This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or interventions proven to be effective in clinical trials. However, such access may be modelled on a broad fair benefits framework that emphasises both collateral benefits and interventional products of research, instead of prescribed post-trial access alone. The wording of the current version of the (...) Declaration of Helsinki could in fact be interpreted to broaden the scope to include other collateral benefits by applying such a broad fair benefits framework. We argue that this possibility should be utilised by low and middle income countries’ health research ethics committees in order to ensure that research participants who enrol in clinical trials so as to receive medical care continue to access care after the trial is concluded, as befits their dignity. Although each LMIC has unique concerns, nonetheless there are common challenges based especially on emerging issues, such as post-trial access to healthcare. Accordingly, the South African perspective is used to draw lessons that can benefit other LMICs. (shrink)

Biobanks are repositories that store human biological materials and their associated data. They are rapidly becoming part of national and international networks and give rise to unique ethico-regulatory issues. Whether consent is informed and whether this term should be used when specimens are collected for biobank research is questionable. Where risks occur, they are usually social and relate to identifiability. Public trust and confidence are important for the success of this type of research. Consensus is growing that governance of biobanks (...) should be harmonised. Controlled specimen and data access agreements are essential. The South African National Health Act and its Regulations, that provide the foundation for the legal framework with regard to human tissue and research in South Africa, are silent on the issue of biobanks and the law lags behind while science and technology advance rapidly. The use of biobank assets will lead to significant benefits in human health and should be encouraged while taking account of the associated ethical, legal and social issues and working towards a balance between these two positions. (shrink)