Table 1.
Definitions of key terms | • Absence of formal definitions of quality, effectiveness, and efficiency • Informal definitions of quality as compliance, effectiveness as researcher satisfaction, and efficiency as turnaround time • Mixed views about value of more standardized definitions |
Reported assessment efforts | • Turnaround time (with acknowledgment of different ways to measure, concern not to make speed a goal unto itself ) • Compliance, audits • Feedback from/about IRB members • Researcher satisfaction (through passive and active channels) • Infrequently assessed: research subject perspectives |
Learning from data and feedback | • Data collection regarding HRPP performance is purpose-driven, with goal of identifying areas in need of improvement and implementing changes • Improvements most often relate to efficiency, researcher satisfaction, and compliance (including changing requirements to avoid “administrative” or non-substantive noncompliance) |
Education to promote quality | • Educating investigators about HRPP standards and requirements • Educating communities and participants about research • Educating IRB members about role and rules |
Satisfaction with quality, assessments | • Generally satisfied with assessments and overall performance, although always room to improve • Challenged by inadequate resources, forcing reactive rather than proactive approaches to quality assessment and improvement |
Organizational structure for quality assessment | • Quality assessment may happen within HRPP or via separate office • Challenges of each model relate to expertise v. independence |