Mistakes have been made in conducting human research worldwide. After reading about what happened in one of these historical events (e.g., Nazi war crimes, Tuskegee syphilis study, death of Jesse Gelsinger, etc.), reflect on how researchers and other officials have acted and responded and on how their actions affected research participants and their families. Fast forward to the present

Although your evidence-based quality improvement project will not involve human research, ethical principles enter into healthcare systems decisions and actions. Which ethical principles (e.g., beneficence, justice, etc.) or sociocultural issues are most important for your consideration in developing your evidence-based quality improvement project? Discuss.

Tuskegee Syphilis Study Conducted by Public Health Service

Study purpose: Determine the natural history of untreated syphilis to autopsy in African American men (400 with syphilis and 200 controls) in Macon County, Alabama.

Violation of the Belmont Report’s “justice” principle

Study was meant to discover how syphilis affected blacks as opposed to whites. How this knowledge would have changed clinical treatment of syphilis is uncertain.

Data collection procedure: Recruitment occurred without informed consent; subjects were told procedures (e.g., spinal taps) were

“special free treatments”.

Violation of Belmont Report’s “respect for person”principle

White scientists of their day viewed all research subjects, especially the uneducated, as basically unable to grasp the nature of a scientific research project and unwilling to consent to research unless given special inducements.

Follow-up: In 1946, penicillin was an effective treatment for syphilis; however, the men were neither informed nor treated with penicillin.

In 1952, Public Health Service utilized local health departments to track men who had left Macon County to keep them from receiving penicillin.

Violation of Belmont Report’s “beneficence”principle

When nationwide campaigns to eradicate venereal disease came to Macon County, the men were prevented from participating and receiving penicillin.

During World War II, 250 of the men registered for the draft and were consequently ordered to get treatment for syphilis, only to have Public Health Service exempt them from receiving penicillin.

 Evidence based quality improvement:

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