Sequenom Inc., a developer of medical diagnostic products, recently made their noninvasive test for Down syndrome available for clinical practice.1 The DNA-based test—given the name “MaterniT21”—requires only a simple maternal blood sample as early as 10 weeks of gestation. In recent clinical trials involving thousands of pregnant women, the MaterniT21 test identified 99.1% of cases of Down syndrome, and gave the correct result in 99.9% of cases when the fetus did not have Down syndrome. Sequenom’s test is thought to be (...) an improvement on previous prenatal testing techniques because of its. (shrink)

The individual self and its critics -- The individualist assumptions of bioethical frameworks -- The genetic self is the connected self -- The failures of individual ethics in the genetic era -- The communal turn -- Developing alternatives: benefit sharing -- Developing alternatives: trust -- The ethical toolbox part one: recognising goods and harms -- The ethical toolbox part two: applying appropriate practices -- Possible futures.

The ethics of biobanking is one of the most controversial issues in current bioethics and public health debates. For some, biobanks offer the possibility of unprecedented advances which will revolutionise research and improve the health of future generations. For others they are worrying repositories of personal information and tissue which will be used without sufficient respect for those from whom they came. Wherever one stands on this spectrum, from an ethics perspective biobanks are revolutionary. Traditional ethical safeguards of informed consent (...) and confidentiality, for example, simply don’t work for the governance of biobanks and as a result new ethical structures are required. Thus it is not too great a claim to say that biobanks require a rethinking of our ethical assumptions and frameworks which we have applied generally to other issues in ethics. This paper maps the key challenges and controversies of biobanking ethics; it considers; informed consent (its problems in biobanking and possibilities of participants’ withdrawal), broad consent, the problems of confidentiality, ownership, property and comercialisation issues, feedback to participants and the ethics of re-contact. (shrink)

Biological samples are routinely collected and used in biomedical research. As Weir and Olick (2004) point out in their book The Stored Tissue Issue, there are four ways in which samples can be sto...

It is generally assumed in research ethics that research participants have an unconditional right to withdraw from research without any detriment or reprisal. This paper analyses this right in the context of biobank research and argues that the traditional shape of the right in clinical research can be modified in biobank research without incurring significant ethical cost. The paper falls in three parts. The first part is a brief explication of the philosophical justification of the right to withdraw. The second (...) part presents a number of extant criticisms of the right. And the third and final part argues that although a right to withdraw is crucial in relation to biobank research, such a right has to be specified in a different way to the similar right in relation to clinical research. (shrink)

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...) range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

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. (shrink)

This paper is about the actual and potential development of an ethics that is appropriate to the practices and institutions of biobanking, the question being how best to develop a framework within which the relevant ethical questions are first identified and then addressed in the right ways. It begins with ways in which a standard approach in bioethics – namely upholding a principle of individual autonomy via the practice of gaining donors’ informed consent – is an inadequate ethical framework for (...) biobanking. In donating material to a biobank, the individual donor relinquishes a degree of control and knowledge over the way their material is used in large-scale and typically open ended projects; and the identifying nature of genetic material means that third parties have rights and interests which must be taken into account as well as those of the individual donor. After discussing the problems for informed consent in the biobanking context, the paper then considers three emerging alternative approaches which, broadly speaking, conceptualize the subject of biobanking ethics in communal or co-operative terms: one version sees participants in biobanking research as ‘shareholders’ whilst the other expands on the notion of participation to include the wider public beneficiaries of biobanking as ‘stakeholders’. It concludes by outlining a third view, on which the biobanking institution itself is conceived as an ethical subject whose defining function can do useful normative work in guiding and evaluating its activities. (shrink)