Ethics Study Guide
Authored By: The Group Of 14 Slackers
SESSION #1
Ethics can be used to answer questions. “The fact that [ethics] panels exist acknowledges that
there are ethical matters that cannot be dealt with responsibly without special knowledge and
study…one’s person’s opinion is NOT always as good as another’s” but there are instances in
which everyone can agree that certain things are wrong or right…or one should act in this way or
that.
Four types of Right and Wrong:
Ethical
Clincal
Professional
Legal
Clinical Norms:
Deals with effectives in diagnosis, promoting and restoring health. Providing
“Good” Standard of Care.
Clinically Right is ideally ethically right, but is not always.
Legal Norms:
Avoiding criminal or civil liability.
Legally is ideally ethically right, but not always.
Professional Codes:
Oath of Hippocrates
AMA Principles of Medical Ethics
AMA Declaration of Professional Repsonsibility
Confidentiality, Honesty, Integrity, Teamwork, Educating the public, etc.
Professionally right is usually ethically right, because ethical principles are used to define
professional guidelines.
Guidelines for Ethical Analysis:
1. Identify and Describe the Problem.
2. identify the applicable values and facts
3. Identify all possible solutions.
4. (No joke, it says) Identify the BEST solution.
5. Justify the conclusion:
a. Assess each alternative solution…which values and facts does this solution
sustain, which does it undermine?
b. Present why the “best” resolution sustained better the values and facts where
the others failed.
General vs. Special Obligations:
Special (Professional) Obligations:
Those outlined in the AMA Declaraion and Principles and Oath of Hippocrates such as “educate
the public” and “to hold him who has taught me this art as equal to my parents…”.
General Obligations:
Respect for human dignity, Honesty, etc.
Difference between ethics and ethical theory:
Ethics: questions of moral conduct
Ex: Should I sleep with Jeff Walch?
Ethical theory:
a) What principles should be used to justify moral judgements?
Ex: Should I consider that Jeff is very good looking or should I consider
his history of breaking hearts in deciding whether or not to sleep with him?
b) Are there any absolute truths or is every moral decision subjective?
Ex: Maybe it is right for Marc Rogers to sleep with Jeff Walch, but not for
Kevin Carl.
vs.
Everyone MUST sleep with Jeff Walch.
All in all, this lecture was very “common sense”, basic stuff. Email me with any questions!
prashant.atri@gmail.com
Lecture #2:
Introduction to Law, Tort, and Professional Liability
9/07/05
1. To understand how law is made:
Law is made by all three branches of government. The law made by the judicial branch
tends to be the most dominant in today’s system, and is referred to as “case law,” or “common
law.” Case law is generally made through a process in which a civil suit’s verdict in a lower
court is appealed. If a higher court agrees to hear the case, its written, published decision
becomes precedent for other cases that are similar. The decision of the higher court becomes
binding on lower courts in the same state, but not on courts in other states.
2. To understand the difference between civil law and criminal law
In civil law, private parties prosecute. In criminal law, the state prosecutes. Civil law can
be further divided into tort law and contract law. Tort is difficult to define, but can be
distinguished from a crime or breach of contract. A tort is a legal wrong and, taken literally, can
mean “conduct which is twisted or crooked, not straight” (see slide 12). A crime is a wrong
against the state (and is prosecuted by the state), whereas a tort is a wrong against an individual
(and must be remedied by the individual). Tort litigation will involve the plaintiff (the person
injured), the defendant (the person who allegedly caused the injury), and often an insurance
company, as tort is the class of legal infraction that medical malpractice and other insurable
liabilities can full under. Torts can be seen as either negligent or intentional.
3. To understand the elements of professional negligence (medical malpractice)
To establish negligence, the following must be proved:
1. The defendant owed the plaintiff a duty to use reasonable care.
2. The defendant failed to use reasonable care.
3. The defendant’s failure to use reasonable care directly caused harm to the plaintiff’s person or
property.
In the context of medical malpractice, all of the above must be established. That a patient suffers
bad results from a medical procedure is not sufficient to prove malpractice. Rather, a plaintiff
must show that the doctor did not act within the guidelines of the established “standard of care”
surrounding a medical procedure or practice. The standard of care is generally established by the
medical profession itself. Deviation from the standard of care must be verified by testimony of
other physicians and comparison to policy statements of official medical organizations.
Examples of malpractice offered in lecture were:
Negligent diagnosis
Negligent treatment (e.g. failure to read medical record)
Negligent failure to warn (e.g. a psychiatrist failing to report that a psychiatric patient admitted a
desire to murder someone)
Negligent failure to make legally required reports, such as child abuse or contagious disease
Session 3: Informed Consent
September 14 – Kevin Carl
Learning Objectives:
1) To understand the concept of informed consent.
2) To identify and explain the components of informed consent.
3) To identify a physician’s roles and responsibilities in relation to informed decision-making.
1) Informed consent is defined as autonomous authorization. In other words, it is freely assenting
to something, knowing the details of what this decision entails. While informed consent is often
ignored in emergent situations, it is otherwise almost universally required for medical
intervention. It is NOT merely a signature on a piece of paper, but a shared and collective
decision making process between doctor and patient.
2) A patient’s consent to something is only valid, however, if the patient is actually INFORMED.
Don’t forget this part. First, there are 4 criteria for defining when someone is even capable of
autonomous authorization. They are decision-making capacity, comprehension, voluntariness,
and assent. Decision-making capacity is typically an informal clinical judgment call. It involves
capacity to understand relevant information, ability to weigh treatment options, stable values and
goals, and the capacity of communicating their preferences. DMC can change, or only affect
certain decisions but not others. Ultimately, patient authorization is not required if DMC is
absent, and on the flip side – patients with DMC have a right to accept or refuse treatment.
