When enough is too much: Community consent and biospecimen banking

Background: Community Based Participatory (CBPR) researchers discuss ideas of individual versus community consent. These concepts variously apply to consent to participate in research. The case of biobanking for genetic and other research presents special considerations for consent processes.

Method: CBPR principals were reviewed identifying consent issues applicable to genetics, individuals, families, communities and over time.

Results: Some genetic issues have yet to be thoroughly discussed in regards to family consent in genetics biobanking. In the case where family members disagree about participation in one time and/ or “forever” consent for biobanking specimen collections, many questions remain unresolved. If male and female siblings participate in biobanking research, are the analyzed results and information conclusive for other members of the family that do not consent to know such information. Do unwelcome disclosures of information create situations for liability or breach of released medical information? What percentage of a family needs to consent for broad based testing? Can families give consent for future tests that may be unknown and unanticipated at the time of consent? Do significant health benefits or treatment options create an obligation to inform? Ethical principles inform consent considerations.

Conclusions: Policy and ethical considerations must consider a wide range of consent issues for banks of biomedical specimens especially when broad permission applies like unlimited time frames. Future breakthroughs may afford testing opportunities unknown at the time of consent. Community or family participation in such studies presents challenges to CBPR principles and scientific protocols for community and family Consent.