CITI Training Practice Exam

Who recommends stating the probability of assignment to trial arms in consent forms?

1. FDA only

2. ICH only

3. Both FDA and ICH

4. Neither FDA nor ICH

The correct answer is: ICH only

When it comes to ethics and regulations in medical and scientific research, there are various organizations that provide guidelines and recommendations. Two of the most prominent ones are the FDA (Food and Drug Administration) and ICH (International Conference on Harmonisation). In this case, the correct answer is B, which states that it is only ICH that recommends stating the probability of assignment to trial arms in consent forms. FDA does not have this specific recommendation, and neither do both organizations or none. It is important to understand the regulations and guidelines of these organizations to ensure ethical and safe research practices. Therefore, option B is the most appropriate answer for this question.