Table 1.

Variables in biobanking that have practical implications for the return of individual research findings

Variables related to the design and usage of biobank

Purpose of biobank

Nature of samples/data

Organization of biobank (centralized, distributed, tissue procurement, virtual bank)

Linkages to subject identifiers and information

Clinical, disease-based biobank versus large population study

Existing samples versus prospectively collected samples

Project-directed collection versus collection for future unspecified use

Volume of specimen and data sharing (i.e., numbers of samples and data distributed)

Variables related to the participants

Number of participants

Healthy participants versus participants with diseases

Nature of ongoing relationship between the biobank and participants

Relationship of researcher and biobank to participants

Extent of prior consent: none, consent silent on return of results, consent addresses return of results

Ease and possibility of recontact of participants

Variables related to the research

Likelihood that clinically relevant findings will be generated

Clinical relevance/significance of expected results

Accuracy

Clinical reliability

Interpretation of results

Time between specimen collection, subject consent, and generation of research finding