PH 150A MT3 EXAM STUDY SET A+ GRADED
What were the three classes of Nazi Medical Experiments? - ANSWER 1. To facilitate the
survival of military personnel (freezing experiments)
2. To develop and test pharmaceuticals and treatment methods
3. To advance the racial and ideological tenets of the Nazi worldview (serological and
sterilization experiments)
What are the standards implemented by the Nuremberg Code (1947)? - ANSWER Basic
principles of ethical conduct in human subject research
- voluntary and informed consent from human subjects
- experiments should yield fruitful results for the good of society
- experiments should be based on data from animal trials and knowledge of natural
history of diseae
= avoid unnecessary physical and mental suffering and injuty
- no experiment when there is reason to believe death or disabling injury will occur
- degree of risk shouldn't exveed the humanitarian importance of solving the problem
- proper preparations and adequate facilities
- experimenters should be qualified
- subjects can withdrawal at any time
- experiment mut be terminated if continuation is likely to cause injury, disability, or
death
Declaration of Helsinki (1964) - ANSWER - standard in medical research ethics
- adopted by the 18th World Medical Association
- Modified Nuremberg Code (more extensive in clinical research and non-therapeutic
clinical research)
- initially addressed primarily to physicians
- controversies lead to many revisions including updating placebo use being acceptable
in situations were the patient's medical condition was not serious and the patient would
not be placed at increased risk and the reason for placebo use were scientifically
compelling
,Food and Drug Administration (FDA) - ANSWER rejected the placebo usage guidelines
outlined by Declaration of Helsinki and replaced guidlines with Food Clinical Practice
National Institutes of Health (NIH) - ANSWER no longer refers to the Declaration of
Helsinki
What was the Tuskegee Study? - ANSWER - philanthropic program study of syphilis in
South 1929-1930
- Year 1 establish prevalence (higher in African Americans, specifically Macon County);
Year 2 treatment (never happened as program vanished due to lack of funding from
Great Depression)
Where and when did the Tuskegee Study take place? - ANSWER - Macon County,
Alabama
- 1932-1972
Who conducted the Tuskegee Study? What was the rationale? - ANSWER - step toward
national eradication program
- funded by USPHS
What were the problems with the Tuskegee study? - ANSWER - no informed consent
- no disclosure
- patients were prevented from receiving treatment
- no guidelines for biomedical research at the time (Belmont Report emerged)
How were participants of the Tuskegee Study recruited? What were they told? Given? -
ANSWER - Nurse Rivers was employed by USPHS for recruitment
- free physical exams
- free rides to the clinic
- hot meals on exam days
- free treatment for minor ailments
- burial stipend
Why were Tuskegee participants vulnerable? - ANSWER - poor
- limited literacy
- most have never seen a doctor before
What was 'bad blood'? Were Tuskegee Study participants treated? - ANSWER - subjects
were told that if treated, they would b3 dropped from the study
, What was the standard treatment in the Tuskegee Study? - ANSWER penicillin
What was the significance of the Guatemala syphilis study? - ANSWER - goal: to
determine th effect of penicillin on the prevention and treatment of venereal diseases
including syphilis
When did the Guatemala Study take place? Who was involved? - ANSWER - 1946-1948
- funded by NIH
- conducted by US
- participants were vulnerable populations including prisoners, those in mental health
facilities, and soldiers
How was the Guatemala Study different from the Tuskegee study? - ANSWER -
deliberate infection of syphilis and other STIs in Guatemala
Did the US take any responsibility for either the Tuskegee or Guatemala studies? -
ANSWER - no
- Bill Clinton issues apology for Tuskegee
What is the USPHS - ANSWER - US Public Health Service Commissioned Corps
- overseen by the Surgeon General
- team of highly qualified public health professionals
What are the Basic Ethical Principles for Studies of Human Subjects as outlined in the
Belmont Report? - ANSWER 1. Respect for persons
2. Beneficence
3. Justice
What is Respect for persons? - ANSWER individuals should be treated as autonomous
agents and persons with diminished autonomy are entitled to protection
What is Beneficence? - ANSWER Do no harm and maximize possible benefits and
minimize possible harms
What is Justice? - ANSWER benegits and burdens are fairly distrbuted among the
population
Institutional Review Board (IRB) - ANSWER - risk to subjects are minimized
- risk is reasonable in relation to anticipated benefits
- subject selection is equitable
- informed consent is appropriately documented
