Managing Samples & Biobanking
Privacy and consent are raised in relation to physical samples and the storage of samples in biobanks for future use by the individual or for research. Issues include appropriate storage of samples, sample ownership, equitable and ethical sample sharing including appropriate research ethics approval for all research projects, awareness and adherence to relevant regulations for transfer of samples within and between countries including instructions on whether samples should be returned or destroyed at the end of the research project.
Another area of attention is whether biobanks should require users to return the related research data and information generated from access to the samples and beyond that, decisions about return of clinically relevant results to the sample donor. These issues will continue to be of interest over coming years as genomic medicine implementation initiatives around the world collect and store samples, some in central facilities, leading to a growing number of biobanks /biorepositories.
Genomics England has partnered with the National Institute of Health Research (NIHR) National Biosample Centre to store the samples of rare disease and cancer patients taking part in the 100,000 Genomes Project. The foundations for this national centre were provided by the experience of recruiting and collecting samples from 500,000 adults in the UK for the UK Biobank study. During the design of the Biobank study, funders were well aware of the ethical concerns that might arise from the analysis of health data and biological materials in such depth by many projects over time and they developed a public Ethics and Governance Framework (EGF) to set standards for the project and to ensure that safeguards were in place for scientifically and ethically approved research. Details of the EGF can be found here.
Similarly, the All of Us Research Program in the US has created a biobank that will support the collection, analyses, storage, and distribution of biospecimens for research use. Data from laboratory analyses of biospecimens will be combined with other lifestyle and health information provided by participants. The responsibility to operate this biobank was awarded to the Mayo Clinic.
In 2009, the OECD Council adopted a recommendation on Human Biobanks and Genetic Research Databases (HBGRD) which provides guidelines for the establishment, management, governance, operation, access, use and discontinuation of HBGRDs. Overall, it seeks to facilitate wide access to data and materials for biomedical advances while ensuring that research is conducted in a manner respectful of participants, and that upholds human dignity, fundamental freedoms and human rights.
There are a number of other organisations that provide biobank-related ELSI leadership. The Biobanking and Biomolecular Resources Research Infrastructure - European Research Infrastructure Consortium (BBMRI-ERIC) oversees the pan-European distributed research infrastructure of biobanks and biomolecular resources. It provides tools and expertise, through its Common Service ELSI. Issues such as mutual recognition of ethics reviews and the development of a policy on sharing and access to data and human biospecimens for the benefit of patients are being considered by consortium experts.
Bridging Biobanking and Biomedical Research across Europe and Africa (B3Africa) aims to implement a cooperation platform and technical informatics framework for biobank integration between Africa and Europe. The consortium has 11 partners including the Human Heredity and Health in Africa (H3Africa) project, the European Biobanking and Biomolecular Resources Research Infrastructure Consortium (BBMRI-ERIC), and the Low- and Middle-Income Countries Biobank and Cohort Building Network (BCNet) and it is standardizing the ethical and legal framework from both continents.
The Public Population Project in Genomics and Society (P³G) is an international not-for-profit consortium dedicated to the development and management of multi-disciplinary policy infrastructures and research consortia. It does this through development of free and accessible research tools, resources and methods that help optimize and harmonize the design of biobank infrastructures and research projects One of its programs is an ELSI Interoperability Service which provides a range of services and advice on sample and data collection.