Class 2

Question 1

Nazi Doctor Trials and the Nuremberg Code (1946-1947 and 1947)

Answer 1

During World War II, German scientists conducted research on concentration camp prisoners in the Nazi Experiments. Horrific experiments were performed. Following the war, there were Nazi Doctor Trials (1945- 1946).

These trials led to the development of the Nuremberg Code (1947), which was used to convict the Nazis of their war crimes, and whose first statement is “The voluntary consent of the human subject is absolutely essential.” This was the first international document that advocated for voluntary participation and informed consent.

Question 2

Declaration of Geneva (1948)

Answer 2

As a result of the crimes committed by physicians during World War II, the Declaration of Geneva shows the physician’s dedication to advancing the care of patients, by pledging to consider the health and well-being of patients, respect patient autonomy and human life, avoid discrimination when caring for patients, respect confidentiality, practice medicine with dignity, and pledging not use medical knowledge to violate human rights.

Question 3

Henrietta Lacks and thee HeLa Cell (1951)

Answer 3

An African American woman who lost her life to cervical cancer, cells of her tumor became the source of Hela strain, which allowed for many medical advancements.
Radiation and tx for a year, but the tumor was aggressive + painful, doctor’s took a piece to biopsy and sent a second piece to another doctor/researcher (Dr. Guy).
At Guy’s lab, they were attempting to grow human cells in a dish but every time they tried, the cells died.

The cells from Henrietta’s tumor did not die, rather they thrived - doubling in size q24 hrs - He-La strain. Eventually, her cells were in hundreds of labs.

The cells were infected with polio virus, and then tested for the vaccines. Not just this, her cells helped with research for salmonella tx, HIV tx, gene mapping, HPV vaccines, AIDS research, effects of radiation, toxicity research, parvovirus, heptamethine dyes, etc.

All of this happened without consulting her family until the 1970s. Thye needed to consult the family for blood samples, and the family believed the researchers were making clones of Henrietta which was unsettling. Her genome was published online in 2013 without her family’s permission.

Question 4

Thalidomide tragedy & Kefauver Harris Amendments (1957-1962)

Answer 4

In 1957, thalidomide was marketed in West Germany to treat morning sickness during pregnancy. The drug also first entered the Canadian market in 1959. About 10,000 infants in 46 countries were born with severe birth defects (e.g. stunted limbs) as a result of exposure to this drug.

Following the thalidomide tragedy, the Kefauver Amendments to the Food, Drug, and Cosmetic Act were passed into law to ensure drug efficacy and greater drug safety. For the first time, drug manufacturers had to prove effectiveness and safety of drugs before approval. It requires disclosure of information about side effects.

Question 5

Allan Memorial Institute Experiments in Montreal (1957-1964)

Answer 5

Donald Ewen Cameron was a psychiatrist funded by the CIA as part of Project MKUltra. He led a series of experiments, initially aimed at treating schizophrenia by changing memories and erasing patients’ thoughts using “psychic driving”. The experiments were conducted at McGill at the Allan Memorial Institute. Most patients had depression or schizophrenia and suffered amnesia as a result of the experiments. As an interesting tidbit, a recent Louise Penny mystery novel revisiting research ethics with this shameful bit of Montreal history as a backdrop.

Question 6

The Declaration of Helsinki (1964)

Answer 6

The Declaration of Helsinki is a short, symbolic document providing physicians recommendations for biomedical research involving human subjects. The declaration governs international research ethics and defines rules for “research combined with clinical care” and “non-therapeutic research”. It states that informed consent from participants is necessary, that risks should not exceed benefits, and that research should be conducted by qualified individuals, among other statements.

Question 7

US Radiation Studies (1944-1974)

Answer 7

Human radiation experiments were conducted between 1944 and 1974 in the US. The experiments were carried out by government doctors, scientists, and military officials on as many as 20,000 people and it was learned that over 40,000 experiments had been conducted.

Some examples include:
800 pregnant women being administered radioactive iron in the late
1940s at Vanderbilt University
11 terminally ill cancer patients being injected with radioactive calcium in New York City in the late 1950s
19 mentally disabled teenage boys who were exposed to radioactive
ingredients in food during “nutritional” studies
Experiments done on prisoners in the Washington State Prison and the Oregon State Prison to determine the dosage of radiation to male testicles to cause sterility

Question 8

Willowbrook State School Experiments (1956-1972)

Answer 8

Researchers at the Willowbrook State School in New York, an institution for mentally disabled children, purposefully infected healthy children with a mild form of hepatitis during a series of studies exploring the progression, prevention, and treatment of viral hepatitis. The study was approved by the New York Department of Health. The results contributed to the development of a successful hepatitis vaccine. Questions were raised about the quality of parent consent because there were claims that the studies were incompletely or inaccurately described.

