Research governance in pharmacogenetic based drug development: why the principlist approach?

Williams, June

Abstract

The thesis will examine whether policy considerations based on the normative ethical framework of Principlism are adequate for drug development involving pharmacogenetics. In order to structure the analysis, the main research question will be based on the following three claims: (1) that the overriding deference to the principle of respect for autonomy in the current interpretation of Principlism has asserted a legacy of protectionism towards the research participant at the expense of ignoring pharmacogenetics’ primary ethical issues (which are concerned with equity, fair distribution and research prioritisation); (2) that the principle of justice in Principlism requires specification, and that this principle’s nonspecificity may be a reason for over-compensatory application of respect for autonomy; (3) and finally, that current interpretations of Principlism represent moral values that are culturally dependant. Based on these claims, I argue that a pharmacogenetic research governance ethical framework ought to be representative of common moral values, which are culturally neutral, subscribe to a ‘minimal morality', and are not based on the current precautionary approach that is entrenched in Principlism. From this main argument, I appeal to the principle of justice as fairness from Rawls’s A Theory of Justice to provide specification for the principle of justice inherent in Principlism. As well as establish how the application of this ‘minimal morality’ in governance could be achieved through John Rawls’s overlapping consensus, arguing that this would minimise the variability seen in regulatory decision making. I argue that greater specification of the principle of justice would ensure that this principle could effectively be exercised to alleviate pharmacogenetics’ actual ethical issues, which are not concerned with the inference of disease knowledge, as implied by ethical concerns regarding informed consent, privacy and confidentiality.

Citation

Williams, J. (2016). Research governance in pharmacogenetic based drug development: why the principlist approach?