HISTORY OF UNETHICAL AND ATROCIOUS HUMAN MEDICAL RESEARCH
AND EXPERIMENTATION (1)
3 domains: different ethics/laws
1) Clinical context
- Pt’s initiative (because patient go to hospital = taking initiative)
- Goal: health of Pt (main goal of doctor is taking care of health of patient)
- best effort based (there is no guarantee but effort based)
2) Research context (this is our focus for today)
- Researcher’s initiative (we use PI (=principal investigator) instead of doctor and participant
instead of patient)
- Goal: knowledge increase (this doesn’t focus on health of a single patient but on health of
future group of patients (we want to increase our knowledge))
- ‘Minimal’ harm
3) Screening context
- Health care initiative
- Population focus
- Benefit/outcome based (you need to be sure that it works so good diagnostic tool and good
answer for the problem)
What is Research Ethics?
Research ethics involves a balance between two values:
- The pursuit of scientific knowledge
and
- protecting the rights of research participants
Potential benefits such as advancing of our understanding of health and determinants of health,
gaining generalizable knowledge or helping research participants must be weighed against potential
costs/harm to the study participants
Main objectives of research ethics
- To protect human participants: this is in line with the ethical principle of Non-maleficense—first,
do no harm (Hippocratic oath)
- To ensure that research serves the interests of individuals, groups and/or society as a whole:
this objective can be linked to the emphasis on the social value of research and benefit sharing
- To examine the ethical soundness of research and ensure that they conform to ethical norms
and standards with respect to risk management, confidentiality, informed consent etc
Protecting research participants
- Human subjects are essential to the conduct of research intended to improve human health. As
such, the relationship between investigators and human subjects is critical and should be
based on honesty, trust, and respect (see also later).
- Concern over the treatment of research subjects arouse after the revelation of gross violations
of basic human rights in the name of science.
- There are accounts of unethical, atrociuos and infamous research practices in the past
Historical perspectives of atrocious research
- Many unethical human research and experimentation
1
, - Selected few that were well documented in literatures (examples)
• Nazi Human Experiments
• Tuskegee Syphilis Study
• Guatemala Syphilis Study
• Willowbrook Hepatitis Experiment
• Kano Pfizer Trovan Trial
Nazi Human Experiments
Nazi doctors conducted as many as 30 different types of experiments of concentration camp inmates.
They did these without consent of the victims who suffered indescribable pain, mutilation, permanent
disability, or in the case of many…death. Doctors performed all kind of experiments on people who
were prisoned in camp.
Experiments (examples)
- High Altitude:
• pilots who are shot and fall down from high what is the result of this on brain? To
know this they did test on people and put them in a low pressure chamber while doctors
were dissecting the brain of the person who was still alive (very illegal and unethical)
- Freezing:
• to test what the effect on the body is when you lay in ice cold water
prisoners/patients needed to be naked in ice cold water while the doctors were testen
heart rate etc
- Twins
- Bone, Muscle, Joint Transplants:
• if you lose your arm, can it be attached again to the body?
- Seawater:
• effect of salty water to human body
Nuremberg Code
We learnt lessons out of these bad actions so Nuremberg code was introduced. Set of guiding
principles for the conduct of research involving human subjects :
- Emphasizes on the voluntary consent of all research subjects in any experiment
- Avoidance of unnecessary physical and mental suffering
- Option to quit/responsibility to terminate
- Other safeguards
(patienten moeten het recht hebben om tijdens elk moment van experimenten te stoppen +
geen schade/pijn hebben)
Sypfilis study:
They want to find the treatment for syphillis. Only black poor man can participate. Original study
design was 1 year and they got permission for 1 year but it lasted 40 years.
they manipulated the participants because it was poor people and they said : if a family member
dies, we pay for the cost (=manipulation)
Belmont Report
The Belmont Report (1979) was introduced. This is the start of research ethics.
identified three principles essential to the ethical conduct of research with humans:
1. Respect for persons
2. Beneficence
3. Justice
These three basic principles serve as the foundation of the current guidelines for the ethical conduct of
human subjects research.