Question 9

Research Ethics Board (+3 principles)

Answer 9

Based on the previous abuses in research, the need for structured monitoring of the ethics of research studies was highlighted. Research Ethics Board (or Institutional Review Boards) came into existence in the 1970s.

As you will remember in your TCPS-2 training in NUR1-312, research that involves humans must undergo an evaluation process by a Research Ethics Board (REB). The TCPS-2 outlines expectations as to how benefits and foreseeable risks play out. The core value is the respect for human dignity as reflected by these three principles: Respect for Persons, Concern for Welfare, and Justice.

Question 10

Belmont Report (1979) ( + 3 core principles)

Answer 10

The Belmont Report was a report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It includes three core principles: (1) Respect for Persons (capacity, autonomy, informed consent, limiting risk); (2) Beneficence; (3) Justice (fair subject selection; disadvantaged populations cannot be burdened to advantage the advantaged). It was essential to establish formalized policies/regulations and is one of the most important documents in research ethics.

Question 11

Rules on human research can be in form of:

Answer 11

Laws
Regulations
Policies
Standards

Question 12

Research ethics committee 3 P’s:

Answer 12

Protect participant rights
Promote participant well-being
Prevent participant harm

Question 13

Research Ethics Committee (REC) Composition:

Answer 13

2 members with knowledgeable in relevant research disciplines, fields, and methodologies reviewed by the REB

1 member knowledgeable in ethics

1 member knowledgeable in law relevant to research
(Must not be a legal counsel for the institution)

1 member from the community unaffiliated with the institution

Question 14

What elements does the REB assess?

Answer 14

Research content and methodology

Recruitment procedures

The informed consent process

Study risks, inconveniences, and benefits

The right to privacy and ensuring confidentiality of the data collected

The appropriate diffusion of results

The feasibility of conducting & completing study

Other considerations: e.g., impact on the community

Question 15

normative ethics

Answer 15

Virtue ethics **
Utilitarianism **
Deontology **
feminist and ethics of care can supplement normative ethics

Question 16

Focus on moral agent NOT on the action
What kind of person am I?
What kind of person should I be?
What kind of person should I become?
predominated until 1700s

Answer 16

virtue ethics

Question 17

who created virtue ethics

Answer 17

Aristotle

Question 18

explain virtue ethics

Answer 18

Be like this, be like that = exhibit virtuous character. Not do this or do that

Phronesis - practical wisdom
Acquired trait
Results in actions that requires a perceptual sensitivity to what situation acquires

Eudaimonia - the good life
State of well-being, human flourishing
Not subjective, he believes it to be objective
A life that was well lived, a good life

Virtues: a trait of character manifested into habitual actions

Intermediate between extremes. Vices of deficiency and excess

Question 19

some critique of virtue ethics

Answer 19

No clear guide as to how to act

Weighing of virtues – what if they conflict?

Focuses on agent’s own character, not how to behave towards others

Assumes virtuous people will always make the right choice

Do virtues change over time?
Not culturally relative
Skilled nurse vs. a virtuous nurse?
Lacks guidance as to how to become virtuous

Question 20

The ends justify the means

Answer 20

Utilitarianism (consequentialism = consequences matter more)

Question 21

The means matter

Answer 21

Deontology

Question 22

philosophers of Utilitarianism

Answer 22

Jeremy Bentham (1748-1832)

John Stuart Mill (1806-1873)
- inspired by Bentham

Question 23

describe Utilitarianism

Answer 23

Actions are right based on what produces the “most good”
Actions are right/wrong based on utility/consequences

Weigh consequences for all
Need to look at all possible outcomes

Egalitarian. Not equitable approach

Seeks evidence: agent is impartial
Doing nothing is an action that must be considered as a possible outcome/consequences
Includes sentient beings – animal rights

Question 24

act Utilitarianism

Answer 24

You use your roomates umbrella and break it, so you throw it out and lie about it = act utilitarianism says it’s okay because you spare the roomates feelings and the relationship between the both of you

Specific time at a specific situation; nothing is forbidden

Question 25

rule Utilitarianism

Answer 25

Roommate example: would say that it’s always okay to lie to spare someones’ feelings → if this turns into a rule in society would this be desirable

exits over a continue; can we make this into a social construct or rule?

