Public Umbilical Cord Blood Banking and Charitable Trusts

Umbilical cord blood (UCB) is the blood from foetal and maternal circulation in the placenta and umbilical cord. This blood is rich in haematopoietic stem cells. These cells have the capacity for self-renewal, proliferation and differentiation—developing into all of the mature blood cells and maintaining bone marrow function throughout life. Since the late 1980s, haematopoietic stem cells collected from UCB have been successfully used in haematopoietic stem cell transplantation (HSCT) to treat leukaemia or bone marrow failure syndromes, as an alternative source of stem cells to those obtained from bone marrow or peripheral blood1. As a result, many societies have heavily invested in public banking of cord blood units to provide them as a resource for treatment and research. The chapter examines the nature of public cord blood banking (with a particular focus on the Australian experience) and the notions of ‘stewardship’ and ‘custodianship’ that have been a feature of other accounts of biobanking. Since 2009 a number of common law decisions have recognised the possibility that the res nullius rule (which prevents unprocessed human tissue from being considered an object of property) may be relaxed. Some scholars have begun to examine how notions of stewardship and custodianship might work within a property law framework. Following the work of Winickoff and Winickoff, this chapter will argue that donations of UCB (and tissue more generally) are best regarded as charitable gifts and that public UCB banks might be re-imagined as charitable trusts. The chapter begins by reviewing the history of UCB banking (with a focus on the Australian experience) and the concepts of tissue stewardship and custodianship that are a feature of public biobanking. The chapter then reviews the law of charity and sets out its basic elements. The final part of the chapter applies charity law to public UCB banks, arguing that charity law provides a legal framework for understanding the nature of the steward/custodian relationship in the context of UCB donation.NHMRC Project Grant 102992

An empirical study of tissue banking in Australia: Navigating regulatory and ethical challenges

Collections of tumour samples can be an invaluable resource for medical research. There are, however, numerous ethical and legal challenges associated with tumour banking. While there has been extensive discussion of these issues in the legal and ethical literature, there are few available empirical data in relation to the activities of tumour banks in Australia, their practices around ethically charged issues, and their success in implementing complex regulatory guidelines. The aim of this study was to gain more information about the activities of tumour banks in New South Wales, Australia, with a particular focus on their management of, and attitudes towards, ethical and regulatory issues. A survey of 27 tumour collection and research facilities was conducted using a 55-item questionnaire. There is significant heterogeneity of research methodologies as well as of methods for gaining consent and ensuring donor privacy, and there is general concern among the research community about ethical and regulatory issues related to tumour banking. Heterogeneity of practice and uncertainty about ethical and regulatory requirements is problematic in its potential to hinder research and its potential to generate the space for unethical practice, whether intentional or unintentional. There is a pressing need to address these issues so that tumour banks can be used in the most ethical and efficient way possible

The Problems of Biobanking and the Law of Gifts

The practice of biobanking is of major importance to biomedical research in modern Western economies. However, biobanking is troubled by a number of ethical and legal concerns including issues of consent, control and privacy. Recent developments in the networking of biobanks and the sharing of samples and data have exacerbated these issues. This paper outlines these problems and then examines how they can be understood through the law of gifts. Much of the debate on how tissue is donated to biobanks has occurred without reference to the law of gifts. This is most probably due to the res nullius rule, which, until recently, has prevented unprocessed human tissue from being considered an object of property. But recent changes to the common law’s approach to human tissue now invite a reconsideration of the role that gifts law can play in tissue banking (and tissue donation more generally). This paper will proceed on the assumption that tissue which has not been subject to work and skill may nevertheless be held as property and that the decision to donate to a tissue bank can be treated as an example of a legally recognised gift. The paper begins with an example of tissue banking and the legal and ethical issues which it raises. Most prominent amongst these difficulties is the focus on tissue banking on informed consent, a doctrine originally designed to deal with negligence advice and bodily interferences in medical treatment and research. While understandable, the focus on informed consent has created a number of problems particularly in areas of unspecified research, unanticipated findings and privacy. The chapter then moves to reviewing the basic law of gifts by examining the elements of gifts in both law and equity and the requirements for conveying them. The chapter also explains the law’s capacity to recognise different conditions in gifts that limit the also creates the possibility of conditional dispositions which allow for donors to maintain some rights over the tissue, with the possibility of a form of interest which would enable the donor to regain possession and control of their tissue if here was a breach. This paper argues that an application of the law of gifts is a flexible and useful way of reconceptualising the ethical and legal difficulties of biobanking.NHMRC Project Grant 102992

A case-control study of lactation and cancer of the breast.

We have examined the relation of lactation, by total duration, with breast cancer risk among pre- and post-menopausal women. In a hospital-based case-control study conducted in Athens (1989-91), involving 820 patients with confirmed breast cancer and 795 orthopaedic patient controls and 753 hospital visitor controls, logistic regression was used to analyse the data controlling for demographic, nutritional and reproductive factors, including parity and age at any birth. Among post-menopausal women, there was no association between breastfeeding and breast cancer risk, but among premenopausal women those who has breastfed for > or = 24 months had an odds ratio of 0.50 (95% confidence interval 0.23-1.41). A reduction of the odds ration was also evident among premenopausal women who had breastfed between 12 and 23 months (odds ratio 0.70; 95% confidence interval 0.34-1.60). In conjunction with several other recent reports these results support the hypothesis that breastfeeding of prolonged duration may reduce the risk of breast cancer among premenopausal women but not among post-menopausal women. The biology underlying this different effect remains unknown, and the practical implication of the finding is a marginal importance

Beyond platitudes: a qualitative study of Australian Aboriginal people's perspectives on biobanking.

