Table 2

Comparison of responses to issues raised by US IRB(s) vis à vis issues raised by developing country IRB(s) for the same study

OptionRaised by developing country IRB(s) or ethics board in its review of the index study, n (%)Raised by US IRB(s) in its review of the index study, n (%)p Value
Cultural appropriateness of study procedure75/127 (59)19/30 (63)0.687
Need for local language consent form72/124 (58)27/32 (84)0.006*
Relevance of research question to country where research is conducted and/or rationale for doing study outside the US63/116 (54)16/31 (52)0.842
Availability of intervention (if successful) to host country after study is over51/95 (54)11/24 (46)0.483
Need for letters of approval from developing country representatives53/114 (47)26/33 (79)0.001*
Complexity of language on consent form54/120 (45)18/28 (64)0.070
Appropriateness of procedures for control group39/99 (39)12/24 (50)0.325
Use of placebos22/85 (26)5/23 (22)0.694
Participant voluntaries may be compromised because of benefits study provides27/112 (24)6/30 (20)0.644
Confidentiality protections for participants were not adequate22/121 (18)13/31 (42)0.004*
Political considerations16/97 (16)4/24 (17)0.905
Intervention was considered too risky11/104 (11)4/26 (15)0.571
Others5/41 (12)1/12 (8)0.698