Question 26

Utilitarianism critiques

Answer 26

Only looks at future consequences

We are not considering the act itself, we are not considering the morality of the act itself

Who defines what is “good”?

Possible conflicts with justice & rights

Too demanding

Question 27

how does utilitarianism help in health care decisions making

Answer 27

Scarcity – Limited Resources & Allocation of Resources

Striving for collective good (public health)

Evidence-informed care

Global health

Question 28

“Act as if the maxim of your action were to become by your will a universal law of nature.” -

Answer 28

• (Immanuel Kant 1785) = deontology

Question 29

deontology: Features

Answer 29

Consequences do not matter

Choices must be morally correct and done out of a sense of duty

Do not choose actions because you want to please someone or because you have an impulse

Doing the right thing for the right reason

Actions should be motivated by duty to be right and good

I will tell the truth, I will not lie because this is the right thing to do, but the consequences are not considered (e.g. Do I look fat in this dress? Yes you do).

All humans have dignity and require respect = important concept to Kant and in healthcare

Moral worth involves free will and is found in choices that are in accordance with principles

Question 30

deontology categorical imperative

Answer 30

hypothetical: action is good as a means to something else (condition)

categorical: action is good itself and not dependent on anything

Question 31

3 formulations of deontology

Answer 31

Does my maxim make sense as a universal law?

Would I be treating people with respect? (do not use someone as a tool)

Would my action prevent someone from exercising their rational faculties?

Question 32

deontology: Critiques

Answer 32

Outcomes and contexts are not particularly considered

Truth telling versus lying

Denies exceptions

What about conflicting duties?

Who makes the rules and who do they apply to? Who determines moral duties?

Dismisses moral value of actions motivated by emotions or “good will” because motivation is not duty

Can the motive of duty always justify actions? Does it make moral sense, are these ideas we can take with us?

Question 33

Most frequently used paradigms in bioethics (not the best)

Answer 33

Principlism

Question 34

Principles of ethics

Answer 34

Autonomy :
Right to self determination, in charge of oneself
Cornerstone of our code of ethics, consent, collaborative partnership, informed decision making….

Beneficence:
Need to take steps to help others, to do good and promote good
Definition can be played around of

Nonmaleficence:
Not the opposite of maleficence, just a different facet of it
Idea of seeking to NOT inflict harm
Hippocratic oath: first do no harm

Justice:
Question of fairness, determining what groups are entitled to, how resources are passed out, etc.
How to offer care based on needs
How address disparities and inequalities

+2 more:

Varsity: Tell the truth, obligation to not lie

Fidelity: Obligation to do what we’re gonna say we are going to do, faithful and loyal to our commitments, and keep our promises.

Question 35

Strengths Principlism

Answer 35

Common language = all learned this in school
Widely used
Structured = good order
Focus on rationality

Question 36

Principlism Criticisms

Answer 36

Risks of using as a ‘recipe’ = risk of losing nuance
Ignores complex socio political climates & context = ignores richness of people’s story due to reductionism
Goes into “thin ethics” - flat experiences
Is there consensus on these 4 principles…may not be relevant in other cultures

Question 37

Personhood

Answer 37

“connected, interdependent, uniquely situated, and both rational and emotional, as opposed to one that characterizes persons as autonomous, independent, rational, and unencumbered”

Feminist ethics expands on the idea of seeing people as being more than just autonomous beings but as existing relationally:
- Autonomy beyond just discrete legal entities
- We live in relationships, people rely on us and we rely on others
- Important to understand relationships in order to understand autonomy

Question 38

Relational Ethics

Answer 38

Gained much attention in nursing, elaborates on relational ethics; 3 important tenants:
- Embodiment
- Mutual respect
- Engagement

Relational ethics locates the ethical action in the therapeutic relationship, in our nursing work (something we enact)

Question 39

Narrative Ethics

Answer 39

Based on looking at people’s story

No thinning out process, open up and present a rich perspective

How is the dilemma lived and experienced?

Great way to look at ethics and approach ethical questions = through stories

Can make important political points

Can disrupt master narratives in healthcare

Question 40

Case Study - Casuistry

Answer 40

Casuistry is a branch of applied ethics, NOT one of the normative theories

Relies on case studies (excellent way to learn in nursing and ethics training)

Not a lot of philosophy behind it

Take problems and see how we can draw wisdom from individual cases. What information and wisdom can we draw from it and how can we learn to apply this for future situations.

A method not a theory
Used in jurisprudence (judgment in interpreting the law)

Question 41

What is an ethical dilemma?

