Summary of articles discussing communicating about risks and benefits of research
| Reference (year) | Study description | Study location | Major findings |
| Morris and Wilson53 (2014) | Case study—Research on the use of CPAP in intensive care settings | Ghana | Authors describe how consent was obtained, and express concern about the fact that there were no refusals and that this might reflect that consent was not fully informed or participation was not truly voluntary. The authors do not know to which extent parents understood randomisation, or that CPAP could be used independently of study participation. They discuss how the lack of access for medical care might influence the consent process. |
| Ward et al 54 (2018) | Qualitative research—Interviews with stakeholders about ethical aspects in a paediatric malaria vaccine trial | Ghana and Tanzania | Stakeholders identify the importance of community education and a well-adapted consent process in helping to avoid misconception about trial benefits and healthcare service provision, as well as in preventing undue inducement by clearly stating risks and benefits. |
| Devries et al 55 (2015) | Qualitative research—Experiences of children participating in a cluster RCT of a school-based violence prevention intervention | Uganda | Authors describe the consent process for the RCT and present findings from interviews conducted with children after participating. They found some therapeutic misconception about potential benefits and propose that clearer language in the consent forms might help avoid it. |
| Serce et al 30 (2015) | Quantitative—Questionnaires administered to parents to assess potential participation in research | Turkey | Authors perform univariate and multivariate logistic regression to identify characteristics that might predict participation. Factors associated with willingness to consent include satisfaction with the content of the informed consent and being a business owner. Factors associated with refusal of consent were older age of parents and owning a car. Parents responded that learning more about the trial and its benefits, ensuring health coverage and payment of transport expenses would positively influence consent. |
| Angwenyi et al 28 (2014) | Qualitative—Interviews and group discussions with researchers, community members and parents | Kenya | Authors describe and analyse the community engagement process for the trial. Concerning the consent process, they present results on parents’ understanding of the trial 1 year after recruitment. They report low levels of understanding about the purpose of the trial and the randomisation process. There appeared to be less understanding of the trial where there was less community engagement. |
| Paré Toe et al 27 (2013) | Mixed methods research—Assessment of the relevance of the informed consent procedure in a malaria trial comparing the efficacy of two different treatments | Burkina Faso | Results showed that prior knowledge of the trial was significantly associated with the decision to participate. Common reasons for participating were the perceived aid provided by the trial, better quality of care and better quality of the medication. Information about confidentiality, right to withdraw from the study and potential risks was poorly retained. Randomisation was poorly understood. Authors aim to show that there are other factors besides the information received during the consent process that influence parents' decision to participate in the trial. |
| Rajaraman et al 24 (2011) | Mixed methods research—Analysis of relation between parents’ sociodemographic characteristics and likelihood of asking questions during the consent process | India | The study looked at parents asking questions during the informed consent process. 13.4% of parents asked any questions. There was a high association between asking questions and socioeconomic and educational status, and with presence of both parents. Authors conclude that consent materials should be interactive, to make comprehension easier, and that in paediatric trials effort should be made to get participation of both parents in the consent process. |
| Nabulsi et al 14 (2011) | Qualitative research—Perceptions of Lebanese parents about their children’s participation in research | Lebanon | Fear of potential harm or pain caused to children was identified as a main barrier to parental consent, as were complex consent forms and misunderstanding of randomisation. Perceived direct benefits of participation, trust in the doctor and the institution, financial gains or previous positive experience with research were identified as motivations to participate. Authors recommend improving communication and building trust with parents to enhance recruitment. |
| Oduro et al 56 (2008) | Mixed methods research—Understanding and retention of informed consent process by parents of children participating in a malaria cohort study | Ghana | Findings show overall good recall of procedural aspects of the study. Recall about study benefits was significantly higher than about study risks. Most knew participation was voluntary, but few knew they could withdraw at any time and that information was handled confidentially. Younger parental age was associated with better recall and understanding. Free medical treatment and benefits to the participant were strong motivations for enrolling. |
| Krosin et al 57 (2006) | Quantitative—Parental understanding of the consent process for a malaria vaccine trial | Mali | By using a multiple-choice questionnaire, researchers identified poor comprehension about withdrawal criteria, study side effects and the investigational rather than therapeutic nature of the intervention. Response rate and percentage of correct answers were higher in a more urban setting than in a rural one. |
| Pace et al 26 (2005) | Qualitative—Quality of parental consent in an antimalarial study | Uganda | Most respondents were mothers and had good recall of logistical aspects of the study and study purpose. Comprehension of randomisation was low. The primary reason most respondents gave for enrolling their child was to obtain malaria treatment. Many parents felt pressure to enrol because their child was sick. Only 41% reported they could have refused and 65% knew they could quit. |
| Molyneux et al 58 (2005) | Mixed methods research—Community views about the informed consent process and trust | Kenya | Findings show that trust in the research institution by the community is based on the perceived quality of clinical services it provides, and less on research activities. Trust in the research unit is an important reason behind community members' agreeing to participate in research. Responders valued the informed consent process but thought that low education and being in stressful situations impaired understanding. Authors suggest modifying consent procedures by not giving all information at once and testing to improve comprehension. |
| Leach et al 25 (1999) | Qualitative research—Attitudes of the Gambian people to consent to medical research within the context of a Haemophilus influenzae vaccine trial | The Gambia | Semistructured interviews were conducted with study participants and refusers in urban and rural areas. Results showed that certain points of the trial were recalled well: 90% knew the purpose of the vaccine, but only 10% understood the placebo control design. The main motive for consenting was to receive the vaccine (93%), and for refusing was that the vaccine was experimental (35%) and might have side effects (29%). In all cases, the decision was made by just one of the parents. |
CPAP, continuous positive airway pressure; RCT, randomised controlled trial.