title: Foetal Injury in Clinical Trials and Accountability to the Child Once Born.
abstract: Sponsors of clinical trials have excluded pregnant women from trial participation mainly because of the fear of legal liability for foetal injury. Yet, to prevent untested treatments exposing foetuses generally to unwarranted risks, it is necessary that pregnant women are included in clinical trials. Despite sponsors' fears there are, however, major stumbling blocks for the child once born claiming compensation under English law. Neither the new EU Regulation 536/2014 on clinical trials nor tort law or statutory regulations have achieved a clear and fair avenue for the compensation of children injured in utero. There are also inadequacies with the voluntary pharmaceutical industry guidelines regarding such compensation. Greater clarity and fairness regarding tort and civil liability might encourage sponsors to conduct more trials in pregnant women and more pregnant women to volunteer taking part in research in the knowledge that their children will be compensated if they sustain injuries in utero.
authors.forename: Maria K
authors.initials: MK
authors.lastname: Sheppard
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic; D035881:Compensation and Redress / Q000331:legislation & jurisprudence*; D019988:Children with Disabilities; D005062:European Union; D005260:Female; D006801:Humans; D016365:Liability, Legal; D011247:Pregnancy; D037841:Pregnant People; D049188:Prenatal Injuries; D035842:Research Subjects