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Enhancing Regulatory Legitimacy through Reflexive Collaboration
Published in Sarah Devaney, Stem Cell Research and the Collaborative Regulation of Innovation, 2013
It has been claimed that ‘the discourses and practices of accountability have not yet caught up with the changing role of experts in the political process’.88 In the following two sections, we will consider a case study of how the HFEA dealt with the question of whether research using human-animal hybrid embryos89 was and should be permissible. In the first section, analysis will be undertaken of the process by which scientists in the UK brought this potential new technology to the notice of the regulator and contributed to processes to establish its permissibility. In doing so, the complex and multi-faceted role which scientists can and have played in framing policy stances towards SC research will be demonstrated. Then, the role of scientists as advisers within the regulator itself will be considered. While the focus is on scientific experts here, we will see that their discourse strays beyond the purely scientific. Analysis of their roles will lead to recommendations about how best SC research regulators can manage decision-making in this socially constructed area, drawing on the contributions of experts in a way which reflects a sophisticated understanding of the contributions of such collaborators and the limits upon them.
A ‘strict but permissive approach'
Published in Julie Kent, Regenerating Bodies, 2012
Hence, following the adoption of the EU TCD described in Chapter 3, when it opened for business, the HTA had a wide range of responsibilities relating to the regulation of human tissues. These included oversight of those both collecting and using human tissues in research and therapies. Although wide, its remit did not extend to the collection and use of human embryos or gametes, which, as we have seen, were regulated separately by the HFEA. The regulation of human tissues and cells for research and therapy in the United Kingdom was rooted in the institutional and political histories of these two quite distinct regulatory bodies. The HFEA, as we saw, provided a ‘strict’ but permissive approach to embryo research and, more recently, the creation of human–animal hybrid embryos. In contrast, the HTA was established as a response to national concerns about the donation, use and disposal of body parts from the living and the dead. Its task was to develop a more centralized regulatory system to control a much wider range of activities, both under the terms of the Human Tissue Act and as a competent authority under the EU TCD.
Embryology
Published in Anthony R. Mundy, John M. Fitzpatrick, David E. Neal, Nicholas J. R. George, The Scientific Basis of Urology, 2010
In recent years Embryology has undergone a remarkable transformation from being a largely descriptive science to its current status at the forefront of innovative therapeutic research. Many of the advances in this field, including the cloning of mammalian embryos, can be traced back to early work on assisted conception and in vitro fertilization (IVF), but perhaps the greatest impetus for embryo research came from the isolation and culture of pluripotent embryonic stem cells from early embryonic tissue (1). The ambitious and costly embryo and stem cell research programs that are now being undertaken across the world are underpinned by the expectation that this work will ultimately pave the way to the development of a wide range of clinical applications, including cell transplantation, tissue regeneration, and tissue engineering. More controversially, research is also underway to explore the feasibility of creating artificial gametes using genetic material derived from somatic cells. The creation of human–animal hybrid embryos is being explored as a potential source of (human) pluripotent embryonic stem cells to circumvent the problems created by the scarcity of donated human oocytes. In some controversial areas the pace of scientific advance threatens to outstrip the ability of legislators to adapt regulatory frameworks in a way that is acceptable to the scientific community and society as a whole. In the United Kingdom, responsibility for regulating embryo and stem cell research lies with the Human Fertilisation and Embryology Authority (HFEA).
Responsible Research with Human Tissues: The Need for Reciprocity Toward Both Collectives and Individuals
Published in The American Journal of Bioethics, 2021
Michael A. Lensink, Karin R. Jongsma, Sarah N. Boers, Johannes J. M. van Delden, Annelien L. Bredenoord
In response to this, there has been a broadly shared call to focus less on the protection of autonomy via a one-off consent to provide tissue, but rather to facilitate more direct involvement of individuals in governance and decision-making, and more individual control regarding what happens to their samples and data (Kaye et al. 2015; Lensink et al. 2020). Even the Havasupai case used by Lee herself has been used to demonstrate why it is so important to position tissue providers more like “partners” in this way (Saha and Benjamin Hurlbut 2011). To further illustrate this point, if a person strongly objects to research involving the creation of human-animal hybrid lifeforms, surely it would be a violation of that person’s bodily integrity and their right to self-determination to use his or cells for that purpose. But because initial consent does not offer tissue providers much in terms of control over future use of their tissue, the narrow focus on the consent procedure that currently characterizes biobank governance constitutes a moral gap.