The COVID-19 pandemic has already had widespread effects on healthcare and health-related research worldwide. Early phase responses to the pandemic included restriction of clinical care and research to essential, time-sensitive and COVID-related activities in many institutions. With the re-introduction of clinical services, a number of strategies were imposed to minimize viral transmission to patients and healthcare personnel, such as strict limits on visitors/caregivers in pediatric inpatient facilities, which may have ethical implications on family-centered care.1,2,3 Here we investigate consent rates for a clinical research study before and after implementation of a one-visitor policy at our children’s hospital.

We conducted a retrospective review of enrollment in a clinical research study performed at an academic tertiary care children’s hospital. The parent study is an IRB-approved observational cohort study enrolling children, adolescents, and young adults undergoing congenital heart surgery since 2007.4 All patients undergoing congenital heart surgery at Monroe Carell, Jr. Children’s Hospital at Vanderbilt and subsequently admitted to the pediatric cardiac intensive care unit are eligible for enrollment, regardless of age. The parents/guardians of eligible subjects are approached for enrollment by research nurses prior to the operative procedure, either in the inpatient setting or in the clinic the day before surgery for outpatients. Of note, as an observational study, it is minimal risk, and for minors the written consent of only one parent/guardian is required. On March 10, 2020 enrollment in the study was paused due to institutional restrictions on research in response to the COVID-19 pandemic. Prior to that date, there were no restrictions on elective surgical procedures and both parents were allowed to be with the children in hospital. On March 18, 2020, a restricted visitor policy allowing only one parent/visitor for pediatric inpatients and outpatients was enacted. By May 7, 2020, elective cardiac cases had resumed and enrollment in the study began again, but the one-parent/visitor policy remained in effect.

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