Federal regulations governing the ethical participation of adolescents in research emphasize that adolescents be afforded as much decision-making autonomy as possible according to their developmental capabilities. Yet little empirical research has examined factors that may compromise an adolescent's voluntary assent to participate in research. We propose to conduct two studies that together will explore the influences of family, clinical investigator, and research risk/benefit on the ability of adolescents to provide a voluntary assent to participate in research. The focus in both studies is on examining parental influence strategies in a variety of circumstances where parents and adolescents disagree about research participation. In the first study we will examine investigator influences on assent decisions. In the second study we will hold investigator influences constant and then evaluate the impact of research risk and benefit on the process of adolescent and parent decision making about research participation. In both studies we will use hypothetical asthma research vignettes, presented to families with children diagnosed with asthma. An important preliminary step to the project is a vignette validation Pre-Study, where assessments of risks and benefits of the research vignettes will be independently evaluated by adolescents, parents, and clinical investigators. In both Study 1 and Study 2 all family members will first view the videotaped description of a single hypothetical research protocol. Private reactions and participation decisions will then be obtained from all family members. The family will then participate in a videotaped family interaction with instructions to discuss the research vignette and make a final participation decision. Private views of the final decision will then be obtained from all family members. The focus of the analysis for both studies will be on examining the videotaped communication interactions between adolescents and parents as they discuss the adolescent's participation in the research. We will examine the manner in which family communication patterns mediate the assent process in families. We also will examine the influence of important family factors such as illness severity and family relationships, by testing a structural model which characterizes relationships among these factors and their effects on voluntary assent. We anticipate that the findings of the proposed research will have a direct bearing on issues that facilitate compliance and retention into research protocols. As such we expect to make a significant contribution to enhancing both the effectiveness and ethics of adolescent research.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
5R01HL064677-04
Application #
6765912
Study Section
Special Emphasis Panel (ZRG1-SNEM-4 (03))
Program Officer
Ortega, Hector
Project Start
2001-04-05
Project End
2005-08-31
Budget Start
2004-06-01
Budget End
2005-08-31
Support Year
4
Fiscal Year
2004
Total Cost
$338,478
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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