Part 2 HealthSci

After midterm content

Why should we conduct research? (4)

advancing human welfare

advancing knowledge

advancing understanding

examining cultural dynamics

Why do we need research ethics?

correct past problems and abuses

prevent new problems and abuses

law is not enough (does not deal with things on the same level research ethics does)

What major atrocity spurred the whole movement of ethics research?

Nazi science

What is nazi science?

taking human subjects from nazi prisons and experimenting/dissecting them for research

What was the Tuskagee study?

studied the progression of syphylis in nature

not given medication to treat the disease when it was available

What does it mean “study in nature”?

observing the natural history and progression of a disease

What good thing came out of this intense type of research? (for example nazi science)

informed consent became essential for research

What did people study in residential schools?

malnutrition

What is right to standard of care?

the level of harm you can create in a research project is controlled

What is the TPS (tri-council policy statement)?

code that governs research in North America

How could someone get around the TPS code?

The only way to get around the council is to make a private study with private money

cannot be public at all

What are the 4 basic ethical principles of the Tri-council code?

respect for persons (autonomy, privacy)

non-maleficence (do not cause unnecessary harm)

beneficence (purpose is to benefit the human condition)

justice (benefit as many people as possible)

what are the 9 guiding ethical principles?

human dignity (treat someone as a person not a thing)

free and informed consent

vulnerable persons (include everyone)

privacy and confidentiality

justice and inclusiveness

balancing harm and benefits

non-maleficence

Minimizing harm (try to control as much as possible)

maximizing benefits

Fill in the blank:

As a patient, your consent must be _________

respected

Fill in the blank:

As a research subject, your consent must be ____________ and can (in the right cases must) be ______________

scrutinized

rejected

T/F

You have the right to be in research projects

False, you do not have the right which why your consent can be overlooked

What is coercion?

threatening someone so they make the decision you want

forcible, against your will

What groups of people are most susceptible to coercion?

vulnerable populations

Vulnerable populations can be described as (4)…

institutionalized disparity of power

an inability to respect their own best interests

Do not consider punishment or reward before participating

Susceptibility to power

What is inducement?

providing a reward for something

Ultimately your choice, but persuaded by the reward

What are the 4 characteristics of inducement?

given something good (gift or reward)

seems irresistible

causes people taking unusual risks

the risk taking usually creates unethical or excessively risky situations

What is voluntariness?

a person volunteering to do something

choice of free will

To give valid informed consent to participate in clinical research, potential participants should understand the…

risks, potential benefits, procedures and alternatives 

Potential participants need to understand 3 facts to understand they are being invited to participate in research. What are they?

Research contribution 

• Those who contribute in the study will be contributing to a project designed to gather knowledge to benefit others in the future 

Research relationship 

• The investigators will rely on participants efforts to gather the information 

Research impact 

• The extent to which participating in the study will alter what participants do and what happens to them 

What is the first item on the list of ICH good clinical practices guidelines?

potential participants should understand that the study involves research 

What are the 2 purposes informed consent serves?

The requirement for informed consent allows competent individuals to decide whether participation in research is consistent with their interests 

Informed consent allows individual to decide for themselves whether they will enrol in the study in question 

T/F

Participants relationship with investigators is the same as with their doctors

false

investigators expose participants to risks and burdens

Review committees should consider waiving this aspect of informed consent when the following 3 conditions are obtained:

Participation in the study involves minimal contribution on the part of the participants and it is reasonable to believe they would not object to making this contribution 

Participants have limited or no interaction with investigators 

Participation has none or negligible impact on participants 

What does justice help us determine?

helps us determine how we distribute the scarce rescources

What is distributive justice?

there is not enough for everyone who needs it

how we determine who gets it first and who has to wait

What was Aristotle’s principle of distributive justice?

equals should be treated as equals and those not equal should be treated unequally

What is discrimination?

someone is bias and making decisions prejudicial against a group of people for no good reason

What is discriminative tatse?

