Reconsidering Consent and Biobanking

Co-authored with Heather Widdows

The acquisition of fully informed consent presents a central ethical problem for the procurement and storage of human tissue in biobanks. The tension lies between the apparent necessity of obtaining informed consent from potential research subjects and the projected future use of the tissue. Specifically, under the doctrine of informed consent medical researchers are required to inform their potential research subjects about the relevant risks and purposes of the proposed research. However, because human tissue – when stored in biobanks – can be put to multifarious uses, the information that medical researchers are expected to divulge to their subjects is epistemologically inaccessible. Biobank researchers are thus thought to be unable to obtain informed consent from their subjects, making the practice ethically suspicious. We propose that such suspicions of ethical failure should be reconsidered by presenting two possible solutions. Firstly we argue that the epistemological difficulty might be partially solved by adopting the “waiver model” of informed consent. Secondly, we put forward an argument that individual consent can be supplemented by group ethical models. We thus conclude that while informed consent is problematic for biobank researchers, alternative ethical solutions are available.

Informed consent as waiver: the doctrine rethought?

Neil Manson and Onora O’Neill have recently defended an original theory of informed consent in their book Rethinking Informed Consent in Bioethics (2007). The development of their ‘waiver’ model is premised on the failings of the theory of informed consent as disclosure, which is rejected on two counts: firstly, the disclosure model’s implicit reliance upon a ‘conduit-container’ model of communication means that the regulatory requirements of informed consent can rarely be achieved; secondly, the model’s purported ethical justification via a principle of respect for patient autonomy is presented as being vacuous.

Despite having laudable motivations for rethinking informed consent, I argue that their theory of informed consent as waiver can be criticised on similar grounds. In order to support this thesis I object that Manson and O’Neill’s developed theory of agential communication is too intricate to easily meet the demands of informed consent as waiver. Secondly, I show that the model appears to be implicitly reliant upon a principle of respect for patient autonomy.

Hence, despite improving upon the doctrine of informed consent, the waiver model needs further elucidation in order to avoid the problems mounted against the disclosure model.