Infants were directly fed alcohol to see whether their sleep and activity levels were affected in the short term in research funded by the National Institutes of Health.
In the experiment, 13 lactating women and their infants were tested on two days, separated by an interval of one week. On each testing day, the mother expressed 100mL of milk, while a small, computerized movement detector called an actigraph was placed on the infant's left leg to monitor sleep and activity patterning. After the actigraph had been in place for about 15 minutes, the infants ingested their mother's breast milk flavored with alcohol (32 mg) on one testing day and breast milk alone on the other. The infants' behaviors were monitored for the next 3.5 hours.
The researchers concluded that "short-term exposure to small amounts of alcohol in breast milk produces distinctive changes in the infant's sleep-wake patterning."
Mennella has conducted similar government-funded research but in that case the alcohol was first ingested by the mothers.
The researchers reportedly received permission for the research protocol from the Committee on Studies Involving Human Beings at the University of Pennsylvania.
Federal regulations require that researchers obtain the assent of the children and the permission of their parents or guardians. [45 CFR 46.404 - 407].
In this case, the average age of the infants in this research was 2.7 months. They clearly had no capacity to "assent" to the procedure. Permission of the parents alone is insufficient.
But federal regulations allow institutional review boards like the the University of Pennsylvania's Committee on Studies Involving Human Beings to waive the assent requirement where it is determined that the capability of some or all of the children is so limited that they cannot be reasonably be consulted.
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