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TMHG 529
     Information Ethics and 
    Clinical Decision Making
 Nawanan Theera-Ampornpunt, M.D., Ph.D.
Faculty of Medicine Ramathibodi Hospital, Mahidol University
                       April 22, 2013
            http://www.SlideShare.net/Nawanan
Outline
•   Course Introduction
•   Introduction to Ethics & Bioethics
•   Ethical Issues in Health Informatics
•   Information Ethics & Clinical Decision Making
•   Case Studies




                                                    2
Course Introduction




                      3
Course Introduction
• TMHG 529 Legal and Ethical Issues in Health
  Informatics (1 credit)
• Topics
     Information ethics and clinical decision making
     Health information privacy and security
     Legal aspects in health informatics
     Medico-legal aspects in health informatics
     Case Studies
• Grading
   Class Attendance (30%) & Class Participation (70%)
                                                         4
Introduction to 
Ethics & Bioethics




                     5
Introduction to Ethics & Bioethics
     • Ethics
           a set of moral principles: a theory or system of moral values
           the principles of conduct governing an individual or a group
           the discipline dealing with what is good and bad and with
            moral duty and obligation
     • Moral
        of or relating to principles of right and wrong in behavior
        conforming to a standard of right behavior
     • Norm
        A principle of right action binding upon the members of a
         group and serving to guide, control, or regulate proper and
         acceptable behavior
Source: Merriam‐Webster Dictionary                                          6
Standard of Acceptable Behaviors in Society


                         Society’s Standard

            ?        Option 1


                     Option 2




                                              7
Law as Standard of Acceptable Behaviors


                                Law

          ?        Option 1


                   Option 2




                                          8
Professional Code of Conduct as Standard 
         of Acceptable Behaviors

                Professional Code of Conduct

           ?         Option 1


                     Option 2




                                               9
Ethics as Standard of Acceptable Behaviors


                                Ethics

           ?        Option 1


                    Option 2




                                             10
Reality
                             Law
    Professional Code of Conduct

?              Option 1            Ethics


               Option 2




                                            11
Reconciling Conflicts
• Law
   Is explicit but...
   Often requires interpretation
   Slow to create; outdated; sometimes not keep
    up with technologies or social changes
   Conflicting laws
• Professional Code of Conduct
   Often explicit, but similar issues with law
   Only focuses on narrow & traditional
    professional practice
                                                   12
Reconciling Conflicts
• Ethics
   Implicit
   Requires interpretation, making arguments
    and debates
   Is often the basis when law is created
   Helpful in cases where law & code of
    conduct don’t cover or are conflicting



                                                13
Branches of Ethics
     • Descriptive ethics
            What do people think is right?
     • Normative ethics
            How should people act? (prescriptive)
     • Applied ethics
            How do we take moral knowledge and put it into
             practice?
     • Meta-ethics
            What does “right” even mean?

Source: http://en.wikipedia.org/wiki/Outline_of_ethics        14
Sample Areas in Applied Ethics
     • Business ethics
     • Bioethics
         Study of typically controversial ethics brought about by
          advances in biology and medicine
     • Decision ethics
     • Professional ethics
         Computer ethics
         Journalism ethics and standards
         Research ethics
         Legal ethics
         Marketing ethics
         Medical ethics
         Nursing ethics
Source: http://en.wikipedia.org/wiki/Outline_of_ethics   http://en.wikipedia.org/wiki/Bioethics   15
Some Terms in Ethics
     • Ethical Issue
     • Ethical Dilemma
        A complex situation that often involves an apparent
         mental conflict between moral imperatives, in which
         to obey one would result in transgressing another.
     • Ethical Principle
        a standard of conduct defining the kind of behavior
         an ethical person should and should not engage in.
         (Josephson, 2010)
        Provides a guide to making decisions & establish
         criteria by which decisions will be judged by others.
         (Josephson, 2010)
Source: http://en.wikipedia.org/wiki/Ethical_dilemma
http://josephsoninstitute.org/business/blog/2010/12/12‐ethical‐principles‐for‐business‐executives/   16
Historic Cases in Bioethics
• Real cases of unethical or controversial
  professional practice or research practice
• Raised important ethical issues
• Led to development of important ethical
  principles in use today




                                               17
Nazi Human Experimentation & Murder




Source: http://isurvived.org/TOC‐I.html#I‐6_MedExp
                                                     18
Nazi Human Experimentation & Murder

     • Doctors’ Trial at
       Nuremberg, Germany
     • Gave rise to the
       Nuremberg Code, a set
       of research ethics
       principles for human
       subject research


