PHI 015 - Bioethics UNIT 2 Lecture

first allocation

1. support patient autonomy

2. assess urgency

3. resource availability

4. save the most lives

second allocation

lottery, first come first serve, priority

Utilitarianism + which allocation method?

maxing the amount of good that's done, favors priority/utility based

egalitarianism + which allocation method?

reducing inequality; favors lottery based

four fundamental values of Emmanuel et al Framework

1. max benefits

2. treat people equally

3. promoting/rewarding instrumental value

4. priority to the worst off

disability paradox

those who experience disabilities report to have a higher quality of life compared to those who do not have any disabilities

Stramodo Critiques

1. assessment of quality of life assessments are biased and inexact

2. critique on resource intensity -> deprioritizing patients who need more resources because it is "a waste"

Social Model of Disability

disabled people are only disabled to the extent where they are not given the right resources to be accommodated by society; disability is socially relative --> what do we value in society?

Definition of Disability

physical or mental characteristic that is labeled or perceived as impairment/disfunction

OR a personal/social limitation associated with impairment

impairment

statistical --> average

biological --> if you don't have xyz, then you are impaired

normative --> xyz is what makes life good, so if you don't have it then you are impaired

disability

when you physically or mentally can't do something, lack of ability in performing an activity

impairment

physiological or anatomical limitation

handicap

a disadvantage, resulting from impairment or disability; can be changed if we accomodate

medical model vs social model of disabilities

medical model: we need to fix the impairment to make them a "functional" individual (fixing a cochlear implant on a deaf child)

social model: embracing their disability and society changes to accommodate/accept them

ex: shyness is medicalized, homosexuality is de-medicalized, grief is de-medicalized

libertarianism

maxxing liberty and individual freedom; state is in charge of protecting individual rights

mill's harm principle

as soon as i do something that affects others, the state has the right to redirect my behavior; state is only coercively enforcing no harm is done (negative obligation, rather than enforcing good)

herd immunity + libertarians

herd immunity: if there's enough people that are vaccinated and immune to a disease, the ones that are unvax and not immune are protected enough (no need to be 100% vax)

but libertarians argue that herd immunity and enforcing vax is a public good! and the govt can't force public goods!! ...but the response is that not vax DOES enforce harm

largent and miller conditions for vaccine mandate

1. vax needs to be available

2. threat is persistent

3. efficiency and safety is ensured from evidence

4. voluntary vaccination efforts need to be taken in place first before mandate

research vs clinical practice

research: to find scientific data and get generalizable information

clinical: individualized care

therapeutic misconception

when there is a confusion between research and clinical practice

what did the nuremberg code accomplish?

that informed consent is ESSENTIAL

what did the declaration of helinski do?

that informed consent is important; international ethical code of ethics is established

declaration of helsinki (highlights)

1. rights + interests of subjects > knowledge

2. underrep populations are protected and given the resources to participate in the research

3. importance of research > risks

4. welfare animals

5. info on funding, sponsors, etc

6. research committee approval

7. informed consent

the belmont report

ETHICAL CODE, NOT REGULATORY ONE

part A: clinical vs research practice

part B: ethical principles (4 core principles)

part C: applications --> informed consent, risk benefit analysis, subject selection

three key components of informed consent

providing information that's understandable, comprehension of risks/benefits/procedures, voluntary consent

The Common Rule (45 CFR 46)

Subpart A of The Belmont Report

• protects human rights

• infromed consent, IRB, assurances of compliance
  

IRBs (institutional review boards)

gives initial approval of research and conduct periodic reviews

randomization

done with indifference to patients; undermines individualized care is NOT A PRIORITY and the appearance of the investigator as physician giving individual care

clinical equipoise

- genuine uncertainty about the two legs of treatment; needed for randomized treatment

- default starting point in science

- if not present, then the medical community will think that one arm of the trial is inferior to the other

active control trial

experimental drug vs what's on the market (proven therapy)

placebo control trial

experimental drug vs placebo

- used when there is not proven treatment out there

- fine with non-serious conditions being tested (headaches, anxiety, etc)

what does emanuel , wendler, and grady say about informed consent?

it's neither necessary nor sufficient for clinical research

- necessary: you need to have it to do x (oxygen to fire)

- sufficient: as long as i have it, i can do x (torch or lighter to start a fire)

EWG - Value

social and scientific value (not trivial hypotheses, redundant research, non-generalizable results)

- values/properties

EWG - scientific validity

methodologically sound, valid proof, clinical equipoise, null hypothesis

- values/properties

EWG - fair subject selection

- choice of subjects is driven by scientific goals and NOT by privilege and vulnerability

