SUMMARY ETHICS & LAW – BIOMEDICAL SCIENCES
Ethics Chapter 1: Introduc4on and ethical models
1. General Introduc0on
Health care: 3 domains with different ethics/laws
1. Clinical context
a. Ini4a4ve > pt
i. Eg a<ending consulta4on in hospital)
b. Goal = health of pt
c. Best effort based
i. No guarantee that healing will take place
2. Research context
a. Ini4a4ve > researchers/PI (principal inves4gator, not doctor)
i. Eg clinical trial: invi4ng people for research
b. Goal = knowledge increase
i. Increase global biomedical research, ≠ singular pa4ent
c. Minimal harm of par4cipants (!)
i. Emphasis not helping singular pa4ent
ii. Eg: tes4ng 3 arms with different dose of medicine -> only 1 arm will have best outcome,
rest of group have the less op4mal op4on
3. Screening context
a. Ini4a4ve > health care
i. Eg screening newborns with hielprik
b. Popula4on focus
i. Eg all women over 25 -> mammography
c. Benefit/outcome based
i. Screening has to work well -> faster diagnosis & be<er outcomes
What is Research Ethics?
ð Tradi4onally focused on issues in biomedical research
ð Big development of applica4on of research ethics to examine and evaluate biomedical research & has
influenced much of the exis4ng statues and guidelines
Balance between 2 values
1. The pursuit of scien4fic knowledge
2. Protec4ng the rights of research par4cipants
ð Poten4al benefits must be weighed against poten4cal cost/harm to study par4cipants
o Advancing understanding of health & determinants of health, gaining generalizable knowledge,
helping research par4cipants
Terminology
- Ethics: habitual and inner a[tudes
o Most common way of defining ethics = norms for conduct that dis4nguish between acceptable
and unacceptable behavior
§ Acquire sense of right/wrong during childhood
o Morals: the rules of conduct taken as a whole that are considered to be self-evident within a
group; what “normal people” do
§ Moral development throughout life4me
o Morality: behavior based on internal convic4on
- Moral: publicly approved modes of behavior, grounded on an inner feeling of morality
o In general: moral = ethical; vs amoral
o More specifically: moral=desirable, acceptable; vs immoral
- Deontology: professional codes of ethics
- Ethics: a systema4c study of morality
,Ethics vs law
- ≠ the same
o Ac4on may be legal but unethical
- Ethical norms are broader & more informal than laws
- Although we use laws to enforce widely accepted moral standards
Main objec0ves of research ethics (3)
1. Protect human par4cipants
a. In line with ethical principle of non-maleficence
i. First, do no harm (Hippocra4c oath)
2. Ensure that research serves the interest of individuals, groups and/or society as a whole
a. Can be linked to emphasis on social value of research and benefit sharing
3. Examine the ethical soundness of research
a. & ensure that they conform to ethical norms & standards with respect to risk management,
confiden4ality, informed consent etc
Protec4ng research par4cipants
Human subjects = essen4al to the conduct of research intended to improve human health
ð Rela4onship btwn inves4gators & human subjects = cri4cal
ð Rela4onship should be based on honesty, trust & respect
Concerns over treatment of research subjects arouse ader revela4on of groos viola4ons of basic human rights in
name of science
ð Unethical, atrocious & infamous research prac4ces in the past (see further)
2. Historical perspec0ves of unethical and atrocious research
The Nazi Human experiment
Nazi doctors conducted 30+ # types of experiments of concentra4on camp inmates
ð Without consent of vic4ms & no mandatory professional standards & no protec4on of vic4ms
ð Research + using medical knowledge for race-based program of public health and genocide
ð ‘Racial pathology’: trying to prove that eg Jews responded differently to infec4ons
ð Most of the experiments were scien4fically worthless
ð Es4ma4on of 256000 people killed
Nazi physician: researchers
- Dr. Sigmund Rascher - coagula4on/amputa4on studies; hypothermia experiments
- Dr. Karl Gebhart: heteroplas4c transplanta4on experiments
o c.f. Stalin’s a<empts to create interspecies (half-men/half-apes) “super-warriors”
- Drs. Karl Clausberg and Viktor Brack: X-irradia4on/steriliza4on
- Dr. Joseph Mengele: Sep4cemia/twin vivisec4on studies
Experiments (few examples)
Sterility induc4on – Clauberg
- Injec4ons to induce sterility in women prisoners
Euthanasia
- = euphemism!
