Ethical considerations for quality assurance versus scientific research.

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.