Informed Consent in Clinical Trials of Foetal Therapies


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


Al Hamwi v Johnston and Another (2005) All ER (D) 278, para 69.

Allesee L and Gallagher M (2011) Pregnancy and protection: the ethics of limiting a pregnant woman's participation in clinical trials. Journal of Clinical Research & Bioethics 2 (108): 1000108.

Ashcroft R (2016) Ethical issues in a trial of maternal gene transfer to improve fetal growth. In: Baylis F and Ballantyne A (eds) Clinical Research Involving Pregnant Women. Research Ethics Forum, vol. 4 chap. 14, pp. 247–265. Cham: Springer.

Baylis F and Ballantyne A (2016) Missed trials, future opportunities. In: Baylis F and Ballantyne A (eds) Clinical Research Involving Pregnant Women. Research Ethics Forum, vol. 3 chap. 1, pp. 1–13. Cham: Springer.

Bolam v Friern Hospital Management Committee (1957) WLR 582.

Brazier M (1987) Patient autonomy and consent to treatment: the role of the law? Legal Studies 7: 169–193, 172.

Coleman CH (2009) Vulnerability as a regulatory category in human subject research. Journal of Law and Medical Ethics 37: 12–18.

De Melo I and Ho A (2008) Beyond informed consent: the therapeutic misconception and trust. Journal of Medical Ethics 34: 202–205.

Flory J and Emanuel E (2004) Interventions to improve research participants' understanding in informed consent for research: a systematic review. Journal of the American Medical Association 292: 1593–1601.

General Medical Council (1998) Seeking Patients' Consent: The Ethical Considerations. London: GMC.

General Medical Council (2008) Consent: Patients and Doctors Making Decisions Together. London: GMC.

General Medical Council (2013) Good Practice in Research and Consent to Research. London: GMC.

Jackson E (2006) Informed consent to medical treatment and the impotence of tort. In: McLean SA (ed) First Do No Harm: Law, Ethics and Healthcare, chap 17, pp. 273–287. Abingdon: Routledge.

Johnson LSM (2016) When hypothetical vulnerability becomes actual: research participation and the autonomy of pregnant women. In: Baylis F and Ballantyne A (eds) Clinical Research Involving Pregnant Women. Research Ethics Forum, vol. 3 chap. 9, pp. 161–179. Cham: Springer.

Jones M (1999) Informed consent and other fairy stories. Medical Law Review 7 (2): 103–134.

Heywood R (2015) R.I.P Sidaway: patient‐oriented disclosure—a standard worth waiting for? Montgomery v Lanarkshire Health Board [2015] UKSC 11. Medical Law Review 23: 455–466.

Miola J (2006) Autonomy rued ok? Al Hamwi v Johnston and another. Medical Law Review 14: 108–114.

Macklin R (2010) The art of medicine: enrolling pregnant women in biomedical research. The Lancet 375: 632–633.

Maclean A (2004) The doctrine of informed consent: does it exist and has it crossed the Atlantic? Legal Studies 24: 386–413, 387.

Miola J (2007) , pp. 85–86. Oxford: Hart Publishing.

Montgomery v Lancashire Health Board (2015) UKSC 11.

O'Connor K (2012) The Ethics of Fetal Surgery. Embryo Project Encyclopedia (2012‐11‐20). ISSN: 1940‐5030, (accessed 17 October 2018).

Paton v British Pregnancy Advisory Service Trustees and Another (1979) QB 276.

Rogers v Whitaker (1992) 175 CLR 479.

Schonfeld T (2013) The perils of protection: vulnerability and women in clinical research. Theoretical Medicine and Bioethics 34: 189–206.

Sheppard MK (2016) Vulnerability, therapeutic misconception and informed consent: is there a need for special treatment of pregnant women in fetus‐regarding clinical trials? Journal of Medical Ethics 42: 127–131.

Sidaway v Board of Governors of the Bethlem Royal Hospital and Another (1985) AC 71.

Silverman H (2011) Protecting vulnerable research subjects in critical care trials enhancing the informed consent process and recommendations for safeguards. Annals of Intensive Care 1: 8.

The Medicines for Human Use (Clinical Trials) Regulations (2004) CTRs 2004.

Wild V (2012) How are pregnant women vulnerable research participants? International Journal of Feminist Approaches to Bioethics 5 (2): 82–104.

van der Zande ISE, van der Graaf R and Oudijk MA (2017) Vulnerability of pregnant women in clinical research. Journal of Medical Ethics 43: 657–63.

Further Reading

Chervenak FA and McCullough LB (2011) An ethically justified framework for clinical investigation to benefit pregnant and fetal patients. American Journal of Bioethics 11: 39–49.

Dickenson DL (2002) Ethical issues in maternal‐fetal medicine. Cambridge: Cambridge University Press.

Hervey TK and McHale JV (2015) European Union Health Law: Themes and Implications (Law in Context) Part 3, chap. 12, pp. 292–322. Cambridge: Cambridge University Press.

Jackson E (2012) Law and the Regulation of Medicines. Oxford: Hart Publishing.

Macklin R (2003) Bioethics, vulnerability and protection. Bioethics 17 (5–6): 472–486.

Mason JK (2007) The Troubled Pregnancy: Legal Wrongs and Rights in Reproduction. Cambridge: Cambridge University Press.

McHale JV (2013) Reforming the EU clinical trials directive: streamlining process or a radical “new” agenda. European Journal of Health Law 20 (4): 363–381.

Nuffield Council on Bioethics (2006) Critical Care Decisions in Fetal and Neonatal Medicine: Ethical Issues. London: Nuffield Council on Bioethics.

Scott R (2000) Maternal duties towards the unborn? Soundings from the law of tort. Medical Law Review 8 (1): 1–68.

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