- Targe4ng of ‘worthless lives’
- Also killing to obtain body parts for scien4fic research
High al4tude – Dr Rascher
- Goal: find out how to best save German pilots forced to eject at high al4tude
- Experiment:
o Placing inmates into low-pressure chambers, simula4ng al4tudes as high as 68 000 feet
2
, o Dissec4on of vic4m’s brains while s4ll alive to show that high-al4tude sickness > forma4on of air
bubbles in blood vessels of part of brain
Freezing – Dr Rascher
- Goal: determine most effec4ve means for trea4ng German pilots who had become severly chilled from
ejec4ng into ocean/German soldiers who suffered extreme exposure on Russian front
- Experiment:
o Placing vic4ms into vats of icy water for hours (in aviator suits or naked)
o Taking vic4ms outside and strapped them down naked
o Measure the effect on heart rate, body temperature, muscles reflexes etc
Twins – Dr Mengele
- Goal: find ways to more effec4vely mul4ply the German race (& create ‘ubermensch’)
- Experiment:
o Taking body measurements & other living data
o Injec4on with chloroform to hearth, see how many survived
- * Mengele:
o Determined who would be killed, who would become forced laborer, who worked to death
o Then moved to experimenta4on
§ See above + sewing twins together to create Siamese twins, injec4ng chloroform in
eyeballs to change eyecolor
Bone, Muscle and Joint transplant
- Goal: learn if a limb or joint from 1 person could be successfully a<ached to another
- Experiment:
o Amputa4on of legs & shoulders from inmates & transplant them onto other vic4ms
Seawater – Dr Eppinger
- Goal: how to make seawater drinkable
- Experiment:
o Forcing Gypsies to drink only seawater while also depriving them of food
Adermath of Nazi experimenta4on
Nuremberg Doctor Trial
- 23 German physicians tried
- 16 found guilty
- Rascher died before trial
- Mengele fled for Argen4na
- Hallevorden commi<ed suicide before trial
Nuremberg Code
ð Set of guiding principles (10) for conduct of research involving human subjects
- Emphasizes on voluntary consent of all research subjects in any experiment (informed consent)
- Avoidance of unnecessary physical and mental suffering (minimal harm)
- Op4on to quit/responsibility to terminate
- Other safeguards
ð = 1st lesson > unethical research of past
Tuskegee Syphilis Study
Played key role in crea4ng ins4tu4ons and prac4ces that today govern the use of human volunteers in US
Biomedical Research
Goal: research pathology of syphilis on impoverished African American men with syphilis
- Took place in Tuskegee Alabama
3
, Experiment:
- Non-therapeu4c research and only men with advanced cases of syphilis were selected for study & were
led largely untreated (because they could not afford to treat syphilis)
- Just study fate of untreated syphilis to terminal end
Main inten4on of conduc4ng the research
- Limi4ng to only men
o Mo4va4on: belief that it would be easier to get reliable clinical history from men than women.
Men are more likely to recall appearance of primary chancre
- Limi4ng to only black men
o Mo4va4on: assump4on of some people that advanced syphilis affected whites and blacks
differently => PHS wanted to prove them wrong
§ Whites: suffer higher incidence of brain damage & related neurological disease (more
severe)
§ Blacks: cardiovascular syphilis
- Limi4ng to only blacks
o Mo4va4on: Public Health Service though wanted to use results to pressure Southern state
legislatures into appropria4ng funds for syphilis control work among rural blacks
o By denying the men treatment, the researchers hoped to develop a case for treatment programs
sponsored by state government
The study process
- Original study: for 6 months to 1 year
o (!) lasted for 40 years
- Extending of study ader discovery of more unexpected outcomes
o Eg high incidence of cardiovascular syphilis among pa4ents
- “Annual roundups”
o Teams of medical officers go to Tuskegee at regular intervals
o = rou4ne checks & examina4on to establish the progress of syphilis
o Disguised as forms of treatment to pa4etns who were told to be treated of ‘bad blood’
§ The men were not told they had syphilis
§ ≠ informed consent!
- Men were followed closely un4l they died
- Autopsies were conducted
o Consented by rela4ves on promise of burial insurance by Public Health Service
§ Important, because rela4ves were poor and could not afford to pay the cost
- (!) Even when penicillin was accepted as effec4ve cure -> s4ll no treatment of pa4ents
o & con4nued study for another 25 years
o (!) Treatment would have ended the study
§ Men were subjects, not pa4ents
- Researchers saw no connec4on btwn Nazi Scien4sts and themselves
o BUT: research came to halt ader revela4ons on atroci4es of the study in a publica4on (40 years
later)
o At first: PHS tried to defend the experiment, but public outrage quickly silenced them
Adermath of Tuskegee
- Bill Clinton (president) held public ceremony at White House and officially apologized on behalf of the
state
- He also used moral authority to a<empt to make amends for the Tuskegee Study and to begin the healing
process within the black community
- Adermath of syphilis study noted birth of a significant ethics guiding principles in research known as the
Belmont Report
4
Ethics Chapter 1: Introduc4on and ethical models
1. General Introduc0on
Health care: 3 domains with different ethics/laws
1. Clinical context
a. Ini4a4ve > pt
i. Eg a<ending consulta4on in hospital)
b. Goal = health of pt
c. Best effort based
i. No guarantee that healing will take place
2. Research context
a. Ini4a4ve > researchers/PI (principal inves4gator, not doctor)
i. Eg clinical trial: invi4ng people for research
b. Goal = knowledge increase
i. Increase global biomedical research, ≠ singular pa4ent
c. Minimal harm of par4cipants (!)
