Offshoring The offshoring of clinical trails can offer researchers access to significantly larger subject populations and present lower operating costs for trials management. Conducting a clinical trial offshore can also have ethical ramifications. Consider the following scenario: You are a member of a research team at a biologic company planning a clinical trial for a new drug. As part of the initial planning process for the development of the drug, your team is considering offshoring the trial. You will select a country for the trial and present it to your team. To prepare for this Application Assignment, select a country (other than the U.S.) that uses ICH E6(R1) codes. To complete this Application Assignment, write a 1- to 2-page paper in which you develop a proposal for your team that presents both the benefits and challenges of offshoring in the country you selected. Be sure to include a rationale for why you selected your country, any issues related to the tenet of justice in the Belmont Report, and the ethical oversight in the country you selected. Your written assignments must follow APA guidelines. Be sure to support your work with specific citations from this week’s Learning Resources and additional scholarly sources as appropriate. Refer to the Essential Guide to APA Style for Walden Students to ensure that your in-text citations and reference list are correct.
Sample Solution