Source: http://en.wikipedia.org/wiki/Doctors%27_Trial   http://en.wikipedia.org/wiki/Nuremberg_Code   19
Points from The Nuremberg Code (1)
     • Voluntary consent of human subject is
       absolutely essential
     • Experiment should be to yield fruitful results
       for the good of society, unprocurable by other
       methods or means of study, and not random
       and unnecessary in nature
     • Should be based on animal study & knowledge
       of natural history of disease
     • Avoid all unnecessary physical & mental
       suffering & injury
Source: http://en.wikipedia.org/wiki/Nuremberg_Code   http://www.hhs.gov/ohrp/archive/nurcode.html   20
Points from The Nuremberg Code (2)
     • Avoid study where it’s believed death or
       disabling injury will occur
     • Risk should not exceed importance of study
       problem
     • Proper preparations to protect subjects against
       risks
     • Study conducted by qualified scientists
     • Subjects can decide to terminate participation
     • Researcher in charge must be prepared to
       terminate study if continuing is believed to
       likely to result in injury or death
Source: http://en.wikipedia.org/wiki/Nuremberg_Code   http://www.hhs.gov/ohrp/archive/nurcode.html   21
Beecher’s Article
     • Originally published in 1966
     • Described 22 examples of research studies with
       controversial ethics conducted by reputable researchers
       and published in major journals.
     • “...unethical or questionably ethical procedures are not
       uncommon” (Beecher, 1966)
     • Full text reprinted in Bull World Health Organ.
       2001;79(4):367-72 & available at
       http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2566
       401/pdf/11368058.pdf


Source: Beecher HK. Ethics and clinical research. N Engl J Med. 1966 Jun 16;274(24):1354‐60.   22
Common Ethical Problems in Research
     • Lack of informed consent
     • Coercion or undue pressure on volunteers (or on a parent
       to volunteer his/her child)
     • Use of a vulnerable population
     • Exploitation of a vulnerable population
     • Withholding information
     • Withholding available treatment
     • Withholding information about risks
     • Putting subjects at risk
     • Risks to subjects outweigh benefits
     • Deception
     • Violation of rights
Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.   23
Tea Room Trade Study
     • Investigated homosexual
       practices in public restrooms. The
       researcher went undercover and
       acted as a “look out” to directly
       observe men engaging in sexual
       acts.
     • He then identified 100 subjects
       by tracing their car license
       numbers.
     • A year later, he distributed a
       “social health survey” throughout
       the communities where the
       subjects lived.
Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.   24
Tea Room Trade Study

     • Ethical Issues
        Informed consent
        Deception
        Use of a vulnerable population




Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.   25
Milgram Study

     • Group Exercise #1




Source: http://en.wikipedia.org/wiki/Milgram_experiment   26
Stanford Prison Experiment

     • In 1971 Philip
       Zimbardo, a psychology
       professor at Stanford
       University conducted a
       study of psychological
       effects of becoming a
       prisoner or prison
       guard.

Source: http://en.wikipedia.org/wiki/Stanford_prison_experiment   http://www.prisonexp.org/   27
Stanford Prison Experiment

     • 24 male students
       randomly assigned to
       roles of prisoners and
       guards in a mock prison
       in a basement at
       Stanford which
       continued for several
       days

Source: http://en.wikipedia.org/wiki/Stanford_prison_experiment   http://www.prisonexp.org/   28
Stanford Prison Experiment
     • Participants adapted to their
       roles beyond researcher’s
       expectations
     • Guards enforced authoritarian
       measures, became
       psychologically abusive &
       harassed prisoners
     • Some prisoners joined the
       guards in the abuse
     • Study stopped after 6 days
       (before 2-week intended
       period) when ethical issues
       were raised

Source: http://en.wikipedia.org/wiki/Stanford_prison_experiment   http://www.prisonexp.org/   29
Stanford Prison Experiment

     • Ethical Issues
        Risks in terms of
         psychological harms
         present that should be
         anticipated and
         permitted to continue
         for some time


Source: http://en.wikipedia.org/wiki/Stanford_prison_experiment   http://www.prisonexp.org/   30
Tuskegee Study (1932‐1972)
     • Designed to document natural
       history of syphilis in African-
       American men
     • There was no known treatment
       for syphilis at the time
     • Hundreds of men with and
       without syphilis were enrolled
       but they were misinformed
       about the need for some of the
       procedures.
     • Some procedures were told as
       necessary and free treatment
Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.   31
Tuskegee Study (1932‐1972)

     • After penicillin was found to be
       safe & effective treatment for
       syphilis in 1940s, they were not
       given penicillin.
     • The study continued to track
       the men until 1972 when the
       public became aware of study
     • 28 deaths, 100 cases of
       disabilities, and 19 cases of
       congenital syphilis
Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.   32
Tuskegee Study (1932‐1972)
     • Ethical issues
        Lack of informed consent
        Deception
        Withholding information
        Withholding available treatment, putting
         subjects & families at risk
        Exploitation of a vulnerable group of
         subjects who would not benefit from
         participation (black men)
Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.   33
The Belmont Report

