Ethics & Engagement across the Wellcome Trust Major Overseas Programmes
I hope this post finds you in good health. Please find my end of project report for your perusal.
1. Summary of your project, results, and outputs
The project had three main objectives, namely: (i) to conduct a desk review of related literature with a view to develop a conceptual framework for the project; (ii) to conduct interviews with experts in phylogenetics and bioethics to explore their views on key ethical issues associated with HIV phylogenetics and lastly (iii) to host a capacity building workshop on ethics and HIV phylogenetics.
Initially, the project was supposed to be completed in 2015. However, this target was missed because of delays in obtaining the requisite approvals. These included postgraduate, ethics and Community Advisory Board approvals. The approvals were ultimately received on 30 June, 21 January and 29 August 2016 respectively. Obtaining these approvals was a multi-layered and sequential process, which meant we couldn’t proceed to the next level without meeting all requirements for the preliminary stages. The approvals came after the initial project end date, so we had to apply for a no-cost extension. This was kindly approved by Professor Mike Parker to the end of 31 December 2016.
Most of the project activities were reported in the previous updates. Below is an update of the activities that were conducted during the no-cost-extension period.
Capacity building workshop
A half-day interactive workshop was conducted in Durban on the 9th December 2016. The workshop was designed to explore and deliberate on key ethical issues associated with HIV phylogenetic analysis as applied in our understanding of HIV transmission dynamics. Twenty-four participants from different departments at the university of KwaZulu-Natal attended the workshop.
To give participants grounding on the issues, Professor Tulio de Oliveira gave an oral presentation on HIV phylogenetics with a particular focus on its application and potential ethical dilemmas and complexities associated with its use both in forensic science and in research settings. A key message from his presentation was that it is not possible to prove the direction and directness of HIV infection using HIV phylogenetic analysis and because there are unsampled individuals in the transmission network, conclusions on HIV phylogenetic analysis of viral sequences should be interpreted with caution.
Professor Douglas Wassenaar gave the second presentation, which focused on the Emanuel framework as an ethics framework for considering ethical issues in HIV phylogenetic research. The framework has eight principles and thirty-one benchmarks, which can be used to guide the review of most health research proposals. The eight principles are 1) community participation, 2) social value, 3) scientific validity, 4) fair participant selection, 5) favourable risk-benefit ratio, 6) independent ethics review, 7) informed consent and 8), ongoing respect for participants. He noted that as science evolves, so does ethics. For that reason, there was need for ethics to keep pace with the developments in molecular epidemiology and in particular HIV phylogenetic research. A central question in his presentation was whether current ethical guidelines are adequate for HIV phylogenetic research. Although it has a huge potential to inform targeted prevention and treatment interventions, HIV phylogenetic research is social sensitive with a perceived high risk of social harm. The data can easily be taken out of context to criminalize or stigmatize a particular social group.
Dr. Jantina de Vries (UCT) was scheduled going to give a talk on “Critical issues in genomic research in developing countries”. However, due to a combination of personal and logistical reasons it was not possible for her to travel to Durban.
The last talk was given by Mr. Farirai Mutenherwa, who had an opportunity to present preliminary results from interviews with experts in HIV phylognetics, virology and bioethics.
The desk review of related literature on HIV phylogenetic is now complete. It has culminated in a review paper, which has been completed and reviewed by the supervisors. We are now processing the manuscript for submission to American Journal of Bioethics (AJOB).
Interviews with phylogenetic and ethics experts
Fourteen interviews were conducted between November and December 2016 predominantly via Skype. The use of Skype was necessitated by the geographical distribution of the participants, which made face-to-face interviews logistically difficult and costly to conduct. The interviews were directed by an interview guide, which had two primary questions.
All interviews were transcribed verbatim and checked by for accuracy before being exported into NVivo. The Emanuel framework (EF) was used as the thematic framework for the data analysis, whereby the eight ethical principles formed the nodes or themes at which the transcripts were coded. Preliminary findings were presented at the ethics workshop held in Durban and comments from attendees were incorporated in the final report.
