Research Ethics, Volume 18, Issue 4, Page 265-280, October 2022. Concerns around comprehension and recall of consent information by research participants have typically been associated with low health and research literacy levels. In genomics research, this concern is heightened as the scientific and ethical complexities of genetics research, such as biobanking, genetic susceptibility, data sharing, and incidental findings may be more difficult for potential research participants to understand. However, challenges to research participants’ comprehension of consent information may be compounded by (...) factors beyond health and research literacy levels. To identify factors that may impact research participants’ understanding and recall of consent information, we designed a qualitative study to explore whether participants enrolled in a tuberculosis genetics study in Cameroon understood the objectives of the study, the risks and benefits and certain key aspects of the study such as biobanking and data sharing. The results showed that research participants had limited understanding and/or recall of the TBGEN-Africa study goals and methods. Some participants were of the opinion that TBGEN-Africa was not a genetics study because tuberculosis is not an inheritable condition. Factors that may have hindered understanding and/or recall of study information are diagnostic misconception, and information overload and situational vulnerability. There is a need for improved practices to support research participants’ understanding of consent information in genetics studies including designing the consent process in ways that minimize psychological distress and diagnostic/therapeutic misconception. (shrink)

Volume 19, Issue 10, October 2019, Page 105-107.

Background: There is a significant discourse in the literature that opines that people who use illicit opiates are unable to provide informed consent due to withdrawal symptoms and cognitive impairment as a result of opiate use. Aims: This paper discusses the issues related to informed consent for this population. Ethical considerations: Ethical approval was obtained from both the local REB and the university. Written informed consent was obtained from all participants. Method: This was a qualitative interpretive descriptive study. 22 participants (...) were interviewed, including 18 nurses, 2 social workers and 2 clinic support workers. The findings were analyzed using thematic analysis, which is a way of systematically reducing the complexity of the information to arrive at generalized explanations. Results: The staff at the clinic were overwhelming clear in their judgment that people who use opiates can and should be able to participate in research and that their drug use is not a barrier to informed consent. Conclusions: It is important to involve people who use opiates in research. Protectionist concerns about this population may be overstated. Such concerns do not promote the interests of research participants. People who use heroin need to be able to tell their story. (shrink)

Despite their vulnerability, adolescents are often excluded from health research due to ethical concerns about research with minors, especially in low-income regions like Sub-Saharan Africa. We enrolled adolescent girls aged 15–17 years and caregivers of girls of the same age. Using a 25-question Comprehension Score Sheet, we applied a quantitative approach to compare the comprehension of informed consent of 33 adolescent girls and 41 caregivers of adolescent girls aged 15–17 years. The assessments were audio-recorded and reviewed for quality check. The (...) results showed that adolescent girls were significantly better than caregivers in comprehending informed consent information overall and specifically on study procedures, voluntarism and study purpose. This suggests that adolescents can understand informed consent information at the same level as or better than caregivers who are entrusted with providing permission for adolescents to participate in research. (shrink)

Volume 19, Issue 10, October 2019, Page 103-105.