Biobanks: Consent or Re-Consent?

Participants donating samples to research biobanks are, often, contributing to a research resource that may be used for unanticipated research purposes in the future. For example, a participant may donate to a cardiovascular research biobank, but this donation might also be of value for future diabetes research. If a secondary use for this donation is discovered, should researchers be required to re-contact participants to secure consent for the previously unspecified research? Many researchers consider the labor of re-contact and re-consent to be a burden that will inhibit future research. Acquiring one-time, general consent for research, therefore, would seem to be the best and most efficient way to encourage the pace of medical research.

Many ethicists, and the World Health Organization (WHO), however, argue that one-time consent violates a research participant's autonomy. If a participant does not have the opportunity to evaluate these possible future uses and to decide whether their sample and information can be used for them, is the importance of informed consent being undermined?

Wednesday, at a noon seminar hosted by the IU School of Medicine's Department of Medical and Molecular Genetics, PredictER's Peter Schwartz critically evaluated some of the most prominent ethical arguments against one-time consent and described the complexity of deciding the role of autonomy in this realm. In his presentation, "Changing the Rules? Consent and Re-Consent in Predictive Health Research", Schwartz argued that it is not clear that a carefully constructed policy of one-time consent violates autonomy of subjects. While it would be inappropriate to justify such “one-time consent” simply on the basis of the social value of the research involved, or public support for such a policy, a careful reconsideration of autonomy may allow certain kinds of “blanket consent” policies. In his assessment, the path forward for consent for research involving biobanks is far from clear, but a possibility like one-time consent cannot be dismissed simply by appealing to a simple notion of autonomy. The crafting of responsible policies in this area will require more careful reflection on the relevant ethical notions.

Additional Reading:

45 CFR §46.116 - General requirements for informed consent. Department of Health and Human Services.

Caulfield T, Upshur RE, Daar A. DNA databanks and consent: a suggested policy option involving an authorization model. BMC Med Ethics. 2003 Jan 3;4:E1. PMID: 12513704

Genetic databases. Assessing the benefits and the impact on human and patient rights. World Health Organization, 2003. [PDF]