Informed Consent: Considerations for Biobanks


Informed consent is a central but evolving part of how biobanks function. American and European regulations state that biobanks must obtain valid, voluntary and informed consent from research participants before collecting, storing or using biospecimens for medical research. Participants should have the right to withdraw consent at any time of a study, especially when it is longitudinal.

In recent years, there has also been a significant push from governments and funding organizations—such as the NIH in the U.S., the Medical Research Council in the U.K. and the European Commission—for research organizations and biobanks to reuse biospecimens and data arising from publicly-funded research. Reusing biospecimens can reduce the number of new samples that need to be collected, minimizing the risk of physical harm to research participants.

This move towards reusing biospecimens and data means that many biobanks are exploring the options for broad or enduring consent rather than study-specific consent.

Study-Specific Consent for Biobanks

With study-specific informed consent, research participants consent to their donated biospecimens and data being used in a single specific research study. If biobanks choose this form of consent, they will need to contact sample donors every time a researcher wants to use a particular sample or data point in a new study.

Broad Consent for Biobanks

Broad or enduring informed consent means that research participants agree to future use of their biospecimens and data within the ethical boundaries of the biobank. This sort of agreement usually includes a statement that biospecimens and data will only be used in research studies approved by an institutional review board or ethics committee.

Tiered Consent for Biobanks

Tiered informed consent gives research participants the option of giving broad consent only to certain types of research or research uses e.g. specific diseases/indications such as cancer or neurological diseases; only publicly-funded research; or only specified institutions or researchers. With tiered consent, research participants can also choose whether their samples and data are identifiable or anonymised.

Meta-Consent for Biobanks

Meta-consent is a form of tiered informed consent where research participants can choose a different consent option within the different research tiers. For example, if biobanks offer meta-consent, a research participant could give broad consent to all research conducted in certain institutions but only study-specific consent for genomic research or privately funded research.

Dynamic Consent for Biobanks

Dynamic informed consent is facilitated by interactive digital platforms that allow research participants to regularly check the research activities of a biobank and modify their consent for any upcoming research projects. Dynamic informed consent provides the added benefit of keeping research participants informed on how their samples are used, and any new risks associated with new studies—a requirement of European legislation.


Biobanks undoubtedly perform a central role in biomedical research by collecting, storing and distributing valuable biospecimens and associated data. However, biobankers have the obligation and are mandated to protect the privacy of research participants. Biobanking LIMS and biobank management software, such as CloudLIMS, can help biobanks fulfill these obligations and explore evolving models of informed consent, such as tiered or dynamic consent.