to the FDA is waived in the case of clinical research where the risk posed is insignificant. In this case, the FDA requires only that approval from an IRB be obtained certifying that the device in question poses only insignificant risk. In deciding whether to approve a proposed clinical investigation of a new device, the IRB and the FDA must determine the following (Bronzino et al., 1990a, b):

Risks to subjects are minimized.

Risks to subjects are reasonable in relation to the anticipated benefit and knowledge to be gained.

Subject selection is equitable.

Informed consent materials and procedures are adequate.

Provisions for monitoring the study and protecting patient information are acceptable.

The FDA allows unapproved medical devices to be used without an IDE in three types of situations: emergency use, treatment use, and feasibility studies.

Ethical Issues in Feasibility Studies

Manufacturers seeking more flexibility in conducting investigations in the early developmental stages of a device have submitted a petition to the FDA, requesting that certain limited investigations of significant risk devices be subject to abbreviated IDE requirements (Bronzino et al., 1990a, b). In a feasibility study, or “limited investigation,” human research on a new device would take place at a single institution and involve no more than ten human subjects. The sponsor of a limited investigation would be required to submit to the FDA a “Notice of Limited Investigation" which would include a description of the device, a summary of the purpose of the investigation, the protocol, a sample of the informed consent form, and a certification of approval by the responsible IRB. In certain circumstances, the FDA could require additional information, or require the submission of a full IDE application, or suspend the investigation (Bronzino et al., 1990a, b).

Investigations of this kind would be limited to certain circumstances: (1) investigations of new uses of existing devices, (2) investigations involving temporary or permanent implants during the early developmen­tal stages, and (3) investigations involving modification of an existing device (Bronzino et al., 1990a).

To comprehend adequately the ethical issues posed by clinical use of unapproved medical devices outside the context of an IDE, it is necessary to utilize the distinctions between practice, nonvalidated practice, and research elaborated in the previous pages. How do those definitions apply to feasibility studies?

Clearly, the goal of this sort of study, i. e., generalizable knowledge, makes it an issue of research rather than practice. Manufacturers seek to determine the performance of a device with respect to a particular patient population in an effort to gain information about its efficacy and safety. Such information would be important in determining whether further studies (animal or human) need to be conducted, whether the device needs modification before further use, and the like. The main difference between use of an unapproved device in a feasibility study and use under the terms of an IDE is that the former would be subject to significantly less intensive FDA review than the latter. This, in turn, means that the responsibility for ensuring that use of the device is ethically sound would fall primarily to the IRB of the institution conducting the study.

The ethical concerns posed here are best comprehended with a clear understanding of what justifies research. Ultimately, no matter how much basic research and animal experimentation has been conducted on a given device, the risks and benefits it poses for humans cannot be adequately determined until it is actually used on humans.

The benefits of research on humans lie primarily in the knowledge that is yielded and the generalizable information that is provided. This information is crucial to medical science’s ability to generate new modes and instrumentalities of medical treatment that are both efficacious and safe. Accordingly, for necessary but insufficient condition for experimentation to be ethically sound, it must be scientifically sound (Capron, 1978; 1986).

Although scientific soundness is a necessary condition of ethically acceptable research on humans, it is not of and by itself sufficient. Indeed, it is widely recognized that the primary ethical concern posed by such investigation is the use of one person by another to gather knowledge or other benefits where these benefits may only partly or not at all accrue to the first person. In other words, the human subjects of such research are at risk of being mere research resources, as having value only for the ends of the research. Research upon human beings runs the risk of failing to respect them as people. The notion that human beings are not mere things but entities whose value is inherent rather than wholly instrumental is one of the most widely held norms of contemporary Western society. That is, human beings are not valuable wholly or solely for the uses to which they can be put. They are valuable simply by being the kinds of entities they are. To treat them as such is to respect them as people.

Respecting individuals as people is generally agreed to entail two requirements in the context of biomedical experimentation. First, since what is most generally taken to make human beings people is their autonomy—their ability to make rational choices for themselves—treating individuals as people means respecting that autonomy. This requirement is met by ensuring that no competent person is subjected to any clinical intervention without first giving voluntary and informed consent. Second, respect for people means that the physician will not subject a human to unnecessary risks and will minimize the risks to patients in required procedures.

Much of the ethical importance of the scrutiny that the FDA imposes upon use of unapproved medical devices in the context of an IDE derives from these two conditions of ethically sound research. The central ethical concern posed by use of medical devices in a feasibility study is that the decreased degree of FDA scrutiny will increase the likelihood that either or both of these conditions will not be met. This possibility may be especially great because many manufacturers of medical devices are, after all, commercial enter­prises, companies that are motivated to generate profit and thus to get their devices to market as soon as possible with as little delay and cost as possible. These self-interested motives are likely, at times, to conflict with the requirements of ethically sound research and thus to induce manufacturers to fail (often unwittingly) to meet these requirements. Note that profit is not the only motive that might induce manufacturers to contravene the requirements of ethically sound research on humans. A manufacturer may sincerely believe that its product offers great benefit to many people or to a population of especially needy people and so from this utterly altruistic motive may be prompted to take shortcuts that compro­mise the quality of the research. Whether the consequences being sought by the research are desired for reasons of self-interest, altruism, or both, the ethical issue is the same. Research subjects may be placed at risk of being treated as mere objects rather than as people.

What about the circumstances under which feasibility studies would take place? Are these not suffi­ciently different from the “normal” circumstances of research to warrant reduced FDA scrutiny? As noted above, manufacturers seek to be allowed to engage in feasibility studies in order to investigate new uses of existing devices, to investigate temporary or permanent implants during the early developmental stages, and to investigate modifications to an existing device. As also noted above, a feasibility study would take place at only one institution and would involve no more than ten human subjects. Given these circum­stances, is the sort of research that is likely to occur in a feasibility study less likely to be scientifically unsound or to fail to respect people in the way that normal research upon humans does in “normal” circumstances?

Such research would be done on a very small subject pool, and the harm of any ethical lapses would likely affect fewer people than if such lapses occurred under more usual research circumstances. Yet even if the harm done is limited to a failure to respect the ten or fewer subjects in a single feasibility study, the harm would still be ethically wrong. To wrong ten or fewer people is not as bad as to wrong in the same way more than ten people but it is to engage in wrongdoing nonetheless. In either case, individuals are reduced to the status of mere research resources and their dignity as people is not properly respected.

Are ethical lapses more likely to occur in feasibility studies than in studies that take place within the requirements of an IDE? Although nothing in the preceding discussion provides a definitive answer to this question, it is a question to which the FDA should give high priority in deciding whether to allow this type of exception to IDE use of unapproved medical devices. The answer to this question might be quite different when the device at issue is a temporary or permanent implant than when it is an already approved device being put to new uses or modified in some way. Whatever the contemplated use under the feasibility studies mechanism, the FDA would be ethically advised not to allow this kind of exception to IDE use of an unapproved device without a reasonably high level of certainty that research subjects would not be placed in greater jeopardy than in “normal” research circumstances.

Ethical Issues in Emergency Use

What about the mechanism for avoiding the rigors of an IDE for emergency use?

“The FDA has authorized emergency use where an unapproved device offers the only alternative for saving the life of a dying patient, but an IDE has not yet been approved for the device or its use, or an IDE has been approved but the physician who wishes to use the device is not an investigator under the IDE (Bronzino et al., 1990a, b).

Because the purpose of emergency use of an unapproved device is to attempt to save a dying patient’s life under circumstances where no other alternative is at hand, this sort of use constitutes practice rather than research. Its aim is primarily benefit to the patient rather than provision of new and generalizable information. Because this sort of use occurs prior to the completion of clinical investigation of the device, it constitutes a nonvalidated practice. What does this mean?

First, it means that while the aim of the use is to save the life of the patient, the nature and likelihood of the potential benefits and risks engendered by use of the device are far more speculative than in the sort of clinical intervention that constitutes validated practice. In validated practice, thorough investiga­tion, including preclinical studies, animals studies, and studies on human subjects of a device has established its efficacy and safety. The clinician thus has a well-founded basis upon which to judge the benefits and risks such an intervention poses for his patients.

It is precisely this basis that is lacking in the case of a nonvalidated practice. Does this mean that emergency use of an unapproved device should be regarded as immoral? This conclusion would follow only if there were no basis upon which to make an assessment of the risks and benefits of the use of the device. The FDA requires that a physician who engages in emergency use of an unapproved device must “have substantial reason to believe that benefits will exist. This means that there should be a body of pre – clinical and animal tests allowing a prediction of the benefit to a human patient” (Bronzino et al., 1990a, b).

Thus, although the benefits and risks posed by use of the device are highly speculative, they are not entirely speculative. Although the only way to validate a new technology is to engage in research on humans at some point, not all nonvalidated technologies are equal. Some will be largely uninvestigated, and assessment of their risks and benefits will be wholly or almost wholly speculative. Others will at least have the support of preclinical and animal tests. Although this is not sufficient support for incorporating use of a device into regular clinical practice, it may however represent sufficient support to justify use in the desperate circumstances at issue in emergency situations. Desperate circumstances can justify des­perate actions, but desperate actions are not the same as reckless actions, hence the ethical soundness of the FDA’s requirement that emergency use be supported by solid results from preclinical and animal tests of the unapproved device.

A second requirement that the FDA imposes on emergency use of unapproved devices is the expectation that physicians “exercise reasonable foresight with respect to potential emergencies and make appropriate arrangements under the IDE procedures. Thus, a physician should not “create” an emergency in order to circumvent IRB review and avoid requesting the sponsor’s authorization of the unapproved use of a device” (Bronzino et al., 1990a, b).

From a Kantian point of view, which is concerned with protecting the dignity of people, it is a particularly important requirement to create an emergency in order to avoid FDA regulations which prevent the patient being treated as a mere resource whose value is reducible to a service of the clinician’s goals. Hence, the FDA is quite correct to insist that emergencies are circumstances that reasonable foresight would not anticipate.

Also especially important here is the nature of the patient’s consent. Individuals facing death are especially vulnerable to exploitation and deserve greater measures for their protection than might oth­erwise be necessary. One such measure would be to ensure that the patient, or his legitimate proxy, knows the highly speculative nature of the intervention being offered. That is, to ensure that it is clearly understood that the clinician’s estimation of the intervention’s risks and benefits is far less solidly grounded than in the case of validated practices. The patient’s consent must be based upon an awareness that the particular device has not undergone complete and rigorous testing on humans and that estima­tions of its potential are based wholly upon preclinical and animal studies. Above all the patient must not be lead to believe that there is complete understanding of the risks and benefits of the intervention. Another important point here is to ensure that the patient is aware that the options he is facing are not simply life or death but may include life of a severely impaired quality, and therefore that even if his life is saved, it may be a life of significant impairment. Although desperate circumstance may legitimize desperate actions, the decision to take such actions must rest upon the informed and voluntary consent of the patient, especially when he/she is an especially vulnerable patient.

It is important here for a clinician involved in emergency use of an unapproved device to recognize that these activities constitute a form of nonvalidated practice and not research. Hence, the primary obligation is to the well-being of the patient. The patient enters into the relationship with the clinician with the same trust that accompanies any normal clinical situation. To treat this sort of intervention as if it were an instance of research and hence justified by its benefits to science and society would be to abuse this trust.

