Tissue banking in South Africa: a 19-year history

The establishment of a Tissue Bank and the science of Tissue Banking in South Africa started in the 1960s and is still developing. This article describes the development and growth of Tissue Banking in South Africa. The current emphasis is to supply viable bone products that have been produced under the best possible quality controlled circumstances; with the collaboration between different Organ Donation Organisations. Through collaboration, a dramatic increase in the number of donors was noted over the years. Concurrently, there was a dramatic increase in the usage of different allograft products and now necessitates the development of new graft materials for expanding patient options. As an ongoing concern, the Tissue Bank in South Africa experienced an ever increase in costs to enhance quality/safety controls: increase in historical patient information, documentation and serological testing in a population struggling to control HIV. To date, the South African Tissue Bank has not experienced any untoward patient incidence since the 1960s and currently is getting over 500 donors per year.     

BENEFITS TO RESEARCH SUBJECTS IN INTERNATIONAL TRIALS: DO THEY REDUCE EXPLOITATION OR INCREASE UNDUE INDUCEMENT?

There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally‐sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. It proceeds from the premise that there are good grounds for thinking that, at least some, international research sponsors exploit trial participants because they do not provide the research population with a fair share of the benefits of research. This provides a prima facie argument for increasing the benefits for research participants. Concern over undue inducement is a legitimate moral concern; however, if this concern is to prevent research populations from receiving their fair share of benefits from research there must be sufficient evidence that these benefits will unduly influence patients’ decision‐making regarding trial participation. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants’ motivations and the influence of payments on research subjects’ behaviour and risk assessment. Admittedly, the available research in this field is limited, but the research that has been conducted suggests that financial rewards do not distort research subjects’ behaviour or blind them to the risks involved with research. Therefore, I conclude that research sponsors should prioritise the prevention of exploitation in international research by providing greater benefits to research participants.     

SHOULD RAPID TESTS FOR HIV INFECTION NOW BE MANDATORY DURING PREGNANCY? GLOBAL DIFFERENCES IN SCARCITY AND A DILEMMA OF TECHNOLOGICAL ADVANCE

Since testing for HIV infection became possible in 1985, testing of pregnant women has been conducted primarily on a voluntary, 'opt-in' basis. Faden, Geller and Powers, Bayer, Wilfert, and McKenna, among others, have suggested that with the development of more reliable testing and more effective therapy to reduce maternal-fetal transmission, testing should become either routine with 'opt-out' provisions or mandatory. We ask, in the light of the new rapid tests for HIV, such as OraQuick, and the development of antiretroviral treatment that can reduce maternal-fetal transmission rates to <2%, whether that time is now. Illustrating our argument with cases from the United States (US), Kenya, Peru, and an undocumented Mexican worker in the US, we show that when testing is accompanied by assured multi-drug therapy for the mother, the argument for opt-out or mandatory testing for HIV in pregnancy is strong, but that it is problematic where testing is accompanied by adverse events such as spousal abuse or by inadequate intrapartum or follow-up treatment. The difference is not a 'double standard', but reflects the presence of conflicts between the health interests of the mother and the fetus--conflicts that would be abrogated by the assurance of adequate, continuing multi-drug therapy. In light of these conflicts, where they still occur, careful processes of informed consent are appropriate, rather than opt-out or mandatory testing.