PHL281H1 Lecture Notes - Lecture 12: United States Public Health Service, World Medical Association, Nuremberg Code
12. Research Ethics
Wednesday, October 17, 2018
5:53 AM
Nuremberg code 1974
• WW2 Nazi doctors conducted sadistic experiments on those interned in concentration camps.
• Nuremberg nazi doctors trial: defendants argue there is no international laws governing scientific
experimentation
Tribunal drafts first international code on research with human subjects
1. Voluntary consent of subject is essential
2. Experiments must yielf fruitful results for the good of society, unprocurable by other methods or
means of study, not random or unnecessary in nature
3. No experiment should be conducted when there is an a priori reason to believe that
death/disabling injury will occur
4. The degree of risk to be taken should never exceed that determined by the humanitarian
importance of the problem solved by the experiment
World Medical Association Declaration of Helsinki: Ethical principles for medical research involving
human subjects
• Further develops principles of Nuremburg Code in light of modern clinical trials
• Not legally binding but cornerstone of international research ethics
• Declaration of genva of WMA: binds physician with words: The health of my patient will be my
first consideration
• International code of medical ethics: A physician shall act in the patients best interest when
providing medical care
• While the primary purpose of medical research is to generate new knowledge, this goal can never
take precedence over the rights and interests of individual research subjects
Tuskegee Syphilis Study (study in nature)
• Syphilis: sexually transmitted bacterial disease infecting the nervous system. Potentially fatal,
patients can live with disease for decades
• 1932 US public health service working with the tuskegee institute initiates study of syphilis in Black
sharecroppers in Macron co AL
• Rate of syphilis infection there was high
• Goal: observe progress of disease and how it affected faily lives of men infected
• USPHS considered it a study in nature, not an experiment
Study called physical exams, x rays, and spinal tap
To induce subjects to participate
• Told that exams were free treatments for bad blood (syphilis)
• Promised that their funerals would be paid for
• Never told they had syphilis/given medical information
• Never offered real treatment even after development of safe and effective penicillin treatment
• USPHS sometimes ensured subjects didn't receive treatment from other sources
• Subjects had no reason to seek external treatment, as they believed they were receiving
treatment
• Study discontinued in 1972 after leaks
Document Summary
Nuremberg code 1974: ww2 nazi doctors conducted sadistic experiments on those interned in concentration camps, nuremberg nazi doctors trial: defendants argue there is no international laws governing scientific experimentation. World medical association declaration of helsinki: ethical principles for medical research involving human subjects. Syphilis: sexually transmitted bacterial disease infecting the nervous system. Study called physical exams, x rays, and spinal tap. Subjects had no reason to seek external treatment, as they believed they were receiving treatment. Of mice but not men: problems of the randomized clinical trial. Phase one: test safety, discover side effects, 20- 80 participants. Phase two: test effectiveness, further evaluate safety, 100-300 participants. Phase three: confirm effectiveness, compare to other treatments, 1000-3000 participants. Phase two and three trials: controls: when testing new medical intervention, scientific method requires a test group and control group, double blind studies: minimize influence of patient expectations and researcher bias. Types of control groups: placebo trials, active comparator trials (standard of care)
