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Consent and Research

A new law requiring consent from parents before conducting research on blood spots collected from newborns is raising concerns among some public health experts that such a requirement could hamper both fundamental research and research to improve such screens, Science's Jennifer Couzin-Frankel reports. In the US, the newborn screening program tests infants for some 30 rare and serious diseases that can be treated if caught early enough. These blood spots are often also used for research.

She notes that while "[s]eeking consent sounds innocuous, even welcome," it also is time-consuming for already over-worked hospital staff. When one California hospital sought consent to try a new screening technology on blood spots from 400,000 newborns, the staff could only contact about half the eligible families, limiting the study, Couzin-Frankel adds.

The concern, she reports, comes down to what is defined as 'research.' Federal guidelines, she notes, consider research to be an enterprise that aims to "develop or contribute to generalizable knowledge." But, she asks, does that include testing a new screening technology or examining whether a new disease should be added to the screening panel?

The law, she adds, is also "an early jolt of a larger seismic shift in how de-identified samples are handled." Previously, consent was not required to study such samples. However, the US National Institutes of Health has recently said that investigators it grants need to get consent before performing genomic analyses on de-identified samples, Couzin-Frankel says.