Comprehension is an actual understanding of relevant information necessary to make an
informed decision about treatment. This doesn’t need to be perfectly scientific – just enough to
make a rational choice. Voluntariness implies no coercion or undue pressure from anyone. This
does NOT mean that physicians or family must be completely neutral and not offer their opinion
– just that they allow the patient to make their own choice. Assent is easy – it just means that the
patient accepts the medical intervention.
3) What can docs do to facilitate this? Explain recommended treatments as well as alternative
options (including non-treatment). Go over risks, benefits, and work to integrate understanding
of the medical half with the patient’s values and priorities. Being sure that your patient is well
informed and aware of all possibilities, they will be more likely to follow treatment plans and
accept negative outcomes. Informed decision-making by patients is a RIGHT – give it to them
and everyone is happy.
Learning Objectives # 4
Anne Dudley
1. To understand the origins of the right to refuse treatment in battery law
2. to understand te relationship between informed consent and the right to refuse
3. To understand the requirements imposed on doctors by the doctrine of informed
consent
4. to understand the exceptions to the requirement to make disclosure and obtain
consent
1. To understand the origins of the right to refuse treatment in battery law
INFORMED CONSENT: Originally, to be touched or treated without consent was considered
battery, and the person responsible, ie the physician, was therefore held responsible or liable.
Today there is a “hybrid of battery and negligence” regarding these issues. The physician has
two duties:
1. duty to obtain consent (battery)
2. duty to disclose information to the patient to obtain consent “worthy of the name”
(negligence)
TREATMENT REFUSAL: If treating someone without their consent is battery, then it follows
that there is a right to refuse treatment. Treatment refusal is permitted as long as the patient is
declared competent, even if the patient’s death may result. In cases of incompetent patients, a
surrogate must make decisions for the incompetent patient, in keeping with the patients “wishes”
or best interests.
Ex. Dax’s case- Patient was severely burned in 1973 and repeatedly expressed his desire
to die. His wishes were ignored, despite two videos he made expressing his desire to die. His
videos became examples of medical paternalism, and are used for arguing for patient autonomy.
2. to understand the relationship between informed consent and the right to refuse
Informed consent is based on the idea that all competent patients should have control over their
bodies. “Informed” consent refers to providing patients with relevant information to help weight
benefits and risks of the proposed treatment, as well as helping patients to understand the
treatment to raise compliance.
The physician has a duty to disclose information to the patient relevant to the treatment. This
includes risks, benefits and alternatives of the treatment.
There are four exceptions to the informed consent rule:
1.
Emergency: Disclosure must be tailored to the situation, patients may be treated w/o
consent if it is an “act now or lose the chance” situation
2.
Incompentency: If the patient is incompetent, his/her informed consent is not needed.
A legally responsible party must give informed consent
3.
Waiver: The patient may waive the right to know if he/she does not want to know the
information. This is only valid if the patient was informed of the right to know, and
then decided to waive it.
4.
Therapeutic Privilege: If a physician believes the patient will become too upset to
make a rational decision, information may be withheld. This does NOT apply if the
physician believes the patient might refuse treatment, and withholds information.
The right to refuse is another aspect of the idea of patient autonomy. It gives the patient the right
to refuse treatment he/she does not want; therefore it works with informed consent to educate the
patient about choices. Patients may accept treatment, request an alternative or refuse all together
based on informed consent. It is valid for all types of treatment provided the patient is
competent.
3. To understand the requirements imposed on doctors by the doctrine of informed
consent
The doctrine of informed consent requires doctors to disclose relevant information regarding
treatment and obtain consent for treatment. There are two generally accepted standards of
disclosure
a. Materiality standard- what a reasonable patient would find material to making a decision
b.Customary standard- what a reasonable physician would disclose
As mentioned before there are four exceptions to informed consent: emergency, incompetency,
waiver and therapeutic privilege. Therefore physicians are required to inform the patient of the
risks, benefits and alternatives of the treatment before obtaining consent for a treatment. Failure
to do so could result in malpractice or other legal action, as it is considered battery to treat a
patient without informed consent.
4. to understand the exceptions to the requirement to make disclosure and obtain
consent
There are four exceptions to obtaining consent: emergency, incompetency, waiver and
therpeautic privilege. Therapeutic privilege allows an exception to disclosure of full
information, if the physician believes the information will make the patient unable to make a
decision.
Session 5: Caring for Minors
So, Professor Hartman’s lecture for this topic is incredibly dense, and I cannot honestly decipher
what is important from what is not. As you can tell from reading her two learning objectives,
they are very vague and not answered very directly. I think her L.O.’s were more to guide her
lectures, for her own good.
Here’s the structure:
1)
A section that summarizes the three readings for the corresponding lecture on
Caring for Minors (one article, and two court cases).
2)
Summary of the lectures/themes that indirectly answer the learning objectives.
These are mainly her notes for the first three pages of her slide handout. Since
I did not take any notes on Pages 4-7, I’m pretty sure she skipped over them b/c
she ran out of time.
3)
I recommend browsing over those pages that she didn’t go over, if you have
time. If not, probably not a big deal.
4)
Any questions or complaints, direct to Andres
(turner.andres@medstudent.pitt.edu, 650-888-1277) or Chetan
(Irwin.chetan@medstudent.pitt.edu)
READINGS
Dying Young: Cues From the Courts (Hartman)
Despite extending constitutional guarantees to minors, US Supreme Court has deemed that
minors lack the complement of skills necessary for medical decision making.
