Basics of Ethical Reasoning

ME 760Biomedical Product Development

Ethical Dilemma: Example 1A research engineer in Large Corp X, a medicaldevice company, was asked by the productdevelopment group to design and perform aresearch study on a specific medical device. Theresearch engineer was told by the productdevelopment team to produce specific results inthis study that would be favorable to the productregulatory status and marketing.

What should the research engineer do?Does it matter if she was an engineer in theproduct development group?

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 isalso the engineer’s supervisor) on a new knew implant design. The surgeon is the soleinventor of the design and would have financial gain if the device were developed into aclinically available product. The engineer has told the surgeon that, because of the novelnature 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 conceptcan be translated to a clinical setting. The potential failure mode not yet addressedwould not be immediately life-threatening, but could cause significant pain and sufferingto the patient, as well as a second surgery. A short time later, the MD asks the engineerto participate in a meeting with a group of engineers from a large corporation, CompanyX. Company X has expressed interested in buying the novel device design to developinto a clinically available product. In this meeting, Company X engineers and the surgeonbegin planning the development path for the device, including testing requirements andregulatory concerns. During this discussion, Company X engineers state that the designmust be changed in a specific way just so that it can pass current FDA testingrequirements. The research institute engineer points out that the current FDA testingrequirements were developed for the old design failure modes, and brings up the needfor additional testing to the group. This discussion is immediately shut down by CompanyX engineers who indicate that passing the regulatory tests is their only concern. Thesurgeon does not back his engineer colleague in this discussion, but instead pushesforward with the Company X engineering plan so that the technology transfer canproceed 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?

Ethics Education in Science andEngineering (ESEE) Workshop

• NSF sponsored five day workshop– Kansas University Initiative on Ethics

Education in Science and Engineering– Main presenters

• Dr. Richard DeGeorge – KU DistinguishedProfessor 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

Science and Ethics

• Compliance– Legal rules– Regulatory– Codes of conduct

• Ethics– Rules– Decision framework

Why learn about ethical reasoning?Relation of Ethics and Science/Engineering

• Ethics begins before science/engineeringand research

• Ethics informs and is informed by scienceand research

• Ethics continues after research ends

• Particularly important in bioengineering…

Ethics Begins BeforeEngineering and Research

• Researchers are human beings with moralresponsibility – general moral rules apply

• Human subjects in research are moralbeings with rights

• Moral limits on certain types of research• Moral evaluation of aims of research• Moral evaluation of research methods

Ethics ContinuesAfter Research Ends

• Researchers are responsible for– dissemination of results– uses to which research is put– commercialization of research

• Responsibility of engineering as aprofession– ASME Code of Ethics– NSPE Code of Ethics

Aims of Ethics Education inEngineering 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 studentand as a future professional in your career

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)

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 defersresponsibility

Ethics: A Two-Edged Sword

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

Key Ethical Terms

• Consequences (good and bad)• Fairness and justice• Rights• Duties• Ideals• Virtues• Responsibility

Scientific Method as a Source ofEthics in Engineering

• Moral traits demanded of the engineer– Honesty– Truthfulness– Accuracy– Intellectual integrity– Objectivity– Patience– Intellectual courage

Three Methodsof Ethical Reasoning

• Utilitarianism – consequence basedapproach

• Deontological Approach – duties, rights,justice based approach– Consequences not considered

• Virtue – character based approach

Consequence Based Approachto Ethical Reasoning

• If actions produce more good than badwhen the consequences to all affectedparties are considered, then they areethical. If not, then they are unethical.

• What is good?– Pleasure– Absence of pain– Happiness– Satisfaction of preferences– Well-being

Consequence Based Approachto 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

Duties, Rights & Justice Based Approachto Ethical Reasoning

• Duties: action that should be done or avoidedregardless of the consequences

• Rights: important, justifiable, normative, claimsor entitlements

• Justice: giving to each his due, and treatingsimilar cases similarly and dissimilar casesdissimilarly

• “Veil of Ignorance approach” – put yourselfbehind an imaginary veil in considering issues

Duties, Rights and Justice Based Approachto 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

Character Based Approachto Ethical Reasoning

• Focuses on the integrity of the moral actorrather than the act itself

• Considers intentions and motivations ofthe actor

• Do virtues transcend cultural boundaries?• What virtues are most relevant for

engineers?

Test of Results ofEthical Reasoning Analysis

• How does the end result test againstconventional 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

Pluralistic Approachto Ethical Reasoning

• Three separate approaches can leavegaps in some situations

• Why bother even considering differentapproaches?– When engaged in ethical discussion, use of

standard terminology can help keeparguments less personal and more logical

– Understand approaches to help guide logicalprogression of thought processes andarguments

Pluralistic Steps of the EthicalDecision Making Process

1. Gather the facts2. Define the ethical issues3. Identify the affected parties (stakeholders)4. Identify the consequences5. Identify the obligations6. Consider your character and integrity7. Think creatively about potential actions8. Check your gut9. Decide on the proper ethical action and be

prepared to deal with opposing arguments

Pluralistic Ethical Reasoning Table

Decide on the proper ethical actionand be prepared to deal withopposing arguments

Check your gut

Think creatively about potentialactions

Consider your character andintegrity

Identify the obligations or duties

Identify the consequences of eachpossible action (good and bad)

Identify the affected parties(stakeholders)

Define the ethical issues

Gather the facts ( who, what,where, when, how and why)

AnalysisSteps for Ethical Reasoning

Ethical Dilemma: Example 1A research engineer in Large Corp X, a medicaldevice company, was asked by the productdevelopment group to design and perform aresearch study on a specific medical device. Theresearch engineer was told by the productdevelopment team to produce specific results inthis study that would be favorable to the productregulatory status and marketing.

What should the research engineer do?Does it matter if she was an engineer in theproduct development group?

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 isalso the engineer’s supervisor) on a new knew implant design. The surgeon is the soleinventor of the design and would have financial gain if the device were developed into aclinically available product. The engineer has told the surgeon that, because of the novelnature 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 conceptcan be translated to a clinical setting. The potential failure mode not yet addressedwould not be immediately life-threatening, but could cause significant pain and sufferingto the patient, as well as a second surgery. A short time later, the MD asks the engineerto participate in a meeting with a group of engineers from a large corporation, CompanyX. Company X has expressed interested in buying the novel device design to developinto a clinically available product. In this meeting, Company X engineers and the surgeonbegin planning the development path for the device, including testing requirements andregulatory concerns. During this discussion, Company X engineers state that the designmust be changed in a specific way just so that it can pass current FDA testingrequirements. The research institute engineer points out that the current FDA testingrequirements were developed for the old design failure modes, and brings up the needfor additional testing to the group. This discussion is immediately shut down by CompanyX engineers who indicate that passing the regulatory tests is their only concern. Thesurgeon does not back his engineer colleague in this discussion, but instead pushesforward with the Company X engineering plan so that the technology transfer canproceed 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?