55. Midwives must, in respect of a participant or legal representative, ensure(1) that the participant or legal representative is adequately informed of the research project’s objectives, its benefits, risks or inconveniences, the benefits derived from regular care, if applicable, as well as the fact, if such is the case, that the midwife will derive a benefit from enrolling or maintaining the participant or legal representative in the research project;
(2) that free and enlightened written consent, revocable at all times, is obtained from the participant or legal representative before the participant or legal representative begin participation in the research project or whenever there is any material change in the research protocol; and
(3) that clear, specific and enlightened consent is obtained from the participant or legal representative before communicating information concerning the participant or legal representative to a third person for the purposes of scientific research.