You choose between possibilities

making a choice between people or things and you are picking one over the other

What is unintentional bias? (encultured bias)

everyone has to some degree

people are unaware they feel this way, but when it comes to a live issue, then they realize how strongly they feel about a certain thing

What does likely benefit mean when discussing healthcare?

how likely is it that we can restore this person to some degree

If someone is in a futile condition, this can effect their likelihood to treatment (more or less)

What are 3 elements of justice?

does a decision negatively effect some more than others

are those people the least able to cope with the results of that decision

are the risks taken mostly by one group and the benefits enjoyed by another group

What are substantive or material questions of justice?

answers the question who should receive care first

it states what we value and why we choose one thing over the other

What do procedural or process questions of justice answer?

how we apply the answer of who goes first

What are the 5 substantive questions of justice? Explain each

Need

• a measure of a societies justice is how well it looks after the needs of basic or essential health of its population

• Logic is that illness if a major impediment to happiness

Equality

• there should be equal resources for equal needs

Utility

• do that which will yield the greatest result

Liberty

• people should have access to healthcare in as much as they deserve

• you can disqualify yourself from access by your decisions

Restitution

• access and share should reflect past wrong doings deprived them of that same thing

What is horizontal equality?

equal resources for equal needs

What are the 4 fundamental ethical principles that guide healthcare delivery? Explain each

Beneficence 

• Acting in the best interest of others and promoting the well being of others 

Justice

• Treating people fairly, impartially and equitably 

Autonomy 

• Self determination and making one’s own choices 

Non-maleficence 

• Doing no harm or acting to avoid harm 

What are the recognized values that are assigned to resource allocation during decision processes?

Maximizing benefits

• most lives saved and most life years gained

Equal treatment

• Every person is granted the same moral status 

• lottery system and first come first served

Prioritize the worst off

What does it mean when someone has instrumental value?

People that are valuable in society

For example during the pandemic front line workers had instrumental value

What are 4 typical moral objections to enhancement?

cheating/unfairness

harm to self, others, the institution

intrinsic and extrinsic goods

zero sum or non zero sum

What is normality?

species typical functioning

What is the purpose of therapy?

to restore you to normality (or as close as possible)

Performance enhancing drug use…… (3 things)

predates history

was/is universal (no culture is immune to enhancement)

seems to serve the same purpose (allows people to achieve what they want)

What was beer historically seen as?

energy drink

What was milo of croton famous for?

famous for his strength training routine and pre competition diet

What sport has the biggest drug profile?

cycling

What are the 5 most popular drugs in cycling?

caffeine

cocaine

heroin

ether

digitalis (cardiovascular medicine)

What did Dr. Veronen believe?

believed that men needed a boost of testosterone (inserted a monkey testicle)

when enhancement became more than just for sports

Which athletes started using steroids first?

soviet athletes

What happened to the female swim team as a result of steroids?

began to get masculine features

What is Stuart Green’s 4 elements of cheating?

the rule must be fair and fairly enforced

rule breaking must take place in a co operative rule governed activity

the rule breaker must intend to break rules (accident does not count as cheating)

the rule breaker must admit intend to gain an advantage (cannot just be aimless rule breaking)

What are intrinsic goods?

benefits you gain from doing something that have value only to you

doing something because you want to

What are extrinsic goods?

the things of commercial value that we gain from high performance

not only personal motivation

motivation come from outside sources (endorsement, money, fame)

What does Allen Buchanan believe about performing enhancement drugs?

drugs do not necessarily mean that one is not earning their success

they could be training harder and longer and thereby actually developing more skill

What is zero sum versus non zero sum?

zero sum is winner takes all

non zero sum is everyone gains from the experience

What is affective (emotional) enhancement?

mental health enhancement

a medication that moderates stress response, can damage your memory

give the drug to someone after a traumatic experience to help them slightly forget or see the trauma differently

What are ethical concerns surrounding enhancement?

potential to undermine human nature

the denial of the givenness of life

the temptation to tyranny in parental decisions

the risks of exacerbating social inequalities

What percent of Canadians are vegetarian?

10%

What did Lappe’s protein theory popularize?

popularized health and ecologically based vegetarianism in North America

What is the central thesis of Lappe’s protein theory?

there is a scarcity of food in the world

animals are fed excessive protein in order to grow meat protein

human do not need to eat animal protein to be healthy

eating animals is short sighted and ultimately harmful to us and others

How much meat does the average Canadian consume?

96.8 kgs of meat, per person, per year

What are 3 ecological impacts of animal farming?

claims about an overpopulation of cattle and methane expulsion’s effect on the ozone

fecal run off into water supplies

grazing lands for cattle causing permanent damage to land surfaces

T/F

People who consume organic foods show health improvements

false, they do not show much health improvement

whatever is in the earth is in the food, wind and water can carry pesticides

What are zoonotic infections?

infections that jump from animals to humans

the infections were not originally meant for humans

Ex: SARS, bird flu

What is xenotransplantation?

create a cell profile in an animal that can be used for a human

What did Peter Singer say about reconsidering animals and personhood?

reevaluate people and animals and see what should be categorized as a person

Singer believes that personhood could include higher order mammals but also exclude some disabled or damaged humans

He is a utilitarian meaning all he is doing is expanding the membership of the greatest number. Instead of just humans, it is mammalian persons

What is a trivial item?

an item that contributes to vanity

What is a speciesist?

one who discriminates against another’s rights by virtue of their belonging to another (non human) species

For Singer’s concept of personhood, a person is any creature who meets all of the following criteria…

feel pain

make their own decisions

foresee a future

able to communicate

ability to reason

self aware

autonomous (independent)

What does it mean if someone fails to meet Singer’s concept of personhood?

