Effective implementation of federal regulations governing research assent requirements for minors has been hampered by scant empirical research and limited regulatory guidance on how to appropriately ensure voluntary assent from research participants who span the entire developmental spectrum of childhood and adolescence. This lack of guidance has resulted in disagreements about the most propitious and ethical methods of acquiring consent/assent from minors, with clinicians, investigators, and ethicists endorsing disparate philosophies and procedures for obtaining assent. The two studies proposed in this application begin the much-needed process of harnessing emerging empirical findings to develop testable interventions that enhance the assent process for children and adolescents. There is growing advocacy among scientists, ethicists, and policy makers for increasing the rights of adolescents to make more independent research participation and medical treatment decisions. Study 1 of the present application proposes to test an """"""""autonomy enhanced assent"""""""" intervention for obtaining adolescent research assent and parental permission against an """"""""assent as usual"""""""" intervention conducted in the context of an actual pediatric asthma clinical trial for adolescents (ages 12-17). Relationships between the assent intervention and completion/compliance with the asthma trial will also be evaluated. If the process for obtaining research assent from adolescents emphasizes autonomy, then research assent for younger children, who are more cognitively, psychologically, and functionally dependent upon parents, ought to be conceptualized in a qualitatively different manner. There is almost no empirical literature that addresses how parents and investigators approach research participation decisions for young children, how assent for young children is obtained, or what children are capable of understanding about research. Study 2 of this proposal examines both typical parent behavior and the influence of clinician-investigator recommendations, on permission and assent for the participation of young children (ages 6-11) in a hypothetical asthma research protocol. A brief educational intervention to enhance parents' understanding of the importance of child assent, will also be evaluated for its impact on the willingness of parents to honor child dissent and on the child's understanding of the research protocol.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
5R01HL064677-08
Application #
7455813
Study Section
Special Emphasis Panel (ZRG1-HOP-E (50))
Program Officer
Taggart, Virginia
Project Start
2000-04-01
Project End
2010-06-30
Budget Start
2008-07-01
Budget End
2010-06-30
Support Year
8
Fiscal Year
2008
Total Cost
$341,364
Indirect Cost
Name
Oregon Research Institute
Department
Type
DUNS #
053615423
City
Eugene
State
OR
Country
United States
Zip Code
97403
Annett, Robert D; Brody, Janet L; Scherer, David G et al. (2017) A randomized study of a method for optimizing adolescent assent to biomedical research. AJOB Empir Bioeth 8:189-197
Scherer, David G; Brody, Janet L; Annett, Robert D et al. (2013) Empirically-derived Knowledge on Adolescent Assent to Pediatric Biomedical Research. AJOB Prim Res 4:15-26
Brody, Janet L; Dalen, Jeanne; Annett, Robert D et al. (2012) Conceptualizing the role of research literacy in advancing societal health. J Health Psychol 17:724-30
Brody, Janet L; Turner, Charles W; Annett, Robert D et al. (2012) Predicting adolescent asthma research participation decisions from a structural equations model of protocol factors. J Adolesc Health 51:252-8
Annett, Robert D; Turner, Charles; Brody, Janet L et al. (2010) Using structural equation modeling to understand child and parent perceptions of asthma quality of life. J Pediatr Psychol 35:870-82
Brody, Janet L; Annett, Robert D; Scherer, David G et al. (2009) Enrolling adolescents in asthma research: adolescent, parent, and physician influence in the decision-making process. J Asthma 46:492-7
Scherer, David G; Annett, Robert D; Brody, Janet L (2007) Ethical issues in adolescent and parent informed consent for pediatric asthma research participation. J Asthma 44:489-96
Brody, Janet L; Scherer, David G; Annett, Robert D et al. (2006) Family and physician influence on asthma research participation decisions for adolescents: the effects of adolescent gender and research risk. Pediatrics 118:e356-62
Brody, Janet L; Annett, Robert D; Scherer, David G et al. (2005) Comparisons of adolescent and parent willingness to participate in minimal and above-minimal risk pediatric asthma research protocols. J Adolesc Health 37:229-35
Scherer, David G; Brody, Janet L; Annett, Robert D et al. (2005) Financial compensation to adolescents for participation in biomedical research: adolescent and parent perspectives in seven studies. J Pediatr 146:552-8

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