SOLVED1611

Which of the following informed consent statements is required for medical device studies conducted outside the U.S. (under ISO 14155:2020), but is not required for studies conducted in the U.S.? A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable. The approximate number of subjects involved in the study. A statement including the clinicaltrials.gov language, “A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.” A statement indicating that, upon subject’s approval, the subject’s personal physician will be informed of the subject’s participation in the study shall be included.
SCIENCE
HEALTH SCIENCE
NURSING

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