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Research Misconduct: An Historical Perspective of Unethical Practices. Andrea H. Jackson, Ph.D. Assistant Dean Howard University Office of Research and the Graduate School Responsible Conduct of Research (RCR) Workshop Wednesday, October 19, 2005. Informed Consent

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Andrea h jackson ph d assistant dean howard university

Research Misconduct:

An Historical Perspective

of Unethical Practices

Andrea H. Jackson, Ph.D.

Assistant Dean

Howard University

Office of Research and the Graduate School

Responsible Conduct of Research (RCR) Workshop

Wednesday, October 19, 2005

Andrea h jackson ph d assistant dean howard university

  • Informed Consent

  • African-American Slaves and Medical Experimentation“…blacks were particularly easy targets, given their positions as voiceless slaves or ‘free persons of color’ in a society sensitive to and separated by race.”Todd L. Savitt (1982). “The Use of Blacks for Medical Experimentation and Demonstration in the Old South” Journal of Southern History, Vol. 48 (3):331-348.

  • Nuremberg Codes (Nazi Concentration Camps)

    • Injections with typhus fever

    • Injections of petroleum

    • Ice-cold vat baths

    • “Very few of the prisoners brought into this building to be used in these ‘experiments’ came out alive.” --Buchenwald Reports

Secret human experiments
Secret Human Experiments

  • Plutonium Study (1947)

    • Doctors injected plutonium into the leg of Elmer Allen, a 36-year-old African-American railroad porter.

    • Researchers analyzed tissue sample to determine the physiological dispersion of plutonium.

    • They wanted to determine the lingering levels of plutonium remaining in Allen’s body from the injection 26 years earlier.

Secret human experiments1
Secret Human Experiments

  • Willowbrook Study (Early 1960s)

    • Willowbrook State School in Staten Island, NY conducted research on vulnerable, mentally retarded children to better understand the natural history of the highly infectious hepatitis virus.

    • Only parents who agreed to the research were able to enroll their children into Willowbrook.

Secret human experiments2
Secret Human Experiments

  • Jewish Chronic Disease Hospital Study (1963)

    • Studies were conducted at what is now the Interfaith Hospital of Brooklyn

    • Unwitting, unsuspecting, and unconsenting patients were monitored by doctors to determine the body’s ability to reject cancer cells.

    • Doctors injected live cancer cells intravenously into patients and watched for signs of neoplasia (new growth).

    • In reaction to this study, in 1966 the FDA issued clear requirements for informed consent in research.

Secret human experiments3
Secret Human Experiments

  • The Cincinnati Project (1966)

    • The military’s aim was to determine how much radiation military personnel could endure before becoming unable to function effectively in combat.

    • Subjects were treated with high doses of radiation.

    • Amelia Jackson was treated with 100 rads of full-body radiation (equivalent to 7,500 chest X-rays) and was never able to care for herself after the treatment.

Secret human experiments4
Secret Human Experiments

  • Oregon and Washington State Prisons (1963-71)

    • The testicles of 67 inmates were exposed to X-rays to find out the effects of radiation on sperm production.

    • Prisoners were not informed that exposure to radiation might cause cancer, impotence, potential future birth defects or forced vasectomies.

Beecher article
Beecher Article

  • In 1966, Dr. Henry Beecher published an article in the New England Journal of Medicine (NEJM)thatdescribed 22 examples of unethical research conducted and published by “reputable” researchers.

  • Until that time, it was believed that unethical research was conducted only in Nazi prison camps.

The tuskegee syphilis study 1932 1972
The Tuskegee Syphilis Study (1932-1972)

  • This study involved a large number of black males in rural Alabama.

  • The subjects believed that they were receiving proper medical treatment when, in fact, they received either inadequate treatment or no treatment. At least 40 of these subjects died during the study.

Summerlin case 1973
Summerlin Case (1973)

  • Summerlin initially reported that tissue kept in organ culture for a period of time could be transplanted without rejection into another animal; he used tissues from black mice and transplanted them into white mice.

  • Summerlin used a felt tip pen to mark black patches on the backs of white mice; the “patches” were later discovered in the animal facility.

Veterans administration 1999
Veterans Administration (1999)

  • In 1999, all research projects at the V.A. West Los Angeles Medical Center were halted.

  • Allegations centered on the lack of consent from patients.

Johns hopkins lead paint study 2001
Johns Hopkins Lead Paint Study (2001)

  • Scientists were exploring the long-term effects of exposure of children to lead paint.

  • Low income families were given housing with lead paint but not informed.