Basics of Ethical Reasoning. ME 760 Biomedical Product Development

Transcription

1 Basics of Ethical Reasoning ME 760 Biomedical Product Development

2 Ethical Dilemma: Example 1 A research engineer in Large Corp X, a medical device company, was asked by the product development group to design and perform a research study on a specific medical device. The research engineer was told by the product development team to produce specific results in this study that would be favorable to the product regulatory status and marketing. What should the research engineer do? Does it matter if she was an engineer in the product development group?

3 Ethical Dilemma: Example 2 Ethical Situation 2 An engineer in development of a medical product An engineer with a small company started working with an orthopaedic surgeon (who is also the engineer s supervisor) on a new knew implant design. The surgeon is the sole inventor of the design and would have financial gain if the device were developed into a clinically available product. The engineer has told the surgeon that, because of the novel nature of this device and its difference in function in comparison to current designs, further testing on potential failure modes of the design must be done before the concept can be translated to a clinical setting. The potential failure mode not yet addressed would not be immediately life-threatening, but could cause significant pain and suffering to the patient, as well as a second surgery. A short time later, the MD asks the engineer to participate in a meeting with a group of engineers from a large corporation, Company X. Company X has expressed interested in buying the novel device design to develop into a clinically available product. In this meeting, Company X engineers and the surgeon begin planning the development path for the device, including testing requirements and regulatory concerns. During this discussion, Company X engineers state that the design must be changed in a specific way just so that it can pass current FDA testing requirements. The research institute engineer points out that the current FDA testing requirements were developed for the old design failure modes, and brings up the need for additional testing to the group. This discussion is immediately shut down by Company X engineers who indicate that passing the regulatory tests is their only concern. The surgeon does not back his engineer colleague in this discussion, but instead pushes forward with the Company X engineering plan so that the technology transfer can proceed without interruption. What should the engineer do? Are there any ethical dilemmas presented in this example? If so, what are they? Does the ethical situation change if the engineer is an employee of Company X? Does the ethical situation change if the engineer is a co-inventor with the surgeon?

4 Ethics Education in Science and Engineering (ESEE) Workshop NSF sponsored five day workshop Kansas University Initiative on Ethics Education in Science and Engineering Main presenters Dr. Richard DeGeorge KU Distinguished Professor of Philosophy Dr. Douglas May KU Professor of Management Dr. Dan Bernstein Director, KU Center for Teaching Excellence and Professor of Psychology Source of much of this presentation

5 Science and Ethics Compliance Legal rules Regulatory Codes of conduct Ethics Rules Decision framework

6 Why learn about ethical reasoning? Relation of Ethics and Science/Engineering Ethics begins before science/engineering and research Ethics informs and is informed by science and research Ethics continues after research ends Particularly important in bioengineering

7 Ethics Begins Before Engineering and Research Researchers are human beings with moral responsibility general moral rules apply Human subjects in research are moral beings with rights Moral limits on certain types of research Moral evaluation of aims of research Moral evaluation of research methods

8 Ethics Continues After Research Ends Researchers are responsible for dissemination of results uses to which research is put commercialization of research Responsibility of engineering as a profession ASME Code of Ethics NSPE Code of Ethics

9 Aims of Ethics Education in Engineering Courses Teach pertinent laws and rules Sensitive students to ethical issues Give students tools necessary to think through ethical issues: vocabulary and techniques Enable students to take part in ethical discussions about policy Ethical reasoning is important both now as a student and as a future professional in your career

10 Codes and Rules Examples IRB (Institutional Review Boards) NIH (National Institutes of Health) policy ORI (Office of Research Integrity) Nuremberg Code Academic Misconduct Professional Codes (ASME, NSPE)

11 Why study ethical reasoning? Aren t codes and rules enough? Codes and rules are necessary but not sufficient need interpretation are necessarily incomplete new issues arise can give a false impression that what is not covered is allowed or not required can be morally evaluated immoral laws can exist can create the impression that ethics is imposed from without, and dependent on the rule maker defers responsibility

12 Ethics: A Two-Edged Sword

13 Whose ethics do you follow? Where do you start? Start with Personal ethical base Conventional morality Rules of scientific research Move to Inconsistencies Uncovered areas Open questions

14 Key Ethical Terms Consequences (good and bad) Fairness and justice Rights Duties Ideals Virtues Responsibility

15 Scientific Method as a Source of Ethics in Engineering Moral traits demanded of the engineer Honesty Truthfulness Accuracy Intellectual integrity Objectivity Patience Intellectual courage

16 Three Methods of Ethical Reasoning Utilitarianism consequence based approach Deontological Approach duties, rights, justice based approach Consequences not considered Virtue character based approach

