倫理審査を受けた看護学研究者の倫理審査委員会とその審査に対する思い

Thoughts of nursing researchers regarding research ethics committees and its reviews

　医学研究とは異なる特徴をもつ看護学研究の倫理審査については、審査を受ける側にも審査を行う側にも課題がある。本研究では、審査を受けた経験のある看護学研究者が倫理審査委員会とその審査に対して抱いている思いを明らかにすることを目的とする。「人を対象とする医学系研究に関する倫理指針」施行後に審査を受けた看護学研究者10名を対象に、半構成的インタビューを行い、質的帰納的に分析した。その結果、審査の便益の理解、審査の必要性への疑問、倫理審査委員会のあり方への不満、審査結果への不満、改善に向けた提言の5コアカテゴリが抽出された。分析結果は、委員会の委員構成など組織が取り組むべき課題のほか、審議の進め方など委員会や委員の課題、さらには審査を受ける研究者側の倫理審査に対する理解不足等の課題を示していた。倫理審査に携わる委員に対しても、研究者に対しても、研究倫理に関する研修の必要性が示唆された。

　Ethical review of nursing research, which has different characteristics from medical research, has challenges for both researchers and reviewers. The purpose of this study is to clarify the thoughts of nursing researchers who have undergone the review in their research ethics committees. The research participants were 10 nursing researchers whose researches were reviewed after enforcement of “Ethical Guidelines for Medical and Health Research Involving Human Subjects.” Semi-structured interviews were conducted, and the verbatim record was inductively analyzed. Five core-categories were derived from the data; appreciation for benefit of the review, doubt about necessity of review, disaffectedness to research ethics committees, and suggestion for improvement of research ethics committees and its review process. The results revealed not only challenges to be addressed by institutions such as composition of research ethics committee members, but also challenges to research ethics committees and committee members who review including how to proceed with the review, as well as challenges to researchers with lack of understanding on reviewing. These results suggest the necessity of training seminar to both reviewers and nursing researchers.