Patel Tejal C, Tripathi Raakhi K, Bagle Tushar R, Rege Nirmala N
Department of Pharmacology, HBT Medical College and RN Cooper Hospital, Juhu, Mumbai, India.
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Parel, Mumbai, India.
Perspect Clin Res. 2021 Oct-Dec;12(4):216-222. doi: 10.4103/picr.PICR_148_19. Epub 2020 May 7.
MBBS students lack training in research ethics which is crucial when they enter clinical practice and venture into clinical research in future. This study was planned to implement an educational module to build concepts in research ethics.
To assess the change in the knowledge and attitude of medical students towards research ethics.
The study was initiated after obtaining institutional ethics committee approval. It was an interventional study, conducted on 2nd MBBS students (N=130) subjected to an educational program which comprised of three modules viz., theme lectures, educational visits and small group case based learning. A prevalidated questionnaire(35 items), was administered at baseline and at the end of 3 modules, to assess the change in the knowledge gained and in the attitude towards ethics in animal and human research. Feedback was obtained from students and faculty to assess the outcome of this program.
On analyzing the knowledge gained post intervention in 130 students, it was observed that in the post test for the items on ethics committee- need and composition, principles of research ethics was answered correctly by more number of students, which was statistically significant. The statistically significant positive change was observed for attitude of these students towards both animal and human research ethics. Case based discussions provided better understanding of ethical practices and its importance in conducting research as responded by majority students and faculty.
Educational program on research ethics enhanced learning and brought about the positive attitudinal change. Majority students' and faculty appreciated the program and considered it as relevant for undergraduate training.
医学学士（MBBS）学生缺乏研究伦理方面的培训，而这在他们未来进入临床实践并涉足临床研究时至关重要。本研究计划实施一个教育模块以构建研究伦理的概念。
评估医学生对研究伦理的知识和态度的变化。
在获得机构伦理委员会批准后启动该研究。这是一项干预性研究，对二年级医学学士学生（N = 130）进行，他们参加了一个由三个模块组成的教育项目，即主题讲座、教育参观和基于小组案例的学习。在基线时以及三个模块结束时，使用一份预先验证的问卷（35项）来评估在动物和人类研究中获得的知识以及对伦理态度的变化。从学生和教师那里获得反馈以评估该项目的结果。
分析130名学生干预后获得的知识时发现，在关于伦理委员会的必要性和组成、研究伦理原则的项目后测中，更多学生回答正确，具有统计学意义。观察到这些学生对动物和人类研究伦理的态度有统计学意义的积极变化。正如大多数学生和教师所回应的，基于案例的讨论能更好地理解伦理实践及其在开展研究中的重要性。
研究伦理教育项目促进了学习并带来了积极的态度转变。大多数学生和教师赞赏该项目，并认为它与本科培训相关。
