Ethics
Articles
Watson R. Guidelines on drug trials in children go out for consultation. BMJ. 2006;333:673.
Saint Raymond A, Brasseur D. Development of medicines for children in Europe: ethical implications. Paediatr Respir Rev. 2005;6(1):45-51.
Saint Raymond A, Brasseur D. Development of medicines for children in Europe: ethical implications. Paediatr Respir Rev. 2005 Mar;6(1):45-51.
Sauer PJ. Ethical and practical issues regarding research in children: The European perspective. Toxicol Appl Pharmacol. 2005 Jun 27; [Epub ahead of print]
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)
Clark AM, Jamieson R, Findlay IN. Registries and informed consent. N Engl J Med 2004;351(6):612-4; author reply: 612-4.
Coffey MJ, Wilfond B, Ross LF. Ethical assessment of clinical asthma trials including children subjects. Pediatrics 2004;113(1 Pt 1):87-94.
Peto J, Fletcher O, Gilham C. Data protection, informed consent, and research. BMJ 2004;328:1029-30.
Room S. Data Protection Act does not bar medical research. BMJ 2004;328:1437.
Spriggs M. Canaries in the mines: children, risk, non-therapeutic research, and justice. J Med Ethics. 2004 Apr;30(2):176-81.
Warlow C. Clinical research under the cosh again. This time it is ethics committees. BMJ 2004;329:241-242
Garattini S. Confidentiality. Lancet. 2003 Sep 27;362(9389):1078-9.
Lilford RJ. Ethics of clinical trials from a bayesian and decision analytic perspective: whose equipoise is it anyway? BMJ 2003;326:980.1
Rees E., Hardy J. Novel consent process for research in dying patients unable to give consent bmj.com 2003;327:198
Garattini S, de Andres-Trelles F, Bertele V, Li Bassi L. Ethics of testing drugs with readily available alternatives. Lancet. 2002 Aug 24;360(9333):647.
Glantz LH. Nontherapeutic research with children: Grimes v Kennedy Krieger Institute. Am J Public Health. 2002 Jul;92(7):1070-3.
Halpern SD, Karlawish JH, Berlin JA. The continuing unethical conduct of underpowered clinical trials. JAMA. 2002 Jul 17;288(3):358-62.
Mastroianni AC, Kahn JP. Risk and responsibility: ethics, Grimes v Kennedy Krieger, and public health research involving children. Am J Public Health. 2002 Jul;92(7):1073-6.
Steinbrook R. Improving protection for research subjects. N Engl J Med. 2002 May 2;346(18):1425-30.
McIntosh N, Bates P, Brykczynska G, Dunstan G, Goldman A, Harvey D, Larcher V, McCrae D, McKinnon A, Patton M, Saunders J, Shelley P. Guidelines for the ethical conduct of medical research involving children. Royal College of Paediatrics, Child Health: Ethics Advisory Committee. Arch Dis Child. 2000 Feb;82(2):177-82.
Pilpel D, Leavitt FJ, Elizur-Leiberman E. Ethical and cross cultural questions concerning pediatric clinical trials. Control Clin Trials. 1996 Jun;17(3):201-8.
Vollmann J, Winau R. Informed consent in human experimentation before the Nuremberg code. BMJ. 1996 Dec 7;313(7070):1445-9.
American Academy of Pediatrics CoB. Informed consent, parental permission, and assent in pediatric practice. Committee on Bioethics, American Academy of Pediatrics. Pediatrics. 1995 Feb;95(2):314-7.
Other
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.
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.
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.
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.
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.
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.
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