Midterm 1 Flashcards
Components of Informed Consent (3)
- diagnosis
- nature and purpose of interventions
- burdens, risks, and expected benefits of all options, including of no treatment
EMTALA
Emergency Medical Treatment & Active Labor Act
emergency departments that accept medicare payment must provide stabilizing medical treatment to anyone who comes there in an emergency medical condition
3 main statutes used to decide Baby K case
- EMTALA
- ADA
- Rehabilitation Act
Rehabilitation Act
prohib discrimination against otherwise qualified handicapped individual, solely by reason of handicap, under any program receiving federal financial assistance
ADA
prohibits discrimination against disabled individuals by public accommodations solely on basis of disability
5 types of health systems
- national health service
- national health insurance
- Bismarckian/corporatist insurance
- social safety net
- nothing
national health service
supplied by government, paid for in taxes; providers are government employees
country with national health service
Britain
country with national health insurance
Canada
what is corporatist insurance?
supplied by a corporate body like an employers, nonprofit, or a union
country with corporatist insurance
germany, japan
country with social safety net model
brazil
national health service in US
bureau of indian affairs, military bases, veteran’s healthcare
national health insurance in US
Medicare (people over 65)
problem with corporate health insurance in US
cheaper for corporations to provide healthcare (tax exempt) than bigger salary
social safety net healthcare in US
Medicaid
what qualifies someone to receive Medicaid?
1/4 of poverty line
who gets no healthcare coverage in the US?
not poor enough for Medicaid (Medigap) but can’t afford private insurance
Canterbury vs. Spence
informed consent; doctor failed to inform Canterbury about risks of procedure & he fell out of bed and was almost paralyzed. sued for lack of care, negligence, and lack of informed consent (patient-centered);
Decision: established IC; said that IC should involve what the patient would have wanted to hear (previously was just reveal info another physician would provide) (conspiracy of silence; prevented doctors from testifying against one another)
Culbertson v Mernitz
(current) informed consent; doctor failed to inform Culbertson of risks associated with procedure (doctor-centered); stated that doctors should disclose what other doctors in that region would have disclosed
Moore v Reagents of CA
informed consent; leukemia patient had additional procedures done and his cells were used to make a widely successful drug, sued
what is one problematic thing informed consent does not require?
doctor not required to disclose conflicts of interest, such as how much a procedure will be profitable for a doctor
KKI v Grimes
doctors owed duty of care to subjects in study which exposed them to potentially dangerous of lead; argued that the kids were living in homes with less lead than if they had not partaken. but this didn’t hold up b/c doesn’t conform to the minimal risk model, and risk cannot be relativized
what is the minimal risk standard based on?
the average amount of risk an American faces in their everyday life
4 tenets of belmont report
- any research on human subjects must aim at public benefit
- respect for persons; informed consent
- justice: benefit should flow to the people burdened by the research
- non maleficence: distribute benefits and burdens in a way people can agree with
who has to abide by the common rule?
groups that get federal funding
how is research defined?
systematic investigation designed to contribute to generalizable knowledge
Hurley v. Eddingfield
facts: person died after family physician refused to treat him for no reason; sued for wrongful death
decision: doctors do not have a duty to practice under terms they did not accept
Why can the federal government exercise power over states?
