University of Michigan IRB Metrics

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1 University of Michigan IRB Metrics Table of Contents Approved Projects - All Campus IRBs 2 IRB Health Science & Behavioral Science (HSBS) 3-7 IRBMED 8-12 IRB Dearborn IRB Flint The U-M IRB Metrics reports show the size of the U-M human research protections program (HRPP) and measures IRB activity over recent fiscal years. This compilation contains the Approved Projects report for the U-M IRB offices, plus four (4) reports for each IRB office, including: Volume reports by Review Pathway: o Incoming Submissions (Quarterly) o New Submissions Approvals (Quarterly) o Approvals by Review Type (Quarterly) Turnaround Times by Review Type report (Quarterly) Metrics run: July 2017 Compiled: 07/03/2017

2 ApprovedSubmissionsbyIRB NumberofApprovedProjectsUndertheOversightoftheIRBsasof7/3/20179:12:43AM IRBMED 4,844 HealthSciences. 1,171 Dearborn 70 Flint 44 GrandTotal 6, Notes: UniqueCountofInitial/NewSubmissionsforeachIRB.ColorindicatestheIRB-Dearborn,Flint,IRBHSBSandIRBMED. ThedataisfilteredonProjectStatusoftheInitial/NewSubmission,including-Approved; ContingenciesPending; CoreCommiteeStafContingencyReview; DesignatedReviewerContingencyReview; ValidateCommiteeDecision; ValidateExpeditedDecision

3 IRBHSBSIncomingSubmissionVolume FY2016 1, FY2017 1,085 1, SubmissionType AE/ORIO Amendment InitialSubmission SCR IRBName IRBHSBS Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

4 IRB HSBS: FY 2017 Approvals by Review Type Note: The Number of Projects scale (left) changes for each graph. Full Committee Expedited Exempt Not Regulated

5 IRB HSBS: Turnaround Time by Review Type Full Committee Legend The Number of Submissions scale changes per graph The Median Turnaround Time scale is calendar days Q1 = July September Q2 = October December Q3 = January March Q4 = April June Average Full Committee FY17 = days FY 2016 = days FY 2015 = days FY 2014 = days FY 2013 = days Expedited Average Expedited FY17 = days FY 2016 = days FY 2015 = days FY 2014 = days FY 2013 = days Graphs show the trend of distinct counts of Projects and Median Days between the IRB receipt and IRB Initial approval for each IRB Approval Date Quarter. Non-null Date values only. Initial approval date includes last 8 quarters.

6 IRB HSBS: Turnaround Time by Review Type Exempt Average Exempt FY17 = 3.75 days FY 2016 = 3.00 days FY 2015 = 2.25 days FY 2014 = 2.00 days FY 2013 = 1.00 days Not Regulated Average Not Regulated FY 17 = 4.00 days FY 2016 = 3.25 days FY 2015 = 1.25 days FY 2014 = 1.25 days FY 2013 = 0.75 days Graphs show the trend of distinct counts of Projects and Median Days between the IRB receipt and IRB Initial approval for each IRB Approval Date Quarter. Non-null Date values only. Initial approval date includes last 8 quarters.

7 IRB HSBS: FY 2017 Approvals by Submission Type Note: The Number of Projects scale (left) changes for each graph Initial Amendment AE/ORIO SCR

8 , IRBMEDIncomingSubmissionVolume FY2016 3,818 3,639 3,524 3, FY2017 3,776 3, , SubmissionType AE/ORIO Amendment InitialSubmission SCR IRBName IRBMED NumberofProjects ,283 1, , , , , , , ,141 1,139 1,388 1,221 1,125 1,008 1,281 1,213 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

9 IRBMED: FY 2017 Approvals by Review Type Note: The Number of Projects scale (left) changes for each graph. Full Committee Expedited Exempt Not Regulated

10 IRBMED: Turnaround Time by Review Type Full Committee Legend The Number of Submissions scale changes per graph The Median Turnaround Time scale is calendar days Q1 = July September Q2 = October December Q3 = January March Q4 = April June Average Full Committee FY17 = days FY 2016 = days FY 2015 = days FY 2014 = days FY 2013 = days Expedited Average Expedited FY17 = days FY 2016 = days FY 2015 = days FY 2014 = days FY 2013 = days Graphs show the trend of distinct counts of Projects and Median Days between the IRB receipt and IRB Initial approval for each IRB Approval Date Quarter. Non-null Date values only. Initial approval date includes last 8 quarters.

