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Table 3 Comparisons of ethical considerations by type of specimen/data use

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

Ethical issues New specimen Archived (linked) Archive (unlinked) Medical records/CRF p value
n = 58 n = 11 n = 20 n = 25
n % n % n % n %
Rationale
 Research question 9 15.5 1 9.1 3 15.0 1 4.0 0.49
 Objectives 14 24.1 1 9.1 1 5.0 4 16.0 0.21
Study design
 Study schedule and activities 27 46.6 0 0.0 3 15.0 4 16.0 <0.01
 Risk–benefit balance 37 63.8 0 0.0 2 10.0 3 12.0 <0.01
Study participants
 Inclusion/exclusion criteria 41 70.7 3 27.3 4 20.0 11 44.0 <0.01
 Sample size 22 37.9 3 27.3 3 15.0 2 8.0 0.02
 Recruitment 25 43.1 2 18.2 0 0.0 4 16.0 <0.01
 Compensation 23 39.7 0 0.0 1 5.0 2 8.0 <0.01
Informed consent process
 Participation information sheet 51 87.9 2 18.2 1 5.0 10 40.0 <0.01
 Informed consent form 46 79.3 2 18.2 1 5.0 8 32.0 <0.01
 Privacy and confidentiality 10 17.2 3 27.3 7 35.0 7 28.0 0.38
Data collection and analysis
 Specimen/data collection 45 77.6 6 54.6 7 35.0 11 44.0 <0.01
 Case record form 9 15.5 0 0.0 1 5.0 9 36.0 0.01
 Data analysis 9 15.5 2 18.2 0 0.0 4 16.0 0.29
Facility and support
 Study site/location 4 6.9 0 0.0 0 0.0 0 0.0 0.26
 Budgeting 2 3.5 0 0.0 0 0.0 0 0.0 0.58
 Other supporting documents 12 20.7 1 9.1 0 0.0 4 16.0 0.15
  1. CRF case record form