Abstract
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 (Declaration of Helsinki, 2008, “Section 24.” Accessed November 1, 2009. http://www.wma.net/en/30publications/10policies/b3/index.html). 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.
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Notes
- 1.
The focus of our paper is on informed consent as an inadequate feature of biobank regulation; other ethical guarantees, such as data protection, will not be explored here.
- 2.
“… there should be made known to [the subject] the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment” (Nuremberg Code 1949).
- 3.
The “relevant aspects” required by condition (7) must be restricted to the broad aims of the study, since the requirement that the potential participant be informed of any information relevant to the study is too strong – for instance, it would be impracticable to require that each participant understood the intricacies of the scientific methods used to carry out the research. In this vein, UK Biobank requires only that the potential participant is informed of the broad aims, purpose and nature of the research, reasonably limiting condition (7).
- 4.
The potential subject must be “adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate at any time without reprisal” (Declaration of Helsinki 2008).
- 5.
Notably, the subject is able to be informed of condition (8) – her right to withdraw her consent at a later time. For instance, UK Biobank grants participants the “right to withdraw”: “at any time and without having to explain why and without penalty” (UK Biobank 2007, 6). Options are available with regard to the extent of the withdrawal, from ceasing contact to requiring that their data is put “beyond further use”. However, a problem for condition (8) is that it is not possible for the donor to fully withdraw her consent if that is taken to mean removing all record of ever having been involved (technically not possible) nor can one retrospectively retrieve samples and data from completed studies or subsequent studies which build on these studies. Nonetheless, given our focus in this paper on the difficulties of obtaining informed consent, further discussion of problems surrounding condition (8) will be left aside.
- 6.
In addition to disclosure of information, elements of informed consent include voluntariness and competence (Grisso and Appelbaum 1998, 8–10). The claim that a lack of information fails to respect patient autonomy is premised on thought that even if the patient competently and voluntarily consents she cannot autonomously give her consent if she does not know what it is she is consenting to.
- 7.
For further discussion on this please see previous paper (Widdows 2007b).
- 8.
Since we have already motivated the desirability of seeking alternative models for obtaining consent in the context of biobanking, Manson and O’Neill’s impetus will not be explored here in detail.
- 9.
For further discussion on the problems of confidentiality in the genetic era see Widdows (2007b).
- 10.
Possible family models suggested in the literature are the “joint account” (Parker and Lucassen 2004) and the “family covenant” (Doukas and Berg 2001). The joint account model sees genetic information as belonging to, and available to, all family members. While there may be cases where information could be withheld (for example in situations where such disclosure would seriously harm the individual) the “default” position would be that genetic information is familial and not individual (Parker 2001). The “family covenant” is perhaps the most discussed model of family consent, where the family and not the individual is the “unit of care”. The family covenant is suggested as a model which dictates the manner in which results from genetic tests are to be shared with family members, as such it “offers the individual, family and physician a mechanism to help resolve competing claims for confidentiality and disclosure” (Doukas and Berg 2001, 3). It was intended to pre-empt questions of when and how to disclose potentially distressing information about the genetic status of individuals within families. The thinking behind this approach is that the “bonds that hold families together may not survive such dynamic tension unless there is some framework constructed to allow for balancing of individual and family interests” (Doukas and Berg 2001, 3) These models are discussed in more detail elsewhere (Widdows 2007b).
- 11.
For instance to prevent the wrongs such as those done to the Hagahai tribe from occurring in the future (Widdows 2009a).
- 12.
For example see the Nuffield Council on Bioethics document The ethics of research related to healthcare in developing countries.
- 13.
It is important to note that while there is overlap the public good and the scientific good are not equivalent.
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Bullock, E., Widdows, H. (2011). Reconsidering Consent and Biobanking. In: Lenk, C., Sándor, J., Gordijn, B. (eds) Biobanks and Tissue Research. The International Library of Ethics, Law and Technology, vol 8. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-1673-5_8
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