研究機関における看護研究倫理審査体制に関する調査報告

Survey Report on Nursing Research Ethics Review Systems in Research Institutes

要旨

　目的：臨床研究に関する倫理指針の施行に合わせ，看護学研究教育研究機関での研究倫理審査体制と現在抱えている課題について調査し，今後の研究推進のための倫理審査体制について検討した．

　方法：対象は研究教育機関の中から設置主体別に便宜的抽出を行い，回答者は当該施設の倫理審査体制の責任者とした．調査方法は一部構成型質問紙を含む半構成型面接法とし単純記述集計と質的帰納的データ分析を行った．

　結果：協力機関は6大学であり，単科大学は2大学であった．明らかになった実態は，看護学研究に特化した倫理審査委員会を設置していたのは2大学のみであった．他の4大学は全学の倫理審査終了後に看護学研究者による追加審査等を実施していた．また看護学研究の研究倫理の教授内容も時間数も改善と充実を図る必要性が出された．さらに研究倫理審査委員会の負担が多大だった．

　結論：看護学研究者による倫理審査体制の整備，研究倫理教育の充実を図る必要性が示唆された．

Abstract

　Objective: In accordance with the enforcement of the ethics guidelines for clinical research, the research ethics review systems and exiting problems in the nursing science research/education institutes were investigated, and the ethics review systems to promote future research were studied.

　Method: The survey subjects were taken from each type of research education institute using convenience sampling, and the respondents were the persons in charge of the ethical review systems at the institutes. The survey method was a semi-structured interview which consisted in part of constitutive questionnaires, and a simple descriptive summary with qualitative and inductive data analyses that were conducted.

　Result: The cooperating organizations were four universities and two colleges. The survey showed that one college and one university had an established ethical review board specializing in nursing science. The other four universities implemented follow-up reviews, etc. by nursing researchers after completing the university-wide ethics review. There was need for improvement and fulfillment in both the contents and hours of instruction of nursing research ethics. It was also learned that a tremendous burden had been imposed on the research ethics review committees.

　Conclusion: It was suggested that nursing science researchers are required to facilitate ethical review systems and to enhance research ethics education.