Table 3

Summary of articles discussing social norms, decision-making and autonomy*

Reference (year)Study descriptionStudy locationMajor findings
Kongsholm et al 13 (2018)Qualitative research—Interviews with researchers and donors about consent experience for genetic researchPakistanResearchers report adaptations to consent process including use of elder and oral consent; involving literate witnesses to validate written forms; and disclosure of information adapted to educational level. Challenges include no knowledge about consent process by participants and therapeutic misconception. Donors’ motivations for participating include obtaining direct benefit from their participation and a high level of trust in the research team.
Embleton et al 49 (2015)Case study—Ethical guidelines adaptation for three different studies with street connected youth and childrenKenyaThe authors describe processes of consent for street-connected children and youth participating in three research projects. They discuss the importance of guidelines and working with local and international committees, ethicists and the community to identify areas of special concern. Key recommendations include involving the community and working within the local sociocultural context.
Millum and Emanuel50 (2007)Case study—Research with abandoned childrenRomaniaThe authors discuss how research with abandoned children might be constrained by the challenge of getting informed consent. This might result in this vulnerable group not being included in research for reasons of convenience. They argue that vulnerable groups can be protected by enrolling them in studies that pose no or minimal risks.
Vreeman et al 51 (2012)Qualitative research—Analysis of community discussion sessions regarding the participation of orphaned children in researchKenyaResults showed positive attitudes towards the participation of orphaned children in research, mainly because adults assumed that children would be directly benefited. Consent from parents or guardians was considered necessary but getting assent from children was not. The participation of the community in the consent process was considered appropriate. Authors recommend paying attention to misconceptions about research-related benefits.
Molyneux et al 36 (2005)Qualitative research—Community views regarding the informed consent process, in the context of studies being carried out by KEMRI in KenyaKenyaResults show that seeking consent from community elders is necessary but does not substitute the need for individual parental consent. Most respondents suggested males should make the decision to participate and that assent should not be sought from children before ages 10–13. For inpatient studies, respondents identified illness severity, potential risks and parents’ ability to understand as factors influencing the consent process. Results of the study show some therapeutic misconception and discrepancies regarding which interventions need permission.
  • *In this and subsequent tables, articles are presented by major thematic groupings. Most articles discuss multiple themes, but are grouped here based on the most prominent or significant theme identified in the review.

  • KEMRI, Kenya Medical Research Institute.