State courts have taken more varied stances. In W. Virginia, the case of Belcher (muscular
dystrophy patient, physician did not consult adol patient before carrying out DNR order) the
court recognized that experience with life-threatening disease escalates maturity levels in minors.
Court joined other states in adopting the “mature minor doctrine”: affords legal protection to
minor’s medical decision making based on age, ability, experience, education, training, conduct
and demeanor. Physicians are delegated the responsibility of making the judgment call.
Next push: for states to consider legal validity of minor’s advanced directives. Issues of concern
include how adv. directives could influence adol relationship with parents, esp. if disagreement
exists.
Hart v. Brown, 1972
-Two 7 year old twin girls; one is going to die of kidney failure
-The parents want to have the healthy girl donate her kidney to her sick sister (isograft)
-The issue is of protecting the rights of the potential donor sister (minor)
-The court has assigned a guardian ad litem (of limited scope) for the donor girl
-The court found the medical risks/downsides of the procedure from the donor’s perspective to
be negligible and cited the idea from a previous case of the “grave emotional impact” the death
of the sick sister could have on the donor sister were the transplantation not to take place.
Commonwealth v. Nixon, 2000
- Parents members of Faith Tabernacle church (religion in which illnesses addressed through
spiritual tx, instead of medicine).
- Shannon Nixon, age 16, went comatose and then died of diabetes acidosis while parents prayed
and had her ‘anointed’ at church
-involuntary manslaughter and endangering the welfare of a child
-"mature minor doctrine" did not provide an affirmative defense, and Shannon’s privacy rights
did not remove her parents’ statutory obligations to seek medical care for her.
LECTURES
Professor Hartman had a theme throughout her lecture:
A more uniform system is needed in the U.S. to approach cases that deal with caring for
minors. Right now, every state makes its own decisions w/o really reviewing research on the
topic, so there is too much variation. Keep this in mind when you read the slides.
L.O. 1: To understand the ethical and legal framework guiding the treatment of minors (children
and adolescents).
14th Amendment of U.S. Constitution safeguards medical decision making by competent adults,
including refusal to life-prolonging care. The U.S. Supreme Court has interpreted this strictly by
applying the law only to adults, and not including children and adolescents. The Supreme Court
stated that inexperience limits minors’ legal autonomy for “making life’s difficult decisions.”
Therefore, the Court upheld states’ statues requiring parental notification and consent for
adolescent abortion decisions, and found parental consent, coupled with psychiatric evaluation,
consistent with due process when committing an adolescent to a mental health institution. Some
states have afforded adol autonomous medical decision making for substance abuse and STD’s,
especially in special circumstances (homelessness. pregnancy, etc.), and some states even allow
adol consent for voluntary mental health Tx w/o parental consent or notification. These state
statues, however, authorize adolescent decision making when consenting to, rather than
refusing, Tx and do not expressly include decision making about end-of-life care.
HOWEVER, a particular court case gave minors protection under the Constitution:
1. In re Gault (U.S. 1967): “neither 14th Amendment nor Bill of Rights is for adults alone”
SO, minors are protected by the Constitution, but their rights are diluted and qualified.
2. Bellotti v. Baird; Parham v. J.R. (U.S. 1979): Court said that children and adolescents
cannot make sound judgments concerning medical and other decisions
a. However, did not use facts to support this argument!
IMPT CONCEPT: Parens Patriae (“parent of the country”)
Again, In re Gault – gave “the power of the state to act in loco parentis (in place of the
parent) for the purpose of protecting the person of the child”
- Minors (persons under 18) are regarded as “legally disabled”
- Minors, the aging and elderly, and the disabled are all considered vulnerable, so the
State can play the Parens Patriae role
PARENTS’ INVOLVEMENT according to the constitution
- 14th Amendment: the Due Process clause provides life, liberty, and property that
cannot be denied w/o due process of law
o Therefore, parents have freedom in decision making concerning the raising
and rearing of children, free from undue interference by the state.
- Troxel v. Granville (U.S. 2000): ruled in favor of parents’ decision regarding the best
interest of the child.
o The challenger (in this case, the child’s grandparents) faces the burden of
proof to show that what the parents are doing is harmful.
o Judges tend to not weight the child’s preference or listen to what children say,
unless it’s older adolescents.
HOWEVER, there are limitations to parent’s scope of decision making
- Parents cannot harm their children, even for religious reasons.
o Children can choose later in their lives to become martyrs, but parents cannot
decide for their children
o Nixon case
- Parents are subject to criminal and civil charges if they are involved in abuse, neglect,
or abandonment.
L.O. 2: Apply the framework in specific contexts including religious beliefs for refusing lifesaving treatments, reproductive rights, HIV/AIDS, confidentiality, end-of-life care, and research
participation.
RENA’S CASE
- Rena has been a Jehovah’s Witness since the age of 10, and she has signed a medical
directive denying a blood transfusion in the event that she would need one, even
though she is aware that lack of one may result in her death. Rena lacerates her
spleen snowboarding, is brought into the ER, and docs tell her the she may need a
blood transfusion. She and her parents will not consent. The medical center files a
complaint. Trial judge authorizes a blood transfusion if it is necessary, and parents
appeal to Massachusetts Court of Appeals, arguing that the judge did not take Rena’s
maturity into consideration when making medical decisions in her own best interests.
