Mistakes in planning a dissertation research by graduate students of clinical departments

Abstract

The postgraduate specialist training program contains a scientific component (own research, preparation of publications based on the results, certification based on its findings). Its success depends on how the work is planned from a scientific, legal and ethical positions. The ethics committee of a scientific organization that trains a specialist in postgraduate studies is obliged to conduct an ethical review of scientific projects and guarantee the public that the author's research complies with ethical standards and does not violate the law. The purpose of this work is to analyze the quality of packages of documents for planned studies submitted by postgraduate students of Kazan State Medical University to the ethics committee of the university in 2019–2022. 260 works were analyzed, of which 70 had no comments, 138 had errors that were eliminated without changing the design of the study, 52 required significant revision, 5 researchers applied after the completion of the study, 1 project was not approved. The work done revealed defects in the planning of research work, the analysis of which was carried out. The main comments concerned the substantiation of the number of study participants, the formation of comparison groups, the writing of the protocol and the patient's informed consent sheet for participation in the study, knowledge of the legislation of the Russian Federation. The author analyzes in detail the situations when and from whom consent to medical intervention should be obtained, based on current international and ethical documents. According to the shortcomings identified, recommendations are presented that, in the author's opinion, will be useful both for researchers and their leaders, and will serve to improve the quality of the planned work.

Keywords

dissertation / clinical research / evidence-based medicine / ethical and legal regulation / expertise

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