What were the three classes of Nazi Medical Experiments? - ANSWER 1. To facilitate the
survival of military personnel (freezing experiments)
2. To develop and test pharmaceuticals and treatment methods
3. To advance the racial and ideological tenets of the Nazi worldview (serological and
sterilization experiments)
What are the standards implemented by the Nuremberg Code (1947)? - ANSWER Basic
principles of ethical conduct in human subject research
- voluntary and informed consent from human subjects
- experiments should yield fruitful results for the good of society
- experiments should be based on data from animal trials and knowledge of natural
history of diseae
= avoid unnecessary physical and mental suffering and injuty
- no experiment when there is reason to believe death or disabling injury will occur
- degree of risk shouldn't exveed the humanitarian importance of solving the problem
- proper preparations and adequate facilities
- experimenters should be qualified
- subjects can withdrawal at any time
- experiment mut be terminated if continuation is likely to cause injury, disability, or
death
Declaration of Helsinki (1964) - ANSWER - standard in medical research ethics
- adopted by the 18th World Medical Association
- Modified Nuremberg Code (more extensive in clinical research and non-therapeutic
clinical research)
- initially addressed primarily to physicians
- controversies lead to many revisions including updating placebo use being acceptable
in situations were the patient's medical condition was not serious and the patient would
not be placed at increased risk and the reason for placebo use were scientifically
compelling
,Food and Drug Administration (FDA) - ANSWER rejected the placebo usage guidelines
outlined by Declaration of Helsinki and replaced guidlines with Food Clinical Practice
National Institutes of Health (NIH) - ANSWER no longer refers to the Declaration of
Helsinki
What was the Tuskegee Study? - ANSWER - philanthropic program study of syphilis in
South 1929-1930
- Year 1 establish prevalence (higher in African Americans, specifically Macon County);
Year 2 treatment (never happened as program vanished due to lack of funding from
Great Depression)
Where and when did the Tuskegee Study take place? - ANSWER - Macon County,
Alabama
- 1932-1972
Who conducted the Tuskegee Study? What was the rationale? - ANSWER - step toward
national eradication program
- funded by USPHS
What were the problems with the Tuskegee study? - ANSWER - no informed consent
- no disclosure
- patients were prevented from receiving treatment
- no guidelines for biomedical research at the time (Belmont Report emerged)
How were participants of the Tuskegee Study recruited? What were they told? Given? -
ANSWER - Nurse Rivers was employed by USPHS for recruitment
- free physical exams
- free rides to the clinic
- hot meals on exam days
- free treatment for minor ailments
- burial stipend
Why were Tuskegee participants vulnerable? - ANSWER - poor
- limited literacy
- most have never seen a doctor before
What was 'bad blood'? Were Tuskegee Study participants treated? - ANSWER - subjects
were told that if treated, they would b3 dropped from the study
, What was the standard treatment in the Tuskegee Study? - ANSWER penicillin
What was the significance of the Guatemala syphilis study? - ANSWER - goal: to
determine th effect of penicillin on the prevention and treatment of venereal diseases
including syphilis
When did the Guatemala Study take place? Who was involved? - ANSWER - 1946-1948
- funded by NIH
- conducted by US
- participants were vulnerable populations including prisoners, those in mental health
facilities, and soldiers
How was the Guatemala Study different from the Tuskegee study? - ANSWER -
deliberate infection of syphilis and other STIs in Guatemala
Did the US take any responsibility for either the Tuskegee or Guatemala studies? -
ANSWER - no
- Bill Clinton issues apology for Tuskegee
What is the USPHS - ANSWER - US Public Health Service Commissioned Corps
- overseen by the Surgeon General
- team of highly qualified public health professionals
What are the Basic Ethical Principles for Studies of Human Subjects as outlined in the
Belmont Report? - ANSWER 1. Respect for persons
2. Beneficence
3. Justice
What is Respect for persons? - ANSWER individuals should be treated as autonomous
agents and persons with diminished autonomy are entitled to protection
What is Beneficence? - ANSWER Do no harm and maximize possible benefits and
minimize possible harms
What is Justice? - ANSWER benegits and burdens are fairly distrbuted among the
population
Institutional Review Board (IRB) - ANSWER - risk to subjects are minimized
- risk is reasonable in relation to anticipated benefits
- subject selection is equitable
- informed consent is appropriately documented
