Brandt E N
Public Health Rep. 1983 Mar-Apr;98(2):136-40.
The Public Health Service (PHS) has undertaken a major effort to develop improved policies and procedures for dealing with misconduct in its research programs. Included in the definition of "misconduct" are the violation of Federal laws, regulations, or policies governing research or research training conducted, funded, or regulated by the Department of Health and Human Services; breaches of professional ethics that raise serious questions about an investigator's or institution's scientific or fiscal integrity; and serious failures to comply with other terms or conditions of an award. Recent incidents of falsification or misrepresentation of data and failure to comply with requirements for protection of human and animal subjects of research represent only a fraction of all research projects. However, they are troubling evidence that the traditional safeguards of science are not sufficient to prevent and detect willful wrongdoing. Research agencies, awardee institutions, and individual investigators have a collective responsibility to prevent misconduct in public research programs. The agencies and institutions, in turn, must deal promptly and equitably with allegations or evidence of misconduct. Individual research institutions and their professional organizations have developed policy statements affirming their responsibility for the integrity of the research enterprise and proposing specific procedures for dealing with incidents of misconduct. The National Institutes of Health currently serves as lead agency for a parallel PHS effort that includes a statement of general policies and principles, to be augmented by specific procedures for awarding agencies, regulatory agencies, and PHS intramural programs, as well as procedures for information sharing and joint investigations.
公共卫生服务部(PHS)已做出重大努力,以制定更好的政策和程序来处理其研究项目中的不当行为。“不当行为”的定义包括违反联邦法律、法规或政策,这些法律、法规或政策涉及由卫生与公众服务部开展、资助或监管的研究或研究培训;违反职业道德,引发对研究者或机构的科学或财务诚信的严重质疑;以及严重不遵守拨款的其他条款或条件。近期数据造假或虚假陈述以及未能遵守保护研究中的人类和动物受试者要求的事件,只是所有研究项目中的一小部分。然而,这些事件令人不安地证明,传统的科学保障措施不足以预防和发现故意的不当行为。研究机构、受奖机构和个体研究者对防止公共研究项目中的不当行为负有共同责任。反过来,这些机构必须迅速、公正地处理不当行为的指控或证据。各个研究机构及其专业组织已制定政策声明,确认他们对研究事业诚信的责任,并提出处理不当行为事件的具体程序。美国国立卫生研究院目前是公共卫生服务部一项平行工作的牵头机构,该工作包括一份一般政策和原则声明,并将由拨款机构、监管机构和公共卫生服务部内部项目的具体程序,以及信息共享和联合调查程序加以补充。