Ethical Issues in Adolescent and Parent Informed Consent for Pediatric Asthma Research Participation

References

• Abramovitch R, Freedman J L, Henry K, Van B M. Children's capacity to agree to psychological research: knowledge of risks and benefits and voluntariness. Ethics Behav 1995; 5(1)25–48
   PubMed Web of Science ®Google Scholar
• Kopelman L M. Children as research subjects: A dilemma. Journal of Medicine and Philosophy 2000; 25: 745–764
   PubMed Web of Science ®Google Scholar
• Levine R J. Adolescents as research subjects without permission of their parents or guardians: ethical considerations. J Adolesc Health 1995; 17: 287–297
   PubMed Web of Science ®Google Scholar
• Weithorn L A, Scherer D G. Children's involvement in research participation decisions: Psychological considerations. Children as research subjects: Science, ethics and law, Glanz Grodin. Oxford University Press, Oxford, New York 1994; 133
   Google Scholar
• U.S. Department of Health and Human Services Centers for Disease Control and Prevention. Summary health statistics for U.S. Children: National Health Interview Survey, 2002. Vital and Health Statistics 2004; 10(221)1–87
   Google Scholar
• Recruitment of participants in the childhood Asthma Management Program (CAMP). I. Description of methods: Childhood Asthma Management Program Research Group. J Asthma 1999; 36: 217
   PubMed Web of Science ®Google Scholar
• Sorkness C A, Ford J G, Lemanske R F, Jr. Recruitment strategies in the Asthma Clinical Research Network. Control Clin Trials Dec, 2001; 22: 222S–235S, (6 suppl)
   Google Scholar
• Bender B G, Annett R D, Ikle D, Hamel T R, Rand C, Strunk R C. Relationship between disease and psychological adaptation in children in the Childhood Asthma Management Program and their families. CAMP Research Group. Arch Pediatr Adolesc Med 2000; 154: 706–713
   PubMedGoogle Scholar
• Bender B G, Ikle D N, DuHamel T, Tinkelman D. Retention of asthmatic patients in a longitudinal clinical trial. J Allergy Clin Immunol Feb, 1997; 99: 197–203
   PubMedGoogle Scholar
• Scott E S, Reppucci N D, Woolard J L. Evaluating adolescent decision-making in legal contexts. Law Hum Behav 1995; 19: 224–243
   Google Scholar
• Steinberg L, Cauffman E. Maturity of judgement in adolescence: psychosocial factors in adolescent decision making. Law Hum Behav 1996; 20: 249–272
   Web of Science ®Google Scholar
• Abramovitch R, Freedman J L, Thoden K, Nikolich C. Children's capacity to consent to participation in psychological research: empirical findings. Child Development 1991; 62: 1100–1109
   Web of Science ®Google Scholar
• Gardner W, Scherer D, Tester M. Asserting scientific authority. Cognitive development and adolescent legal rights. Am Psychol Jun, 1989; 44: 895–902
   PubMedGoogle Scholar
• Grisso T. Minors' assent to behavioral research without parental consent. Social Research on Children and Adolescents, B Stanley, J E Seiber. Sage Publications, Newbury Park, California 1992; 109–127
   Google Scholar
• Scherer D G. The capacities of minors to exercise voluntariness in medical treatment decisions. Law Hum Behav 1991; 15: 431–449
   PubMed Web of Science ®Google Scholar
• Scherer D G, Chair. Parents' and children's informed consent to pediatric research and treatment. San Francisco, CA 2001, Symposium conducted at the APA Annual Convention
   Google Scholar
• Thompson R A. Vulnerability in research: a developmental perspective on research risk. Child Dev 1990; 61: 1–16
   PubMedGoogle Scholar
• Woolard J L, Reppucci N D, Redding R E. Theoretical and methodological issues in studying children's capacities in legal contexts. Law Hum Behav 1996; 20: 219–228
   Web of Science ®Google Scholar
• Annett R D, Brody J L, Scherer D G, Perkett E A. Perception of risk associated with asthma research procedures among adolescents, parents, and pediatricians. J Allergy Clin Immunol 2004; 114: 1138–1145
   PubMed Web of Science ®Google Scholar
• Brody J L, Annett R D, Scherer D G, Perryman M L, Cofrin K M. Comparisons of adolescent and parent willingness to participate in minimal and above-minimal risk pediatric asthma research protocols. J Adolesc Health 2005; 37: 229–235
   PubMed Web of Science ®Google Scholar
• Brody J L, Scherer D G, Annett R D, Pearson-Bish M. Voluntary assent in biomedical research with adolescents: a comparison of parent and adolescent views. Ethics Behav 2003; 13: 79–95
