Health Research Ethics Committees in South Africa 12 years into democracy

BACKGROUND: Despite 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. METHODS: The 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. RESULTS: Health 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. CONCLUSION: Most 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

Supporting the sexual and reproductive rights of HIV-infected individuals

The past 10 years have seen major advances in health care policy and services that support sexual and reproductive rights in South Africa. Significant milestones include the legalisation of termination of pregnancy (TOP) and the provision of free public sector services for maternal and child health (MCH) and contraception.1 At the same time the HIV epidemic has expanded rapidly during the last decade, and today an estimated 29% of women of reproductive age (15 - 49 years) in South Africa are HIV-infected.2 Despite these parallel developments, little attention has been paid to the way in which advances in sexual and reproductive rights in South Africa are extended to HIV-infected individuals

Barriers to accessing free condoms at public health facilities across South Africa

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Expanding access to antiretroviral therapy through the public sector--the challenge of retaining patients in long-term primary care.

The growing movement to make antiretroviral therapy (ART) widely available in South Africa has spurred discussion on different aspects of delivering HIV treatment services, deliberations that have taken on new importance in light of the national government’s recent announcement of a plan to make ART widely available in the public sector. Yet one critical aspect of delivering ART effectively within HIV care services has received surprisingly little attention, namely the challenge of retaining patients in long-term programmes of primary care. Here we discuss the importance of distinguishing adherence to medications from retention in care, as well as the possible interventions that may be employed to improve long-term patient retention

Quality of life of HIV-infected individuals in a community-based antiretroviral programme

Purpose of the study: The impact of HAART on health-related quality of life (HRQoL) has been widely researched in the developed world, however, there is limited data coming out of the developing world and, in particular, sub-Saharan Africa, where the vast majority of HIV-infected individuals live. This study examined HRQoL among HIV-positive individuals initiating HAART at the Hannan Crusaid Treatment Centre in Gugulethu, Cape Town, and explored the impact of HAART-related drug toxicities on HRQoL. Methods: HRQoL was assessed using a standardised questionnaire, the Medical Outcomes Survey Short Form 36 (MOS SF36). Physical health summary (PHS) scores and mental health summary (MHS) scores were compared pre-HAART and at regular intervals during the first 48 weeks of HAART. The impact of drug toxicities on HRQoL was described and assessed both in unadjusted bivariate and adjusted multivariate analyses. Summary of results: This study reported a significant increase in HRQoL during the first 48 weeks on HAART with the bulk of this increase occurring during the first 16 weeks. Although there was a general improvement in HRQoL on HAART, 23% of participants reported a decline in PHS score, and 34% a decline in MHS score. Average drops in median PHS and MHS scores were 8.4 units (SD 9.31) and 9.9 units (SD 11.4), respectively. Eleven (4%) participants reported drug toxicity. Most toxicities (63%) occurred between weeks 32 and 48, and 73% were related to stavudine. Participants who experienced drug toxicity reported lower PHS scores than participants without a drug toxicity at all time points. However, only 27% (three) of participants with drug toxicity reported a decline in HRQoL between pre-HAART and week 48. Drug toxicities had little impact on MHS scores. Conclusion: This study confirmed the HRQoL benefits of HAART in a community ARV clinic in South Africa. While the majority of patients experienced a significant improvement in HRQoL on HAART, up to a third of patients reported declines in HRQoL. HAART-related drug toxicities (including those secondary to the use of stavudine) did not have a significant negative impact on HRQoL during the first 48 weeks of HAART supporting the ongoing use of stavudine in the national ARV roll-out programme

Phaco-emulsification versus manual small-incision cataract surgery in South Africa

OBJECTIVES: To compare the results of phaco-emulsification cataract surgery and manual small-incision cataract surgery. METHODS: Consecutive patients aged >50 years undergoing surgery for age-related cataract were recruited into a randomised prospective clinical trial. Randomisation was done using opaque sequentially numbered envelopes opened by the surgeon immediately prior to surgery. The patients were seen after 1 day, 2 weeks, and 8 weeks. Outcome measures. The primary outcome measure was the uncorrected visual acuity at week 8. The secondary outcome measures were the uncorrected visual acuity on day 1, the best corrected visual acuity at week 8, the refraction at week 8, and the intra- and postoperative complications. RESULTS: One hundred patients were recruited into each arm of the study. There was no difference in the incidence of intra-ocular complications (p=0.19). There was no difference in the day 1 visual acuities (p=0.28). However, both the uncorrected and the corrected week 8 visual acuities were better in the eyes that had phaco-emulsification (p=0.02 and p=0.03), and there was less astigmatism (p=0.001) at week 8 in the eyes that had phaco-emulsification. CONCLUSIONS: While manual small-incision surgery has been recommended as an acceptable alternative to phaco-emulsification in middle- and low-income countries, we have found that the results of phaco-emulsification are better. Where appropriate, consideration should be given to encouraging a transition to phaco-emulsification in our Vision 2020 programmes in Africa

Failed contraception?

The frequency, cost and harms of the procedure must have been weighed up by the British National Health Service (NHS) — usually pretty sensible about their medical recommendations — which proposed 3-yearly screening for women aged between 50 and 64 years. Obviously more cancers would be discovered by 2-yearly rather than 3-yearly screening, and yet more by annual screening. Six-monthly screening, in turn, would clearly yield more cancers than annual screening. This would fit well with Dr Whitehorn’s ‘simple arithmetic’. However a balance has to be found between benefits and harms, and we chose the NHS one. The following organised screening programmes recommend 2- yearly mammography, most of them for women between 50 and 69 years: Australia, Finland, Iceland, Israel, Netherlands, France, Belgium, Canada, Denmark, Ireland, Italy, Norway, Portugal and Greece. Annual mammography, and mammography at an early age are the usual recommendations of interest groups. They are also the recommendation of the correspondence printed above. Like Dr Paul Sneider, we conclude with a quote from Boyle: ‘Every woman has a right to participate in an organised screening program . . .’. This right, alas, does not apply to this country, where other health care priorities make an organised programme an impossibility. However, should a woman have the privilege of medical aid, or be able to afford mammography, it is her choice to undergo it, a choice open to only a minority of South Africans. The majority of South African women would, in our opinion, be well served by an organised programme of ‘breast awareness’, a proposal that Dr Russell Whitehorn finds difficult to fathom

Combined condom and contraceptive use among South African women

Women across sub-Saharan Africa face multiple threats to their sexual and reproductive health. In South Africa, almost 20% of pregnancies are unwanted and an additional 36% are unintended at the time of conception, highlighting problems in access to and effective use of contraception. The heavy burden of sexually transmitted infections (STIs), including HIV/AIDS, presents a further challenge to women’s health. In this context there is growing recognition of the importance of dual-method use, defined as the simultaneous use of condoms and a non-barrier contraceptive, as an important strategy for promoting reproductive health. While condoms alone do protect against both pregnancy and STI, condom use over the long term may lead to unacceptable contraceptive failure rates. Therefore, combining condom use with an effective non-barrier contraceptive, usually a hormonal method, helps to ensure effective prevention of both unwanted pregnancy and STI