Keymanthri Moodley

International AIDS Society global scientific strategy: towards an HIV cure 2016

Antiretroviral therapy is not curative. Given the challenges in providing lifelong therapy to a global population of more than 35 million people living with HIV, there is intense interest in developing a cure for HIV infection. The International AIDS Society convened a group of international experts to develop a scientific strategy for research towards an HIV cure. This Perspective summarizes the groups strategy.

Paediatric HIV/AIDS disclosure: towards a developmental and process-oriented approach

Abstract As antiretroviral therapy becomes more widely available in low-resource settings and children with HIV/AIDS live for longer periods, disclosure of HIV diagnosis to infected children is becoming increasingly important. This article reviews the current literature on HIV-related disclosure in light of theories of cognitive development, and argues for the adoption of a process-oriented approach to discussing HIV with infected children. Disclosure presents unique challenges to healthcare workers and caregivers of children with HIV/AIDS that include controlling the flow of information about the childs HIV status to him/her and deciding on what is in his/her best interest. Health care workers’ and caregivers’ views regarding disclosure to children may often be contradictory, with healthcare workers likely to support disclosing the diagnosis of HIV/AIDS to children and caregivers more reluctant to discuss the disease with them. There is a clear need for practical interventions to support paediatric HIV disclosure which provide children with age-appropriate information about the disease.

Paediatric HIV disclosure in South Africa -- caregivers' perspectives on discussing HIV with infected children.

Most paediatric HIV infections in South Africa are transmitted perinatally. Lack of widely available HIV treatment means that most children do not survive to an age at which disclosure becomes a relevant concern. However with the expansion of HIV treatment programmes the proportion of HIV-infected children surviving to an advanced age is likely to increase substantially during the next 5-10 years. A similar phenomenon was observed in Europe and North America with the advent of antiretroviral therapy (ART) in the mid-1990s and in resource-rich settings approximately half of perinatally infected children are expected to survive beyond 13 years of age. While guidelines on the discussion and disclosure of HIV infection among adult patients have received considerable attention there are no such guidelines focusing on the disclosure of paediatric HIV infection in South Africa and other resource-limited settings. Yet in many respects disclosure and discussion of paediatric HIV infection may be more complex than with adult infection. Research from the USA and Europe has shown that when and how a parent discloses to a child can affect the provision of care for the child and may influence the childs psychosocial adjustment and development. Beyond the parent-child relationship public disclosure of a childs HIV status can have significant impact on children and families. Particular sensitivity is required in the case of larger families or households that include both HIV-infected and uninfected members. As HIV infection remains highly stigmatised in many communities disclosure of paediatric HIV infection may also be accompanied by threats to the childs physical and/or psychological health. (excerpt)

Health Research Ethics Committees in South Africa 12 years into democracy

BackgroundDespite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines.MethodsThe 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees.ResultsHealth RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely.ConclusionMost major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity.

Informed consent and participant perceptions of influenza vaccine trials in South Africa

Background and objectives: There are few insights from sub-Saharan Africa on research participants’ experiences of the informed consent process, particularly in the context of randomised controlled trials, where issues of randomisation and the use of placebos may be confusing concepts for participants. This study investigated the knowledge and perceptions of the informed consent process among individuals participating in influenza vaccine trials in two disadvantaged communities in South Africa. Method: Four to 12 months after completion of the trials, participants were contacted to return to participate in the informed consent study. The semistructured questionnaire administered to assess recall of trial procedures and the informed consent process covered key issues including: purpose of the study; awareness that the study was not part of routine treatment; voluntary nature of participation and freedom to withdraw; randomisation; placebos; and remuneration. Results: A total of 334 participants (93% of the original vaccine trial sample; mean age 68 years, median level of education grade 8, 69% women) completed the questionnaire. Only 21% were able to recall that they were allocated randomly to the different treatment arms. Only 19% of those involved in the placebo controlled study had interpreted the concept of placebo as an inactive medication. Conclusion: Although a good general recall of trial concepts was demonstrated, only a small proportion of the participants correctly interpreted and recalled the concepts of randomisation and placebos. Informed consent in this and similarly disadvantaged communities may often be inadequate and new ways to improve understanding of the research process should be explored.

