1. A Short History of Ethics in
Medical Research with Human Subjects
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Sheila Kelleher, MA, CCRC
Regulatory Specialist

2. Overview
History
•Hippocrates
•Scurvy in the Royal Navy
•Vaccination Trials
Regulations (or lack thereof)
•Before the Age of Regulation
•Let the Regulations Begin!
More History
•Sulfanilamide
•The Nazi Experiments
•The Nuremburg Trial
The Nuremburg Code
Even More History
•Willowbrook State School
•Thalidomide
•Jewish Chronic Disease Hospital
Declaration of Helsinki
Yet More History
•Henry Beecher
•Tuskegee Study
Regulations
•The Belmont Report
•The Code of Federal Regulations
•Institutional Review Board
That’s All in the Past--Not
•AIDS Research
Where Do We Go from Here?
Your Research Activities
•Protected Health Information
•Rules for Medical Record Review
•How to Log Off Your Computer
•PHI Quiz
Conclusion
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3. Hippocrates
460 BC – c. 370 BC
“I will prescribe regimens for the good
of my patients according to my ability
and my judgment and never do harm
to anyone.”
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4. Scurvy in the Royal Navy
England, 1747
• One of the first clinical trials
• 1795: The Admiralty ordered juice
on ships-- 48 years later!
James Lind
Royal Navy surgeon
Scurvy: Loose teeth, bleeding gums and
hemorrhages.
12 men with scurvy divided into pairs:
Pair 1: 1 quart of cider daily
Pair 2: 25 drops of elixir of vitriol (sulfuric acid)
Pair 3: 6 spoonfuls of vinegar
Pair 4: Half a pint of seawater
Pair 5: 2 oranges and 1 lemon
Pair 6: Garlic, mustard and horseradish
Source: Wikipedia
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5. Vaccination trials, 1796
• The first scientific attempt to control an infectious
disease by the use of vaccination.
• “Variolation” with small pox (inoculation) was widely
practiced in Europe until Jenner's discovery
• Jenner was inoculated with smallpox in Gloucester as
an 8-year old in 1749
•
Edward Jenner
•
•
•
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A dairymaid say, “I shall never have smallpox for I
have had cowpox.”
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Jenner inoculated an 8-year-old boy using from a
dairymaid’s cowpox lesions.
The boy recovered from a mild illness.
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Jenner inoculated the boy with smallpox. No disease!
In 1800, Thomas Jefferson set up a national vaccination program in the U.S.;
in 1980, WHO declared hat the world was free of smallpox
Cow is vacca in Latin; cowpox is vaccinia in Latin; he called it vaccination
Source: NIH

6. Prior to 1906: Before the Age of Regulation
There were no regulations in the U.S. regarding the
ethical use of human participants in research.
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•No consumer regulations
•No Food and Drug Administration (FDA)
•No Common Rule
•No Institutional Review Boards (IRBs)
•Coca-Cola contained cocaine until 1903
•7-Up contained lithium citrate, a mood-stabilizing drug, until 1950
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1905, Samuel Hopkins Adams published an exposé on patent medicines:
•"The Great American Fraud" in Collier's Weekly
•“For fraud, exploited by the skilfulest of advertising bunco men, is the basis of the trade”

7. 1906: Let the Regulations Begin!
“Truth in labeling” (1906)
•Pure Food and Drugs Act
•Alcohol, opiates, cocaine, cannabis
•"Is there anything in the existing condition that makes it the duty of Congress to put
the liberty of the United States in jeopardy?” (Nelson Aldrich, senator from Rhode
Island [http://prospect.org/article/truth-labeling])
•No law against dangerous, untested, or poisonous drugs
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“Safe” (1938)
•Federal Food, Drug, and Cosmetic Act
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•No law against drugs that don’t work
“Safe and Effective” (1962)
•Kefauver Harris Amendment