New Investigator onboarding programVoluntary Best Practice Offerings | Assessment of [email protected] Recruitment offering HRPP/IRB Metrics

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.

New Investigator Onboarding Program

In May 2019, the QA/QI program implemented a new onboarding offering for new faculty conducting human subjects research and their support staff.  These one-on-one, in-person (and remote via phone or Zoom) on-boarding sessions provide hands-on orientation to the HRPP’s/IRB’s website, forms, processes and policies. The goal is to facilitate a more efficient and timely IRB application review and approval process. We are assessing the combined impact of this offering and other internal procedures relative to the IRB application and review process in the first quarter of 2020. Currently we are providing a summary of research community feedback on the sessions themselves.

To date, a total of nine faculty or support staff have reached out to discuss or request an onboarding session. We have completed six sessions, two other sessions are pending, and one is scheduled.  Overall, these sessions have been very well-received.  We’ve surveyed attendees asking them “What was the most relevant and helpful parts of the session?”  Below is a sampling of responses:

“I found the session was very helpful. And I had several IRB-related questions that are specific to my research and they all were kindly answered.”

 “This session should be offered as part of the overall orientation for new faculty. Christiana was great!”

“Getting a better understanding of IRB processes at Brown.”

The onboarding sessions will continue to be offered to all new faculty and their support staff.  We encourage all departments, schools, centers and institutes to consider adding information about this new investigator onboarding program to new faculty onboarding materials and orientation sessions.

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. Available upon request  or contact Chris Provencal 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 upon request  or contact Chris Provencal at 3-5729.

Assessment of [email protected] Recruitment Offering

In February 2019, the HRPP announced the availability of using [email protected] for certain types of human subjects research recruitment. The Office of Research Integrity partnered with University Communications to provide this new resource to the research community, first piloting this offering for Full Board and Expedited submissions, and subsequently expanding it to include Exempt studies.  Solicitations through [email protected] for human subjects research recruitment are permitted for Brown University research faculty if the study is supported by sponsored funding and has Brown IRB/HRPP approval to use this recruitment procedure.

As of November 2019, sixteen protocols (14 PIs) had been approved by the IRB to advertise their studies in [email protected]. A brief survey was emailed to the fourteen PIs asking them to evaluate the effectiveness of this recruitment method.  As of 12/6/19 we received 12 survey responses (86%). 

84 percent of respondents indicated that there “Has...been a measurable impact on participant recruitment since using "[email protected]?"

Qualitative feedback received from the respondents was also very positive.  A few examples are noted:

“We have used [email protected] once and it has been a highly effective recruitment method thus far.”

“We've gotten a great number of responses compared to other recruitment methods!”

“We have had a strong response from potential participants after advertising our project on [email protected].”

This feedback helps to confirm that, to date, this appears to be a very effective recruitment method for studies which have been eligible to use it.  We will continue to monitor this recruitment procedure and perhaps consider expanding the criteria in the future, allowing more studies to take advantage of this recruitment method.

HRPP/IRB Metrics 

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.

Average Turnaround-Time (Submission to Approval) in Calendar Days: 2020 Fiscal Year to Date

 

July 2019

August 2019

September 2019

October 2019

November 2019

December 2019

January 2020

All Full Board Reviews (Initial Submissions & Amendments)

48

43

15

24

18

N/A

N/A

All Expedited Reviews (Initial Submissions & Amendments)

55

56

54

43

56

24

41*

Exempt Reviews

74

60

38

32

65

17

48*

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

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

Starting in November 2019, the QA/QI program will now publish 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 2018, prior to the changes to Exempt categories under the revised Common Rule. With the implementation of the revised Common Rule in January 2019, many submissions previously requiring Expedited review now meet Exempt review criteria. As such, the Brown HRPP saw a significant spike in Exempt submissions in calendar year 2019 (thereby accounting, in part, for slower turnaround times). The 2018 AAHRPP data will be replaced with the 2019 data, when published, to provide a better representation of the Brown HRPP's target turnaround times for all review types. 

 

Brown HRPP/IRB
November 2019

Brown HRPP/IRB

December 2019

Brown HRPP/IRB

January 2020

AAHRPP Benchmark Data (2018)

All Full Board Reviews (Initial Submissions & Amendments)

18 

N/A

N/A

44

All Expedited Reviews (Initial Submissions & Amendments)

27

14

41*

20

Exempt Reviews

67

8

59*

12

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