48 - Understanding Our QA/QI Programs: Research Compliance Network Metrics Survey Results

Background: Unlike the IRBs, QA/QI criteria are not outlined in the regulations and QA/QI functions vary between organizations. To better define the characteristics, scope, and time trends of these functions, a national consortium representing more than 100 institutions conducted surveys in 2019 and 2022. This poster will highlight some findings.

Methods: An online survey was distributed to all members of the consortium via the Qualtrics platform. The survey included 74 closed-ended questions organized in five sections including: organizational characteristics, QA/QI program scope, policy and procedures, single IRB issues, and resources.

Ten business days were provided to complete the survey with two reminders. The survey was anonymous, and members were instructed to submit one response per organization.

Minor modifications were made to the survey in 2022 to evaluate the impact of the pandemic on QA/QI work arrangements and workload. However, the core questions were similar in order to identify time trends. Descriptive statistics were conducted on data collected from both surveys. Qualitative data will be presented graphically and in tables.

Results: Forty-five organizations responded to 2022 survey. Over half were academic medical centers or universities and 78% were AAHRPP-accredited (a 17% increase since 2019). Organizations conducted both biomedical and SBER and ranged in size. Half indicated having < 4000 active protocols.

Most respondents (84%) had a QA/QI Program/function which was well-established, i.e., 5+ years implementation. Programs were independent of the IRB (62%) with most housed within the HRPP or compliance unit. Most QA/QI Programs operated in hybrid fashion (68%).

QA/QI Programs offered varying activities though auditing remained a hallmark. Roughly half did not conduct audits of external IRB studies, i.e., studies in which the organization serves as a participating site (57%); however, even less reported auditing participating sites when serving as a single IRB (38% as compared to 30% reported in 2019). Related, there was a 37% increase of remote audits of external sites since the 2019 survey.

Limitations: QA/QI Programs are not well defined. As a result, the survey relied upon AAHRPP elements I.5.A and I.5.B to inform this threshold. Doing so may inadvertently conflate AAHRPP accreditation status and unnecessarily narrow the scope of organizations having a QA/QI Program or function.

Additionally, the survey was conducted anonymously; therefore, the 2022 survey may not draw from the exact sample of organizational respondents solicited in 2019.

Discussion: QA/QI Programs continue to evolve. The results of these surveys help us understand their current landscape, including organizational characteristics such as demographics and program structure; scope of work, including the range of activities and initiatives; policies and procedures; how Programs adapt to changes in regulations and policy, namely the NIH single IRB policy, and resources such as staffing and training. Still further, there is a need to collect more data in order to identify trends over time and propose best practices.