- The MA Court of Appeals considered the interests of the parents, State, and the minor
in question. They stated that the minor’s maturity in assessing expressed preferences,
religious conviction, and present/future incapacity should be taken into consideration.
- THEREFORE, this court determined that in this legal framework, the minor’s
opinions should have been considered because she had the testimonial capacity to
answer questions.
-
Would have sent the case back to the trial court to rehear the case including Rena’s
best interests, but moot because Rena was discharged from the hospital.
RANGE OF RELATED ISSUES
- Weight the impact of religious dynamic on factors such as maturity of the minor, riskbenefit analysis of the situation, experience, age, etc.
o For ex, research suggests advanced levels of maturity in adolescents who have
confronted serious and/or long-term illness.
PA LAW:
- Define an “Adolescent” as someone 14-17 y.o.
- Considered legally disabled (even though quite cognitively developed)
o w/ the exception of social circumstances (eg. Homelessness) and medical
condition (though not on whether capable of making a legal decision).
o According to Prof Hartman, PA Law exempts teens if they have graduated
H.S., are married, or have been pregnant (regardless of maturity!)
EXCEPTIONS TO PRESUMTION OF DECISIONAL INCAPACITY
- Mature Minor Doctrine: Judge creates a law by determining that an adolescent is
capable of making a health care decision based on factors including age, experience,
maturity, condition of long-term or life-threatening illness.
- Essentially, a teen can dispute a treatment in court, but the cannot argue if they
want to refuse a treatment
The other issues, such as mental health, STD’s (HIV/AIDS), Substance Abuse, etc vary by state
in conditions where teens are either considered legally disabled or are actually allowed to make
decisions or require a physicians advice to determine Tx.
GOOD LUCK!
David Jones
(412)578-9816
Ethics Lecture #6: Law at the End of Life
Prof. Stella L. Smetanka, Esq.
Learning Objectives:
1. To understand the relationship between the right to refuse treatment and end-of-life
decision making.
2. To understand that the legal basis for end-of-life decision making is based not only on
law but also on societal consensus composed in part of public opinion and professional
ethics.
3. To understand the procedures and standards governing end-of-life decision making for
both competent patients and incompetent patients.
1) All patients have a constitutionally protected right to refuse treatment, including lifesustaining treatments. However, the consequences of refusing life-sustaining treatment are
different than refusing a band-aid. Therefore, while the right to refuse treatment is universally
accepted, end-of life questions are more complex, and have involved ethicists, courts, and public
opinion.
2) Law alone cannot justify end-of-life decisions. Ethics, public opinion, clinical practice,
legislation, and court decisions all play into this complex issue.
3) Competent patients have the right to choose for themselves how their treatment occurs,
incompetent patients have surrogates who choose the “patients wishes” for them.
Lecture Outline
Def. Terminally ill—someone with an incurable disease and likely to die within 6 months.

Due to a multitude of jurisdictions, consensus has not been found on this issue.
o Some states have lack of legislation, some have lack of judicial decisions
o Out of jurisdiction decisions are not binding precedents.
 Part of the difficulty is that these decisions can not just be governed based on law, but
also by ethics and public policy and opinion.
 Clinical practice often shapes ethical/legal questions as an act becomes more acceptable
as it becomes more common. Therefore, physicians play a primary role in determining
end-of-life issues.
Eight points to consider regarding law at the end of life
 A competent patient has a virtually absolute right to refuse treatment based on common
law rulings and the 14th amendment to the constitution.
 Incompetent patients have the same rights as competent patients, however, acting on
these rights is different since an incompetent patient may or may not understand the
consequences of their decision. Grey area of law.
 There is a difference between acting vs. omitting, withholding vs. withdrawing treatment,
and ordinary vs. extraordinary treatment.





o Even with the patients wishes, acts leading to death of a patient are morally
unacceptable (slippery slope leading to forced euthanasia), but omission of action
is morally acceptable with patients wishes.
 However, if there is a duty to act, omission is another grey area.
o As a variation on the act/omission theme, withdrawing treatment once begun is
generally unacceptable, but withholding treatment to begin with is acceptable.
 Concern is that since withdrawal is unacceptable, therapeutic treatments
may not even be tried.
o Ordinary treatment is required to be accepted by the social contract between the
physician/patient, however, extraordinary treatment is not required.
 How does one define extraordinary?
Decision making procedures for competent patients should be made without involving
the courts, and immediate family has the duty to make decisions for incompetent patients,
in the perceived best interest/wishes of the patient.
o Courts should be involved when there is a question about the patients
competence, who should act as the surrogate, or there is a conflict of interest
Decision making for incompetent patients should be done by surrogates (family) and
should be the decision in the best interests of the patient, or the patients own wishes.
Proper advanced directives give the patients wishes, and should be heeded. This may be
a living will or power of attorney, or other written or oral directive.
o Advanced directives give patients wishes at that point in time, and wishes can
change
Artificial nutrition and hydration is a “life prolonging medical treatment (AMA
definition),” with is under the same rules as other medical treatments.
o Controversial because, is feeding a medical procedure?
o Most different medical societies agree with AMA
Actively hastening death is not legal. Euthanasia and physician assisted suicide are
different than foregoing life-sustaining treatment (act vs. omission again).
o Euthanasia is illegal by definition of the court and is equal to murder
Session 7 -- Actively Hastening Death
October 12, 2005; Eric Schenfeld
Learning Objectives:
1. To undersand the relationship between actively hastening death and passively hastening
death.
Actively hastening death: killing
Physician-assisted suicide (PAS): lethal prescription
Active Euthanasia: lethal injection
Passively hastening death: letting die, withholding, or withdrawing
Debate lies in the in-betweenies:
- Terminating feeding tube? Active or passive?
