儿科创伤性脑损伤研究中获取基因组同意的最佳实践。

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

机构信息

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.

出版信息

Nurs Res. 2019 Mar/Apr;68(2):E11-E20. doi: 10.1097/NNR.0000000000000335.

DOI:10.1097/NNR.0000000000000335

PMID:30829926

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6400301/

Abstract

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.

摘要

背景

精准医疗依赖于大样本量，以确保足够的效力、普遍性和可重复性；然而，任何研究的关键第一步都是成功招募参与者。

目的

本研究旨在探讨在一项主要研究中使用的入组策略如何促成高同意率，确定可用于未来研究的当前最佳实践，并确定有助于儿科创伤性脑损伤生物库入组的其他因素。

方法

对高同意率的主要研究中的数据进行回顾性二次分析，以探讨影响生物库研究同意率的因素。

结果

在 76 名被接触、符合入选标准并审查了知情同意书的受试者中，只有 16 名（21.1%）拒绝参与。同意组（n=60）代表符合初始筛选入选标准的 93 名受试者中的 64.5%（n=60），以及符合确定入选标准的 76 名受试者中的 78.9%（n=60）。筛选数据的分析表明，同意入组该儿科创伤性脑损伤生物库的主要障碍并不存在。

讨论

没有任何人口统计学或研究相关特征能显著解释入组率。从伦理上讲，为了获得真正的知情同意，家长只需要了解他们孩子的诊断、预后和医疗护理，以及拟议研究的目的及其风险和益处。研究人员需要实施最佳实践，包括全面审查人口普查数据以确定要接触的合格参与者、预筛选协议以及有效的知情同意过程，以获得知情同意，从而可以开展精准护理计划。