Adolescent Participation In Research Research Articles

Family and Physician Influence on Asthma Research Participation Decisions for Adolescents: The Effects of Adolescent Gender and Research Risk

There is considerable ethical and legal ambiguity surrounding the role of adolescents in the decision-making process for research participation. Depending on the nature of the study and the regulations involved, adolescents may have independent responsibility for providing informed consent, they may be asked to provide their assent, or they may be completely excluded from the decision-making process. This study examined parent and adolescent perceptions of decision-making authority and sources of influence on adolescent research participation decisions, and examined whether perceptions of influence differed based on adolescent gender and level of research risk. Adolescents (n = 36) with asthma and their parents reviewed 9 pediatric research protocols, decided whether they would choose to participate, rated the extent they would be responsible for the actual decision, and indicated the ability of family and physician to influence their decisions. Multivariate analyses of variance were used to evaluate differences in perceptions of decision-making authority and sources of influence on the decisions. Adolescents were less willing to cede decision making authority to parents than parents anticipated. Parents and adolescents acknowledged a greater openness to influence from physicians than from family for above minimal risk studies. Parents were more willing to consider opinions from male adolescents. Adolescents desire responsibility for research participation decisions, though parents may not share these views. Physicians' views on research participation are important to families, especially for above minimal risk studies. Parents may grant more decision-making autonomy to adolescent males than to females. Researchers, physicians, and institutions play a key role in facilitating the ethical enrollment of adolescents into biomedical research. Educational, policy, and oversight processes that support both adolescent autonomy and parental responsibility for research participation decision-making in biomedical research are discussed.

Comparisons of adolescent and parent willingness to participate in minimal and above-minimal risk pediatric asthma research protocols

Purpose Through the processes of permission and assent, parents and adolescents have a shared involvement in decision-making about adolescent research participation. Yet little empirical data exists examining the prevalence and contexts in which adolescents and parents disagree on research participation decisions. The purpose of this study was to compare parent and adolescent willingness to participate in minimal and above-minimal risk pediatric asthma research protocols. Method Thirty-six adolescents diagnosed with asthma and a parent of each, independently rated their willingness to participate in nine pediatric asthma research protocol vignettes. The selected protocols were chosen by an expert panel as representative of typical minimal and above-minimal risk pediatric asthma studies. Results Parents and adolescents were significantly less likely to enroll in above-minimal risk studies. However, this was qualified by a finding that adolescents were significantly more willing than parents to enroll in above-minimal risk research. Across all nine studies, parents and adolescents held concordant views on participation decisions 60% of the time, on average. Perception of potential study benefit was the most frequent reason provided for participation decisions by both parents and adolescents. Conclusion Parents and their adolescents report substantial discordance in their views about participating in asthma research across a variety of protocols. These differences of opinion highlight the need to carefully consider the process by which families are offered the option of adolescent research participation. Investigators may want to adopt recruitment procedures that involve adolescents in initial discussions, especially for above-minimal risk studies.

Third-party informed consent in research with adolescents: The good, the bad and the ugly

Third-party informed consent for child and adolescent participation in research is a legal requirement that has been questioned by authors who argue that children over 10 are fully able to make decisions regarding this matter. The extent to which this requirement encumbers survey researches in this age range has not been fully reported. In order to understand the reasons for the inconsistent use of condoms among adolescent students in Rio de Janeiro, we designed a survey based on an anonymous self-reported questionnaire. Two informed consent terms were distributed: one for the adolescent and one for the legal representative signature. Participation was offered to all students aged 12–18 attending class at the day of the consent term distribution. Among 906 distributed legal represents consent terms, 734 (81%) were not returned. The final sample probably presented a bias of selection. Researchers must foresee third-party consent as a major encumbrance. There is a need for the definition of a range of interventions in which the adolescent might have the legal recognition of autonomy for decision about his/her voluntary participation.

Guidelines for Adolescent Health Research*1, *2A position paper of the Society for Adolescent Medicine

Guidelines for Adolescent Health Research*1, *2A position paper of the Society for Adolescent Medicine

A Case Study in Adolescent Participation in Clinical Research: Eleven Clinical Sites, One Common Protocol, and Eleven IRBs

A Case Study in Adolescent Participation in Clinical Research: Eleven Clinical Sites, One Common Protocol, and Eleven IRBs

Adolescent participation in clinical research: Eleven sites, one common protocol, eleven IRBS

Adolescent participation in clinical research: Eleven sites, one common protocol, eleven IRBS

Adolescents as Research Subjects Without Permission of Their Parents or Guardians: Ethical Considerations

This paper is presented in five sections: I. The first is an overview of current ethical standards for all research involving children relating them to the recommendations of the National Commission for the Protection of Human Subjects (hereafter called The National Commission). II. The second section reviews the exceptions from the general requirements of the regulations for children permitted for some research involving adolescents. This section demonstrates that current regulations may be interpreted to permit the conduct without parents or guardians permission of much more research involving adolescents than is currently being done. This point notwithstanding I recommend that such interpretations should not be implemented without first having the relevant policies reviewed by an authoritative agency such as The National Commission. III. This section explains why I consider this an appropriate time to reconsider national policies regarding research involving adolescents. Current policies reflect the attitude of the time in which they were written--that research is both dangerous to and exploitative of persons particularly those who are vulnerable. They do not reflect the recent changes in the publics perception that participation in research is often beneficial particularly for some vulnerable populations and their individual members. IV. This section is an appraisal of the Guidelines for Adolescent Participation in Research proposed by The Adolescent Scientific Committee of the Pediatric AIDS Clinical Trials Group. The availability of this document affords a valuable opportunity to evaluate a carefully thought out comprehensive proposal. V. The final section presents my recommendations for guidelines for the conduct of research involving mature minors without permission of their parents or guardians. (excerpt)

Guidelines for Adolescent Participation in Research: Current Realities and Possible Resolutions

Guidelines for Adolescent Participation in Research: Current Realities and Possible Resolutions

Guidelines for Adolescent Participation in Research: Current Realities and Possible Resolutions

morbidity in adolescents from drug abuse, preventable injury, violence, and unprotected sexual activity continues to increase. Moreover, with AIDS this generation of adolescents is threatened by an epidemic of potentially devastating proportions. This epidemic requires that the origins of risk-taking behaviors be understood in appropriate developmental and behavioral terms and that every opportunity be seized to learn what programs are effective in adolescent risk reduction and health mainte-