Genes contribute to how certain individuals and populations respond to a given treatment regimen. There is an increase in research conducted among people living with HIV to understand what anti-retroviral drugs are appropriate to certain individuals or populations, and the required doses to produce a desirable effect with minimum adverse reactions. This information is equally important for participants to understand why certain individuals may receive the different drugs or doses, yet they suffer from the same disease. However, whether and how to return the results of genetic research to participants remains a challenge in low-resource setting, like Uganda. There are several ethical and social issues that may arise if there is no contextualized guidance on how such results can be safely returned to participants.
A team of researchers at Makerere University College of Health Sciences, , has developed procedural guidance and a logical process for the return of individual pharmacogenomic results to research participants in HIV/AIDS research studies. The guidance is a result of a long research process that involved the engagement of stakeholders, including genetics professionals and researchers, research participants who have been involved in pharmacogenomic research, members of research ethics committees, bioethicists and community representatives from various HIV research institutions affiliated with the College of Health Sciences, Makerere University..
The research findings show that while return of individual pharmacogenomic (concerned with an individual’s genes interact with drugs ) research results is increasingly recognized as an ethical obligation, in Uganda and similar settings, there are several ethical challenges that could arise including the possibility of misinterpretation of results due to complex genomic terms, absence of direct translated genetic terms, anxiety and unnecessary worry, and society misconceptions. Through interviews with the key stakeholders, the research team found out that while many agreed that returning these test results is a symbol of reciprocity and respect, it is also a source of hope for many people living with HIV and those with other long-term/chronic conditions.
As mentioned by one genomic researcher, “participants need to appreciate that we are all different, that’s why we respond differently to the same drugs even when we are suffering from the same disease.”
“Returning pharmacogenomic test results to research participants involves provision of appropriate information on how genes interact with drugs. This information enables research participants to understand the role genes play in their bodies and facilitates effective decision-making. Sometimes participants may need to make decisions regarding switching treatment regimens (which may sometimes require them to buy expensive drugs if government is not offering them free). So, they need to know why you are changing their current treatment regimen to another”, says Dr. Sylvia Nabukenya, the Lead Researchers on this study at Makerere University College of Health Sciences.
The research team noted that while nearly all stakeholders engaged in the study noted the importance of communicating individual results to the individual study participants, the absence of practical guidance on how to do this presents potential ethical, social and legal hurdles.
The research team has therefore suggested A logical process describing the steps that researchers can undertake to communicate individual pharmacogenomic research results, right from when the study participants are being recruited into research studies.
“This will not only support researchers and clinicians in educating and communicating pharmacogenomic results to individual participants and patients but will also empower participants and build their capacity beyond simply being participants but become co-creators of knowledge and key decision-makers”, says Dr. Nabukenya.
Presenting the proposed guidance to key stakeholders in policy and practice, at an engagement meeting at Makerere University College of Health Sciences campus on 8th October 2025, Dr. Nabukenya emphasized that what is contained in the guidance is a synthesis of what the stakeholders engaged during the research shared. She therefore implored the participants at the meeting to recommend to the Ministry of Health, research regulators, and other relevant authorities to turn the guidance into guidelines, recognized nationally.
Researchers, ethics committees, decision-makers, and clinicians are some of the groups that encounter most challenges with returning pharmacogenomic results to research participants and patients; therefore, they were urged to be frontline advocates for a safe return of individual results from all genomic and genetic studies.
Participants noted that genomics technologies are evolving and what is working currently may be obsolete in 2 months, urging government and key players to invest in such technologies to ensure that the country remains competitive in this area of work.
They appreciated the fact that genomics and genes science is not easy to communicate, complicated even further by the need to translate into local languages, and called for ethical creativity to especially communicate with the lowest level of community.
It was noted that in settings like public health facilities where the workload can be overwhelming for health workers, there is need for support so that they can effectively communicate individual pharmacogenomic test results to patients.
Participants recommended that future studies should be conducted on how to return such test results to communities and urged research institutions to lead on educating communities on genes and genomics, as health facilities may not have adequate capacity to do so.
Participants came from Uganda National Council of Science and Technology, research institutions, study sites where the research was conducted, service providers, among others. The event was conducted at the Davis Lecture Theatre at Makerere University College of Health Sciences, Mulago.
