Ethical issues in clinical trials in children

J. Glasa, H. Glasová, M. Glasová 3 , and T. Krčméryová 2
  • 1 Faculty of Medicine, Institue of Pharmacology, Clinical and Experimental Pharmacology, Comenius University in Bratislava
  • 2 Faculty of Nursing and of Professional Health Studies, Institue of Health Care Ethics, Slovak Medical University in Bratislava
  • 3 Faculty of Pedagogy, Institute of Psychology and Logopaedy Studies, Comenius University in Bratislava
  • 4 Institue of Medical Ethics and Bioethics n. f., Bratislava

Ethical issues in clinical trials in children

Clinical trials (CTs) in children involve much methodological specificity that are reflected in the ethical issues related to them, as well as in the evaluation of ethical acceptability of the given protocol by an ethics committee. A child in comparison to an adult exhibits numerous patho/physiological differences that are in addition characterized by the quick changes during the child's growth and development. Nowadays, there are no doubts about the necessity of conducting specific CTs in children that are not possible to perform in adults. Despite children are not able to give legally valid informed consent and it is necessary to obtain consent from the child's parents, or from the legal representative, it is also necessary, before including the child into the trial, to obtain his/her appropriate agreement (assent) with participation. It is a must always to fully respect the requirements of minimization of pain, discomfort, fear, and separation from the parents especially from the mother. Special ethical issues are connected with CTs conducted in neonatal period. On the part of the professional public, producers of medicinal drugs, as well as from the positions of the European institutions, considerable attention is being paid to the area of CTs in children. It is reflected in numerous scientific researches, and professional and legislative activities. In the Slovak Republic, the area of biomedical research, including CTs, in children and minors is covered by up-to-date, comprehensive legislation. It ensures not only the maximal protection of the child or minor taking part in biomedical research or CT, but it also provides sufficient level of legal certainty to the sponsors and investigators of biomedical research projects/CTs.

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  • Based on the authors' presentation given at the 20th Symposium of Clinical Pharmacy in honour of late Assoc. Prof. PharmDr. Lívia Magulová, PhD., Nitra, Slovakia, April 28 - 29, 2011.

  • Regulation (EC) No 1901/2006 of the European Parliament and the Council, as amended, on medicinal products for paediatric use (‘Paediatric Regulation’). Available at:

  • ICH E11 Note for Guidance on the Clinical Investigation of Medicinal Products in the Paediatric Population (CPMP/ICH/2711/99). Available at:

  • ALRAVILLA, A. - MANFREDI, C. - BAIARDI, P. et al.: Impact of the new European paediatric regulatory framework on ethics committees: overview and perspectives. Acta Paediatr, 2012, 101, No. 1, p. e27-32. (Epub 2011 Jul 23).

  • ICH E11, p. 5 - 6.

  • ICH E11, p. 5 - 6.

  • ICH E11, p. 6 - 7.

  • ICH E11, p. 11 - 13.

  • Ethical Considerations for Clinical Trials on Medicinal Products Conducted with Paediatric Population. Recommendations of the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use. European Commission, 2008, 34 pgs. (further on "EC Recommendations 2008") Available at:

  • Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

  • EC Recommendations 2008, p. 13.

  • EC Recommendations 2008, p. 13 - 14.

  • Committee for Medicinal Products for Human Use (CHMP): Guideline on Conduct of Pharmacovigilance for Medicines Used by the Paediatric Population, EMEA, London, 25 January 2007. Doc. Ref. EMEA/CHMP/PhVWP/235910/2005- rev.1, p. 3 - 4. Available at:

  • We refer in this text to the provisions contained in the law No. 326/2011 Coll., which since December 2011 has superseded the original law No. 140/1998 Coll. on medicinal drugs and medical devices. The later version of the medicinal drugs and devices law was valid at the time of delivery of the original authors' presentation (see ref. 1). The text of the law available in Slovak language at:


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