Why is it important to allocate limited vaccination as a priority for healthcare providers first?
Because they are vectors for taking care of other patients
Belmont Report
Respect for persons that individuals are autonomous agents and make their own informed decisions and that those with diminished capacity (therefore diminished autonomy) should be protected (prisoners, children, handicapped), cornerstone document on ethical principles and HHS regulations for protection of research subjects
American Eugenics
Principles promoted by powerful elites of American society that inspired Hitler’s ideology regarding the idea that sterilizing the disabled would benefit society
Beauchamp and childress
Did landmark work for respect for autonomy regarding the patient including obtaining consent for intervention and helping others when asked to make difficult decisions
Voluntariness
The idea that an individual acts voluntarily only to the extent that they are not under control from others
Informed consent requires 6 things listed
1) disclosure of all necessary information
2) capacity of the patient to understand the info and form reasonable judgement
3) voluntariness of the patient to exercise decision without external pressure
4) risks excluding remote unless paralysis or death
5) benefit
6) alternatives including doing nothing
“Given the info about my condition, what would you do?”
Its irrelevant to me, my belief system is different. What would your parents do?
Material fact
What a reasonable patient would need/want to know to make a decision
Rule of double effect
The idea that one action could have 2 possible outcomes, one unethical and one ethical, but the guiding principle being intent
ex) if you alleviate pain with a narcotic but then the patient has a reaction and dies
Paternalism
When beneficence trumps autonomy, only recently has autonomy gained ascendancy in certain situations “weak paternalism”
Charlie Gard case
CRISPR Ethical case
Anti-kickback policy
Laws that prevent healthcare providers from referring to something that they profit off of
Overcoding
Reporting codes in a manner that results in higher payment for the practicioner
Who has a right to know the results of a test?
- Physician and other relevant healthcare providers
- the patient
- if the patient is a minor then the guardians
- any family the patient has approved to know
Factors to consider when ordering a test (3)
- accuracy
- risks
- is there a treatment?
Gold standard test
The most accurate test possible under reasonable conditions, may not be able to perform due to complications
Why do we diagnose and overtreat? (4)
- medico-legal threats***
- commercial interests
- technology developments
- deliberate profiteering
Screening tests tend to be highly ___, confirmatory tend to be highly ___
sensitive, specific
Can you tell a partner of a patient who has HIV and doesn’t want to share that info with them?(when is breach ethically justified?)
Yes because there is harm to a 3rd party and greater good would result from breaking confidentiality rather than maintaining it
Once a drug is FDA approved for a particular purpose, a physician can prescribe it for…
…any clinical condition, regardless of if the marketing outruns the research
Drug reps can see how many prescriptions of a drug a provider has prescribed the past (true or false)
True
1997 FDA direct to consumer advertising
When the law was changed to allow pharm companies to advertise directly to patients as long as they provide benefits and risks and use it on label, has pros and cons (helps educate patient to inform them but can be misleading and lead to overprescription for non-disease processes)
Providers in PA have the right to refuse treatment based on ______, but they have to…
conscientious objection, …have to provide alternatives or refer to another provider
Guidelines for promotional material provided to healthcare providers on behalf of a company should… (4)
- be accurate
- make claims only when properly substantiated
- reflect balance between risks and benefits
- be consistent with all FDA requirements
Regulations regarding drug rep provider interactions
- can occur any time of the day and include meals of appropriate price
- no recreation or entertainment
- CME funds must be allocated to a CME provider
- no financing trips to conferences for providers
- no items that do not advance disease treatment education even of minimal value are allowed
- items designed for education of patients or professionals should be offered only occasionally and must have a value less than 100$
Primary value of the PA is responsability to…
….health, safety, welfare, and dignity of all humans
Who created the PA profession? What day is National PA day/week?
Eugene A. Stead Jr, MD, October (6)-12
Beneficence
Act of kindness or charity, a duty to maximize benefits, prevent and remove harm, rescue those in danger
Justice
In research refers to fairness of distribution - what is deserved and equal, what justifies deviation from equal distribution?
