Transcript Document 7276384

CUMC IRB Investigator Meeting
Status of the IRB
January 18, 2005
Objectives
This presentation will provide information on:
• Challenges facing the IRB
• Statistics on IRB Performance in 2004
• Changes during the past year
• Solutions/Plans to Improve IRB Quality and Performance
Challenges Facing the IRB
• High volume of submissions
• Regulatory requirements
• Addressing past noncompliance issues
• Staffing issues
• RASCAL
• IRB members – Broaden expertise
2004 – IRB volume measured by submissions
Month
Total
January
284
February
336
800
March
415
700
April
522
600
May
483
500
June
562
July
577
August
630
September
588
October
618
November
640
December
639
400
Series1
300
200
100
0
January
April
July
October
2004 Staffing levels of the IRB adjusted for leave
Staff
27.74
February
27.8
March
26.63
April
26.2
May
26.4
June
21.09
July
22.5
August
20.77
September
19.26
October
19.38
November
19.4
December
18.61
31
26
21
16
Ja
nu
Fe a ry
br
ua
r
M y
ar
ch
Ap
ril
M
ay
Ju
ne
Ju
A u ly
Se gu
s
pt
em t
b
Oc er
t
No o be
ve r
De mb
ce e r
m
be
r
January
FTE (adjusted for leave)
Staff
Staff
2004 Total approvals by CU/CUMC IRBs
Type
TM
600
400
200
0
NF
N- B
EX
N- E
EX
P
RF
R- B
EX
R- E
EX
P
MF
M- B
EX
M- E
EX
P
AE
Number
Chart 1: 2004 Total Approvals By IRB
IRB 1
IRB 2
IRB 3
MS IRB
2004 Total approvals by CU/CUMC IRBs
New
180
160
140
120
100
80
60
40
20
0
Renewals
Ju
ly
Au
gu
Se
st
pt
em
be
Oc r
to
be
No
r
ve
m
be
De
r
ce
m
be
r
Modifications
Ap
ril
M
ay
Ju
ne
Ja
nu
ar
y
Fe
br
ua
ry
M
ar
ch
Number
Chart 2: 2004 Total Approvals All IRBs
Month
#REF!
AE Repts
Term
Individual IRB Performance – Turnaround Time
Expedited Review
IRB“K”
(coded)
Prot. #
Review
Sub date
App'l date
Total
IRB
PI
# Returns
A1455
Exp
31223
40104
12
5
7
0.03
A4136
Exp
30123
30128
5
5
0
1
A3010
Exp
40114
40201
18
14
4
2
A3107
Exp
40311
40402
21
6
15
1
A2379
Exp
31015
40406
174
6
168
1
A4537
Exp
40227
40406
39
5
34
1
A7131
Exp
40514
40707
53
14
39
1
A6154
Exp
40514
40707
53
33
20
1
A6819
Exp
40602
40710
38
18
20
3
A6860
Exp
40702
41013
94
43
51
3
A9618
Exp
40907
41005
28
7
21
1
A9676
Exp
41001
41012
11
9
2
1
Total
546
165
381
Average
45.5
13.75
31.75
1.335833
Individual IRB Performance – Turnaround Time
Full Board Review
IRB“K”
(coded)
Prot. #
Review
Sub date
App'l date
Total
IRB
PI
# Returns
A1186
FB
31124
40107
43
30
13
2
A1902
FB
31031
40118
79
30
49
2
A3919
FB
31230
40130
31
29
2
1
A2649
FB
31205
40406
123
46
77
3
A0174
FB
31119
40406
139
30
109
2
A4506
FB
40226
40414
50
25
25
1
A5771
FB
40408
40712
95
63
32
3
A6615
FB
40421
40712
82
54
29
2
A7958
FB
40621
40707
16
16
0
0
A5304
FB
40311
41005
208
40
168
3
A6281
FB
40412
41005
176
84
92
4
A7666
FB
40716
41027
103
40
63
2
1145
487
659
95.41667
40.58333
54.91667
Total
Average
2.083333
Individual IRB Performance – Turnaround Time
Expedited Review
IRB“L”
(coded)
Prot. #
Review
Sub date
App'l date
Total
IRB
PI
# Returns
A3707
Exp
31224
40102
9
9
0
0
A3389
Exp
31204
40104
31
20
11
1
A3784
Exp
31219
40107
19
18
1
2
A2857
Exp
40302
40408
37
23
14
2
A6674
Exp
40419
40422
3
3
0
0
A5588
Exp
40405
40423
18
4
14
1
A5908
Exp
40603
40701
28
15
13
2
A7967
Exp
40615
40701
16
16
0
0
A6014
Exp
40622
40708
16
11
5
1
A9041
Exp
40806
41004
59
43
16
2
B0070
Exp
40930
41012
12
12
0
0
B0050
Exp
40929
41012
13
13
0
0
261
187
74
21.75
15.58333
6.166667
Total
Average
0.916667
Individual IRB Performance – Turnaround Time
Full Board Review
IRB“L”
(coded)
Prot. #
Total
Average
Review
Sub date
