How Do Accredited Organizations Evaluate the Quality and Effectiveness of Their Human Research Protection Programs?

Area of Science:

• Human research protection
• Institutional Review Boards
• Accreditation standards

Background:

• Evaluating the quality, effectiveness, and efficiency (QEE) of Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) is a recognized challenge.
• The Association for the Accreditation of Human Research Protection Programs (AAHRPP) requires accredited organizations to demonstrate HRPP QEE measurement and improvement.

Purpose of the Study:

• To understand how AAHRPP-accredited organizations interpret and meet the HRPP QEE standard.
• To identify strengths, weaknesses, and gaps in current HRPP QEE assessment approaches.
• To inform recommendations for improving HRPP quality evaluation.

Main Methods:

• Conducted 3 small-group interviews with 19 representatives from AAHRPP-accredited organizations.
• Participants were familiar with their organization's methods for satisfying the HRPP QEE standard.
• Interviews were conducted at the 2019 AAHRPP annual meeting.

Main Results:

• Participants lacked clear definitions for HRPP quality and effectiveness.
• Current QEE assessments often focus on turnaround time, compliance, and researcher satisfaction, with superficial evaluation of IRB members.
• Information on research subject experience was not central to QEE assessment, though efforts exist to incorporate patient, subject, and community perspectives.
• Stakeholder education and relationship-building were identified as key to high-quality HRPPs.
• Organizations expressed concerns about resource and time constraints leading to reactive rather than proactive QEE assessment.

Conclusions:

• The AAHRPP accreditation standard may obscure critical gaps in defining and measuring HRPP QEE.
• Recommendations for AAHRPP include providing a definition of QEE or requiring organizations to define it.
• A further recommendation is to require accredited organizations to establish QEE objectives and measures focused on participant outcomes and the deliberative quality of protocol review.