Understanding of Critical Elements of Informed Consent in Genomic Research: A Case of a Paediatric HIV-TB Research Project in Uganda

Abstract

Several studies have reported inadequate comprehension of informed consent for genomic research. This study aimed to assess research participants’ understanding of critical elements of informed consent for genomic research. A cross-sectional survey involving 123 parents/caregivers of children participating in a paediatric genomic TB/HIV study was conducted. Only 47.2% of the participants had adequate understanding of consent information. The mean objective (actual) and subjective (perceived) understanding scores were 78.7% and 91.7% respectively. Participants adequately understood most elements of consent however, some elements were poorly understood including foreseeable risks, protection of confidentiality and compensation for research related injury. Overall there was inadequate comprehension of critical elements of informed consent and there was dissonance between actual and perceived comprehension of informed consent.

Genetic and Genomic Researchers’ Perspectives on Biological Sample Sharing in Collaborative Research in Uganda: A Qualitative Study

“…These approaches pose a challenge to informed consent for biobanking research in Africa because of the communitarian nature of society, customary beliefs, spirituality and relational autonomy (Akpa-Inyang & Chima, 2021). Recent studies from Uganda have reported inadequate understand of consent information in genetic and genomic research (Amayoa et al, 2022; Mwaka et al, 2021; Nabukenya et al, 2022; Rutakumwa et al, 2020); and this has been attributed to low genetic literacy, inaccuracy of translation of technical terminologies and concepts into local languages, reluctance of research participants to read informed consent documents in their entirety, key research team members not being well conversant with genetic/genomic concepts (Amayoa et al, 2022; Mwaka et al, 2021; Nabukenya et al, 2022), and ineffective community engagement approaches (Rutakumwa et al, 2020). Researchers therefore need to be flexible and reflexive enough in the way they think and approach the consenting process in genetic/genomic research (Barugahare, 2019).…”

Research Participants’ Preferences for Individual Results of Pharmacogenomics Research: A Case of a Ugandan HIV Research Institute

“…Participants' concerns were an indicator that they did not adequately understand information about the procedure of disseminating the research findings before consenting to participation. Recent studies have reported a poor understanding of the informed consent process for pharmacogenomics and genomics research in Uganda (Amayoa et al, 2022;Nabukenya, 2019). An inadequate understanding of pharmacogenomics research procedures makes it difficult for participants to make informed decisions when choosing the different kinds of results they would prefer to receive.…”