   PubMed Web of Science ®Google Scholar
• Brody J L, Scherer D G, Annett R D, Turner C, Dalen J. Family and physician influence on asthma research-participation decisions for adolescents: the effects of adolescent gender and research risk. Pediatrics 2006
   PubMedGoogle Scholar
• Scherer D G, Brody J L, Annett R D, Hetter J, Roberts L W, Cofrin K M. Financial compensation to adolescents for participation in biomedical research: adolescent and parent perspectives in seven studies. J Pediatr 2005; 146: 552–558
   PubMed Web of Science ®Google Scholar
• Broome M E. Consent (assent) for research with pediatric patients. Semin Oncol Nurs 1999; 15: 96–103
   PubMedGoogle Scholar
• Broome M E, Richards D J. The influence of relationships on children's and adolescents' participation in research. Nurs Res 2003; 52: 191–197
   PubMed Web of Science ®Google Scholar
• Broome M E, Richards D J, Hall J. Children in research: the experiences of ill children and adolescents. J Fam Nurs 2001; 7: 32–49
   Google Scholar
• Kodish E D, Pentz R D, Noll R B, Ruccione K, Buckley J, Lange B J. Informed consent in the Childrens Cancer Group: results of preliminary research. Cancer 1998; 82: 2467–2481
   PubMed Web of Science ®Google Scholar
• Olechnowicz J Q, Eder M, Simon C, Zyzanski S, Kodish E. Assent observed: children's involvement in leukemia treatment and research discussions. Pediatrics 2002; 109: 806–814
   PubMed Web of Science ®Google Scholar
• Hochhauser M. Concepts, categories, and value judgments in informed consent forms. IRB 2003; 25: 7–10
   PubMedGoogle Scholar
• Lawson S L, Adamson H M. Informed consent readability: subject understanding of 15 common consent form phrases. IRB 1995; 17(5-6)16–19
   PubMedGoogle Scholar
• Paasche-Orlow M K, Taylor H A, Brancati F L. Readability standards for informedconsent forms as compared with actual readability. N Engl J Med 2003; 348: 721–726
   PubMed Web of Science ®Google Scholar
• Ogloff J R, Otto R K. Are research participants truly informed? Readability of informed consent forms used in research. Ethics Behav 1991; 1: 239–252
   PubMedGoogle Scholar
• Cohn L D, Schydlower M, Foley J, Copeland R L. Adolescents' misinterpretation of health risk probability expressions. Pediatrics 1995; 95: 713–716
   PubMed Web of Science ®Google Scholar
• Fogas B S, Oesterheld J R, Shader R I. A retrospective study of children's perceptions of participation as clinical research subjects in a minimal risk study. J Dev Behav Pediatr 2001; 22: 211–216
   PubMedGoogle Scholar
• Tates K, Meeuwesen L. ‘Let mum have her say’: turntaking in doctor-parent-child communication. Patient Educ Couns 2000; 40: 151–162
   PubMed Web of Science ®Google Scholar
• Tates K, Meeuwesen L. Doctor-parent-child communication. A (re)view of the literature. Soc Sci Med 2001; 52: 839–851
   PubMed Web of Science ®Google Scholar
• Young R A, Lynam M J, Valach L, Novak H, Brierton I, Christopher A. Joint actions of parents and adolescents in health conversations. Qual Health Res 2001; 11: 40–57
   PubMedGoogle Scholar
• Responsible research: A systems approach to protecting research participants. Institute of Medicine, Washington, DC 2003
   Google Scholar
• Fisher C B. A relational perspective on ethics-in-science decisionmaking for research with vulnerable populations. IRB: A Review of Human Subjects Research 1997; 19: 1–4
   Google Scholar
• Fisher C B. Participant consultation: Ethical insights into parental permissions and confidentiality procedures for policy-relevant research with youth. Handbook of applied developmental science: promoting positive child, adolescent, and family development through research, policies, and programs, R M Lerner, F Jacobs, D Wertlieb. Sage Publications, Imprint Thousand Oaks, California 2003; 371–396
   Google Scholar
• Geller G, Tambor E S, Bernhardt B A, Fraser G, Wissow L S. Informed consent for enrolling minors in genetic susceptibility research: a qualitative study of at-risk children's and parents' views about children's role in decision-making. J Adolesc Health 2003; 32: 260–271
   PubMed Web of Science ®Google Scholar
• Field M J, Behrman R E, Institute of Medicine. Ethical conduct of clinical research involving children. National Academies, Washington, DC 2004
   Google Scholar
• Mccabe M A, Rushton C H, Glover J, Murray M G, Leikin S. Implications of the Patient Self-Determination Act: guidelines for involving adolescents in medical decision making. J Adolesc Health 1996; 19: 319–324
