Examining How Parents Decide Whether to Enroll Their Infant in a Research Study

Clinical research is essential to improve clinical care in neonatology. Randomized controlled trials (RCTs) are the best way to test new ways to treat infants requiring intensive care, such as those born premature, those with birth injury and those with congenital abnormalities. Recruiting patients for clinical research in a manner that is respectful, promotes trust and avoids taking unfair advantage of their need for medical care is important. There is significant controversy, however, regarding what constitutes the best approach to recruitment of parents who are dealing with the stress and uncertainty of having an infant in the neonatal intensive care unit (NICU).

Many domains may influence whether an individual joins a research study. Despite the fact that multiple relevant factors have been identified – ranging from participant understanding of study parameters to trust to demographics – it is not clear which of these are most important or how they interact. This makes it difficult to design interventions to better inform potential participants, improve the process and increase clinical trial enrollment. Within neonatology, little is known regarding which of these factors are important, and to what extent, for parents considering enrolling their infant in a clinical trial.

Neonatologist and bioethics faculty Dr. Elliott Weiss, along with bioethics faculty Seema Shah and Dr. Benjamin Wilfond, aims to learn how parents made the decision whether to enroll their infant in the High-Dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial, a multisite RCT of a therapeutic agent for neonates with brain injury. The team, with 10 collaborating sites, intends to recruit 310 parents who have been approached for the HEAL trial, so that researchers can better understand how parents make the decision whether to enroll their infant in a research study.

“Clinical research is essential to improving the care of infants requiring intensive care. Protection of potential neonatal research subjects and their families is also mandatory. How best to recruit for research in this population remains controversial. We must perform research that enables us to do a better job.”

Dr. Elliott Weiss

Ultimate Goal

To better characterize the decision-making processes of potential NICU research participants, which can in turn lead to processes that are both more effective at recruitment and better aligned with the needs of this population.

Primary Collaborators

  • Steve Joffe, University of Pennsylvania Perelman School of Medicine
  • Sunny Juul, Seattle Children’s
  • Brooke Magnus, Marquette University

Funding

  • Clinical Research Scholars Program, Center for Clinical and Translational Research, Seattle Children's
  • Bioresearch Fund, Division of Neonatology, Department of Pediatrics, University of Washington School of Medicine

Representative Publications