IntroductionEgenis researchers Dr Dana Wilson-Kovacs and Dr Christine Hauskeller have had a paper published in the latest issue of Sociology of Health and Illness.
Their paper, ‘Stem cells clinical trials for cardiac repair: regulation as practical accomplishment’, explores the effect of different regulatory environments in the UK and Germany upon clinical work and clinical trials.
Despite talk of (and even moves towards) homogenization of regulatory frameworks for stem cell therapies, different countries do have different organisational cultures and each of these cultures have their own advantages and disadvantages, the authors argue. They suggest that rather than comparing the differences in an abstract way we need to see how clinical teams 'make-sense' of and interpret the regulation in each national and institutional context.
“Regulatory frameworks are an integral part of how clinical staff make sense of what they do,” says Dr Wilson-Kovacs. “They provide structure and legitimacy to routine activities. Regulation is not simply seen as a bureaucratic and administrative burden, but relied upon in the identification of good research and clinical practice.
Regulation guides, channels and directs clinical research and fosters collaborations in the production of new therapies,” adds Dr Wilson-Kovacs. “Existing resources are adapted to meet the legislative requirements – for example, established infrastructures for bone marrow transplantation are used to advance the use of stem cells treatments for heart repair.”