Article Text

Download PDFPDF

Original article
Cultural considerations for informed consent in paediatric research in low/middle-income countries: a scoping review
  1. Marcela Colom1,
  2. Peter Rohloff1,2
  1. 1 Centre for Research in Indigenous Health, Wuqu’ Kawoq | Maya Health Alliance, Tecpán, Guatemala
  2. 2 Division of Global Health Equity, Brigham and Women’s Hospital, Boston, Massachusetts, USA
  1. Correspondence to Dr Peter Rohloff; prohloff{at}


Introduction Conducting research with children in low/middle-income countries (LMIC) requires consideration of socioeconomic inequalities and cultural and linguistic differences. Our objective was to survey the literature on informed consent in paediatric LMIC research, assessing for practical guidance for culturally and linguistically appropriate procedures.

Methods We conducted a scoping review on informed consent in paediatric LMIC research searching the PubMed, Web of Science and PsycINFO databases. Eligible articles were published in English, from any date range, of any study design or format.

Results The search identified 2027 references, of which 50 were included in the analysis following full-text review. Reviewed guidelines emphasised individual, informed and voluntary consent from parents and caregivers. Reviewed articles provided detailed practical guidance on adapting these guiding principles to LMIC settings, including considerations for community engagement, verbal or other alternative consent procedures for low-literacy settings or less commonly spoken languages and guarding against therapeutic misconception by caregivers. There was uncertainty, however, on how to best protect individual autonomy, especially when influenced by gender dynamics, leadership hierarchies or the social status of researchers themselves. There was, furthermore, limited research discussing the special case of research involving adolescents or of procedures for documenting assent by participating children.

Conclusions A scoping review of paediatric research in LMICs revealed substantial guidance on several features of culturally appropriate informed consent. However, additional research and guidance is needed, especially in the areas of gender imbalances, research with adolescents and children’s own assent to participate in research.

  • ethics
  • health services research

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:

View Full Text

Statistics from


  • Contributors MC designed the search strategy, extracted data from articles and wrote the first draft of the manuscript. PR conceived the study, reviewed abstracts and revised the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement No additional data are available.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.