Patients as consumers of health care in South Africa : the ethical and legal implications

BackgroundSouth Africa currently has a pluralistic health care system with separate public and private sectors. It is, however, moving towards a socialised model with the introduction of National Health Insurance. The South African legislative environment has changed recently with the promulgation of the Consumer Protection Act and proposed amendments to the National Health Act. Patients can now be viewed as consumers from a legal perspective. This has various implications for health care systems, health care providers and the doctor-patient relationship.DiscussionCalling a recipient of health care a ‘consumer’ as opposed to a ‘patient’ has distinct connotations and may result in differential behaviour. Labels reflect the ideals of the context in which they are used. Various models of the doctor-patient relationship exist and different metaphors have been used to describe it. Increasingly there are third parties involved within the doctor-patient relationship making it more difficult for the doctor to play the fiduciary role. In certain parts of the world, there has been a shift from a traditional paternalistic model to a consumerist model. The ethical implications of the commodification of health care are complex. As health care becomes a ‘product’ supplied by the health care ‘provider’, there is the risk that doctors will replace professional ethics with those of the marketplace. Health care is a universal human need and cannot be considered a mere commodity. In modern medical ethics, great emphasis is placed on the principle of respect for patient autonomy. Patients are now the ultimate decision-makers. The new Consumer Protection Act in South Africa applies to consumers and patients alike. It enforces strict liability for harm caused by goods and services. Everyone in the supply chain, including the doctor, can be held jointly and severally liable. This may lead to enormous challenges in health care delivery.SummaryViewing patients as consumers may be detrimental to the doctor-patient relationship. While it facilitates an emphasis on respect for patient autonomy, it inadvertently results in the commodification of health care. The new legislative environment in South Africa promotes the protection of patient rights. It may, however, contribute to increased medical litigation.

Microbicide research in developing countries: have we given the ethical concerns due consideration?

BackgroundHIV prevention research has been fraught with ethical concerns since its inception. These concerns were highlighted during HIV vaccine research and have been elaborated in microbicide research. A host of unique ethical concerns pervade the microbicide research process from trial design to post-trial microbicide availability. Given the urgency of research and development in the face of the devastating HIV pandemic, these ethical concerns represent an enormous challenge for investigators, sponsors and Research Ethics Committees (RECs) both locally and internationally.DiscussionEthical concerns relating to safety in microbicide research are a major international concern. However, in the urgency to develop a medically efficacious microbicide, some of these concerns may not have been anticipated. In the risk-benefit assessment of research protocols, both medical and psycho-social risk must be considered. In this paper four main areas that have a potential for medical and/or psycho-social harm are examined. Male partner involvement is controversial in the setting of covert use of microbicides. However, given the long-term exposure of men to experimental products, this may be methodologically, ethically and legally important. Covert use of microbicides may impact negatively on relationship dynamics leading to psychosocial harm to varying extents. The unexpectedly high rates of pregnancy during clinical trials raise important methodological and ethical concerns. Enrollment of adolescents without parental consent generates ethical and legal concerns that must be carefully considered by RECs and trial sites. Finally, paradoxical outcomes in recent trials internationally have advanced the debate on the nature of informed consent and responsibility of researchers to participants who become HIV positive during or after trials.SummaryPhase 3 microbicide trials are an undisputed research and ethical priority in developing countries. However, such trials must be conducted with attention to both methodological and ethical detail. It is imperative that guidelines are formulated to ensure that high ethical standards are maintained despite the scientific urgency of microbicide development. Given the controversy raised by emergent ethical issues during the course of microbicide development, it is important that international consensus is reached amongst the various ethics and regulatory agencies in developing and developed countries alike.

