Skip to main content

Table 2 Comparisons of ethical considerations by study design

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

Ethical issue

Biomedical

Drug trial

Laboratory

Epidemiology

p value

n = 19

n = 15

n = 28

n = 52

n

%

n

%

n

%

n

%

Rationale and significance

 Research question

6

31.6

2

13.3

1

3.6

5

9.6

0.03

 Objectives

5

26.3

6

40.0

6

21.4

3

5.8

0.01

Study design

 Study schedule and activities

7

36.8

9

60.0

10

35.7

8

15.4

0.01

 Risk–benefit balance

13

68.4

10

66.7

12

42.9

7

13.5

<0.01

Study participants

 Inclusion/exclusion criteria

11

57.9

11

73.3

20

71.4

17

32.7

<0.01

 Sample size

11

57.9

6

40.0

7

25.0

6

11.5

<0.01

 Recruitment

5

26.3

5

33.3

13

46.4

8

15.4

0.03

 Compensation

6

31.6

10

66.7

7

25.0

3

5.8

<0.01

Informed consent process

 Participation information sheet

17

89.5

14

93.3

21

75.0

12

23.1

<0.01

 Informed consent form

13

68.4

14

93.3

21

75.0

9

17.3

<0.01

 Privacy and confidentiality

2

10.5

1

6.7

10

35.7

14

26.9

0.08

Data collection and analysis

 Specimen/data collection

15

79.0

14

93.3

17

60.7

23

44.2

<0.01

 Case record form

4

21.1

1

6.7

4

14.3

10

19.2

0.64

 Data analysis

1

5.3

5

33.3

4

14.3

5

9.6

0.07

Facility and support

 Study site/location

3

15.8

1

6.7

0

0.0

0

0.0

0.01

 Budgeting

0

0.0

1

6.7

1

3.6

0

0.0

0.27

 Other supporting documents

2

10.5

4

26.7

5

17.9

6

11.5

0.46