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Best Practices for Obtaining Genomic Consent in Pediatric Traumatic Brain Injury Research

Schnur, Kaylee C.; Gill, Eliana; Guerrero, Alejandro; Osier, Nicole; Reuter-Rice, Karin

doi: 10.1097/NNR.0000000000000335
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Background Precision health relies on large sample sizes to ensure adequate power, generalizability, and replicability; however, a critical first step to any study is the successful recruitment of participants.

Objectives This study seeks to explore how the enrollment strategies used in a parent study contributed to the high consent rates, establish current best practices that can be used in future studies, and identify additional factors that contribute to consent into pediatric traumatic brain injury biobanks.

Methods Retrospective secondary analysis of data from a parent study with high consent rates was examined to explore factors affecting consent into biobanking studies.

Results Of the 76 subjects who were approached, met the eligibility criteria, and reviewed the consent form, only 16 (21.1%) declined to participate. The consented group (n = 60) represents 64.5% of those who met the eligibility criteria upon initial screening (n = 93) and 78.9% of those with confirmed eligibility (n = 76). Analysis of screening data suggested there were no major barriers to consenting individuals into this pediatric traumatic brain injury biobank.

Discussion There were no demographic or research-related characteristics that significantly explained enrollment. Ethically, to obtain true informed consent, parents need to understand only their child’s diagnosis, prognosis, and medical care, as well as the purpose of the proposed research and its risks and benefits. Researchers need to implement best practices, including a comprehensive review of census data to identify eligible participants to approach, a prescreening protocol, and effective consenting process to obtain informed consent so that precision care initiatives can be pursued.

Kaylee C. Schnur is Nursing Honors Undergraduate Student, University of Texas at Austin School of Nursing. She is working toward earning her BSN.

Eliana Gill, RN, BSN, is Registered Nurse, Seton Medical Center, Austin, Texas.

Alejandro Guerrero is Undergraduate Student, University of Texas at Austin. He is working toward earning a BS in Neuroscience.

Nicole Osier, PhD, RN, is Assistant Professor, University of Texas at Austin School of Nursing and Department of Neurology, University of Texas at Austin Dell Medical School.

Karin Reuter-Rice, PhD, CPNP-AC, FCCM, FAAN, is Associate Professor, Duke University School of Nursing and Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina.

Accepted for publication November 19, 2018.

The authors would like to thank Registered Nurse Champions Ron Ryen, Erin McCallum, Martina Watkins, and Jared Leonard for their dedication to this research study.

Research reported in this publication was supported by the National Institutes of Health, the Adaptive Leadership for Cognitive Affective Symptom Science ADAPT Institute of Nursing Research Center of Excellence under Award Number NINR 1P30 NR014139-01, and the Robert Wood Johnson Foundation Nurse Faculty Scholar under Award Number 71244.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

All procedures performed in this study were in accordance with the ethical standards approved by the Duke University Institutional Review Board.

The authors have no conflicts of interest to report.

Corresponding author: Karin Reuter-Rice, Duke University School of Nursing, DUMC 3322, 307 Trent Drive, Durham, NC 27710 (e-mail: karin.reuter-rice@duke.edu).

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