Informed Consent in Clinical Trials of Foetal Therapies

Abstract

Obtaining informed consent is an essential part of the doctor's duty of care when treating a patient and is governed by English common law. In the case of clinical trials, the duty to obtain consent from prospective trial participants pertains to the researcher and is laid down by statute. Informed consent refers to a duty to provide the person with information about the (experimental) treatment, its likely benefits and risks and any possible alternatives, and requires the information to be understood. While pregnant women used to be largely excluded from clinical trial participation because of a concern for the foetus, international and national regulations now accept the need for clinical trials in pregnancy and envisage special protective measures to safeguard pregnant women and their foetuses. Because of the possible vulnerability of pregnant women in clinical trials of foetal therapies, even more effort must be expended on obtaining properly informed consent.

Key Concepts

  • The duty of care of a doctor in common law involves obtaining informed consent from the patient.
  • Clinical trials require the informed consent of the prospective trial participant in statutory law.
  • Informed consent covers information about the experimental treatment, its benefits and risks and possible alternatives.
  • Properly informed consent includes understanding by the trial participant. The concern for the foetus has prevented the inclusion of pregnant women in clinical trials. Pregnant women asked to participate in clinical trials of foetal therapy may be vulnerable in limited circumstances. Statutes provide for protective measures when including pregnant women in clinical trials. In clinical trials of foetal therapy, great care needs to be taken to obtain properly informed consent from the pregnant woman.

Keywords: duty of care; informed consent; clinical trials; pregnant woman; foetus; foetal therapy; vulnerability protective measures; safeguard

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Sheppard, Maria Kreszentia(Dec 2018) Informed Consent in Clinical Trials of Foetal Therapies. In: eLS. John Wiley & Sons Ltd, Chichester. http://www.els.net [doi: 10.1002/9780470015902.a0028015]