1. Professionalism and Ethics

Question 1

Review from DENT552
́Distinction between ethics and morals:
́“____ refers to your own personal moral choices based on your upbringing, faith traditions, and experiences;
́____ refers to the formal process of intentionally and critically analyzing the basis for your moral judgments for clarity and consistency”
́Professionalism – relies on ____
́Comes from the word “profess” because professionals make a vow to
follow a universal moral code
́Professionals are given certain privileges by society in exchange for upholding professional ethics and serving the public
́Ethics evaluates ____

Answer 1

morality
ethics
ethics
behaviors

Question 2

Why do we have an Ethics Class?
́Reliable moral judgment is not ____
́Your “gut feeling” may be unreliable and prejudiced ́It is not always clear what is the right thing to do
́The purpose of this class is not necessarily to make you “ethical” in the sense of increasing your desire to do the right thing or to be a “good person”
́The goal is to teach you how to view issues and reason through ethical challenges from a consistent, universal point of view rather than “____”
́Teach you tools so you can think through ethical issues yourself rather than rely on law, family, culture, authority to think for you.
́Explain WHY you believe something is right or wrong

Answer 2

innate

good person

Question 3

Why do we have an Ethics Class?
́Can you teach someone to be “ethical”? ____!
́
́ Dramatic changes occur in young adults in their 20s and 30s in terms of the basic problem- solving strategies they use to deal with ethical issues.
́ These changes are linked to fundamental changes in how a person perceives society and his or her role in society.
́ The extent to which change occurs is associated with the number of years of ____ (college or professional school).
́ Deliberate ____ attempts (formal curriculum) to influence awareness of moral problems and to influence the reasoning or judgment process have been demonstrated to be effective.
́ Studies indicate that a person’s behavior is influenced by his or her moral ____ and moral judgments.

Answer 3

YES
formal education
educational
perception

Question 4

Consequentialism
́Consequentialism (Utilitarianism): “ends justify the means” – John Stuart Mill
́Whether an action is good (or best possible) or bad is judged entirely based on whether the ____ of that action are good or bad
́“All is well that ends well”
́Goal is to maximize the amount of “____” you are doing – the most good for
the most people
́No action is wrong in and of itself – the action is only judged based on the ____

Answer 4

consequences
good
outcome

Question 5

Deontology
́Deontology: “moral duty and obligation” – Immanuel Kant
́Based on moral principles, duties, or commandments – you shall and you shall not
́Judge action by whether it conforms to ____
́Ends do not justify the means
́People have ____, infinite worth
́Every rational being exists as an ____ in himself and not merely as a means to be used by others
́____ imperative: “Act in a way that your action could become a universal law of nature without contradiction” – do onto others as you would have them do onto you

Answer 5

principles
equal
end
categorical

Question 6

Autonomy
́Right to self-____ and self-____
́Right to choose and make decisions about self (or proxy) ́Within Standard of Care
́____ consent
́Professional Autonomy: having the authority to make decisions and the freedom to act in accordance with
one’s ____ knowledge base

Answer 6

governance
determination
informed
professional

Question 7

Veracity
́____, honesty
́Clinically: accurately describe ____ found,
document findings and procedures, use correct codes
́Academically: maintain academic ____, avoid plagiarism and cheating, do not manipulate research data/statistics
́Legally: reporting child ____, forgery

Answer 7

truthfulness
conditions
integrity
abuse

Question 8

Beneficence
́Do ____
́Individual: treat people with ____, provide quality treatment for oral conditions within your ability and scope of practice
́Community: maintain ____ of the profession, share clinical expertise with others, provide ____ to the community

Answer 8

good
respect
integrity
education

Question 9

Nonmaleficence
́Do No ____
́Individual: Act ____ in a manner that does not harm patient, Practice within scope of competency, Refrain from treatment when ____
́____: Ensure all personnel are well educated and competent, Prevent others from doing harm, Influence authorities to change laws and policies that cause harm

Answer 9

harm
conservatively
impaired
community

Question 10

Justice
́ ____
́Fair does not always mean ____, equal does not
always mean fair
́Clinically: treat people without ____, maintain standard of care
́Academically: Grades and exam scores reflect ____ and skill
́Legally: Treated equally before the law, “Punishment fits the ____”

