Imagine you are a compliance officer in a research organization that has been contracted to test a new vaccine for the Zika virus. The organization has been under increased public, corporate, political, and financial pressure to determine whether the new vaccine is a solution to the international public health emergency. To be the first organization to declare the vaccine viable, your organization has side-stepped compliance protocols by skipping straight to human trials.
Your executive leadership has been reluctant to adopt organizational practices that you believe would satisfy compliance standards and reduce risk.
Create a 10- to 15-minute, 9- to 12-slide voice-over presentation using either Microsoft® PowerPoint® or websites such as Google Slides™, Adobe® Slate, or Prezi®.
Include at least 1 slide on each of the following:
Conflicts of interest.
Cost allocation and reporting expectations.
What research regulations may have been violated?
What the reporting protocols to the government may look like.
The consequences of clinical research misconduct.
The steps you will take to investigate the situation.
Your recommendation of an organizational policy to minimize risk until the investigation can occur.
Persuade the executive leadership that you are a knowledgeable compliance officer, that this is the correct course of action, and that they should adopt your recommendations.
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