看護研究の倫理審査に関する考察：アメリカ合衆国の事例を踏まえて

Ethics Review of Nursing Research: Possible Implications from the USA Experience

要旨

目的：アメリカ合衆国の看護研究の特徴と研究倫理審査体制に関する情報より，わが国の看護研究の倫理審査体制のあり方を考察する．

方法：アメリカ合衆国の看護研究の特徴に関する文献検討と看護学部のある総合大学の研究者からの研究倫理審査体制に関する情報収集．

結果：①看護研究は，研究と質向上，根拠に基づく実践，プログラム評価に分類．②審査は，審査免除，迅速審査，通常審査の3種類．③通常審査はIRBで審査し，迅速審査は小規模な審査委員会で審査することや，審査の振り分けや研究者が相談できる人材の設置等，整備された研究倫理審査体制．④質向上，根拠に基づく実践，プログラム評価という看護研究の多くは，迅速審査の対象．

考察：看護研究の特徴を踏まえて，看護研究の方法，対象及び内容に応じて審査を分類し行うことの必要性とスムーズな審査のための組織的な審査体制の整備と人材育成の重要性が示唆された．

Objective: To determine the characteristics of nursing research considered by the IRBs and how to improve IRBs reviewing nursing research in Japan in comparison with IRBs in the USA with respect to types of reviews, the IRB reviewing systems.

Methods: We classified nursing research based on the research characteristics through a literature review, and obtained information about the types of reviews and review systems of IRBs from two universities with nursing departments in the USA.

Results: (1) Nursing research is classified into four types (research, quality improvement, evidence-based practice, and program evaluation). (2) Depending on the anticipated risks of research subjects, protocol reviews are classified as follows: exemption, expedited, and full board. (3) In the USA, research proposals are generally reviewed by a full IRB, but there is a sub-committee for expedited review. The reviewing system is very well-organized with sufficient staffing, which allows distribution of staff to various sections, including a consulting section for inquiries of researchers. (4) The objectives of nursing research are largely associated with improvement in nursing care, evaluation of programs, and evidence-based practice, and these types of research are categorized as exempted or expedited reviews.

Conclusion: There are significant needs for improvement in the IRB system in Japan regarding reviewing procedures, which should be modified depending on the methods of nursing research, subjects, and content. In addition, there is a need for staff development so staff can provide advice or consultation with researchers who want to apply to the IRB.