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1) Included in your reading for this module are details of two independent research studies conducted in the U.S. on vulnerable populations, the Tuskegee Syphilis Study and the Willowbrook Hepatitis study. Both the Tuskegee study and the Willowbrook Study were either conducted or approved by federal and state agencies. Although both studies concluded over sixty years ago, the deleterious effects on the communities involved, the medical profession, public trust and healthcare in general are ongoing.

In defense of the studies, some point to the intentional improvements made in the understanding, prevention and treatment of Venereal Disease and Hepatitis. While from all accounts the ethical breaches committed in the research studies had devastating consequences, questions remain regarding whether the results are necessarily invalid, and if the use of the data collected is unethical. In the article, "When Evil Intrudes", the authors claim that the notion of "bad ethics equals bad science" is invalid, providing the following explanation for their position:

The "bad ethics, therefore bad science" argument actually has two distinct components. One part of the argument holds that researchers engaged in obvious immoral conduct with their subjects could not generate useful or valid scientific findings. The second part holds that when the ethical conduct of research is egregiously immoral then any findings obtained ought not to be admitted into the body of scientific knowledge. While it may often be true that it is difficult to trust findings obtained using subjects who were abused or harmed (as was the case in Nazi concentration camp studies), this part of the argument is not always true. Even a cursory glance through the literature of health care reveals that the Tuskegee study was and remains a key source of information about the diagnosis, signs, symptoms, and course of syphilis. No effort has been made to impugn its findings, and the biomedical community has relied upon them for decades." (Hastings Center Report, When Evil Intrudes, Vol. 22, Issue 6)

As you go through your reading, consider the ethical or moral justifications for using human research subjects in experiments that provide little or no benefit to the research participants and whether certain research participants should be excluded from research trials altogether due to their inherent vulnerability. Consider as well the ethical or moral justifications for supporting or prohibiting the use of the data collected, and the potential impacts on the individual stakeholders, such as the researchers, the research subjects and their families, medical professionals, and healthcare in general.

Read the following before continuing to the activity:

The Deadly Deception: A rare documentary

Please discuss the following:

Both the Tuskegee study and the Willowbrook study produced research data that was beneficial to advancing medical science. Is the use of the data from these and other such experiments ethically defensible? Why or Why Not? In composing your response, include the justifications for your position using the ethical theories we have studied in Module 1 - 3.

Would the ethical deficiencies in the Tuskegee Study have been eliminated had the men been informed that they were part of a research study that would provide them no direct benefit, but they would be financially compensated? Why or Why Not? Remember to justify your response.

2) In this activity, you will discuss and consider elements of the doctor-patient relationship and professional responsibility with respect to truth telling and trust.

Read the following case scenario and respond to the discussion prompts that immediately follow:

Six months ago, Mrs. Plicibo, a 42-year old patient with Stage IV non-small cell lung cancer and an inoperable brain metastises was referred to Dr. Rogue by her Oncologist, who had exhausted all other treatment options. Dr. Rogue is known as an expert herbologist, having spent years studying alternative natural medicines used around the world.

Dr. Rogue prescribed the standard therapies of anti-seizure medications and steroids to reduce brain swelling, but he also offered her the option of trying a ‘secret' natural supplement that he had discovered on his latest trip to the Orient. Explaining that the treatment would require a weekly injection, but that he would cover the cost, Dr. Rogue took considerable time explaining to Mrs. Plicibo that he could make no guarantees as to the effectiveness of the treatments, other than the fact that other patients had reported positive results along with no adverse side effects. Desperate for a chance, Mrs. Plicibo had tearfully agreed.

Today, after examining Mrs. Plicibo and reviewing her recent lab results, it is clear that her condition is deteriorating rapidly, despite the apparent improvements she has made over the past few months. "I just don't understand," sobs Mrs. Plicibo, "I was doing so well with the shots-it was like a miracle. Isn't there something more you can do?" "We can try upping the dose for the next week or two, Mrs. Plicibo, but if there is no improvement, I am afraid we will have to discuss some options and support services to make things easier and to keep you comfortable." "Please don't tell me that, Dr. Rogue. I think this will work!" Promising to give it a try, Dr. Rogue leaves to get his assistant. Taking her aside he whispers "Molly, please prepare the ‘hope shot' for Mrs. Plicibo - and of course - do not tell her that it is only water!" "Of course not, Dr. Rogue," smiles Molly. "Why mess with something that is working!"

Discuss the following:

Given the positive outcome over the last few months, and Mrs. Plicibo's insistence that Dr. Rogue continue the shots, was Dr. Rogue's treatment ethical? Why or Why not? Remember to justify your response using the ethical theories,

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