Regulatory Systems and Human Health Research

Bringing empirical coherence to the intersecting governance structures of human subjects research, animal welfare regulation and stem cell oversight.

Understanding human functioning, at the cellular, organ system and whole body levels, is the goal of biomedical research. On this front, researchers are developing a range of new tools and methods; for example, developments in stem cell science and gene editing techniques enable researchers to integrate human cells more accurately and comprehensively into non-human animals at different stages of development.

Traditionally, ethical concerns and regulation in biomedicine have focused on the human subject, with ensuing allowances to address animal welfare and human embryos. Biomedical ethics itself tends to be focused on either animal welfare and animal rights on the one hand, or human-beings and the ethical mistreatment of human subjects, on the other. To this end, the experimental use of animals and human beings in research have received separate, but intensely animated public and academic discussion.

This project, however, argues that new forms of biomedical research require social scientists to work across human and animal boundaries in biomedicine and ethics. By empirically exploring the ethical and governing structures of biomedicine, our project brings into view different institutional environments which are often treated as separate. For instance, over the last ten to fifteen years new forms of animal regulation have emerged in the UK, USA, Japan, and other countries that bring layers of ethical oversight that has not previously existed. While laboratory animals continue to be regulated via animal welfare in these countries, new regulations have emerged alongside these which address the ability researchers have to ‘humanise’ the biology of other organisms.

Our project foregrounds these significant areas of governance and ethics, moving across key institutional structures, including laws and regulation of animal research (via institutional animal care and use committees), research with human subjects, (via institutional review board/research ethics committees), and guidelines for research involving the use of human stem cells (via stem cell oversight committees). Our goal is to initiate a much needed productive platform to understand the politics of the human in biomedical research and its relationship to pressing issues of health and welfare for all living beings.