Participants’ understanding of informed consent for genomic research: a case of the CAfGEN study.

Abstract

Introduction: For informed consent to be valid, prospective participants are required to have adequate understanding of research prior to making decisions about participation. Studies have reported that participants in genomic research have inadequate understanding of consent information. The study aim was to assess participants’ understanding and determine the factors that influence comprehension of consent information provided to them during genomic research. Method: This was a cross sectional study that employed both quantitative and qualitative methods. Participants were recruited from the Collaborative African Genomic Network II (CAfGEN II), a genomic study that was on-going then. 123 participants were consecutively recruited to take part in a survey that used the Quality of Informed Consent tool while 11 participants were purposively selected to participate in the focus group discussions (FGDs). STATA was used to assess understanding of consent information. Descriptive statistics were used to summarize the data. Chi square test, fishers exact test and logistic regression were used for inferential statistics while thematic analysis was used for the FGDs. Findings: Only 47.2% of the participants had adequate overall objective understanding of consent information. Mean objective understanding of consent elements was moderate at 78.7% while the mean subjective understanding was adequate at 91.7%. The most understood aspects of consent were; nature of research, benefits to future patients and study duration while the least understood aspects were; foreseeable risks and discomforts, confidentiality and compensation for injury. Participants aged 35 years and above were less likely to understand consent information compared with their counter parts aged less than 35 years. Participants of the focus group discussions demonstrated good understanding of consent elements. They also had a positive attitude towards sample storage and expressed a desire to receive clinically significant results of genomic tests. Conclusion: This study adds to the existing evidence on failure of genomic research participants to adequately understand consent information. Majority of the research participants had moderate objective understanding of the information provided to them during the consent process but felt very well informed about the consent information. UNCST and RECs should make proof of assessment of prospective research participants’ understanding of consent information a mandatory requirement and researchers need to explore more objective ways of assessing understanding of consent information for genomic research.