Challenges in biobank governance in Sub-Saharan Africa

BackgroundBiological sample and data transfer within and out of Africa is steeped in controversy With the H3Africa project now aiming to establish biobanks in Africa, it is essential that there are ethical and legal governance structures in place to oversee the operation of these biobanks. Such governance is essential to ensuring that donors are protected, that cultural perspectives are respected and that researchers have a ready availability of ethically sourced biological samples.MethodsA literature review of all legislation, regulations, guidelines and standard operating procedures on informed consent, confidentiality and the transfer of biological samples amongst countries in Sub-Saharan Africa was conducted. In addition, an examination of the websites of departments of health and national ethics committees was performed. Researchers and research ethics scholars in the field in various African countries were contacted for assistance. A literature review of all studies examining participants views on issues related to biobanking in Africa was carried out and five separate studies were found.ResultsIt was found that biobanking guidelines differ substantially across Sub-Saharan Africa regarding biobanking and often conflicted across borders. This has the potential to negatively impact collaboration. Furthermore, the guidelines in place often do not recognise the ethical difficulties arising from the transfer of biological samples and are unsuitable to regulate biobanks. Additionally, there is insufficient research into the views of research participants and stakeholders on the use of biological /samples.ConclusionCollaboration is necessary to ensure the success of biobanking projects in Africa. To achieve this, there should be some harmonization of guidelines across Africa which would aid in transferring biological samples across borders. These guidelines should reflect the unique ethical issues arising out of the storage and secondary uses of biological samples. Finally, further research into the views of research participants is necessary. Such studies should aid in the drafting of any new harmonization guidelines.

It's my blood: ethical complexities in the use, storage and export of biological samples: perspectives from South African research participants

BackgroundThe use of biological samples in research raises a number of ethical issues in relation to consent, storage, export, benefit sharing and re-use of samples. Participant perspectives have been explored in North America and Europe, with only a few studies reported in Africa. The amount of research being conducted in Africa is growing exponentially with volumes of biological samples being exported from the African continent. In order to investigate the perspectives of African research participants, we conducted a study at research sites in the Western Cape and Gauteng, South Africa.MethodsData were collected using a semi-structured questionnaire that captured both quantitative and qualitative information at 6 research sites in South Africa. Interviews were conducted in English and Afrikaans. Data were analysed both quantitatively and qualitatively.ResultsOur study indicates that while the majority of participants were supportive of providing samples for research, serious concerns were voiced about future use, benefit sharing and export of samples. While researchers view the provision of biosamples as a donation, participants believe that they still have ownership rights and are therefore in favour of benefit sharing. Almost half of the participants expressed a desire to be re-contacted for consent for future use of their samples. Interesting opinions were expressed with respect to export of samples.ConclusionsEliciting participant perspectives is an important part of community engagement in research involving biological sample collection, export, storage and future use. A tiered consent process appears to be more acceptable to participants in this study. Eliciting opinions of researchers and research ethics committee (REC) members would contribute multiple perspectives. Further research is required to interrogate the concept of ownership and the consent process in research involving biological samples.

Teaching medical ethics to undergraduate students in post-apartheid South Africa, 2003–2006

The apartheid ideology in South Africa had a pervasive influence on all levels of education including medical undergraduate training. The role of the health sector in human rights abuses during the apartheid era was highlighted in 1997 during the Truth and Reconciliation Commission hearings. The Health Professions Council of South Africa (HPCSA) subsequently realised the importance of medical ethics education and encouraged the introduction of such teaching in all medical schools in the country. Curricular reform at the University of Stellenbosch in 1999 presented an unparalleled opportunity to formally introduce ethics teaching to undergraduate students. This paper outlines the introduction of a medical ethics programme at the Faculty of Health Sciences from 2003 to 2006, with special emphasis on the challenges encountered. It remains one of the most comprehensive undergraduate medical ethics programmes in South Africa. However, there is scope for expanding the curricular time allocated to medical ethics. Integrating the curriculum both horizontally and vertically is imperative. Implementing a core curriculum for all medical schools in South Africa would significantly enhance the goals of medical education in the country.