Ethical issues of informed consent in malaria research proposals submitted to a research ethics committee in Thailand: a retrospective document review

Table 1 Malaria studies reviewed by FTM-EC

Study characteristics	All Protocols Submitted to FTM-EC
	Reviewed	Approved & Deferred^a	Required new ICP^b
	N = 124	N = 112	N = 63
	n	n	n	%
Type of Study
Clinical (IND) trial	14	11	11	100.0
Other clinical study	32	31	17	54.8
Laboratory (basic science) study	49	42	22	52.4
Social/behavioral/epidemiology study	29	28	13	46.4
Specific type of study
Multicenter study	18	15	14	93.3
International study	6	4	3	75.0
Review together with other IRB	39	34	29	85.3
Involvement of vulnerable population
Children	21	18	18	100.0
Minority	38	33	33	100.0
Others (pregnant/older/unconscious)	13	12	6	50.0
Data/specimen collection
Collect new specimens	62	52	52	100.0
Use archived specimens (linked)	28	27	2	7.4
Review medical records/charts (linked)	16	16	2	12.5
Administer questionnaire or interview	9	8	7^c	87.5
Use specimens/medical records (unlinked)	9	9	0	0.0
Final review outcome
Approved		106	57	53.8
Deferred		6	6	100.0

Notes:
% shows percentage of deferrals that required a new ICP
^aExcluded six new protocols pending review; three protocols not approved; three withdrawn by investigator/FTM-EC
^bExcluded studies using unlinked/left-over specimens/data, or ones where prior consent was obtained
^cExempt PIS/ICF for one protocol using Delphi technique (malaria expert consensus)

ISSN: 1472-6939