Returning to your role as VP for a healthcare system engaged in research, you are informed by the CEO that there is interest in greatly expanding the volume and variety of research engaged in at your organization. You realize that such expansion will require the creation of a Compliance Department to oversee the ethical conduct of research; therefore, you must begin to determine and design what that department should contain.
Review the concepts covered in this course, and then comment on how they should be addressed in an organization-wide compliance program. Perform a literature search on real-world systems, and then incorporate the information you learn into your design. Primary questions to consider include:
- Who does the Compliance Department report to in the organizational structure?
- What are the primary ethical concerns to address, and why?
- How will the Compliance Department maintain oversight of research operations? What tools and approaches are used, and why would these be effective?
- How would you help physicians and research personnel accept this additional layer of oversight?
Support your paper with at least seven scholarly resources. In addition to these specified resources, other appropriate scholarly resources, including older articles, may be included.
Length: 12-15 pages, not including title and reference pages
Your response should demonstrate thoughtful consideration of the ideas and concepts presented in the course by providing new thoughts and insights relating directly to this topic. Your response should reflect scholarly writing and current APA standards. Be sure to adhere to Northcentral University’s Academic Integrity Policy.
The following rubric applies to the grading for this Signature Assignment.
| Grading Rubric |
| Criteria |
| Content (20 points) |
Points |
| 1 |
Commented on how concepts covered in the course should be addressed in an organization-wide compliance program. |
5 |
| 2 |
Performed a literature search on real-world systems and incorporated the information learned into the design. |
5 |
| 3 |
Answered the primary questions:
- Who does the Compliance Department report to in the organizational structure?
- What are the primary ethical concerns to address, and why?
- How will the Compliance Department maintain oversight of research operations? What tools and approaches are used, and why would these be effective?
- How would you help physicians and research personnel accept this additional layer of oversight?
|
10 |
| Organization (5 points) |
| 1 |
Organized and presented in a clear manner. Included a minimum of seven scholarly references, with appropriate APA formatting applied to citations and paraphrasing. Paper is 12-15 pages long. |
5 |
| Total |
25 |
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