In a recent commentary, Mongoven and Solomon suggest that informed consent is not completely applicable to biobanking, and surrogacy may be an appropriate alternative. The authors highlight four major differences between informed consent for research and informed consent for biobanking. These include participating in an activity (e.g. a clinical trial) vs. an institution (e.g. a biobank), one-time participation vs. ongoing decision-making, unidirectional vs. multidirectional information flow, and active vs. detached research participation. Because participants are consenting to something that may happen years down the road, perhaps even after the participant’s lifetime, the authors propose a model more akin to clinical surrogacy. In this model from clinical practice, surrogate decision makers act on behalf of incapacitated patients, informed by advance directives expressing the patients’ values. To model this for biobanks, the biobanking institution assumes the responsibility of a surrogate by 1) becoming familiar with the donor’s values that influence future decisions and 2) becoming trustworthy and acting on the values of the donor. The authors acknowledge a surrogacy model may present challenges and will not replace the ethical intuitions of informed consent. However, focusing on patients’ values has the potential for transformation from a legal-transactional model to a communications model.
Trust is vital for participation in any biobank, and a recent study in China explored attitudes of hospital patients and the public towards using discarded biopsy samples for research. Nearly 2/3 of participants (64%) were willing to donate samples, and 16% wanted the option to withdraw their donation at any time. Only 12% were willing to donate samples for unknown future use, and less than half (43%) stated they trusted medical institutions. The authors suggest that low levels of trust are hindering biospecimen collection efforts in China. Public trust must be restored to encourage individuals to participate in biobanking. This is likely a global message, and efforts are needed to build trust between potential research participants, investigators, and research institutions.
With the rapid increase in biobanking both domestically and internationally, it is relevant to explore the public’s general understanding and opinion of biobanking, particularly in underserved and underrepresented communities. Two recent studies used a deliberative engagement process to assess opinions and understanding of biobanking in African-American populations from Southside Chicago. In the first study, the majority of people participating in focus groups expressed a strong interest in biobank participation, broad consent, recontact, and data sharing. Many discussed fear and distrust of research, stemming from a lack of understanding and education about biobanks, as well as concern for breaches of confidentiality. For many in the second study, the return of individual research results was a motivator for participation. The main deterrent to participation was lack of trust in research and the people performing it. Some participants also mentioned the sacredness of donated tissues, and expressed wishes for researchers to show respect towards their donations.
Rare Disease-HUB (RD-HUB) is a biospecimens/biorepositories resource managed by the Office of Rare Diseases Research (ORDR) at the NIH. The website provides a searchable database to help researchers find biospecimens collected and stored by domestic and international biorepositories. Although RD-HUB focuses on rare diseases, common diseases are included in the resource. RD-HUB can assist investigators and others locate and identify specific biospecimens, and facilitate sharing of material and information. RD-HUB includes a convenient list of fields required for entering biorepository data. If you have a biospecimen collection, be sure to register your collection at RD-HUB today.