QA/QI ActivitiesHRPP/IRB Metrics | Voluntary Best Practice Offerings | Assessment of CY2019 Activities

Quality Assurance / Quality Improvement Program

Brown’s Quality Assurance / Quality Improvement Program (QA/QI Program) is housed within the Office of Research Integrity and reports to the Senior Director of the Office of Research Integrity.  The goal of this program is to promote a culture of integrity and excellence at Brown related to human subjects research, and to provide exceptional support and services to our research community in the form of education and outreach.

The QA/QI Program objectives are two-fold:

  1. To support institutional regulatory compliance; and

  2. To educate and assist the Brown research community in the conduct of compliant research to promote research excellence and reduce administrative burden

Associated with these overarching objectives, the QA/QI Administrator will facilitate the conduct of research at Brown by serving as a resource to researchers and the IRB.  

QA/QI Activities

  • Provide new faculty and their study teams with one-on-one, in-person (or via phone / Zoom) on-boarding sessions to orient them to the Brown HRPP’s/IRB’s website, forms, processes and policies. This resource is geared toward new investigators joining the Brown community and can be conducted before a new faculty member is physically at Brown.

  • Conduct random, on-site reviews to assess regulatory compliance and human subject safety for approved studies and to ensure research teams are maintaining compliance.

  • Provide investigators with quality improvement recommendations to ensure that research is conducted in accordance with best practices.

  • Conduct directed (for-cause) audits at the request of the IRB or authorized Institutional Official. Directed audits focus on areas of concern that have been identified or reported. Recommend actions to the IRB based on on-site observations.

  • Investigate allegations and findings of non-compliance. Report potential serious or continuing non-compliance to the IRB and Institutional Official and propose corrective actions.

  • Provide general guidance or study-specific services at study start-up or throughout the lifetime of a project.  These services can include On-site Reviews, Study Consultations, In-services, External Audit Preparation, and Study Management Tools.

  • Assess the performance of HRPP operations via metrics and use these data to design and implement targeted and broad-based quality improvement activities.

  • Assess the performance of the IRB and its membership.

HRPP/IRB Metrics 

Median Turnaround Times | Number of Active Protocols

The QA/QI program tracks and publishes metrics as an important element of monitoring IRB and HRPP performance and assessing the impact of quality improvement activities. The initiative to create transparency and to engage the Brown research community in quality assurance and quality improvement activities aimed at increasing efficiency, facilitating compliance, and maintaining excellence in human subjects research, kicked off in earnest starting in fiscal year 2020. This portion of our website and our program will expand throughout the fiscal year and in the years to come.

The QA/QI program will work collaboratively with the Brown Human Research Advisory Group (BhRAG) to identify targeted and broad-based quality improvement activities in furtherance of the aforementioned aims. Each activity will be announced on this page, with a pilot program description, implementation date, and time-period for evaluation. Evaluation of effectiveness and progress toward achieving stated goals will rely on internal quantitative data, as well as qualitative data gathered from the HRPP and the research community.

Median Turnaround-Time (Submission to Approval) in Calendar Days: Beginning November 2019

Starting in November 2019, the QA/QI program began publishing monthly median turnaround-time data, benchmarked against Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) median data for academic institutions. The AAHRPP data represent the Brown HRPP's target turnaround times for each review type. Currently AAHRPP's published data reflect calendar year 2019.

TABLE: MEDIAN TURNAROUND TIMES


Nov '19

 

Dec '19

 

Jan '20

 

Feb '20

 

Mar '20

 

Apr '20

 

May '20

 

Jun '20

 

Jul '20

 

Aug '20

 

Sept '20

 

AAHRPP Benchmark Data (2019)

All Full Board Reviews (Initial Submissions & Amendments)

18 

N/A

N/A

28

N/A

35

48

46

29

21

46

44.25

All Expedited Reviews (Initial Submissions & Amendments)

27

14

41*

14

6

28

25

32

24

24

28

21

Exempt Reviews

67

8

59*

22

9

9

60

49

57

26

16

13

*includes 12 days Brown University was closed for the holiday break.

Number of Active Protocols


Voluntary Best Practices Offerings

Best Practices 

This is a one hour session which focuses on providing guidance and recommendations related to IRB file organization and maintenance. Topics covered include best practices related to the maintenance of IRB approved study procedures and protocols, and consistency with Brown University policies and procedures concerning human research participants. Investigators and any research staff involved in field work, data collection and/or study record keeping may find this session particularly helpful. Best Practices sessions may be scheduled to take place at your research lab or you may choose to attend a pre-scheduled session located at South Street Landing. Contact Christiana Provencal by email or at 3-5729.

Best Practices Checklist

Investigators and study staff can confirm if they are incorporating best practices into their research projects by using this checklist. This is a good way to quickly, easily and independently confirm the use of basic best practices and consistency between IRB approved research procedures and actual research activities. This checklist can also serve to remind investigators of some of the important details related to human research participant protections as well as identify issues that need attention, helping to minimize the chance of an impact on study progress.

Voluntary, Best Practices Individualized Review:

Another helpful resource for investigators is a one-on-one Best Practices review. This is an in person review of study procedures and IRB documentation related to human research participants. It offers individualized assistance and guidance from HRPP staff. The completion of this review can help with streamlining IRB submissions which may reduce the time between submission and approval. Available [email protected]">mailto:[email protected]">upon request  or contact Chris Provencal at 3-5729.

Assessments of QA/QI Activities

Starting in calendar year 2019, the QA/QI program assesses the impact of certain measures implemented to improve the HRPP program and researcher support. Please click here for the www.brown.edu/research/sites/research/files/QAQI%20Assessment%20report%2...">https://www.brown.edu/research/sites/research/files/QAQI%20Assessment%20...">CY2019 Assessment Report, which looked at the effectiveness of two significant programmatic changes: creation of a new PI / research team onboarding program and creating a process for Brown researchers to use [email protected] for recruitment.