1. Lecture 6: Ethical Issue

2. Outline Nature and Relevance Criteria for Making Ethical Decisions
Characteristics of Professional Occupations
Principles of Ethics for Clinical Engineers
The Ethical Significance of Professionalism
Ethical Theory and Applied Ethics
Ethical Issues of Concern of a Clinical Engineer
Human Experimentation

3. Nature and Relevance
Ethics is defined as the study of standards of conduct and moral judgment
Deals with human behavior and seeks to establish the principles defining the right or correct course of action in a given situation
Specifically deals with sensitive topics such as professional fees, salaries of coworkers, patient rights and professional competency

4. Nature and Relevance
Moral standards should be known, as well as, how they apply to the changes and possibilities created by technology

5. Criteria for Making Ethical Decisions
Codes of behavior established by law
Codes of ethics for professional groups (e.g. engineers, physicians, and lawyers, among others)
Personal moral code

6. Characteristics of Professional Occupations
High degree of generalized and systematic knowledge
Primary orientation to the community interest rather than to individual self-interest
High degree of self-control of behavior through codes of ethics internalized in the process of work socialization and through voluntary associations organized and operated by the work specialists
System of rewards that is primarily a set of symbols of work achievements and thus ends in themselves, not means to some end of individual self-interest

7. Principles of Ethics for Clinical Engineers
Hold paramount the safety, health, and welfare of the public
Improve the efficacy and safety of healthcare through the application of technology
Support the efficacy and safety of healthcare through the acquisition and exchange of information and experience with other engineers and managers
Manage healthcare technology programs effectively and resources responsibly
Accurately represent their level of responsibility, authority, experience, knowledge and education and perform services only in their area of competence
Maintain confidentiality of patient information as well as proprietary employer or client information, unless doing so would endanger public safety or violate any legal obligations.
Not engage in any activities that are conflicts of interest or that provide the appearance of conflicts of interest and that can adversely affect their performance or impair their professional judgment
Conduct themselves honorably and legally in all their activities

8. The Ethical Significance of Professionalism
High degree of generalized and systematic knowledge
recognizes knowledge and skills from training and education that has valuable capabilities that may have a significant power to affect lives of the others.
Ethical dimensions should be known in order for power not to be abused and misused

9. The Ethical Significance of Professionalism
Primary orientation to the community interest rather than to individual self-interest
Occupational skills and knowledge should be dedicated for the use of the public good rather than for self-interest
High degree of self-control of behavior
Self-regulation should be done to minimize abuse and misuse of power entailed by their expertise since they are the once that are more knowledgeable of the nature and consequences of their expertise

10. Ethical Theory and Applied Ethics
Applied ethics is to ethical theory, what engineering is to pure science
Ethical theory is primarily concerned with extending general knowledge
Pure science’s main concerned is factual knowledge and ethical theory’s main concern is generalized knowledge of right and wrong, good and evil, virtue and vice, and the like

11. Ethical Theory and Applied Ethics
Applied science seeks to increase ability to act and enhance what can be achieve, applied ethics seek primarily to provide answers that could be implemented to concrete questions about how should we act, what we should we choose to do, etc.
Theory without practice is often empty and practice without theory is often blind applies to science and ethics alike

12. Ethical theory Metaethics
Concerned with the analysis of moral concepts and other concepts central to moral reasoning and argument
Focuses in clarifying moral terminology
Understanding of metaethics begins with conceptual analysis of the necessary and sufficient conditions that must be met for proper use of particular concepts

13. Ethical theory Normative ethics
Efforts to answer the question “How is such knowledge of valid moral standards are obtained? Since knowledge of valid moral standard are required to arrive at valid moral judgments
Two schools of thoughts that dominate normative ethics
Utilitarianism, a form of consequentialism
Kantianism, a form of nonconsequentialism

14. Ethical theory Consequentialism
Holds that morally right action is always the one among the available options that has the best consequences
Important implication is that no specific actions or courses of conduct are automatically ruled out as immoral or ruled in as morally obligatory
Rightness or wrongness of an action is wholly contingent upon its effects

15. Ethical theory Utilitarianism Dominant form of consequentialism
Two steps to determining what to be done in a situation:
Determine which courses of actions are open
Determine the consequences of each alternative
Morally right course of action is:
the one that maximizes pleasure, minimizes pain, or both
The one that does the “greatest good for the greatest number”

16. Ethical theory Nonconsequentialism
Deny that moral evaluation is simply and wholly a matter of determining the consequences of human conduct
Agree that other considerations are relevant to moral assessment and rejects the view that morally right conduct is has the best consequences

17. Ethical theory Kantianism
Are attempt to capture in secular form the basic tenet of Christian morality
What makes human beings morally special entities deserving a unique type of respect?
According to Christian ethics only human beings have the intrinsic value due to having an eternal soul and this is the very reason that humans deserve rights that limits how they may be properly treated
Central task of this ethics is to specify what is required by respect for the unique dignity of human beings

18. Ethical Issues of Concern of a Clinical Engineer
Patient Selection
Confidentiality of Patient Records
Benefit-risk analysis for diagnostic and treatment procedures
Experimental Instrumentation and Procedures: Informed Consent
Dying, Death and Euthanasia