Answer 10

fairness
equal
discrimination
knowledge
crime

Question 11

Four models of the Patient-Provider relationship
́ ____ ́ ____ ́ ____ ́ ____
́Each model has a different interpretation and balance of Autonomy and Beneficence, and differs in how the physician ought to fulfil these obligations

Answer 11

paternalistic
informative
interpretive
deliberative

Question 12

Paternalistic
́ Provider gives the patient whatever is best for the patient – ____
́ Physician determines the treatment, and ensures that patients receive the interventions that best promote their health and well-being.
́ Assumes the patient will be ____ for decisions made by the physician even if they would not ____ to them initially.

Answer 12

beneficence
thankful
agree

Question 13

Paternalistic
́ Assumes that there are shared ____ criteria for determining what is best, hence the physician can discern what is in the patient’s best interest with limited patient ____.
́ The physician has obligations, including that of placing the patient’s interest above his or her own and soliciting the views of others when lacking adequate knowledge.
́ The conception of patient autonomy is patient assent, either at the time or later, to the physician’s ____ of what is best.

Answer 13

objective
participation
determinations

Question 14

Paternalistic
́ Doctor’s role: figure out what in your professional opinion would be ____ for the patient and carry out the treatment
́ Patient’s role: ____, follow whatever the doctor orders

Answer 14

best

passive

Question 15

Informative
́ Physician provides the patient with all relevant ____, the patient ____ the medical interventions, and the physician executes the selected interventions – ____
́ Physician informs the patient of his or her disease state, the nature of possible diagnostic and therapeutic interventions, the nature and probability of risks and benefits associated with the interventions, and any uncertainties of knowledge.
́ At the extreme, patients could come to know all medical information relevant to their disease and available interventions and select the interventions that best realize their values.

Answer 15

information
selects
autonomy

Question 16

Informative
́ The patient’s values are well defined and known; what the patient lacks is ____.
́ It is the physician’s obligation to provide all the available facts, and the patient’s values then determine what treatments are to be given.
́ There is no role for the physician’s values, the physician’s understanding of the patient’s values, or his or her judgment of the worth of the patient’s values.
́ Physician is a technical expert. Physician’s obligations are to provide truthful information, to maintain competence in their area of expertise, and to consult others when their knowledge or skills are lacking. ____
́ The conception of patient autonomy is patient ____ over medical decision making.

Answer 16

facts
veracity
control

Question 17

Informative
́ Doctor’s role: provide all the medical ____ about the conditions, treatment options, risks and benefits, without any ____ about own thoughts, feelings, or values; carry out the treatment that the patient chooses
́ Patient’s role: know own ____ very clearly, choose off of the “menu” given by the doctor

Answer 17

knowledge
commentary
values

Question 18

Interpretive
́ ____ the patient’s values and what he or she actually wants, and ____ the patient select the available medical interventions that realize these values.
́ Physician provides the patient with information, assists patient in elucidating and articulating their values, and helps determine which medical interventions best realize the specified values.
́ The patient’s values are not necessarily ____ or known to the patient. The physician working with the patient must elucidate and make coherent these values.

Answer 18

elucidate
help
fixed

Question 19

Interpretive
́ Physician does not dictate to the patient nor ____ patient’s values; it is the patient who ultimately ____ which values and course of action best fit who he or she is.
́ Physician’s obligations include those enumerated in the informative model but also require engaging the patient in a ____ process of understanding.
́ Conception of patient autonomy is self-____; the patient comes to know more clearly who he or she is and how the various medical options bear on his or her identity.

Answer 19

judge
decides
joint
understanding

Question 20

Interpretive
́ Doctor’s role: figure out and help articulate the patient’s ____, provide medical information, help ____ the patient to the treatment options that will best help serve those values
́ Patient’s role: work with the doctor to figure out own ____, follow the ____ of the doctor to achieve the values through treatment

Answer 20

values
guide
values
recommendations

Question 21

Deliberative
́ Physician must delineate information on the patient’s ____ situation and then help ____ the types of values embodied in the available options.
́ Help the patient determine and ____ the best health-related values that can be realized in the clinical situation.
́ The physician’s objectives include suggesting why certain health related values are more ____ and should be aspired to. The physician aims at no more than ____ persuasion; coercion is avoided, and the patient must ____ his or her life and select the ordering of values to be espoused.