14th amendment; says that states can’t deprive anyone of life, liberty, or property w/o due process, or deny equal protection under the law
Federal Supremacy Clause
part of constitution; says that state law is subordinate to federal
problem with Medicare
some things like nursing care aren’t covered; people get private Medigap insurance or spend savings until qualify for Medicare
problem with US corporatist insurance
cheaper for companies to buy healthcare for citizens than higher wages, so they buy healthcare and pay lower wages
inefficiency in having some people not covered by healthcare
have to be seen in emergency room, but no basic preventive care
problem with the fact that Medicaid kicks in at 65
private insurance doesn’t want to cover wellness advice b/c they don’t have to pay anymore after 65 when many people’s life choices catch up w/them; in UK, because govt always has to pay, emphasize wellness
Wilmington v. Manlove
Facts: baby had diarrhea and fever; doctor prescribed meds, but condition worsened so parents took to emergency room. baby was turned away and died later that night
Decision: private hospitals do not have an obligation to take patients - if they have an emergency room they might, but only if it’s an unmistakable emergency. it wasn’t, so hospital has no liability
detrimental reliance
upon entrance to a contract; reliance on promise I could foresee. e.g. caterer says they’ll bring food, but doesn’t
no duty rule
physicians not obligated to provide care to particular patient unless they have agreed to do so, or it is during a current treatment episode
Wideman v. Shallowford
state does not have obligation to provide people the essential medical treatment of their choice
Facts: woman in early labor and told doctor to meet her at a hospital. ambulance took her to a different hospital, and baby died
Decision: State did nothing wrong and there is no constitutional right to medical care; the infringement on her rights would have only arisen if the state, by exercise of significant custody or control, puts a person in a worse situation than they would be in if govt hadn’t acted. the state didn’t coerce her into ambulance
analogy to abortion rulings in Wideman v. Shallowford
while there is a right to be free of burdensome interference in getting an abortion, there is no right to have it paid for by the state - so while state can’t interfere with you getting medical care, it is not required to provide it
Burditt v. US Department of Health and Human Services
Facts: A woman needed medical treatment while in labor but the doctor was afraid to treat her because she had very high blood pressure. he ordered her transfer
Decision: Doctor lost, violated EMTALA by transferring her while she had an “emergency medical condition” (extremely high bp)
Walker v Pierce
Facts: women sued because a doctor had a policy where he would only deliver a child to a woman with two children on Medicaid/unable to pay if he can sterilize them
Decision: the doctor is allowed to have this idea; it was made clear, and he applies it to all Medicaid patients
US v University Hospital
Facts: child w spina bifida; parents refused surgical treatment and opted for more conservative approach
Decision: no violation of rehabilitation act, parents acted in child’s best interest and hospital offered the same treatment they would offer any person w/o disability
Glanz v Vernick
Facts: doctor refused to do surgery for ear pain after learning patient had HIV. doctor claimed that HIV increased risk of infection, and the procedure was elective.
patient alleges Rehab Act violation because he was “otherwise qualified” for surgery
Decision: None; settled
Tarasoff v Regents of University of California
Facts: patient told psychologist he was going to kill his ex girlfriend
Decision: MH professionals have duty to protect an intended victim, e.g. by notifying victim w/o giving details
HMO
health maintenance organization; doctor signs contract to see patients, and has an obligation to see them
patient dumping
not allowed; doctors have a legal obligation to see people who can’t pay under EMTALA until they are stabilized and can be transferred safely
malpractice & 3 components
doctor failed to use proper care
- duty
- breach
- harm caused by breach
HIPAA
identifiable health information cannot be shared beyond those taking care of you
3 exceptions to confidentiality
- suspected abuse
- suicidal ideation
- other person is in danger
if a doctor refuses to do what a patient wants, the doctor has an obligation to___
arrange a transfer for the patient, e.g. in the case where refuse to stop giving hydration to an ALS patient b/c catholic
fiduciary
person who holds ethical or legal relationship of trust with another person; higher duty than just a contract/special duty of care; not always do exactly what principal wants, but move towards their objectives and avoid conflicts of interest
2 requirements of fiduciary relationship
- maintain independence and impartiality in medical decisionmaking
- always put wellbeing of patient first
standards for informed consent (2)
- the kinds of things doctors around here tend to disclose
2. what information the reasonable person would want in order to make their decision
usually, a doctor is required to get a child’s ___
assent
whether a particular minor is able to consent depends on (2)
- maturity/competence, judged by doctor
