A key ethical issue would be informed consent, whether the parents get
evidence-based, forthright information about the potential risks of
exogenously-motivated supplementing (i.e. premature weaning--before the
recommended duration from the AAP, allergies / intolerance...). Ask UC's
IRB to see the consent forms, which would have to have been approved by
the UC's IRB (Institutional review board). I think the IRB would give you
this info, and would take seriously any well-reasoned and evidence-based
concern. You could call the IRB and ask how to best express your concern.
At a minimum, they can make the investigators make the consent forms
explicit about the risks. Despite Duke's problems, most IRBs are
extraordinarily careful about protecting patients from potential harm,
expecially children, who can't ensure their own protection.
*********************************************************************
MaryAnn O'Hara, MD, MSt
Robert Wood Johnson Clinical Scholars Program
University of Washington
1959 NE Pacific, Rm H-220 Health Sciences Center, Box 357183
Seattle, WA 98195-7183
(office) # 206-616-8724
(home office) 206-329-6870
(fax) 206-685-2473
e-mail: [log in to unmask]
*********************************************************************
On Sun, 6 Jun 1999, J. Rachael Hamlet wrote:
> From: "J. Rachael Hamlet" <[log in to unmask]>
>
> I am very concerned about the ethics of this experimentation on
> babies. What possible benefit could these babies derive from this
> experiment that would justify the risks imposed on them? Does
> anyone know which office of the NIH handles the ethics of human
> experimentation or which other governmental agency can review
> such a questionable study?
>
> Rachael Hamlet
> Breastfeeding Busybody
>
> On 6 Jun 99, at 8:03, [log in to unmask] wrote:
> <forwarded by Katie:>
>
> > We have been contacted by researchers at the Center for Human
> > Nutrition, University of Colorado Health Sciences Center,
> > concerning an infant nutrition study they are conducting. They
> > would like to ask you and your child to be a part of their study.
> > They are interested in looking at the nutrition of infants to learn
> > more about their nutritional requirements. An infant's eating habits
> > affect physical and developmental growth as well as overall health.
> >
> > This study is for male babies who are exclusively breast-fed for
> > the first three months. Formula will be introduced during the third
> > month - three to four ounces twice a day. The study is looking at
> > zinc absorption in babies supplemented with either high or low iron
> > formula.
> >
> > For your participation you will be provided formula for the three
> > weeks of the study, the use of an electric breast pump, and $400.00
> > for the successful completion of the study. The study is conducted
> > at home.
> >
> > We have reviewed the credentials of the researchers and found them to be
> > in good order. They have been doing similar research for over two decades
> > in the Denver-Metropolitan area. This project is being sponsored by Mead
> > Johnson and has been reviewed and approved by the Colorado Multiple
> > Institutional Review Board of the University of Colorado Health Sciences
> > Center.
> >
>
>
>
>
> ------------------------------------------------------------------------
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