Ethical Issues in Treatment Use

The FDA has adopted regulations authorizing the use of investigational new drugs in certain circumstances where a patient has not responded to approved therapies. This “treatment use” of unapproved new drugs is not limited to life-threatening emergency situations, but rather is also available to treat “serious” diseases or conditions (Bronzino et al., 1990a, b).

The FDA has not approved treatment use of unapproved medical devices, but it is possible that a manufacturer could obtain such approval by establishing a specific protocol for this kind of use within the context of an IDE.

The criteria for treatment use of unapproved medical devices would be similar to criteria for treatment use of investigational drugs: (1) the device is intended to treat a serious or life-threatening disease or condition, (2) there is no comparable or satisfactory alternative product available to treat that condition,

The device is under an IDE, or has received an IDE exemption, or all clinical trials have been completed and the device is awaiting approval, and (4) the sponsor is actively pursuing marketing approval of the investigational device. The treatment use protocol would be submitted as part of the IDE, and would describe the intended use of the device, the rationale for use of the device, the available alternatives and why the investigational product is preferred, the criteria for patient selection, the measures to monitor the use of the device and to minimize risk, and technical information that is relevant to the safety and effectiveness of the device for the intended treatment purpose (Bronzino et al., 1990a, b).

Were the FDA to approve treatment use of unapproved medical devices, what ethical issues would be posed? First, because such use is premised on the failure of validated interventions to improve the patient’s condition adequately, it is a form of practice rather than research. Second, since the device involved in an instance of treatment use is unapproved, such use would constitute nonvalidated practice. As such, like emergency use, it should be subject to the FDA’s requirement that prior preclinical tests and animal studies have been conducted that provide substantial reason to believe that patient benefit will result. As with emergency use, although this does not prevent assessment of the intervention’s benefits and risks from being highly speculative, it does prevent assessment from being totally speculative. Here too, although desperate circumstances can justify desperate action, they do not justify reckless action. Unlike emergency use, the circumstances of treatment use involve serious impairment of health rather than the threat of premature death. Hence, an issue that must be considered is how serious such impairment must be to justify resorting to an intervention whose risks and benefits have not been solidly established.

In cases of emergency use, the FDA requires that physicians not use this exception to an IDE to avoid requirements that would otherwise be in place. This particular requirement would be obviated in instances of treatment use by the requirement that a protocol for such use be previously addressed within an IDE.

As with emergency use of unapproved devices, the patients involved in treatment use would be particularly vulnerable patients. Although they are not dying, they are facing serious medical conditions and are thereby likely to be less able to avoid exploitation than patients under less desperate circumstances. Consequently, it is especially important that patients be informed of the speculative nature of the intervention and of the possibility that treatment may result in little or no benefit to them.

The Safe Medical Devices Act

On November 28, 1991, the Safe Medical Devices Act of 1990 (Public Law 101-629) went into effect. This regulation requires a wide range of healthcare institutions, including hospitals, ambulatory-surgical facilities, nursing homes, and outpatient treatment facilities, to report information that “reasonably suggests” the likelihood that the death, serious injury, or serious illness of a patient at that facility has been caused or contributed to by a medical device. When a death is device-related, a report must be made directly to the FDA and to the manufacturer of the device. When a serious illness or injury is device-related, a report must be made to the manufacturer or to the FDA in cases where the manufacturer is not known. In addition, summaries of previously submitted reports must be submitted to the FDA on a semiannual basis. Prior to this regulation, such reporting was voluntary. This new regulation was designed to enhance the FDA’s ability to quickly learn about problems related to medical devices. It also supplements the medical device reporting (MDR) regulations promulgated in 1984. MDR regulations require that reports of device-related deaths and serious injuries be submitted to the FDA by manufac­turers and importers. The new law extends this requirement to users of medical devices along with manufacturers and importers. This act represents a significant step forward in protecting patients exposed to medical devices.

References

Bronzino, J. D., Flannery, E. J., and Wade, M. L. “Legal and Ethical Issues in the Regulation and Devel­opment of Engineering Achievements in Medical Technology,” Part I IEEE Engineering in Medicine and Biology, 1990a.

Bronzino, J. D., Flannery, E. J., and Wade, M. L. “Legal and Ethical Issues in the Regulation and Devel­opment of Engineering Achievements in Medical Technology,” Part II IEEE Engineering in Medicine and Biology, 1990b.

Bronzino, J. D., Chapter 10 “Medical and Ethical Issues in Clinical Engineering Practice” In: Management of Medical Technology. Butterworth, 1992.

Bronzino, J. D., Chapter 20 “Moral and Ethical Issues Associated with Medical Technology” in: Instruction to Biomedical Engineering. Academic Press, 1999.

Capron, A. “Human Experimentation: Basic Issues.” In: The Encyclopedia of Bioethics vol. II. The Free Press, Glencoe, IL, 1978.

Capron, A. “Human Experimentation.” In: (J. F. Childress, et al., eds.) University Publications of America, 1986.

Further Information

Daniels, N. Just Health Care. Cambridge University Press, Cambridge, 1987.

Dubler, N. N. and Nimmons, D. Ethics on Call. Harmony Books, New York, 1992.

Jonsen, A. R. The New Medicine and the Old Ethics. Harvard University Press, Cambridge, MA, 1990. Murphy, J. and Coleman, J. The Philosophy of Law. Rowman and Allenheld, 1984.

Laxminarayan, S., Bronzino, J. D., Beneken, J. E. W., Usai, S., Jones, R. D.

"Swamy Laxminarayan, Joseph D. Bronzino, Jan E. W. Beneken, Shiro Usai, Richard D. Jones" The Biomedical Engineering Handbook: Second Edition.

Ed. Joseph D. Bronzino

Boca Raton: CRC Press LLC, 2000

Ethical Issues of Animal and Human Experimentation in the Development of Medical Devices


191.1

191.2

191.3

подпись: 191.1
191.2
191.3

Subrata Saha

Clemson University

Pamela S. Saha

Clemson University

Introduction Clinical Trials

The Reason for Clinical Trials • Dilemmas Presented by Clinical Trials • The Need for Double-Blind Trials Animal Experimentation Animal Testing • The Need for Animal Research • Regulations/Guidelines Related to Animal Research • The Public Debate

Introduction

The number and sophistication of new medical devices is transforming modern medicine at a rate never experienced before. These developments have saved the lives of many more patients and improved their quality of life drastically. Artificial joint replacements alone have transformed the field of orthopaedic surgery, and over 250,000 total hip and total knees are implanted annually in the United States. Ventricular assistive devices (VASs) have extended lives by years, lives that before would have certainly ended at the point the device would have been needed. An estimated two to three million artificial or prosthetic parts, manufactured by hundreds of different companies, are implanted in America each year. The massive production of such devices is not only big science but big business.

New medical devices, however, require thorough testing for safety and efficacy as well as submission for approval by the federal Food and Drug Administration (FDA) before being put on the market for public use. Testing of a new product takes considerable time and expense and is not without problems beyond those of a technical nature. This paper considers the ethical questions that arise when the demands of science, economics, and progress are not entirely compatible with issues raised about the rights and obligations toward human beings and animals.

One of the first levels of testing where ethical debate is more prominent is at the stage when the biomedical scientist is faced with the need to use animal subjects.1 Over the last 30 years there has been a growing debate over whether or not the use of experimental animals is even appropriate. Some animal rights activists have made violent protests and vandalized research facilities where animal experimentation takes place. Increased public sensitivity did help promote an effort by the government, as well as the
Scientific community, to regulate the use of animal subjects and to educate the public as to the importance of such research to the health and well being of both animals and humans. As a result efforts to promote the humane use of experimental animals that are used to advance knowledge of biomedical sciences are to be supported.

Inevitably human beings are involved during the final stages of testing medical devices or systems. While this imposes numerous ethical concerns and has stirred much discussion, clinical trials are nec­essary as the alternative would mean an end of learning anything new for the betterment of medical science and continued use of unsupported practices based on conjecture.2

Consequently, engineers involved with the development and design of medical technology need to become familiar with various aspects of clinical trials and animal research as well as the ethical issues that they raise. Normally, conduction of human experimentation is not a part of the training of an engineer,3 nor are complications presented by ethical concerns a traditional part of engineering educa­tion.4 In this chapter various ethical concerns are examined that are essential elements in the animal testing and the clinical trial of any new treatment modality.

Clinical Trials

The Reason for Clinical Trials

Clinical trials are designed to ascertain the effectiveness and safety of a new medical device as compared with established medical practice. This form of rigorous scientific investigation in a controlled environ­ment for the assessment of new treatment modalities is superior to the is forum of private opinion and individual chance taking. Holding the practice of medicine at the status quo and discontinuing all innovative work would be the only way to prevent exposing patients to some unforeseen risks in new treatments that come with the promise of improved care. Yet, even this does not protect patients from uncontrolled experimentation as conditions change even if the practice of medicine stands still. The changing effectiveness of antibiotics as well as the increase in antibiotic resistant strains through unin­formed overuse of such drugs is a perfect example of how even standard care held stationary can lead to a decline rather than just a status quo in level of medical care. If we wish to continue to seek out new ways to conquer disease or even maintain a current level of care, then we are essentially forced to decide on a manner in which human beings are to shoulder the risks involved.

Total Mastectomies for Stage I and II breast tumors and extracranial-intracranial anastomosis for internal carotid atherosclerosis were once routinely practiced. However, randomized trials have brought the necessity of these surgical procedures under closer scrutiny. Certain procedures which are continually used, such as the now twenty-year-old use of obstetric ultrasonography, are losing support in the battle to cut medical costs as these do not have the benefit of randomized clinical trials to prove their value. Answers are needed to questions concerning health and economic risks and benefits, and the burden of false positive and negative results, especially in this time of multiple options in a profit-driven atmosphere, along with dwindling resources and government aid to the sick, old, and poor.5

A clinical trial is the most reasonable means to test a device as well as control risks and prevent abuse of human subjects because of the following six major factors: (1) A limited number of closely monitored subjects in a controlled environment are in a safer situation than are the same subjects unobserved in relation to one another within the larger population, where the same kinds of risks are imposed by uncertainty about the efficacy of new devices. (2) Clinical trials give conclusive answers to important medical inquiries that otherwise could only be answered by guessing. Medical decisions based on proven results are certainly superior to those dependent on untested clinical opinion. One author has stated that “trials were introduced because personal opinion was so notoriously fragile, biased, and unreliable.” 6 Risks would indeed be greater and potential for harm magnified if doctors are made to make decisions in an environment of general uncertainty and when medical products available are unsupervised by review boards. In an uncontrolled situation, the individual practitioner can be influenced by motives of economic profit, the need to appear knowledgeable and abreast of the new, or by high-pressure sales­manship. In the zeal to argue for individual rights in clinical trials, worry should be placed on how those same rights are threatened in an environment without objective controls. (3) A society that restricts and oversees the advancement of medicine through regulated human experimentation will prevent the sub­jection of people to needless risks brought on by a plurality of devices that may cause harm and offer only a maintenance of the status quo as a benefit. There are a plentitude of types of redundant consumer goods on the market today, e. g., soft drinks that offer multiple ways to relieve one condition—thirst. However, in medicine the concerns are different. The onslaught of numerous types of drugs to relieve nausea during pregnancy should be limited to the testing of a few medicines that offer the greatest benefit. Control of the market place in medicine through government or private testing of the few most promising forms of treatment is a much safer environment than an extensive supermarket full of many possibilities and many potential risks. (4) Clinical trials advance expedient corroboration of medical theories so that research can be channeled in directions that show meaningful results. Promising research is rapidly pinpointed, and harmful products are removed from the hiding place of private opinion and promotional tactics. (5) Clinical trials are the answer to the moral imperative to thoroughly test all new medical devices. Such testing is deficient without a controlled study on human subjects. No researcher can state confidently that a product is safe and effective for human use without such a test. (6) AH clinical trials are evaluated by specialized committees formed for the objective of supervising the ethical conduct of investigators using human beings as subjects. In this manner, individual rights are protected and ethical guidelines effectively imposed in a manner superior to what could be expected in the isolated world of private clinical practice, with its competition for patients and pressures from manufacturers.