- cannot pick people because they are convenient

- JUSTICE CONNECTED

- values/properties

EWG - Favorable Risk Benefit Ratio

1. risks are minimized,

2. Benefits are enhanced

3. potential benefits to individual subjects and society are proportionate to or outweigh the risks

- values/properties

EWG - independent review

use of an ethics committee -- IRB

- procedural

EWG - informed consent

UNLIKE THE 5 OTHER CONDITIONS

- procedural in the sense that they tend to generate good ethical results, but these procedures could be replaced

- informed consent or some other processes that could do something similar

EWG - Respect for potential and enrolled subjects

respect privacy, permit subjects to change their minds, provide new info as the trial continues

very silly fairies run in intense rain

value, scientific validity, fair selection of candidates, risks/benefits, informed consent, institutional review board, respect for canidates

Kreiger Lead Paint

- goal of study was to find cheap ways to reduce lead contamination

- targeted baltimore families and were told their children's blood levels would be reported if they had high lead (but report took 9 months..)

- crime case: parents cannot consent for their children if it is more than a minimal risk compared to a direct benefit

- IRB rationale was that these families were gonna be exposed to lead poisoning anyways

Sufraxin (US vs Bolivia)

US: there is something to compare surfaxin w/ so it's unethical to do PCT

Bolivia: there is no standard care, so it's tech ethical to do PCT. but it's overall unethical because it's still available in different parts of the world

AZT trials

- wanted to compare low dose AZT to placebo

- placebo wasn't gonna hurt them anyways because they weren't able to access the AZT to begin with...

Surfaxin vs AZT

BOTH trial subjects were not worse off without the trial

- AZT provided infro to potentially improve lives of the people in the population. Surfaxin wasnt...

market model

- supply and demand

PROS: great at enrolling people, meets demand, removes the financial sacrifice of participation

CONS: incentive might be too high (bribery, undue inducement)

wage-payment model

- Payment is based on unskilled but essential jobs

PROS: less concern for undue inducement, reduces financial burden

CONS: less effective at enrolling people, attracts poor rather than wealthy ($500 is great!), research is basically employment?

reimbursement model

- reimburses subjects for expenses

PROS: alleviates concern for undue inducement, does not incentivize the poor

CONS: might not yield participants

which model is the most preferred and why?

wage-payment model because it has the most ethical balance, fairness, practicality, and safeguard

undue inducement

when an incentive in participating in a trial is just too good to be true that it clouds an individual's judgement in making decisions they usually wouldn't do without the incentive

- becomes a concern when they expose participants to risks

common rule

the investigator MUST seek consent from their participants only under circumstances where they consider whether or not to participate--minimizing coercion and undue inducement

challenge trials

directly exposing participants to viruses un order to test vaccines; faster, cheaper, small numbers BUT dangerous

sex

biological based (usually) assigned based on genitalia

gender

socially constructed and used to identify as a person as man, woman

sexuality

biological sex, sexual orientation, gender, sexual practices--very complex category

androcentrism

the practice of centering masculine perspectives, values, anchoring man's perspective from which woman is considered "deviant"

EX: supreme court rules that businesses could exclude pregnancy related disabilities from insruance coverage//pregnancy and risks are "additional" conditions

EX: debate whether the ACA will cover birth control pills

traditional moral value theory

emotion is a threat to moral reasoning. BUT feminist theorist argue that emotions are essential for understanding

3 Rs (non-human research)

Replacement: replace methods using animals as much as you can

Refinement: methods that enhance well being and minimize/eliminate pain

Reduction: using fewer animals, max information

two main premises of animal research

moral: if doing research or inflicting harm on animals is neccessary for human health, then it is justified

empirical: research on animals is essential to promoting human health

Cohen's Stance on Animal Rights

animals do not have rights, but we own them moral treatment

- only beings that can make claims have rights

- in order to have rights you need to be a part of a moral and autonomous community

- humans are a part of the human species and animals are not

first objection - cohen

he talks about moral agency: describes the ability for an individual to reason with their choices and be held accountable. BUT moral agency is irrelevant to having moral status: the capacity to feel, suffer, etc.

second objection - cohen

lots of humans don't fit this description

speciesism

humans matter morally and animals do not (humans have more rights, matter more, etc)

- non speciests can still think that certain capacities matter to moral status. BUT NOT SPECIES. Species is a rough proxy.

7 uses of animals in research

1. basic bio, behavioral or psych research

2. applied biomedical and psychological research

3. development of drugs and therapeutic chemicals

4. food/fiber research

5. toxicity studies

6. educational -- dissection

7. animals for extraction of drugs

human vs animals bioavailability

little to no correlation...because of difference in scale, anatomy, physiology, captivity, etiology, etc