Autonomy
Respect for the patients right to remain in control of their lives
Non-maleficence
Do not kill, cause pain or suffering, incapacitate, cause offense, or deprive another of the goods of life
Utilitarianism
The doctrine that actions are right if they are useful for or benefit the majority (similar to consequentialism where if the outcome is good, it doesn’t matter the morality of the action - in this case if it benefits the majority)
Unless the rare instance where a patient may be a threat to themselves or requests informed preference not to be told the truth, a patient must always be told…
….truthful disclosure about condition
Deontology/formalism
Theory that morality of an action should be based on whether that action itself is right or wrong under a set of rules rather than based on the consequences of that action (killing is wrong even in self defense)
Consequentialism
Theory that morality of an action depends on the consequences as the ultimate basis for judgement about the right or wrongness of the conduct (results matter, whatever has the best outcome is the best action, even if it violates a “moral”, so killing is right in self defense if it saves a child)
11 structural attributes of professionalism
- specialized body of knowledge and skills
- unique socialization of student members
- licensure/cert
- professional organizations
- governance by peers
- social prestiege
- vital service to society
- code of ethics
- autonomy
- equivalence of members
- special relationship with clients
5 attitudinal attributes of professionalism
- use of professional organization as major reference
- belief in service to others
- belief in self regulation (one’s peers are best qualified to judge ones work)
- sense of calling to the field regardless of extrinsic reward
- autonomy
7 barriers to professionalism
- abuse of power
- arrogance
- greed
- misrepresentation
- impairment
- lack of conscientiousness
- conflict of interest
6 elements of professionalism
- altruism
- accountability
- excellence
- duty
- honor and integrity
- respect for others
___ is taking an action to help someone, while ___ requires intentionally refraining from an action that will harm someone
beneficence, nonmaleficence
Ethics and circumcision
Only recently did it become standard to provide anesthesia in circumcision of infants based on principle that infants nervous systems cannot feel pain, the “liverpool technique” was changed and policy on use of analgesia use in neonatal surgery only 33 years ago
Children and research
Often children are not included in research due to inability to direct consent to research and fear of exploitation, oncology remains one of the only fields well researched
Willowbrook school hepatitis studies
A residential living facility for mentally handicapped children where parents were coerced into signing their children’s rights away for admission to the school where they were then experimented on transmission of hep A (fecal oral)
Ethical order to practicing procedures on children***
- learn in textbooks
- learn on adults and manikins
- learn on children
Rules of discontinuing practice to a patient
- must supply 30 day of care after official notification
- must provide all medical records for their access
- must provide list of other providers that they can transfer to that are within their insurance plan
3 types of misbehaviors
- Financial (fraud billing)
- Misrepresentation (introducing self as MD)
- Boundary violations (sexual harrassment)
5 domains of emotional intelligence (Goleman)
- know own emotions
- manage own emotions
- recognize emotions in others
- manage relationships
- motivate oneself
4 essential behavioral attributes as part of professionalism (civility)
- tolerance
- respect
- proper conduct
- diplomacy
Civility is a foundational value for…
…professionalism
3 pillars on which professionalism is built
Structural
Attitudinal
Behavioral
4 features of ethical decision making and virtue ethics
Agent (faced with making choices)
Choices (generally perceived as right or wrong, deontology)
Consequences (anticipate certain consequences of actions, consequentialism and utilitarianism)
Context (The setting as it influences the decisions)
Virtue ethics places emphasis on the moral character of the agent, so the first
Casuistry and narrative
Context focused theories that compare similar cases or use insight to supply the theory around why a decision was made`
Donald “Dax” Cowart case
Critically injured but kept insisting consistently and coherently he did not want care or want to live, should his wishes have been respected? Right to die?
Limits to beneficence
Duty to ones self respect and personal well being including psychological capacity for suffering
What is the primary economic barrier to healthcare access in the US and which of the 4 principles of the profession does it impact?
Inadequate or unequal insurance coverage, justice (distribution of a resource while considering marginalization of certain identities such as the poor)
AAPA ethics vs AMA
PA’s maintain idealism, enthusiasm, and moral values with less exposure to “tacit curriculum” that plagues doctors
Tacit cirriculum
The behaviors doctors are inclined to as a result of years of schooling grounded on ethics of detachment, self interest, distrust, and objectivity, in stark contrast to the education systems teachings of commitment to empathy, compassion, and altruism
Student response to the dichotomy of the American medical education (3)
- give up tradtional values and become technicians
- give liip service to traditional values but remain coolly objective and scientific
- manage to hold onto values, resist tacit values, and internalize and develop personal virtue
Civility
Behavioral expression of foundation for professionalism - the minimum behavioral standard
Professionalism
More specialized evelopment of ethical and civil behavior beyond what is expected for a non professional
Passive vs active incivility
Passive involves forms of disrespect that are behaviors done for oneself (sleeping in class, watching videos)
Active involves action that directly combats authority (talking back to preceptor, cheating)
4 goals of medicine
- do no harm
- improve quality of life
- relieve pain and suffering
- extend life within construct
Ultimate goal of an IRB
