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 biologics 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, select a country (other than the U.S.) that uses ICH E6(R1) codes. To complete this Assignment, write a 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.