     • A report by the U.S. National Commission
       for the Protection of Human Subjects of
       Biomedical and Behavioral Research to
       address ethical issues in the Tuskegee
       Study
     • Identifies 3 basic ethical principles for all
       human subject research called “Belmont
       Principles”
Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.   34
Belmont Principles

      • Respect for Persons (or Autonomy)
      • Beneficence
      • Justice




Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.   35
Belmont Principles
      • Respect for Persons (or Autonomy)
         Treat individuals as autonomous human
          beings. People must be allowed to choose
          for themselves
         We must also provide extra protection to
          those with limited autonomy
         Autonomy includes mental capacity (ability
          to understand and process information)
          and voluntariness (freedom from control,
          coercion, or influence of others)
Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.   36
Belmont Principles

      • Beneficence
         Minimize harms and maximize benefits
          within constraints of sound research
          design
         Avoid research without a favorable risk-
          benefit ratio



Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.   37
Belmont Principles

      • Justice
          Treat people fairly and design studies so
           that burdens and benefits are shared
           equitably
          Select subjects equitably
          Avoid exploitation of vulnerable
           populations or “populations of
           convenience”
Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.   38
An Additional Ethical Principle

      •   Non-maleficence
      •   Primum non nocere
      •   “First, do no harm.”
      •   Included in the Hippocratic Oath

                 “...Whatever houses I may visit, I will
                  come for the benefit of the sick...”

Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.   39
Ethical Issues in Health 
      Informatics




                            40
Why Important in Informatics?

       Research ethics
       Leads to patient outcomes, including deaths
       Provider-patient relationship threatened by IT?
       “Rationing” of health care through CDSS
       Information risks
       Informatics practitioners as “professionals” with
        specific skills, training, & competencies?
       Most common question “Who owns the data?”


Source: Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes. 
In Shortliffe (3rd Edition).                                                                            41
ELSI

• ELSI - Ethical, Legal, and Social Issues
• These three aspects are often interrelated
• ELSI in Informatics
   AMIA ELSI-WG
  http://www.amia.org/programs/working-groups/ethical-legal-social-issues

   Professional Code of Conduct
  AMIA: http://www.amia.org/about-amia/ethics/code-ethics
  IMIA: http://www.imia-medinfo.org/new2/pubdocs/Ethics_Eng.pdf




                                                                            42
IMIA General Ethical Principles in Informatics

     •   Information Privacy & Disposition
     •   Openness
     •   Security
     •   Access
     •   Legitimate Infringement
     •   Least Intrusive Alternative
     •   Accountability

Source: http://www.imia‐medinfo.org/new2/pubdocs/Ethics_Eng.pdf   43
Some ELSI References




 Shortliffe 3rd Edition (2006)
Chapter 10 by Goodman KW &                 Anderson JG & Goodman KW (2002)
           Miller RA

•   Anderson JG. The role of ethics in information technology decisions: a case-
    based approach to biomedical informatics education. Int J Med Inform. 2004
    Mar 18;73(2):145-50.
                                                                                   44
Information Ethics & 
Clinical Decision Making




                           45
A Model of Clinical Decision Making
                                                  PATIENT


                                                Perception
     CLINICIAN

                                                 Attention


     Long Term Memory                                                            External Memory
                                                  Working
                                                  Memory
      Knowledge           Data                                                   Knowledge           Data


                                                Inference


                                                 DECISION
Source: Elson RB, Faughnan JG, Connelly DP. An industrial process view of information delivery to support 
clinical decision making: implications for system design and process measures. J Am Med Inform Assoc. 1997 Jul‐
Aug;4(4):266‐78. http://jamia.bmj.com/content/4/4/266.full.pdf+html                                          46
Clinical Decision Support Systems (CDSSs)
• The real place where most of the values of
  health IT can be achieved
• A variety of forms and nature of CDSSs
   Expert systems
     • Based on artificial intelligence, machine learning,
       rules, or statistics
     • Examples: differential diagnoses, treatment options




                                                             47
Clinical Decision Support Systems (CDSSs)
• A variety of forms and nature of CDSSs
   Alerts & reminders
      • Based on specified logical conditions
      • Examples: drug-allergy checks, drug-drug interaction
        checks, drug-lab interaction checks, drug-formulary
        checks, reminders for preventive services or certain
        actions (e.g. smoking cessation), clinical practice
        guideline integration
   Evidence-based knowledge sources e.g. drug database,
    literature
   Simple UI designed to help clinical decision making
                                                               48
Example of “Alerts & Reminders”




                                  49
Clinical Decision Support Systems (CDSSs)
Issues
• CDSS as a supplement or replacement of clinicians?
    The demise of the “Greek Oracle” model (Miller & Masarie,
     1990)

                                            The “Greek Oracle” Model




                                            The “Fundamental Theorem”




