Parental interest in genomic sequencing of newborns: enrollment experience from the BabySeq Project.

Genetti CA1, Schwartz TS1, Robinson JO2, VanNoy GE1, Petersen D2, Pereira S2, Fayer S3, Peoples HA2, Agrawal PB1,4,5, Betting WN3, Holm IA1,4, McGuire AL2, Waisbren SE1,4, Yu TW1,4,6, Green RC3,4,6, Beggs AH1,4, Parad RB7,8,9; BabySeq Project Team.

Abstract

PURPOSE:

Newborn genomic sequencing (nGS) has great potential to improve pediatric care. Parental interest and concerns about genomics are relatively unexplored. Understanding why parents decline research consent for nGS may reveal implementation barriers.

METHODS:

We evaluated parental interest in a randomized trial of nGS in well-baby and intensive care unit nursery settings. Interested families attended an informational enrollment session (ES) with a genetic counselor prior to consenting. Reason(s) for declining participation and sociodemographic associations were analyzed.

RESULTS:

Of 3860 eligible approached families, 10% attended ES, 67% of whom enrolled. Of 1760 families queried for decline reasons, 58% were uninterested in research. Among 499 families considering research, principal reasons for decline prior to ES included burdensome study logistics (48%), feeling overwhelmed postpartum (17%), and lack of interest/discomfort with genetic testing (17%). Decliners after ES more often cited concerns about privacy/insurability (41%) and uncertain/unfavorable results (23%).

CONCLUSION:

Low interest in research and study logistics were major initial barriers to postpartum enrollment and are likely generic to many postpartum research efforts. Concerns over privacy and result implications were most commonly cited in decliners after ES. Understanding parental concerns around research nGS may inform future integration of nGS into newborn screening, predictive testing, and pediatric diagnostics.