Best Practice
Guiding Principles
Biobanks are not isolated entities. They exist within an "ecosystem" of stakeholders that is diverse and includes the public, patients, healthcare workers, scientists, government, funders of science, providers of healthcare services, ethicists, regulators and others.
Biobanks play a central role in a multidisciplinary chain of supply that extends from donors through to researchers, influenced by the many stakeholders who interact with the supply processes. Each
person or organisation interacting with this chain of supply has a responsibility to adhere to over-arching guiding principles, to ensure that biosample supply is served and benefits realised.
The Guiding Principles of the Confederation place responsibility on all involved to maintain chains of trust, custodianship and benefit along the supply chain for biosamples from donors to researchers. In addition, such activities should be conducted with appropriate consent and under cost-contribution financial models for the provision of biosamples for clinical research.
The CCB's Guiding Principles can be summarised as:
- - Biosample resources exist for the public benefit
- - Biosample resources should be managed in a way that will protect public trust
- - Biobanks act as custodians of their biosample resources
- - Biosample resources should be based on donation with appropriate consent
- - Biobanks exist to provide a quality service
- - Collection and storage of biosample resources should be purposeful
- - Biosample resources should not be traded as commodities
View the CCB's Guiding Principles document
Appropriate Consent
Appropriate consent should be generic and enduring. Use of samples for defined studies, with specific consent for each study, does not constitute biobanking in accordance with the CCB's Guiding Principles, since samples cannot be made available to other researchers or for further studies without additional consent.
Biosample donation for use in biomedical research should be made in the context of informed consent. As well as details of any specific studies planned for samples, it is important that the process of obtaining generic research consent includes information or discussion about the range of potential uses to which samples may be put, in particular where these may be sensitive or emotive to the donor.