Answer 21

clinical
elucidate
choose
worthy
moral
define

Question 22

Deliberative
́ By engaging in moral deliberation, the physician and patient judge the worthiness and importance of the health-related values.
́ Not only does the physician indicate what the patient could do, but, knowing the patient and wishing what is best, the physician indicates what the patient ____ do, what decision regarding medical therapy would be admirable.
́ The conception of patient autonomy is moral self ____; the patient is empowered not simply to follow unexamined preferences or examined values, but to consider, through dialogue, ____ health-related values, their worthiness, and their implications for treatment.

Answer 22

should
development
alternative

Question 23

Deliberative
́ Doctor’s role: help the patient formulate and ____ their values, provide medical information about the conditions and treatments, provide ____ about and judgment of the different values embodied by each treatment, and ____ the patient, without ____, to choose the most worthy treatment
́ Patient’s role: work with the doctor to discover and judge own ____, and then get the treatment that best ____ with these values

Answer 23

identify
guidance
persuade
coercion
values
aligns

Question 24

Beyond the Four models of the Patient-Provider relationship
́ Framework for classification of patients in terms of: ́ degree of ____
́ formation of healthcare-related ____
́ extent of medical ____
́ These models exist on a ____
́ Consider influences of other ____ in the patient’s life
́ The role of ____ in the patient-provider relationship
́ ____ has changed the relationship between doctors and patients

Answer 24

autonomy
values
information
continuum
people
trust
internet

Question 25

Dr. Google
́ Eighty-five percent of respondents had experienced a patient bringing Internet information to a visit.
́ The quality of information was important: accurate, relevant information benefited, while inaccurate or irrelevant information harmed health care, health outcomes, and the physician-patient relationship.
́ However, the physician’s feeling that the patient was ____ his or her authority was the most consistent predictor of a perceived deterioration in the physician-patient relationship, in the quality of health care, or health outcomes.
́ Thirty-eight percent of physicians believed that the patient bringing in information made the visit less time efficient, particularly if the patient wanted something inappropriate, or the physician felt challenged

Answer 25

challenging

Question 26

The importance of accurate models of patient–provider interaction
́ Physicians who seem unable or troubled in adjusting to the modern dynamic have been associated with worsened ____ of care and health outcomes
́ Patients displeased with their physician seek a second opinion, change physicians, or change health plans entirely
́ physician ____ skills
́ ____ to patient information
́ ____ of feeling threatened or overly challenged
́ Those who resist conforming to this new variable risk not only serious damage to the patient–physician relationship, but also threaten patient health care.

Answer 26

quality
communication
reactions
appearance

Question 27

Informed consent
 ́ \_\_\_\_ – what do we tell the patient?
 ́ \_\_\_\_ – what does the patient comprehend? 
 ́ \_\_\_\_ – patient’s willingness
 ́ \_\_\_\_ – the capacity to make a choice

Answer 27

disclosure
understanding
voluntariness
competence

Question 28

Disclosure
Disclosure: what should we disclose? How to decide how much to disclose? It is pretty much not possible to disclose EVERYTHING. We have three standards of disclosure

́ ____: what is typically done? Do what people normally do in these cases. ́ A lot of cases require on the fly thinking!
́ It is very generic, not specific to each patient.
́ What if the standard is BAD?
́ Even if the standard is good, may not be possible or beneficial depending on circumstances

́ ____ person: what would a reasonable person want to know?
́ Who is reasonable?
́ What do you do about the people you consider unreasonable?

́ ____: disclose whatever the specific patient would want to know or may need to know
́ You would have to have a good ear for determining what a person would want to know.
́ But what if a person would want to know but you don’t know that they would want to know?
́ They don’t think there will be swelling, so you won’t know to tell them!
́ Many patients do not know how much and which information is relevant to their decision; most physicians cannot be expected to do exhaustive background and character research on their patients

Answer 28

professional practice
reasonable
subjective

Question 29

Understanding
́ Not much is getting in!
́ A layperson might not want to say, “ I don’t understand” – will just nod…
́ ____ dynamics – person might not think it is appropriate to ask questions
́ How will you weigh the information/options?
́ Information comes in a ____ language, in huge waves
́ You don’t know WHY the person is telling you something - is it a legal precaution, or is the doctor truly worried?

