Tony Perez
Chief Health Sciences Counsel
University of California, San Diego
(formerly Director, IRB Administration University of California, Davis)



Measure IRB Approval Process
Establish Common Milestones
Define Milestones
◦ When has milestone been achieved?


Measurement
Understanding of Variables Affecting
Milestone Achievement
•
Variables Influencing Achievement
– Complexity of Protocol
– Receipt of Documents From Sponsor
– Complexity of IRB Application Form
– Assistance from IRB or Other Office
• Clinical Trials Office
• IRB Administration Office
– PI Staffing
• Competence
• Amount

Variables Influencing Achievement
◦ Administrative Approval
 Administration Sign-off
 Resource Sign-off
◦ Other Required Approvals
 Scientific Review Committee
 Radiation Use Committee
•
Variables Influencing Achievement
– Workload of IRB Administration
• Administrative Pre-Review for Completeness
• Substantive Pre-Review
– Response of PI to Correct Submission Deficiencies
– Response of Sponsor to Correct Submission
Deficiencies
– Workload of IRB
• Overworked IRB Members
• Lack of IRB Members

Variables Influencing Achievement
◦ Workload of IRB Members
 Large Volume of Protocols to Review
 Large Volume of Revisions to Review
◦ Workload of IRB Committees
 Limitations on Meeting Agenda Items
 Other Items to Review
 Substantive Modifications
 Unanticipated Problems

Variables Influencing Achievement
◦
◦
◦
◦
Workload in IRB Administration Office
Expertise of IRB Administration Staff
Clarity of Requests by IRB Members
Method of Transmission

Variables Influencing Achievement
◦ Volume of Required Revisions
◦ Complexity of Required Revisions
◦ Communication with and Approval from Sponsor

Variables Influencing Achievement
◦ Workload of IRB Administration Office
◦ Method of Transmission
Quantitative Analysis of HRPP Workflow
Michael Caligiuri, Ph.D.
Director, HRPP
UCSD
June, 2008



Time Period: IRB Review to Final Approval
4 biomedical committees; randomly assigned a
code number
Independent variables (project characteristics):
Dates of
Correspondence
Vulnerable
populations
Initial Review
Status
Risk level (0-4)*
Cancer Trial
Renewal
Funding
Device Study
PI Department
Radiation
Use of DNA
VA
*0=surveys, chart reviews; 1=observational; 2=minimal risk, blood draw, vulnerable population;
3=Phase III, investigational drug or device; 4=Phase I or II safety trial
20
18
Mean = 37.2 days
Median = 27 days
16
14
12
10
8
Number of Projects
6
4
2
0
0
10
20
30
40
50
60
70
80
Total Time, days
90
100
110
120
30
28
PI
26
Mean PI time: 19.97 ± 21.7 days
24
22
20
18
16
14
12
Number of Protocols
10
8
6
4
2
0
-10
0
10
20
30
40
50
60
70
80
Number of Days with PI
90
100
35
30
HRPP
25
Mean HRPP time: 19.86 ± 15.9 days
20
15
Number of Protocols
10
5
0
-10
0
10
20
30
40
50
60
Number of Days with HRPP
70
80
90
y = 8.24 - 0.2 * x
80
60
3 weeks
40
20
0
-20
HRPP Time - PI Time,
-40
-60
-80
-20
0
20
40
60
80
Total Approval Time, days
100
120
140
Predictive Models
Model 1:
3 factors
Committee, Funding, Radiation
Statistic:
F=4.33; p<0.01
Test 1:
C=1; F=C; R=No
67 days
C=2; F=C; R=No
59 days
C=3; F=C; R=No
51 days
Conclusion:
Committee assignment accounts for 8 days
Predictive Models
Model 1:
3 factors
Committee, Funding, Radiation
Statistic:
F=4.33; p<0.01
Test 2:
C=1; F=C; R=No
67 days
C=1; F=NC; R=No
49 days
Conclusion:
Funding source accounts for 18 days
Impact of Funding Source on Approval Delays
for each Biomedical IRB
140
120
100
80
60
40
Total Time for Approval, in da
20
0
-20
1
2
3
Committee
4
Fed
Com
Impact of Radiation Exposure and PRMC Review
on Approval Delays for each Biomedical IRB
110
100
90
80
No PRMC review
70
60
50
40
30
Total Time for Approval, in days
20
10
0
-10
1
2
3
Committee
4
No Rad
Rad
Tony Perez, J.D.
Chief Health Sciences Counsel
University of California, San Diego
University Center 201
9500 Gilman Drive #0097
La Jolla, California 92093-0097
(858) 246-0222
tonyperez@ucsd.edu
Michael Caligiuri, Ph.D.
Director, Human Research Protections Program
University of California, San Diego
La Jolla Village Professional Center Suite A208
8950 Villa La Jolla
La Jolla, California 92037
Phone: 858-455-5050
mcaligiuri@ucsd.edu