Children and Clinical Research Resources

This page provides resources to accompany the eLearning course Children and Clinical Research / los-ninos-y-la-investigacion-clinica

If you have any questions or comments about the course please let us know in this discussion group. 

Websites and reports:

European Commission
This page of the European Commission’s website summarises recent major developments in its approach to medicines for children. 

GenerationR
GenerationR is a UK-based collective of young persons’ advisory groups (YPAGs), which support children and young people’s involvement in the design and delivery of paediatric research. In 2013, the organisation has published a report which details its work and future aims.

iCAN
iCAN (the International Children’s Advisory Network) is an umbrella group for YPAGs worldwide.

UNESCO
Area of UNESCO’s website which provides a definition of the meaning of ‘youth’.

WHO Paediatric medicines Regulators’ Network (PmRN)
Part of the WHO’s Better Medicines for Children initiative; comprised of representatives from national medicines regulatory authorities from across the world.

YoungHealthParticipation
A blog which explores current research on children and young people’s participation in health services and research and provides practical guidance for researchers who want to involve children and young people. 

YouthHealthTalk
YouthHealthTalk hosts a large number of films where young people recount their experiences of a range of health issues.

UK paediatric research centres:

Alder Hey Children’s Hospital, Liverpool

Centre for Paediatrics and Child Health, University of Manchester

Child Life and Health, University of Edinburgh

Children’s Clinical Research Facility, Barts Health NHS Trust, London

Department of Child Health, Cardiff University

Department of Paediatric Research, University of Oxford

Evelina London Children’s Healthcare

Great Ormond Street Hospital Biomedical Research Centre, London

Paediatric Research Unit, Imperial College Healthcare NHS Trust, London

Sheffield Children’s Clinical Research Facility, Sheffield Children’s NHS Foundation Trust

UCL Institute of Child Health, London

University of Cambridge Department of Paediatrics

Further reading:

• Berkley JA (2014) Randomised trials in developing countries Archives of Disease in Childhood 99(7): 607-8

• Bwakura-Dangarembizi M, Musesengwa R, Nathoo K et al. (2012) Ethical and legal constraints to children’s participation in research in Zimbabwe: experiences from the multicenter pediatric HIV ARROW trial BMC Medical Ethics 13(1): 17

• Cheah PY, and Parker M (2015) Research consent from young people in resource-poor settings Archives of Disease in Childhood 100(5): 438-40

• Cheah PY, and Parker M (2014) Consent and assent in paediatric research in low-income settings BMC Medical Ethics 15(1): 22

• Folayan MO, Haire B, Harrison A et al. (2014) Ethical issues in adolescents’ sexual and reproductive health research in Nigeria Developing World Bioethics: Published online first (9 June 2014)

• Gikonyo C, Kamuya D, Mbete B et al. (2013) Feedback of research findings for vaccine trials: experiences from two malaria vaccine trials involving healthy children on the Kenyan coast Developing World Bioethics 13(1): 48-56

• Goenka A, Magnus D, Rehman T et al. (2013) Child health in low-resource settings: pathways through UK paediatric training Archives of Disease in Childhood 98(11): 898-901

• Jao I, Mwangome N, Davies A, Molyneux CS and Marsh V (2014) Nuffield Council on Bioethics Working Party on ethical issues for research involving children: report on consultations with community representatives and secondary school students in Kilifi, Kenya (Kilifi, Kenya: KEMRI Wellcome Trust Research Programme)

• Modi N, Vohra J, Preston J et al. (2014) Guidance on clinical research involving infants, children and young people: an update for researchers and research ethics committees Archives of Disease in Childhood 99(10): 887-91

• Molyneux E, Mathanga D, Witte D, and Molyneux M (2012) Practical issues in relation to clinical trials in children in low-income countries: experience from the front line Archives of Disease in Childhood 97(9): 848-51

• Morrow V, Boddy J, and Lamb R (2014) The ethics of secondary data analysis: learning from the experience of sharing qualitative data from young people and their families in an international study of childhood poverty: ESRC National Centre for Research Methods working paper (Swindon:National Centre for Research Methods)

• Nabulsi M, Khalil Y, and Makhoul J (2011) Parental attitudes towards and perceptions of their children’s participation in clinical research: a developing-country perspective Journal of Medical Ethics 37(7): 420-3

• Norwegian National Ethics Committee (2013) Cross-cultural child research: ethical issues (Oslo: Norwegian National Ethics Committee)

• Powell MA, Graham A, Taylor NJ, Newell S and Fitzgerald R (2011) Building capacity for ethical research with children and young people: an international research project to examine the ethical issues and challenges in undertaking research with and for children in different majority and minority world contexts - report prepared for the Childwatch International Research Network, Oslo, Norway

• Royal College of Paediatrics and Child Health (2013) Training in research for the benefit of children (London: Royal College of Paediatrics and Child Health)

• Southern Cross University and University of Otago (2012) International literature review: ethical issues in undertaking research with children and young people (Lismore and Dunedin: Southern Cross University and University of Otago)

• Smit-Marshall P (2010) Pediatric trials: a worldview Applied Clinical Trials 19(1): 32-7

• Spriggs M, and Gillam L (2013) Deception of children in research Journal of Medical Ethics 41(2): 179-82

• Swartling U, Hansson MG, Ludvigsson J, and Nordgren A (2011) “My parents decide if I can. I decide if I want to.” Children's views on participation in medical research Journal of Empirical Research on Human Research Ethics: An International Journal 6(4): 68-75

• Vreeman RC, Nyandiko WM, and Meslin EM (2009) Pediatric assent for a study of antiretroviral therapy dosing for children in western Kenya: a case study in international research collaboration Journal of Empirical Research on Human Research Ethics 4(1): 3-16

• Waligora M, Dranseika V, and Piasecki J (2014) Child’s assent in research: age threshold or personalisation? BMC Medical Ethics 15(1): 44

• Whyte SR (2014) Therapeutic research in low-income countries: studying trial communities Archives of Disease in Childhood 99: 1029-32