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妇科肿瘤学研究员研究标准的遵守情况:妇科肿瘤学研究员研究网络(GOFRN)研究。

Compliance with research standards within gynecologic oncology fellowship: A Gynecologic Oncology Fellowship Research Network (GOFRN) study.

机构信息

Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic Foundation, 9500 Avenue, Desk A81, Cleveland, OH 44195, USA.

Division of Gynecologic Oncology, Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA.

出版信息

Gynecol Oncol. 2017 Sep;146(3):647-652. doi: 10.1016/j.ygyno.2017.06.034. Epub 2017 Jul 8.

Abstract

OBJECTIVES

Participation in clinical and basic science research is emphasized in gynecologic oncology training. We sought to identify trends in adherence to expected research practices and reasons for non-adherence among gynecologic oncology fellows.

METHODS

An anonymous 31-question online survey assessing academic behaviors, including IRB compliance, authorship assignment, data sharing, and potential barriers to non-adherence was distributed to all SGO gynecologic oncology fellow members in July 2016. Descriptive statistics and univariate analyses were performed.

RESULTS

Of 190 members, 35.3% (n=67) responded. 73% (n=49) of respondents reported personal non-compliance and 79.1% (n=53) reported having witnessed others being non-complaint with at least one expected research practice. Areas of compliance failure included changing a research question without appropriate IRB amendment (20%; n=14), conducting research under a nonspecific IRB (13.9%; n=9), and performing research without IRB approval (6.1%; n=4). Longer institutional time for IRB approval was significantly associated with IRB non-adherence (p<0.05). First year fellows were more likely to use a nonspecific IRB (p=0.04) or expand a question without amending the IRB (p=0.04). When asked about storage of protected health information (PHI) for research, 53% reported non-secure storage with 17.1% (n=6) having done so for >1000 patients. Thirty respondents (45.5%) assigned authorship to someone who failed to meet ICMJE criteria and twelve (18.5%) accepted authorship without meeting ICMJE criteria. Most commonly cited reasons for non-adherence were: cumbersome IRB processes (80.3%), pressure from senior authors (78.8%), fear of someone else publishing first, (74.2%) and lack of support navigating appropriate research practices (71.2%).

CONCLUSIONS

Fellow non-compliance with expected research practices is high, particularly with regards to secure storage of PHI and appropriate authorship assignment. Time-consuming and cumbersome IRB procedures, perceived pressure from senior authors, and lack of research support contribute to non-adherence. Further support and education of gynecologic oncology fellows is needed in order to help address these barriers.

摘要

目的

参与临床和基础科学研究是妇科肿瘤培训的重点。我们试图确定妇科肿瘤研究员遵守预期研究实践的趋势和不遵守的原因。

方法

2016 年 7 月,向所有 SGO 妇科肿瘤研究员成员分发了一份匿名的 31 个问题在线调查,评估学术行为,包括 IRB 合规性、作者分配、数据共享和不遵守的潜在障碍。进行了描述性统计和单变量分析。

结果

在 190 名成员中,有 35.3%(n=67)做出了回应。73%(n=49)的受访者报告个人不遵守规定,79.1%(n=53)的受访者报告至少有一次目睹他人违反至少一项预期的研究实践。合规失败的领域包括在没有适当 IRB 修正案的情况下更改研究问题(20%;n=14)、在非特定 IRB 下进行研究(13.9%;n=9)和在没有 IRB 批准的情况下进行研究(6.1%;n=4)。更长的机构 IRB 批准时间与 IRB 不遵守显著相关(p<0.05)。第一年的研究员更有可能使用非特定的 IRB(p=0.04)或在不修改 IRB 的情况下扩展问题(p=0.04)。当被问及研究中保护健康信息(PHI)的存储时,53%的人报告说存储不安全,17.1%(n=6)的人存储了超过 1000 名患者的 PHI。30 名受访者(45.5%)将作者身份分配给未达到 ICMJE 标准的人,12 名(18.5%)接受了未达到 ICMJE 标准的作者身份。不遵守的最常见原因是:繁琐的 IRB 流程(80.3%)、资深作者的压力(78.8%)、害怕别人先发表(74.2%)和缺乏适当研究实践的支持(71.2%)。

结论

研究员不遵守预期的研究实践是很高的,特别是在 PHI 的安全存储和适当的作者分配方面。耗时且繁琐的 IRB 程序、来自资深作者的感知压力以及缺乏研究支持是导致不遵守的原因。需要进一步支持和教育妇科肿瘤研究员,以帮助解决这些障碍。

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