Dilemmas Presented by Clinical Trials The Problem of Informed Consent

One of the most controversial issues generated by clinical trials is that of informed consent.7 Informed consent protects certain human rights, such as the patient’s freedom to decide what risks to take with his/her own body, the right to the truth from the doctor in the doctor-patient relationship, and a just distribution of goods in accordance with a standard of equity and access to redress for undeserved harm. These values cannot be sacrificed for any sort of anticipated benefit from research. “The loss of such values is so harmful that benefits become meaningless.”8

Clinical Trials and the Doctor-Patient Relationship

Another issue currently debated is the conflict of clinical trials with the therapeutic obligation. Some authors argue that we must face the fact that if we are to expand the knowledge needed for obtaining high-quality treatment, we must sacrifice our therapeutic obligation. There are others who take a more apprehensive view of clinical trials, stating that trials on healthy subjects are condemned by the Nurem – burg Code, the Tokyo Declaration, and the Helsinki Declaration of the World Medical Association.9

However, outright condemnation of experimentation on healthy human subjects ignores the vital need for progress in preventive as well as remedial medical treatment. For example, the development and use of vaccines carry minimal but real risks to their recipients. Yet few dispute that vaccine research using human subjects is morally justified and may even be compulsory, despite the reality that persons can and do die from experimental as well as FDA approved vaccines. The control of crippling and deadly diseases, and their eventual elimination (i. e., small pox), is due to the study and implementation of vaccines. Those who support clinical trials say that a validated medical practice is a far better alternative for both the individual and society as a whole than subjection to treatments whose effectiveness are not validated by controlled trials.

One article offers several ideas for the elicitation of informed consent and assignment to randomized groups. The best model suggested for general use begins with selection of eligible patients, who are pre­randomized and given the entire protocol with an explanation of benefits and risks of all the options; consent is then sought, the patient knowing his or her group assignment.10

Proposed deviations from the above standard could be defended before review boards; for example, investigations that would be impeded by the patient knowing his or her group’s assignment but that promise the patient major benefits. However, the patient should be informed of any such stipulations and of the relative risks and benefits.

Standards of research require further consideration as a consensus needs to be achieved. For example, in order to test the effectiveness of transplanted embryonic pig cells into the brain for the treatment of Parkinson’s disease, a control group is required in which surgical boring of a hole into the skull occurs without the addition of any cells. This is to remove any placebo effect or any other unforeseeable effect of a mock surgical procedure on Parkinson’s disease. However, the question of simply boring a hole does subject a human being to a procedure with significant risk with little bases for suspecting a beneficial outcome. The design of scientific studies needs to weigh the risks to the human subjects against the need for scientific purity. Such opinions have been voiced by Arthur Caplan, director of the University of Pennsylvania’s Center for Biomedical Ethics who recently told the Boston Herald that, “striving for scientific accuracy is a commendable goal, but asking someone to have a hole drilled in their head for no purpose is putting science ahead of the subject’s interest.”

There has been much effort particularly in recent years toward the protection of individual rights. This is not surprising in this age of rising autonomy and declining paternalism. This concern has led to the consideration of whether or not treatment should be changed mid-course in an experiment due to the “appearance” of a tendency toward one result as opposed to another. At some point in collecting data, the experimenter may begin to surmise a particular outcome or even come to expect it (although he/she may not be certain). In these circumstances, the question arises as to whether the individual subject should be granted the hypothetical benefit of the “good guess,” or should the guess be treated as merely a guess and, hence, a gamble. To do so would mean that the best treatment for the individual might not be one that has been proven valid. In fact, such a choice implies that the best treatment is a perpetual gamble. Nonetheless, treatment methods that maximize the good guess have been presented.11

Another issue that has surfaced from the debate on informed consent is the idea of the “therapeutic misconception,” which refers to an unyielding expectation of personalized care on the part of patients during a clinical trial. This finding shows a need for better communication between the patient and the doctor. However, such “false expectations” could be due to a fundamental trust on the patient’s part believing that through cooperation with the physician in research, personal health needs will eventually be met according to the best available data at any given time. Perhaps, this notion should be addressed during a clinical trial.12

A local newspaper reported that some companies are enticing private physicians to register patients for their studies that have significant fees. What used to be the domain of academic researchers motivated by the drive for new discoveries, fame, and career advancement is now a multibillion dollar industry with numerous companies working with thousands of doctors in private practice having a profound impact on the doctor-patient relationship. Often the patient is unaware that significant amounts of money are involved in their recruitment for a study.13 In addition to the expected problems of human research that have been debated in the past, the influence of a growing industry invites the need for continued inspection and control not only for the prevention of abuse of human subjects but for even the possible effect such methods of recruiting could have on scientific integrity.

The Need for Double-Blind Trials

The double-blind study has magnified the issues concerning clinical trials already mentioned. Obviously, this type of trial means that both the physicians and the patients involved will not be given full information about the experiment. The double-blind study is the best safeguard against biased results. Indeed, the purpose of the double-blind trial is to bring about a treatment plan based on objective fact rather than on biased personal belief or guess work. Even well intentioned and honest researchers can fall victim to seeing their data too subjectively. For instance, an investigator may have a vested interest in the study because of personal prestige, financial gain, or merely normal enthusiasm and faith in his own work.14 These represent obstacles to objective results in research that are not blind. The originator and/or sponsor Of a project may suffer from a conflict of interest when either becomes directly involved in a study. The double-blind approach protects against such conflict. Although some investigators have argued that it is unethical for them to deprive control subjects of their product because they believe so strongly in its efficacy, personal conviction of the usefulness of one’s own work is not a good ethical reason for failing to thoroughly test a new device for safety and effectiveness. The moral imperative to thoroughly test is a basic concept to be followed to achieve a standing of good biomedical engineering.15

The biomedical engineer must face the current debate over the use of medical technology in accordance with the ethical, professional, and scientific imperative to thoroughly test his or her innovation. It is now time for biomedical engineers to stand up and support the sound moral use of clinical trials for the purposes of (1) scientific credibility of the biomedical engineering field, (2) protection of the individual from improper medical care due to unsupervised, unethical market-place forms of human research, and (3) the promotion of medical care based on sound reasoning and scientific fact. These principles are at the heart of the professionalism required of biomedical engineering research.16

Animal Experimentation

Animal Testing

Animal experimentation is an important step in the development of new implants and devices to determine their safety and effectiveness prior to their use in humans. There is no current alternative to the use of animal models to evaluate the biocompatibility of new materials and the response by a host.17 However, animal rights groups have raised important ethical considerations and have challenged the scientific community to justify the use of animals in research. The scientific community should respond and debate these issues. They should help to educate the public and increase understanding of the need for such research. A more proactive approach in this matter is imperative. It is also important that efforts be made by scientists to demonstrate to the public that animal research is done humanely, sparingly, and only when alternatives do not exist.18

The Need for Animal Research

Biomedical engineering has brought remarkable advancement to the field of medicine in a very short time frame. Just in the last quarter of this century we have seen achievements such as (1) pacemakers,

Total joint replacement, (3) artificial hearts, (4) CAT scan machines, and (5) improved surgical techniques made possible through the use of fiber optics, lasers, and ultrasonic devices. Along with these remarkable advances came the need for closer monitoring of the safety and effectiveness of inventions before their release for public use. More regulations, standards, and testing protocols were devised to ensure that each new product is subjected to a uniform system of scrutiny and procedure for approval. As part of that process, the testing of a product in animals is a likely necessary step. For example, NIH Guidelines for the Physicochemical Characterization of Biomaterials outlines a stepwise process for testing blood-contacting devices progressively in animals. A possible hierarchy of testing starting from in vitro to in vivo systems may be as follows:19

Cell culture cytotoxicity (mouse L929 cell line)

Hemolysis (rabbit or human blood)

Mutagenicity [human or other mammalian cells or Ames test (bacterial)]

Systemic injection acute toxicity (mouse)

Sensitization (guinea pig)

Pyrogenicity (limulus amebocyte lysate [LAL] or rabbit)

Intracutaneous irritation (rat, rabbit)

Intramuscular implant (rat, rabbit)

Blood compatibility (rat, dog)

Long-term implant (rat, rabbit, dog, primate)

Animal testing is a necessary means of evaluating a device in the internal environment of the living system. The suggestion that this can be replaced by computer modeling can only be made by one unaware of the lack of knowledge about in vivo conditions.20 The nearly inscrutable chemical pathways, the complex milieu of high chemical, mechanical and electrical activity, and the incalculable number of interactions inside the living organism cannot possibly be modeled theoretically today. Add to this the fact that normal conditions are different from disease states such as thrombosis or inflammation, and we find ourselves still further removed from the prospects of using simulation methods. Yet to thoroughly rule out both long and short-term failure of these products, they must be tested sufficiently to rule out risks of toxicity and even possible carcinogenic effects over many years. In response to questions raised about animal research, the American Association for the Advancement of Science issued a resolution in 1990 that supports the use of animals in research while emphasizing that experimental animals be treated humanely.

Regulations/Guidelines Related to Animal Research

A biomedical engineer must become familiar with regulations with regard to animal research. The National Research Council published a Guide for the Care and Use of Laboratory Animals initially as early as 1963 and most recently in 1996.

In addition to becoming familiar with this Guide, it is important to be aware of all applicable federal, state, and local laws, regulations, and policies such as the Animal Welfare Regulations and the Public Health Service Policy on Humane Care and Use of Laboratory Animals.22

The general objective is to have a cogent reason for conducting a particular experiment. It must be important to the health and well-being of humans or animals.23 It must be demonstrated that alternative means would not achieve the necessary goal. The choice of species must be shown to be essential and that species lower on the evolutionary ladder would not be suitable. An effort must be made to minimize the number of animals required and to prevent unnecessary duplication of tests. Pain and discomfort must be minimized unless important to the conduction of the experiment. Standards must be followed concerning (1) space allotment, (2) type of confinement, (3) availability of food and water, (4) care in transit, and (5) periods of exercise. The experiment must have clear limits and be performed under the close supervision of individuals appropriately trained. Provisions for veterinary care, environmental conditions, and euthanasia must also be made. If palliation of discomfort or pain must be withheld, a detailed explanation must be made available.

