Determining Caregivers’ Logic in Saying No to Research (DECLINE)

Introduction: The pediatric intensive care unit (PICU) presents unique challenges for research study enrollment given the stressors associated with enrolling acutely ill children. However, few studies have directly asked caregivers the reasons for declining to participate in research, and caregivers’ rationales remain largely speculative. Therefore, we aimed to assess the stated motivations of caregivers who declined research, hypothesizing that the reasons would vary according to patient race, interpreter use, and whether families were approached in-person or by telephone.


Methods: This was a prospective cohort study of caregivers of subjects approached for research in the Children’s Hospital of Philadelphia PICU between July 2022 and June 2024. After declining research participation, parents were directly asked reasons for declining. Answers were coded as one of 10 pre-determined, non-exclusive (could give > 1 answer) categories. Reasons for declining research were compared between patients’ racial categories (Black, Hispanic, White, Other), interpreter use, and in-person or telephone consent using Fisher exact test.


Results: Over the study period, 241 families declined research. Patients were primarily White (37%) and Black (32%), and were approached at a median of 1.5 days after PICU admission. Interpreter use was 7%, and 10% were approached by telephone. “Family too overwhelmed” (36%) and “no additional procedures” (33%) were the most common reasons for declining research participation, nearly 2- to 3-fold higher than other reasons. Neither of these reasons for declining varied by race or interpreter use. However, families who declined research who were approached in-person answered “family too overwhelmed” as a reason for declining in 38% of cases, whereas those approached by telephone only reported this reason in 13% of cases (p = 0.021).


Conclusions: We provide an atlas of caregiver reasons for declining PICU research participation, with answers highlighting the unique emotional and time stressors of pediatric critical illness that preclude the ability to fully engage with the consent process. Caregivers’ reasons did not change according to race and interpreter use, but may differ by in-person versus alternative approaches. Our results may inform how to optimize consent rates in PICU studies.