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Bosede Adedire , Rachel Adejoh , Sylvia Assiamah and Tracy Brooks

TUSKEGEE SYPHILIS STUDY. Prepared by. Bosede Adedire , Rachel Adejoh , Sylvia Assiamah and Tracy Brooks. Coppin State University July 18, 2013. Content Outline. Background of study What is syphilis? Case study Literature review

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Bosede Adedire , Rachel Adejoh , Sylvia Assiamah and Tracy Brooks

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  1. TUSKEGEE SYPHILIS STUDY Prepared by BosedeAdedire, Rachel Adejoh, Sylvia Assiamah and Tracy Brooks Coppin State University July 18, 2013

  2. Content Outline • 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

  3. Warning! Be advised this presentation may contain explicit and disturbing graphics. Thank you!

  4. 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 Macon County, Alabama • 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

  5. What is Syphilis? • Syphilis is an infectious venereal disease caused • by the spirochete Treponemapallidum. Transmissible primarily by: • Sexual contact with infectious lesions • Mother to fetus in utero • Via blood product transfusion • Signs and Symptoms • Chancre • Skin rash • Flu-like symptoms • Untreated syphilis can eventually lead to organ damage including • The brain • Nerves • The heart • Blood vessels, liver, bones, and joints

  6. The Case Faces of Tuskegee team • 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 • 616 participant, 399 with disease and 217 as control group • No stated ethical guidelines for research study • Order of events in study

  7. 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 .

  8. 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

  9. 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

  10. Exhibit A - Analysis of study violations • VIOLATIONS • CODES VIOLATED Recruitment Letter • Recruitment letter used vague and unclear words to lure participants into study • Nuremberg codes • Researchers exploited unsuspecting participants who were illiterates and uneducated sharecroppers • Nuremberg codes • Tuskegee syphilis experiment was meant to study untreated syphilis progression in human, not designed to yield any fruitful results • Nuremberg codes Some study subjects • Participants were not allowed to leave the study when they ‘wanted out’ • Principle of respect for persons

  11. Exhibit B - Analysis of study violation Cont.. • VIOLATIONS • CODES VIOLATED • Experiment involved unnecessary spinal taps and blood draws • Nomaleficence • Use of placebos without participant consent • Principle of respect for persons • Participants suffered physical and mental suffering • No maleficence • Study continues when treatment to disease was found • Beneficence

  12. Exhibit C - Analysis of study violations cont... • VIOLATIONS • CODES VIOLATED • Risk involved in study outweighs its benefit • Beneficence • 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 • Nomaleficence • Study continues even when numbers of participant death were reported • Nomaleficence

  13. 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.

  14. Questions??

  15. References • Beauchamp, L., & Childress, F., (2009). Principles of Biomedical Ethics. • (5thed.). New York: Oxford University Press Bozeman, B., Slade, C., & Hirsch, P. (2009). Ethics in research and practice. American Journal ofPublic 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

  16. References 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.

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