2
,(other examples in slides but you dont need to know them)
ETHICS OF BIOMEDICAL RESEARCH: MODELS (1)
1.Introduction:
- Delicate ethical dilemmas in genetic research: what is good? What is allowed? Is all that is
possible, allowed?
- Ethics is our reflection on what is good to do, what is allowed…
- Ethics as a vague concept?
- What is output of ethics? What is purpose of ethics? And what is characteristic of it?
- Moral experience (intuition and feelings) as point of departure/first step: everyone is an
amateur ethicist
- Ethic is needed for further reasoning and communication: a systematic reflection on
responsible behaviour
Moral experience:
- Everyone has their own vision, even if there are no concrete arguments for it
- People do not like to deviate from vision: With a rational argument it is not always possible to
change someone's mind
- Moral experience = intuitive opinion
- Negative contrast experiences and fullness experiences
o Contrast experience : 'I hope I will never be.... '
o Fullness experience : ‘ I wish I could deal with patients like that too...’
- In conversation with others: explanation behind own moral experience, accountability
(verantwoording) = giving arguments for own actions
- Further argumentation and communication requires ethics: systematic reflection on responsible
action
- Once moral experience turns to intuition : opinion change difficult ( e.g. gene therapy)
- If there is a problem, you have a first meaning about it even if you don’t know anything about it.
2.Terminology:
- Ethics = habitual and inner attitude
o Morals: rules of conduct taken as a whole that are considered to be self-evident within a
group; what “normal people” do
o Morality = act or follow rules of behavior on the basis of an inner conviction
- Moral = publically approved modes of behaviour, grounded on an inner feeling of morality
o In general : moral = ethical vs amoral
o More specific : moral = desirable, acceptable vs. immoral
- Deontology = theory of duties, professional codes, concrete recommendations and guidelines
for ethical conduct within certain professional group, bound by rules without effectively being
laws
- Ethics = a systematic study of moral
3.Classification of ethics:
Three approaches in ethics:
1) Descriptive ethics
= Study of actual norms and values in a specific community.
3
, o 2 steps:
Empirical study of ethos
A first attempt at internal explanation
o Empirical approach: gaining insight into morality/morality of particular group
o Internal explanation: how did common norms and value systems grow that way
(hypothesis formation)
o Descriptive ethics, mapping things out. Describing what you see
o Mapping empirically (with research) how many people have a certain view e.g. on
clinical trials on children
o Asking different people what they think about something
o Qualitative interviews, focus groups, survey....
o Hypothesis formation : first form of internal explanation
o Bv: we have data about the amount of euthanasie each year
2) Normative ethics: core of ethics
= First step with distance: how to judgde common norms and values?
o Taking another step further away from numbers
o Is it allowed or not allowed, do we consider something ethically acceptable or not?
o Establish norms on which we will base our judgment
o Abstract and theoretical framework: argue why one standard is better than others
o Ethical judgments: what is ethical action?
o Bv: is euthanasie good or bad (we evaluate a situation in good or bad)
3) Meta-ethics
= The critical study of concepts and methods used in normative ethics
o Questions: What is good? What is healthy? What is medicine/health (geneeskunde)?
o The concepts and models we use
o Thinking about the own concepts, words, models we use as ethicists
o bv medicine (geneeskunde) only for healing (reconstruction after mastectomy
(borstamputatie)) or also for improving (breast augmentation (borstvergroting))
Further chapters mainly discuss normative and discriptive ethics
4.Values and norms: important distinction
Norm = that which you use to judge an action concrete direction indicators (future), with which you
assess an action (past)
- The result of collective experiential wisdom
- Grown from/cithin a particular narrative community (e.g. driving on the left, no smoking in the
auditorium...)
