A manufacturer, research institution, or researcher shall, prior to the administration of an AIDS vaccine to a research subject, obtain that woman’s 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 subject’s willingness to continue participation will be provided to the subject.
(b) A copy of the informed consent shall be maintained with the woman’s medical records.