In 1985 congress passed The Food Security Act which amended the Animal Welfare Act of 1966. This required that research institutions have a committee of no less than three persons who are qualified to monitor animal care and practices in experimentation.17 These persons are to represent society’s interest in the proper treatment of animal subjects. The committee requires one veterinarian and one other person not connected with the institution. This committee must inspect all animal research and care facilities at the institution twice a year. The institution should in turn keep a report of each inspection on file for 3 years and report any information that notes violation of legal standards on the treatment of animals to federal officials. The committee must review specific areas of treatment of experimental animals, including pain management, veterinary care, and pre – and post-surgical care. A single animal must not be subjected to major survival surgery more than once unless justified scientifically. Dogs must be exercised and envi­ronmental conditions must be conducive to psychological well-being of primates. Note that policies by the National Science Foundation now extend to all vertebrate animals which is broader than the Animal Welfare Act that did not include (1) rats, (2) mice, (3) farm animals, and (4) birds.

The Public Debate

The debate about animal experimentation is marred by extremes on both sides of the issue.24 Scientists have been physically threatened and assaulted and their laboratories vandalized by extremist animal rights groups.25 Unwarranted charges that scientists only conduct animal research for personal gain and that these experiments are cruel and unnecessary demonstrate the extent of misinformation that exists for the public.

The actions of irresponsible activists must not obscure the serious philosophical issues raised by animal rights advocates. Some of them argue that there exists no justification for the claim that animals can be exploited for human benefit. This line of reasoning is that animals have rights equal to that of humans and as animals cannot give informed consent for an experiment they should be precluded from use. This represents a radical change that would have consequences beyond the use of animals in science. When animals are used as beasts of burden for example, should this be considered slavery? What of the use of animals for food, clothing, or even simply in sport. One author noted that a 1990 study showed that although 63% of literature advocating animal rights addresses only their use in research, such use annually is only 0.003% of the number of animals used as food.26 What about protection against pests in the home as well as in agriculture? Even the ownership of pets may be called into question, as a case of imprison­ment. Of all possible targets for basing a case against human exploitation of animals, the use of them in medical experiments is the least worthy. Scientists not only make the least use of animals but do so under strict regulation and with all attempts being made to minimize their use. If we are seriously going to elevate animals to a moral standing equal to human beings, then the research laboratory is not the appropriate place to start. The burden of explaining how all future interaction should take place with the rest of the animal kingdom lies with those who make such a claim.

The other extreme however, is the claim by some scientists that animals have no moral standing or intrinsic value. A report by the National Research Council in 1988 on the Use of Laboratory Animals in Biomedical and Behavioral Research says “Our society does, however, acknowledge that living things have inherent value.”27 This is consistent with society’s tendency to treat animals differently than inanimate objects. Even a mouse merits higher consideration than a stone. That animals have value, moral standing, or even rights is not equivalent to the suggestion that they are equal to human beings in their value, standing, and rights.

Humans are not the only beneficiaries of research on animals. Veterinary medicine would suffer without such research and the care of animals has significantly improved as a result of responsible animal experimentation. Today, human psychoactive drugs are being used for pets with behavioral problems.28

Conclusion

While there is continued consensus within the scientific community on the need for animal research, there is also increased sensitivity and awareness of the need for humane treatment of animals and the intrinsic value and moral standing of non-human animals. This has lead to improved guidelines and regulation on such use as well as much needed discussion on the purpose and ethics of animal research. While the debate will certainly continue, the use of violence, slander, and media sensationalism should be discouraged. This will only lead to further polarization of extreme views. Constructive and responsible discussion will help bring about a consensus on this very important matter that concerns the health and welfare of animals and humans alike.

References

An, Y. H. and Friedman, R. J. Animal Models in Orthopaedic Research, CRC Press, Boca Raton, FL, 1998.

Saha, P. and Saha, S. “Clinical trials of medical devices and implants: Ethical concerns,” IEEE Eng. Med. Y Biol. Mag., 7, 85-87, 1988.

Saha, P. and Saha, S. Ethical responsibilities of the clinical engineer, J. Clin. Eng., 11, 17-25, 1986.

Saha, P. and Saha, S. The need of biomedical ethics training in bioengineering, In Biomedical Engineering I: Recent Developments, S. Saha, Ed., Pergamon Press, New York, 369-373, 1982.

Bracken, M. B. Clinical trials and the acceptance of uncertainty, British Med. J., 294, 1111-1112, London, 1987.

Vere, D. W. Problems in controlled trials: A critical response. J. Med. Ethics, 9(2), 85-89, 1983.

Kaufmann, C. L. Informed consent and patient decision making: Two decades of research, Soc. Sci. Med., 21, 1657-1664, 1983.

Dyck, A. J. and Richardson, H. W. The moral justification for research using human subjects, In Biomedical Ethics and the Law, J. M. Humber and R. F. Almeder, Eds., Plenum Press, New York, 243-259.

Arpzilange, P., Dion, S., Mathe, G. Proposal for ethical standards in therapeutic trials, British Med. J., 291, 887-889, 1985.

Kopelman, L. Randomized clinical trials consent and the therapeutic relationship, Clin. Res., 31(1), 1-11, 1983.

Meler P. Terminating a trial: The ethical problem, Clin. Pharmacol. Therap., 25, 637-640, 1979.

Appelbaum, P., Lidz, C. W., Benson, P., et al. False Hopes and Best Data: Consent to Research and the Therapeutic Misconception, Hastings Center Report, 17(2), 20-24, 1987.

Eichenwald, K. and Kolata, G. Drug trials threaten doctors’ credibility, Anderson Independent Mall, Sunday, May 16, 1999, 13A.

Saha, S. and Saha, P. Bioethics and applied biomaterials, J. Biomed Mat. Res., App. Biomat., 21(A-2), 181-190, 1987.

Saha, S. and Saha, P. Biomedical ethics and the biomedical engineer: A review, Crit. Rev. Biomed. Eng., 25(2), 163-201, 1997.

Mappes, T. A. and Zembaty, J. S. Biomedical Ethics, 2nd ed., McGraw-Hill, New York, 1986.

Saha, P. and Saha, S. Ethical Issues on the Use of Animals in the Testing of Medical Implants, J. Long-Term Effects of Med. Impl., 1(2), 127-134, 1991.

Lukas, V. and Podolsky, M. L. The Care and Feeding of an IACVC, CRC Press, Boca Raton, FL, 1999.

Vale, B. H., Wilson, J. E., and Niemi, S. M. Animal models, In Biomaterials Science, Academic Press, San Diego, CA, 240, 1996.

Malakoff, D. Alternatives to animals urged for producing antibodies, Science, 284, 230, 1999.

National Research Council, Guide for the Care and Use of Laboratory Animals, 2nd ed., 1996.

Rollin, B. E. and Kesel, M. D. The Experimental Animal in Biomedical Research, CRC Press, Boca Raton, FL, 1, 1990.

Saha, S. and Saha, P. Biomedical ethics and the biomedical engineer: A review, Crit. Rev. Biomed. Eng., 25(2), 163-201, 1997.

Saha, S. and Saha, P. Biomedical engineering and animal research, BMES Bulletin, 16(2), 22, 1992.

Kower, J. Activists ransack Minnesota labs, Science, 284:410-411, 1997.

Conn, P. M and Parker, J. Animal Rights: Reaching the Public, Science, 282:1417, 1998.

Herzog, H. A. Jr. Informed Opinions on Animal Use Must Be Pursued, ILAR News, Institute of Laboratory Animal Resources, 31(2), Spring 1989.

Bunk, S. Market Emerges for Use of Human Drugs on Pets, The Scientist, 1 & 10, April 12, 1999.

Bronzino, J. D. “Regulation of Medical, Device Innovation.” The Biomedical Engineering Handbook: Second Edition.

Ed. Joseph D. Bronzino

Boca Raton: CRC Press LLC, 2000

Beneficence, Nonmaleficence, and Technological Progress


190.1

190.2

Joseph D. Bronzino 190.3

Trinity College/Biomedical Engineering Alliance for Connecticut (BEACON)

Introduction

Defining Death: A Moral Dilemma Posed by

Medical Technology

Euthanasia

Active Versus Passive Euthanasia • Involuntary and Non Voluntary Euthanasia • Should Voluntary Euthanasia be Legalized?

Introduction

Two moral norms have remained relatively constant across the various moral codes and oaths that have been formulated for health-care deliverers since the beginnings of Western medicine in classical Greek civilization, namely beneficence—the provision of benefits—and nonmaleficence—the avoidance of doing harm. These norms are traced back to a body of writings from classical antiquity known as the Hippocratic Corpus. Although these writings are associated with the name of Hippocrates, the acknowl­edged founder of Western medicine, medical historians remain uncertain whether any, including the Hippocratic Oath, were actually his work. Although portions of the Corpus are believed to have been authored during the sixth century BC, other portions are believed to have been written as late as the beginning of the Christian Era. Medical historians agree, though, that many of the specific moral directives of the Corpus represent neither the actual practices nor the moral ideals of the majority of physicians of ancient Greece and Rome.

Nonetheless, the general injunction, “As to disease, make a habit of two things—to help or, at least, to do no harm," was accepted as a fundamental medical ethical norm by at least some ancient physicians. With the decline of Hellenistic civilization and the rise of Christianity, beneficence and nonmaleficence became increasingly accepted as the fundamental principles of morally sound medical practice. Although beneficence and nomaleficence were regarded merely as concomitant to the craft of medicine in classical Greece and Rome, the emphasis upon compassion and the brotherhood of humankind, central to Christianity, increasingly made these norms the only acceptable motives for medical practice. Even today the provision of benefits and the avoidance of doing harm are stressed just as much in virtually all contemporary Western codes of conduct for health professionals as they were in the oaths and codes that guided the health-care providers of past centuries.

Traditionally, the ethics of medical care have given greater prominence to nomaleficence than to beneficence. This priority was grounded in the fact that, historically, medicine’s capacity to do harm far exceeded its capacity to protect and restore health. Providers of health care possessed many treatments
that posed clear and genuine risks to patients but that offered little prospect of benefit. Truly effective therapies were all too rare. In this context, it is surely rational to give substantially higher priority to avoiding harm than to providing benefits.

The advent of modern science changed matters dramatically. Knowledge acquired in laboratories, tested in clinics, and verified by statistical methods has increasingly dictated the practices of medicine. This ongoing alliance between medicine and science became a critical source of the plethora of technol­ogies that now pervades medical care. The impressive increases in therapeutic, preventive, and rehabil­itative capabilities that these technologies have provided have pushed beneficence to the forefront of medical morality. Some have even gone so far as to hold that the old medical ethic of “Above all, do no harm” should be superseded by the new ethic that “The patient deserves the best.” However, the rapid advances in medical technology capabilities have also produced great uncertainty as to what is most beneficial or least harmful for the patient. In other words, along with increases in ability to be beneficent, medicine’s technology has generated much debate about what actually counts as beneficent or nonma – leficent treatment. To illustrate this point, let us turn to several specific moral issues posed by the use of medical technology (Bronzino, 1992; 1999).

