Fresh or frozen? Classifying ‘spare' embryos for donation to human embryonic stem cell research

This article is available open access, funded by the Wellcome Trust. It is distributed under a Creative Commons License (http://creativecommons.org/licenses/by/3.0/). Copyright @ 2010 Elsevier Ltd.United Kingdom (UK) funding to build human embryonic stem cell (hESC) derivation labs within assisted conception units (ACU) was intended to facilitate the ‘In-vitro fertilisation (IVF)-stem cell interface’, including the flow of fresh ‘spare’ embryos to stem cell labs. However, in the three sites reported on here, which received this funding, most of the embryos used for hESC research came from long term cryopreservation storage and/or outside clinics. In this paper we explore some of the clinical, technical, social and ethical factors that might help to explain this situation. We report from our qualitative study of the ethical frameworks for approaching women/couples for donation of embryos to stem cell research. Members of staff took part in 44 interviews and six ethics discussion groups held at our study sites between February 2008 and October 2009. We focus here on their articulations of social and ethical, as well as scientific, dimensions in the contingent classification of ‘spare’ embryos, entailing uncertainty, fluidity and naturalisation in classifying work. Social and ethical factors include acknowledging and responding to uncertainty in classifying embryos; retaining ‘fluidity’ in the grading system to give embryos ‘every chance’; tensions between standardisation and variation in enacting a ‘fair’ grading system; enhancement of patient choice and control, and prevention of regret; and incorporation of patients’ values in construction of ethically acceptable embryo ‘spareness’ (‘frozen’ embryos, and embryos determined through preimplantation genetic diagnosis (PGD) to be genetically ‘affected’). We argue that the success of the ‘built moral environment’ of ACU with adjoining stem cell laboratories building projects intended to facilitate the ‘IVF-stem cell interface’ may depend not only on architecture, but also on the part such social and ethical factors play in configuration of embryos as particular kinds of moral work objects.The Wellcome Trus

The embryo as moral work object: PGD/IVF staff views and experiences

Copyright @ 2008 the authors. This article is available in accordance with the Creative Commons Deed, Attribution 2.5, see http://creativecommons.org/licenses/by-nc-nd/2.5/deed.en_CA.We report on one aspect of a study that explored the views and experiences of practitioners and scientists on social, ethical and clinical dilemmas encountered when working in the field of preimplantation genetic diagnosis (PGD) for serious genetic disorders. The study produced an ethnography based on observation, interviews and ethics discussion groups with staff from two PGD/IVF Units in the UK. We focus here on staff perceptions of work with embryos that entails disposing of ‘affected’ or ‘spare’ embryos or using them for research. A variety of views were expressed on the ‘embryo question’ in contrast to polarised media debates. We argue that the prevailing policy acceptance of destroying affected embryos, and allowing research on embryos up to 14 days leaves some staff with rarely reported, ambivalent feelings. Staff views are under-researched in this area and we focus on how they may reconcile their personal moral views with the ethical framework in their field. Staff construct embryos in a variety of ways as ‘moral work objects’. This allows them to shift attention between micro-level and overarching institutional work goals, building on Casper's concept of ‘work objects’ and focusing on negotiation of the social order in a morally contested field.The Wellcome Trust Biomedical Ethics Programme, who funded the projects‘Facilitating choice, framing choice: the experience of staff working in pre-implantation genetic diagnosis’ (no: 074935), and ‘Ethical Frameworks for Embryo Donation:the views and practices of IVF/PGD staff’ (no: 081414)

Embryo futures and stem cell research: The management of informed uncertainty

This article is available open access and is distributed under a Creative Commons license (http://creativecommons.org/licenses/by/3.0/). Copyright @ 2011 The Authors.In the social worlds of assisted conception and stem cell science, uncertainties proliferate and particular framings of the future may be highly strategic. In this article we explore meanings and articulations of the future using data from our study of ethical and social issues implicated by the donation of embryos to human embryonic stem cell research in three linked assisted conception units and stem cell laboratories in the UK. Framings of the future in this field inform the professional management of uncertainty and we explore some of the tensions this involves in practice. The bifurcation of choices for donating embryos into accepting informed uncertainty or not donating at all was identified through the research process of interviews and ethics discussion groups. Professional staff accounts in this study contained moral orientations that valued ideas such as engendering patient trust by offering full information, the sense of collective ownership of the National Heath Service and publicly funded science and ideas for how donors might be able to give restricted consent as a third option.The Wellcome Trus

Donation of 'spare' fresh or frozen embryos to research: Who decides that an embryo is 'spare' and how can we enhance the quality and protect the validity of consent?

