Blood and tissue samples as ‘human subjects’


  • Dr Amy Hinterberger

    University of Warwick

Project summary

This project examines transformations in the definition of the human research subject in biomedical research. On 8 September 2015, the USA announced an overhaul for research regulations: the expansion of the definition of ‘human subject’ to include biospecimens (ie blood and tissue samples). This change points towards the increasing importance of biospecimens in health research, along with their politicisation. 

In addition, advisory bodies have issued guidance on the ‘humanisation’ of other life forms brought about by the increasing use of human biological material in other animals (eg human ‘admixed embryos’ in the UK and the US moratorium for animals containing human cells in early development). 

This project investigates such new and changing understandings of the human subject in biomedical research through a qualitative based pilot study in the USA and Germany.