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

Levine, Robert J.

doi:10.1016/1054-139x(95)00175-r

Cited by 69 publications

(50 citation statements)

References 13 publications

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“…Studies of adolescent substance use have grappled with the issue of parental consent for several decades [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19]. Obtaining permission from parents for participation in research may improve adherence with study protocols, enhance parent-child communication, and promote trust and respect among family members [20,21].…”

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confidence: 99%

The Role of Parental Consent in Adolescent Substance Use Research

Rojas¹,

Sherrit²,

Harris³

et al. 2008

Journal of Adolescent Health

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confidence: 99%

The Role of Parental Consent in Adolescent Substance Use Research

Rojas¹,

Sherrit²,

Harris³

et al. 2008

Journal of Adolescent Health

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“…Moreover, minimal risk studies on sensitive topics such as HIV or substance use may be hindered by privacy concerns when parental permission is required [14]. A National Survey of Institutional Review Boards' attitudes finds substantial support for revision of legal requirements that would allow adolescents to independently consent to certain categories of minimal risk research [15], a position also recently endorsed by the Society for Adolescent Medicine [16].…”

mentioning

confidence: 99%

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

Brody

Annett

Scherer

et al. 2005

Journal of Adolescent Health

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Purpose-Much has been written about conceptual concern for voluntary assent with children and adolescents. However, little empirical data exists examining the frequency with which, or context 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-36 adolescents diagnosed with asthma and one of their parents independently rated their willingness to participate in 9 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 agree 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 9 studies, parents and adolescents held concordant views on participation decisions approximately 60% of the time. 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 a consistent 40% discordance in their views about participating in asthma research across a variety of asthma research protocols, with adolescents more willing than their parents to enroll in above minimal risk studies. These differences of opinion highlight the need to carefully consider the process by which families are offered the option of adolescent research participation. The role of the adolescent in research participation decision-making is ambiguous. While federal regulations give parents legal responsibility for providing permission, consensus standards view adolescent assent as a moral and ethical imperative [1][2][3][4], with an adolescent's desire to dissent generally considered binding, particularly for non-therapeutic research. KeywordsSeveral models for adolescent participation in research and treatment decision-making have been proposed [5][6][7][8]. Inherent in the formulation of these models are differing views on the best way to protect the rights and interests of children and adolescents. Autonomy focused models [6,9] propose that adolescents should be approached alone after parental permission has been granted. This procedure highlights concern that adolescents exercise decision-making independently of their parents and treatment providers. Proponents of this model argue there may be competing interests between parents and adolescents in participation decision-making that result in different choices [10][11][12] Recent interview studies of parents and adolescents involved in research find that parents see their role as ensuring their child's best interest is upheld and protecting them from harm [6,17]. Factors that appear salient to parents' attitudes on what constitutes the child's best interest...

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“…There is evidence of great variability in decision-making on adolescent consent and a general tendency to favour cautious approaches to the matter (Mammel and Kaplan, 1995;Piercy and hargate, 2004;Rogers et al, 1999;Wagener et al, 2004). There certainly seems to be a need to clarify the scope that RECs have in waiving parental informed consent requirements (Wagener et al, 2004) and there is an acknowledgement of the ethical weight of arguments in favour of full adolescent consent for at least certain categories of research (Levine, 1995;Mammel and Kaplan, 1995). Some proposals for ethical guidance for adolescent research have been made, highlighting the need for facilitating research to increase knowledge of adolescent health (Rogers et al, 1994;Santelli et al, 1995 and.…”

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confidence: 99%