Informed consent for maternal serum alpha-fetoprotein screening in an inner city population: how informed is it?

To determine if women who received information from a provider and viewed a videotape about maternal serum alpha-fetoprotein (MSAFP) screening understood enough to sign informed consent.

A prospective qualitative design using tape recorded interviews of women who were provided information regarding MSAFP testing from a provider and from viewing a videotape.

Fifty-three inner city pregnant women (58% Hispanic, 39% African-American, 3% white).

Two women answered all questions correctly; no one answered all questions incorrectly. Sixty-two percent correctly answered "What is MSAFP?" Sixteen percent thought "something has to be taken from my belly" for the test. Fifty-nine percent understood that children with spina bifida could have difficulty walking or urinary problems. Seventy-two percent thought their infant would be healthy in all respects if the test was negative. Only 45% could describe the follow-up to a positive test. Eighty percent planned to have the test. Many misconceptions were apparent, and for some knowledge items, as many as 80% of the women answered incorrectly.

Obtaining truly informed consent for a complex test is not a simple process. Participants met a few, but not all, of the criteria for informed consent. Women understood that the test was voluntary, but their comprehension of the meaning and implication of a positive test results was deficient. Despite this, they signed the informed consent document. The larger question of just how much comprehension is required to consider a woman "informed" has not been answered.