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MEDS6013 Sem 1 2023 Assessment 1

MEDS6013 Sem 1 2023 Assessment 1
The values of respect, research merit and integrity, justice, and beneficence have become prominent in the ethics of human research in the past six decades, and they provide a substantial and flexible framework for principles to guide the design, review and conduct of such research” (National Health and Medical Research Council, 2015, p.11).
To complete this assessment you are required to access a copy of the Declaration of Helsinki and any relevant national ethics guidelines, for example, The National Statement on Ethical Conduct in Human Research (Australia) and use these to guide your analysis of an unethical study.
For this assignment, you are required to investigate what is now known as the “Tuskegee Study of Untreated Syphilis in the Negro Male.” This study was conducted in 1932 in the United States of America by the Public Health Service, working with the Tuskegee Institute. The study aimed to record the natural history of syphilis in hopes of justifying treatment programs for African Americans. The researchers initially recruited 600 African American men (399 with syphilis and 201 who did not have the disease) for the study. The study was conducted without the benefit of the patient’s informed consent. Researchers told the men they were being treated for -bad blood,- a local term used to describe several ailments, including syphilis, anaemia, and fatigue. In truth, they did not receive the proper treatment needed to cure their illness. In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance. Although originally projected to last 6 months, the study actually went on for 40 years. Please watch a 6-minute video about this study on the following link: https://www.abc.net.au/news/programs/planet-america/2021-04-30/the-horrifying-%E2%80%98experiment%E2%80%99-of-tuskegee/13325030
There is sufficient information on this study in credible sources (e.g. peer-reviewed journal articles, books, reports and historical records) so please do not use or refer to Wikipedia. Continue to investigate this study until you have an understanding of the research question that was posed, the aims and objectives of this research, its design, how participants were recruited, how data was collected, analysed and interpreted, and the outcomes of the research. Briefly summarise these methods/methodology and results in 250-300 words.
With the knowledge you have from investigating this study scrutinise the conduct of the research against the Declaration of Helsinki and the relevant national guideline (Australia), describing how the researchers failed to uphold 2 of the 4 values in the above statement and the impact their actions had on participants in this study and potential participants in future research studies (400 words for each value chosen). In addition, describe how international research ethics practices changed as a result of investigations into this study (200 words).
Please structure your written submission according to the APA 7th Edition style (https://apastyle.apa.org/instructional-aids/student-paper-setup-guide.pdf), paying attention to the need for an introduction (150 words) and conclusion (150 words). Your submission should be 1600 words +/- 10%. Please note that the word count includes in-text citations and headings but excludes end-text citations and the title page. It is expected that only credible references will be used and that you will include at least 10 references (no more than 15) to support your work. Please note that there is no age limit to the references used in this assessment.
Due date: Monday, 3 April 2023 @ 23:59 Hours AWST
Reference:
National Health and Medical Research Council (2007). National Statement on Ethical Conduct in Human Research. Canberra, Australian Government.
World Medical Association (2001). World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bulletin of the World Health Organization, 79(4), 373.
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Introduction

The Tuskegee Study of Untreated Syphilis in the Negro Male was a medical experiment conducted by the United States Public Health Service (PHS) from 1932 to 1972. The study involved 600 African American men in Macon County, Alabama, who were infected with syphilis. The men were not told that they had syphilis, and they were not offered treatment. Instead, they were monitored over the course of 40 years to see how the disease progressed.

The Tuskegee Study is widely considered to be a major ethical violation. The researchers violated the men’s right to informed consent, and they exposed them to unnecessary risks. The study also had a significant impact on the men’s families and communities.
Methods and Results

The Tuskegee Study was designed to track the natural history of syphilis. The researchers wanted to see how the disease progressed in untreated men. They also wanted to learn more about the effects of syphilis on the men’s families and communities.

The men in the study were recruited from a pool of patients who were already receiving medical care from the PHS. The researchers told the men that they were being treated for “bad blood,” a local term for a variety of health problems. The men were not told that they had syphilis, and they were not offered treatment.

The men in the study were followed for 40 years. During that time, they were periodically examined by the researchers. The researchers also collected data on the men’s health, their families, and their communities.

The results of the Tuskegee Study showed that syphilis can have a devastating impact on a person’s health. The men in the study died at a much younger age than men who were not infected with syphilis. They were also more likely to develop complications from syphilis, such as heart disease, blindness, and brain damage.

The Tuskegee Study also had a significant impact on the men’s families and communities. Many of the men’s wives and children were also infected with syphilis. The study also led to a loss of trust between the African American community and the medical establishment.
Ethical Violations

The Tuskegee Study violated a number of ethical principles. First, the researchers did not obtain the men’s informed consent. The men were not told that they had syphilis, and they were not given the opportunity to decide whether or not to participate in the study.

Second, the researchers exposed the men to unnecessary risks. The men in the study could have been treated for syphilis, but the researchers chose not to do so. As a result, the men suffered from the effects of syphilis for 40 years.

Third, the researchers did not protect the men’s privacy. The men’s names and medical records were made public, which led to stigma and discrimination.
Impact on Future Research

The Tuskegee Study had a significant impact on the ethics of human research. The study led to the development of new ethical guidelines for human research, such as the Declaration of Helsinki. The study also led to a greater awareness of the importance of informed consent and the protection of human subjects.
Conclusion

The Tuskegee Study was a major ethical violation. The researchers violated the men’s right to informed consent, and they exposed them to unnecessary risks. The study also had a significant impact on the men’s families and communities.

The Tuskegee Study led to the development of new ethical guidelines for human research. The study also led to a greater awareness of the importance of informed consent and the protection of human subjects.
References

National Health and Medical Research Council (2007). National Statement on Ethical Conduct in Human Research. Canberra, Australian Government.
World Medical Association (2001). World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bulletin of the World Health Organization, 79(4), 373.
Brandt, Allan M. (1978). Racism and research: The case of the Tuskegee Syphilis Study. The Hastings Center Report, 8(4), 21-29.
Reverby, Susan M. (2009). Examining Tuskegee: The infamous study and its legacy. University of North Carolina Press.
Jones, James H. (1993). Bad blood: The Tuskegee syphilis experiment. Free Press.

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