- Something very concrete
- What you are allowed to do and not allowed to do (prohibited and mandatory)
- Sometimes a legal rule, sometimes not
- Often prohibited, because a prohibition creates freedom
o E.g. you are not allowed to eat in the auditorium, but you are allowed to do many other
things there
- Context-bound, evolving (change over time and place)
o E.g. in the past people still smoked indoors
4
AND EXPERIMENTATION (1)
3 domains: different ethics/laws
1) Clinical context
- Pt’s initiative (because patient go to hospital = taking initiative)
- Goal: health of Pt (main goal of doctor is taking care of health of patient)
- best effort based (there is no guarantee but effort based)
2) Research context (this is our focus for today)
- Researcher’s initiative (we use PI (=principal investigator) instead of doctor and participant
instead of patient)
- Goal: knowledge increase (this doesn’t focus on health of a single patient but on health of
future group of patients (we want to increase our knowledge))
- ‘Minimal’ harm
3) Screening context
- Health care initiative
- Population focus
- Benefit/outcome based (you need to be sure that it works so good diagnostic tool and good
answer for the problem)
What is Research Ethics?
Research ethics involves a balance between two values:
- The pursuit of scientific knowledge
and
- protecting the rights of research participants
Potential benefits such as advancing of our understanding of health and determinants of health,
gaining generalizable knowledge or helping research participants must be weighed against potential
costs/harm to the study participants
Main objectives of research ethics
- To protect human participants: this is in line with the ethical principle of Non-maleficense—first,
do no harm (Hippocratic oath)
- To ensure that research serves the interests of individuals, groups and/or society as a whole:
this objective can be linked to the emphasis on the social value of research and benefit sharing
- To examine the ethical soundness of research and ensure that they conform to ethical norms
and standards with respect to risk management, confidentiality, informed consent etc
Protecting research participants
- Human subjects are essential to the conduct of research intended to improve human health. As
such, the relationship between investigators and human subjects is critical and should be
based on honesty, trust, and respect (see also later).
- Concern over the treatment of research subjects arouse after the revelation of gross violations
of basic human rights in the name of science.
- There are accounts of unethical, atrociuos and infamous research practices in the past
Historical perspectives of atrocious research
- Many unethical human research and experimentation
1
, - Selected few that were well documented in literatures (examples)
• Nazi Human Experiments
• Tuskegee Syphilis Study
• Guatemala Syphilis Study
• Willowbrook Hepatitis Experiment
• Kano Pfizer Trovan Trial
Nazi Human Experiments
Nazi doctors conducted as many as 30 different types of experiments of concentration camp inmates.
They did these without consent of the victims who suffered indescribable pain, mutilation, permanent
disability, or in the case of many…death. Doctors performed all kind of experiments on people who
were prisoned in camp.
Experiments (examples)
- High Altitude:
• pilots who are shot and fall down from high what is the result of this on brain? To
know this they did test on people and put them in a low pressure chamber while doctors
were dissecting the brain of the person who was still alive (very illegal and unethical)
- Freezing:
• to test what the effect on the body is when you lay in ice cold water
prisoners/patients needed to be naked in ice cold water while the doctors were testen
heart rate etc
- Twins
- Bone, Muscle, Joint Transplants:
• if you lose your arm, can it be attached again to the body?
- Seawater:
• effect of salty water to human body
Nuremberg Code
We learnt lessons out of these bad actions so Nuremberg code was introduced. Set of guiding
principles for the conduct of research involving human subjects :
- Emphasizes on the voluntary consent of all research subjects in any experiment
- Avoidance of unnecessary physical and mental suffering
- Option to quit/responsibility to terminate
- Other safeguards
(patienten moeten het recht hebben om tijdens elk moment van experimenten te stoppen +
geen schade/pijn hebben)
Sypfilis study:
They want to find the treatment for syphillis. Only black poor man can participate. Original study
design was 1 year and they got permission for 1 year but it lasted 40 years.
they manipulated the participants because it was poor people and they said : if a family member
dies, we pay for the cost (=manipulation)
Belmont Report
The Belmont Report (1979) was introduced. This is the start of research ethics.
identified three principles essential to the ethical conduct of research with humans:
1. Respect for persons
2. Beneficence
3. Justice
These three basic principles serve as the foundation of the current guidelines for the ethical conduct of
human subjects research.
