There is a strong need for well-designed clinical trials in congenital heart disease. Research in children, including children with congenital heart disease, must adhere to the highest ethical standards at all times.
BronnerFHarrisRSMaletskosCJBendaCE. Studies in calcium metabolism; the fate of intravenously injected radiocalcium in human beings. J Clin Invest. 1956;35(1):78–88.
Protection of human subjects—research involving children: proposed rule. Fed Regist. 1978;43(141 pt 2):31785–31794.
4.
ShaddyREDenneSC. Clinical report—guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics. 2010;125(4):850–860.
5.
OhyeRGSleeperLAMahonyLComparison of shunt types in the Norwood procedure for single-ventricle lesions. N Engl J Med. 2010;362(21):1980–1992.
6.
WhitneySN. The python’s embrace: clinical research regulation by institutional review boards. Pediatrics. 2012;129(3):576–578.
7.
BekelmanJELiYGrossCP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA. 2003;289(4):454–465.
8.
LiJSEisensteinELGrabowskiHGEconomic return of clinical trials performed under the pediatric exclusivity program. JAMA. 2007;297(5):480–488.
9.
GoldbergDJFrenchBMcBrideMGImpact of oral sildenafil on exercise performance in children and young adults after the fontan operation: a randomized, double-blind, placebo-controlled, crossover trial. Circulation. 2011;123(11):1185–1193.
10.
FlotteTRFrentzenBHumphriesMRRosenbloomAL. Recent developments in the protection of pediatric research subjects. J Pediatr. 2006;149(3):285–286.
11.
Protection of human subjects. Code Fed Regul Shipping. 1982;Part 46, Sections 46.101 to 46.306:Unknown.
12.
MillerFGEmanuelEJ. Quality-improvement research and informed consent. N Engl J Med. 2008;358(8):765–767.