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited - Copyright @ The Author 2012.This paper analyses elements of the legal process of consent to the donation of ‘spare’ embryos to research, including stem-cell research, and makes a recommendation intended to enhance the quality of that process, including on occasion by guarding against the invalidity of such consent. This is important in its own right and also so as to maximise the reproductive treatment options of couples engaged in in vitro fertilisation (IVF) treatment and to avoid possible harms to them. In Part 1, with reference to qualitative data from three UK IVF clinics, we explore the often delicate and contingent nature of what comes to be, for legal purposes, a ‘spare’ embryo. The way in which an embryo becomes ‘spare’, with its implications for the process of consent to donation to research, is not addressed in the relevant reports relating to or codes of practice governing the donation of embryos to research, which assume an unproblematic notion of the ‘spare’ embryo. Significantly, our analysis demonstrates that there is an important and previously unrecognised first stage in the donation of a ‘spare’ embryo to research, namely: consent to an embryo being ‘spare’ and so, at the same time, to its disuse in treatment. This is not explicitly covered by the Human Fertilisation and Embryology (HFE) Act 1990, as amended by the HFE Act 2008. Having identified this important initial stage in the process of consent to the donation of a ‘spare’ embryo to research in conclusion to Part 1, in Part 2 we analyse the idea of consent to an embryo's disuse in treatment on the basis that it is ‘spare’ with reference to the legal elements of consent, namely information as to nature and purpose, capacity, and voluntariness. We argue that there are in fact three related consent processes in play, of which the principal one concerns consent to an embryo's disuse in treatment. If the quality of this first consent is compromised, in turn this will impact on the quality of the consent to the donation of that ‘spare’ embryo to research, followed by the quality of consent to future cycles of assisted reproduction treatment in the event that these are needed as a result of a donation decision. The analysis overall is of central relevance to the debate as to whether, and if so when, it should be permissible to request the donation of fresh embryos for research, as opposed to those that have been frozen and, for instance, have reached the end of their statutory storage term. This has a particular bearing on the donation of embryos to stem-cell research since there is a debate as to whether fresh embryos are most useful for this.This work is funded by the Wellcome Trust Biomedical Ethics Programme, Project Grant No 081414

Choosing embryos: Ethical complexity and relational autonomy in staff accounts of PGD

Copyright @ 2008 the authors. This article is available in accordance with the Creative Commons Deed, Attribution 2.5, see http://creativecommons.org/licenses/by-nc-nd/2.5/deed.en_CA.The technique of preimplantation genetic diagnosis (PGD) is commonly explained as a way of checking the genes of embryos produced by IVF for serious genetic diseases. However, complex accounts of this technique emerged during ethics discussion groups held for PGD staff. These form part of a study exploring the social processes, meanings and institutions that frame and produce ‘ethical problems’ for practitioners, scientists and others working in the specialty of PGD in the UK. Two ‘grey areas’ raised by staff are discussed in terms of how far staff are, or in the future may be, able to support autonomous choices of women/couples: accepting ‘carrier’ embryos within the goal of creating a ‘healthy’ child; and sex selection of embryos for social reasons. These grey areas challenged the staff’s resolve to offer individual informed choice, in the face of their awareness of possible collective social effects that might ensue from individual choices. We therefore argue that these new forms of choice pose a challenge to conventional models of individual autonomy used in UK genetic and reproductive counselling, and that ‘relational autonomy’ may be a more suitable ethical model to describe the ethical principles being drawn on by staff working in this area.The Wellcome Trust Biomedical Ethics Programme, who funded the project ‘Facilitating choice, framing choice: the experience of staff workingin pre-implantation genetic diagnosis’ (no: 074935)