Answer 41

Involves a choice of a course of action in the face of multiple alternatives and possible consequences

It often generates uncertainty to those involved about the best alternative to be chosen

Question 42

Ethical Decision-Making Tools & Frameworks
(4)

Answer 42

IDEA Framework
Canadian Nurses Association (CNA)
Storch model
Community ethics toolkit

Question 43

IDEA: Ethical Decision-Making Framework

Answer 43

REFER to image

Question 44

Canadian Nurses Association (CNA)
ethical framework (11)

Answer 44

Determine who is involved
Describe the issue
Assess the situation
Clarify values
Explore the story and note reactions
Identify ethical principles
Clarify legal rules
Explore options and alternatives
Decide the course of action
Develop an action plan
Evaluate the plan

Question 45

Storch Model

Answer 45

refer to image

Question 46

Moral Distress is…

Answer 46

Negative feelings that arise when one knows the correct response to a situation but cannot act accordingly because of institutional or hierarchical constraints

Psychological disequilibrium and state of negative feelings experienced when a person makes a moral decision but does not follow through by performing the moral behavior indicated by that decision

Question 47

Moral uncertainty

Answer 47

when one does not know the correct course of action or moral choice when faced with a number of different options and differing values

Question 48

Moral Agency

Answer 48

agency: capacity for a person to engage in deliberate action

Moral agency: A stronger framework for understanding the moral dimension of clinical practice:
A person capacity to engage in deliberate actions that are morally relevant
Pertaining to matters of right & wrong, good & bad, just & unjust
All nurses are moral agents!

Question 49

What Nurses Can Do to Address Moral Distress
(hint: leadership)

Answer 49

Recognize the symptoms of moral distress
Reflect on and be curious about the ethical aspects of clinical situations
Reconnect to your original purpose and intention for being a nurse
Commit to your personal well-being
Support and restore your moral integrity
Learn to listen to your intuition and somatic responses
Develop ethical competence
Speak up about your ethical concerns
Take principled actions
Contribute to a culture of ethical practice

Question 50

an expression of moral agency

Answer 50

Moral Courage:

Question 51

“The capacity of an individual to sustain or restore their integrity in response to moral complexity, confusion, or setbacks.”

Answer 51

Moral Resilience:

Question 52

Moral Community

Answer 52

Workplace where values are made clear and are shared, where these values direct ethical action and where individuals feel safe to be heard.

Coherence between publicly professed values and the lived reality is necessary for there to be a genuine moral community.

Question 53

Milgrim Shock Experiments (1961-1962)

Answer 53

Milgrim Shock Experiments (1961-1962)
A decade earlier psychologist Stanley Milgram had also looked at how we respond to Authority in order to understand how people were induced to obey unjust regimes and participate in atrocities such as the Holocaust.
He set up an experiment where volunteers were told they were taking part in scientific research to improve memory. Separated by a screen the teacher would ask the learner questions in a word game and administer an electric shock when the answer was incorrect he was told to increase the voltage with each wrong answer. Participants didn’t know that the learner was really an actor and the so called shocks harmless
two-thirds of volunteers were prepared to administer a potentially fatal electric shock when encouraged to do so by what they perceived as a legitimate authority figure in this case a man in a white coat
Milgram’s findings horrified America they showed that decent American citizens were as capable of committing acts against their conscience as the Germans had been under the Nazis

Question 54

Beecher exposes unethical practices (USA: 1966)

Answer 54

Doctor Beecher was noted for this definition of death, he was also important to the hx of research ethics governance. Many credit him for changing the attitudes and practices towards participants in research. He was a top anesthesiologist and researcher (today, we call him a whistleblower). His seminole study published in the New England journal of medicine in 1966, played a role in requiring studying to undergo review. In this article, doctor Beecher succeeded in publicizing abuses committed by his fellow research colleagues.
They were performing medical research procedures without obtaining consent from patients.
The editors of the New England Journal of Medicine wanted him to name these colleagues but he refused. Doctor Beecher said that these practices were unethical and so widespread, he was not interested in punitive actions, but in actively changing medical culture and practice.
Some of his research colleagues assumed a paternalistic approach towards pts, stating that they were in the role of guarantees of participants’ rights and safety. They “knew better than the pts”, all actions were legitimate. What occurred with the syphilis experiments as well as other unethical clinical trials at the time, led to the creation of Belmont report in the US. This report led to the creation of US federal laws to govern research conduct.

