Table 3.

Summary of the Relevant Themes Identified in Each Included Paper.

	Study Author (Date)	Summary of the Relevant Themes	CASP Score
1	Dekking et al (2016)18	Infringement of autonomy may arise because of emotional distress and the influence of professionals. Deciding on treatment levels and conflicting perspectives constituted a challenge.	9
2	Byrne-Davis et al (2010)8	Parents did not understand certain aspects of the trial and they were emotionally distressed while informed consent was collected.	9
3	Dekking et al (2015)13	Parental comprehension and satisfaction in informed consent in pediatric clinical trials. Provided information was appropriate. One-fifth did not realize that their child had been included in a research study. Randomization concept is not well understood. Half of the parents could explain neither the aim of the clinical trial nor the potential benefit of inclusion to their child. Only one-third were aware of alternatives.	8
4	Kupst et al (2003)11	Forty-five percent did not understand the concept of randomization. Half of the parents could explain neither the aim of the clinical trial nor the potential benefit to their child of inclusion.	9
5	Levi et al (2000)12	Parents’ situations are interrelated to the decision-making choices, treatment expectations, and interactions with healthcare providers.	9
6	Oppenheim et al (2005)14	There is ambiguity regarding the categorization of research or treatment, and conflicts appear within the work of the pediatric oncologists.	6
7	Stevens et al (2002)15	Involvement of the physician in the informed consent process is valuable and has a positive impact.	8
8	Bartholdson et al (2015)16	There was wide variation in parents’ understanding of the aims, costs, and benefits. Most mothers reported the aim of the trial as being to compare “old” and “new” treatments.	7
9	Eiser et al (2015)10	Satisfaction with the consent process and with parents’ decisions to enroll children in protocols, but there were significant gaps in parental understanding of clinical trials and of the experimental nature of treatment. Misperceived the notion of randomization. Insufficient or no discussion of the alternatives to enrolling their child on the proposed clinical trial.	8
10	Chappuy et al (2010)9	Dialogues regarding the diagnosis and treatment options occurred amid tremendous stress; a sense of constraint and lack of control were common. Parents experienced variable degrees of choice regarding their child’s participation in a clinical trial. Parents did not verbalize distinctions between understanding of treatment and research.	9
11	Chappuy et al (2013)4	Emotion distress and influence of caregivers required to show more respect to the ethical principles including autonomy.	8
12	Deatrick et al (2002)17	Mothers find themselves in life-and-death circumstances, and this reality alters the entire research enterprise. There is an effect of mothers’ emotional trauma on research enrollment.	7
13	De Vries et al (2010)5	Clinicians do not always provide adolescents with all available information.	9

Abbreviation: CASP, Critical Appraisal Skills Program.