  Friedman CP. A ʺfundamental theoremʺ of biomedical informatics. J Am Med 
                    Inform Assoc. 2009 Apr;16(2):169‐170.
                                                                              50
Clinical Decision Support Systems (CDSSs)

Issues
• Alert sensitivity & alert fatigue




                                             51
Workarounds




              52
Workarounds (Zoomed In)




                          53
Unintended Consequences of Health IT

• “Unanticipated and unwanted effect of health IT implementation”
  (ucguide.org)
• Must-read resources
    www.ucguide.org
    Ash JS, Berg M, Coiera E. Some unintended consequences of
     information technology in health care: the nature of patient care
     information system-related errors. J Am Med Inform Assoc. 2004 Mar-
     Apr;11(2):104-12.
    Campbell, EM, Sittig DF, Ash JS, et al. Types of Unintended
     Consequences Related to Computerized Provider Order Entry. J Am
     Med Inform Assoc. 2006 Sep-Oct; 13(5): 547-556.
    Koppel R, Metlay JP, Cohen A, Abaluck B, Localio AR, Kimmel SE, Strom
     BL. Role of computerized physician order entry systems in
     facilitating medication errors. JAMA. 2005 Mar 9;293(10):1197-203.

                                                                             54
Unintended Consequences of Health IT




Ash et al. (2004)                                 55
Unintended Consequences of Health IT

     • Errors in the process of entering and retrieving
       information
         A human-computer interface that is not
          suitable for a highly interruptive use context
         Causing cognitive overload by
          overemphasizing structured and “complete”
          information entry or retrieval
           • Structure
           • Fragmentation
           • Overcompleteness

Ash et al. (2004)                                          56
Unintended Consequences of Health IT

     • Errors in the communication and coordination process
         Misrepresenting collective, interactive work as a linear, clearcut, and
          predictable workflow
            • Inflexibility
            • Urgency
            • Workarounds
            • Transfers of patients
         Misrepresenting communication as information transfer
            • Loss of communication
            • Loss of feedback
            • Decision support overload
            • Catching errors

Ash et al. (2004)                                                                   57
Unintended Consequences of Health IT




Campbell et al. (2006)                           58
Unintended Consequences of Health IT




Campbell et al. (2006)                           59
Unintended Consequences of Health IT




Koppel et al. (2005)                             60
Unintended Consequences of Health IT




Koppel et al. (2005)                             61
Appropriate Use of Health IT

      Standard view
       With uncertainties around new technology, “scientific
        evidence counsels caution and prudence.”
       Evidence & reason determine appropriate level of
        caution
       If such systems improve care at acceptable cost in
        time & money, there’s an obligation to use it
       Follows evolving evidence and standards of care


Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes. 
In Shortliffe (3rd Edition).                                                                    62
Appropriate Use of Health IT

      Standard view
       For computer-assisted clinical diagnosis CDS, human
        cognitive processes are more suited to complex task
        of diagnosis than machine, and should not be
        overridden or trumped by computers.
       When adequate CDS tools are developed, they should
        be viewed and used as supplementary and subservient
        to human clinical judgment



Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes. 
In Shortliffe (3rd Edition).                                                                    63
Fundamental Theorem of Informatics
             (Friedman, 2009)
                                     64
Appropriate Use of Health IT

      Standard view
       Practitioners have obligation to use tools responsibly,
        through adequate training & understanding the
        system’s abilities & limitations
       Practitioners must not ignore their clinical judgment
        reflexively when using CDS.




Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes. 
In Shortliffe (3rd Edition).                                                                    65
Appropriate Use of Health IT

       Health IT “should be used in clinical practice only
        after appropriate evaluation of its efficacy and the
        documentation that it performs its intended task at an
        acceptable cost in time & money”
       Qualified (licensed, trained & experienced) health
        professionals as users
       Systems should be used to augment/supplement,
        rather than replace or supplant individuals’ decision
        making
       Adequate training
Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes. 
In Shortliffe (3rd Edition).                                                                    66
Ethics for Developers
       Follow standard of care & scientific progress
        (evidence-based)
       System evaluation is ethically imperative




Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes. 
In Shortliffe (3rd Edition).                                                                    67
Why Clinical Judgment Is Still Necessary?

