Paper Homework
Guidelines for the paper.
The Homework is a two page paper. Do not be misled by the short length. The paper requires focus. So, it presupposes that you have been selective - that you have chosen to write about some aspect of the case that is relevant and significant to the biomedical topics covered in the course. The idea is to limit yourself to an ethically relevant aspect or two of the case and develop your paper around that.
The following points are offered for consideration to aid in structuring your paper.
Jesse Gelsiuzer Gene Therapy Case.
1) What is the scientific value of the study/experiment? What scientific question is being addressed?
2) Is the value of the study/experiment important enough to justify the use of human research subjects?
3) At the time of this study, what was the status of gene therapy in the medical community?
4) Did gene therapy trials pose an acceptable or unacceptable risk to research subjects?
5) What phase clinical trial was the study in which Gelsinger was a research subject?
6) What is OTC deficiency? Describe the nature of the gene therapy that was sought to treat this condition.
7) Describe the chief technical obstacle to successful gene therapy for OTC deficiency
8) DQCS answering the scientific question in the Gelsinger case require violating any of the following ethical obligations: veracity, medical beneficence, non-maleficence, patient autonomy?
9) Did this study violate any of these obligations? Explain which ones, and how.
10) Was this a therapeutic or non-therapeutic trial? What criteria were used to select research subjects?
11) What was the informed consent process? What information was disclosed or withheld?
12) Were conditions of ethical informed consent satisfied, or not? Explain in detail.
13) Who / what was responsible for the failure of this study?
14) What legal remedies did the Gelsinger family seek in this case?
15) What was the legal decision in the Gelsinger lawsuit?
16) What other lawsuits were sought in this case and by whom?
17) What does this case teach about the importance of trust as a component of the professional relationship between patient/research subject and physician?
Format your homework according to the following formatting requirements:
i) The answer should be typed, using Times New Roman font (size 12), double spaced, with one-inch margins on all sides.
ii) The response also includes a cover page containing the title of the homework, the student's name, the course title, and the date. The cover page is not included in the required page length.
iii) Also include a reference page. The Citations and references must follow APA format. The reference page is not included in the required page length.