Answer 29

power

convoluted

Question 30

Voluntariness
́ Voluntariness: are you coerced?
́ ____ for treatment
́ Continuing ____

Answer 30

incentives

permission

Question 31

Competence
́ Competence: informed consent is only a possibility if you are competent; if you are not competent, you get a ____ decision maker.
́ Examples of “non-competence”: ____ patient, incapacitated patient, patient with advanced Alzheimer’s disease
́ Here are the 3 standards for surrogate decision maker:
́ ____: What would the patient do?
́ ____: There is written or verbal record of what the patient would want in certain circumstances.
́____: What would be BEST for the patient?

Answer 31

surrogate
pediatric
substituted judgement
pure autonomy
best interest

Question 32

Informed consent
What is it that providers should disclose to the patients?
 ́ \_\_\_\_ of treatment/procedure
 ́ \_\_\_\_ vs. reality
 ́ Cosmetic procedures
 ́ Time and cost commitment

́ ____
́ Conflict of interest
́ Judgment of efficacy/skepticism ́ Evidence - not efficacious
́ Ethical judgments

́ ____ of treatment (and the way they are conveyed)
́ Imagine that the benefits are just not the same
́ X is the gold standard, but Y is also an option
́ X is most popular, but Y can also be done.
́ If it were me, I would go with X, though Y is also possible
́ In your particular case, X would be better, though Y can also be done

́ You can’t be ____ - if you say the two options are identical, then either you don’t care about the choices, or in your mind they are equal, then you have shaped the information according to how you see it. What if there is an option that you just think is not good - it would be odd to pretend that you have no opinion. You are not a robot!

Answer 32

risks
expectations
alternatives
benefits
neutral

Question 33

Principles of ethical research

NIH Clinical Center researchers published seven main principles to guide the conduct of ethical research:
́ ____ value
́ Scientific validity
́ Fair ____ selection
́ Favorable risk-benefit ratio ́ Independent review
́ Informed ____
́ Respect for potential and enrolled subjects

Answer 33

social and clinical
subject
consent

Question 34

Coercion and Undue Influence

́ Undue Inducement:
́ Undue influence occurs through an offer of ____, unwarranted, inappropriate, or improper reward or other overture in order to obtain compliance
́ Monetary inducements may be undue if they ____ patients’ decision- making processes such that they do not appropriately consider the risks of participating
́ These things are in the eyes of the beholder.
́ An offer one could not refuse is essentially ____ or undue. Undue
inducements may be troublesome because:
́ Offers that are too attractive may ____ prospective subjects
́ Subjects will lie to be paid and not be disqualified from the study.

́ “Macklin Principle: inducements are undue if a subject is willing to ____ to get into the study”
́ But you don’t know people are lying!
́ Money is undue to some and not undue to others
́ People will want to go into studies because it is their “last chance” and so they will lie!

Answer 34

excessive
alter
coercive
blind
lie

Question 35

Nuremberg Code 1947
́ The ____ consent of the human subject is absolutely essential.
́ The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
́ The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
́ The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
́ No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will
occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
́ The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
́ Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
́ The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
́ During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
́ During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probably cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Answer 35

voluntary

Question 36

Declaration of Helsinki 1964
́ Created by the World Medical Association for the medical community
́ Is ____ a legally binding document
́ “The Declaration is ____ binding on physicians, and that obligation overrides any national or local laws or regulations, if the Declaration provides for a higher standard of protection of humans than the latter. Investigators still have to abide by local legislation but will be held to the higher standard”
́ Helsinki Report has undergone ____ revisions (most recently in 2013)
́ “Concern for the interests of the ____ must always prevail over the interests of science and society.”