• Nothing is certain in medicine & health care
• Large variations exist in patient presentations,
  clinical course, underlying genetic codes, patient
  & provider behaviors, biological responses &
  social contexts
• Human is good at pattern recognition, while
  machine is good at logic & computations.
• Diagnosis is often achieved through recognizing
  clinical patterns
• Not everything can be digitized or digitally
  acquired
• Experience, context & human touch matters
                                                       68
“Learned Intermediary” Doctrine

     • A defense doctrine used in the U.S. legal
       system (and some other countries) which
       states that “a manufacturer of a product has
       fulfilled his duty of care when he provides all
       of the necessary information to a ‘learned
       intermediary’ who then interacts with the
       consumer of a product.” (Wikipedia)
     • Primarily used by pharmaceutical & medical
       device manufacturers in defense of tort
       lawsuits.
Source: http://en.wikipedia.org/wiki/Learned_intermediary   69
“Learned Intermediary” Doctrine

• Because health IT developers can’t expect a
  CDS advice (e.g., alerts & reminders) to be
  100% appropriate for each individual patient,
  clinical judgment is still necessary.
• Health IT developers & manufacturers are
  protected from liabilities for
  poor/inappropriate advices or for bad
  outcomes associated with them, as long as
  there is a clinician using it that can intervene
• What about software bugs (e.g. wrong dose
  calculations)?
                                                     70
“Learned Intermediary” Doctrine

• Applicability of this doctrine varies based
  on legal jurisdictions, context of each
  case, and legal arguments
• Recently, this doctrine has been noted by
  some legal and informatics experts that it
  doesn’t apply to health IT cases
• It remains unclear until there are rulings
  from real legal cases

                                                71
Summary

• Ethical principles are guides and standards
  of practice that can help us navigate
  through situations that arise.
• History was full of unethical conduct
• 4 important principles in bioethics
    Respect for persons (autonomy)
    Beneficence
    Justice
    Non-maleficence
                                                72
Summary

• Ethical issues are present in informatics
  practice (whether as developers, implementers,
  executives, users, researchers, etc.)
• Codes of conduct & ethics codes by
  professional organizations govern acceptable
  & ethical behaviors by informaticians
• In use of health IT in clinical decision
  making, there are standard & appropriate
  guidelines that are based on ethical principles

                                                    73

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Information Ethics and Clinical Decision Making

