After you graduate from University, you went to work for President Trump, Senate Majority Leader Mitchell, or Speaker of the House Pelosi (your choice). One morning, your boss shows you an article in the New York Times Newspaper about human challenge trials called, “Researchers Debate Infecting People on Purpose to Test Coronavirus Vaccines.” You are then tasked to prepare an information paper about the ethical dilemmas posed by human challenge trials.
First, you find a copy of the article to read.
Researchers Debate Infecting People with Coronavirus to Test Vaccines… by Denise Grady published online at the New York Times on July 7, 2020 – Copy in Final Project Folder and hyperlink is
Next, you pulled a WHO advisory to review (hint – concentrate on pg 10-11) and a journal article to read. Both items were cited in the New York Times article.
Feasibility, potential value and limitations of establishing a closely monitored challenge model of experimental COVID-19 infection and illness in healthy young adult volunteers published by WHO as a draft advisory for public comments on June 15, 2020 – Copy in Final Project Folder and hyperlink is https://www.who.int/docs/default-source/coronaviruse/blueprint-feasiblitiy-potential-valuelimitationsdraft-.pdf.
Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure by Nir Eyal, et al. published in the Journal of Infectious Diseases on March 31, 2020 – Copy in Final Project Folder and hyperlink is https://dash.harvard.edu/handle/1/42639016.
You also learned that a medical ethicist interviewed in the newspaper article, Arthur Caplan, Ph.D., appeared on a videocast presented by the Journal of the American Medical Association. Dr. Caplan’s quotes were interesting and entertaining in the article, so you find the link for the videocast and watch it.
Ethics Talk: Vaccine Ethics and the Novel Coronavirus (SARS-CoV-2) with Arthur Caplan, MD published as a videocast on JAMA’s website in May 2020 – Click Here or cut & paste
Then you come back to reality and realize your staring at MCR 801’s lecture slides. Your
instructor’s mesmerizing lecture is the only thing keeping you awake after an already long day at work. Yet, you realize you have found your calling and a Master’s from University will help you reach your goals!
Please answer the following questions to take the next couple of steps towards those goals. Good luck in the future!
Please identify and briefly summarize which recommendations in WHO’s Feasibility Report
were not unanimous (Max. 150 words).
Dr. Eyal’s article, “Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure,” contained a section titled, “Autonomous Authorization.” In the section, Dr. Eyal used the assertion that “wide news coverage and widespread fear of Covid-19 should keep it clear that exposure to this virus is no small matter” to bolster his proposed informed consent process.
Do you agree with Dr. Eyal’s assertion? Why or Why not? Please ignore other parts of the consent process when answering this question (Max. 500 words).
Please identify and describe the reasons argued by Dr. Caplan in his Videocast interview which compel the development of a Covid 19 vaccine as fast as possible (Max. 250 words).
Dr. Caplan explained during his videocast interview that development of a Covid 19 vaccine using human challenge trials posed unique ethical dilemmas.
Please identify and describe the unique dilemmas explained by Dr. Caplan (Max. 250 words).
Dr. Caplan argued in the videocast interview that the researchers may adequately address the ethical dilemmas posed by the use of human challenge trials to develop of a Covid 19 vaccine by emphasizing one of the three ethical principles described in the Belmont report.
Please identify the ethical principle and describe Dr. Caplan’s argument that the principal is most essential to beginning any human challenge trials for a Covid 19 vaccine (Max. 250 words).
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