Human Subject Research or Quality Improvement Project?
نویسندگان
چکیده
منابع مشابه
Quality improvement or research? The ethics of hospital project oversight.
D etermining appropriate hospital project oversight is a struggle commonly encountered by healthcare providers who perform quality improvement (QI) projects and hope to publish their findings. A typical question that comes up is this: “Were ethical standards upheld in the project reported in the submitted manuscript?” The essence of this question may instead be, What degree of oversight should ...
متن کاملPerformance Improvement/Research Advisory Panel: a model for determining whether a project is a performance or quality improvement activity or research.
The determination of whether an activity is performance improvement governed by The Joint Commission standards and local hospital policy or research governed by federal regulation and requiring institutional review board (IRB) review and approval can be complex, especially in academic clinical organizations. Both processes can address scientific validity, fair participant selection, favorable r...
متن کاملRandomized n-of-1 Trials: Quality Improvement, Research, or Both?
The regulatory demarcations between clinical research and quality improvement (QI) are ambiguous and controversial. Some projects that were undertaken as a form of QI were deemed by regulatory agencies to be research and thus to require institutional review board approval. In the era of personalized medicine, some physicians may ask some patients to participate in n-of-1 trials in an effort to ...
متن کاملOrganising a manuscript reporting quality improvement or patient safety research.
BACKGROUND Peer-reviewed publication plays important roles in disseminating research findings, developing generalisable knowledge and garnering recognition for authors and institutions. Nonetheless, many bemoan the whole manuscript writing process, intimidated by the arbitrary and somewhat opaque conventions. METHODS This paper offers practical advice about organising and writing a manuscript...
متن کاملResearch monitoring by US medical institutions to protect human subjects: compliance or quality improvement?
In recent years, to protect the rights and welfare of human subjects, institutions in the USA have begun to set up programmes to monitor ongoing medical research. These programmes provide routine, onsite oversight, and thus go beyond existing oversight such as investigating suspected misconduct or reviewing paperwork provided by investigators. However, because of a lack of guidelines and eviden...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Ear, Nose & Throat Journal
سال: 2020
ISSN: 0145-5613,1942-7522
DOI: 10.1177/0145561319827724