Biobanks are an organized collection of biological material and associated data. They are a fundamental resource for life science research and contribute to the development of pharmaceutical drugs, diagnostic markers and to a deeper understanding of the genetics that regulate the development of all life on earth. Biobanks are well established in High Income Countries (HIC) and are rapidly emerging in Low and Middle Income Countries (LMIC). Surveys among biobanks operating in a LMIC setting indicate that limited resources and short term funding tied to specific projects threaten the sustainability of the biobanks. Fit-for-purpose biobanks targeting major societal challenges such as HIV and Malaria provide an excellent basis for integrating biobanks with the available research communities in LMIC regions. But to become sustainable for the future it is important that biobanks become an integrated part of local research communities. To achieve this, the cost of operating biobanks must be lowered, templates must be developed to support local ethics committees and researchers must be given the opportunity to build experience in successfully operating biobank based research projects. The B3Africa consortium is based on these conclusions and set up to support biobank based research by creating a cost efficient Laboratory Information Management System (LIMS) for developing biobanks and also contribute to the training and capacity building in the local research community. The technical platform called the eB3Kit is open source and consists of a LIMS and a bioinformatics module based on the eBiokit that allow researchers to take control over the analysis of their own data. Along with the technical platform the consortium will also contribute training and support for the associated infrastructures necessary to regulate the ethical and legal implications of biobank based research.
Resolving ethical and legal concerns is a time consuming but rarely insurmountable task when obtaining samples from biobanks. The BBMRI-LPC project has throughout its lifetime resolved numerous such issues and intense communication between involved researchers and experts have been necessary to resolve various issues. To facilitate efficient communication it is useful for non-experts to have an at least basic understanding on how the regulatory system for managing biological samples is constructed to balance the sometimes conflicting needs of privacy, trust and scientific progress. Although laws regulating research oversight have been implemented differently in every country, there is a similarity of core principles founded on international charters. These core principles are based on the concept of consent and actions taken by the biobank in regards to sample usage rely on either an explicit or presumed consent. In interview studies among donors chief concerns among donors are focused on privacy, efficient sample utilization and if donors are given access to information generated from their samples. Despite a lack of clear evidence regarding which concern takes precedent among donors, scientific as well as public discourse has largely focused on privacy concerns and the right of donors to control the usage of their samples. As a result biobank governance has taken a largely negative approach to uncertainties in sample utilization. This mean that sample usage is likely to be restricted if there is any uncertainty if the intended usage is in line with donor expectations. To help biobank professionals avoid making unnecessary mistakes we have developed this basic primer covering the relationship between ethics and law, the concept of informed consent and consideration for returning findings to donors.
This article examines the role of sector-specific international, organizations such as BBMRI-ERIC and its possibilities of influencing (soft) law-making within the EU and beyond, using tools available within the EU participatory democracy. B3Africa is used as an example of how the EU procedures also can be used to influence (soft) law-making beyond the EU, influencing the biomedical community to enact their own standards and guidelines to approve ethical governance in transnational biobanking.
There are two core principles in the law and ethics of biomedical research that could be considered universally accepted: first, all handling of personal data and human biological samples is conditioned by the informed consent of the individual involved; second, all medical research on human biological samples and personal data should be placed under the review of research ethics committees. These concepts are included in international, regional and national guidelines, rules and regulations for processing of data and biobanking. However, the legal implementations are carried out within each national legal order, by national organs enacting administrative decisions applicable within the state. In order for the research project to function in a multinational setting, the EU has developed soft law tools and governance mechanisms to facilitate European biomedical research. The question is whether this can be considered valuable and legitimate on the grounds of enhancing conditions for medical research.