The Code of Practice for the Generation and Use of Human Stem Cell Based Embryo Models is an important step towards the regulation of stem-cell-based embryo models (SCBEMs) in the UK (see BioNews 1246). The Code identifies three factors as showing a need for some kind of regulation:
- The current lack of a clear governance framework.
- Ethical considerations.
- Public support for oversight of research involving SCBEMs.
The Code has no official or legal status but may, if adopted by research organisations and by major funders, become the basis on which SCBEM research is de facto regulated in the UK.
The structure of the oversight system proposed in the Code is based on the prior approval of research proposals by a national SCBEM Oversight Committee, and is thus structurally similar to the research ethics committee (REC) system that has been in place in a number of iterations since the 1970s for biomedical research with human participants.
There is, however, one ethically very significant difference between the REC system and what is proposed in the Code, and that is the absence of a specified set of ethical standards or criteria for review.
The main impetus for the establishment of RECs was the World Medical Association's 1975 revision of the Declaration of Helsinki, and the 1976 requirement by the Vancouver group (later the International Council of Medical Journal Editors) that research published in medical journals had to conform to the Declaration and have REC approval.
Although early RECs differed immensely in composition and effectiveness, they were all supposed to work to a particular set of substantive standards delineating what constituted ethically acceptable research. The Code, in contrast provides very little guidance to the SCBEM Oversight Committee as to what ethical considerations are important. It asserts that 'research involving SCBEMs advances scientific and medical knowledge – which is a significant ethical consideration in its own right', which is true at the level of the SCBEM research programme as a whole, but not necessarily true at the level of the individual research project (compare the similar issue in relation to animal research).
The Code also states that 'it is important that this research is ethically robust', but provides no clear standards for what might make a research project unethical, except in relation to the implantation of SCBEMs.
The Code mentions some ethical concerns raised during public consultation 'relating to SCBEMs displaying such recognisable features as a spinal cord or heartbeat.' But then it immediately dismisses their importance, first by stating that these concerns are not necessarily ethically important, and then by glossing them as based on 'emotional responses'.
The 'X is not necessarily ethically important' is a prevalent move in the bioethics literature, as is the claim that something is an emotional response and thereby implicitly not a rational response. But even if it can be shown that X is not necessarily ethically important, that does not rule out that X is ethically important in some, many or most cases where X occurs, and there is no compossibility problem in something being at the same time an emotional and a rational response.
In the section on 'Core principles' the Code requires research proposals to 'explain the potential benefits of the research, and how relevant ethical considerations have been taken into account (see further sections 3 and 4)'. But sections 3 and 4 never commit to any ethical considerations being relevant apart from considerations around implantation, so it is not clear what a researcher should take into account, or how the Oversight Committee should judge whether relevant ethical considerations have been taken into account, or whether a research project is ethically (as distinct from scientifically) problematic.
This leads to the worry that the SCBEM Oversight Committee, despite being eventually established according to the best principles of impartial appointment, and despite therefore containing only members of the highest integrity, will not be able to provide ethically robust oversight, since the Code does not provide sufficient guidance on what ethically robust oversight is, substantively. What will be provided is, therefore, likely not to be governance or regulation, but (merely?) legitimation.
As we say in Danish, 'it takes honesty to sell elastic by the metre'. But even honesty is not enough, if elastic is being sold by the metre in the absence of a ruler.
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