Ethical issues in research involving minority populations: the process and outcomes of protocol review by the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, Thailand

Table 1 Ethical review outcomes of studies at FTM-EC, 2009-2012

Ethical review process and outcomes	All studies				Studies involving minority groups
	Clinical studies		Non-clinical studies		Clinical studies		Non-clinical studies
	Initial review	Continuing review	Initial review	Continuing review	Without extra-vulnerable minority	With extra-vulnerable minority	Without extra-vulnerable minority	With extra-vulnerable minority
	N = 96	N = 43	N = 195	N = 39	N = 19	N = 14	N = 4	N = 7
	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)
Type of review
Full board	96 (100%)	11 (25.6%)	129 (66.1%)	1 (2.6%)	19 (100%)	14 (100%)	4 (100%)	7 (100%)
Expedited	0	32 (74.4%)	59 (30.3%)	38 (97.4%)	0	0	0	0
Exempted	0	0	7 (3.6%)	0	0	0	0	0
Initial review outcome
Simple approval	0	27 (62.8%)	13 (6.7%)	38 (97.4%)	0	0	0	0
Approval after clarification/revision	92 (96%)	13 (30.2%)	176 (90.2%)	0	17 (89.4%)	12 (86%)	3 (75%)	7 (100%)
Deferment	3 (3%)	0 (0%)	5 (2.6%)	0	1 (5.3%)	1 (7%)	0	0
Non-approval	1 (1%)	3 (7%)	1 (0.5%)	1 (2.6%)	1 (5.3%)	1 (7%)	1 (25%)	0

Notes: 1. “Continuing review” includes studies where an amended protocol was requested and continual annual approval was awarded.
2. “Extra-vulnerable minority” includes pregnant women, fetuses, and neonates.
3. Percentages in parentheses are relative to N of respective column.

ISSN: 1472-6939