  • 1. TMHG 529 Information Ethics and  Clinical Decision Making Nawanan Theera-Ampornpunt, M.D., Ph.D. Faculty of Medicine Ramathibodi Hospital, Mahidol University April 22, 2013 http://www.SlideShare.net/Nawanan
  • 2. Outline • Course Introduction • Introduction to Ethics & Bioethics • Ethical Issues in Health Informatics • Information Ethics & Clinical Decision Making • Case Studies 2
  • 4. Course Introduction • TMHG 529 Legal and Ethical Issues in Health Informatics (1 credit) • Topics  Information ethics and clinical decision making  Health information privacy and security  Legal aspects in health informatics  Medico-legal aspects in health informatics  Case Studies • Grading  Class Attendance (30%) & Class Participation (70%) 4
  • 6. Introduction to Ethics & Bioethics • Ethics  a set of moral principles: a theory or system of moral values  the principles of conduct governing an individual or a group  the discipline dealing with what is good and bad and with moral duty and obligation • Moral  of or relating to principles of right and wrong in behavior  conforming to a standard of right behavior • Norm  A principle of right action binding upon the members of a group and serving to guide, control, or regulate proper and acceptable behavior Source: Merriam‐Webster Dictionary 6
  • 7. Standard of Acceptable Behaviors in Society Society’s Standard ? Option 1 Option 2 7
  • 9. Professional Code of Conduct as Standard  of Acceptable Behaviors Professional Code of Conduct ? Option 1 Option 2 9
  • 10. Ethics as Standard of Acceptable Behaviors Ethics ? Option 1 Option 2 10
  • 11. Reality Law Professional Code of Conduct ? Option 1 Ethics Option 2 11
  • 12. Reconciling Conflicts • Law  Is explicit but...  Often requires interpretation  Slow to create; outdated; sometimes not keep up with technologies or social changes  Conflicting laws • Professional Code of Conduct  Often explicit, but similar issues with law  Only focuses on narrow & traditional professional practice 12
  • 13. Reconciling Conflicts • Ethics  Implicit  Requires interpretation, making arguments and debates  Is often the basis when law is created  Helpful in cases where law & code of conduct don’t cover or are conflicting 13
  • 14. Branches of Ethics • Descriptive ethics  What do people think is right? • Normative ethics  How should people act? (prescriptive) • Applied ethics  How do we take moral knowledge and put it into practice? • Meta-ethics  What does “right” even mean? Source: http://en.wikipedia.org/wiki/Outline_of_ethics 14
  • 15. Sample Areas in Applied Ethics • Business ethics • Bioethics  Study of typically controversial ethics brought about by advances in biology and medicine • Decision ethics • Professional ethics  Computer ethics  Journalism ethics and standards  Research ethics  Legal ethics  Marketing ethics  Medical ethics  Nursing ethics Source: http://en.wikipedia.org/wiki/Outline_of_ethics http://en.wikipedia.org/wiki/Bioethics 15
  • 16. Some Terms in Ethics • Ethical Issue • Ethical Dilemma  A complex situation that often involves an apparent mental conflict between moral imperatives, in which to obey one would result in transgressing another. • Ethical Principle  a standard of conduct defining the kind of behavior an ethical person should and should not engage in. (Josephson, 2010)  Provides a guide to making decisions & establish criteria by which decisions will be judged by others. (Josephson, 2010) Source: http://en.wikipedia.org/wiki/Ethical_dilemma http://josephsoninstitute.org/business/blog/2010/12/12‐ethical‐principles‐for‐business‐executives/ 16
  • 17. Historic Cases in Bioethics • Real cases of unethical or controversial professional practice or research practice • Raised important ethical issues • Led to development of important ethical principles in use today 17
  • 19. Nazi Human Experimentation & Murder • Doctors’ Trial at Nuremberg, Germany • Gave rise to the Nuremberg Code, a set of research ethics principles for human subject research Source: http://en.wikipedia.org/wiki/Doctors%27_Trial http://en.wikipedia.org/wiki/Nuremberg_Code 19
  • 20. Points from The Nuremberg Code (1) • Voluntary consent of human subject is absolutely essential • Experiment should be to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature • Should be based on animal study & knowledge of natural history of disease • Avoid all unnecessary physical & mental suffering & injury Source: http://en.wikipedia.org/wiki/Nuremberg_Code http://www.hhs.gov/ohrp/archive/nurcode.html 20
  • 21. Points from The Nuremberg Code (2) • Avoid study where it’s believed death or disabling injury will occur • Risk should not exceed importance of study problem • Proper preparations to protect subjects against risks • Study conducted by qualified scientists • Subjects can decide to terminate participation • Researcher in charge must be prepared to terminate study if continuing is believed to likely to result in injury or death Source: http://en.wikipedia.org/wiki/Nuremberg_Code http://www.hhs.gov/ohrp/archive/nurcode.html 21
  • 22. Beecher’s Article • Originally published in 1966 • Described 22 examples of research studies with controversial ethics conducted by reputable researchers and published in major journals. • “...unethical or questionably ethical procedures are not uncommon” (Beecher, 1966) • Full text reprinted in Bull World Health Organ. 2001;79(4):367-72 & available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2566 401/pdf/11368058.pdf Source: Beecher HK. Ethics and clinical research. N Engl J Med. 1966 Jun 16;274(24):1354‐60. 22
  • 23. Common Ethical Problems in Research • Lack of informed consent • Coercion or undue pressure on volunteers (or on a parent to volunteer his/her child) • Use of a vulnerable population • Exploitation of a vulnerable population • Withholding information • Withholding available treatment • Withholding information about risks • Putting subjects at risk • Risks to subjects outweigh benefits • Deception • Violation of rights Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 23
  • 24. Tea Room Trade Study • Investigated homosexual practices in public restrooms. The researcher went undercover and acted as a “look out” to directly observe men engaging in sexual acts. • He then identified 100 subjects by tracing their car license numbers. • A year later, he distributed a “social health survey” throughout the communities where the subjects lived. Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 24
  • 25. Tea Room Trade Study • Ethical Issues  Informed consent  Deception  Use of a vulnerable population Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 25
