Table 2

Summary of review and opinion articles on ethical conduct of research in children

Reference (year)Study descriptionStudy locationMajor findings
Ott et al 38 (2018)Review—Participation of children of minor parents in researchMultipleDiscussion on international research documents and existing laws and practices regarding consent for research for children of minor parents. Few countries have regulations about the subject, which might result in exclusion of those children from research. Authors recommend involving minors in the decision-making about their children and adapting consent procedures so minor parents can participate and their children’s vulnerabilities correctly addressed.
Zulu et al 34 (2018)Review—Ethical challenges of postabortion care research in adolescents in LMICsMultipleAuthors included 14 articles in their analysis. Regarding the consent process, challenges identified include difficulties in seeking consent from parents/guardians of adolescents who are below the consent age, vulnerability of adolescents compromising ability to make decisions, fear of losing access to healthcare affecting informed consent process and inadequate guidance on how and when to involve communities in the consent process.
Regmi et al 39 (2017)Review—Informed consent in health research in LMICsMultiple, but focused on NepalAuthors discuss challenges in adapting informed consent: verbal versus written informed consent in areas of limited literacy; difficulties posed by having to translate consent documents to local languages; issues around the legal age to consent; and how clear threshold ages of consent are not clear in local guidelines.
Mandava et al 40 (2012)Review—Comparison between consent processes in low/middle-income countries and developed countriesMultipleAuthors aimed to compare data about comprehension and voluntariness. In both settings, comprehension of study information varies among participants, and comprehension of randomisation and placebo use is poor. Participants in low/middle-income countries seem to be less likely to say they can refuse participation or withdraw and worry more about the consequences of doing so. Recommendations include developing validated questions to measure comprehension and voluntariness and conducting studies on the impact of cultural norms and sociodemographic characteristics on informed consent.
Joseph et al 41 (2016)Review—Views of stakeholders on aspects of conducting research with children in LMICsMultipleRegarding informed consent, stakeholders believe that disempowerment, poor education and difficulty in translating scientific concepts were barriers to informed decision-making. Authors recommend simplifying consent forms and presenting them in culturally and linguistically appropriate format with verification of parental comprehension. Authors discuss that Western ethical principles of consent and child assent, autonomy and individualism need to be contextualised.
Morrow et al 42 (2015)Opinion—Consent for paediatric critical care research in South AfricaSouth AfricaAuthors discuss legal issues in South Africa that create confusion for informed consent for children. They identify barriers to the consent process: impracticability of getting consent when urgent action is needed; the validity of consent in high-stress settings; addressing parents during stressful situations; sociocultural issues and the differences in communication and response to authority figures. The authors discuss alternatives to the prospective informed consent, such as the deferred consent model.
MacLeod et al 11 (2015)Review—Ethical issues of paediatric drug trials in LMICsMultipleThe review discusses vulnerabilities of paediatric research participants, in particular children in LMICs. Authors discuss characteristics of the consent process, and how socioeconomic status, religious belief and distribution of power affect decisions to participate. They point to the need to consider cultural differences, and the appropriateness of obtaining community consent in some contexts.
Swain43 (2014)Opinion—Barriers to paediatric clinical drug trials in low-resource settings, with emphasis in IndiaIndiaThe author discusses how the consent process for research can be affected by poverty and lack of education. The author points out that the consent process should be clear and assent should be sought from children 7–18 years old, as per Indian guidelines. Deferred consent for neonatal intensive care studies and other high-acuity settings may reduce caregiver stress and be preferred.
Bekker et al 31 (2014)Review—Ethical issues of HIV research in resource limited countriesMultipleThe authors review ethical issues in HIV research with adolescents in LMICs. They point out best practices for consenting adolescents: auditing ethical-legal requirements for consent; involving adolescents in decision-making; ensuring language, age and cultural appropriateness; and giving sufficient time and resources to consent.
Ruiz-Casares44 (2014)Review—Culturally responsive mental health researchMultipleRegarding informed consent, the author discusses how to obtain culturally appropriate consent, how to ensure adequate understanding of the consent information, consideration of community structures, documenting informed consent and determination of decision-making capacity.
Offringa et al 45 (2013)Review—Background and summary of Standards for Research (StaR) in Child Health published standards on the conduction of paediatric clinical researchNASummary of first six StaR Child Health published standards: (1) consent and recruitment; (2) containing risk of bias; (3) data monitoring committees; (4) determining adequate sample sizes; (5) selection, measurement and reporting of outcomes; and (6) age groups for paediatric trials.
Daley et al 46 (2013)Review—Ethical issues associated with autism spectrum disorders research in low/middle-income countriesMultipleAuthors discuss ethical aspects relevant to the conduct of autism spectrum disorders research in low/middle-income countries. They mention challenges to informed consent such as parents' lack of knowledge about research.
Denburg et al 47 (2012)Review—Ethical aspects and challenges of paediatric oncology research in LMICsMultipleAuthors conducted a review of ethical issues related to standards of care, trial benefits, ethics review and informed consent. They focused on the ethical implications of drug development and intervention research. Regarding informed consent, they discuss illiteracy, social and political power imbalances, validity of consent in face of ancillary benefits of research, mistrust of foreign investigators by parents and difficulties aligning local perspectives with international norms.
Mystakidou et al 48 (2009)Review—Informed consent in human HIV research in low/middle-income countriesMultipleIn trials involving children and adolescents, authors discuss the process of enrolling subjects, including challenges in getting informed consent from parents or guardians while protecting the privacy of the subjects. Most studies on this topic involve adolescents, and there are limited data about the assent process in younger children. Authors discuss the characteristics that informed consent should have in the context of HIV trials in the developing world, including the need to address cultural differences.
Bhutta10 (2004)Review—Analysis of international guidelines on the subject of informed consentMultipleReview and discussion of guidelines for obtaining informed consent. The discussion notes that more focus is put on written documentation of consent and less understanding of the process and adaptation to local contexts, and differences regarding when and how communities should be involved in the consent process.
McClure et al 32 (2004)Review—Challenges to conducting HIV vaccine trials with adolescents, including in low/middle-income countriesMultipleAuthors identified challenges to HIV vaccine trials with adolescents. Adolescents are minors and need parental consent for participating in research. At the same time, their autonomy and privacy need to be respected. The consent process might be affected by less perception of personal risk.
  • LMIC, low/middle-income country; NA, not applicable.