看護における研究倫理指針の歴史的展開―米国での形成と発展

Analyzing the Early Historical Development of Ethics Guidelines for Nursing Research in the United States

　人を対象とする医学系研究における被験者保護に向けた専門職規範の確立が世界的に進められてきた。看護界では，1968年に米国看護師協会（ANA）が世界で最初となる看護学研究に関する倫理指針を策定した。本研究は，ANAによる米国での看護学研究に関する倫理指針の形成・発展経緯と，その背後にある米国での研究規制を巡る社会政策的要因について歴史的分析を行なうものである。本研究の分析から以下のことが明らかとなった。①ANAの1968年指針は，1950～60年代にかけて米国社会を揺るがした臨床研究での被験者保護をめぐる諸事件を端緒とする，国立衛生研究所や公衆衛生局レベルでの大きな政策転換の影響を強く受けて策定された，②1975年指針では，タスキギー梅毒研究事件等の発覚と米国社会での公民権運動の流れの中で，特に人権保障に焦点が当てられた，③1995年のSilva指針は，全米委員会によるBelmont Reportで示された研究倫理の基本的枠組みを採用するとともに，1980年代に相次いで明るみに出た研究不正事件に対する連邦政府による研究規制の強化並びに学術界による自主規制の高まりを受けて，その基本的な研究倫理の骨格が形成された。

　To protect human research subjects involved in biomedical as well as social and behavioral research, great effort shave been made by various professional associations in the world for developing codes of ethics for research. Among such, American Nurses' Association (ANA) was the first professional association that formally adopted ethics guidelines for nursing research in 1968. This analysis traced the early historical developments of ANA's ethics guidelines as well as some of the early policy developments in the Unites States with regard to regulations on human subjects research that influenced ANA's guidelines. The findings were : 1) that ANA's first ethics guidelines were shaped by the major national policy-changes mainly at the National Institutes of Health and Public Health Service in response to the abuses of human research subjects as well as the abuses of laboratory animal sin 1950s through mid-1960s ; 2) that ANA's second ethics guidelines in 1975 focusedon the protection of human rights in research, following the tide for civil rights movement in American society at the time ; and 3) that ANA's third ethics guidelines in 1995 were characterized not only by its adoption of the ethical principles and framework for the protection of human research subjects presented by the Belmont Report, but also by its incorporation of ethics codes for scientific integrity induced by the successive scandals of scientific misconducts in the 1980s. This study illuminated the historical and political backdrops of how ethics frameworks for nursing research by ANA were developed in the United States.