title: Empirically-derived Knowledge on Adolescent Assent to Pediatric Biomedical Research.
abstract: BACKGROUND
  There has been a recent growth in empirical research on assent with pediatric populations, due in part, to the demand for increased participation of this population in biomedical research. Despite methodological limitations, studies of adolescent capacities to assent have advanced and identified a number of salient psychological and social variables that are key to understanding assent.
  
  
  METHODS
  The authors review a subsection of the empirical literature on adolescent assent focusing primarily on asthma and cancer therapeutic research; adolescent competencies to assent to these studies; perceptions of protocol risk and benefit; the affects of various social context variables on adolescent research participation decision making; and the inter-relatedness of these psychological and social factors.
  
  
  RESULTS
  Contemporary studies of assent, using multivariate methods and updated approaches to statistical modeling, have revealed the importance of studying the intercorrelation between adolescents' psychological capacities and their ability to employ these capacities in family and medical decision-making contexts. Understanding these dynamic relationships will enable researchers and ethicists to develop assent procedures that respect the authority of parents, while at the same time accord adolescents appropriate decision-making autonomy.
  
  
  CONCLUSIONS
  Reviews of empirical literature on the assent process reveal that adolescents possess varying capacities for biomedical research participation decision making depending on their maturity and the social context in which the decision is made. The relationship between adolescents and physician-investigators can be used to attenuate concerns about research protocols and clarify risk and benefit information so adolescents, in concert with their families, can make the most informed and ethical decisions. Future assent researchers will be better able to navigate the complicated interplay of contextual and developmental factors and develop the empirical bases for research enrollment protocols that will support increased involvement of adolescents in biomedical research.
authors.affiliation: Department of Psychology, University of Massachusetts Amherst, 610 Tobin Hall, 135 Hicks Way, Amherst, MA 01003.
authors.forename: David G
authors.initials: DG
authors.lastname: Scherer
authors.forename: Janet L
authors.initials: JL
authors.lastname: Brody
authors.forename: Robert D
authors.initials: RD
authors.lastname: Annett
authors.forename: Charles
authors.initials: C
authors.lastname: Turner
authors.forename: Jeanne
authors.initials: J
authors.lastname: Dalen
authors.forename: Yesel
authors.initials: Y
authors.lastname: Yoon
keywords: Assent; Informed Consent; Pediatric Biomedical Research; Research Ethics; Research Participation Decision-making
references.citation: Arch Dis Child. 2011 Oct;96(10):960-2
references.pmid: 21775300
references.citation: Child Dev. 2010 Mar-Apr;81(2):636-51
references.pmid: 20438465
references.citation: Ethics Behav. 2003;13(1):79-95
references.pmid: 14552306
references.citation: J Asthma. 2009 Jun;46(5):492-7
references.pmid: 19544171
references.citation: New Dir Child Adolesc Dev. 2005 Summer;(108):61-9
references.pmid: 16121897
references.citation: Soc Sci Med. 1995 Apr;40(7):903-18
references.pmid: 7792630
references.citation: Health Psychol. 1995 May;14(3):217-22
references.pmid: 7641662
references.citation: J Pediatr. 1992 Oct;121(4):547-52
references.pmid: 1403387
references.citation: Pediatrics. 2010 Apr;125(4):e876-83
references.pmid: 20351001
references.citation: Pediatr Clin North Am. 2008 Feb;55(1):211-22, xii
references.pmid: 18242322
references.citation: Pediatr Blood Cancer. 2010 Jul 15;55(1):123-8
references.pmid: 20486177
references.citation: Child Dev. 1982 Dec;53(6):1589-98
references.pmid: 7172783
references.citation: J Allergy Clin Immunol. 2004 Nov;114(5):1138-45
references.pmid: 15536422
references.citation: Law Hum Behav. 1991 Aug;15(4):431-49
references.pmid: 11660093
references.citation: Am Psychol. 1973 Jul;28(7):587-91
references.pmid: 11643586
references.citation: Health Expect. 2008 Dec;11(4):343-54
references.pmid: 19076663
references.citation: J Med Ethics. 2009 Jul;35(7):450-5
references.pmid: 19567697
references.citation: Soc Sci Med. 2004 May;58(9):1689-97
references.pmid: 14990370
references.citation: Ethics Behav. 2003;13(3):237-47
references.pmid: 14680002
