Although Canada has not yet enacted any biobanking-specific privacy law, guidance and oversight are provided via various federal and provincial health and privacy-related laws as well as via ethics and policy documents. The primary policy document governing health research, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, provides the framework for the strong role of Research Ethics Boards in Canada, and limits research funding from Canada's three main federal funding agencies to those who agree to adhere to its (...) policies. The broad consent model is gaining traction in Canada, although lack of legal and constitutional precedence for the broad consent or opt-out options makes this an evolving issue. In general, data is required to be coded; more specific security measures are outlined in guidelines that may be implemented by local policy. International sharing is allowed, and Canada meets the European Union's standards for receipt of data and samples. (shrink)

Like many other countries, South Korea has recognized the importance of biobanks as a tool for medical research and has engaged in two very important tasks to foster biobanking infrastructure: funding biobanks and setting up rules to protect the integrity of biobanks that share potentially sensitive personal information.

Health research raises profound concerns of an ethical and legal nature — concerns primarily centered on how to balance researchers’ quest for scientific discovery against societal interest in protecting individuals whose participation makes the discovery possible. Particularly in a country such as Nigeria, which, not too long ago, suffered major abuse of research subjects, deploying a robust ethicolegal regime capable of curbing excesses and protecting research participants whilst contemporaneously not frustrating scientific progress is not an easy task. This is even (...) more critical in the context of novel scientific endeavors, such as biobanking and genomic research, particularly when a significant pool of potential donors are inadequately informed about the processes involved in their participation or the result. (shrink)

In this paper, we explore the perspectives of expert stakeholders about who owns data in a medical information commons and what rights and interests ought to be recognized when developing a governance structure for an MIC. We then examine the legitimacy of these claims based on legal and ethical analysis and explore an alternative framework for thinking about participants' rights and interests in an MIC.

In addressing the creation and regulation of biobanks in different countries, a short descriptive introduction to the social and cultural backgrounds of each country is mandatory. The State of Israel is relatively young, and can be characterized as a multi-religious, multi-ethnic, multi-cultural society, somewhat similar to the American melting pot. The current population is 8.3 million, a sharp rise resulting from a 1.2 million influx of immigrants from the former Soviet Union in the 1990s. Seventyfive percent are Jewish, 20% Arabs, (...) and several other minorities. The birth rate is 3.8 per family, the highest in the Organization for Economic Cooperation and Development. (shrink)

A 10-year retrospective analysis of consent documentation for the donation of leftover or residual human tissue from surgical interventions at a major academic healthcare institution in Singapore was conducted. Findings suggest that demographics like gender, religious belief and socioeconomic status could be indicators of the willingness of a patient to donate residual tissue to a tissue repository or biobank for future research use. Patients in general did not decide to donate based on specific details that were provided to them. Instead, (...) those who donated were of a background that engendered a level of security or confidence that harm would not befall them. It is argued that willingness to donate depended more on this sense or perception of security that arose from systemic trustworthiness than from the rigour of consent-taking. In 2015, changes to the regulation of tissue banking and related activities in Singapore include legislative requirement for a prescribed list of information to be provided to a prospective tissue donor in consent-taking. While this and other legislative changes are important to ensure that tissue donation for research remains informed and voluntary, it is argued that trust and trustworthiness remain an unfinished project. Tissue repositories or biobanks more broadly must be constituted as moral institutions that safeguard the interests and rights of altruistic tissue donors. More critically, they must advance security and trustworthiness through good stewardship that is directed at promoting the common good through accountability, transparency and control. (shrink)