- Terminating ventilatory support? Active or passive?
2. To understand the traditionally voiced objects [sic] (objections?) to legalization of actively
hastening death.
Objection
1. People will be pressured (esp
vulnerable groups)
2. Patients’ trust in doctors will
be undermined
3. Slippery Slope argument
Response
- All patients are susceptible to pressure by physicians,
despite grouping;
- Physicians can already subtly or forcefully pressure
patients to forego life-sustaining treatment in other
ways
- Not providing assistance via actively hastening death
already undermines patients’ trust in physicians
- Recognition of any right creates the possibility of
abuse
- abortion critics say that it would be used as (a) a form
of birth control or (b) racial genocide
3. To understand how actively hastening death has been practiced in Oregon and the
consequences of legalization.
Threshold Requirements
1. Adult of 18 yrs or more
2. Oregon resident
3. Capable of making
decisions
4. Diagnosed with terminal
illness that will lead to death
w/in 6 months.
Eligibility to Rcv Rx
1. 2 oral requests to doc separated by at least 15 days
2. Written request to physician signed in the presence of 2
witnesses
3. Prescribing & consulting docs confirm Dx & prognosis
4. Prescribing & consulting docs confirm pt is capable
5. If either dr. questions pt’s mental state, psych exam
6. Prescribing dr. must provide pt with feasible
alternatives (hospice, palliative, etc).
7. Prescribing dr must request but not require pt to inform
next of kin.
General Notes:
1. Physicians must report to Oregon Dept of Human Svcs all Rx’s unless the pt never
actually receives it.
2. Pharmacists must be informed of the medication’s ultimate use
3. Physician’s and pts who adhere to the rules of DWD (death w/ dignity) Act are protected
from criminal prosecution.
4. Choosing PAS cannot affect life / health insurance policies.
5. No one is obligated to participate in DWD-act
4. My Other Thoughts.
Supreme Court’s Stance:
1. There is no CONSTITUTIONAL right to actively hastening death
2. States may legalize Physician Assisted suicide
3. Terminal sedation - sedating pharmacotherapy + removal of feeding tube
Double Effect - it is ethical to treat a pt. For pain even if it will hasten death SO
LONG as its application is to relieve pain and not actually cause death.
BOTH Terminal Sedation & Double Effect are ok; paradox?
4. Future challenges are possible
Section 8: Confidentiality
October 19th Tara Marsh
1. To understand the concept of confidentiality.
Confidentiality: a physician’s duty not to disclose information about a patient, without the
patient’s consent. Confidentiality involves:
A. A disclosure of personal/private information
B. A pledge that the person receiving the information will not disclose it
2. To identify and explain the values underlying confidentiality.
Three values underlie confidentiality:
A. Trust: a patient’s belief that he or she can count on the physician’s competence, integrity,
concern and loyalty. If a patient cannot trust a physician to maintain confidentiality, he will be
reluctant to seek medical care or will be hesitant to fully disclose all relevant information
B. Privacy: an individual’s ability to control access to info about himself. Breaches of
confidentiality hurt patient privacy in many ways, including embarrassment, damage to
reputation, and loss of employment/insurance. Also produces feelings of vulnerability and
discomfort.
C. Autonomy: the right of a patient to decide who besides the physician has access to personal
info. Essential to maintaining intimate relationships and a sense of self, as the patient retains the
ability to tell a spouse, child, or other loved one about their medical condition.
3. To identify the scope of confidentiality.
Confidentiality can be breached in several cases:
A. Members of a health care team: HIPPA permits sharing of Protected Health Information
(i.e. confidential info) for the purposes of treatment, payment, and health care operations.
B. Public Health Risks: doctors are required to report gunshot wounds, STD’s and infectious
diseases, and child abuse
C. Third party danger: confidentiality can be breached to inform third parties who are at
risk…..specific criteria outlined in learning objective 4.
4. To identify and analyze conflicts between confidentiality and competing values.
Confidentiality protects patients, but sometimes third parties must be protected as well.
Should doctors inform the spouses of HIV positive people of their risk? Should a child of
someone with a deadly genetic disease be informed? Some criteria exist to determine when
confidentiality should be breached:
A. Harm analysis.
Magnitude of Harm
Major
Minor
Probability of Harm High
1
2
3
4
Low
Score of 1: Physician should breach confidentiality, tell third party
Score of 4: Do not tell third party, maintain confidence
Score of 2-3: Consider other factors….
B. Other factors to consider: Is there a foreseeability of harm? Could the harm be prevented if
the person were to be informed? No clear cut answers exist to these questions under current
legislature. Often up for interpretation.
Session 9:
Abortion
October 26
Deylin Negron
Background:
 Abortion was legal until the mid 1850’s (a fetus was not a person until post partum)
 Abortion was allowed until “quickening” = feeling the baby.
 1920’s: abortion was a common backroom procedure.
 1930’s: 1/5 of maternal death was due to abortion
 1960-1970: Abortion was legalized in the UK. Many women spent a lot of money to
travel there to get legal abortions. Consequently, abortions were available to those
women who had the money to travel.
 1970’s: Abortion was legalized in NY, WA, HI, and AK. Women had to be a resident of
the state for at least 30 days.
1. To acquire a basic understanding of the Constitutional and legal framework
established in Roe v. Wade and the reasons for the Supreme Court’s decision in that
case


Roe v. Wade (1973) - Jane Roe was an anonymous woman in Texas.
