National trends in regulatory oversight and focus. For example, national communications from the federal human subjects regulatory agencies may make it clear that they are currently focusing on issues related to children in research. New information about specific risks. For example, highly publicized complaints by individuals about the use of their research samples for genetic analyses in unrelated studies across the country might suggest that the QA program examine the information provided to subjects in consent forms for UW genetics research. Prioritization and selection. The regulatory affairs team meets periodically to collate and discuss possible QA activities. About once per quarter, the team develops a slate of recommendations about QA needs, priorities, scope of specific QA activities, and resource needs. Prioritization criteria include (but are not limited to): External requirements Risk of serious non-compliance Risk of harm to subjects Institutional risk The extent of a possible problem across HSD or the IRBs About once per quarter, the recommendations are presented to the management team for discussion. The recommendations are generally accepted except when: There are resource constraints. The HSD Director has identified an urgent need that requires a higher priority. The quarterly QA plan can be revised in response to urgent issues. The QA plan may or may not change from one quarter to next, depending upon size and length of specific projects and other demands on the regulatory affairs team. Methods of assessment and monitoring. The regulatory affairs team draws upon a variety of methods for assessment and monitoring. These include (but are not limited to): Reports and data from the HSD database and Zipline, the electronic submission system Examination of IRB study files and other IRB documents (e.g., meeting minutes) Examination of HSD files and documents Interviews with HSD staff or IRB members Observation of IRB meetings Who conducts assessment and monitoring? The regulatory affairs team does much of the assessment and monitoring but may draw upon other HSD staff (and from outside of HSD), as needed and appropriate for the scope, size, and subject matter of projects.
National trends in regulatory oversight and focus. For example, national communications from the federal human subjects regulatory agencies may make it clear that they are currently focusing on issues related to children in research. New information about specific risks. For example, highly publicized complaints by individuals about the use of their research samples for genetic analyses in unrelated studies across the country might suggest that the QA program examine the information provided to subjects in consent forms for UW genetics research. Prioritization and selection. The regulatory affairs team meets periodically to collate and discuss possible QA activities. About once per quarter, the team develops a slate of recommendations about QA needs, priorities, scope of specific QA activities, and resource needs. Prioritization criteria include (but are not limited to): External requirements Risk of serious non-compliance Risk of harm to subjects Institutional risk The extent of a possible problem across HSD or the IRBs About once per quarter, the recommendations are presented to the management team for discussion. The recommendations are generally accepted except when: There are resource constraints. The HSD Director has identified an urgent need that requires a higher priority. The quarterly QA plan can be revised in response to urgent issues. The QA plan may or may not change from one quarter to next, depending upon size and length of specific projects and other demands on the regulatory affairs team. Methods of assessment and monitoring. The regulatory affairs team draws upon a variety of methods for assessment and monitoring. These include (but are not limited to): Reports and data from the HSD database and Zipline, the electronic submission system Examination of IRB study files and other IRB documents (e.g., meeting minutes) Examination of HSD files and documents Interviews with HSD staff or IRB members Observation of IRB meetings Who conducts assessment and monitoring? The regulatory affairs team does much of the assessment and monitoring but may draw upon other HSD staff (and from outside of HSD), as needed and appropriate for the scope, size, and subject matter of projects.
SOP-Quality-Assurance-Program.docx