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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