Institutional review board barriers and solutions encountered in the Collaboration Among Pharmacists and Physicians to Improve Outcomes Now Study: a national multicenter practice-based implementation trial.
Institutional review board barriers and solutions encountered in the Collaboration Among Pharmacists and Physicians to Improve Outcomes Now Study: a national multicenter practice-based implementation trial.
复制标题
机构审查委员会在药剂师和医生合作改善结果研究中遇到的障碍和解决方案：一项基于实践的国家多中心实施试验。
DOI：
10.1002/phar.1276
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发表时间：
2013
期刊：
影响因子：
4.1
通讯作者：
Carter,BarryL
中科院分区：
文献类型：
--
作者：
Maclaughlin,EricJ;Ardery,Gail;Jackson,EricA;Ives,TimothyJ;Young,RodneyB;Fike,DavidS;Carter,BarryL
研究目的对机构审查委员会（IRB）在多中心基于实践的研究网络（PBRN）研究中遇到的挑战和解决方案进行分类，并评估IRB要求对个体主要研究者（PI）参与未来PBRN研究意愿的影响。设计描述性分析在药剂师和医生合作立即改善结局（CAPTION）试验中遇到的IRB挑战和解决方案。一项由国家跨学科初级保健PBRN进行的多中心前瞻性随机分组研究，以及一项来自单个研究中心PI调查的相关性分析。测量和主要结果对研究中心遇到的IRB障碍和解决方案进行分类。对研究中心PI进行了调查，并进行了相关性分析，评估了各种IRB要求的影响和个体PI参与未来PBRN研究的意愿;在参与CAPTION研究的31家研究中心中，对28家研究中心PI进行了调查。IRB提出了许多挑战，包括关于申请来源的偏倚、关于研究设计、研究工具、患者记录访问、研究程序、仅讲西班牙语的受试者、诊所医生的作用、跨部门问题和持续审查的更新等问题。PI调查的答复（28名参与调查的主要研究者中有21名[回应率为75%]）表示，个人未来担任主要研究者的意愿与获得初步调查结果的难度呈负相关。（rS=-0.599，p=0.004）并持续（rS=-0.464，p=0.034）IRB批准。结论需要大量的时间和资源来解决与IRB批准相关的各种挑战，这对个人PI参与未来PBRN项目的意愿产生了负面影响。修订关于保护人类受试者进行基于实践的研究的现行规则和法规，改善IRB流程，以及协调中心的支持，可能会减少与IRB批准相关的负担，并增加对基于实践的研究的参与。
Study ObjectiveTo categorize institutional review board (IRB) challenges and solutions encountered in a multicenter practice‐based research network (PBRN) study and to assess the impact of IRB requirements on the willingness of individual principal investigators (PIs) to participate in future PBRN studies.DesignDescriptive analysis of IRB challenges and solutions encountered in the Collaboration Among Pharmacists and Physicians to Improve Outcomes Now (CAPTION) trial, a multicenter prospective cluster‐randomized study conducted by the National Interdisciplinary Primary Care PBRN, and a correlational analysis from a survey of individual site PIs.Measurements and Main ResultsIRB barriers encountered and solutions were categorized for study sites. A survey of study‐site PIs was conducted with a correlational analysis assessing the impact of various IRB requirements and the willingness of individual PIs to participate in future PBRN studies; of 31 study sites participating in the CAPTION study, 28 study‐site PIs were surveyed. IRBs posed a number of challenges including bias regarding the source of the application, issues regarding study design, study instruments, access to patient records, study procedures, Spanish‐only speaking subjects, role of clinic physicians, interdepartmental concerns, and updates at continuing review. Responses from the PI survey (21 of 28 PIs surveyed [75% response rate]) indicated that the willingness of an individual to serve as a PI in the future was inversely related to the perceived difficulty of obtaining initial (rS= −0.599, p=0.004) and continuing (rS= −0.464, p=0.034) IRB approval.ConclusionSignificant time and resources were required to address various challenges associated with IRB approval, which had a negative impact on an individual PI's willingness to participate in future PBRN projects. A revision of current rules and regulations regarding the protection of human subjects for practice‐based studies, improvement in IRB processes, and support from coordinating centers may decrease the burden associated with IRB approval and increase participation in practice‐based research.