Towards better enrollment decision-making for perinatal clinical research: Reconsidering recruitment and consent processes to support family values and preferences

Abstract

Objective

Whether to participate in clinical research is a special type of decision for parents with infants in the neonatal intensive care unit (NICU). Parents often report negative experiences being approached for NICU research and researchers struggle to enroll a representative sample. We consider how enrollment decision-making might be better supported by integrating learnings from clinical decision-making.

Finding

Approaches to supporting decision-making about clinical research, though distinct from those for clinical decision-making, share many similarities. We consider ways researchers may incorporate advances in knowledge about clinical decision-making to: (a) improve documents used for regulatory purposes (e.g., consent forms), and (b) better support relationship building between researchers and parents considering research enrollment.

Conclusion

Researchers may benefit from considering approaches to enrollment decision-making that draw on clinical decision-making methods. Future work should assess the impact of such approaches on parental experiences of recruitment; enrollment and retention rates; and representative inclusion of NICU populations.