A Short History of Ethics in Medical Research with Human Subjects

Sheila Kelleher, MA, CCRCRegulatory Specialist

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Overview

History•Hippocrates•Scurvy in the Royal Navy•Vaccination TrialsRegulations (or lack thereof)•Before the Age of Regulation•Let the Regulations Begin! More History•Sulfanilamide •The Nazi Experiments•The Nuremburg TrialThe Nuremburg CodeEven More History•Willowbrook State School•Thalidomide•Jewish Chronic Disease HospitalDeclaration of Helsinki

Yet More History•Henry Beecher•Tuskegee StudyRegulations•The Belmont Report•The Code of Federal Regulations•Institutional Review BoardThat’s All in the Past--Not•AIDS ResearchWhere Do We Go from Here?Your Research Activities•Protected Health Information•Rules for Medical Record Review•How to Log Off Your Computer•PHI QuizConclusion

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Hippocrates460 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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Scurvy in the Royal NavyEngland, 1747

James LindRoyal Navy surgeon

• One of the first clinical trials• 1795: The Admiralty ordered juice

on ships-- 48 years later!

Scurvy: Loose teeth, bleeding gums and hemorrhages.

12 men with scurvy divided into pairs: Pair 1: 1 quart of cider dailyPair 2: 25 drops of elixir of vitriol (sulfuric acid)Pair 3: 6 spoonfuls of vinegarPair 4: Half a pint of seawaterPair 5: 2 oranges and 1 lemonPair 6: Garlic, mustard and horseradish

Source: Wikipedia

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Vaccination trials, 1796

Edward Jenner

• 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

• A dairymaid say, “I shall never have smallpox for I have had cowpox.”

• Jenner inoculated an 8-year-old boy using from a dairymaid’s cowpox lesions.

• The boy recovered from a mild illness.• Jenner inoculated the boy with smallpox. No disease!

Cow is vacca in Latin; cowpox is vaccinia in Latin; he called it vaccination

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

Source: NIH

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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.

•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

Patent medicineQuackeryNostrums

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”

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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

“Safe” (1938)•Federal Food, Drug, and Cosmetic Act•No law against drugs that don’t work

“Safe and Effective” (1962)•Kefauver Harris Amendment

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