Opt-in or opt-out to increase organ donation in South Africa? Appraising proposed strategies using an empirical ethics analysis.

Utilising empirical ethics analysis, we evaluate the merits of systems proposed to increase deceased organ donation in South Africa (SA). We conclude that SA should maintain its soft opt-in policy, and enhance it with 'required transplant referral' in order to maximise donor numbers within an ethically and legally acceptable framework. In SA, as is the case worldwide, the demand for donor organs far exceeds the supply thereof. Currently utilising a soft opt-in system, SA faces the challenge of how to increase donor numbers in a context which is imbued with inequalities in access to healthcare, multiplicitous personal beliefs and practices, distrust of organ transplant and varying levels of education and health literacy. We argue that a hard opt-in, opt-out or mandated consent system would be problematic, and we present empirical data from Gauteng Province illustrating barriers to ethically sound practice in soft consent systems. Ultimately, we argue that in spite of some limitations, a soft opt-in system is most realistic for SA because its implementation does not require extensive public education campaigns at national level, and it does not threaten to further erode trust at a clinical level. However, to circumvent some of the clinical-level barriers identified in our empirical study, we propose a contextually sensitive option for "enabling" soft opt-in through "required transplant referral". We argue that this system is legally defensible, enhances ethical practice and could also increase donor numbers as it has in many other countries.