The psychology of "cure" - unique challenges to consent processes in HIV cure research in South Africa.

BACKGROUND: Consent processes for clinical trials involving HIV prevention research have generated considerable debate globally over the past three decades. HIV cure/eradication research is scientifically more complex and consequently, consent processes for clinical trials in this field are likely to pose a significant challenge. Given that research efforts are now moving toward HIV eradication, stakeholder engagement to inform appropriate ethics oversight of such research is timely. This study sought to establish the perspectives of a wide range of stakeholders in HIV treatment and research to inform consent processes for cure research. METHODS: In total, 68 South African stakeholders participated in two qualitative research modalities. In-depth interviews (IDIs) were conducted with a purposive sample of 42 individuals - audiotaped with consent. Twenty-six stakeholders participated in three focus group discussions (FGDs). Thematic analysis of transcribed IDIs and FGDs was conducted. RESULTS: The majority of respondents indicated that there could be unique challenges in HIV cure research requiring special attention. In particular, given the complexity of cure science, translation of concepts into lay language would be critical for potential participants to adequately appreciate risks and benefits in early phase research with experimental interventions. Furthermore, to aid understanding of risks and benefits against a background of desperation for a cure, specially trained facilitators would be required to assist with a psychological assessment prior to consent to avoid curative misconceptions. Long-term participant engagement to assess durability of a cure would mean that the consent process would be prolonged, necessitating annual re-consent. Building trust to maintain such long-term relationships would be critical to retain study participants. CONCLUSION: Unique consent requirements for cure research in South Africa would include significant efforts to maximise understanding of trial procedures, risks and the need for long-term follow-up. However, the psychological dimension of cure must not be underestimated. Beyond an understanding of cure science, the emotional impact of HIV cure advances the discourse from cure to healing. Consequently, the consent process for cure research would need to be enhanced to include psychological support and counselling. This has several important implications for research ethics review requirements for consent in HIV cure research.

HIV cure research in South Africa: a preliminary exploration of stakeholder perspectives.

Innovative strategies for HIV cure are in development and research studies are being designed and planned globally. South Africa is no exception. However, little is known about stakeholders' knowledge, understanding and expectations of future cure research. This study aimed to obtain in-depth qualitative insights into stakeholder perspectives at this formative stage of HIV cure research. Fifteen stakeholders were interviewed in an HIV research clinic in the Western Cape, South Africa with their consent. Interviews were transcribed verbatim and analysed using thematic content analysis. Broad themes that emerged included the meaning of cure, awareness of HIV cure research, risks and benefits of such research. General awareness and understanding of HIV cure research was lower than expected. Some participants expressed a fatalistic attitude to HIV and described it as an "end-time illness" with no prospect of cure. In general, HIV cure research was regarded as risky - biologically psychologically and socially. If study designs were to include treatment interruption, participants would comply only if success was guaranteed. Given these perceptions of HIV cure research, significant challenges to consent processes and participant recruitment can be anticipated. Authentic community engagement and intensive educational interventions will be necessary prior to future cure research in South Africa.

Healing Without Waging War: Beyond Military Metaphors in Medicine and HIV Cure Research.

Military metaphors are pervasive in biomedicine, including HIV research. Rooted in the mind set that regards pathogens as enemies to be defeated, terms such as "shock and kill" have become widely accepted idioms within HIV cure research. Such language and symbolism must be critically examined as they may be especially problematic when used to express scientific ideas within emerging health-related fields. In this article, philosophical analysis and an interdisciplinary literature review utilizing key texts from sociology, anthropology, history, and Chinese and African studies were conducted to investigate the current proliferation of military metaphors. We found the use of these metaphors to be ironic, unfortunate, and unnecessary. To overcome military metaphors we propose to (1) give them less aggressive meanings, and/or (2) replace them with more peaceful metaphors. Building on previous authors' work, we argue for the increased use of "journey" (and related) metaphors as meaningful, cross-culturally appropriate alternatives to military metaphors.

Are there limits to respect for autonomy in bioethics?

I discuss the significance of respect for personal autonomy in bioethics with reference to its practical expression: rational informed patient choice. The question is whether, given the apparent practical limitations to this notion, bioethical autonomy should be seen as an absolute. After a historical review of informed consent and its development, I discuss the requirements for informed consent. Some inherent tensions are evaluated, as is the applicability of the notion that in order to be legitimate, autonomy should do some ethical work. Limits to the notion of informed consent are explored with reference to six examples: the right of women to reproductive autonomy; the autonomy of legally minor Jehovah's Witnesses; autonomy in cosmetic surgery; inappropriate treatment; autonomy and human medical research, and euthanasia and other end-of-life options. The discussion is within a South African framework with reference to other jurisdictions and decisions where appropriate. I conclude that whilst some unusual instances of limitation of bioethical informed consent might be ethically justifiable, the arguments presented point to the opposite: the unfounded limitation of informed consent.

Ethical challenges in developing an educational video to empower potential participants during consent processes in HIV cure research in South Africa.

Obtaining consent for HIV research is complex, particularly in low- and middle-income countries. Low levels of education, complexity of science and research processes, confusion about basic elements of research, and socio-economic conditions that make access to medical care difficult have collectively led to concerns about the adequacy of the consent process. Given the exponential growth of HIV prevention and treatment research in South Africa, HIV researchers are increasingly facing challenges obtaining authentic informed consent from potential participants. It is anticipated that HIV cure research, despite being in its infancy in South Africa, will introduce a new discourse into a population that is often struggling to understand the differences between 'cure', 'preventive and therapeutic vaccines' and other elements of the research process. Coupled with this, South Africa has a complex history of 'illegitimate' or 'false cures' for HIV. It is therefore logical to anticipate that HIV cure research may face significant challenges during consent processes. HIV prevention research in South Africa has demonstrated the importance of early community engagement in educating potential research participants and promoting community acceptance of research. Consequently, in an attempt to extrapolate from this experience of engaging with communities early regarding cure research, a 15-minute educational video entitled 'I have a dream: a world without HIV' was developed to educate and ultimately empower potential research participants to make informed choices during consent processes in future HIV cure clinical trials. To aid others in the development of educational interventions, this paper discusses the challenges faced in developing this educational video.

The decolonialisation of medicine in South Africa: Threat or opportunity?

The South African Traditional Health Practitioners Act 22 of 2007 is now fait accompli. The Act has been promulgated and the Department of Health (DoH) is proceeding with its implementation. An Interim Traditional Health Practitioners Council and a dedicated DoH deputy director have been appointed, the appointment of a registrar is being finalised, and the DoH has conducted a roadshow to introduce the Act and its implications to groups of traditional health practitioners (THPs) countrywide. The objective is eventual formalisation and professionalisation of THP practice to provide appropriate primary healthcare services through co-operation with biomedical service providers. Biomedical practitioners should understand the provisions of Act 22, and how this may affect their own practices.

An Evaluation of Research Ethics in Undergraduate Health Science Research Methodology Programs at a South African University.

The amended research ethics policy at a South African University required the ethics review of undergraduate research projects, prompting the need to explore the content and teaching approach of research ethics education in health science undergraduate programs. Two qualitative data collection strategies were used: document analysis (syllabi and study guides) and semi-structured interviews with research methodology coordinators. Five main themes emerged: (a) timing of research ethics courses, (b) research ethics course content, (c) sub-optimal use of creative classroom activities to facilitate research ethics lectures, (d) understanding the need for undergraduate project research ethics review, and (e) research ethics capacity training for research methodology lecturers and undergraduate project supervisors.