Defining Death: A Moral Dilemma Posed by Medical Technology

Supportive and resuscitative devices, such as the respirator, found in the typical modern intensive care unit provide a useful starting point for illustrating how technology has rendered medical morality more complex and problematic. Devices of this kind allow clinicians to sustain respiration and circulation in patients who have suffered massive brain damage and total permanent loss of brain function. These technologies force us to ask: precisely when does a human life end? When is a human being indeed dead? This is not the straightforward factual matter it may appear to be. All of the relevant facts may show that the patient’s brain has suffered injury grave enough to destroy its functioning forever. The facts may show that such an individual’s circulation and respiration would permanently cease without artificial support. Yet these facts do not determine whether treating such an individual as a corpse is morally appropriate. To know this, it is necessary to know or perhaps to decide on those features of living persons that are essential to their status as “living persons.” It is necessary to know or decide which human qualities, if irreparably lost, make an individual identical in all morally relevant respects to a corpse. Once those qualities have been specified, deciding whether total and irreparable loss of brain function constitutes death becomes a straightforward factual matter. Then, it would simply have to be determined if such loss itself deprives the individual of those qualities. If it does, the individual is morally identical to a corpse. If not, then the individual must be regarded and treated as a living person.

The traditional criterion of death has been irreparable cessation of heart beat, respiration, and blood pressure. This criterion would have been quickly met by anyone suffering massive trauma to the brain prior to the development of modem supportive technology. Such technology allows indefinite artificial maintenance of circulation and respiration and, thus, forestalls what once was an inevitable consequence of severe brain injury. The existence and use of such technology therefore challenges the traditional criterion of death and forces us to consider whether continued respiration and circulation are in them­selves sufficient to distinguish a living individual from a corpse. Indeed, total and irreparable loss of brain function, referred to as “brainstem death,” “whole brain death,” and, simply, “brain death,” has been widely accepted as the legal standard for death. By this standard, an individual in a state of brain death is legally indistinguishable from a corpse and may be legally treated as one even though respiratory and circulatory functions may be sustained through the intervention of technology. Many take this legal standard to be the morally appropriate one, noting that once destruction of the brain stem has occurred, the brain cannot function at all, and the body’s regulatory mechanisms will fail unless artificially sustained. Thus mechanical sustenance of an individual in a state of brain death is merely postponement of the inevitable and sustains nothing of the personality, character, or consciousness of the individual. It is merely the mechanical intervention that differentiates such an individual from a corpse and a mechan­ically ventilated corpse is a corpse nonetheless.

Even with a consensus that brainstem death is death and thus that an individual in such a state is indeed a corpse, hard cases remain. Consider the case of an individual in a persistent vegetative state, the condition known as “neocortical death.” Although severe brain injury has been suffered, enough brain function remains to make mechanical sustenance of respiration and circulation unnecessary. In a persistent vegetative state, an individual exhibits no purposeful response to external stimuli and no evidence of self-awareness. The eyes may open periodically and the individual may exhibit sleep-wake cycles. Some patients even yawn, make chewing motions, or swallow spontaneously. Unlike the complete unresponsiveness of individuals in a state of brainstem death, a variety of simple and complex responses can be elicited from an individual in a persistent vegetative state. Nonetheless, the chances that such an individual will regain consciousness virtually do not exist. Artificial feeding, kidney dialysis, and the like make it possible to sustain an individual in a state of neocortical death for decades. This sort of condition and the issues it raises were exemplified by the famous case of Karen Ann Quinlan. James Rachels (1986) provided the following description of the situation created by Quinlan’s condition:

In April 1975, this young woman ceased breathing for at least two 15-minute periods, for reasons that were never made clear. As a result, she suffered severe brain damage, and, in the words of the attending physicians, was reduced to a “chronic vegetative state” in which she “no longer had any cognitive function.” Accepting the doctors’ judgment that there was no hope of recovery, her parents sought permission from the courts to disconnect the respirator that was keeping her alive in the intensive care unit of a New Jersey hospital.

The trial court, and then the Supreme Court of New Jersey, agreed that Karen’s respirator could be removed. So it was disconnected. However, the nurse in charge of her care in the Catholic hospital opposed this decision and, anticipating it, had begun to wean her from the respirator so that by the time it was disconnected she could remain alive without it. So Karen did not die. Karen remained alive for ten additional years. In June 1985, she finally died of acute pneumonia. Antibiotics, which would have fought the pneumonia, were not given.

If brainstem death is death, is neocortical death also death? Again, the issue is not a straightforward factual matter. For, it too, is a matter of specifying which features of living individuals distinguish them from corpses and so make treatment of them as corpses morally impermissible. Irreparable cessation of respiration and circulation, the classical criterion for death, would entail that an individual in a persistent vegetative state is not a corpse and so, morally speaking, must not be treated as one. The brainstern death criterion for death would also entail that a person in a state of neocortical death is not yet a corpse. On this criterion, what is crucial is that brain damage be severe enough to cause failure of the body’s regulatory mechanisms.

Is an individual in a state of neocortical death any less in possession of the characteristics that distinguish the living from cadavers than one whose respiration and circulation are mechanically main­tained? Of course, it is a matter of what the relevant characteristics are, and it is a matter that society must decide. It is not one that can be settled by greater medical information or more powerful medical devices. Until society decides, it will not be clear what would count as beneficent or nonmaleficent treatment of an individual in a state of neocortical death.

190.3 Euthanasia

A long-standing issue in medical ethics, which has been made more pressing by medical technology, is euthanasia, the deliberate termination of an individual’s life for the individual’s own good. Is such an act ever a permissible use of medical resources? Consider an individual in a persistent vegetative state. On the assumption that such a state is not death, withdrawing life support would be a deliberate termination of a human life. Here a critical issue is whether the quality of a human life can be so low or so great a liability to the individual that deliberately taking action to hasten death or at least not to postpone death is morally defensible. Can the quality of a human life be so low that the value of extending its quantity is totally negated? If so, then Western medicine’s traditional commitment to providing benefits and avoiding harm would seem to make cessation of life support a moral requirement in such a case.

Consider the following hypothetical version of the kind of case that actually confronts contemporary patients, their families, health-care workers, and society as a whole. Suppose a middle-aged man suffers a brain hemorrhage and loses consciousness as a result of a ruptured aneurysm. Suppose that he never regains consciousness and is hospitalized in a state of neocortical death, a chronic vegetative state. He is maintained by a surgically implanted gastronomy tube that drips liquid nourishment from a plastic bag directly into his stomach. The care of this individual takes seven and one-half hours of nursing time daily and includes

Shaving, (2) oral hygiene, (3) grooming, (4) attending to his bowels and bladder, and so forth.

Suppose further that his wife undertakes legal action to force his care givers to end all medical treatment, including nutrition and hydration, so that complete bodily death of her husband will occur. She presents a preponderance of evidence to the court to show that her husband would have wanted this result in these circumstances.

The central moral issue raised by this sort of case is whether the quality of the individual’s life is sufficiently compromised by neocortical death to make intentioned termination of that life morally permissible. While alive, he made it clear to both family and friends that he would prefer to be allowed to die rather than be mechanically maintained in a condition of irretrievable loss of consciousness. Deciding whether the judgment in such a case should be allowed requires deciding which capacities and qualities make life worth living, which qualities are sufficient to endow it with value worth sustaining, and whether their absence justifies deliberate termination of a life, at least when this would be the wish of the individual in question. Without this decision, the traditional norms of medical ethics, beneficence and nonmaleficence, provide no guidance. Without this decision, it cannot be determined whether termination of life support is a benefit or a harm to the patient.

An even more difficult type of case was provided by the case of Elizabeth Bouvia. Bouvia, who had been a lifelong quadriplegic sufferer of cerebral palsy, was often in pain, completely dependent upon others, and spent all of her time bedridden. Bouvia, after deciding that she did not wish to continue such a life, entered Riverside General Hospital in California. She desired to be kept comfortable while starving to death. Although she remained adamant during her hospitalization, Bouvia’s requests were denied by hospital officials with the legal sanction of the courts.

Many who might believe that neocortical death renders the quality of life sufficiently low to justify termination of life support, especially when this agrees with the individual’s desires, would not arrive at this conclusion in a case like Bouvia’s. Whereas neocortical death completely destroys consciousness and makes purposive interaction with the individual’s environment impossible, Bouvia was fully aware and mentally alert. She had previously been married and had even acquired a college education. Televised interviews with her portrayed a very intelligent person who had great skill in presenting persuasive arguments to support her wish not to have her life continued by artificial means of nutrition. Nonetheless, she judged her life to be of such low quality that she should be allowed to choose to deliberately starve to death. Before the existence of life support technology, maintenance of her life against her will might not have been possible at all and at least would have been far more difficult.

Should Elizabeth Bouvia’s judgment have been accepted? Her case is more difficult than the care of a patient in a chronic vegetative state because, unlike such an individual, she was able to engage in meaningful interaction with her environment. Regarding an individual who cannot speak or otherwise meaningfully interact with others as nothing more than living matter, as a “human vegetable,” is not especially difficult. Seeing Bouvia this way is not easy. Her awareness, intelligence, mental acuity, and ability to interact with others means that although her life is one of discomfort, indignity, and complete dependence, she is not a mere “human vegetable.”

Despite the differences between Bouvia’s situation and that of someone in a state of neocortical death, the same issue is posed. Can the quality of an individual’s life be so low that deliberate termination is morally justifiable? How that question is answered is a matter of what level of quality of life, if any, is taken to be sufficiently low to justify deliberately acting to end it or deliberately failing to extend it. If there is such a level, the conclusion that it is not always beneficent or even nonmaleficent to use life-support technology must be accepted.

Another important issue here is respect for individual autonomy. For the cases of Bouvia and the hypothetical instance of neocortical death discussed above, both concern voluntary euthanasia, that is, euthanasia voluntarily requested by the patient. A long-standing commitment, vigorously defended by various schools of thought in Western moral philosophy, is the notion that competent adults should be free to conduct their lives as they please as long as they do not impose undeserved harm on others. Does this commitment entail a right to die? Some clearly believe that it does. If one owns anything at all, surely one owns one’s life. In the two cases discussed above, neither individual sought to impose undeserved harm on anyone else, nor would satisfaction of their wish to die do so. What justification can there be then for not allowing their desires to be fulfilled?

One plausible answer is based upon the very respect of individual autonomy at issue here. A necessary condition, in some views, of respect for autonomy is the willingness to take whatever measures are necessary to protect it, including measures that restrict autonomy. An autonomy-respecting reason offered against laws that prevent even competent adults from voluntarily entering lifelong slavery is that such an exercise of autonomy is self-defeating and has the consequence of undermining autonomy altogether. By the same token, an individual who acts to end his own life thereby exercises his autonomy in a manner that places it in jeopardy of permanent loss. Many would regard this as justification for using the coercive force of the law to prevent suicide. This line of thought does not fit the case of an individual in a persistent vegetative state because his/her autonomy has been destroyed by the circumstances that rendered him/her neocortically dead. It does fit Bouvia’s case though. Her actions indicate that she is fully competent and her efforts to use medical care to prevent the otherwise inevitable pain of starvation is itself an exercise of her autonomy. Yet, if allowed to succeed, those very efforts would destroy her autonomy as they destroy her. On this reasoning, her case is a perfect instance of limitation of autonomy being justified by respect for autonomy and of one where, even against the wishes of a competent patient, the life-saving power of medical technology should be used.