- treatment risks (e.g. 17 year old who has been through chemo before is more capable of consenting to it than one who hasn’t)
Grimes v Kennedy Krieger Institute
Facts: institute arranged for (some) landlords to receive public funding for partial abatement; for all, required that housing be given partial lead abatement and in one case encouraged them to rent to families with young children. wanted to measure effectiveness of partial abatement; tested children’s blood. partial abatement was ineffective; parents’ consent may not have involved complete info
Decision: unethical to conduct an experiment that might entice healthy children into lead-tainted housing; parents could not consent to this on behalf of kids. case remanded to court
Ethical issues: parental consent; encouraging kids to be put into this situation; research for greater good when nontherapeutic
Moore v Regents of University of California
Facts: Moore treated for leukemia; doctors, without telling him about their intent, took his cells and developed them into a profitable drug. Moore sued for failure of IC and conversion (theft of his cells) and wanted cut of profits
Decision: problem with informed consent (doctor should have disclosed financial interests) but patients do not have a property claim to their discarded cells
Beriberi study
scientist found that chickens got Beriberi when fed white rice instead of brown; scientist replicated at insane asylum, patients died of Beriberi
Nazi experiments
Nazis tested various ways of reviving a person who is freezing on prisoners; found that cold water bath works. Jewish ethicists were uncertain as to whether to publish the results but they did and it was beneficial
Tuskegee study
black men with syphilis were told they were receiving treatment but were just monitored; they were not told about antibiotics and were prevented from being drafted. public outrage led to creation of research ethics
three principles of ethics from Belmont Report
- respect for persons
- beneficence
- justice
respect for persons
subjects must enter research voluntarily and with awareness of possible adverse consequences
- people should be treated as autonomous agents (can’t repudiate their judgments, deny freedom to act on those judgments, or withhold info necessary to make judgments)
- people with diminished autonomy are entitled to protection
- extent of protection should depend on risk of harm and likelihood of benefit
(e. g. prisoners)
beneficence
making efforts to secure person’s wellbeing
1. do not harm
2. maximize possible benefits, minimize possible harms
may involve weighing larger benefits even when individuals aren’t direct beneficiaries
(e.g. children)
justice
- the benefits or burdens of research should be distributed fairly
- requires scrutiny of selection of research subjects (e.g. welfare recipients, racial minorities, people in institutions) are being selected simply b/c of availability, compromised position, or manipulability rather than for reasons related to the problem
- when research supp by public funds leads to development of therapeutic devices/procedures, should not provide advantages only to those who can afford them, and should not unduly involve persons from groups unlikely to benefit
3 groups that must adhere to human subject guidelines
- universities (voluntary)
- groups looking for FDA approval
- groups receiving federal funding
Common Rule definition of research
activity designed to test an hypothesis, permit conclusions to be drawn, and thereby develop or contribute to generalizable knowledge
2 possible standards of informed consent for research + problem with each
- info commonly prov by practitioners in field or locale (research takes place when a common understanding doesn’t exist)
- info reasonable person would want to know (subject may wish to know more about risks gratuitously undertaken than patients who are seeking care)
reasonable volunteer standard
extent and nature of info should be such that persons, knowing procedure is neither necessary for care nor fully understood, can decide whether they want to participate in furthering of knowledge
3 standards for not fully informing volunteers of research aspects
- incomplete disclosure truly necessary to accomplish research goals
- no undisclosed risks that are more than minimal
- adequate plan for debriefing and disseminating results to them
4 requirements for IRBs (+ general)
General: have diversity, consider including member of vulnerable population if relevant
- 5+ members
- one with primary concern in scientific areas (w/ related expertise)
- one with primary concern in nonscientific areas
- one member not affiliated with institution
children should not participate in a study if…
there is more than minimal risk to them, unless there is a direct benefit to the kids
4 groups of vulnerable populations
- children
- prisoners
- people with impaired decisionmaking
- economically/educationally disadvantaged persons
- pregnant women/fetuses
broad consent
applies to specimen collection; if you remove someone’s tissue, you must ask consent for use in some future research (but don’t specify what types of research)
4 requirements for informed consent
- diagnosis
- prognosis
- recommendation (risks and benefits)
- alternatives, including risks and benefits of doing nothing
4 problems with informed consent
- no way of monitoring
- may be presented in inconsistent ways
- people may not be able to properly understand the risks they face
- different/unclear standards