11 IRBMED: Turnaround Time by Review Type Exempt Average Exempt FY17 = days FY 2016 = days FY 2015 = days FY 2014 = days FY 2013 = days Not Regulated Average Not Regulated FY 17 = days FY 2016 = days FY 2015 = days FY 2014 = days FY 2013 = 9.25 days Graphs show the trend of distinct counts of Projects and Median Days between the IRB receipt and IRB Initial approval for each IRB Approval Date Quarter. Non-null Date values only. Initial approval date includes last 8 quarters.

12 IRBMED: FY 2017 Approvals by Submission Type Note: The Number of Projects scale (left) changes for each graph. Initial Amendment AE/ORIO SCR

13 70 65 DearbornIncomingSubmissionVolume FY FY2017 SubmissionType AE/ORIO Amendment InitialSubmission SCR IRBName Dearborn NumberofProjects Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

14 Dearborn: FY 2017 Q2 Approvals by Review Type Note: The Number of Projects scale (left) changes for each graph. Full Committee Expedited Exempt Not Regulated

15 Dearborn: Turnaround Time by Review Type Full Committee Legend The Number of Submissions scale changes per graph The Median Turnaround Time scale is calendar days Q1 = July September Q2 = October December Q3 = January March Q4 = April June Average Full Committee Submission volume too low to provide meaningful average Expedited Average Expedited FY17 = days FY 2016 = days FY 2015 = days FY 2014 = days FY 2013 = days Graphs show the trend of distinct counts of Projects and Median Days between the IRB receipt and IRB Initial approval for each IRB Approval Date Quarter. Non-null Date values only. Initial approval date includes last 8 quarters.

16 Dearborn: Turnaround Time by Review Type Exempt Average Exempt FY17 = days FY 2016 = days FY 2015 = days FY 2014 = days FY 2013 = days Not Regulated Average Not Regulated FY 17 = days FY 2016 = days FY 2015 = days FY 2014 = 1.50 days FY 2013 = 8.50 days Graphs show the trend of distinct counts of Projects and Median Days between the IRB receipt and IRB Initial approval for each IRB Approval Date Quarter. Non-null Date values only. Initial approval date includes last 8 quarters.

17 Dearborn: FY 2017 Approvals by Submission Type Note: The Number of Projects scale (left) changes for each graph. Initial Amendment AE/ORIO SCR

18 90 FY2016 FlintIncomingSubmissionVolume 90 FY2017 SubmissionType AE/ORIO Amendment InitialSubmission SCR IRBName Flint NumberofProjects Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

19 Flint: FY 2017 Approvals by Review Type Note: The Number of Projects scale (left) changes for each graph. Full Committee Expedited Exempt Not Regulated

20 IRB Flint: Turnaround Time by Review Type Full Committee Legend The Number of Submissions scale changes per graph The Median Turnaround Time scale is calendar days Q1 = July September Q2 = October December Q3 = January March Q4 = April June Average Full Committee Submission volume too low to provide meaningful average Expedited Average Expedited FY17 = days FY 2016 = days FY 2015 = days FY 2014 = days FY 2013 = days Graphs show the trend of distinct counts of Projects and Median Days between the IRB receipt and IRB Initial approval for each IRB Approval Date Quarter. Non-null Date values only. Initial approval date includes last 8 quarters.

21 IRB Flint: Turnaround Time by Review Type Exempt Average Exempt FY17 = 4.50 days FY 2016 = 3.00 days FY 2015 = 4.25 days FY 2014 = 6.50 days FY 2013 = days Not Regulated Average Not Regulated FY 17 = 3.00 days FY 2016 = 3.00 days FY 2015 = 1.25 days FY 2014 = 5.25 days FY 2013 = 9.50 days Graphs show the trend of distinct counts of Projects and Median Days between the IRB receipt and IRB Initial approval for each IRB Approval Date Quarter. Non-null Date values only. Initial approval date includes last 8 quarters.

22 Flint: FY 2017 Approvals by Submission Type Note: The Number of Projects scale (left) changes for each graph. Initial Amendment AE/ORIO SCR

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