Informed consent in pediatric clinical trials

Current Opinion in Pediatrics

Volumn 17, Issue 1, 2005, Pages 20-24

  Barfield, Raymond C ^a   Church, Christopher ^b  

^a ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^b Baptist College of Health Sciences   (United States)

Author keywords

Assent; Clinical trials; Consent; Pediatrics; Permission

Indexed keywords

DNA TOPOISOMERASE INHIBITOR;

AVERSION; CANCER PALLIATIVE THERAPY; CANCER RISK; CANCER SUSCEPTIBILITY; CHILD PARENT RELATION; CHILDHOOD CANCER; CLINICAL PROTOCOL; CLINICAL RESEARCH; CLINICAL TRIAL; COMPETENCE; CULTURAL FACTOR; GOVERNMENT REGULATION; HUMAN; INFORMED CONSENT; LIFE EVENT; PARENTAL CONSENT; PEDIATRICS; PRIORITY JOURNAL; RECURRENT DISEASE; REVIEW; RISK ASSESSMENT;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

ADOLESCENT; AGE FACTORS; CHILD; CLINICAL TRIALS; CLINICAL TRIALS, PHASE I; COMPREHENSION; HUMANS; INFORMED CONSENT; MENTAL COMPETENCY; PARENTAL CONSENT; RANDOMIZED CONTROLLED TRIALS;

EID: 12744269208     PISSN: 10408703     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.mop.0000145718.77939.b1     Document Type: Review

References (34)

