Determining the Appropriateness of Including Children in Clinical Research: How Thick Is the Ice?

JAMA

Volumn 291, Issue 4, 2004, Pages 494-496

  Sugarman, Jeremy ^a,b  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CHILD; CLINICAL RESEARCH; CLINICAL TRIAL; EDITORIAL; EVIDENCE BASED MEDICINE; HUMAN; INFORMED CONSENT; MEDICAL ETHICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZATION; RISK ASSESSMENT;

EID: 1642458580     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.291.4.494     Document Type: Editorial

References (20)

1. Kahn JP, Mastroianni AM, Sugarman J, eds. Beyond Consent: Seeking Justice in Research. New York, NY: Oxford University Press; 1998.
2. Roberts R, Rodriquez W, Murphy D, Crescenzi T. Pediatric drug labeling: improving the safety and efficacy of pediatric therapies. JAMA. 2003;290:905-911.
3. Budetti PP. Ensuring safe and effective medications for children. JAMA. 2003;290:950-951.
4. Sugarman J. Ethics in the design and conduct of clinical research. Epidemiol Rev. 2002;24:54-58.
5. 45 CFR §46 (2002).
6. Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York, NY: Oxford University Press; 1986.
7. 45 CFR §46, Subpart D (2002).
8. Shah S, Whittle A, Wilfond B, Gensler G, Wendler D. How do institutional review boards apply the federal risk and benefit standards of pediatric research? JAMA. 2004;291:476-482.
9. Silverman H, Hull SC, Sugarman J. Variability among institutional review boards' decisions within the context of a multicenter trial. Crit Care Med. 2001;29:235-241.
10. National Institutes of Health. Required education in the protection of human research participants. Available at: http://grants.nih.gov/grants/guide/notice-files /NOT-OD-00-039.html. Accessibility verified December 8, 2003.
11. Applied Research Ethics National Association (ARENA). ARENA's objectives. Available at: http://www.primr.org/arena.html.Accessibility verified December 8, 2003.
12. Association for the Accreditation of Human Research Protection Programs. Final standards. Available at: http://www.aahrpp.org/images/standards.pdf. Accessibility verified December 9, 2003.
13. Partnership for Human Research Protection Inc. About PHRP. Available at: http://www.phrp.org/e3front.dll?durki=4002&site=54&return=3990. Accessibility verified December 8, 2003.
14. Kodish E, Eder M, Noll RB, et al. Communication of randomization in childhood leukemia trials. JAMA. 2004;291:470-475.
15. Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W. False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep. 1987;17:20-24.
16. Tejeda HA, Green SB, Trimble EL, et al. Representation of African-Americans, Hispanics, and whites in National Cancer Institute cancer treatment trials. J Natl Cancer Inst. 1996;88:812-816.
17. Institute of Medicine. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: Institute of Medicine; 2002:16.
18. Institute of Medicine. Clinical research involving children. Available at: http: //www.iom.edu/project.asp?id=4864. Accessed November 12, 2003.
19. Agre P, Campbell FA, Goldman BD, et al. Improving informed consent: the medium is not the message. IRB. 2003;25:S11-S19.
20. Lavori PW, Sugarman J, Hays MT, Feussner JR. Improving informed consent in clinical trials: a duty to experiment. Control Clin Trials. 1999;20:187-193.