Bosede Adedire, Rachel Adejoh, Sylvia Assiamah and Tracy Brooks

Coppin State University

July 18, 2013

TUSKEGEE SYPHILIS STUDY

PREPARED BY

Background of study What is syphilis? Case study Literature review Exhibit 1- Analysis of study violations

of ethical codes Exhibit 2- Analysis of study violations

of ethical codes Exhibit 3- Analysis of study violations of ethical codes Demonstration of study events to the

evolution of current laws guiding use of human subjects in research

Questions

CONTENT OUTLINE

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Warning!

BACKGROUND Syphilis was prevalent in the early

1930s, disease and its progression was unknown

As the disease evolved , it prompted an urgent need to study disease progression more vigorously Public Health Service (PHS) carried out a surveillance that revealed widespread of syphilis in Macon County, Alabama Initiation of a program aimed at controlling the disease

A two-year demonstration study in Macon County, Alabama

Study result from demonstration brought the study to an abrupt end

Macon County, Alabama

WHAT IS SYPHILIS? Syphilis is an infectious venereal disease caused by the spirochete Treponema pallidum. Transmissible primarily by:

Sexual contact with infectious lesions

Mother to fetus in utero Via blood product transfusion

Signs and SymptomsChancreSkin rashFlu-like symptoms

Untreated syphilis can eventually lead to organ damage includingThe brain Nerves The heart Blood vessels, liver, bones, and

joints

THE CASE Due to lack of funding to follow-up with

treatment, another study was initiated to study the progression of syphilis in the people that already got the disease.

The origination of this study started what is now known as the Tuskegee Syphilis Study

Faces of Tuskegee team

616 participant, 399 with disease and 217 as control group

No stated ethical guidelines for research study

Order of events in study

Literature Review..Davis, L., Green, B., & Katz, R. V. (2012). Influence of scary beliefs

about the Tuskegee syphilis study on willingness to participate in research. ABNF Journal, 23, 59-62. Literature explores the impact of past events on the willingness of African Americans to

participate in biomedical research

Scholars found out that the sequence of events in the Tuskegee syphilis study played a significant role in explanations why African Americans are reluctant to participate in medical research.

Also, researchers concludes Tuskeegee syphilis study violates moral and ethical principles .

 

Literature Review cont.. Walker, C. A. (2009). Lest we forget: The Tuskegee experiment. Journal of Theory Construction and Testing. pp. 5-6. Press. Article investigates reasons why the Tuskegee study was only on

black men in a low socio-economic group to demonstrate the effect of inequality and segregation during the period

Findings concludes that the Tuskegee study was racially motivated and confirms the effect of disparity of that period.

Affirms that the Tuskegee study violates the moral framework of beneficence, nomaleficence, autonomy, and justice

Literature Review cont…Gupta, U. (2013). Informed consent in clinical research: Revisiting few concepts and areas. Perspectives in Clinical Research, 1, 26-32.

Study evaluate procedures used by study researchers to conduct the study including the quality of information given to study participants and how it meets subject’s understanding.

Concludes participants were not provided with adequate information to give proper consent

Article asserts that the Tuskegee syphilis study violates ethical principles

Exhibit A - Analysis of study violationso VIOLATIONS CODES VIOLATED

o Recruitment letter used vague and unclear words to lure participants into study

Nuremberg codes  o Researchers exploited unsuspecting

participants who were illiterates and uneducated sharecroppers

Nuremberg codeso Tuskegee syphilis experiment was meant to

study untreated syphilis progression in human, not designed to yield any fruitful results

Nuremberg codeso Participants were not allowed to

leave the study when they ‘wanted out’

Principle of respect for persons

Recruitment Letter

Some study subjects

Exhibit B - Analysis of study violation Cont.. o VIOLATIONS CODES VIOLATEDo Experiment involved

unnecessary spinal taps and blood draws

Nomaleficenceo Use of placebos without participant consentPrinciple of respect for persons

o Participants suffered physical and mental suffering

No maleficenceo Study continues when

treatment to disease was foundBeneficence

Exhibit C - Analysis of study violations cont...o VIOLATIONS CODES VIOLATED

o Scientist not ready to terminate experiment even when they knew participant could end up with consequences of untreated syphilis which could cause harm, organ damage, disability or death

Nomaleficenceo Study continues even when numbers of participant death were reported

Nomaleficence

o Risk involved in study outweighs its benefitBeneficence

Demonstration of study events to the evolution of current laws guiding use of human subjects in research Regulatory bodies institutionalized to ensure instituted policies are implemented in research studies to minimize harm to participant's mental or physical wellbeing

Research protocols to be reviewed by an independent committee prior to initiation and research with humans, need to be based on results from laboratory animals and experimentation

Current knowledge of ethical obligations mandates a study to stop or come to an end if fatality or any forms of harm results

Research studies be screened by IRBs to protect human rights and welfare, to ensure consent is voluntary and subjects are well informed about the benefits and risks involved in a study.

Department of health education and welfare regulations (DHEW) mandates rules to guide the use of subjects with diminished autonomy

Researchers are now obligated to provide and improve the quality information to subjects and to make sure that subjects are competent enough to comprehend such information.

Questions??

References

 Bozeman, B., Slade, C., & Hirsch, P. (2009). Ethics in research and practice. American Journal of Public Health, 99, 1549-1556.

Burns, N., & Grove, S.K. (2011). Understanding nursing research. (5th ed). Saunders Elsevier

Davis, A.J., & Aroskar, M. A. (2011). Ethical dilemmas and nursing practice. (5th ed). Pearson Publishers.Davis, L., Green, B., & Katz, R. V. (2012). Influence of scary beliefs about the Tuskegee syphilis study on willingness to participate in research. ABNF Journal, 23, 59-62

Gupta, U. (2013). Informed consent in clinical research: Revisiting few concepts and areas. Perspectives in Clinical Research, 1, 26-32. Retrieved from http://www.picronline.org/article.asp?issn=2229- 3485;year=2013;volume=4;issue=1;spage=26;epage=32;aulast=Gupta

Levine, S., & Williams, C., Kilbourne, A., & Juarez, P. D.(2012). Tuskegee redux: Evolution of legal mandates for human experimentation. Journal of Health Care for the Poor and Underserved 23(4), 104-125. The Johns Hopkins University

Beauchamp, L., & Childress, F., (2009). Principles of Biomedical Ethics. (5thed.). New York: Oxford University Press

McCance, K., Huether, S., Brashers, V., & Rote, N. (2010).

Pathophysiology: The

Biologic Basis for Disease in Adults and Children (6th ed.).

Missouri: Mosby Inc.

Ogungbure, A. (2011). The Tuskegee syphilis study: Some ethical

reflections.

Thought and practice: A Journal of the Philosophical

Association of Kenya (PAK),

3(3), 75-92.

Porth, C. & Matfin, G. (2009). Pathophysiology: Concepts of altered

health states

(8th ed.). Philadelphia: J.B. Lippincott-Raven.

Walker, C. A. (2009). Lest we forget: The Tuskegee experiment.

Journal of

Theory Construction and Testing. pp. 5-6. Press.

References