1. Lederer SE: Children as guinea pigs: historical perspective. Account Res 2003; 10:1-16. An excellent historical review that gives much of the background for current debates on participation of children in medical research.
2. Kipnis K: Seven vulnerabilities in the pediatric research subject. Theor Med Bioeth 2003; 24:107-120. Identifies seven vulnerabilities in the pediatric research population and offers the important contribution of suggestion strategies for accommodating these populations so that research may proceed to their benefit.
3. Harris J: In praise of unprincipled ethics. J Med Ethics 2003; 29:303-306.
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5. Kodish E: Informed consent for pediatric research: is it really possible? J Pediatr 2003; 142:89-90. Provides an argument for "best interests of the child" as the basis for consent in pediatrics rather than "autonomy." Makes a clear distinction between giving permission for treatment and for research.
6. National Commission for the protection of human subjects of biomedical and behavioral research: The Belmont Report. DHEW Publication OS 78-0012, 1978.
7. Cohen IG: Therapeutic orphans, pediatric victims: the best pharmaceuticals for children act and existing pediatric human subject protection. Food Drug Law J 2003; 58:661-710. This assessment extends well beyond the legal issues and underscores the question whether current regulations in the United States and the "common rule" adequately protect children.
8. Burns JP: Research in children. Crit Care Med 2003; 31(Suppl 3):S131-S136. A useful update on federal regulations in the United States with an interesting historical background.
9. Shah S, Whittle A, Wilfond B, et al. How do institutional review boards apply the federal risk and benefit standards for pediatric research? JAMA 2004; 291:476-482.
10. Wendler D, Forster H: Why we need legal standards for pediatric research. J Pediatr 2004; 144:150-153. Calls attention to gaps in federal regulations in the United States regarding assent as well as to the wide variance in institutional review board practice.
11. Lantos JD: Pediatric research: what is broken and what needs to be fixed? J Pediatr 2004; 144:147-149.
12. Offit K, Bertagnolli MM, Bombard AT, et al. ASCO Working Group. American Society of Clinical Oncology Policy Statement Update: Genetic testing for cancer susceptibility. J Clin Oncol 2003; 21:2397-2406. Especially helpful regarding the complex issues of testing children for cancer susceptibility, including how much leeway parents have to consent in different contexts and what is age-appropriate involvement of the child.
13. Kerr C, Robinson E, Stevens A, et al. Randomization in trials: do potential trial participants understand it and find it acceptable? J Med Ethics 2004; 30:80-84.
14. Kodish E, Eder M, Noll RB, et al. Communication of randomization in childhood leukemia trials. JAMA 2004; 291:470-475. Suggestions to improve understanding of randomization are especially good. This article documents factors associated with understanding of randomization.
15. Flynn JT: Ethics of placebo use in pediatric clinical trials: the case of antihypertensive drug studies. Hypertension 2003; 42:865-869. Reviews the complexity of placebo use and offers guidelines derived from the specific context of using placebos in hypertension trials.
16. Kodish E: Pediatric ethics and early-phase childhood cancer research: conflicted goals and the prospect of benefit. Account Res 2003; 10:17-25. A useful response to the changing character of Phase I studies in children based on optimal biologic dose rather than maximal tolerated dose.
17. Simon C, Zyzanski SJ, Eder M, et al. Groups potentially at risk for making poorly informed decisions about entry into clinical trials for childhood cancer. J Clin Oncol 2003; 21:2173-2178. Identifies problems in making poorly informed decisions about randomized clinical trials, especially problems faced by Spanish speakers at hospitals in the United States.
18. Rossi WC, Reynolds W, Nelson RM: Child assent and parental permission in pediatric research. Theor Med Bioeth 2003; 24:131-148. The question of when assent is reasonably sought from the child is important. The authors rightly question the usual threshold of assent and offer suggestions for a more fluid model.
19. Olds RS: Informed-consent issues with adolescent health behavior research. Am J Health Behav 2003; 27(Suppl 3):S248-S263.
20. Lothen-Kline C, Howard DE, Hamburger EK, et al. Truth and consequences: ethics, confidentiality, and disclosure in adolescent longitudinal prevention research. J Adolesc Health 2003; 33:385-394.
21. Brody JL, Scherer DG, Annett RD, et al. Voluntary assent in biomedical research with adolescents: a comparison of parent and adolescent views. Ethics Behav 2003; 13:79-95. Helps to fill in the gap in research about the differences in perception between parents and adolescents regarding biomedical research, with an interesting analysis of "risk" versus "aversion."
22. Freyer DR: Care of the dying adolescent: special considerations. Pediatrics 2004; 113:381-388. The final stage conference is an interesting idea. This is also a very useful synthesis of existing opinion on topics such as the age-dependent differences in Phase I, II, and III trials; truth telling in end-of-life situations; and the importance of the family.
23. Spinetta JJ, Masera G, Jankovic M, et al. SIOP Working Committee on psychosocial issues in pediatric oncology. Valid informed consent and participative decision-making in children with cancer and their parents: a report of the SlOP Working Committee on psychosocial issues in pediatric oncology. Med Pediatr Oncol 2003; 40:244-246.
24. Salazar JC: Pediatric clinical trial experience: government, child, parent and physician's perspective. Pediatr Infect Dis J 2003; 22:1124-1127.
25. Kupst MJ, Patenaude AF, Walco GA, et al. Clinical trials in pediatric cancer: parental perspectives on informed consent. Pediatr Hematol Oncol 2003; 25:787-790. Useful in identifying problem areas regarding the consent discussion for complex ideas such as randomization and alternatives to clinical trials.
26. Tait AR, Voepel-Lewis T, Malviya S: Participation of children in clinical research: factors that influence a parent's decision to consent. Anesthesiology 2003; 99:819-825. Understanding all factors that influence the consent process - including those unrelated to risk or treatment efficacy - is important for improving the process. This article examines many such factors in the context of anesthesia and shows an approach that might be used for similar research in other contexts.
27. Rothmier JD, Lasley MV, Shapiro GG: Factors influencing parental consent in pediatric clinical research. Pediatrics 2003; 111:1037-1041. Defines a group of factors that influence parental consent in clinical asthma research with children. These factors are generalizable and should be attended to by researchers from other fields.
28. Knapp JF, Dolan MA, Furnival RA, et al. Consent for emergency medical services for children and adolescents. Committee on Pediatric Emergency Medicine. Pediatrics 2003; 111:703-706.
29. Connelly R: Ethical issues in the use of covert video surveillance in the diagnosis of Munchausen syndrome by proxy: the Atlanta study - an ethical challenge for medicine. HEC Forum 2003; 15:21-41. An interesting analysis of a situation in which obtaining informed consent may be self-defeating, given the best interests of the child.
30. Berger JE: Consent by proxy for nonurgent pediatric care. American Academy of Pediatrics Committee on Medical Liability. Pediatrics 2003; 112:1186-1195. A thorough presentation of the demographics that make "consent by proxy" a necessary and common occurrence, with practical suggestions for implementing such consent in the context of nonurgent pediatric care.
31. Halpern J: Responding to the need behind the question "Doctor, if this were your child, what would you do?". J Clin Ethics 2003; 14:71-78. Helps to uncover the unspoken complexities underlying this common question asked by parents.
32. Fernandez CV, Kodish E, Taweel S, et al. Children's Oncology Group. Disclosure of the right of research participants to receive research results: an analysis of consent forms in the Children's Oncology Group. Cancer 2003; 97:2904-2909. A study finding that the right to receive research results is rarely made explicit in the consent forms. Discusses ways in which summaries might be used.
33. Vitiello B: Ethical considerations in psychopharmacological research involving children and adolescents. Psychopharmacology (Berl) 2003; 171:86-91.
34. Angiolillo AL, Simon C, Kodish E, et al. Staged informed consent for a randomized clinical trial in childhood leukemia: impact on the consent process. Pediatr Blood Cancer 2004; 42:433-437. With the increasing complexities of treatments for childhood diseases, new and better approaches to consent are needed. This study shows one very interesting innovation.