Advising parents about children's participation in clinical research

Pediatric Annals

Volumn 33, Issue 11, 2004, Pages 778-781

  Hoehn, K Sarah ^a,c   Nelson, Robert M ^b  

^a Department of Anesthesia ^*  (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; DECISION MAKING; DOCTOR PATIENT RELATION; PEDIATRICIAN; PHYSICIAN ATTITUDE; REVIEW; RISK BENEFIT ANALYSIS;

EID: 8744265095     PISSN: 00904481     EISSN: None     Source Type: Journal    
DOI: 10.3928/0090-4481-20041101-13     Document Type: Review

References (9)

1. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Committee on Drugs, American Academy of Pediatrics. Pediatrics. 1995; 95(2):286-294.
2. Field M, Behrman R, eds. Ethical Conduct of Clinical Research Involving Children. Washington, DC: National Academies Press; 2004.
3. 45 CFR 46; 21 CFR 50,56. 66 FR 20598, April 24, 2001 Code of Federal Regulations.
4. Informed consent, parental permission, and assent in pediatric practice. Committee on Bioethics, American Academy of Pediatrics. Pediatrics. 1995;95(2):314-317.
5. Nelson RM, Reynolds WW. Child assent and parental permission: a comment on Tait's "Do they understand?" Anesthesiology. 2003; 98(3):597-598.
6. Faden R, Beauchamp T. A History and Theory of Informed Consent. New York, NY: Oxford University Press; 1986.
7. Nelson RM, Reynolds WW. We should reject passive resignation in favor of requiring the assent of younger children for participation in nonbeneficial research. Am J Bioeth. 2003; 3(4):11-13.
8. Denham EJ, and Nelson RM. Self-determination is not an appropriate model for understanding parental permission and child assent. Anesth Analg. 2002;94(5):1049-1051.
9. Rossi WC, Reynolds W, Nelson RM. Child assent and parental permission in pediatric research. Theor Med Bioeth. 2003;24(2):131-148.