Question 55

In 1999, Jesse Gelsinger

Answer 55

In 1999, Jesse Gelsinger was a 16 yr old boy, who had a rare metabolic disorder. Pain managed with medication. He asked to take part in an experimental medication study using gene therapy = wanted to contribute to science and wanted to help other children and his parents allowed him to volunteer in a gene therapy study using a technique for which the Investigator’s company held the patent.
He and his father consented to clinical trials. 4 days after he took the medication, he died. His father linked the death to the risks associated with the experiment, but found out through a PI there was a conflict of interest they both were uninformed about.
Managing conflicts of interest
The REB that approved the study was not properly informed that data from pre-existing animal studies showed toxicity, and previous people who had been enrolled in this study have suffered side effects. Not enough info was provided orally or in the consent form. The father later sued and the university settled with them.

Question 56

Cameron’s experiments (Allen memorial 1951-1980s)

Answer 56

Conducting research in 1960s. His discredited methods included massive electroshock treatments and other brutal deep patterning techniques such as sensory deprivation that all but erased the personalities of some pts. He proclaimed these methods aimed at easing depression and other mental illnesses. But later discovered that his aims included mind control experiments backed by the CIA. These vulnerable pts with mental health issues never consented. They sued, but public trust was broken. The Verdun hospitals and prisons were also involved. Students were also taken to the Allen basement with eyes, ears, arms, legs, wrapped = goal was to disorient. We do not know what happened to them.

Question 57

Doctor Poisson (1990s)

Answer 57

Quebec doctor who received funding from the US funding body = NIH for breast cancer research. He falsified 20% of pt records. He held a double set of medical files, he included progress reports of people who had been dead for years, these people in the trials did not give their consent. His conduct put into question the scientific integrity of the entire study. In quebec, this event led to many changes in creating guidelines for the conduct of research and is thought that our research governance in quebec is ahead of other provinces.

Question 58

Nutrition research and human biomedical experimentation in aboriginal communities and residential schools (1942-1952)

Answer 58

Ian Mosby is a food historian. His research published in 2013, revealed how the Canadian government funded unethical experiments on undernourished children from indigenous communities in residential schools. The goal was to see whether physical manifestations of the disease (malnutrition) could be treated with vitamin supplements alone. The children in this study were so malnourished and hungry, and the research knew it, and they knew that even if this experiment was successful, vitamin supplements alone would not resolve their acute hunger. Neither children, nor parents consented.

Question 59

name recent (in the past year) unethical research in Canada

Answer 59

Last year, Health Canada shut down a clinical trial conducted on children at the Ste-Justine hospital. Several children died, while it is still unknown whether it was the experimental drug that caused these deaths. The trials were shut down anyway, since it was not conducted according to regulations that govern clinical trials. Today, data security is one of the many emerging ethical issues that we need to pay attention to. Researchers are responsible for keeping data secure.

This august, the Massacheussets General had a major data breach, which affected 10k pts, an unauthorized party had access to 2 computer applications used by researchers in their neuro dept for 6 days.

As a result of abuses, we must stress that public trust can be broken. We need people to participate in research, and if they don’t, society suffers.

Question 60

feminist ethics key features

Answer 60

• prevent oppression
• importance of attention to context, especially social context, and to unique properties of individuals
  asks questions about how power before questions of care and justice
• care and justice co-exist and both are important

Central ideas:
Moral attention: attention to the complexity, to all of the different dimensions within the situation
Sympathetic understanding: Open to identifying with individuals the idea of attunement to sympathizing or empathizing with the people.
Relationship awareness: This is again the idea of situational aspects in terms of the relationships involved. So we are part of complex relationships and it informs situations.
Accommodation: Including and accommodating needs of all, including the agent, including the self.
Response: Carrying out concrete actions taken to respond to these needs.

Question 61

care ethics key features

Answer 61

• prevent oppression
• importance of attention to context, especially social context, and to unique
• a way of viewing problems as opposed to solving them
  differentiates voice of care and voice of justice; either a problem for justice or care but not both
• care > justice

Question 62

Reflecting on Power and Relationships
(feminist and care ethics)

Answer 62

• Both feminist and care ethics OR care ethics feminine, include an interest and gives value to concepts of power, privilege, and relationships. They also place significance on women’s experience as a primary source of moral insight.
• So both attend to power dynamics, power and oppression care ethics more at the private level, the home and in relationship.
• Whereas feminist ethics is stronger in advocating for political change. Feminist ethics and care ethics understand relationships as being central in our understanding of what is right and what is good, and they understand personhood a bit differently than other normative theories.