|
Study type
|
N
|
Rationale
|
Study design
|
Study participants
|
|---|
|
n
|
%
|
OR (95 % CI)
|
n
|
%
|
OR (95 % CI)
|
n
|
%
|
OR (95 % CI)
|
|---|
|
Study locations
|
|
International
|
|
Y
|
5
|
3
|
60.0
|
4.3 (0.7–27.3)
|
4
|
80.0
|
4.5 (0.5–42.0)
|
4
|
80.0
|
1.9 (0.2–17.6)
|
|
N
|
109
|
28
|
25.7
|
1
|
51
|
46.8
|
1
|
74
|
67.9
|
1
|
|
Multi-centre/-site
|
|
Y
|
15
|
7
|
46.7
|
2.7 (0.9–8.3)
|
10
|
66.7
|
2.4 (0.8–7.5)
|
13
|
86.7
|
3.4 (0.7–15.9)
|
|
N
|
99
|
24
|
24.2
|
1
|
45
|
45.5
|
1
|
65
|
65.7
|
1
|
|
Additional review by other IRB
|
|
Y
|
35
|
12
|
34.3
|
1.7 (0.7–3.9)
|
22
|
62.9
|
2.4 (1.0–5.3)
|
30
|
85.7
|
3.9 (1.4–11.1)
|
|
N
|
79
|
19
|
24.1
|
1
|
33
|
41.8
|
1
|
48
|
60.8
|
1
|
|
Study population
|
|
Involved minority populations
|
|
Y
|
32
|
12
|
37.5
|
2.0 (0.8–4.8)
|
26
|
81.3
|
7.9 (2.9–21.5)
|
31
|
96.9
|
23.1 (3.0–177.3)
|
|
N
|
82
|
19
|
23.2
|
1
|
29
|
35.4
|
1
|
47
|
57.3
|
1
|
|
Involved vulnerable populations
|
|
Y
|
28
|
13
|
46.4
|
3.3 (1.3–8.1)
|
19
|
67.9
|
2.9 (1.1–7.2)
|
22
|
78.6
|
2.0 (0.7–5.4)
|
|
N
|
86
|
18
|
20.9
|
1
|
36
|
41.9
|
1
|
56
|
65.1
|
1
|
|
Clinical study design
|
|
Biomedical studies
|
19
|
10
|
52.6
|
6.1 (1.9–19.8)
|
15
|
79.0
|
11.3 (3.2–40.0)
|
16
|
84.2
|
7.3 (1.9–28.1)
|
|
Drug trial
|
15
|
6
|
40.0
|
3.7 (1.0–13.2)
|
11
|
73.3
|
8.2 (2.2–30.4)
|
15
|
100.0
|
–
|
|
Laboratory
|
28
|
7
|
25.0
|
1.8 (0.6–5.7)
|
16
|
57.1
|
4.0 (1.5–10.6)
|
25
|
89.3
|
11.4 (3.0–42.4)
|
|
Epidemiology
|
52
|
8
|
15.4
|
1
|
13
|
25.0
|
1
|
22
|
42.3
|
1
|
|
Specimen collection/use
|
|
New specimen collection
|
58
|
20
|
34.5
|
2.1 (0.7–6.4)
|
44
|
75.9
|
10.0 (3.3–29.8)
|
52
|
89.7
|
8.0 (2.5–25.3)
|
|
Archived specimen (linked)
|
11
|
2
|
18.2
|
0.9 (0.1–5.5)
|
0
|
0.0
|
–
|
6
|
54.6
|
1.1 (0.3–4.6)
|
|
Archived specimen (unlinked)
|
20
|
4
|
20.0
|
1.0 (0.2–4.3)
|
5
|
25.0
|
1.1 (0.3–4.1)
|
7
|
35.0
|
0.5 (0.1–1.7)
|
|
Medical records
|
25
|
5
|
20.0
|
1
|
6
|
24.0
|
1
|
13
|
52.0
|
1
|
| | |
Informed consent process
