It is important for this type of work to receive the recognition that is

It is important for this type of work to receive the

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receive little or no recognition. It is important for this type of work to receive the recognition that is deserved. Therefore, we have named a QI team to develop proposed methods for faculty members who participate in QI activities to receive professional recognition. As part of our QI culture, we expect all departments and work groups to recognize patient safety and improve- ment issues, to initiate projects, and to continually learn about QI methods. Coordination Between QI and Research At M. D. Anderson, there are no clear and distinct boundaries between QI and research, and the federal definition of research is sometimes applied to QI projects. Organizational leaders and IRB chairs use an informal triage process to decide which projects should be considered QI and which should be considered research. Projects that are not likely to be submitted to the IRB include those that do not collect patient data and those that are of no risk to patients or personnel and that are obviously intended to improve a process. Examples of QI projects focus- ing on clinical practices at M. D. Anderson that have not been submitted to the IRB for review include the collection of data associated with observations of the environment, hand-hygiene practices, medical-record reviews for documentation requirements such as “do-not-use” abbre- viations, and timeliness of medical-record completion. These are practice behaviors that we must monitor and quantify by using the QI process to meet required standards. When a QI project is submitted to the IRB for review, the QI staff view the project as infiltrating the research paradigm and disrupting standard operations. At M. D. Anderson, the IRB assesses research protocols for safety and protection of research participant autonomy but also requires stringent scientific review and approval of the study design. Clinical trials must strictly define sample-size calculations and inclusion and exclusion criteria, classify objectives as primary and secondary, describe human-subject evaluation and methods for subject recruit- ment during a specified time, specify disease groups and treatment agents, state biosafety mech- anisms, develop a clear statistical design, and define resource and space requirements. For a full IRB review, there are multiple pre-reviews before the project reaches the IRB. All human- subjects treatment research protocols are presented to one of the clinical research committees; quality-of life, cancer-prevention, and population-based human-subjects studies are presented to the Psychosocial, Behavioral and Health Service Research Committee. Each protocol is reviewed for scientific merit by two scientific reviewers and, when needed, one reviewer from each applicable department among Nursing, Diagnostic Imaging, Biostatistics, and Pathology.

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