Ethical Challenges of Obtaining Informed Consent: Qualitative Research on the Perspectives of Tuberculosis Patients Participating in Human Genomic Research in Ethiopia.

The use of human genetic variation to comprehend complex diseases has also introduced several ethical, legal, and societal issues (ELSI). Despite the important contribution of Human Genome Research (HGR), full comprehension of these issues by all its stakeholders remains challenging. This research focused on exploring the understanding of research participants on the informed consent process of HGR. Nineteen Ethiopian TB patients, who participated in genomics research, were purposely selected for in-depth interviews. Their recorded responses were transcribed into text-based versions and analyzed thematically using MAXQDA Analysis Software. The patterns in the informed consent process showed the following themes: Therapeutic misconception, Limited clarity on perceived benefit, Partial understanding of third-party use, Addressed suspicion or concerns, Mixed feelings about sample and data extraction, Concerns about sample governance, Variations in information and understanding, Barriers and facilitators to comprehension, and Volunteerism and influencing factors. The findings incorporated both the strengths and challenges of the consenting process of a genomic study, while informing the need for ethical improvements.