The courts acknowledged the “sensitive and emotional nature of the abortion
controversy”
 Texas invaded the right of a pregnant woman to terminate her pregnancy. The
woman claimed that it violated the 14th amendment which “protects persons from
being deprived of life, liberty or property without due process of law.”
 Since mid 19th century, most states had “relatively recent vintage” of strict
abortion bans except when necessary to preserve pregnant woman’s life.
The courts weighed the State’s interest for banning abortion:
a. Victorian sexual morality – dismissed as an anachronism.
b. Medical procedure: Concern for the safety of pregnant women – Courts found that
women would engage in even more dangerous backroom procedures when abortion was
illegal. Also, due to the new medical advances, abortion was now considered relatively
safe (within the 1st trimester)
c. Protection of fetal life – A legitimate concern, but courts rejected that a fetus was a
person. It was not a person until post partum.
Woman’s right to Privacy:
a. No textual right to privacy, but implicitly protected in 1st, 4th, 5th, 9th, and 14th
amendments.
b. Without legal abortion, courts cited medical, social, and psychological harm on women.
c. Abortion was a right to “liberty,” courts did not adopt argument based on women’s
equality.
d. “Abortion on demand” was rejected
e. Abortion based on a trimester framework.
f. There was NOT an absolute right to abortion: it was a right to FREEDOM from STATE
intervention. (1st trimester only)
2. To acquire a basic understanding of how the Supreme Court’s decision in Planned
Parenthood v. Casey modified Roe’s Constitutional framework and the reasons for
the Court’s decision in that case (1992)
 3 concerns leading to the case: PA and the US urging to overrule Roe.
i. Informed consent: woman given information 24 hrs before abortion
ii. Parental consent for minors
iii. Husband notification for married women.
 The court retained Roe and refused to overturn the decision BUT they did
REVISE Roe:
i. The right is to “stop the state from imposing undue burden”
ii. The state does have an interest in protecting fetal life.
iii. Viability of the fetus is the marker for when the state can ban abortion
entirely
(Except when the life/health of the pregnant woman is in danger)
The Casey Case:
 Rejected the trimester framework established in Roe v. Wade because it did not fulfill its
own promise in that the State has an interest in protecting fetal life or potential life
throughout pregnancy. Not all burdens on the right to decide will be undue.
 Undue Burden = “state regulation that places substantial obstacle in the path of a woman
seeking an abortion of a nonviable fetus.”
o Before viability, the state may not prohibit any woman from making the ultimate
decision to terminate her pregnancy. Restrictions on abortion violate her right if
they impose an undue burden
o After viability, the state can ban abortion to protect fetal life.
(Both of these allow exceptions for medical emergencies protecting the life/health of
a pregnant woman)
3. To gain an introductory understanding of some of the current legal and ethical
issues likely to affect access to abortion in the future and the legal environment for
abortion providers and women seeking access to abortion.
Current legal uncertainties:
1. When is a restriction to abortion an “undue burden?”
a. Incidental effect of making abortion more expensive is OK
2. How broad is the medical emergency exception? What is the scope of constitutionally
required exceptions from restrictions?
3. Requirements that 2nd trimester abortions be preformed in hospitals even though such
requirements would restrict access to abortion.
4. Legitimacies of the state’s interest in protecting fetal life where the fetus has lethal
deformities - **TEST CASE**
5. The ability of states to ban particular procedures. i.e. “partial birth”
a. Partial birth: Stenberg v. Carhart (2000) Courts turn down NE law preventing
“partial birth abortion” – intentionally delivering an unborn child or substantial
portion into the vagina for the purpose of killing the unborn child.
Currently in PA: (all the information that Dr. Mc Neil gave us)
1. Medical emergencies are up to the doctor’s good faith clinical judgment to avert serious
risk or substantial and irreversible impairment of major bodily function.
2. At least 24 hr prior to abortion, physician must provide in person, state-mandated
information on abortion, including info on gestational age, fetal development, and
abortion alternatives.
3. As long as the information is truthful and not misleading, the state may try to persuade
women to not abort – no infringement on doctor’s free speech.
4. Courts invalidated husband notification for married women.
5. Courts uphold state requirement that a minor get parental/guardian consent. But a minor
can get a court appointed advocate (judicial by-pass provision)
Session 10: Artificial Reproductive Technology
Marc Rogers
1. Define the term “reproductive freedom”
Reproductive freedom refers to a person’s (couples) perceived right to choose to
reproduce (or not to) as they see fit. This includes if/when to have a child, the option of using
birth control, and by some definitions the choice of abortion or not. There is also the right to
NOT have genetic screening/testing implied under this phrase. This right is not considered
absolute and is why sometimes this phrase will be used in pro-life arguments.
2. Describe indications for the gender selection of offspring.
LEGALLY it is acceptable bc reproductive freedom is protected.
