Compliance with regulatory and ethical requirements for theses by students of general medicine

被引:0
作者
Medeiros, Sophie [1 ]
Mestre, Capucine [1 ]
Rousselot, Nicolas [1 ]
Magot, Laurent [1 ]
机构
[1] Univ Bordeaux, Dept Gen Med, 146 rue Leo Saignat, F-33076 Bordeaux, France
来源
EXERCER-LA REVUE FRANCOPHONE DE MEDECINE GENERALE | 2024年 / 205期
关键词
dissertations or academic; general practice; ethics committees; personally identifiable information; protection committee; research;
D O I
暂无
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background. General medicine theses contribute to research. Their dissemination implies compliance with regulatory and ethical requirements with complex texts. They have been recently modified by the Jard & eacute; (2016) and "informatique et libertes" (2019) laws. Before these legislative changes, only 23.4% of general medicine theses at Bordeaux University complied with these obligations. Aim: Determining proportion of general medicine theses defended during the year 2021 at Bordeaux University respecting regulatory and ethical obligations required. Method. Cross-sectional descriptive study. Collection of characteristics about thesis, investigators and regulatory procedures carried out by survey and by reading the thesis. Independent determination in triple reading of theses, with the help of tools created by Rennes and Strasbourg University, of procedure required (CPP, CNIL and ethics committee) versus taken. Results. 161 of the 167 theses defended in 2021 was analyzed (96.4%). 37 of the 58 theses requiring a procedure to the CNIL did so and 33 that didn't require it had done wrongly. 8 of the 11 theses requiring opinion of a CPP had requested it and 15 opinions that were unnecessary had been taken. The ethics committee's opinion was recommended for 19 theses but only requested 4 times. 42.2% of theses were compliant for all the procedure. The fact that a job does not require a process is the main factor associated with this compliance of the work with regulatory and ethical requirements. Conclusion. The quasi-exhaustive analysis of the theses from one academic year and the limitation of biases of interpretation related to the poorly defined limits of certain regulatory texts by a triple analysis of the works reinforce the validity of our study. The rate of compliance of theses with legislation is increasing but insufficient. The department of general medicine could carry out an early identification of the regulatory procedures necessary and support investigators.
引用
收藏
页码:329 / 334
页数:6
相关论文
共 13 条
  • [1] Comite consultatif national d'ethique, 2024, Population vulnerable
  • [2] Commission nationale de l'informatique et des libertes, 2024, Donnee sensible
  • [3] Commission nationale de l'informatique et des libertes, 2019, Entree en vigueur de la nouvelle loi informatique et libertes et de son nouveau decret d'application
  • [4] De Pouvourville G, 2006, Rapport au ministre de la Sante
  • [5] Frappe P, 2011, Initiation a la recherche
  • [6] Hugonneng M., 2018, These de medecine
  • [7] Jouannin A, 2018, exercer, V150, P68
  • [8] Jouannin A, 2019, exercer, V155, P306
  • [9] Le Portz C, 2016, These de medecine
  • [10] Rat C, 2017, exercer, V135, P327