App'l date
Total
IRB
PI
# Returns
A1307
FB
30724
40105
165
91
74
1
A2643
FB
30130
31217
48
40
8
2
A2596
FB
31021
40102
73
45
28
5
A2368
FB
31021
40403
165
108
57
5
A3921
FB
40227
40405
38
25
13
2
A4591
FB
40210
40405
55
22
23
2
A2926
FB
40324
40703
101
66
35
1
A4792
FB
40414
40703
80
43
37
3
A5398
FB
40406
40703
88
76
12
1
A8030
FB
40629
41001
95
83
12
2
A6806
FB
40616
41011
117
85
32
3
A8826
FB
40729
41011
74
64
10
3
1099
748
341
91.58333
62.33333
28.41667
2.5
Individual IRB Performance – Turnaround Time
Expedited Review
IRB“M”
(coded)
Prot. #
Total
Average
Review
Sub date
App'l date
Total
IRB
PI
# Returns
A1699
Exp
30819
40114
148
43
105
2
A1520
Exp
31021
40115
86
39
47
4
A0200
Exp
30407
40122
290
41
249
3
A2578
Exp
40214
40411
57
54
3
1
A4323
Exp
40202
40411
69
45
24
2
A3752
Exp
31217
40411
116
57
59
3
A6194
Exp
40625
40716
21
15
6
2
A3070
Exp
31212
40727
228
69
159
5
A5920
Exp
40506
40727
82
38
44
4
A8480
Exp
40715
41001
79
39
40
1
A8712
Exp
40720
41001
74
59
15
2
A7631
Exp
40611
41010
121
51
70
2
1371
550
821
114.25
45.83333
68.41667
2.583333
Individual IRB Performance – Turnaround Time
Full Board Review
IRB“M”
(coded)
Prot. #
Total
Average
Review
Sub date
App'l date
Total
IRB
PI
# Returns
A2696
FB
31031
40105
66
64
2
1
A2363
FB
31010
40112
94
63
31
4
A4143
FB
40122
40405
74
48
26
2
A1823
FB
31125
40406
132
44
88
2
A1562
FB
31117
40409
143
96
47
4
A1500
FB
30728
40705
342
112
230
3
A0360
FB
30611
40705
390
149
241
7
A1789
FB
40108
40705
178
65
113
3
A8837
FB
40816
41001
46
35
11
2
B0177
FB
40930
41006
6
6
0
1
A2466
FB
40824
41010
47
38
9
1
1518
720
798
138
65.45455
72.54545
2.727273
Individual IRB Performance – Turnaround Time
Expedited Review
IRB“N”
(coded)
Prot. #
Total
Average
Review
Sub date
App'l date
Total
IRB
PI
# Returns
A3750
Exp
31223
40101
9
9
0
0
A3325
Exp
31207
40105
29
28
1
1
A1414
Exp
31001
40115
116
3
113
1
A5319
Exp
40324
40412
19
15
4
2
A6074
Exp
40325
40420
26
26
0
0
A5528
Exp
40315
40420
36
33
3
1
A7738
Exp
40615
40709
24
9
15
1
A8001
Exp
40614
40714
30
17
13
2
A7764
Exp
40615
40721
36
23
13
3
A9899
Exp
40920
41006
16
16
0
0
A8466
Exp
40921
41011
20
14
6
1
A9103
Exp
40923
41013
20
20
0
0
381
213
168
31.75
17.75
14
1
Individual IRB Performance – Turnaround Time
Full Board Review
IRB“N”
(coded)
Prot. #
Review
Sub date
A3142
FB
31123
A1812
FB
A3077
App'l date
Total
IRB
PI
# Returns
40115
53
49
4
1
31210
40128
49
30
19
4
FB
40108
40121
13
6
7
2
A4484
FB
40311
40401
20
20
0
0
A1985
FB
30922
40405
196
50
146
7
A3073
FB
40212
40427
69
55
14
2
A2886
FB
40512
40630
49
38
11
1
A6716
FB
40512
40711
60
57
3
2
A7673
FB
40602
40714
48
42
6
1
A8347
FB
40806
41005
60
40
20
1
A8885
FB
40819
41006
48
38
10
2
A9370
FB
40916
41011
25
20
5
1
Total
690
445
245
Average
57.5
37.08333
20.41667
2
Individual IRB Performance – Turnaround Time
Expedited Review
2004
IRB
#
Studies
Days
From
Subm. To
Approval
Days
w/
IRB
Days
w/
PI
#
Returns
IRB K Total
12
546
165
381
16
IRB L Total
12
261
187
74
11
IRB M Total
12
1371
550
821
29
IRB N Total
12
381
213
168
12
Total
48
2,559
1,115
1,444
68
23 days
30 days
Average
IRBs are coded to maintain confidentiality
Total of 48 studies
53 days
1.42
Individual IRB Performance – Turnaround Time
Full Boards Review
2004
IRB
#
Studies
Days
From
Subm. To
Approval
Days
w/
IRB
Days
w/
PI
#
Returns
IRB K Total
12
1,145
487
659
25
IRB L Total
12
1,099
748
341
30
IRB M Total
12
1,518
720
798
30
IRB N Total
12
690
445
245
24
Total
48
4,452
2,400
2,043
109
50 days
43 days