   PubMedGoogle Scholar
• Burke T M, Abramovitch R, Zlotkin S. Children's understanding of the risks and benefits associated with research. J Med Ethics 2005; 31: 715–720
   PubMed Web of Science ®Google Scholar
• Weithorn L A, Campbell S B. The competency of children and adolescents to make informed treatment decisions. Child Dev 1982; 53: 1589–1598
   PubMed Web of Science ®Google Scholar
• Halpern-Felsher B L, Caufmann E. Costs and benefits of a decision: Decisionmaking competence in adolescents and adults. Appl Devel Psychol 2001; 22: 257–273
   Web of Science ®Google Scholar
• 56 Federal Register 28003 (codified at 45 CFR 46). US Government Printing Office, Washington, DC 1991
   Google Scholar
• Weijer C. The ethical analysis of risk. J Law, Med Ethics 2000; 28: 344–361
   PubMed Web of Science ®Google Scholar
• Office for Human Research Protections, http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm IRB Guidebook (Chapter VI, Special Classes of Subjects) 2001Available from: URL: Available: at
   Google Scholar
• Cohn L D, Macfarlane S, Yanez C, Imai W K. Risk-perception: differences between adolescents and adults. Health Psychol 1995; 14: 217–222
   PubMed Web of Science ®Google Scholar
• Quadrel M J, Fischhoff B, Davis W. Adolescent (in)vulnerability. Am Psychol 1993; 48: 102–116
   PubMed Web of Science ®Google Scholar
• Susman E J, Dorn L D, Fletcher J C. Participation in biomedical research: the consent process as viewed by children, adolescents, young adults, and physicians. J Pediatr 1992; 121: 547–552
   PubMed Web of Science ®Google Scholar
• Kaser-Boyd N, Adelman H S, Taylor L. Minors' ability to identify risks and benefits of therapy. Prof Psychol Res Pr 1985; 16: 411–417
   PubMed Web of Science ®Google Scholar
• Arnold L E, Stoff D M, Cook E, Jr, Cohen D J, Kruesi M, Wright C, et al. Ethical issues in biological psychiatric research with children and adolescents. J Am Acad Child Adolesc Psychiatry 1995; 34: 929–939
   PubMed Web of Science ®Google Scholar
• Fradet C, McGrath P J, Kay J, Adams S, Luke B. A prospective survey of reactions to blood tests by children and adolescents. Pain 1990; 40: 53–60
   PubMed Web of Science ®Google Scholar
• Ondrusek N, Abramovitch R, Pencharz P, Koren G. Empirical examination of the ability of children to consent to clinical research. J Med Ethics 1998; 24: 158–165
   PubMed Web of Science ®Google Scholar
• Michaels T F, Oetting E R. The informed consent dilemma: an empirical approach. J Soc Psychol 1979; 109: 223–230
   PubMed Web of Science ®Google Scholar
• Sullivan D S, Deiker T E. Subject-experimenter perceptions of ethical issues in human research. Am Psychol 1973; 28: 587–591
   PubMed Web of Science ®Google Scholar
• Kupst M J. Clinical trials in pediatric cancer: Parental perspectives on informed consent. Parents' and children's informed consent to pediatric research and treatment 2001;Symposium conducted at the APA Annual Convention, San Francisco, CA. D G Scherer, Chair
   Google Scholar
• Skinner L J, Berry K K, Biro M, Jackson T. Research ethicality: the perceptions of participants and their participation willingness. Curr Psychol 1991; 10(1-2)79–91
   PubMedGoogle Scholar
• Holder A R, Veatch R M. Can teenagers participate in research without parental consent?. IRB 1981; 3(2)5–8
   PubMedGoogle Scholar
• English A, Kenney K E. State Minor Consent Laws: A Summary, 2nd ed. Center for Adolescent Health & the Law, Chapel Hill, NC 2003
   Google Scholar
• Mammel K A, Kaplan D W. Research consent by adolescent minors and institutional review boards. J Adolesc Health 1995; 17: 323–330
   PubMed Web of Science ®Google Scholar
• Society for Adolescent Medicine. Guidelines for adolescent health research. J Adoles Health 2003; 33: 396–409
   PubMedGoogle Scholar
• McGee G. Children's participation in nonbeneficial research: should they decide? Open peer commentaries. Am J Bioeth 2003; 3: 8–40
   PubMedGoogle Scholar
• Wendler D, Shah S. Should children decide whether they are enrolled in nonbeneficial research?. Am J Bioeth 2003; 3: 1–7
   PubMed Web of Science ®Google Scholar
• Milgram S. Behavioral study of obedience. J Abnorm Psychol 1963; 67: 371–378
   PubMed Web of Science ®Google Scholar
• Scherer D G, Reppuci N D. Adolescents' capacities to provide voluntary informed consent: the effects of parental influence and medical dilemmas. Law Hum Behav 1988; 12: 123–141