Active Versus Passive Euthanasia

Discussions of the morality of euthanasia often distinguish active from passive euthanasia in light of the distinction made between killing a person and letting a person die, a distinction that rests upon the difference between an act of commission and an act of omission. When failure to take steps that could effectively forestall death results in an individual’s demise, the resultant death is an act of omission and a case of letting a person die. When a death is the result of doing something to hasten the end of a person’s life (giving a lethal injection, for example), that death is caused by an act of commission and is a case of killing a person. When a person is allowed to die, death is a result of an act of omission, and the motive is the person’s own good, the omission is an instance of passive euthanasia. When a person is killed, death is the result of an act of commission, and the motive is the person’s own good, the commission is an instance of active euthanasia.

Does the difference between passive and active euthanasia, which reduces to a difference in how death comes about, make any moral difference? It does in the view of the American Medical Association. In a statement adopted on December 4, 1973, the House of Delegates of the American Medical Association asserted the following (Rachels, 1978):

The intentional termination of the life of one human being by another—mercy killing—is contrary to that for which the medical profession stands and is contrary to the policy of the American Medical Association (AMA).

The cessation of extraordinary means to prolong the life of the body where there is irrefutable evidence that biological death is imminent is the decision of the patient and immediate family. The advice of the physician would be freely available to the patient and immediate family.

In response to this position, Rachels (1978) answered with the following:

The AMA policy statement isolates the crucial issue very well, the crucial issue is “intentional termi­nation of the life of one human being by another.” But after identifying this issue and forbidding “mercy killing,” the statement goes on to deny that the cessation of treatment is the intentional termination of a life. This is where the mistake comes in, for what is the cessation of treatment in those circumstances (where the intention is to release the patient from continued suffering), if it is not “the intentional termination of the life of one human being by another?”

As Rachels correctly argues, when steps that could keep an individual alive are omitted for the person’s own good, this omission is as much the intentional termination of life as taking active measures to cause death. Not placing a patient on a respirator due to a desire not to prolong suffering is an act intended to end life as much as the administration of a lethal injection. In many instances the main difference between the two cases is that the latter would release the individual from his pain and suffering more quickly than the former. Dying can take time and involve considerable pain even if nothing is done to prolong life. Active killing can be done in a manner that causes death painlessly and instantly. This difference certainly does not render killing, in this context, morally worse than letting a person die. Insofar as the motivation is merciful (as it must be if the case is to be a genuine instance of euthanasia) because the individual is released more quickly from a life that is disvalued than otherwise, the difference between killing and letting one die may provide support for active euthanasia. According to Rachels (1978), the common rejoinder to this argument is the following:

The important difference between active and passive euthanasia is that in passive euthanasia the doctor does not do anything to bring about the patient’s death. The doctor does nothing and the patient dies of whatever ills already afflict him. In active euthanasia, however, the doctor does something to bring about the patient’s death: he kills the person. The doctor who gives the patient with cancer a lethal injection has himself caused his patient’s death; whereas if he merely ceases treatment, the cancer is the cause of death.

According to this rejoinder, in active euthanasia someone must do something to bring about the patient’s death, and in passive euthanasia the patient’s death is caused by illness rather than by anyone’s conduct. Surely this is mistaken. Suppose a physician deliberately decides not to treat a patient who has a routinely curable ailment and the patient dies. Suppose further that the physician were to attempt to exonerate himself by saying, “I did nothing. The patient’s death was the result of illness. I was not the cause of death.” Under current legal and moral norms, such a response would have no credibility. As Rachels (1978) notes, “it would be no defense at all for him to insist that he didn’t do anything. He would have done something very serious indeed, for he let his patient die.”

The physician would be blameworthy for the patient’s death as surely as if he had actively killed him. If causing death is justifiable under a given set of circumstances, whether it is done by allowing death to occur or by actively causing death is morally irrelevant. If causing someone to die is not justifiable under a given set of circumstances, whether it is done by allowing death to occur or by actively causing death is also morally irrelevant. Accordingly, if voluntary passive euthanasia is morally justifiable in the light of the duty of beneficence, so is voluntary active euthanasia. Indeed, given that the benefit to be achieved is more quickly realized by means of active euthanasia, it may be preferable to passive euthanasia in some cases.

Involuntary and Non-Voluntary Euthanasia

An act of euthanasia is involuntary if it hastens the individual’s death for his own good but against his wishes. To take such a course would be to destroy a life that is valued by its possessor. Therefore, it is no different in any morally relevant way from unjustifiable homicide. There are only two legitimate reasons for hastening an innocent person’s death against his will: self-defense and saving the lives of a larger number of other innocent persons. Involuntary euthanasia does not fit either of these justifications. By definition, it is done for the good of the person who is euthanized and for self-defense or saving innocent others. No act that qualifies as involuntary euthanasia can be morally justifiable.

Hastening a person’s death for his own good is an instance of non-voluntary euthanasia when the individual is incapable of agreeing or disagreeing. Suppose it is clear that a particular person is sufficiently self-conscious to be regarded a person but cannot make his wishes known. Suppose also that he is suffering from the kind of ailment that, in the eyes of many persons, makes one’s life unendurable. Would hastening his death be permissible? It would be if there were substantial evidence that he has given prior consent. This person may have told friends and relatives that under certain circumstances efforts to prolong his life should not be undertaken or continued. He might have recorded his wishes in the form of a Living Will (below) or on audio – or videotape. Where this kind of substantial evidence of prior consent exists, the decision to hasten death would be morally justified. A case of this scenario would be virtually a case of voluntary euthanasia.

But what about an instance in which such evidence is not available? Suppose the person at issue has never had the capacity for competent consent or dissent from decisions concerning his life. It simply cannot be known what value the individual would place on his life in his present condition of illness. What should be done is a matter of what is taken to be the greater evil—mistakenly ending the life of an innocent person for whom that life has value or mistakenly forcing him to endure a life that he radically disvalues.

To My Family, My Physician, My Clergyman, and My Lawyer:

If the time comes when I can no longer take part in decisions about my own future, let this statement stand as testament of my wishes: If there is no reasonable expectation of my recovery from physical or mental disability,

I, , request that I be allowed to die and not be kept alive by artificial means

Or heroic measures. Death is as much a reality as birth, growth, maturity, and old age—it is the one certainty. I do not fear death as much as I fear the indignity of deterioration, dependence, and hopeless pain. I ask that drugs be mercifully administered to me for the terminal suffering even if they hasten the moment of death.

This request is made after careful consideration. Although this document is not legally binding, you who care for me will, I hope, feel morally bound to follow its mandate. I recognize that it places a heavy burden of responsibility upon you, and it is with the intention of sharing that responsibility and of mitigating any feelings of guilt that this statement is made.

Signed:

Date:

Witnessed by:

Living Will statutes have been passed in at least 35 states and the District of Columbia. For a Living Will to be a legally binding document, the person signing it must be of sound mind at the time the will is made and shown not to have altered his opinion in the interim between the signing and his illness. The witnesses must not be able to benefit from the individual’s death.

Should Voluntary Euthanasia be Legalized?

The recent actions of Dr. Kavorkian have raised the question: “Should voluntary euthanasia be legalized?” Some argue that even if voluntary euthanasia is morally justifiable, it should be prohibited by social policy nonetheless. According to this position, the problem with voluntary euthanasia is its impact on society as a whole. In other words, the overall disutility of allowing voluntary euthanasia outweighs the good it could do for its beneficiaries. The central moral concern is that legalized euthanasia would eventually erode respect for human life and ultimately become a policy under which “socially undesirable” persons would have their deaths hastened (by omission or commission). The experience of Nazi Germany is often cited in support of this fear. What began there as a policy of euthanasia soon became one of eliminating individuals deemed racially inferior or otherwise undesirable. The worry, of course, is that what happened there can happen here as well. If social policy encompasses efforts to hasten the deaths of people, respect for human life in general is eroded and all sorts of abuses become socially acceptable, or so the argument goes.

No one can provide an absolute guarantee that the experience of Nazi Germany would not be repeated, but there is reason to believe that its likelihood is negligible. The medical moral duty of beneficence justifies only voluntary euthanasia. It justifies hastening an individual’s death only for the individual’s benefit and only with the individual’s consent. To kill or refuse to save people judged socially undesirable is not to engage in euthanasia at all and violates the medical moral duty of nomaleficence. As long as only voluntary euthanasia is legalized, and it is clear that involuntary euthanasia is not and should never be, no degeneration of the policy need occur. Furthermore, such degeneration is not likely to occur if the beneficent nature of voluntary euthanasia is clearly distinguished from the maleficent nature of involuntary euthanasia and any policy of exterminating the socially undesirable. Euthanasia decisions must be scrutinized carefully and regulated strictly to ensure that only voluntary cases occur, and severe penalties must be established to deter abuse.

References

Bronzino, J. D. Chapter 10 Medical and Ethical Issues in Clinical Engineering Practice. In: Management of Medical Technology. Butterworth, 1992.

Bronzino, J. D. Chapter 20 Moral and Ethical Issues Associated with Medical Technology. In: Introduction to Biomedical Engineering. Academic Press, 1999.

Rachels, J. “Active and Passive Euthanasia,” In: Moral Problems, 3rd ed., Rachels, J., (Ed.), Harper and Row, New York, 1978.

Rachels, J. Ethics at the End of Life: Euthanasia and Morality, Oxford University Press, Oxford, 1986.

Further Information

Daniels, N. Just Health Care. Cambridge University Press, Cambridge, 1987.

Dubler, N. N. and Nimmons, D. Ethics on Call. Harmony Books, New York, 1992.

Jonsen, A. R. The New Medicine and the Old Ethics. Harvard University Press, Cambridge, MA, 1990. Murphy, J. and Coleman, J. The Philosophy of Law, Rowman and Allenheld, 1984.

>., Saha, P. S. “Ethical Issues of Animal and Human Experimentation in the Development of Medical Dev omedical Engineering Handbook: Second Edition.

;eph D. Bronzino

Laton: CRC Press LLC, 2000

Ethical Issues Associated with the Use of Medical Technology

Subrata Saha

Clemson University

Joseph D. Bronzino

Trinity College/Biomedical Engineering Alliance for Connecticut (BEACON)

Professional Ethics in Biomedical Engineering Daniel E. Wueste

A Variety of Norms Govern Human Contact • Professional Ethics and Ethics Plain and Simple • Professions • The Profession of Biomedical Engineering • Two Sources of Professional Ethics • Professional Ethics in Biomedical Engineering • Tools for Design and Decision in Professional Ethics • Professional Integrity, Responsibility, and Codes

Beneficence, Nonmaleficence, and Technological Progress Joseph D. Bronzino Defining Death: A Moral Dilemma Posed by Medical Technology • Euthanasia

Ethical Issues of Animal and Human Experimentation in the Development of Medical Devices Subrata Saha, Pamela S. Saha

Clinical Trials • Animal Experimentation

Regulation of Medical Device Innovation Joseph D. Bronzino

Ethical Issues in Feasibility Studies • Ethical Issues in Emergency Use • Ethical Issues in Treatment Use • The Safe Medical Devices Act

B

Iomedical engineering is responsible for many of the recent advances in modern medicine. These developments have led to new treatment modalities that have significantly improved not only medical care, but the quality of life for many patients in our society. However, along with such positive outcomes new ethical dilemmas and challenges have also emerged. These include: (1) involvement of humans in clinical research, (2) definition of death and the issue of euthanasia, (3) animal experi­mentation and human trials for new medical devices, (4) patient access to sophisticated and high cost medical technology, (5) regulation of new biomaterials and devices. With these issues in mind, this section discusses some of these topics. The first chapter focuses on the concept of professional ethics and its importance to the practicing biomedical engineer. The second chapter deals with the role medical technology has played in the definition of death and the dilemmas posed by advocates of euthanasia. The third chapter focuses on the use of animals and humans in research and clinical experimentation. The final chapter addresses the issue of regulating the use of devices, materials, etc. in the care of patients.

