legally-effective informed research consent

Informed consent for research participation is legally effective when it is obtained and documented from the subject or the subject’s legally authorized representative in a manner that is consistent with: 1) the applicable laws of the jurisdiction in which the research is conducted; and 2) any other applicable regulations (such as the Common Rule human subjects regulations at 45 CFR 46 and the Food and Drug Administration (FDA) human subjects regulations at 21 CFR 50 and 56).