2
,(other examples in slides but you dont need to know them)
ETHICS OF BIOMEDICAL RESEARCH: MODELS (1)
1.Introduction:
- Delicate ethical dilemmas in genetic research: what is good? What is allowed? Is all that is
possible, allowed?
- Ethics is our reflection on what is good to do, what is allowed…
- Ethics as a vague concept?
- What is output of ethics? What is purpose of ethics? And what is characteristic of it?
- Moral experience (intuition and feelings) as point of departure/first step: everyone is an
amateur ethicist
- Ethic is needed for further reasoning and communication: a systematic reflection on
responsible behaviour
Moral experience:
- Everyone has their own vision, even if there are no concrete arguments for it
- People do not like to deviate from vision: With a rational argument it is not always possible to
change someone's mind
- Moral experience = intuitive opinion
- Negative contrast experiences and fullness experiences
o Contrast experience : 'I hope I will never be.... '
o Fullness experience : ‘ I wish I could deal with patients like that too...’
- In conversation with others: explanation behind own moral experience, accountability
(verantwoording) = giving arguments for own actions
- Further argumentation and communication requires ethics: systematic reflection on responsible
action
- Once moral experience turns to intuition : opinion change difficult ( e.g. gene therapy)
- If there is a problem, you have a first meaning about it even if you don’t know anything about it.
2.Terminology:
- Ethics = habitual and inner attitude
o Morals: rules of conduct taken as a whole that are considered to be self-evident within a
group; what “normal people” do
o Morality = act or follow rules of behavior on the basis of an inner conviction
- Moral = publically approved modes of behaviour, grounded on an inner feeling of morality
o In general : moral = ethical vs amoral
o More specific : moral = desirable, acceptable vs. immoral
- Deontology = theory of duties, professional codes, concrete recommendations and guidelines
for ethical conduct within certain professional group, bound by rules without effectively being
laws
- Ethics = a systematic study of moral
3.Classification of ethics:
Three approaches in ethics:
1) Descriptive ethics
= Study of actual norms and values in a specific community.
3
, o 2 steps:
Empirical study of ethos
A first attempt at internal explanation
o Empirical approach: gaining insight into morality/morality of particular group
o Internal explanation: how did common norms and value systems grow that way
(hypothesis formation)
o Descriptive ethics, mapping things out. Describing what you see
o Mapping empirically (with research) how many people have a certain view e.g. on
clinical trials on children
o Asking different people what they think about something
o Qualitative interviews, focus groups, survey....
o Hypothesis formation : first form of internal explanation
o Bv: we have data about the amount of euthanasie each year
2) Normative ethics: core of ethics
= First step with distance: how to judgde common norms and values?
o Taking another step further away from numbers
o Is it allowed or not allowed, do we consider something ethically acceptable or not?
o Establish norms on which we will base our judgment
o Abstract and theoretical framework: argue why one standard is better than others
o Ethical judgments: what is ethical action?
o Bv: is euthanasie good or bad (we evaluate a situation in good or bad)
3) Meta-ethics
= The critical study of concepts and methods used in normative ethics
o Questions: What is good? What is healthy? What is medicine/health (geneeskunde)?
o The concepts and models we use
o Thinking about the own concepts, words, models we use as ethicists
o bv medicine (geneeskunde) only for healing (reconstruction after mastectomy
(borstamputatie)) or also for improving (breast augmentation (borstvergroting))
Further chapters mainly discuss normative and discriptive ethics
4.Values and norms: important distinction
Norm = that which you use to judge an action concrete direction indicators (future), with which you
assess an action (past)
- The result of collective experiential wisdom
- Grown from/cithin a particular narrative community (e.g. driving on the left, no smoking in the
auditorium...)
- Something very concrete
- What you are allowed to do and not allowed to do (prohibited and mandatory)
- Sometimes a legal rule, sometimes not
- Often prohibited, because a prohibition creates freedom
o E.g. you are not allowed to eat in the auditorium, but you are allowed to do many other
things there
- Context-bound, evolving (change over time and place)
o E.g. in the past people still smoked indoors
4
