看護学研究における倫理的環境整備に向けた実態調査（第1報）—看護系大学における研究倫理審査の現状

A Survey of Ethics Review Boards in Nursing Research Part 1: The State of Ethics Review in Nursing Programs at Universities

要旨

　目的：看護系大学における研究倫理審査の現状を明らかにし，看護学研究における研究倫理審査体制の在り方を検討する．

　方法：全国の看護系大学で看護学研究倫理審査に精通している専任教員を対象に，郵送による無記名自記式質問紙調査を行った．

　結果：回答があった看護系大学89校（回収率44.5％）のうち，倫理審査委員会が設置されている87校を分析対象とした．看護単科大学と看護学部・学科のみの運営形態では委員の人数が少なく看護学専門家の割合が高かった．倫理審査に関する規程は，ほとんどの大学が整備・公表していた．委員会の予算があるのは46校（52.9％），研究実施過程のチェックシステムがあるのは28校（32.2％），新委員に対する研修があるのは11校（12.6％）であった．迅速審査の制度があるのは50校（57.5％）であった．

　結論：看護学に特化した視点と学際的・多元的な視点を併せ持つ委員構成の実現，迅速審査の適正な導入と予算確保による委員の負担軽減，研究実施過程のモニタリング，倫理的資質の向上，等の課題が明示された．

　Purpose: To clarify the current state of ethics review in nursing programs at universities and discuss the ideal state of ethics review for nursing research.

　Methods: Self-administered questionnaires were distributed by postal mail to full-time faculty members at schools of nursing in all regions of Japan. The faculty members selected were those who had thorough knowledge of ethics review in nursing research.

　Results: Out of 89 faculty members of schools of nursing that responded to the questionnaires (44.5% response rate), two faculty members indicated that their school did not have an ethics review board; therefore, data on 87 schools were analyzed. Ethics review boards that were managed by a nursing college, school of nursing, or department of nursing all had a small number of committee members, many of whom were qualified with a nursing specialty. Most of the schools had an official ethics code. Forty-six schools (52.9%) had a budget for an ethics committee, 28 schools (32.2%) had a review system that continues even after a study has started, and 11 schools (12.6%) provided new committee members with a training course. Expedited reviews were performed at 50 schools (57.5%).

　Conclusions: The present findings demonstrate the importance of the following considerations in ethics review in nursing research: organizing an interdisciplinary ethics committee with a pluralistic perspective; introducing an appropriate expedited review system and allocating a budget to reduce the burden on members; monitoring the progress of applicants' research; and improving each member's ethics qualifications.