Since the space allocated in this Handbook is limited, a complete discussion of the many ethical dilemmas encountered by practicing biomedical engineers is beyond the scope of this section. Therefore, it is our sincere hope that the readers of this Handbook will further explore these ideas from other texts and articles, some of which are referenced at the end of the chapter. Clearly, a course on biomedical ethics should be an essential component of any bioengineering curriculum.

With new developments in biotechnology and genetic engineering, we need to ask ourselves not only if we can do it, but also “should it be done?” As professional engineers we also have an obligation to educate the public and other regulatory agencies regarding the social implications of such new develop­ments. It is our hope that the topics covered in this section can provide an impetus for further discussion of the ethical issues and challenges faced by the bioengineer during the course of his/her professional life.

Wueste, D. E. “Professional Ethics in Biomedical Engineering.” The Biomedical Engineering Handbook: Second Edition.

Ed. Joseph D. Bronzino

Boca Raton: CRC Press LLC, 2000

189

Professional Ethics in Biomedical Engineering

A Variety of Norms Govern Human Contact

Professional Ethics and Ethics Plain and Simple

Professions

The Profession of Biomedical Engineering

Two Sources of Professional Ethics

Professional Ethics in Biomedical Engineering

Tools for Design and Decision in Professional

Daniel E. Wueste Ethics

Clemson University 189.8 Professional Integrity, Responsibility, and Codes

A Variety of Norms Govern Human Conduct

Various norms or principles govern our activities. They guide us and provide standards for the evaluation of conduct. For example, our conduct is governed by legal and moral norms. These two sets of norms overlap, but it is clear that the overlap is not complete. Morality requires some acts that are not legally required of us and vice versa. Not surprisingly, then, we speak of legality and morality, of legal obligations and moral obligations. This is appropriate primarily because (1) law and morality are distinct sources of obligation and (2) it is possible for legal and moral obligations to conflict. Recognizing that moral and legal obligations have distinct sources, it is easier to appreciate the nature of a conflict between them and work toward its resolution. The same thing can be said within the sphere of morality. Moral rules and principles can and do give rise to conflicting obligations. Here too, the way people speak is revealing. People speak of professional obligations and social responsibilities, as well as the duties of “ordinary morality.” Such talk is increasingly heard in the high-tech fields of biomedicine and biomedical engi­neering, for here the development and use of sophisticated technology intersect with the rights and interests of human beings in an especially profound way.

Professional Ethics and Ethics Plain and Simple

Talk of professional ethics presupposes a distinction between the constraints that arise “from what it means to be a decent human being” (Camenisch, 1981) and those that come with one’s role or attach to the enterprise in which one is engaged. Paul Camenisch calls the former “ethics plain and simple.” The latter are the elements of an occupational or role morality. They only apply to persons who occupy a specific role. The idea here is simple enough. A father, for example, has responsibilities that a man who is not a father does not have. So too, a college teacher, a cleric, or a police officer has responsibilities that persons not occupying these roles do not have.

A professional ethic is an occupational or role morality. It is like the law in several ways. For example, it is not a mere restatement of the norms of ordinary morality. Another point of similarity is that like the law, its scope is limited; it has a jurisdiction in the sense that what it requires or permits is role specific. Thus, for example, the norms of the lawyer’s professional ethic do not impose obligations on people who are not lawyers. Still another similarity is that a professional ethic may allow (or even require) acts that ordinary morality disallows or condemns. An explanation of this fact begins with the observation that, in general, as professionals do their work they are allowed to put to one side considerations that would be relevant and perhaps decisive in the ethical deliberations of nonprofessionals. So, for instance, an attorney is free to plead the statute of limitations as a bar to a just claim against his/her client or to block the introduction of illegally seized evidence in a criminal trial even though his/her client committed the alleged offense. Now one thing that might be said here is that the attorney is simply doing his/her job. The point would be well taken. However, it leaves something rather important unsaid, namely, that the conduct in question is obligatory for the attorney.

Thinking along lines such as these is not confined to the paradigm professions of law and medicine. For example, scientists have been known to claim that as scientists they are free to (indeed must) put to one side social, political, and moral concerns about the uses to which their discoveries may be put. Indeed, some have claimed that scientists are morally obligated not to forgo inquiry even if what emerges from it can be put to immoral or horrendous uses. Plainly, such an appeal to a professional ethic can excite controversy. And this reveals another respect in which a professional ethic (role morality) is like law: it is subject to moral critique. Indeed, it is not only subject to moral criticism, its validity depends on its being morally justified (i. e., justified in terms of “ethics plain and simple”).

One important way in which a professional ethic differs from law is that it is widely held that its standards are in some sense higher than those of ordinary morality. More is expected of professionals than nonprofessionals. They are expected to act on the basis of the knowledge that sets them apart and in doing so they are expected to put the interests of clients or patients ahead of their own interests. Clearly, if professionals are governed by special, higher standards, if the rights and duties of professionals differ from the rights and duties of nonprofessionals, then it makes a difference whether one’s occupation counts as a profession.

Professions

As it happens, there is no generally accepted definition of the term “profession”. However, several writers have suggested that some characteristics common to recognized professions are necessary or essential. The idea that these writers share is that with these characteristics in mind one can mark a serviceable distinction between professional and nonprofessional occupations.

Bayles [1989] maintains that three features of a profession are necessary: (1) extensive training, (2) that involves a significant intellectual component, and (3) puts one in a position to provide an important service to society. To be sure, other features are common. For example: (1) the existence of a process of certification or licensing, (2) the existence of a professional organization, (3) monopoly control of tasks,

Self-regulation, and (5) autonomy in work. But, according to Bayles, they are not essential. The crucial point in the argument that they are not essential is that a large (and growing) number of professionals work in organizations (e. g., HMOs or institutions such as hospitals) where tasks are shared and activities are directed and controlled by superiors. Two things are noteworthy here. First, Bayles’s analysis does not include normative features among those that distinguish professions from non professions. Second, in his analysis an occupation may count as a profession though it lacks certain features common to most professions. While Bayles’s decision not to include normative features among the distinguishing features of professions has been criticized by several writers who insist that such features are indeed essential, the second point has met with widespread agreement.

It will be well to avoid the controversy respecting what is and what is not essential to a profession. Happily, a survey of the substantial literature on professions reveals agreement on several points that, taken together, provide a helpful picture of professions and professional activity. This picture is rather Like a sketch made by a police artist who works with descriptions provided by various witnesses. It has five elements. The first is the centrality of abstract, generalized, and systematic knowledge in the perfor­mance of occupational tasks. The second element is the social significance of the tasks the professional performs; professional activity promotes basic social values. The third element is the claim to be better situated/qualified than others to pronounce and act on certain matters. This claim reaches beyond the interests and affairs of clients. Professionals (experts) believe that they should define various aspects of society, life, and nature and we generally agree. For example, we defer to them (or at least our elected representatives do) in matters of public policy and national defense. Moreover, in certain settings, a hospital for example, it is simply impossible not to defer to the judgment of experts/professionals. The crucial premise can scarcely be doubted: in the contemporary world there is more to know (much of it having immediate practical application) than any one person is capable of knowing. The fourth point is that, on the basis of their expertise and the importance of the work that requires it, professionals claim that as practitioners they are governed by role-specific norms—a professional ethic—rather than the norms that govern human conduct in general. Now, it cannot be denied that particular applications of the relevant norms have been a source of controversy. However, since controversy of this sort generally presupposes the applicability and validity of the role-specific norms, it only serves to confirm the general point. The final element of the composite picture is that now most professionals work in bureaucratic organizations/institutions. The romantic appeal of the model of the professional as solo-practitioner may incline one to balk at this. But romance must not be allowed to prevail over evidence. And in this case the evidence is substantial. In fact, some of it is arresting. For example, it was recently reported that eighty percent of recent medical school graduates are salaried employees of HMOs, clinics, or hospitals (US News and World Report, 1999).

The Profession of Biomedical Engineering

As we have seen, it is not an idle question whether biomedical engineering is a profession. If professionals are governed by special, higher standards, if the rights and duties of professionals differ from the rights and duties of nonprofessionals, then it makes a difference whether one’s occupation counts as a profession.

Since there is no standard definition, no set of necessary and sufficient conditions the satisfaction of which would be decisive, in answering the question we will have to proceed in a different way. It is suggested that we think in terms of characteristics shared by recognized professions that, taken together, constitute a composite picture akin to what a police sketch artist might draw. What is seen when one looks at this picture? In particular, does the picture match the reality of biomedical engineering practice? Looking at this composite picture of a profession it is seen that (1) abstract, generalized, and systematic knowledge is crucial to the performance of occupational tasks (2) these tasks promote basic social values,

Practitioners claim to be better situated/qualified than others to pronounce and act on certain matters,

The conduct of practitioners is governed by role-specific norms, and (5) most of the work done by practitioners is done within bureaucratic institutions. The fit between the reality of biomedical engineer­ing practice and this composite picture of professions is tight. Indeed, looking to this picture to answer the question whether biomedical engineering is a profession, it can scarcely be doubted that the answer is yes.

One possible objection to this answer might be that there is no code of ethics for bioengineers, and thus bioengineering does not count as a profession because the fourth requirement is not satisfied. The objection could be met by pointing to a code for bioengineers, if there was one. But a better response is that the objection itself is misplaced. It is based on the mistaken assumption that there is a set of conditions the satisfaction of which is necessary and sufficient for the ascription of the term “profession” to an occupation. But the existence of a code of ethics is neither necessary nor sufficient for an occupation to count as a profession; what we are working with is a composite picture, not a definition. The objection is misplaced for a second reason as well. Even if there is no code of ethics for bioengineers, codes of ethics are well known in engineering. For example, the National Society of Professional Engineers and the Institute of Electrical and Electronic Engineers have codes of ethics. In addition, the National

Committee on Biomedical Engineering (Australia) has produced a set of professional standards. More­over, a professional ethic may develop by other than quasi-legislative means; in this respect it is like law which has both legislative and customary forms. Thus, there is nothing here to impugn the claim that bioengineering is a profession.

Two Sources of Professional Ethics

It is important to be clear about the fact that a professional ethic may develop in more than one way. A professional ethic is a role morality. The norms of a profession’s role morality need not be expressly “legislated” by, for example, a professional organization, because most of them are implicitly legislated in practice. Thus, one way to identify the norms of a profession’s role morality is to reflect on the expectations one has respecting the conduct of one’s peers. The stable interactional expectancies of practice can constitute what amounts to a customary morality of a profession, an uncodified professional ethic. To be sure, these customary norms may be codified (and often are). However, just as in the case of customary law, codification is not necessary for their validity. Indeed, it is entirely appropriate to say that codification of some such norms (like some laws) is the result of the codifier’s recognition of their independent validity.

