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卫生专业教育研究专用机构审查委员会模板的开发。

Development of a Health Professions Education Research-Specific Institutional Review Board Template.

作者信息

DeMeo Stephen D, Nagler Alisa, Heflin Mitchell T

机构信息

S.D. DeMeo is attending neonatologist, WakeMed Health & Hospitals, Raleigh, North Carolina, and adjunct professor of pediatrics, Duke University Medical Center, Durham, North Carolina. A. Nagler is assistant director, Accreditation, Validation, and Credentialing, American College of Surgeons, Chicago, Illinois. M.T. Heflin is associate professor of medicine, Department of Medicine-Geriatrics, Duke University Medical Center, Durham, North Carolina.

出版信息

Acad Med. 2016 Feb;91(2):229-32. doi: 10.1097/ACM.0000000000000987.

Abstract

PROBLEM

Health professions education (HPE) has become a core component of the mission of academic health centers (AHCs) nationwide. The volume of HPE research projects being reviewed has increased, presenting new challenges for institutional review boards (IRBs). As HPE research becomes increasingly sophisticated in its design and methods, IRBs and researchers alike have a duty to better understand its unique characteristics. Researchers must be better able to conceptualize and describe their research to IRBs, and IRBs should be able to provide timely review and assure protection of research subjects (or participants).

APPROACH

The creation of HPE research-specific IRB templates may be one way to improve the interactions between education researchers and IRBs. This report describes the development and early implementation of an HPE research-specific IRB template at Duke University from 2013 to 2014.

OUTCOMES

Early adopters have noted increased ease of preparation and submission, while IRB staff have reported improved proposal clarity and more attention to protecting learners as research participants. Focus during educational or training sessions about the new template has shifted-from merely a description of the new submission process to a more comprehensive education series that includes discussion of regulatory definitions, examination of case studies, and opportunity for audience feedback.

NEXT STEPS

Continued collection of quantitative and qualitative data regarding the implementation of this IRB template will help its developers more precisely describe its effects on HPE research projects. Formalizing and streamlining the interactions between HPE researchers and IRBs is an important goal for all AHCs.

摘要

问题

卫生专业教育(HPE)已成为全国学术医疗中心(AHCs)使命的核心组成部分。正在接受审查的HPE研究项目数量有所增加,这给机构审查委员会(IRBs)带来了新的挑战。随着HPE研究在设计和方法上日益复杂,IRBs和研究人员都有责任更好地理解其独特特征。研究人员必须更有能力向IRBs概念化并描述他们的研究,而IRBs应该能够提供及时审查并确保研究对象(或参与者)得到保护。

方法

创建针对HPE研究的IRB模板可能是改善教育研究人员与IRBs之间互动的一种方式。本报告描述了2013年至2014年杜克大学针对HPE研究的IRB模板的开发和早期实施情况。

成果

早期采用者指出准备和提交工作变得更加容易,而IRB工作人员报告称提案清晰度有所提高,并且更加注重保护作为研究参与者的学习者。关于新模板的教育或培训课程的重点已从仅仅描述新的提交过程转变为更全面的教育系列,包括监管定义的讨论、案例研究的审查以及听众反馈的机会。

下一步

持续收集关于此IRB模板实施情况的定量和定性数据,将有助于其开发者更精确地描述其对HPE研究项目的影响。规范和简化HPE研究人员与IRBs之间的互动是所有AHCs的一个重要目标。

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