Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.
Department of Neurosurgery, Hyogo college of Medicine, Nishinomiya, Japan.
BMJ Open. 2021 Oct 21;11(10):e052351. doi: 10.1136/bmjopen-2021-052351.
To explore the awareness and practice of clinical research integrity among Japanese physicians.
A nationwide cross-sectional study conducted in March 2020.
All hospitals in Japan.
Physicians aged <65 years who work at hospitals participated in clinical research over the past 5 years. The sample was stratified according to geographical location and subspecialty, and 1100 physicians were proportionally selected.
Knowledge and awareness of research integrity.
Among the 1100 participants, 587 (53%) had the experience of being the first author, 299 (27%) had been co-authors only and 214 (19%) had no authorship. A total of 1021 (93%) had experienced learning research integrity, and 555 (54%) became aware of research integrity. The experience of learning about research integrity was highest among those with first authorship (95%) and lowest among those without authorship (89%) (p=0.003). The majority of participants learnt about research integrity for passive reasons such as it being 'required by the institution' (57%) or it being 'required to obtain approval of institutional review board (IRB)' (30%). Potentially inappropriate research behaviours were observed in participants, with 11% indulging in copying and pasting for writing the paper, 11% for gifted authorship and 5.8% for the omission of IRB approval. Factors significantly associated with copying and pasting were being below 40 years old (OR: 1.84; 95% CI: 1.05 to 3.26), being the first presenter (OR: 1.64; 95% CI: 1.05 to 2.57) or having passive reasons for learning research integrity (OR: 2.96; 95% CI: 1.57 to 5.59). Furthermore, gifted authorship was significantly associated with being a co-author only (OR: 1.84; 95% CI: 1.18 to 2.87) and having passive reasons for learning about research integrity (OR: 1.79; 95% CI: 1.03 to 3.12).
Most physicians conducting clinical research have learnt about research integrity, but potentially inappropriate research behaviours are associated with passive reasons for learning.
探究日本医师对临床研究诚信的认知和实践情况。
2020 年 3 月进行的全国性横断面研究。
日本所有医院。
年龄<65 岁、在过去 5 年内参与过临床研究的医院医师。根据地理位置和亚专科对样本进行分层，按比例选择 1100 名医师。
研究诚信的知识和意识。
在 1100 名参与者中，587 名（53%）有第一作者的经历，299 名（27%）仅为合著者，214 名（19%）无作者身份。共有 1021 名（93%）曾有学习研究诚信的经历，555 名（54%）意识到研究诚信的重要性。有第一作者经历的人学习研究诚信的比例最高（95%），无作者身份的人最低（89%）（p=0.003）。大多数参与者学习研究诚信是出于被动原因，如“机构要求”（57%）或“获得机构审查委员会（IRB）批准”（30%）。参与者中存在潜在的不适当研究行为，11%的人存在复制粘贴写论文的行为，11%的人存在馈赠署名的行为，5.8%的人存在省略 IRB 批准的行为。与复制粘贴显著相关的因素包括年龄<40 岁（OR：1.84；95%CI：1.05 至 3.26）、作为第一报告人（OR：1.64；95%CI：1.05 至 2.57）或出于学习研究诚信的被动原因（OR：2.96；95%CI：1.57 至 5.59）。此外，馈赠署名与仅为合著者（OR：1.84；95%CI：1.18 至 2.87）和出于学习研究诚信的被动原因显著相关（OR：1.79；95%CI：1.03 至 3.12）。
大多数进行临床研究的医师都了解研究诚信，但潜在的不适当研究行为与学习的被动原因有关。