It should be noted here that the norms of a customary morality are valid only if they are accepted in practice. It is important, however, that while acceptance is necessary, it is not sufficient. It cannot be sufficient, because if it were, the idea that something is right simply because someone or some group believes it is right would have to be granted. And that, of course, is patently false. What, then, are the additional conditions for the validity of such norms? This is surely a fair question. However, answering it completely would lead us far afield. Consequently, a short answer will have to suffice. The case for the validity of a norm of customary morality (in other words, for its status as a moral norm) turns on whether, in addition to being accepted in practice, compliance with it has good consequences and does not infringe upon the rights of other persons. It will be noticed that these are precisely the sorts of considerations that persons charged with the task of rule making do, or at any rate should, regard as decisive in doing their work. In any case, whether the norms of a professional ethic arise in practice or are expressly “legislated” by a group, they are “dual aspect norms” (Wellman, 1985). They are in play for role agents who are trying to decide what action to take; they are also in play for others within and outside of the profession who observe or by other means become aware of deviation from (or conformity to) them and react accordingly.

Professional Ethics in Biomedical Engineering

It is clear that biomedical engineering has an ethical dimension. After all, human well being is at stake in much if not most of what a biomedical engineer does. Indeed, error or negligence on the part of a biomedical engineer can result in unnecessary suffering or death. Of course, much the same can be said of other engineering fields. Yet, there is something distinctive here. The National Committee on Biomed­ical Engineering has identified three ways in which biomedical engineering differs from other branches of engineering. First, biomedical engineers work with biological materials that behave differently from and have different properties than the materials that most engineers work with. Second, preparation for a career as a biomedical engineer involves study of both engineering principles and the life sciences. Third, and most important for present purposes, is “the indirect and very often direct responsibility of biomedical engineers for their work with patients.” Such responsibility for the well-being of others is a clear indicator that a role has an ethical dimension.

Many things in biomedical engineering that fall under the rubric of professional ethics have to do with policies or procedures. For example, the development of

Methods for obtaining informed consent and criteria for justified departure from these methods,

Means for identifying subjects for clinical trials,

Criteria of thorough testing,

Standards to obviate or mitigate conflicts of interest, as well as mechanisms for their application and enforcement, and

Criteria for just distribution of scarce biomedical resources (expertise and technology).

AH of these things (in this far from exhaustive list) fall under the rubric of professional ethics. However, they are institutional in the sense that they call for decisions about policies or procedures rather than individual action. Decisions in these areas are not decisions to be made by individual practitioners nor are they decisions to be taken case by case. They are decisions about structures of practice that require quasi-legislative activity. Relying on others with requisite expertise, and soliciting input from persons whose interests are at stake in biomedical engineering practices, biomedical engineers should work to develop structures of practice that satisfy legal requirements and ensure, as far as possible, that their professional practice manifests a commitment to safety and the promotion of human well-being. These carefully designed structures of practice should be part of the explicitly quasi-legislated portion of the professional ethic of biomedical engineering.

The question that arises naturally here is how to proceed in this undertaking. Precisely which of the dominant approaches in ethics—utilitarian, deontological, or aretaic—is best is a subject of vigorous debate among philosophers. But this issue will not be debated here. Instead, a sketch will be presented of an approach that can be employed in designing ethical structures of practice, and then, with one difference to be explained, used in making individual ethical decisions in one’s capacity as a professional.

Tools for Design and Decision in Professional Ethics

Multiple analyses or several independent judges are often relied on in making decisions. In general, this is done when something significant turns on the final decision. For example, physicians frequently call for a consultation and patients are encouraged to seek a second opinion before an invasive procedure is performed. Similarly, hospitals and universities rely on panels or commissions—an Institutional Review Board, for example—to make decisions about proposed research or other pressing issues. In such cases it is assumed, rightly, that relying on multiple modes of analysis or several judges is wise even though (1) they produce the same judgment in many—hopefully most—cases and, thus, appear to involve redundancy; and (2) in some cases they produce conflict that could have been avoided by relying on a single mode of analysis or single judge. Why is this a wise course? One part of the answer is that our confidence is bolstered when the same conclusion is reached by different trustworthy means or judges. Here redundancy is a value. The second part of the answer is that being open to conflicting opinions and analyses can help us to avoid errors that would occur otherwise. This will happen when the conflict prompts reexamination of the question that reveals facts previously overlooked or undervalued or mistaken analyses. It should be noted that the approach recommended here is not political; logical and evidentiary considerations rather than simple consensus justify the judgments it produces. Randy Barnett sums up the case for such an approach:

The virtue of adopting multiple or redundant modes of analysis is… twofold: (a) convergence (or agreement) among them supports greater confidence in our conclusions; and (b) divergence (or conflict) signals the need to critically reexamine the issue in a search for reconciliation. In sum, convergence begets confidence, divergence stimulates discovery. [Barnett, 1990]

In the context of professional ethics an approach of this sort would involve reliance on three modes of analysis: (1) utilitarian, (2) rights-based deontological, and (3) role-based institutional. A brief descrip­tion of each mode of analysis is presented in the following paragraphs.

A utilitarian analysis begins with the assumption that rightness is a function of value and tells us that what is morally required of us is the production of the greatest amount of good possible in a situation for all of the affected parties. Utilitarian thinking leads quite directly to an embrace of the familiar principles of nonmaleficence and beneficence. Deontological analysis denies the essential connection between rightness and goodness asserted by utilitarianism. Unlike utilitarians, deontologists hold that some actions are intrinsically right and some actions are intrinsically wrong. More particularly, they insist that the fact that the consequences of an action are the best possible in a given situation does not show that the action is right. The most famous of deontological theories, that of Immanuel Kant, teaches that what is morally required of us is that wherever found, in ourselves or others, humanity is always treated as an end and never as a mere means to an end. In other words, persons have intrinsic worth (as Kant said, they have a dignity rather than a price) and must never be treated as if their value were merely instrumental (as if they were things). That is our duty; the other side of that coin is the right others have to receive that sort of treatment from us. What matters on this approach, then, is whether one is treating people as they deserve to be treated. Thus, deontological thinking leads directly to an embrace of the familiar principles of autonomy and justice. These two modes of analysis are alike in this: both proclaim independence from what the commonly accepted ideas regarding right and wrong are in a community; on both views morality is not something that is instituted (made); rather, it is discovered (not by empirical investigation, but by ratiocination). Thus, these modes of analysis contrast sharply with the third mode of analysis to be discussed here, namely, the role-based institutional mode.

Thinking in terms of role morality rightness is a function of conformity with the stable interactional expectations—accepted norms of conduct—associated with a role. Responsibilities and rights are tied to the function of a role agent within an institution. A role morality is institutional in the quite basic sense that it is instituted, that is, brought into existence by human beings. Sometimes, of course, this is accomplished by quasi-legislative means. But such activity is neither necessary nor the most common means of creation. A role morality is implicit in practice, it is established through mutually beneficial interaction over time. It is a customary or conventional morality. (There is an analogy here to the law in its customary and legislative forms.) One final point, noted earlier, is that considerations of non – institutional morality play a critical role in the validation of the norms of a role morality. The familiar maxim in medicine, primum non nocere, as well as the implicit rule of lawmaking that lawmakers must promulgate the laws they make (no secret laws), are examples of principles that would be readily embraced by those thinking along these lines and validated by considerations of non-institutional morality.

We can summarize this brief description of the three modes of analysis in the following way. The key question for the utilitarian is one of maximal value; for the rights-based deontological thinker it is one of deserved or rightful treatment; with role morality it is one of conformity to established custom or practice.

The recommended approach for the design of ethical structures of practice is to use all three modes of analysis. The hope is that they will converge on the same result. When they do we can be confident that implementation of the principle or policy is justifiable. That is the case, for example, with the rules of professional practice requiring fidelity, confidentiality, privacy, and veracity.

Using this approach one hopes for convergence on the same result. That is to be expected in easy cases. But not all cases are easy cases. Our analyses may diverge rather than converge. What then? Barnett suggests that divergence “stimulates discovery.” The idea is that achieving convergence may be difficult, but at least sometimes it may be achieved on a second pass by retracing one’s steps—going through the analyses again, paying special attention to the input—or rethinking the analyses themselves, paying special attention to previously identified sources of difficulty. For example, utilitarian and deontological analyses may diverge because they deal with individual rights in different ways. Deontologists treat rights as trumps; utilitarians simply include them among the considerations that count in their calculations respecting likely consequences. It may be that the two modes of analysis diverge because of an erroneous assignment of weight to the rights that are in play. If so, convergence can be achieved by rethinking the weight assigned to the rights in the utilitarian calculations. It must be admitted, however, that divergence may not be eliminated by such means. What then? In anticipation of such cases, a presumption should be made in favor of one of the modes of analysis.

When one’s project is the design of ethical structures of practice, the presumption should be made in favor of rights-based deontological analysis, it being understood that utilitarian considerations may rebut the presumption favoring rights in some circumstances. When one’s project is not the design of decision Devices (structures of practice), but deciding what one ought to do as a professional, a presumption should be made in favor of institutional responsibilities, i. e., professional ethics, it being understood that utilitarian or deontological considerations may rebut the presumption in favor of role responsibilities under some circumstances. The point of this presumption is that the burden of justification is properly placed on those who would depart from valid norms. Two things argue in favor of this: (1) a presumption in favor of institutional responsibilities (professional ethics) presupposes a justification of the sort pro­vided by the convergence of the three modes of analysis and (2) making this presumption guards against the dangers of failing to take the professional ethic seriously and robbing the earlier work—constructing ethical structures of practice—of its point.

Professional Integrity, Responsibility, and Codes

Professional ethics involves more than merely complying with the norms of a code of ethics. This is true for several reasons, not the least of which is that there may not be a code. But even if there is a code, for example, the NSPE code, or the code of the AMA or ABA, there is still much more to professional ethics than compliance with the norms of that code. The rules and principles of a code set out the criteria for distinguishing malpractice from minimally acceptable practice. They do not reach to, nor do they define responsible practice. Indeed, they cannot do this, for responsible practice is more than doing one’s duty (thus we speak of responsibilities rather than duties); responsible practice involves discretion and judg­ment in an essential way. Moreover, it involves the integration of professional judgment (expertise) and moral judgment [Whitbeck, 1998]. Here the boundaries between fact and value are fluid or at any rate they vary much as boundaries marked by a river, the course of which changes over time.

It is perhaps best to conceive professional ethics as a call for responsible conduct on the part of practitioners. The call is justified because the integrity of individual practitioners is required for the integrity of a profession, which, in turn, is necessary to justify the trust of others essential to the success of professional practice in any area. There is much work to be done in making clear what the demands of responsible practice are and in maintaining integrity in practice (which is produced by adherence to the standards of responsible practice). There is no ethical algorithm; responsible judgment and action are essential in the development, interpretation, and application of the normative principles governing the profession of biomedical engineering.

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