Among the key findings were that the experts noted that there was great potential for HIV phylogenetics in improving human lives. However, the respondents expressed concern over the tension between public health benefits of phylogenetic research and the risk to privacy for individuals and sub-populations whose data is used in such studies. Researchers should therefore exercise extreme caution when interpreting and communicating results from HIV phylogenetic analysis. Results should be communicated in ways that prevent loss of privacy, unintentional HIV disclosure and stigmatization of individuals, communities or subpopulations.
A manuscript on the views of experts is being finalized for publication. These findings were also presented at a separate PhD career development workshop in Durban in February 2017 hosted by SARETI and bioethicists from the US NIH, including one co-author of the Emanuel Framework, Dr. Christine Grady.
2. Added value
One institution that has expressed an interest in ethical issues in HIV phylogenetics is the Centre for the AIDS Programme of Research in South Africa (CAPRISA). CAPRISA has agreed in principle to allow us to do the community interviews at their research site. We will endeavour to continue exploring opportunities for partnerships with research sites already involved in HIV phylogenetics research and others with an interest in this area.
A key challenge that I faced was obtaining relevant approvals to conduct my work. After approval from the postgraduate committee, I needed to get permission from the Africa Centre for Population Health (ACPH) Community Advisory Board (CAB) and subsequently ethics approval from the UKZN Biomedical Research Ethics Committee. The approvals were sequential, which meant I couldn’t get one without the other. A merger between the ACPH and the K-RITH occurred when I was still waiting for institutional approval from the ACPH. Although I had received permission from the ACPH-CAB, I was required to submit my proposal to a newly constituted scientific committee under the two merged units. The committee suggested adjustments to the initially agreed design and methods. It also meant some changes in terms of supervision. Upon consultation with my supervisors and Professor Parker, a consensus decision was made to go ahead with the original study design and withdraw my requests for support from the newly merged ACPH. Instead, CAPRISA has been approached for the fieldwork component with research participants.
Most of the interviews with experts were conducted via Skype due to the geographical location of the respondents, which cut across continents. One of the challenges that I faced was poor Internet connectivity. As these were scheduled interviews, it was difficult to re-schedule an interview once a respondent was lost due to poor connectivity as the respondents had other commitments. Additionally, not all respondents were at the same level in terms of their knowledge and appreciation of HIV phylogenetics. An ethical issue that arose was that I had to explain HIV phylogenetics to those prospective respondents with limited experience in phylogenetics in ways that made them understand and anticipate relevant critical ethical issues associated with it. The ethical question is: How much information was required before respondents could give informed views on the topic? Commentators at the NIH workshop suggested that some expert respondents had unfounded and uninformed views about the risks of HIV phylogenetic research
4. Your satisfaction
I am satisfied with what has been achieved so far given the practical challenges that were faced. The approval delays were frustrating. Specifically, I am looking forward to the two publications, which are on their way and the contribution of our work to research ethics scholarship on this novel molecular epidemiological technique. Through talking to the attendees of the capacity building workshop that was conducted in Durban, we are convinced that it was very relevant, illuminating and positively received. A majority of the participants were keen to learn what HIV phylogenetics was and to explore the ethical issues associated with it.
Considering the challenges highlighted in section 1 and 3 above regarding the merger of the ACPH and the K-RITH and the subsequent developments, it might be difficult to comment on usefulness of the bursary specifically to the MOP. However, I can confidently attest that the fellowship was very useful to me personally through knowledge acquisition and by participating at the Summer School in Vietnam. It is our sincere hope that our work will also strengthen the engagement work of CAPRISA and HIV phylogenetics.
I had an opportunity to present the results from the interviews at three conferences (i) the University of KwaZulu-Natal School of Applied Human Sciences postgraduate conference in October 2016 (ii) the capacity building ethics and phylogenetics workshop held in Durban in December (described above) and (iii) a bioethics early career workshop hosted jointly by the South African Research Ethics Training Initiative (SARETI) and the US National Institutes of Health Department of Bioethics. This opportunity strengthened my presentation skills and enabled me to interact and get constructive feedback on my work from internationally renowned bioethics experts.
I would recommend others to apply for such a bursary project and I thank Professor Parker and Wellcome Trust for this invaluable support.
6. Your future
I would like to continue my involvement with the GHBN and to attend the Summer School. I would like to pursue a postdoctoral fellowship in community engagement and HIV phylogenetics, and to have an opportunity to teach and mentor others with an interest in this area.
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