The FDA recently proposed banning oral phenylephrine, a common ingredient in over-the-counter (OTC) cold and cough medicines, after studies showed it is no more effective than a placebo. This raises critical questions not only about the interpretation of statistical evidence in health care but also about ethical responsibility in public health decision-making. 

Consider the following questions as they relate to health care statistics and ethics:

1. Institutional Review Board:  Explain the rationale for ethical research guidelines, including Institutional Review Board (IRB) guidelines as they relate to this topic.
2. Interpreting Statistical Evidence: The FDA's findings are based on studies demonstrating that phenylephrine is statistically no more effective than a placebo. Why is statistical evidence crucial in evaluating the efficacy of medications, and what challenges might arise when communicating these findings to the public? 

Initial discussion question posts should be a minimum of 200 words and cite at least two references using APA style.