17 Consequence Based Approach to Ethical Reasoning If actions produce more good than bad when the consequences to all affected parties are considered, then they are ethical. If not, then they are unethical. What is good? Pleasure Absence of pain Happiness Satisfaction of preferences Well-being

18 Consequence Based Approach to Ethical Reasoning, cont. Steps: State action to be considered. Identify all affected by the action. Is there some dominant consideration? (weighting of issues) Specify all good and bad consequences for all affected parties. Total the good and bad (weighted considerations) Consider all alternatives imaginatively Limitations Cannot always know all consequences of an act Can sometimes produce counter-intuitive results

19 Duties, Rights & Justice Based Approach to Ethical Reasoning Duties: action that should be done or avoided regardless of the consequences Rights: important, justifiable, normative, claims or entitlements Justice: giving to each his due, and treating similar cases similarly and dissimilar cases dissimilarly Veil of Ignorance approach put yourself behind an imaginary veil in considering issues

20 Duties, Rights and Justice Based Approach to Ethical Reasoning, cont. Tests of duties/rights/justice reasoning outcome If I were on the receiving end of this decision or policy would I accept it as fair or just? Does it respect the rights of all parties? Does it produce more benefit than harm overall? Am I willing to have this decision or policy made public? Can I explain it to my family? Does it go beyond the moral minimum and reach towards moral ideals? Limitations Does not consider consequences Influence of virtue is inadequate Can fail to consider possible exceptions Justice often needs to be tempered with mercy

21 Character Based Approach to Ethical Reasoning Focuses on the integrity of the moral actor rather than the act itself Considers intentions and motivations of the actor Do virtues transcend cultural boundaries? What virtues are most relevant for engineers?

22 Test of Results of Ethical Reasoning Analysis How does the end result test against conventional morality (gut check)? If the result seriously contradicts it in many places, it is then questionable Conventional morality may be flawed Supplements to conventional morality may be required

23 Pluralistic Approach to Ethical Reasoning Three separate approaches can leave gaps in some situations Why bother even considering different approaches? When engaged in ethical discussion, use of standard terminology can help keep arguments less personal and more logical Understand approaches to help guide logical progression of thought processes and arguments

24 Pluralistic Steps of the Ethical Decision Making Process 1. Gather the facts 2. Define the ethical issues 3. Identify the affected parties (stakeholders) 4. Identify the consequences 5. Identify the obligations 6. Consider your character and integrity 7. Think creatively about potential actions 8. Check your gut 9. Decide on the proper ethical action and be prepared to deal with opposing arguments

25 Pluralistic Ethical Reasoning Table Steps for Ethical Reasoning Gather the facts ( who, what, where, when, how and why) Define the ethical issues Analysis Identify the affected parties (stakeholders) Identify the consequences of each possible action (good and bad) Identify the obligations or duties Consider your character and integrity Think creatively about potential actions Check your gut Decide on the proper ethical action and be prepared to deal with opposing arguments

26 Ethical Dilemma: Example 1 A research engineer in Large Corp X, a medical device company, was asked by the product development group to design and perform a research study on a specific medical device. The research engineer was told by the product development team to produce specific results in this study that would be favorable to the product regulatory status and marketing. What should the research engineer do? Does it matter if she was an engineer in the product development group?

27 Ethical Dilemma: Example 2 Ethical Situation 2 An engineer in development of a medical product An engineer with a small company started working with an orthopaedic surgeon (who is also the engineer s supervisor) on a new knew implant design. The surgeon is the sole inventor of the design and would have financial gain if the device were developed into a clinically available product. The engineer has told the surgeon that, because of the novel nature of this device and its difference in function in comparison to current designs, further testing on potential failure modes of the design must be done before the concept can be translated to a clinical setting. The potential failure mode not yet addressed would not be immediately life-threatening, but could cause significant pain and suffering to the patient, as well as a second surgery. A short time later, the MD asks the engineer to participate in a meeting with a group of engineers from a large corporation, Company X. Company X has expressed interested in buying the novel device design to develop into a clinically available product. In this meeting, Company X engineers and the surgeon begin planning the development path for the device, including testing requirements and regulatory concerns. During this discussion, Company X engineers state that the design must be changed in a specific way just so that it can pass current FDA testing requirements. The research institute engineer points out that the current FDA testing requirements were developed for the old design failure modes, and brings up the need for additional testing to the group. This discussion is immediately shut down by Company X engineers who indicate that passing the regulatory tests is their only concern. The surgeon does not back his engineer colleague in this discussion, but instead pushes forward with the Company X engineering plan so that the technology transfer can proceed without interruption. What should the engineer do? Are there any ethical issues presented in this example? If so, what are they? Does the ethical issue change if the engineer is an employee of Company X? Does the ethical issue change if the engineer is a co-inventor with the surgeon?