Skip to main content

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