Week 7 Essay Test The Tuskegee Syphilis Study Dropbox Tuskegee Syphilis Study



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Week 7 Essay Test - The Tuskegee Syphilis Study Dropbox



Tuskegee Syphilis Study

  1. List at least three things wrong with the Tuskegee study and provide at least three examples of unethical decisions made by the researchers conducting the study.

The three factors that went wrong with the Tuskegee study were that people were harmed, unethical practices were used and a vulnerable group was targeted. The participants never knew the risks for being involved in the study. Their involvement not only harmed them, but also harmed their wives, or other significant other and children. The men did not know about the possible consequences of the treatment they received and its impact on their significant other and children (Tuskegee University, n.d). It was noted that between the start of the study in 1932 and 1947, many men, women and children had been infected and/or died. Next, unethical practices were applied in the study. For example, the participants were not told what they were being studied for, there was no informed consent used, and participants were withheld treatment after penicillin was discovered. It was unethical for researchers to not explain to participants the details of the study. They were only told that they were being treated for “bad blood” which was used to describe anemia, fatigue and syphilis (Tuskegee University, n.d). Additionally, they were never even informed about the study’s real name which was “Tuskegee Study of Untreated Syphilis in Negro Male.” It should have been their right to know detailed information. Similarly the informed consent was never used in the research. They were never told about the consequences of treatment or no treatment during the study. Hence, this related to the harm it had on them and their loved ones. Also they were given no choice to quit the study if treatment became available which could have been signed in the informed consent if it was used. Most importantly, it was unethical to withheld treatment even after it became available. It was withheld for both the experimental and control groups. Lastly, the study started off wrong by choosing the most vulnerable population which was also unethical. The researchers choose Macon County, Alabama which had poor and illiterate Black sharecroppers. The researchers offered them “medical exams, rides to and from the clinics, meals on examination days, free treatment for minor ailments and guarantees that provisions would be made after their deaths for burial” (Tuskegee University, n.d). They were vulnerable because they were minority and illiterate, which impacted their knowledge as to their rights of participants.

  1. What would you have changed about the way this study was run and why?

I would want to completely change the purpose of this study. Instead of the purpose being to record the natural history of syphilis in Black, I would want the purpose to be to control, prevent and cure syphilis for all human. This means my subjects would not only be Black man, but include different race and both genders. Most importantly, I would make sure informed consent was used. This would give detailed information about the study as well as the background of the infection. It would also list risk and benefits. The participants would have open right to drop out of the study. Also, if treatment were available they would not be withheld for study purposes. Similarly, treatment rules would apply to control groups if they developed syphilis. The participants would be kept current on the status of the study. I believe these steps are giving the participants “rights”. They are not being treated unethically for solo purpose of the study. They are considered individuals whose’ health is the main concept.

  1. Discuss the most essential elements of informed consent and discuss whether any of those were met with the Tuskegee Syphilis Study participants? 

Informed consent is the process of knowing consent of an individual before conducting research, treatment or intervention. A researcher must “educate the participants about the risks and benefits, obtain their consent before involving them in the research and keep them informed” (University of North Carolina at Charlotte, n.d). It is important that the consent forms be written in simple language for participants to understand (University of North Carolina at Charlotte, n.d).

In the Tuskegee Syphilis Study, there was no informed consent used between the researchers and participants. Therefore majority of the elements of informed consent were not met in the study. For example, the researchers did not educate the participants about the risk and benefits. Therefore there were many deaths related to the study. Next, they were not kept informed about the study. The participants in the study did not even know the true purpose of the study. This showed that they were kept in the dark and not informed about the study. The only element of the informed consent used was that the researchers did not force the participants by any threats. Yet, it was not for the benefit for them. Once they were involved in the study, the researchers did not allow them to leave. They purposely choose a vulnerable community which can be easily manipulated by free access to medical care, food, and etc.



  1. Are there any scenarios where informed consent is not needed? If so, explain describe three of them.

There are few exceptions in human research where informed consent is not needed. For example informed consent is not needed when following situation arises:

  1. Life-threatening situations: When human subjects are in situations which include diseases or conditions where death might occur unless an intervention must be given before getting consent.

  2. Medical conditions: When the human subjects are not in a state of mind due to their medical conditions which prevents the use of informed consent. The IRB determines this based on clinical investigation of each human subject. (United States Food and Drug Administration, n.d).

  3. Certain studies involving in-vitro diagnostic device: The FDA states informed consent is not needed in certain circumstances for IVD investigation. For example, it is not needed when the specimens are not individually identifiable. (Northwestern University Research, n.d).

  1. What are the three core principles of the Belmont Report?

“In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published a report, Ethical Principles and Guidelines for the Protection of Human Subjects for Research” (University of Wisconsin-Madison, 2007). This was named the Belmont Report for the Belmont Conference Center where the first draft was started. The Belmont Report attempts to summarize the basic ethical principles. The three core principles of the Belmont Report are respect for person, beneficence and justice.

  1. What does individual autonomy mean and who does it specifically protect? Was the principle applied appropriately in the Tuskegee study?