Provide a risk benefit analysis to determine if research should be done, the priority being to protect human subjects from physical or psychological harm
Individual vs social justice (research)
In regards to research, individual justice requires that the benefits of research are offered to a diverse eligible population and risk while social is consideration for classes of subjects that should not participate in research based on accessory burdens
Nuremberg code
Created post ww2 in response to atrocities committed by nazis requiring voluntary consent, scientific merit, benefit outweighing risks, and ability of subjects to withdraw at any time in research
Beecher article
Pointed out that ethics violations in research have been performed by many US prestiegous journals including the tuskegee syphillis study, jewish chronic disease study, and willowbrook study - argued that responsible investigators should enforce ethical behavior
1974 research act
Established national commission for protection of human subjects of biomedical and behavioral research and developed guidelines on enforcing them (belmont report)
Jesse Gelsinger
1999 research study in gene transfer clinical trial died due to reaciton to recombinant viral vector due to deficiency in enzyme at university of Penn, later found investigator of research was inventor of technology used in trial and this raised huge issue about financial conflicts in interest of research
Declaration of helsinki
World medical association raft of the first international agreement recommending ethical standards for research
Privacy vs confidentiality
;Privacy is having agency over extent, timing, and circumstances of sharing oneself or info about oneself to others, while confidentiality is how that info is handled once it is obtained (used, stored, reported)
IRB members
At least 5 from variety of backgrounds including expertise and diversity in different populations
Aristotle philosophy
Nichomachean/virtue ethics, law begins by considering what makes a person morally good
Thomas Aquinas philosophy
Good should be done and evil avoided, we have a natural inclination on which is which
Kant philosophy
Deontological imperitive - only good is as true as good will
Mill philosophy
Consequentialism/utilitarianism the idea that outcome matters more than action
“the ends, they justify my means” -that one slipknot song
Law of proportionality
The idea that one should be punished to the extent of which they deserve - those who do worse things should receive worse punishments
Egalitarianism
Opposite of utilitarianism, idea that each person is equal and deserves equal rights and opportunities
Rawls philosophy
Egalitarianism
Utilitarianism vs egalitarianism
“you should do something for me if it will hurt you less than it will help me,”
“you should do something for me if you are better off than I am”
Coercion vs persuasion vs manipulation
Coercion involves a threat, persuasion involves rational exploration and merit of anothers advice, manipulation is expression of info in a biased way
Rule of thumb (religion)
Acceptable religions are mainstream with significant number of people believing (not pastafarian)
Legal incompetence and LAR’s
Legal incompetence is determined by a judge alone, and a legally authorized representative are required for subjects of potential research capable of providing surrogate consent for the individual in question
Only adverse events that are also ___ need to be reported to an IRB
Unanticipated problems
Is de-identified data considered PHI under HIPPA?
No
Should you tell your supervising physician about all errors? What about the patient?
Yes must tell supervising doctor all errors, tell patient all errors, even trivial, that will affect their well being (others say should be only required if it is significant to patients well being)
Some common cultural aspects of western medicine not present in other cultures
- make it better
- dominance over nature
- treat sooner than later
- stronger therapy is better
- new is better
- treat same conditions the same
5 essential elements that contribute to an institutions ability to become more culturally competent
1) value diversity
2) capacity for cultural self assessment
3) consciousness of cultural interactions
4) cultural knowledge
5) adapt service delivery that reflects understanding of cultural diversity
Empathy vs sympathy
Empathy is retaining objectivity to do job better, not becoming too emotionally involved
Children and refusal of treatment
Adults can refuse anything they want, children’s parents cannot deprive children of medical tx or life saving therapy regardless of beliefs (but it varies somewhat state by state)
Assent in research
What a child must provide to the extent they are capable alongside parental permission to be part of research
Singer vs Wear and Kuczewski
Singer states that professionalism and ethics are the same, while Wear and Kuczewski think they are different as excess work deprofessionalizes a student and may harm their character
Patient centered vs relationship centered vs deliberative vs consumerist vs interpretive vs paternalistic models of the patient PA relationship
Patient centered focuses on what the patient wants and needs
Relationship centered emphasizes the reciprocal nature of of the valuable relationship
Deliberative describes where the PA acts as a friend or teacher to help patient select own health related values
Consumerist involves PA’s informing patients about issues which patient uses according to own values to determine what they want to implement
Interpretative engages the PA in elucidating and interpreting patient values and advising what interventions realize these values
Paternalistic sees the PA as a guardian that should determine best intervention of assenting patients
Therapeutic privelege
Refers to situation where there is compelling evidence that disclosure of a condition will cause real and predictible harm to the patient (such as making them hurt themselves), then truthful disclosure may be withheld
Prudence
Practical wisdom that a PA has to make the right moral choice in a given circumstance - doing the right thing for THIS particular patient
Reason tests are performed
To reduce uncertainty about a suspected diagnosis for the provider
The biggest success of western medicine
Vaccination