  • 26. Milgram Study • Group Exercise #1 Source: http://en.wikipedia.org/wiki/Milgram_experiment 26
  • 27. Stanford Prison Experiment • In 1971 Philip Zimbardo, a psychology professor at Stanford University conducted a study of psychological effects of becoming a prisoner or prison guard. Source: http://en.wikipedia.org/wiki/Stanford_prison_experiment http://www.prisonexp.org/ 27
  • 28. Stanford Prison Experiment • 24 male students randomly assigned to roles of prisoners and guards in a mock prison in a basement at Stanford which continued for several days Source: http://en.wikipedia.org/wiki/Stanford_prison_experiment http://www.prisonexp.org/ 28
  • 29. Stanford Prison Experiment • Participants adapted to their roles beyond researcher’s expectations • Guards enforced authoritarian measures, became psychologically abusive & harassed prisoners • Some prisoners joined the guards in the abuse • Study stopped after 6 days (before 2-week intended period) when ethical issues were raised Source: http://en.wikipedia.org/wiki/Stanford_prison_experiment http://www.prisonexp.org/ 29
  • 30. Stanford Prison Experiment • Ethical Issues  Risks in terms of psychological harms present that should be anticipated and permitted to continue for some time Source: http://en.wikipedia.org/wiki/Stanford_prison_experiment http://www.prisonexp.org/ 30
  • 31. Tuskegee Study (1932‐1972) • Designed to document natural history of syphilis in African- American men • There was no known treatment for syphilis at the time • Hundreds of men with and without syphilis were enrolled but they were misinformed about the need for some of the procedures. • Some procedures were told as necessary and free treatment Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 31
  • 32. Tuskegee Study (1932‐1972) • After penicillin was found to be safe & effective treatment for syphilis in 1940s, they were not given penicillin. • The study continued to track the men until 1972 when the public became aware of study • 28 deaths, 100 cases of disabilities, and 19 cases of congenital syphilis Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 32
  • 33. Tuskegee Study (1932‐1972) • Ethical issues  Lack of informed consent  Deception  Withholding information  Withholding available treatment, putting subjects & families at risk  Exploitation of a vulnerable group of subjects who would not benefit from participation (black men) Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 33
  • 34. The Belmont Report • A report by the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to address ethical issues in the Tuskegee Study • Identifies 3 basic ethical principles for all human subject research called “Belmont Principles” Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 34
  • 35. Belmont Principles • Respect for Persons (or Autonomy) • Beneficence • Justice Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 35
  • 36. Belmont Principles • Respect for Persons (or Autonomy)  Treat individuals as autonomous human beings. People must be allowed to choose for themselves  We must also provide extra protection to those with limited autonomy  Autonomy includes mental capacity (ability to understand and process information) and voluntariness (freedom from control, coercion, or influence of others) Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 36
  • 37. Belmont Principles • Beneficence  Minimize harms and maximize benefits within constraints of sound research design  Avoid research without a favorable risk- benefit ratio Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 37
  • 38. Belmont Principles • Justice  Treat people fairly and design studies so that burdens and benefits are shared equitably  Select subjects equitably  Avoid exploitation of vulnerable populations or “populations of convenience” Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 38
  • 39. An Additional Ethical Principle • Non-maleficence • Primum non nocere • “First, do no harm.” • Included in the Hippocratic Oath “...Whatever houses I may visit, I will come for the benefit of the sick...” Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 39
  • 41. Why Important in Informatics?  Research ethics  Leads to patient outcomes, including deaths  Provider-patient relationship threatened by IT?  “Rationing” of health care through CDSS  Information risks  Informatics practitioners as “professionals” with specific skills, training, & competencies?  Most common question “Who owns the data?” Source: Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.  In Shortliffe (3rd Edition). 41
  • 42. ELSI • ELSI - Ethical, Legal, and Social Issues • These three aspects are often interrelated • ELSI in Informatics  AMIA ELSI-WG http://www.amia.org/programs/working-groups/ethical-legal-social-issues  Professional Code of Conduct AMIA: http://www.amia.org/about-amia/ethics/code-ethics IMIA: http://www.imia-medinfo.org/new2/pubdocs/Ethics_Eng.pdf 42
  • 43. IMIA General Ethical Principles in Informatics • Information Privacy & Disposition • Openness • Security • Access • Legitimate Infringement • Least Intrusive Alternative • Accountability Source: http://www.imia‐medinfo.org/new2/pubdocs/Ethics_Eng.pdf 43
  • 44. Some ELSI References Shortliffe 3rd Edition (2006) Chapter 10 by Goodman KW &  Anderson JG & Goodman KW (2002) Miller RA • Anderson JG. The role of ethics in information technology decisions: a case- based approach to biomedical informatics education. Int J Med Inform. 2004 Mar 18;73(2):145-50. 44
  • 46. A Model of Clinical Decision Making PATIENT Perception CLINICIAN Attention Long Term Memory External Memory Working Memory Knowledge Data Knowledge Data Inference DECISION Source: Elson RB, Faughnan JG, Connelly DP. An industrial process view of information delivery to support  clinical decision making: implications for system design and process measures. J Am Med Inform Assoc. 1997 Jul‐ Aug;4(4):266‐78. http://jamia.bmj.com/content/4/4/266.full.pdf+html 46
  • 47. Clinical Decision Support Systems (CDSSs) • The real place where most of the values of health IT can be achieved • A variety of forms and nature of CDSSs  Expert systems • Based on artificial intelligence, machine learning, rules, or statistics • Examples: differential diagnoses, treatment options 47
  • 48. Clinical Decision Support Systems (CDSSs) • A variety of forms and nature of CDSSs  Alerts & reminders • Based on specified logical conditions • Examples: drug-allergy checks, drug-drug interaction checks, drug-lab interaction checks, drug-formulary checks, reminders for preventive services or certain actions (e.g. smoking cessation), clinical practice guideline integration  Evidence-based knowledge sources e.g. drug database, literature  Simple UI designed to help clinical decision making 48