i. Emphasis not helping singular pa4ent
ii. Eg: tes4ng 3 arms with different dose of medicine -> only 1 arm will have best outcome,
rest of group have the less op4mal op4on
3. Screening context
a. Ini4a4ve > health care
i. Eg screening newborns with hielprik
b. Popula4on focus
i. Eg all women over 25 -> mammography
c. Benefit/outcome based
i. Screening has to work well -> faster diagnosis & be<er outcomes
What is Research Ethics?
ð Tradi4onally focused on issues in biomedical research
ð Big development of applica4on of research ethics to examine and evaluate biomedical research & has
influenced much of the exis4ng statues and guidelines
Balance between 2 values
1. The pursuit of scien4fic knowledge
2. Protec4ng the rights of research par4cipants
ð Poten4al benefits must be weighed against poten4cal cost/harm to study par4cipants
o Advancing understanding of health & determinants of health, gaining generalizable knowledge,
helping research par4cipants
Terminology
- Ethics: habitual and inner a[tudes
o Most common way of defining ethics = norms for conduct that dis4nguish between acceptable
and unacceptable behavior
§ Acquire sense of right/wrong during childhood
o Morals: the rules of conduct taken as a whole that are considered to be self-evident within a
group; what “normal people” do
§ Moral development throughout life4me
o Morality: behavior based on internal convic4on
- Moral: publicly approved modes of behavior, grounded on an inner feeling of morality
o In general: moral = ethical; vs amoral
o More specifically: moral=desirable, acceptable; vs immoral
- Deontology: professional codes of ethics
- Ethics: a systema4c study of morality
,Ethics vs law
- ≠ the same
o Ac4on may be legal but unethical
- Ethical norms are broader & more informal than laws
- Although we use laws to enforce widely accepted moral standards
Main objec0ves of research ethics (3)
1. Protect human par4cipants
a. In line with ethical principle of non-maleficence
i. First, do no harm (Hippocra4c oath)
2. Ensure that research serves the interest of individuals, groups and/or society as a whole
a. Can be linked to emphasis on social value of research and benefit sharing
3. Examine the ethical soundness of research
a. & ensure that they conform to ethical norms & standards with respect to risk management,
confiden4ality, informed consent etc
Protec4ng research par4cipants
Human subjects = essen4al to the conduct of research intended to improve human health
ð Rela4onship btwn inves4gators & human subjects = cri4cal
ð Rela4onship should be based on honesty, trust & respect
Concerns over treatment of research subjects arouse ader revela4on of groos viola4ons of basic human rights in
name of science
ð Unethical, atrocious & infamous research prac4ces in the past (see further)
2. Historical perspec0ves of unethical and atrocious research
The Nazi Human experiment
Nazi doctors conducted 30+ # types of experiments of concentra4on camp inmates
ð Without consent of vic4ms & no mandatory professional standards & no protec4on of vic4ms
ð Research + using medical knowledge for race-based program of public health and genocide
ð ‘Racial pathology’: trying to prove that eg Jews responded differently to infec4ons
ð Most of the experiments were scien4fically worthless
ð Es4ma4on of 256000 people killed
Nazi physician: researchers
- Dr. Sigmund Rascher - coagula4on/amputa4on studies; hypothermia experiments
- Dr. Karl Gebhart: heteroplas4c transplanta4on experiments
o c.f. Stalin’s a<empts to create interspecies (half-men/half-apes) “super-warriors”
- Drs. Karl Clausberg and Viktor Brack: X-irradia4on/steriliza4on
- Dr. Joseph Mengele: Sep4cemia/twin vivisec4on studies
Experiments (few examples)
Sterility induc4on – Clauberg
- Injec4ons to induce sterility in women prisoners
Euthanasia
- = euphemism!
