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Table 4 Comparisons of ethical considerations by different study characteristics

From: Ethical considerations in malaria research proposal review: empirical evidence from 114 proposals submitted to an Ethics Committee in Thailand

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

  1. Italics denotes statistically significant values
  2. CI confidence interval, IRB institutional review board, OR odds ratio
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