They are not a person

Meaning an Alzheimer’s patient would not be entitled to personhood

What does Singer’s conception of personhood think about abortion?

acceptable

he feels that humans do not reach personhood until at least 3 months after birth

What does Singer’s conception of personhood think about euthanasia?

acceptable and encouraged

humans who slip below personhood status should not occupy resources which could be used for people

What does Singer’s conception of personhood think about xenotransplantation?

disallowed

mammals who qualify for personhood cannot have their interests defiled for another person even if they are human

What does Singer’s conception of personhood think about animal research?

disallowed

since monkeys could be persons, you could no longer use them for research than you could any human

What is speciesism?

Speciesism is a form of discrimination favouring those who belong to a certain species or group against other individuals. Examples include sexism and racism 

Speciesism is the unjustified comparatively worse consideration or treatment of those who do not belong to a certain species

What are 3 features that are found in all forms of discrimination?

Being comparatively worse for someone 

• To be discriminated against someone has to be treated worse than someone else

Lacking justification 

• Treating or considering someone worse than others needs to be unjustified in order to be discriminatory 

Involving consideration or treatment 

What is an example of inclusion oriented speciesism?

 treating rats poorly because they are not humans or a favoured animal 

What is meta discrimination?

favours some individuals over others by giving more importance to the discriminations that affect humans (one species or group) than those who affect another group/species

When can speciesism be justified?

Sometimes speciesism can be justified. For example during a forest fire saving land animals before birds. Yes, many birds did die but a larger population of animals were saved 

What is the doctrine of double effect?

a person may licitly perform an action that he foresees will produce a good effect and a bad effect

What are the 4 conditions that need to be verified fro the doctrine of double effect?

that the action in itself from its vert object be good or at least indifferent

that the good effect and not the evil intent be intended

that the good effect be not produced by means of the evil effect

that there be a proportionately grave reason for permitting the evil effect

In Bill C 14 what was the key factor that needed to be present to be granted medically assisted suicide?

it had to be foreseeable that someones life will end in the next few years

What is the difference between Bill C7 and Bill C14?

Eligibility criteria: 14 requires the individual to be able to consent at the time of request and administration, 7 only needs consent at the time of request

waiting period: 14 mandates a 10 day waiting period, 7 has no waiting period for ill individuals

assessment: 7 requires 2 assessors, 14 does not require any

Which bill excludes mental illness as a condition for MAID?

Bill C7

People with what condition have the highest rates of MAID?

cancer patients

Are mental health challenges currently supported as a reason to be considered for MAID?

no

What are 5 principles that need to be considered when discussing MAID?

ethics of care

non-abandonment

access to care

harm reduction (suffering reduction)

fairness

What does a “grievous and irremediable medical condition” imply?

a serious and incurable illness, disease of disability that has led to an advanced state of irreversible decline and intolerable suffering

In the model practice standard for MAID how is incurable defined?

there is no reasonable treatments remaining

In the model practice standard for MAID how is irreversible defined?

there are no reasonable interventions remaining

What are ongoing concerns regarding MAiD?

assessing irremediability

distinguishing MAID requests from suicidality

lack of professional consensus

protecting the vulnerable

Who is considered vulnerable when discussing MAID>

women, indigenous people, people with disabilities, people living in poverty and people in geographically underserved areas

T/F clinicians are allowed to decline to provide maid due to having a conscientious or religious objection

true

When a physician declines providing MAID to a patient what rules must they follow:

they must not impede the patients access to MAID

must communicate reasons for their objection to the patient, and make it clear that its a personal issue

they cannot express moral judgement to the patient choosing MAID

Must provide all information about the patients option of care and not withhold information that conflicts with their beliefs

must not abandon the patient and provide them with the correct referrals to people that can assist their wishes

What is the argument against minors being allowed to consent to MAID?

brain development is not complete until early 20’s and they may not be able to correctly assess the situation

Minors may not understand the severity of this decision

What is the age requirement for accessing MAID?

18 and older