The only ETHICALLY unquestioned time when using pre-implantation diagnosis (PGD)
followed by embryonic sex selection is when this method is used to prevent the transmission of
an X-linked genetic disorder. This is followed (in order) of:
-sex selection of embryos that were being tested with PGD and IVF for other reasons (bc there is
no extra burden on medical resources, but there is still some inherent bias)
-sex selection is added to PGD and IVF where it was not normally included (again no extra
burden, but more perceived bias since the parents request information)
-IVF is necessary but PGD is not, yet patient requests it solely for sex selection purposes (some
burden along with a lot of implied bias)
-neither IVF or PGD is necessary and is only used for sex selection of the embryo (both
burdensome to medical resources and showing clear bias)
The reasons for sex selecting (besides eliminating X-linked diseases) are:
-family gender balance (1 son, 1 daughter)
-gender birth order (1 older brother and younger daughter)
-companionship (father’s feel closer to sons, mothers to daughters)
-family economic welfare (more for countries where males primarily provide income)
-“more wanted gender” (some families just “want” a boy or girl)
-*population control (families wont need to have 10 kids just to get that 1 son)
-*unbalanced sex ratios (cultures so desirous of 1 sex, that the other one would become scarce)
* = extreme cases that are only being speculated at and are not fully “proven” or “accepted”
3. Understand physician-patient relationships as they pertain to artificial reproduction
this is not heavily discussed and is more presented as hypotheticals. Some key points
though:
-doctor should consider the ‘child-to-be’ as a patient
-dr should not try to persuade the family either way but simply present the facts
(informed consent)
-doctors should be more rigorous in their policing of themselves in this field
-LEGALLY doctors can use artificial reproduction techniques (incl sex selection)
anytime. ETHICALLY it should be for infertile couples/couples with offspring potentially
having x-linked disorders or other genetic diseases
4. Understand government involvement in regulating and financing artificial reproductive
technology.
In the 2004 executive report the council found minimal government regulation/oversight
and very little legislature for this area. (although gene transfer technology is HEAVILY
regulated) There is extensive professional self-regulation, but compliance is not standard.
The council recommends the following adjustments:
-Federal data collection (study outcomes of these procedures and provide clearinghouse
of information for those interested (cost, good docs, etc)
- Increased professional oversight (increase compliance/enforcement with policies,
consider child-to-be a “patient”
-more targeted legislation (current legislation usually applies to other venues and is then
also applied to artificial reproduction issues)
Not much is mentioned in terms of funding, except that for any funding to be distributed
to artificial reproduction research it must first be examined and approved by a governmental
ethics committee. The committee believes research to be important, but precautions must be
taken to “show the utmost respect for the embryo.”
SESSION #11
Legal and Ethical Issues in Stem Cell Research
CASE STUDY:
The case in this study was about an embryologist who had been performing experiments on
monkey embryos for over a decade. Her lab is entirely federally funded. She now wants to
get human embryos left over from IVF at her hospital and attempt to derive stem cells to
research on.
President Bush issued an Executive Order permitting use of federal funds to perform
research on human embryonic stem cells derived from blastocysts left over from in vitro
fertilization. The funds, however, may only be used to support research on approved stem
cell lines that were in existence at the time the Executive Order was issued.
You are the hospitals CEO. Do you support the doctors plans?
Involved Issues
1. The cells are probably not on of the approved stem cell lines
2. The President’s order also requires informed consent of the donors be granted, AND
3. The consent and embryo must have been given without any financial inducement.
In this case it doesn’t seem that any of the above conditions have been met.
Please be aware that human embryonic stem cell research (hESC) and therapeutic cloning
(SCNT) are not illegal at the federal level (ESC and/or cloning are prohibited by law in 10
states, including PA); the federal funding of these technologies is simply limited.
In the NIH Guidance (provided in our syllabus) on these types of research the second two
conditions are recommended for any facility performing these types of research, regardless of
the source of the funding. In addition, the Guidance strongly suggests an Embryonic Stem
Cell Research Oversight (ESCRO) committee be appointed for ethical and legal issues that
might arise with this type of research. Other recommendations: all laws should be followed,
privacy of donors ensured, cell lines should be protected when banked (because products
may one day be introduced into humans in clinical trials), and conscientious personnel
objecting to procurement should not be made to be involved.
LEARNING OBJECTIVES
1. To understand the nature of the moral objections to human embryonic stem cell(hESC)
research and therapeutic cloning(SCNT)
a. Destruction of human life when stem cells are extracted from the embryo
b. Creation of human life for research when SCNT is used
c. “Slippery slope” argument – would lead to reproductive cloning on the sly
2. To understand the moral (and other) bases for performing hESC research and SCNT
a. Harm to human well-being: a ban would foreclose promising medical research
that has the following advantages: avoids rejection, greater availability (of organs,
cells, etc.) better viability
b. Loss of international competitiveness in biomedical research (other countries have
legalized research (SCNT: UK, Spain, Holland, Finland))
c. Use of therapies developed abroad
3. To discuss the role of religion in public policy-making and law making.
There wasn’t much information on this –
In a nutshell: People’s religious views influence what they think about when life begins. “Is
this a scientific or theological issue?” The lecture points out that both sides of the argument
have supporters. One slide commented that both sperm and egg are “alive,” that an embryo
is simply another layer of complexity, and that science will never be able to determine “when
life begins” for that reason.
Public Policy issues: Constitutionality of Prohibiting ESCR or SCNT
(This is where the above question comes into play)
1. “To the extent prohibitions are based on religious arguments, bans might violate
establishment clause.” The establishment clause of the First Amendment says Congress
shall make no law respecting establishment of religion… basically it is the separation of
church and state argument. The slide notes, however, that there is probably adequate secular
basis for the ban (see 2 and 3 below)
2. Due process – the right to life, liberty and the pursuit of happiness…
3. Due process – the right to reproductive liberty
Questions: stockwell.carrie@mail.medstudent.pitt.edu
(602)617-5407
Session 12: Interactions with Pharmaceutical Companies
November 16
Anuja Vora
1. Define the types of relationships which exist between physicians and the pharmaceutical
industry
Relationships exist between the pharmaceutical industry and…
 Clinicians (via gifts/promotional info)
 Researchers
 Professional societies
 Medical journals
 Continuing medical education
Relationships begin in medical school, continue during residency, and persist throughout
physicians’ careers. As physicians mature, their relationships with drug companies also change,
becoming more likely to involve consulting and honoraria and less likely to involve luncheon
seminars.
