ABSTRACT
The decision whether to feed back findings to research participants has been the subject of much unresolved debate in medical research, as it challenges the boundary between the clinic and the research context (Wolf, Paradise and Caga-anan 2008). Despite this, there has been relatively little discussion of the issue of feedback in the context of biobanks. Feedback is particularly significant for biobanks and other large-scale repositories of human tissue and medical information,1 where there maybe an on-going relationship with participants over many years and over time, the knowledge about health risks is likely to increase. This issue will become even more acute with the use of new approaches in genomic research, such as genome-wide association studies (GWAS) (Cho 2008), and the future use of whole genome sequencing technology, where the possibility of incidental findings increases (Van Ness 2008, Wolf et al. 2008). This chapter considers the nature, extent and enforceability of the legal duties that custodians of biobanks and the scientists and others who use tissue or information from these sources may owe to participants – and possibly also to their close blood relatives – in the case of significant findings. The nature of those duties will depend ultimately on the precise legal relationship between the parties and the legal principles that may be applied. This chapter focuses principally on Australian law, but this discussion will be important for biobanks based in other countries, as similar legal issues will arise and a similar analysis will need to be undertaken.
