Chapter 1 Introduction and ethical models

Question 1

Goals research ethics

Answer 1

1. Protect human participants
2. ensure research serves interests of society/individuals
3. Examine of research is ethical, by e.g. looking at process of informed consent

Question 2

Unethical research examples

Answer 2

Nazi
Tuskegee syphilis study
Guatamala syphilis experiment
Willowbrook Hepatitis experiment
Kano Pfizer Trovan trial

Question 3

Tuskegee syphilis study: what was the goal

Answer 3

1. To provide data that would allow treatments programs for blacks
2. To test wehether advanced syphilis affected blacks and whites differently, so to document natural disease in black people

Question 4

What was unethical about the tuskegee syphilis study

Answer 4

1. no informed consent:
   a. withholding criticial information about the nature of the ddiease (they told the people they had ‘bad blood’)
   b. withholding information abut the true purpose of the study
2. withholding treatment (penicillin became widely available in 1940s)

Question 5

What was theguatamala spyhilis experiment about

Answer 5

test the value of different antiobiotic medication in the prevent ing of symptoms following infection with STDs and to test STD screening techniques.

Question 6

what was special about the sutyd popultaion of guatamala experiment

Answer 6

It included vulnerable populations: prisoners, sex workers, soldiers, children, and psychiatric patients

Question 6

What was unethical about the guatamala

Answer 6

1. No protection of vulnerable propulations
2. deliberatiely infected with STDs
3. enrollment without consent
4. Withholding study results

Question 6

Kano Pfizer trial: what was this about?

Answer 6

They tested a drug for cerebral menignitis in Nigeria.

Question 6

What was the willowbrook experiment about

Answer 6

testing a protective antbiody for hepatitis

Question 6

What was unethical about the willowbrook

Answer 6

1. The research was done not for the benefit of the children involved in the study, but for others
2. deliberate infection with a virus in a subset of children
3. the parents who consented were unaware of the risks of participation
4. undue influence: lack of availability in the school coerced parents to enroll into the research.

Question 7

What was unethical about the Kano Pfizer Trovan trial

Answer 7

1. Children who were very sick, who should have receive ceftriaxone (already appporoved drug), got the experimental drug (Trovan) instead. This caused a lot of unnessecary death.
2. Many of the patients did not sign consent forms and communication about the consent by translation was not detailed enough.
3. forgery (Vervalsing) of research documents
4. lack of oversight of research procedures

Question 7

What is descriptive ethics

Answer 7

Literally describes what norms and values count in a specific community. Answers for example: What are the prevailing attitudes towards euthanasia in different cultures around the world?

Question 8

What is normative ethics

Answer 8

Wonders how we can judge the norms and values in a specifi c community , i.e.e answerering what is ethically responsible conduct? Answers for example: Is it morally permissible for a doctor to assist in the euthanasia of a terminally ill patient who is experiencing unbearable pain

Question 9

What is meta ethics

Answer 9

Study of the concepts and methods used during a consideration of normative ethical questions. Such as: what is good, what is bad? In the context of health, what do we mean with ‘‘healthy’’ and ‘‘medicine’’

Question 10

What are the three ethical models within normative ethics?

Answer 10

Utilitarianism, Deontology, Principlism

Question 11

What is utilitarianism?

Answer 11

An action is morally good from an utilitarian pov if it produces the biggest genefit for the largest amount of people and causes the least amount of harm to the fewest number of people

Question 12

Arguments against utilitarianism

Answer 12

1. How we define the advantages and disadvtantages is very difficult (for who, and for what) and this is subject to manipulation depending on which side you take.
2. It takes the intention out of the equation
3. Everyone will favor their own side so a scientist might make decisions to only favor their own group and the greatest benefit will probably be for the strongest

Question 13

What is deontology

Answer 13

The opposite of utilitarianism: the INTENTION outweighs the consequences, regardless of the consequences in a positive or negative sense.

Question 14

What are the problems with deontology

Answer 14

1. it denies bad outcomes
2. It relies on very grounded ideas on what i good and bad, an hence cannot adopt changing values in society.

Question 15

What is principlism

Answer 15

The researcher must use certain principles as a guiding for a decision. This avoids the pitfalls of other forms, and hence researchers has more freedom.

Question 16

Principles in principilism?

Answer 16

1. Benificence
2. Non-malificence
3. Justice
4. Autonomy

Question 17

What does benificence mean in contact of the biomedical research?

Answer 17

The researcher must always act in the intererst of the patient (haha, this is often not really how it goes, because often the aim in increasing the scientific knowledge). Therefore, a better principle to use for guidance is..

Question 18

The principle of non-maleficence: what is that?

Answer 18

The moral obligaton to not harm others, i.e. to not harm the patient.

Question 19

Four types of harm in non-malificence?

Answer 19

1. physical / psychological harm
2. harm to interest
3. harm as injustice
4. harm as a violation of moral integrity

Question 20

Issues with non-malificencce?

Answer 20

1. Much research is impossible without one or other form of harm to the patient
2. Sometimes its necessary to cause a little bit of harm to prevent greater harm
3. Wht is the scope? Does it apply to the individual (Abortion pro) or also the group (whole society: culture of death)

Question 21

Rule of Double effect aim

Answer 21

Aims to align non-malifence with benifecence to justify our actions

Question 22

Rule of double effect 4 conditions

Answer 22

1. immediate Ethical consequence of the action must not be wrong
2. intention must only be aimed towards the positive effect
3. Negative effect cant be a means to achieve a good effect
4. Good effects&raquo_space;> bad effects

Question 23

2 problems with rule of double effect?

Answer 23

1. Intention = not always clear
2. Who decides what is good and bad? not clear, and RDE already assumes an ethical position in this debate

Question 24

what is the principle of justice about?

Answer 24

The principle of distributive justive governs the distribution of benefits and burndens in societey, The aim is to give each person what they have right to .

Question 25

Examples principle of justice

Answer 25

1. Everyone receives equal share
2. Everyone receives what they need
3. Everyone receives in proportion to the effort made

Question 26

Principle of autonomy and importance in biomedical

Answer 26

Connected to independence, freedom, dignity. In context of research ethics, it is often linked to informed consent.

Question 27

For informed consent the following three conditions must be met:

Answer 27

1) a competent person 2) independent of third parties 3) with knowlegde of the action and the consequences

Question 28

Criticism of principlism

Answer 28

It is like a checklist to go off and hence working with principles confuses and misunderstands the fundamental ethical issue. there is danger that although it may appear like well-founded principles are used, this is fundamentally not the case.