Here is your prompt:
Joe the Plumber is a 40-year-old black man who was diagnosed with diabetes at age 25. He has worked at Pro Plumbing for 10 years and is grateful for the comprehensive health care insurance benefits that help him manage his diabetes. Unfortunately, due to the COVID-19 pandemic, business has slowed for Pro Plumbing and Joe the Plumber loses his job.
Determined to assist in economic recovery and to keep his bills paid, he enters a research study that is testing a COVID-19 vaccine.
The data on COVID-19 states that people with the following characteristics are more likely to contract COVID:
Older age
Pre-existing chronic conditions such as heart disease, diabetes, obesity and lung disease
Cancer patients
Minorities
Those with weakened immune systems
The study specifically seeks blacks and hispanics with diabetes to participate in the study.
Dr. Larry Fauci, on behalf of Smith & Smith, leads the study and reviews the consent form with Joe the Plumber. Key parts of the consent form include:
Dr. Fauci will monitor your health throughout the study.
There is a risk of adverse effects from the vaccine being tested, including death.
Care will be provided for any health effects related to the study.
Care will not be provided for any pre-existing conditions.
You will be compensated weekly for your participation in the research study.
If the vaccine is found to be effective and sold for a profit, you will not be entitled to any additional compensation.
You can withdraw from the study at any time.
Any information that is obtained in connection with this study and that can be identified with you will remain confidential and will be disclosed only with your permission or as required by law.
Participants start to get inexplicably ill and one participant suffers a stroke, so Dr. Fauci decides to pause the research.
A few days following the postponement of the study, Joe the Plumber passes out and an ambulance takes him to Seattle Grace Hospital. The on-call physician, Dr. Preston Burke, examines Joe, stabilizes him, admits him for overnight observation, then discharges him the next morning saying that he will call with the remaining test results so that Joe can get follow-up care in his office. The tests results reveal that Joe had a spike in his blood sugar (that is easily treated), has recently developed some unexplained respiratory issues, and has a unique protein in his blood. Dr. Burke requests that Joe return to his office for several visits. Joe is concerned about the bills because he no longer has health care insurance and does not know how to obtain health insurance on his own. Dr. Burke tells him not to worry about the bills; it is most important that he just keeps coming back for care. But he also tells Joe that he is only able to treat his diabetes issues. He is not able to treat his respiratory issues. Joe is just grateful that he found a doctor who cares enough to offer any free care and he is relieved that his diabetes is under control again.
Joe contacts Dr. Fauci about his respiratory issues, but Dr. Fauci says it is no longer his problem because the study is over. Seeing no other option, Joe returns to Seattle Grace Hospital and racks up thousands of dollars in bills for respiratory therapy.
As it turns out, Dr. Burke went to medical school with Dr. Fauci. He knows that Dr. Fauci has been working on a COVID-19 vaccine and contacts him about the special protein in Joe’s blood. Dr. Fauci ends up sharing the health details of the research participants with Dr. Burke and they develop a successful COVID-19 vaccine, which makes millions of dollars.
When Joe finds out that Dr. Fauci and Dr. Burke shared his information to develop the vaccine unbeknownst to him, he finds a lawyer to help him sue for malpractice and compensation for the vaccine. Dr. Fauci presents the research consent form as proof that he and Dr. Burke should not have to pay Joe.
What issues are presented?
Does this study need to be approved by the IRB?
If this requires IRB approval, what factors would the IRB consider and would the IRB approve such a study?
Are there any insurance options available for Joe?
How would the lawsuit shake out…
Please focus on the attached PowerPoint and using the IRAC…please summarize the analysis
