Empirically Derived Knowledge on Adolescent Assent to Pediatric Biomedical Research

Abstract

Background There has been a recent growth in empirical research on assent with pediatric populations, due in part, to the demand for increased participation of this population in biomedical research. Despite methodological limitations, studies of adolescent capacities to assent have advanced and identified a number of salient psychological and social variables that are key to understanding assent. Methods The authors review a subsection of the empirical literature on adolescent assent focusing primarily on asthma and cancer therapeutic research; adolescent competencies to assent to these studies; perceptions of protocol risk and benefit; the affects of various social context variables on adolescent research participation decision making; and the inter-relatedness of these psychological and social factors. Results Contemporary studies of assent, using multivariate methods and updated approaches to statistical modeling, have revealed the importance of studying the intercorrelation between adolescents’ psychological capacities and their ability to employ these capacities in family and medical decision-making contexts. Understanding these dynamic relationships will enable researchers and ethicists to develop assent procedures that respect the authority of parents, while at the same time accord adolescents appropriate decision-making autonomy. Conclusions Reviews of empirical literature on the assent process reveal that adolescents possess varying capacities for biomedical research participation decision making depending on their maturity and the social context in which the decision is made. The relationship between adolescents and physician-investigators can be used to attenuate concerns about research protocols and clarify risk and benefit information so adolescents, in concert with their families, can make the most informed and ethical decisions. Future assent researchers will be better able to navigate the complicated interplay of contextual and developmental factors and develop the empirical bases for research enrollment protocols that will support increased involvement of adolescents in biomedical research.

Children's self reported discomforts as participants in clinical research

“…Furthermore, we suggest that mental discomforts should be given 409 more attention in the evaluation of discomfort in pediatric study protocols, which is in 410 accordance with a previous study that children may be more focused on the immediate 411 psychological discomforts than physical discomforts and risks (Scherer,Brody,Annett,412 Turner, Dalen, & Yoon, 2013). 413…”

A randomized study of a method for optimizing adolescent assent to biomedical research

“…Scherer and colleagues have previously highlighted these challenges, particularly as they pertain to research decision making across pediatric diseases (Scherer et al 2013). The body of research in this area is still quite small, and caution is appropriate when considering generalization of decision-making findings to other pediatric diseases.…”

“…Ethicists and biomedical researchers have made significant progress in our understanding of child and adolescent assent to biomedical research, although these efforts have also revealed the intricacy and complexity of the assent process (Scherer et al 2013). Important questions remain unanswered, particularly those regarding child and adolescent competence to assent and how to best respect the autonomy of children and adolescents to assent (Baines 2011, Hein et al 2015, Kodish 2003).…”

Contrasting Views of Risk Perception and Influence of Financial Compensation Between Adolescent Research Participants and Their Parents

“…The latter groups have other reasons to enroll in research and different perspectives and experiences regarding invasive procedures. Those who are ill likely have different motivations for participating in research or derive alternative kinds of benefits, including hope for a cure or desire to help others with their same condition (Scherer et al, 2013; Stunkel & Grady, 2011) and these motivations should be carefully weighed and understood prior to initiating treatment.…”