PP217 Lecture Notes - Lecture 19: United States Public Health Service, Fiduciary, Epidemiology
PP217 Lecture 19
Peter Buxton
• Whistleblower who leaked information about the study to the Washington Star in
1972
• Buxton, was a social worker and epidemiologist working w/ the US public health
service
• He notified his superiors of the study at least 2x in the 1960s but nothing was done
in the USPHS
Bill Jenkins
• Worked at the USPHS in 1967
• Learned about the study in 1968
• Helped Buxton put an end to the story
After Tuskegee – An Exercise
• What ethical procedures & rules would you set to try to prevent this sort of harm in
the future?
o Participants must provide informed consent
o Full disclosure of procedures and risks must be provided
o Participant should be allowed to back out of the study at any time
o Study should benefit the participants as well as the science
o Participants should be made aware of their medical conditions
• What agencies or bodies might you set up and what mandates would they have?
o Ethics Review Board – ensure ethical guidelines of procedures and
experiments are being followed
• What laws would you have in place for conducting clinical trials on human subjects?
Belmont Report: outlines ethical principles (respect, beneficence, justice)
Ethics of Research
• The ethical considerations of research have so far been lumped in with the ethical
concerns that arise in contexts of treatment
• Today that changes
• We will look at ethical issues regarding the treatment of subjects in clinical trials
• Specifically, we will look at the ethics of large scale “randomized clinical trials”
(RCTs)
Stages of Clinical Development
1) Checking for safety
2) checking for efficacy
3) confirm findings in large patient population
• Our primary concern!
• Sample of >1000 participants