  • 50. Clinical Decision Support Systems (CDSSs) Issues • CDSS as a supplement or replacement of clinicians?  The demise of the “Greek Oracle” model (Miller & Masarie, 1990) The “Greek Oracle” Model The “Fundamental Theorem” Friedman CP. A ʺfundamental theoremʺ of biomedical informatics. J Am Med  Inform Assoc. 2009 Apr;16(2):169‐170. 50
  • 54. Unintended Consequences of Health IT • “Unanticipated and unwanted effect of health IT implementation” (ucguide.org) • Must-read resources  www.ucguide.org  Ash JS, Berg M, Coiera E. Some unintended consequences of information technology in health care: the nature of patient care information system-related errors. J Am Med Inform Assoc. 2004 Mar- Apr;11(2):104-12.  Campbell, EM, Sittig DF, Ash JS, et al. Types of Unintended Consequences Related to Computerized Provider Order Entry. J Am Med Inform Assoc. 2006 Sep-Oct; 13(5): 547-556.  Koppel R, Metlay JP, Cohen A, Abaluck B, Localio AR, Kimmel SE, Strom BL. Role of computerized physician order entry systems in facilitating medication errors. JAMA. 2005 Mar 9;293(10):1197-203. 54
  • 56. Unintended Consequences of Health IT • Errors in the process of entering and retrieving information  A human-computer interface that is not suitable for a highly interruptive use context  Causing cognitive overload by overemphasizing structured and “complete” information entry or retrieval • Structure • Fragmentation • Overcompleteness Ash et al. (2004) 56
  • 57. Unintended Consequences of Health IT • Errors in the communication and coordination process  Misrepresenting collective, interactive work as a linear, clearcut, and predictable workflow • Inflexibility • Urgency • Workarounds • Transfers of patients  Misrepresenting communication as information transfer • Loss of communication • Loss of feedback • Decision support overload • Catching errors Ash et al. (2004) 57
  • 62. Appropriate Use of Health IT Standard view  With uncertainties around new technology, “scientific evidence counsels caution and prudence.”  Evidence & reason determine appropriate level of caution  If such systems improve care at acceptable cost in time & money, there’s an obligation to use it  Follows evolving evidence and standards of care Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.  In Shortliffe (3rd Edition). 62
  • 63. Appropriate Use of Health IT Standard view  For computer-assisted clinical diagnosis CDS, human cognitive processes are more suited to complex task of diagnosis than machine, and should not be overridden or trumped by computers.  When adequate CDS tools are developed, they should be viewed and used as supplementary and subservient to human clinical judgment Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.  In Shortliffe (3rd Edition). 63
  • 65. Appropriate Use of Health IT Standard view  Practitioners have obligation to use tools responsibly, through adequate training & understanding the system’s abilities & limitations  Practitioners must not ignore their clinical judgment reflexively when using CDS. Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.  In Shortliffe (3rd Edition). 65
  • 66. Appropriate Use of Health IT  Health IT “should be used in clinical practice only after appropriate evaluation of its efficacy and the documentation that it performs its intended task at an acceptable cost in time & money”  Qualified (licensed, trained & experienced) health professionals as users  Systems should be used to augment/supplement, rather than replace or supplant individuals’ decision making  Adequate training Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.  In Shortliffe (3rd Edition). 66
  • 67. Ethics for Developers  Follow standard of care & scientific progress (evidence-based)  System evaluation is ethically imperative Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.  In Shortliffe (3rd Edition). 67
  • 68. Why Clinical Judgment Is Still Necessary? • Nothing is certain in medicine & health care • Large variations exist in patient presentations, clinical course, underlying genetic codes, patient & provider behaviors, biological responses & social contexts • Human is good at pattern recognition, while machine is good at logic & computations. • Diagnosis is often achieved through recognizing clinical patterns • Not everything can be digitized or digitally acquired • Experience, context & human touch matters 68
  • 69. “Learned Intermediary” Doctrine • A defense doctrine used in the U.S. legal system (and some other countries) which states that “a manufacturer of a product has fulfilled his duty of care when he provides all of the necessary information to a ‘learned intermediary’ who then interacts with the consumer of a product.” (Wikipedia) • Primarily used by pharmaceutical & medical device manufacturers in defense of tort lawsuits. Source: http://en.wikipedia.org/wiki/Learned_intermediary 69
  • 70. “Learned Intermediary” Doctrine • Because health IT developers can’t expect a CDS advice (e.g., alerts & reminders) to be 100% appropriate for each individual patient, clinical judgment is still necessary. • Health IT developers & manufacturers are protected from liabilities for poor/inappropriate advices or for bad outcomes associated with them, as long as there is a clinician using it that can intervene • What about software bugs (e.g. wrong dose calculations)? 70
  • 71. “Learned Intermediary” Doctrine • Applicability of this doctrine varies based on legal jurisdictions, context of each case, and legal arguments • Recently, this doctrine has been noted by some legal and informatics experts that it doesn’t apply to health IT cases • It remains unclear until there are rulings from real legal cases 71
  • 72. Summary • Ethical principles are guides and standards of practice that can help us navigate through situations that arise. • History was full of unethical conduct • 4 important principles in bioethics  Respect for persons (autonomy)  Beneficence  Justice  Non-maleficence 72
  • 73. Summary • Ethical issues are present in informatics practice (whether as developers, implementers, executives, users, researchers, etc.) • Codes of conduct & ethics codes by professional organizations govern acceptable & ethical behaviors by informaticians • In use of health IT in clinical decision making, there are standard & appropriate guidelines that are based on ethical principles 73