Through the process of permission and assent, parents and adolescents have a shared involvement in research participation decision-making. When family members are in agreement to either accept or decline an offer of research participation, there are no legal or ethical concerns. When differences in opinion between parents and adolescents exist, however, a host of potential problems may transpire in ensuring that the rights and responsibilities of each person are protected and honored. Understanding the frequency of and contexts in which differences of opinion between parent and adolescents are likely to emerge is, therefore, a significant requisite to addressing situations that may challenge the ethical conduct of research with adolescents.
In this study we found surprising consistency in the frequency of concordance/discordance between adolescents and their parents across nine research vignettes, encompassing both minimal and above minimal risk asthma protocols. The overall frequency of discordance was a substantial 40%, with differences in the patterns of concordance/discordance found across the nine studies. Parents were more willing than adolescents to participate in the minimal risk studies, while adolescents were more willing than parents to enroll in above minimal risk research. Thus, the erosion of voluntary assent resulting from a parent's desire to enroll an unwilling adolescent in research appears more likely to occur in minimal risk rather than above minimal risk research.
Because adolescents and parents often disagree on research participation decisions, concerns over authority and responsibility for research participation decision-making and the process by which adolescent assent is obtained becomes a highly salient consideration. In the standard informed consent model for children, parents are approached first to obtain permission for child research participation. If parental permission is obtained, child assent is then requested. Our research suggests that for minimal risk research with adolescents, parents are generally more likely to provide permission, allowing adolescents the opportunity to participate, either through assent or dissent, in the decision-making process. However, the extent to which unwilling adolescents might face potentially coercive strategies by parents or others to participate in minimal risk studies is unknown.
In above minimal risk studies, the situation is different because adolescents appear less risk averse than their parents. We found they were more willing than parents to participate in above minimal risk studies and their comments suggested they were much less focused on potential risk when making participation decisions. If parents are approached first to provide permission for their adolescent to participate in above minimal risk research, the findings from this study suggest parents will frequently decline. Thus, utilizing this commonly recommended consent process would result in adolescents having a limited opportunity to participate in decisions concerning research participation in above minimal risk studies.
Integral to the discussion of the ethical nature of any consent process, however, are perspectives surrounding who ought to have the final authority and responsibility for research participation decision-making. A recent extensive discussion of the ethical considerations inherent in allocating greater adolescent decision-making autonomy for nonbeneficial research serves to highlight the existence of a spectrum of views [1
]. While parents are currently authorized to make such decisions, there is growing advocacy for and legislation authorizing adolescent legal rights to make independent health care decisions in a variety of areas. This is a relevant connection because federal regulations link authority to provide research consent to state laws concerning consent for medical treatment. Moreover, several other potential models for obtaining research consent involving initial adolescent involvement have been proposed. Preliminary qualitative findings reveal that parents and adolescents hold a range of opinions on how consent is most appropriately obtained for adolescent research participation [17
]. A systematic examination of views from parents, adolescents, researchers, and policy makers will be important for a thorough consideration of this topic. In the meantime, researchers can be attentive to the possibility that adolescents and parents may hold different views about research participation and provide opportunity for dialogue that both respects adolescents' desire to participate in health care-related decisions and acknowledges parental responsibility for providing permission to enroll in biomedical research.
This study provides a preliminary examination of the independent views parents and adolescents hold concerning participation in nine minimal and above minimal risk asthma research protocols. There are both strengths and limitations to the design that may limit interpretation of the findings. Hypothetical research protocols were presented in summary format with limited discussion of each study. Adolescents and parents were queried independently and did not discuss protocols with one another. Therefore, actual research participation decisions may be different in a more naturalistic setting. While the presentation order of the protocols was systematically varied across participants, reviewing all nine protocols sequentially may have influenced responses in unanticipated ways. However, the use of a spectrum of protocols enhances the generalizability of the findings and provides some important preliminary data on the acceptability of a variety of research designs to the families of adolescent asthma patients. Generalizability was also enhanced through the use of a clinical sample of adolescents with asthma recruited from a medical setting. In summary, our findings suggest that researchers ought to carefully consider the process by which families are offered the option of adolescent research participation.