Koschnitzke L, McCracken S C, Pranulis M F
Nursing Research Committee, Veterans Administration (VA) Medical Center, Salt Lake City, UT.
West J Nurs Res. 1992 Jun;14(3):392-6. doi: 10.1177/019394599201400311.
There is increasing evidence to support the contention that the boundaries between QA and scientific clinical research are blurred. This blurring is of particular concern in relation to the protection of human subjects rights (Brett & Grodin, 1991). The article thus concludes that it is essential that proposals for QA programs undergo periodic appraisal by an institutionally responsible, disinterested review panel. It further concludes that it is essential to submit proposals for all prospective QA projects, potentially scientifically meritorious QA projects, and all scientific clinical research projects to an institutional review board (IRB) to render decisions about the protection of human subject's rights before accessing data. Doing so protects the subject's rights, protects the investigator from unwittingly rendering harm rather than good, and enhances the ethical credibility of the projects. It also protects the investigator from embarrassing and potentially litigious situations. It is also incumbent on IRBs to develop efficient, effective, and expeditious review processes that encourage rather than discourage the a priori review process.
越来越多的证据支持这样一种观点，即质量保证（QA）与科学临床研究之间的界限正在变得模糊。这种模糊性在保护人类受试者权利方面尤其令人担忧（布雷特和格罗丁，1991年）。因此，本文得出结论，质量保证计划的提案必须由一个具有机构责任、公正无私的审查小组进行定期评估。它还得出结论，对于所有前瞻性质量保证项目、可能具有科学价值的质量保证项目以及所有科学临床研究项目的提案，在获取数据之前，必须提交给机构审查委员会（IRB），以便就保护人类受试者的权利做出决定。这样做既能保护受试者的权利，使研究者避免无意中造成伤害而非益处，又能提高项目的伦理可信度。它还能使研究者避免陷入尴尬且可能引发诉讼的局面。机构审查委员会也有责任制定高效、有效且迅速的审查程序，鼓励而非阻碍事先审查程序。