BACKGROUND: Biobanks are vital resources for genetics and genomics, and it is broadly recognised that for maximal benefit it is essential that they include samples and data from diverse ancestral groups. The inclusion of First Nations people, in particular, is important to prevent biobanking research from exacerbating existing health inequities, and to ensure that these communities share in the benefits arising from research. AIMS: To explore the perspectives of Australian Aboriginal people whose tissue - or that of their family members - has been stored in the biobank of the National Centre for Indigenous Genomics (NCIG). METHODS: Semi-structured interviews with 42 Aboriginal people from the Titjikala, Galiwinku, Tiwi Islands, Yarrabah, Fitzroy Crossing, Derby, One Arm Point and Mulan communities, as well as a formal discussion with A. Hermes, an Indigenous Community Engagement Coordinator at the NCIG who had conducted the interviews. The interviews and the structured discussion were double coded using a procedure informed by Charmaz's outline of grounded theory analysis and Morse's outline of the cognitive basis of qualitative research. RESULTS: In this article, we report on A. Hermes' interviews with members from the above Aboriginal communities, as well as on her personal views, experiences, and interpretations of the interviews she conducted with other community members. We found that participation in the NCIG biobank raised issues around broken trust, grief and loss, but also - somewhat unexpectedly - was perceived as a source of empowerment, hope and reconnection. CONCLUSIONS: This research reminds us (again) of the need to engage deeply with communities in order to respond appropriately with respect for their cultural values and norms, and to develop culturally relevant policies and processes that enhance the benefits of biobank participation and minimise potential harms

Dietary vitamin D and cancers of the oral cavity and esophagus

Background: Data on the association between vitamin D and upper digestive tract neoplasms are limited. Methods: In two case-control studies in Italy, we examined the relation between dietary vitamin D intake and squamous cell carcinoma of the esophagus (SCCE; 304 cases) and oral/pharyngeal cancer (804 cases). Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated by multiple logistic regression. Results: Adjusted ORs for SCCE and oral/pharyngeal cancer were 0.58 (95% CI 0.39-0.86) and 0.76 (95% CI 0.60-0.94), respectively, for the highest tertile of vitamin D intake. Using a reference group of those in the highest tertile of vitamin D who were never/former smokers, ORs were 8.7 (95% CI 4.1-18.7) for SCCE and 10.4 (95% CI 6.9-15.5) for oral/pharyngeal cancer among heavy smokers in the lowest vitamin D tertile; similarly, compared with those in the highest tertile of vitamin D who drank <3 alcoholic drinks/day, corresponding ORs were 41.9 (95% CI 13.7-128.6) for SCCE and 8.5 (95% CI 5.7-12.5) for oral/pharyngeal cancer, among heavy alcohol drinkers in the lowest vitamin D tertile. Conclusion: We observed inverse associations between dietary vitamin D intake and risk of SCCE and, perhaps, oral/pharyngeal cancer, which were most pronounced among heavy current smokers and heavy consumers of alcoho

Public trust and global biobank networks.

BACKGROUND: Biobanks provide an important foundation for genomic and personalised medicine. In order to enhance their scientific power and scope, they are increasingly becoming part of national or international networks. Public trust is essential in fostering public engagement, encouraging donation to, and facilitating public funding for biobanks. Globalisation and networking of biobanking may challenge this trust. METHODS: We report the results of an Australian study examining public attitudes to the networking and globalisation of biobanks. The study used quantitative and qualitative methods in conjunction with bioethical analysis in order to determine factors that may contribute to, and threaten, trust. RESULTS: Our results indicate a generally high level of trust in biobanks and in medical research more broadly. Key factors that can reduce perceived trustworthiness of biobanks are commercialisation and involvement in global networking. CONCLUSIONS: We conclude that robust ethical oversight and governance standards can both promote trust in global biobanking and ensure that this trust is warranted

Diabetes and Prostate Cancer Screening in Black and White Men

PURPOSE: Prior studies conducted primarily among white men find a reduced risk of prostate cancer associated with time since developing diabetes. While biologic explanations are plausible, the association may in part arise from more frequent prostate cancer screening among those with a diabetes diagnosis. The purpose of the present study was to investigate the association between diabetes and prostate cancer screening. METHODS: We examined differences in prostate cancer screening (prostate-specific antigen and/or digital rectal examination) testing practices after a diabetes diagnosis among lower-income persons living in the southeastern United States and enrolled in the Southern Community Cohort Study between 2002 and 2009. Baseline in-person interviews collected information on history of diabetes and prostate cancer screening from 18,809 black and 6,404 white men aged 40-79 years. RESULTS: After adjustment for confounding, diabetic black [odds ratio (OR) 1.12, 95 % confidence interval (CI) 1.01-1.25] and white (OR 1.25, 95 % CI 1.03-1.51) men were more likely to undergo recent prostate cancer screening compared to non-diabetic men of the same race. The increased risk for prostate cancer screening, however, occurred primarily within the first 12 months after diabetes diagnosis. CONCLUSIONS: Our results suggest that a diabetes diagnosis modestly increases the likelihood of having a prostate cancer screening test for both black and white men. The prevalence of screening was higher nearer to the time of diabetes diagnosis, which may contribute to an early increase in prostate cancer detection followed by lower prostate cancer detection after an extended time