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

Table 1 The context for the included studies

Context of study	Reviews	Questionnaires/Surveys	In-depth interviews	Miscellaneous
Emergency perinatal research	Hundley 2004 [56]	East 2006 [49]	Baker 2005 [24]
	Tooher 2008 [30]	Kenyon 2004 [50]	Kenyon 2004 [50]
		Smyth 2009 [22]	Smyth 2012 [23]
		Smyth 2009 [22]	Snowdon 2006 [28]
Emergency neonatal research		Ballard 2004 [46]	Allmark 2006 [47]	Schmidt 1999 (observation of outcomes) [57]
		Burgess 2003 [25]	Mason 2000 [34]
		Culbert 2005 [53]	Snowdon 1997 [48]
		Maayan-Metzger 2008 [19]	Snowdon 1998 [33]
		Stenson 2004 [35]
		Zupancic 1997 [21]
Research during pregnancy		Daniels 2006 [52]	Mohanna 1999 [58]
Research during pregnancy		Woodward 2012 [54]	Mohanna 1999 [58]
Non-emergency neonatal research		Ballard 2011 [51]	Hoehn 2009 [32]	Hoehn 2005 (analysis of unsolicited comments) [17]
		Burgess 2003 [25]	Jollye 2009 [18]	Hulst 2005 (observational study) [31]
		Hayman 2001 [16]	Korotchikova 2010 [29]
		Marc-Aurele 2012 [45]	Rogers 1998 [55]
		Morley 2005 [20]	Simon 2006 [60]
		Nathan 2010 [59]	Snowdon 1998 [33]
		Singhal 2002 [26]	Snowdon 2004 [42]
		Singhal 2004 [41]	Snowdon 2004 [39] Ward 2009 [27]
Clinical decision-making (not research)		Paulmichl 2011 [43]	Albersheim 2010 [40]	Sharma 2011 (analysis of decisions made by mothers) [64]
			Brinchmann 2002 [36]
			De Leeuw 2000 [61]
			Garel 2004 [62]
			Kavanaugh 2005 [37]
			McHaffie 2001 [38]
			Saigal 1999 [63]