Individual autonomy refers to the “capacity to be one’s own person, to live one’s life according to reasons and motives that are taken as one’s own and not by other manipulated forces” (Stanford Encyclopedia of Philosophy, 2015). It specifically protects the most vulnerable individuals like children, mentally ill or the elderly. Individual autonomy principle was not applied in the Tuskegee Study. The participants were unable to make autonomous decisions because they were not informed about the reality of the study. Deceiving the participants means that their autonomy was not respected.

  1. Define beneficence; was this principle adhered to in the Tuskegee study? Explain your answer.

Beneficence principle assures that human subjects are treated in an ethical manner by respecting their decisions, protecting them from harm and securing their well-being (United States Department of Health and Human Services, n.d). This means that the benefit must outweigh the risks. The beneficence principle was not applied to the Tuskegee study. The participants were not treated with ethical manner. They were not given the penicillin treatment even after it was proven to work. This was not in favor of the beneficence principle since the participants were being harmed by withholding of the treatment.

  1. What does respect for persons mean and how is it applied in research? Was it applied in the Tuskegee study? Explain your answer.

Respect for persons principle makes sure that the human subjects are treated as autonomous agents and that subjects with weak autonomy is protected as well (United States Department of Health and Human Services, n.d). This means that the subjects have the right to decide if they want to participant in the research (Bryn Mawr College, n.d). In addition, information cannot be used about them without first getting their informed consent. In the Tuskegee study, respect for persons principle was not applied. Informed consent was not used in the study which means that the participants did not have a full knowledge of their rights. They were not allowed to leave the study. Most importantly, the researchers targeted a vulnerable population, whereas this principle is to protect the vulnerable.

  1. What is the Nuremburg Code? What was it inspired by? What are the core elements in it?

The Nuremberg Code was inspired by the war crimes post World War II. The Nuremberg Code has 10 standards that researchers must keep in mind when experimenting on human subjects (The Nuremberg Code, 2002). The core elements include:

  1. The experiment is required to use informed consent.

  2. The experiment should be done for the benefit of the society and not random and unnecessary in nature.

  3. The experiment should be based on the results of animal experiments and knowledge of the history of the problem under study must rationalize the performance of the experiment.

  4. The experiment should avoid suffering and injury of physical and mental health.

  5. The experiment should not conduct if there is a chance for death or disability of the human subjects. No experiment should be conducted where there is a chance that death or disabling injury will occur.

  6. The experiment should avoid actions that injure human subjects.

  7. The experiment should have proper preparations to protect the human subjects.

  8. The experiment should be done by qualified persons.

  9. The human subject should have the right to an end the research due to physical or mental state.

  10. The researchers should end the experiment at any state if injury, disability or death may occur to the subject (The Nuremberg Code, 2002).

  1. Name what went right in the Tuskegee study. Which aspects of it could be replicated today, following the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report?

The only thing that went right in the Tuskegee study was that we got a chance to set ethical boundaries from learning about the wrong doings. This study prompted the need for ethical guidelines during human research. The study influenced the guidelines in the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report. Under these standards, the Tuskegee study would be in favor of the participants. For example, informed consent would be used which will give the participants full overview of the study. In addition, they would know what they are being studied for and not just for “bad blood”. They will also know the risk and benefits of the study. Next, they would not be denied the penicillin shot for treatment. Lastly, they will have the right to leave the study when they wish. If this study was done today, the participants would be treated fairly, with little harm and everything under their consent.

References

Bryn Mawr College. (n.d). Ethics of fieldwork. Retrieved from http://www.brynmawr.edu/ceo/students/ethics/belmontreport.html#benificence.

Northwestern University Research. (n.d). FDA: Informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable. Retrieved from http://irb.northwestern.edu/process/new-study/informed-consent/fda-informed-consent-vitro-diagnostic-device-studies-using-leftov.

Stanford Encyclopedia of Philosophy. (2015). Autonomy in moral and political philosophy. Retrieved from http://plato.stanford.edu/entries/autonomy-moral/#Aca.

The Nuremberg Code. (2002). Permissible medical experiments. Retrieved from http://www.cirp.org/library/ethics/nuremberg/.

The University of North Carolina at Charlotte. (n.d). Informed consent. Research & Economic Development. Retrieved from http://research.uncc.edu/departments/office-research-compliance-orc/human-subjects/informed-consent#what is.

Tuskegee University. (n.d). About the USPHS Syphilis Study. Retrieved from http://www.tuskegee.edu/about_us/centers_of_excellence/bioethics_center/about_the_usphs_syphilis_study.aspx.

United States Department of Health and Human Services. (n.d). The Belmont Report. Retrieved from http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html#xbasic.



United States Food and Drug Administration (n.d). Exception from informed consent for studies conducted in emergency settings: Regulatory language and excerpts from preamble. Retrieved from http://www.fda.gov/RegulatoryInformation/Guidances/ucm126482.htm.

University of Wisconsin-Madison. (2007). Belmont Report. Retrieved from https://kb.wisc.edu/page.php?id=19200.
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