A manufacturer, research institution, or researcher shall, prior to the administration of an AIDS vaccine to a research subject, obtain that womanâs informed consent, that shall comply with all applicable statutes and regulations. (a) The informed consent shall contain a statement that significant new findings developed during the course of the research that may relate to the subjectâs willingness to continue participation will be provided to the subject. (b) A copy of the informed consent shall be maintained with the womanâs medical records.
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