Center for Genetic Research Ethics and Law

This paper draws on ideas from the Sociology of Science and Technology, to explore informed consent issues surrounding the use of the drug Herceptin, widely cited as an example of a novel approach to drug development called pharmacogenetics. Drawing on qualitative semi-structured interviews with 25 UK-based breast cancer specialists, this paper explores Herceptin's disputed epistemological status, as an example of pharmacogenetics or as something out of the ordinary in terms of clinical practice. It considers how, in turn, this impacts on the way in which informed consent is sought and influenced by clinicians' desire to protect patients from possibly distressing test results. It highlights the flexible, contingent and context dependent nature of informed consent in the clinical setting.

Public health and the challenge of genomics.
Kirkman M
Aust N Z J Public Health. 2005 Apr ; 29(2): 163-5

There is controversy in Australia and internationally over the eugenic implications of genomics, with desirable outcomes for public health set against 'slippery slope' arguments. Controversy cannot be avoided; we risk divisiveness if it is not carefully managed with informed, social-consensus-building debate. Furthermore, the intrinsic tension between genomics (with its individual and family choices) and public health (operating for the public good) may even necessitate a reconceptualisation of public health.

Building on relationships of trust in biobank research.
Hansson MG
J Med Ethics. 2005 Jul ; 31(7): 415-418

The submission of an informed consent is an act of trust by a patient or a research subject, but a strict application of the rule of informed consent may not be sensitive to the multiplicity of patient interests at stake, and could thus be detrimental to trust. According to a recently proposed law on "genetic integrity" in Sweden, third parties will be prohibited from requesting or seeking genetic information about an individual. Cumbersome restrictions on research may be lifted, thus creating a more favourable climate for medical research.

Potential harms, anonymization, and the right to withdraw consent to biobank research.
Eriksson S, Helgesson G
Eur J Hum Genet. 2005 Jun 29;

There is less risk involved in biobank research than in human subject research; it should therefore be treated differently. Apart from not being particularly appropriate for protecting the interests of individuals, anonymization of samples has a negative impact on research. We suggest that the current view on withdrawal from research, supported by the Declaration of Helsinki and subsequent ethical guidelines, be abandoned in the context of biobank research and be replaced by an approach inspired by the Nuremberg Code. This approach requires those wishing to withdraw their samples from research to present sufficient reason for doing so.