The ethics of innovation in pediatric surgery.

Ethical issues in pediatric research have long been debated, and experimentation in pediatric surgery is under intense scrutiny. Extensive legislation and institutional systems that attempt to protect children while supporting necessary research are at times ineffective. Pediatric surgery has less funding and resources for innovation than fields with higher clinical volume. Not unlike pediatrics in general, innovation in pediatric surgery must be beyond criticism. And yet, for the sake of patients, innovation should not only be maintained, but must be encouraged.

[1]  D. Caniano Ethical issues in the management of neonatal surgical anomalies. , 2004, Seminars in perinatology.

[2]  W. Souba,et al.  Judging surgical research: how should we evaluate performance and measure value? , 2000, Annals of surgery.

[3]  J. Frader,et al.  Innovation and research in pediatric surgery. , 2001, Seminars in pediatric surgery.

[4]  Seema K. Shah,et al.  Should Children Decide Whether They Are Enrolled in Nonbeneficial Research? , 2003, The American journal of bioethics : AJOB.

[5]  V. Fuster,et al.  Long-term outcome in patients undergoing surgical repair of tetralogy of Fallot. , 1993, The New England journal of medicine.

[6]  B. Brody The Ethics of Biomedical Research: An International Perspective , 1998 .

[7]  Paul S. Appelbaum,et al.  Informed Consent: Legal Theory and Clinical Practice , 1987 .

[8]  H. Shirkey Editorial Comment: Therapeutic Orphans , 1999 .

[9]  D. Wendler Risk Standards for Pediatric Research: Rethinking the Grimes Ruling , 2004, Kennedy Institute of Ethics journal.

[10]  H. Beecher Surgery as placebo. A quantitative study of bias. , 1961, JAMA.

[11]  L. Kopelman,et al.  Ethical concerns about federal approval of risky pediatric studies. , 2004, Pediatrics.

[12]  F D Moore,et al.  Three ethical revolutions: ancient assumptions remodeled under pressure of transplantation. , 1988, Transplantation proceedings.

[13]  A. Boudreaux,et al.  Ethical dilemmas for pediatric surgical patients. , 2002, Anesthesiology clinics of North America.

[14]  D. Bar-Tal,et al.  Motivations for Donation Behavior by Boys of Three Different Ages. , 1980 .

[15]  W. Merrill,et al.  What's past is prologue. , 1999, The Annals of thoracic surgery.

[16]  A. Levin IOLs, innovation, and ethics in pediatric ophthalmology: let's be honest. , 2002, Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus.

[17]  T. Starzl,et al.  HOMOTRANSPLANTATION OF THE LIVER IN HUMANS. , 1963, Surgery, gynecology & obstetrics.

[18]  S. Ijichi,et al.  The scientific establishment of a new therapeutic intervention for developmental conditions: practical and ethical principles , 2003, Child's Nervous System.

[19]  W. Bartholome Informed consent, parental permission, and assent in pediatric practice. , 1995, Pediatrics.

[20]  B. Lo,et al.  Institutional review board guidance on pediatric research: missed opportunities. , 2005, The Journal of pediatrics.

[21]  H. Beecher,et al.  Ethics and clinical research. , 1966, The New England journal of medicine.

[22]  R. Schwartz,et al.  Why a Teenager over Age 14 Should Be Able to Consent, Rather than Merely Assent, to Participation as a Human Subject of Research , 2003, The American journal of bioethics : AJOB.

[23]  Seema K. Shah,et al.  How do institutional review boards apply the federal risk and benefit standards for pediatric research? , 2004, JAMA.

[24]  Experimentation in Man. , 1959, Journal of the American Dental Society of Anesthesiology.

[25]  S. Lederer Children as Guinea Pigs: Historical Perspectives , 2003 .

[26]  G. Klintmalm,et al.  Transplantation of the Liver , 1996 .

[27]  L. Schlam,et al.  Informed consent to the medical treatment of minors: law and practice. , 2000, Health matrix.

[28]  Christopher L Church,et al.  Informed consent in pediatric clinical trials , 2005, Current opinion in pediatrics.