Marilyn J. Field and Richard E. Berman, Editors, Committee on Clinical Research Involving Children. The Ethical Conduct of Clinical Research Involving Children. [Report] Board on Health Sciences Policy, Institute of Medicine. 2004.
	Related article: Ault A. Children need more protection in clinical trials, says IOM. Panel concludes that current regulations are misapplied, but stops short of calling for strict enforcement. The Lancet 2004;363(9415):1119. (3 April 2004) (Free after registration on The Lancet website)

Articles

Lilford RJ.

Abstracts

Ballard H.O., Shook L.A., Desai N.S., and Anand K.J.S. Neonatal Research and the Validity of Informed Consent Obtained in the Perinatal Period Journal of Perinatology (2004) 24, 409-415.

Michael K. Paasche-Orlow, M.D., M.P.H., Holly A. Taylor, Ph.D., M.P.H., and Frederick L. Brancati, M.D., M.H.S. Readability Standards for Informed-Consent Forms as Compared with Actual Readability N Engl J Med 2003;348:721-6.

Sharav, VH Children in clinical research: A conflict of moral values Am J Bioeth 2003;3(1):InFocus

Tait AR, Voepel-Lewis T, Malviya S Do They Understand? (Part I) Parental Consent for Children Participating in Clinical Anesthesia and Surgery Research Anesthesiology 2003; 98:603–8

Tait AR, Voepel-Lewis T, Malviya S Do They Understand? (Part II) Assent of Children Participating in Clinical Anesthesia and Surgery Research Anesthesiology 2003; 98:609–14

Citations

Antes G, Chalmers I. Under-reporting of clinical trials is unethical. Lancet 2003;361(9362):978-9.

Fylkesnes K, Fylkesnes TK. Informed consent as part and parcel of the scientific inquiry. The Lancet 2003;361:2171-2.

Horton R. The Clinical Trial: Deceitful, Disputable, Unbelievable, Unhelpful, and Shameful-What Next? Controlled Clinical Trials 2001;22:593-604. (No available link)

Kodish E. Informed consent for pediatric research: is it really possible? J Pediatr. 2003 Feb;142(2):89-90.

Koren G, Kearns GL, Reed M, Pons G. Use of healthy children as volunteers in drug studies: the ethical debate. Clin Pharmacol Ther 2003;73(3):147-52.

Miller FG, Wendler D, Wilfond B. When do the federal regulations allow placebo-controlled trials in children? J Pediatr 2003;142(2):102-7.

Pich J, Carne X, Arnaiz JA, Gomez B, Trilla A, Rodes J. Role of a research ethics committee in follow-up and publication of results. Lancet 2003;361(9362):1015-6.

Ross LF. Do healthy children deserve greater protection in medical research? J Pediatr 2003;142(2):108-12.

Tait AR, Voepel-Lewis T, Malviya S. Factors that influence parents' assessments of the risks and benefits of research involving their children. Pediatrics 2004;113(4):727-32.