Answer 36

not
morally
seven
subject

Question 37

Tuskegee Syphilis Study
́ Conducted between 1932 and 1972 by the U.S. Public Health Service
́ The purpose of this study was to observe the natural history of untreated ____
́ The African-American men in the study were told they were receiving ____ health care from the United States government
́ Led to the ____ Report

Answer 37

syphilis
free
belmont

Question 38

Belmont Report 1978
́ Belmont report identifies the basic ____ principles that should underlie the conduct of research involving human subjects
́ ____ (includes do no harm)
́ ____
́ Respect for persons (____, informed ____)

Answer 38

ethical
beneficence
justice
autonomy
consent

Question 39

Milgram Experiment of Obedience
́ Stanley Milgram, Yale, 1961
́ 65% (two-thirds) of participants (i.e., teachers) continued to the ____ level of 450 volts. All the participants continued to 300 volts.

Answer 39

highest

Question 40

Jesse Gelsinger Gene Therapy trial 1999
́ Gelsinger had ornithine transcarbamoylase (OTC) deficiency, a metabolic disorder that affects 1 in 40 000 newborns by impeding the elimination of ammonia. Most of these babies become comatose within 72 hours of birth and experience severe brain damage. Half die within a month of birth, and half of the survivors die by age 5.
́ Gelsinger’s outcome was different because he had only partial OTC deficiency, which he kept in check with a low-____ diet and drugs. He was considered an ideal candidate for the trial, led by Dr. James Wilson, director of the Institute for Human Gene Therapy at the University of Pennsylvania.

Answer 40

protein

Question 41

Willowbrook Hepatitis Study 1956-1970
Healthy mentally retarded children whose parents were seeking a placement in an institutional setting at Willowbrook State School in Staten Island, New York, were intentionally infected with ____ in an attempt to track the development of the viral infection
The children were offered ____ and better conditions at the institution.
́ The researcher also wanted to determine the effectiveness of gamma globulin injections as protection against hepatitis.

Answer 41

hepatitis A

placement

Question 42

The Common Rule 1991
́ The Federal Policy for the ____ of Human Subjects ́ Additional Protections for ____ women, fetuses,
neonates, ____, and ____

Answer 42

protection
pregnant
children
prisoners

Question 43

Pediatric research Constraints:
́ ____ levels of protection
́ If no benefits to the child, then less than or ____ risk is
acceptable
́ If some benefit to the child, then ____ than minimal risk (benefit to risk ratio is at least as good as what currently exists)
́ If research will yield vital knowledge of the disease group but not direct benefit to the actual child, then only ____ increase over minimal risk

Answer 43

three
minimal
greater
minor

Question 44

IRB – Institutional Review Board
́ The Institutional Review Board (IRB) is a type of committee or administrative body that aims to protect the ____ of human research subjects by reviewing the proposed research to ensure that it is ethical

Answer 44

rights and welfare

Question 45

IRB – Institutional Review Board

́ The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research proposed Title 45, Part 46 of the Code of Federal Regulations, widely known as the Common Rule, which was signed into law in 1981.

́ These federal regulations require that all human subjects research funded by United States federal money be conducted under the oversight of the ____.

́ The local IRBs, which are overseen by the Office for Human Research Protections, are charged with protecting the ____, safety, and welfare of human subjects in research activities under the auspices of an institution to which the IRB has an affiliation.

́ In fact, the requirement for IRB oversight now extends to all ____ subjects research, regardless of the funding, supporting, or designing source, so all human-subjects research must be reviewed and approved by an ____ registered with the Office for Human Research Protections before any research procedures, including eligibility screening, can be performed with human subjects in the United States.

́ Since these regulations derive from federal legislation, it is ____ to conduct any human-subjects research procedures without first obtaining approval from an IRB or other appropriate ethics committee (such as an institutional ethics committee, research ethics committee, or ethical review board). The penalties for doing so may be severe, ranging from monetary fines to the individual and/or the institution to imprisonment.

́ In addition, most journals have adopted the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, as put forth by the International Committee of Medical Journal Editors. These requirements necessitate an indication that the research procedures were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000. To fulfill this requirement, most journals now require a ____ in every submitted manuscript that approval was obtained from the IRB, or equivalent entity, prior to initiating the research. Some journals even request a copy of the IRB determination prior to considering any submitted manuscript. If IRB approval was not obtained, the journals refuse to even consider the manuscript.

Answer 45

office for human research protections
rights
human
IRB
illegal
statement