Carol, I agree that this study, because it went through an IRB, would have
to have explored the risks to the patient and that these risks would have
to be communicated to the patient; however, I wonder how thorough they were
when including "risks" of formula in their proposal?  The reviewers made
their decision based on the proposal they were given. Were they given
complete information? Any way possible to get the proposal or a copy of the
consent form? I have never tried this, but I wonder if it is possible to
furnish additional information to a review board after it has been
approved.  I am concerned that the mothers who agree to be in this study
will not have the complete information on what this will do to the health
of their infant and of the long term consequences.
Carol L'Esperance, RN, MSN, IBCLC
Albuquerque, NM 87106 USA

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