Accepted truths:
 Pharmaceutical companies fund the process of developing new drugs
 Physicians control drug prescribing and therefore drug sales
 Pharmaceutical companies are in business to make money
 Everyone likes gifts, including physicians
2. Understand the various methods of drug promotion by pharmaceutical companies
Promotional spending on prescription drugs increased from $9 billion in 1996 to $21 billion in
2002. Methods of promotion include:





Samples
- Account for over 50% of promotional spending
- Affect physician prescribing patterns (see LO #3)
Detailing to doctors
- Accounts for 25% of promotional spending
- Examples: conference lunches, dinner lectures, happy hours, CME opportunities,
travel to and lodging at events/conferences, meeting with company reps,
pharmaceutical branding of common objects (pens, calculators, reflex hammers,
stethoscope tags, penlights, etc.)
- Affect physician prescribing patterns (see LO #3)
Direct-to-Consumer ads (see LO #4)
Hospital detailing
Journal ads
3. Be aware of the impact drug marketing can have on physician prescribing patterns
Most physicians (61% in a survey) tend to be confident that they themselves are not influenced
by drug companies’ marketing efforts, but only a few (16% in same survey) had the same
confidence in other physicians. But they are mistaken…
Surveys show that physicians subjected to drug marketing efforts are more likely to request the
inclusion of the company’ drugs on hospital or HMO formularies, more likely to prescribe the
company’s products, and less likely to prescribe generic medications. Consequences: newly
prescribed or requested drugs are usually more expensive and do not provide a therapeutic
advantage over alternatives/generic equivalents.
The physician cost of prescribing (i.e. the cost of a prescription written by a physician) increases
with increased perceived credibility of information provided by pharmaceutical reps and
increased frequency of use of reps as an information source.
4. Define the concept and impact of Direct-to-Consumer (DTC) marketing
DTC marketing includes advertisements (e.g. TV commercials) directed specifically towards the
layperson/potential patient.
Spending on DTC advertising increased from $0.8 billion in 1996 to $2.5 billion in 2002.
Impact: survey showed that only a minority of patients spoke with their doctor about the
advertised drug. Of those who did speak with their doctor, nearly half received a prescription for
the requested drug; only about a third of the physicians recommended a different drug.
5. Be familiar with the professional guidelines established by several organizations (AMA,
ACP-ASIM, PhRMA) regarding interactions between physicians and pharmaceutical
representatives
AMA guidelines:
 Any gifts accepted by physicians individually should primarily entail a benefit to patients
and should not be of substantial value
 Subsidies from industry should not be accepted directly or indirectly to pay for the costs
of travel, lodging, or personal expenses of the physicians who are attending the
conferences and meetings
 No gifts should be accepted if there are strings attached
ACP-ASIM (American College of Physicians-American Society of Internal Medicine) guidelines
for acceptable industry gifts:
 Inexpensive gifts for office use (pens and calendars)
 Low-cost gifts of an educational or patient-care nature (textbooks)
 Modest refreshment
PhRMA (Pharmaceutical Research and Manufacturers of America) guidelines:
 Items primarily for the benefit of patients may be offered to healthcare professionals if
they are not of substantial value ($100 or less)
 Items of minimal value may be offered if they are primarily associated with a healthcare
professional’s practice
 Items intended for the personal benefit of healthcare professionals (CDs, tickets to
sporting events) should not be offered
Session 14: Impaired Physicians
Jeff Walch
Learning Objectives:
1) Understand the definition of impaired physicians:
- Term refers to any physician who is unable to practice medicine with reasonable skill
and safety.
- Impairment can be due to mental illness, a physical illness, or the substance abuse.
- Some have expanded the use of the term to include physicians with unique health issues
such as HIV infection or disruptive behavior.
2) Know the prevalence and characteristics of physician substance abuse:
- No medical specialty is immune to substance abuse, however, physicians with greater
access to injectable drugs (anesthesiology, emergency medicine) may be at a
higher risk. Physician substance abuse is common.
- Emergency physicians reported using more marijuana; physchiatrists more
benzodiazepines; anesthesiologists more opiods.
- Physicians are: MORE likely to use alcohol, prescription analgesics and tranquilizers
compared to the general population; LESS likely to use illicit drugs
- Substance abuse is defined as a cluster of cognitive, behavioral and physiological
symptoms indicating that the individual continues use despite significant
problems;
3) Understand the consequences of substance abuse to the individual physician:
- Characteristics of physician substance abuse include: acute intoxication, symptoms of
withdrawal (including alcohol hangovers)
- Impaired physicians commonly cite that use improves their performance; work
performance is often last facet of the patient’s life to be impaired; however use
accelerates leading to dependence
- After treatment/rehab, physician may return to work immediately under the monitoring
of a local physician health program for several years, this is done with high rates
of success
4) Know the appropriate course of action if one suspects a colleague of substance abuse:
- Hospitals and individual states have program designed to assist physicians with
substance abuse disorders.
- If you have a reasonable suspicion that a physician is on drugs, you have an
obligation to report to the state board; same goes for alcohol if work impairment
becomes evident
- Treatment programs begin with a 2-3 day acute detoxification under medical
supervision; followed by intense individual, group, educational therapy; as well as
attendance at 12-step support meetings; family involvement is key
- Treatment programs are most successful if they last 3-4 months