   PubMed Web of Science ®Google Scholar
• Lidz C W, Meisel A, Zerubavel E, Carter M, Sestak R M, Roth L H. Informed Consent: A Study of Decisionmaking in Psychiatry. Guilford Press, New York 1984
   Google Scholar
• Ong L M, de Haes J C, Hoos A M, Lammes F B. Doctor-patient communication: a review of the literature. Soc Sci Med 1995; 40: 903–918
   PubMed Web of Science ®Google Scholar
• Nucci L, Smetana J G. Mothers' concepts of young children's areas of personal freedom. Child Dev 1996; 67: 1870–1886
   PubMed Web of Science ®Google Scholar
• Pomerantz E M, Ruble D N. The role of maternal control in the development of sex differences in child self-evaluative factors. Child Dev 1998; 69: 458–478
   PubMed Web of Science ®Google Scholar
• Smetana J G, Daddis C. Domain-specific antecedents of parental psychological control and monitoring: the role of parenting beliefs and practices. Child Dev 2002; 73: 563–580
   PubMed Web of Science ®Google Scholar
• Kaminsky A, Roberts L W, Brody J L. Influences upon willingness to participate in schizophrenia research: an analysis of narrative data from 63 people with schizophrenia. Ethics Behav 2003; 13: 279–302
   PubMed Web of Science ®Google Scholar
• Aby J S, Pheley A M, Steinberg P. Motivation for participation in clinical trials of drugs for the treatment of asthma, seasonal allergic rhinitis, and perennial nonallergic rhinitis. Ann Allergy Asthma Immunol 1996; 76: 348–354
   PubMed Web of Science ®Google Scholar
• Dickert N, Grady C. What's the price of a research subject? Approaches to payment for research participation. N Engl J Med 1999; 341: 198–203
   PubMed Web of Science ®Google Scholar
• Dresser R. Payments to research participants: the importance of context. Am J Bioeth 2001; 1: 47
   PubMedGoogle Scholar
• Kuczewski M. Is informed consent enough? Monetary incentives for research participation and the integrity of biomedicine. Am J Bioeth 2001; 1: 49–51
   PubMedGoogle Scholar
• Vere D W. Payments to healthy volunteers–ethical problems. Br J Clin Pharmacol 1991; 32: 141–142
   PubMedGoogle Scholar
• Viens A M. Socio-economic status and inducement to participate. Am J Bioeth 2001; 1: 1f–2f
   Google Scholar
• Erlen J A, Sauder R J, Mellors M P. Incentives in research: ethical issues. Orthop Nurs 1999; 18: 84–87
   PubMedGoogle Scholar
• Grady C. Money for research participation: does in jeopardize informed consent?. Am J Bioeth 2001; 1: 40–4
   PubMedGoogle Scholar
• Savulescu J. The fiction of “undue inducement”: Why researchers should be allowed to pay participants any amount of money for any reasonable research project. Am J Bioeth 2001; 1: 1g–3g
   Google Scholar
• Siminoff L A. Money and the research subject: A comment on Grady. Am J Bioeth 2001; 1: 65–66
   PubMedGoogle Scholar
• Wilkenson M, Moore A. Inducement in research. Bioethics 1997; 11: 373–389
   PubMedGoogle Scholar
• Zink S. Maybe we should pay them more. Am J Bioeth 2001; 1: 1h
   Google Scholar
• Fernhoff P M. Paying for children to participate in research: a slippery slope or an enlightened stairway?. J Pediatr 2002; 141: 153–154
   PubMedGoogle Scholar
• Weise K L, Smith M L, Maschke K J, Copeland H L. National practices regarding payment to research subjects for participating in pediatric research. Pediatrics 2002; 110: 577–582
   PubMed Web of Science ®Google Scholar
• Wendler D, Rackoff J E, Emanuel E J, Grady C. The ethics of paying for children's participation in research. J Pediatr 2002; 141: 166–171
   PubMed Web of Science ®Google Scholar
• Lidz C W, Appelbaum P S, Grisso T. Therapeutic misconception and the appreciation of risks in clinical trials. Soc Sci & Med 2004; 58: 1689–1697
   PubMed Web of Science ®Google Scholar
• Vitiello B, Aman M G, Scahill L, McCracken J T, McDougle C J, Tierney E, Davies M, Arnold L E. Research knowledge among parents of children participating in a randomized clinical trial. JAm Acad Child Adol Psych 2005; 44: 145–149
   PubMed Web of Science ®Google Scholar
• Lemanek K L. Adherence. Handbook of Pediatric Psychology in School Settings, R T Brown. Lawrence Erlbaum Associates, Mahwah, NJ 2004; 149–168
   Google Scholar
• Brody J L, Gluck J P, Aragon A S. Participants' understanding of the process of psychological research: informed consent. Ethics Behav 1997; 7: 285–298
   PubMed Web of Science ®Google Scholar