Table 1.

Approaches to consent of biosamples

Initial consent methods
Opt-in consent	The storage and use of biosamples for research on the basis that the donor has actively agreed to do so
Opt-out consent	The storage and use of samples for research on the basis that the donor has not objected, after previously being given the opportunity to do so
Opt-in consent methods
Consent once for life	Consent is provided once for life for use of any residual samples for research with the option of withdrawing permission at a later stage if the donor wishes to do so
Consent at certain points	Consent is provided at certain points for use of residual biosamples for research, eg, every 10 years or at the beginning of a particular episode of care
Consent every time	Consent is requested every time residual biosamples may become available for use in research
Consent for research use of biosamples
Generic consent	Consent to the use of donated samples for a range of unknown uses, on the basis of general information about those possible uses and about the governance arrangements in place. Also referred to as ‘broad’ or ‘blanket’ consent
Tiered consent	A more restricted form of consent for use of samples, where the donor is invited to agree to the use of their samples in unknown projects, but given the option of specifying particular categories of research that they wish to exclude, eg, embryonic research. Also referred to as ‘categorical’ consent
Specific consent—once only	Consent to the use of donated samples for a specified study only, on the basis of information provided about that study. Any residual sample will be discarded at the end of that study
Specific consent—for every new study	Consent to the use of donated samples for a specified study, on the basis of information provided about that study. However, participants are recontacted and asked to consider participating in every new study for which their biosamples are eligible

Consent terms were selected based on common usage within the UK biobanking system (eg, generic consent is the term used by the Human Tissue Authority, National Research Ethics Service and National Cancer Research Institute) and definitions chosen in consultation with a team of representatives from universities, hospital biobank staff, pathologists and industry.