EBM Exam 1

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Author:
Rx2013
ID:
130851
Filename:
EBM Exam 1
Updated:
2012-01-26 18:00:50
Tags:
EthicsandResearch
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Description:
Ethics and Research
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  1. Import drug act of ____
    1848
  2. Pure food and drug act
    1906
  3. Shirley amendment
    1912
  4. USPHS tuskegee syphilis study begins
    1932
  5. FD&C act
    1938
  6. US involvement in WWII
    1941
  7. WWII Ends
    1945
  8. Nuremberg doctors trial
    1946
  9. Permissible medical experiments (nuremberg code) (10)
    • voluntary consent
    • yeild fruitful results
    • based on animal experimentation
    • avoid all unnecessary physical and mental suffering/injury
    • no experiments if death or disability may occur
    • risk taken to experiment may not exceed risk of the illness
    • protect test subjects from injury
    • experiments conducted by qualified persons
    • test subject can end tests at any time
    • scientist incharge must be prepared to terminate exp at any time
  10. kefauver harris act
    1962
  11. declaration of helsinki
    1964
  12. NIH/DHHS form IRBs
    1966-74
  13. Tuskegee syphilis study ended
    1972
  14. national research act
    • 1974
    • national commission for protection of human subjects of biomedical and behavioral research
  15. Belmont report
    • 1978
    • first report of national commission
    • defined boundaries of research
    • est. 3 ethical principles of human experimentation
    • basic principles that guide work of IRBs in protecting human subjects in research
  16. 3 ethical principles of human experimentation established by the Belmont report
    • Respect
    • Beneficence
    • Justice
  17. Respect
    • self determination
    • voluntary
    • autonomy
    • non-coercive
    • basis of informed consent
  18. beneficence
    • benefits maximized
    • risk minimized
    • good research design
  19. Justice
    • benefits and burdens distributed fairly
    • vulnerable subject groups
  20. Office of human research protection
    1999/2000
  21. updated declaration of helsinki
    2001
  22. Updating declaration of helsinki
    2011
  23. Use of placebo is ethical if:
    • there is currently no standard of care
    • added to standard treatment
  24. Use of placebo may be ethical if:
    • current treatment is not very effective
    • safeguards in place to minimize discomfort (rescue treatments)
  25. Use of placebo is unethical if:
    efficacy of treatment is established or diagnosis is fatal or disabling without treatment
  26. Pharmacists roles in research
    • principle investigator
    • investigational drug control
    • IRB member
    • counsel patients

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