The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) research

Table 2 Themes and context of the philosophical arguments

		Themes revealed
		Ethical basis for consent	Validity of consent	Issues of risk	Other options for consent	Miscellaneous topics
Context in which philosophical arguments have been developed	Emergency neonatal research		Manning, 2000 [24]		Manning, 2000 [24]
	Perinatal clinical decision-making	Pinkerton et al., 1997 [20]
	Foetal-maternal research		American College of Obstetricians and Gynecologists, Committee on Ethics; American Academy of Pediatrics, Committee on Bioethics, 2011 [26]			American College of Obstetricians and Gynecologists, Committee on Ethics; American Academy of Pediatrics, Committee on Bioethics, 2011 [26]
	Neonatal clinical decisions	Rostain and Bhutani, 1989 [13]	Rostain and Bhutani, 1989 [13]	Rostain and Bhutani, 1989 [13]
	Neonatal clinical decisions	Schneider, 1988 [15]	Rostain and Bhutani, 1989 [13]	Rostain and Bhutani, 1989 [13]
	Neonatal research	McDonnell, 1990 [14]	Silverman, 1988 [29]	Silverman, 1988 [29]	Silverman and Altman, 1996 [35]
				Silverman and Altman, 1996 [35]	Tyson and Knudson, 2000 [32]
				Tyson and Knudson, 2000 [32]	Allmark, 1999 [40]
				Vain et al., 2004 [38]	Allmark, 1999 [40]
	Perinatal emergency research				Vain et al., 2004 [31]
	Trials in general (but discusses ECMO)				Worrall, 2008 [39]
	Trials in general (but discusses ECMO)				Braunholtz, 1999 [41]

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