Box 6.2
Quality Assurance Versus Quality Improvement

QA and QI are complementary, yet distinct strategies. QA asks the question, “Did we do the things that should be done?” and redresses problems as they are identified. QI asks the question, “What causes us not to do the things that should be done?” and seeks to modify the cause.

An illustration of QA and QI in participant protection might be found in continuing review of protocols. For example, a QA self-assessment might show that the Research ERB is late in completing continuing reviews on 20 percent of studies that, under regulation, should have ceased enrolling patients once the approval period expired. Having identified these errors, it would be necessary for the Research ERB to notify the investigators of this and to take steps to bring the institution and the studies into compliance. In contrast, a QI approach would be to prevent this from occurring.

QI would collect data about the processes used by the Research ERB and analyze more frequent and less frequent causes of the failure to learn why these deadlines were missed. Hypothetically, the QI study might determine that there is no system to trigger reminders, that the investigators fail to respond to notices, or that the Research ERB sometimes loses its quorum and cannot complete scheduled reviews. The most frequent causes would be subject to a review and refinement of the Research ERB’s work processes to prevent future occurrences—e.g., education of investigators or a longer lead-time in a reminder system. Subsequently, a QI study would remeasure the same variables to see if improvement occurred and to identify remaining causes of failure.

This illustration is a simple one, involving a process measure used in research reviews, but, of course, QI studies should also be undertaken to posit and measure participant protection outcomes.

for noncompliance.3 Unlike OHRP, ORCA does not have regulatory authority, and thus is currently better able to emphasize proactive, culture-building efforts within its oversight activities (as this committee has encour-


The information provided to OHRP in these documents can be requested under the Freedom of Information Act, but there is an exemption that allows an institution not to release any information that could potentially reveal noncompliance. Regarding communication with the compliance office of OHRP, the Division of Assurances and Quality Improvement “will not ordinarily communicate its observations during the QI activity to the OHRP Division of Compliance Oversight. In the unlikely event that serious systemic noncompliance or a serious problem(s) that had resulted in or may pose a threat to the safety and well-being of research subjects is discovered during a QI consultation, institutional officials will be appropriately notified and will be expected to take immediate action to remedy the situation, including filing an appropriate corrective action plan with OHRP. In such a case, OHRP will work intensively with the institution to develop and implement a corrective action plan in a timely and collegial manner” (OHRP, 2002b).

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