Knowledge development, quality improvement, and research ethics.

Significant contributions to the improvement of health care have been made through research and quality improvement activities. Scientists are involved in knowledge generation and new forms of evidence as they test or reshape theory. Clinicians more typically are involved in identifying ways to improve the quality of practice and patient care in their practice environments. These types of activities often are referred to as quality improvement projects. While quality improvement and research projects both rely on powerful and precise measurement, the lines between these domains and how they may relate to each other have been blurred (Grady, 2007). Recent insights have helped to clarify the contributions of quality improvement activities as well as some of the challenges those types of projects may face from an ethical perspective. Keywords: quality improvement; research ethics; clinical practice improvements A definition and framework for quality improvement projects help to increase understanding on how quality improvement activities relate to the improvement of practice, generative research, knowledge testing, and, potentially, theory development. Quality improvement is defined as the "combined and unceasing efforts of everyone (providers, patients and families, researchers, and educators) to make the changes that will lead to better patient outcomes (health), better system performance (care), and better professional development (learning)" (Batalden & Davidoff, 2007, p. 2). Quality improvement projects aim to improve health care outcomes and quality through local innovations in and assessment of the processes and systems of care delivery. A framework has been provided to identify different knowledge systems involved in improvement activities, ranging from the generation of scientific evidence that can be generalized to examining how the particular context of a local practice environment affects the application of new scientific evidence in practice. In scientific research, effort is directed at controlling context as a variable to minimize or eliminate its effect on what is being studied. But it is also known that having better knowledge is not a guarantee that it will be adopted or will actually improve practice in all settings. One contribution of the quality improvement movement is that it examines how context, or a local practice environment, shapes or influences the implementation of knowledge locally and, through the examination of variation in that local practice, helps to identify where and how practice might be improved. In addition, the variation that is often found in practice can lead to the development of new hypotheses or the need for additional research. Quality improvement and research are related processes whereby newly developed knowledge and local practice are examined and evaluated. While the ultimate focus in quality improvement is the development of better patient outcomes and provider practices in a local setting, these can also inform the need for development of new knowledge and testing of that knowledge across multiple settings. In this perspective, each process or activity can inform the other. As the importance and role of quality improvement projects are better understood, it also raises issues related to research ethics. In the research world of scientists, regardless of discipline, the requirements for ethical conduct of research and the involvement of humans as research participants are widely understood. …