VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R019

4.1 QI/QA Activities Requiring IRB Review In some instances, QA/QI activities are designed to accomplish a research purpose, as well as the purpose of improving existing services and programs or for developing new services or programs. DHHS Regulations define research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalize knowledge.” (45 CFR 46.102(1) Common Rule). These activities require IRB approval when human subjects are involved. In such cases, federal human subjects regulations (45 CFR 46) apply, and IRB review and approval must be in place BEFORE project initiation. For example, activities where data are gathered for improvement of a program AND to generalize the results across institutions/hospitals/practices should be viewed as research. QA/QI activities with the express purpose of prospectively implementing a change in practice, which will later be evaluated through outcomes research, qualifies as research. Prospective collection of identifiable patient or subject‐ level data for future research is considered human subjects research, regardless of whether the institution that collects the data will de‐identify the data before analysis. Failing to accurately determine whether an activity is research versus QA/QI could potentially jeopardize: • the safety, welfare, and/or rights of participants • an investigator and/or the Institution's ability to conduct research • an investigator and/or the Institution’s ability to receive federal funding • publication of results The following characteristics make it more likely that a project involves both QA/QI and research and would fall under the jurisdiction of both the institution and IRB. • Randomization of patients into different intervention groups in order to enhance confidence in differences that might be obscured by nonrandom selection (but not to achieve equitable allocation of a scarce resource). • Testing issues that are beyond current science and experience, such as new treatments. • The involvement in key project roles of researchers who have no ongoing commitment to improvement of the local care situation. • Delayed or ineffective feedback of data, especially if feedback is delayed or altered in 4.2 QI/QA Activities Not Requiring IRB Review An IRB application is not required for QA/QI projects where the project does not meet the definition of research or where there is no research component. QI/QA activities meeting the following definitions do not require IRB review: • Research on Organizations - Information gathering about organizations, including information about operations, budgets, etc. from organizational spokespersons or data sources. Does not include identifiable private information about individual members, employees, or staff of the organization. • QA and QI Activities Related to Operational Procedures – Investigations done in the normal scope of clinical care in a hospital, clinic, or health care system. These are systematic, data-guided activities designed to implement potential improvements to clinical care workflows, patient safety, and health care operations. The activity is designed order to avoid biasing the interpretation of results. • Funding from an outside research organization.

VCOM Policy on Quality Assurance (QA) and Quality Improvement (QI)

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