references.citation: J Pediatr Hematol Oncol. 2008 Nov;30(11):823-8
references.pmid: 18989159
references.citation: Soc Sci Med. 2007 Nov;65(10):2105-15
references.pmid: 17689846
references.citation: Pediatrics. 2006 May;117(5):1806-10
references.pmid: 16651340
references.citation: J Soc Psychol. 1979 Dec;109(2):223-30
references.pmid: 11665208
references.citation: Res Nurs Health. 2006 Jun;29(3):223-32
references.pmid: 16676342
references.citation: J Pediatr. 2006 Jul;149(1 Suppl):S25-30
references.pmid: 16829238
references.citation: J Adolesc Health. 2012 Sep;51(3):252-8
references.pmid: 22921135
references.citation: Child Dev. 2002 Mar-Apr;73(2):563-80
references.pmid: 11949909
references.citation: Nurse Res. 2012;19(2):23-7
references.pmid: 22338805
references.citation: Cancer. 1998 Jun 15;82(12):2467-81
references.pmid: 9635541
references.citation: Am Psychol. 1993 Feb;48(2):102-16
references.pmid: 8442566
references.citation: Law Hum Behav. 1988 Jun;12(2):123-41
references.pmid: 11653858
references.citation: Arch Intern Med. 2004 Apr 12;164(7):801-3
references.pmid: 15078651
references.citation: J Adolesc Health. 2003 Apr;32(4):260-71
references.pmid: 12667730
references.citation: J Pediatr. 2003 Feb;142(2):89-90
references.pmid: 12584521
references.citation: J Med Ethics. 2005 Dec;31(12):715-20
references.pmid: 16319237
references.citation: Ethics Behav. 2004;14(3):255-95
references.pmid: 15875339
references.citation: Ethics Behav. 1995;5(1):25-48
references.pmid: 11654169
references.citation: Pediatrics. 2002 May;109(5):806-14
references.pmid: 11986440
references.citation: Med Health Care Philos. 2005;8(3):307-13
references.pmid: 16283493
references.citation: Pediatrics. 2006 Aug;118(2):e356-62
references.pmid: 16882778
references.citation: Pain. 1990 Jan;40(1):53-60
references.pmid: 2339016
references.citation: J Pediatr Hematol Oncol. 2000 Jan-Feb;22(1):3-12
references.pmid: 10695815
references.citation: J Med Ethics. 2011 Aug;37(8):504-9
references.pmid: 21636608
references.citation: Psychol Sci Public Interest. 2006 Sep;7(1):1-44
references.pmid: 26158695
references.citation: PLoS Med. 2007 Nov 27;4(11):e324
references.pmid: 18044980
references.citation: J Am Acad Child Adolesc Psychiatry. 1995 Jul;34(7):929-39
references.pmid: 7649964
references.citation: Pediatrics. 2006 May;117(5):1706-11
references.pmid: 16651328
references.citation: J Med Ethics. 1998 Jun;24(3):158-65
references.pmid: 9650109
references.citation: J Adolesc Health. 2002 Dec;31(6 Suppl):208-15
references.pmid: 12470917
references.citation: IRB. 2003 Sep-Oct;Suppl 25(5):S20-S23
references.pmid: 14870734
references.citation: J Exp Psychol Appl. 2011 Dec;17(4):396-405
references.pmid: 22059954
references.citation: J Adolesc Health. 2005 Sep;37(3):229-35
references.pmid: 16109343
references.citation: J Pediatr. 2006 Dec;149(6):862-868
references.pmid: 17137908
references.citation: J Adolesc Health. 2003 Nov;33(5):396-409
references.pmid: 14596961
references.citation: Prof Psychol Res Pr. 1985 Jun;16(3):411-7
references.pmid: 11650746
references.citation: Pediatrics. 2007 Jan;119(1):46-51
references.pmid: 17200270
references.citation: Arch Pediatr Adolesc Med. 2011 Jun;165(6):533-9
references.pmid: 21646586
references.citation: J Adolesc Health. 2002 Jul;31(1 Suppl):10-27
references.pmid: 12093608
references.citation: J Empir Res Hum Res Ethics. 2011 Dec;6(4):68-75
references.pmid: 22228061
references.citation: Child Dev. 1996 Aug;67(4):1870-86
references.pmid: 8890513
references.citation: J Pediatr. 2005 Apr;146(4):552-8
references.pmid: 15812465
references.citation: J Pediatr Hematol Oncol. 2003 Oct;25(10):787-90
references.pmid: 14528101
references.citation: J Med Ethics. 2012 Jan;38(1):3
references.pmid: 22174366
references.citation: Cancer. 2001 Aug 1;92(3):691-700
references.pmid: 11505417
references.citation: BMC Med Ethics. 2011 Sep 27;12:18
references.pmid: 21943406
references.citation: J Asthma. 2007 Sep;44(7):489-96
references.pmid: 17885849
references.citation: J Law Med Ethics. 2008 Fall;36(3):567-76
references.pmid: 18840250
references.citation: Child Dev. 1998 Apr;69(2):458-78
references.pmid: 9586219
references.citation: Pediatrics. 2007 Jul;120(1):e68-77
references.pmid: 17606551
references.citation: Theor Med Bioeth. 2003;24(2):131-48
references.pmid: 12943268
references.citation: IRB. 2003 Sep-Oct;Suppl 25(5):S4-S10
references.pmid: 14870730
references.citation: BMC Public Health. 2012 Jul 07;12:509
references.pmid: 22768870
references.citation: Curr Psychol. 1991 Spring-Summer;10(1-2):79-91
references.pmid: 11653992