- Targe4ng of ‘worthless lives’
- Also killing to obtain body parts for scien4fic research
High al4tude – Dr Rascher
- Goal: find out how to best save German pilots forced to eject at high al4tude
- Experiment:
o Placing inmates into low-pressure chambers, simula4ng al4tudes as high as 68 000 feet
2
, o Dissec4on of vic4m’s brains while s4ll alive to show that high-al4tude sickness > forma4on of air
bubbles in blood vessels of part of brain
Freezing – Dr Rascher
- Goal: determine most effec4ve means for trea4ng German pilots who had become severly chilled from
ejec4ng into ocean/German soldiers who suffered extreme exposure on Russian front
- Experiment:
o Placing vic4ms into vats of icy water for hours (in aviator suits or naked)
o Taking vic4ms outside and strapped them down naked
o Measure the effect on heart rate, body temperature, muscles reflexes etc
Twins – Dr Mengele
- Goal: find ways to more effec4vely mul4ply the German race (& create ‘ubermensch’)
- Experiment:
o Taking body measurements & other living data
o Injec4on with chloroform to hearth, see how many survived
- * Mengele:
o Determined who would be killed, who would become forced laborer, who worked to death
o Then moved to experimenta4on
§ See above + sewing twins together to create Siamese twins, injec4ng chloroform in
eyeballs to change eyecolor
Bone, Muscle and Joint transplant
- Goal: learn if a limb or joint from 1 person could be successfully a<ached to another
- Experiment:
o Amputa4on of legs & shoulders from inmates & transplant them onto other vic4ms
Seawater – Dr Eppinger
- Goal: how to make seawater drinkable
- Experiment:
o Forcing Gypsies to drink only seawater while also depriving them of food
Adermath of Nazi experimenta4on
Nuremberg Doctor Trial
- 23 German physicians tried
- 16 found guilty
- Rascher died before trial
- Mengele fled for Argen4na
- Hallevorden commi<ed suicide before trial
Nuremberg Code
ð Set of guiding principles (10) for conduct of research involving human subjects
- Emphasizes on voluntary consent of all research subjects in any experiment (informed consent)
- Avoidance of unnecessary physical and mental suffering (minimal harm)
- Op4on to quit/responsibility to terminate
- Other safeguards
ð = 1st lesson > unethical research of past
Tuskegee Syphilis Study
Played key role in crea4ng ins4tu4ons and prac4ces that today govern the use of human volunteers in US
Biomedical Research
Goal: research pathology of syphilis on impoverished African American men with syphilis
- Took place in Tuskegee Alabama
3
, Experiment:
- Non-therapeu4c research and only men with advanced cases of syphilis were selected for study & were
led largely untreated (because they could not afford to treat syphilis)
- Just study fate of untreated syphilis to terminal end
Main inten4on of conduc4ng the research
- Limi4ng to only men
o Mo4va4on: belief that it would be easier to get reliable clinical history from men than women.
Men are more likely to recall appearance of primary chancre
- Limi4ng to only black men
o Mo4va4on: assump4on of some people that advanced syphilis affected whites and blacks
differently => PHS wanted to prove them wrong
§ Whites: suffer higher incidence of brain damage & related neurological disease (more
severe)
§ Blacks: cardiovascular syphilis
- Limi4ng to only blacks
o Mo4va4on: Public Health Service though wanted to use results to pressure Southern state
legislatures into appropria4ng funds for syphilis control work among rural blacks
o By denying the men treatment, the researchers hoped to develop a case for treatment programs
sponsored by state government
The study process
- Original study: for 6 months to 1 year
o (!) lasted for 40 years
- Extending of study ader discovery of more unexpected outcomes
o Eg high incidence of cardiovascular syphilis among pa4ents
- “Annual roundups”
o Teams of medical officers go to Tuskegee at regular intervals
o = rou4ne checks & examina4on to establish the progress of syphilis
o Disguised as forms of treatment to pa4etns who were told to be treated of ‘bad blood’
§ The men were not told they had syphilis
§ ≠ informed consent!
- Men were followed closely un4l they died
- Autopsies were conducted
o Consented by rela4ves on promise of burial insurance by Public Health Service
§ Important, because rela4ves were poor and could not afford to pay the cost
- (!) Even when penicillin was accepted as effec4ve cure -> s4ll no treatment of pa4ents
o & con4nued study for another 25 years
o (!) Treatment would have ended the study
§ Men were subjects, not pa4ents
- Researchers saw no connec4on btwn Nazi Scien4sts and themselves
o BUT: research came to halt ader revela4ons on atroci4es of the study in a publica4on (40 years
later)
o At first: PHS tried to defend the experiment, but public outrage quickly silenced them
Adermath of Tuskegee
- Bill Clinton (president) held public ceremony at White House and officially apologized on behalf of the
state
- He also used moral authority to a<empt to make amends for the Tuskegee Study and to begin the healing
process within the black community
- Adermath of syphilis study noted birth of a significant ethics guiding principles in research known as the
Belmont Report
4
