Question

The FDA provides no regulatory basis to conduct research if written informed consent cannot be obtained from subjects prior to the entry into a study?

A)True
B)False

Answer 1

The FDA requires informed consent from subjects prior to their entry into a research study.

Step-by-step explanation:

The FDA requires that informed consent be obtained from subjects prior to their entry into a research study. This means that participants must be fully informed about the experiment, including potential risks and implications, and provide their written consent to participate. If written informed consent cannot be obtained, the FDA does not provide a regulatory basis to conduct the research.