|
Data collection and analysis
|
Facility and support
|
|---|
|
Study locations
|
|
International
|
|
Y
|
5
|
4
|
80.0
|
2.0 (0.2–18.3)
|
3
|
60.0
|
0.8 (0.1–4.8)
|
3
|
60.0
|
6.7 (1.0–42.6)
|
|
N
|
109
|
73
|
67.0
|
1
|
72
|
66.1
|
1
|
20
|
18.4
|
1
|
|
Multi-centre/-site
|
|
Y
|
15
|
13
|
86.7
|
3.6 (0.8–16.7)
|
13
|
86.7
|
3.9 (0.8–18.2)
|
8
|
53.3
|
6.4 (2.0–20.3)
|
|
N
|
99
|
64
|
64.7
|
1
|
62
|
62.6
|
1
|
15
|
15.2
|
1
|
|
Required other IRB review
|
|
Y
|
35
|
30
|
85.7
|
4.1 (1.4–11.6)
|
26
|
74.3
|
1.8 (0.7–4.3)
|
14
|
40.0
|
5.2 (2.0–13.7)
|
|
N
|
79
|
47
|
59.5
|
1
|
49
|
62.0
|
1
|
9
|
11.4
|
1
|
|
Study populations
|
|
Involved minority populations
|
|
Y
|
32
|
31
|
96.9
|
24.3 (3.2–186.3)
|
29
|
90.6
|
7.5 (2.1–26.8)
|
14
|
43.8
|
6.3 (2.4–16.9)
|
|
N
|
82
|
46
|
56.1
|
1
|
46
|
56.1
|
1
|
9
|
11.0
|
1
|
|
Involved vulnerable populations
|
|
Y
|
28
|
23
|
82.1
|
2.7 (0.9–7.9)
|
19
|
67.9
|
1.1 (0.5–2.8)
|
9
|
32.1
|
2.4 (0.9–6.5)
|
|
N
|
86
|
54
|
62.8
|
1
|
56
|
65.1
|
1
|
14
|
16.3
|
1
|
|
Clinical study designs
|
|
Biomedical studies
|
19
|
17
|
89.5
|
10.7 (2.2–51.2)
|
15
|
79.0
|
3.8 (1.1–12.8)
|
5
|
26.3
|
2.7 (0.7–10.3)
|
|
Drug trial
|
15
|
15
|
100.0
|
–
|
14
|
93.3
|
14.0 (1.7–114.4)
|
6
|
40.0
|
5.1 (1.3–19.5)
|
|
Laboratory
|
28
|
22
|
78.6
|
4.6 (1.6–13.3)
|
20
|
71.4
|
2.5 (0.9–6.7)
|
6
|
21.4
|
2.1 (0.6–7.2)
|
|
Epidemiology
|
52
|
23
|
44.2
|
1
|
26
|
50.0
|
1
|
6
|
11.5
|
1
|
|
Specimen collection/use
|
|
New specimen collection
|
58
|
53
|
91.4
|
9.8 (2.9–32.7)
|
46
|
79.3
|
2.6 (0.9–7.1)
|
18
|
31.0
|
2.4 (0.7–7.9)
|
|
Archived specimen (linked)
|
11
|
4
|
36.4
|
0.5 (0.1–2.3)
|
7
|
63.6
|
1.2 (0.3–5.1)
|
1
|
9.1
|
0.5 (0.1–5.3)
|
|
Archived specimen (unlinked)
|
20
|
7
|
35.0
|
0.5 (0.1–1.7)
|
7
|
35.0
|
0.4 (0.1–1.2)
|
0
|
0.0
|
–
|
|
Medical records
|
25
|
13
|
52.0
|
1
|
15
|
60.0
|
1
|
4
|
16.0
|
1
|
- Italics denotes statistically significant values
-
CI confidence interval, IRB institutional review board, OR odds ratio