2.27
Average
IRBs are coded to maintain confidentiality
Total of 48 studies
93 days
Factors affecting data on IRB delays
1) Possible causes from the IRB:
•
Waiting for Cancer Cmte. approval
•
Waiting for IBC approval
•
Reviewer delay (Need for more members)
•
Need to obtain consultant/consultant’s review
•
Volume at next available IRB meeting resulting in study scheduled on
following meeting’s agenda
Factors affecting data on IRB delays
2) Possible causes from the Investigator:
•
Waiting for approval of changes or updated documentation from the
sponsor
•
Waiting for documentation/action from FDA or other external agency
•
Waiting for resolution of contract or other funding matters
Possible causes of delays
1) Investigator causes of delays:
•
Resubmitting a protocol without addressing all requests/concerns
•
Timeliness of renewal submissions
•
Lack of clarity of Rascal functions
•
Missing documentation for protocols reviewed under an authorization
agreement
•
Attaching documents that the IRB cannot approve; not archiving
documents that have been replaced
•
Attaching files in a format that cannot be opened by the IRB
Possible causes of delays (cont’d)
1) Investigator causes of delays:
•
Attaching files in a format that cannot be opened by the IRB
•
Including protocol version dates in protocol titles, but not updating them
when the version changes
•
Making personnel changes in one document but not another
•
Requesting a waiver of consent or documentation of consent, but not
providing the justification
•
Selecting names of attached files that are not related to the file, thus
requiring IRB staff/members to open each document to find a specific
file
Possible causes of delays (cont’d)
2) IRB causes of delays:
•
Lack of clarity of Rascal functions with staff
•
Lack of clarity of Rascal functions with IRB members
•
Inflexibility of an electronic IT system
Solutions/Plans to Improve IRB Quality
and Performance
• Provide more educational training targeted to issues related to IRB delays
- Start regular workshops on RASCAL training?
• Improve IRB’s website so that it becomes a valuable resource
• Improve management of IRB office; use of tracking systems, increase
accountability and performance
• Improve IRB committees by adding to the already high level of expertise
with representation of more disciplines
Tips to avoid IRB delays and returns
• Review the “Tips to Facilitate Efficient Review” documents on the IRB
website
• Complete all fields in RASCAL, entering “NA” if appropriate
• Read the information on the Help buttons in the RASCAL screens
• Use cover letters attached to the submission to communicate to the IRB
• Review the list of attachments before each submission and archive
superceded or obsolete documents
• Verify the protocol status after you “submit” and event
• Submit renewals 60 days prior to the expiration date
Policy or Procedural Changes in IRB
April 1, 2004 – Discontinued continuing review of exempt research
April 13, 2004 – Released new AE Reporting policy
September 2004 – Implementation of accountability measures in IRB
December 16, 2004 – RASCAL change: Allowing renewals to be
resubmitted for expired protocols
IRB Goals for 2005
• Apply for Accreditation and receive full accreditation status
• Improve the efficiency of the IRB so that average turnaround time is less
than 2 months
• Improve the quality of IRB review
• Improve the quality of Columbia’s human subjects protection program