Instructions: Submit the Short Topical Paper as a Word document (doc or docs). Contact the instructor via email if you are having difficulty uploading the assignment by the due date deadline. Be sure to attach a copy of your paper in your email notification. If a copy of your paper is not emailed by the due date deadline, it will be considered late.
TOPIC – Ethical Principles of Research
Choose one of the topics below:
- Fair Subject Selection
- Informed Consent – (This is my choice)
- Write a communication paper to be presented at a staff meeting at a study site about an issue that does not conform to the ethical issue you chose (see below for more instructions). Paper should not exceed two (2) full pages. Must be written in APA-format using normal or double spaced setting. Abstract not required.
- Cover page and reference page are not included in the page count; however, they are included in the grading.
- Include citations and references from at least three (3) credible sources to support your ideas. Wikipedia is not considered a credible source for academic papers. Credible sources include magazine and journal articles, books, newspapers, interviews, internet (i.e., association websites, databases, blogs), etc.
- Be sure to properly cite your references in the body of the paper (Author[s] Last Name, Year). (If you use a direct quote you must include the page number.)
- Be sure your reference page begins on a new page, reference entries are in alphabetical order and include a hanging indentation for the second and subsequent lines of each entry. (First line is aligned left and following lines indented.)
- It is strongly recommended you review the online APA guide available at: https://owl.purdue.edu/owl/research_and_citation/apa_style/apa_formatting_and_style_guide/general_format.html(Links to an external site.)
Paper Format and Instructions:
- You will be writing this paper to present to staff at a clinical research site.
- Introduction – Create a hypothetical site issue that does not conform to the ethical issue you chose. (For example, the site is initiating a Phase 1 study for the first time, a recent audit identified a major informed consent problem. In an audit it has been discovered that non-English speaking patients aren’t being approached or considered for a study for which they are eligible. ) Provide relevant background information on topic that relates to the ethical issue you chose. Why is it important?
- Body – be sure to present evidence &/or quote sources (citations/references) to support the rationale for the position you take on the topic you chose. These include federal regulations, informed consent requirements, Belmont Report, etc. Explain things fully and clearly. Two pages does not allow you to discuss everything about the topic (e.g., the entire history regarding the ethic. Use one or two brief examples.) Just be sure you cover the key points and provide details.
- Conclusion – Discuss why the ethic chosen is important to human research and the site. Refer to how the site failed to meet the ethic. Include specific strategies your site will implement to correct the ethical issue.