bosede adedire , rachel adejoh , sylvia assiamah and tracy brooks
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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 - PowerPoint PPT PresentationTRANSCRIPT
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