19. Patient Selection
Clinical engineer either directly through communication with physicians or indirectly through his choice of equipment characteristics may limit the suitability of certain patients for diagnostic examination or treatment
Clinical engineers become influential in matching patients to hospital systems and in so, they assume a part of the overall responsibility for the patient selection process

20. Confidentiality of Patient Records
Personal and medical records frequently contain sensitive information, discretion must be used in the use and publication of such data
Codes of conduct may specify limitations on release of patient data
Personal and medical data are confidential until appropriateness and justification for release are established

21. Benefit-risk Analysis for Diagnostic and Treatment Procedures
Medical procedures instituted for the ultimate benefit of the patient are associated with significant risk, which are documented for procedures (e.g. radiotherapy and catheterization)
Clinical engineers must objectively assess system capabilities, expected reliability and in particular any significant attendant risks.
Clinical team must decide in each case or for class of patient disorders, whether the risks of contributing to the development or advance of pathological conditions are outweighed by the benefits anticipated

22. Experimental Instrumentation and Procedures: Informed Consent
When human subjects are used for research in new instrumentation systems, “informed consent” for their participation should be obtained
to afford legal protection with respect to patient rights
to give patients enough information to make a rational decision whether or not to participate
Informed consent in brief consists of adequate written or oral explanation to the would-be subject of the objectives of the procedures to be used.
In any case of patient instrumentation, with new or relatively untried devices, care should be taken to see that the patient has been informed.

23. Dying, death and Euthanasia
The clinical engineer with the major role in instrumentation may be called upon to provide information that will in part affect decisions whether or not to continue a treatment to extend a patient’s life
Euthanasia is the deliberate termination of an individual’s life for the individuals own good

24. Euthanasia
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.
Central moral issue raised is whether the quality of the individual’s life is sufficiently compromised by neocortical death to make intended termination of that life morally permissible

25. Euthanasia
Another important issue is respect for individual autonomy whereas it 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

26. Active vs. Passive Euthanasia
Active Euthanasia
When a person is killed
Death is the result of an act of commission
The motive is the person’s own good
Passive Euthanasia
When a person is allowed to die
Death is the result of an act of omission

27. Involuntary and Nonvoluntary Euthanasia
Involuntary Euthanasia
It hastens the individual’s death for his own good but against his wishes
Destroy a life that is valued by its possessor
Nonvoluntary Euthanasia
Hastening of an individual’s death for his own good when the individual is incapable of agreeing and disagreeing

28. Human Experimentation
Therapy is to provide benefits to individuals
Experimentation aims to expand the boundaries of scientific knowledge
Therapeutic vs. Nontherapeutic experimentation
Therapeutic experimentation
A course of action is undertaken in respect to the subject for the purpose of determining how best to procure a medical benefit to the subject
The purpose is to determine how best to benefit the patient
Nontherapeutic experimentation
Is the acquisition of new information
The purpose is to generate new knowledge

29. Human Experimentation
Practice and Research
Practice
Refers to interventions that are designed solely to enhance the well-being of an individual and that have a reasonable expectation of success
Uses a proven technique in an attempt to benefit one or more individual
Research
Activity designed to test a hypothesis to permit conclusions to be drawn and thereby develop or contribute to generalizable knowledge
Studies a technique in an attempt to increase knowledge

30. Human Experimentation
Nonvalidated Practice
Selected course of action is to benefit the patient
Primary purpose is to benefit the patient while making clear that it has not been shown to be safe and efficacious
“A practice might be nonvalidated because it is new; i.e. it has not been tested sufficiently often or sufficiently well to permit satisfactory prediction of its safety or efficacy in patient population. An equally common way for a practice to merit the designation “nonvalidated” is that in the course of its use in the practice of medicine there arises some legitimate cause to question previously held assumptions about its safety or efficacy.” – Robert Levine

31. Mini-Case

32. List three typical ethical issues of concern to the clinical engineer.
Research on ethics for clinical engineers or biomedical engineers in other countries .
List three groupings of criteria for deciding the ethical status of a given situation.
Research the following theories and their application in field of engineering
consequentialism
nonconsequentialism
utilitarianism
Kantianism
List three typical ethical issues of concern to the clinical engineer.

33. Get a host hospital and do the following:
Interview a biomedical engineer or clinical engineer
Identify any ethical issues from their experience
How does the management of the hospital resolve the issues

34. References
ACCE Code of Ethics, and Dyro, JF, et al. American College of Clinical Engineering Clinical Engineering Handbook , 2004.
Bronzino, J.D. (Ed.). (1992). Management of medical technology: a primer for clinical engineers. Boston: Butterworth-Heinemann
Code of Ethics for Engineers, National Society of Professional Engineers (NSPE),
Jendrucko, RJ & Favoriti, RE, (1979) Legal, Professional, and Ethical Aspects, in Clinical Engineering; Principles and Practices; Ed. J Webster & A. Cook, Prentice-Hall, NJ
Online Ethics Center for Engineering and Science,
Webster, J.G. & Cook, A.M. (Ed.). (1979). Clinical engineering: principles and practices. Englewood Cliffs, N.J..: Prentice-Hall, Inc.