Include medical ethics in the Research Excellence Framework

The Research Excellence Framework of the Higher Education Funding Council for England is taking place in 2013, its three key elements being outputs (65% of the profile), impact (20%), and “quality of the research environment” (15%). Impact will be assessed using case studies that “may include any social, economic or cultural impact or benefit beyond academia that has taken place during the assessment period.”1 Medical ethics in the UK still does not have its own cognate assessment panel—for example, bioethics or applied ethics—unlike in, for example, Australia. Several researchers in medical ethics have reported to the Institute of Medical Ethics that during the internal preliminary stage of the Research Excellence Framework several medical schools have decided to include only research that entails empirical data gathering. Thus, conceptual papers and ethical analysis will be excluded. The arbitrary exclusion of reasoned discussion of medical ethics issues as a proper subject for medical research unless it is based on empirical data gathering is conceptually mistaken. “Empirical ethics” is, of course, a legitimate component of medical ethics research, but to act as though it is the only legitimate component suggests, at best, a partial understanding of the nature of ethics in general and medical ethics in particular. It also mistakenly places medicine firmly on only one side of the science/humanities “two cultures” divide instead of in its rightful place bridging the divide. Given the emphasis by the General Medical Council on medical ethics in properly preparing “tomorrow’s doctors,” we urge medical schools to find a way of using the upcoming Research Excellence Framework to highlight the expertise residing in their ethicist colleagues. We are confident that appropriate assessment will reveal work of high quality that can be shown to have social and cultural impact and benefit beyond academia, as required by the framework

Social welfare, genetic welfare? Boundary-work in the IVF/PGD clinic

Copyright @ 2006 Elsevier Ltd. All rights reserved.Through the lens of the ‘welfare of the child’ assessment, this paper explores how staff working in the area of in vitro fertilisation and preimplantation genetic diagnosis (IVF/PGD) balance reflexive relations of legitimacy and accountability between the public and private spheres, and between medicine, the citizen and the state. The wider research of which this analysis is a part uses multiple methods to study two National Health Service Assisted Conception Units in England. Research methods used included observation clinics and interviews with staff from a range of disciplines. We illustrate how the staff reveal tensions between their views that the welfare of the child assessment can be seen as intrusive and discriminatory, and on the other hand that medical intervention in reproduction should be socially and professionally accountable. These tensions can be understood sociologically in terms of a gradual movement from socially based solutions to fertility problems and disabilities, towards a biomedical, and arguably genetically oriented world view of such problems. Rather than being viewed as discrete, these two orientations should be seen as indicating an emergent direction of travel along a continuum, with elements of both being present in the accounts. We argue that consideration of the welfare of the child involves staff in ethical boundary-work across the two orientations and between the accountabilities and responsibilities of healthcare professionals, individuals and the state.The Wellcome Trust Biomedical Ethics Programme, who funded the project ‘Facilitating choice, framing choice: the experience of staff working in preimplantation genetic diagnosis’ (no. 074935)

Research with children and young people: not on them

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Increasing the acceptability and rates of organ donation among minority ethnic groups: a programme of observational and evaluative research on Donation, Transplantation and Ethnicity (DonaTE)

Background: Black, Asian and minority ethnic (BAME) groups have a high need for organ transplantation but deceased donation is low. This restricts the availability of well-matched organs and results in relatively long waiting times for transplantation, with increased mortality risks. Objective: To identify barriers to organ donor registration and family consent among the BAME population, and to develop and evaluate a training intervention to enhance communication with ethnic minority families and identify impacts on family consent. Methods: Three-phase programme comprising (1) community-based research involving two systematic reviews examining attitudes and barriers to organ donation and effective interventions followed by 22 focus groups with minority ethnic groups; (2) hospital-based research examining staff practices and influences on family consent through ethics discussion groups (EDGs) with staff, a study on intensive care units (ICUs) and interviews with bereaved ethnic minority families; and (3) development and evaluation of a training package to enhance cultural competence among ICU staff. Setting: Community focus group study in eight London boroughs with high prevalence of ethnic minority populations. Hospital studies at five NHS hospital trusts (three in London and two in Midlands). Participants: (1) Community studies: 228 focus group participants; (2) hospital studies: 35 nurses, 28 clinicians, 19 hospital chaplains, 25 members of local Organ Donation Committees, 17 bereaved family members; and (3) evaluation: 66 health professionals. Data sources: Focus groups with community residents, systematic reviews, qualitative interviews and observation in ICUs, EDGs with ICU staff, bereaved family interviews and questionnaires for trial evaluation. Review methods: Systematic review and narrative synthesis. Results: (1) Community studies: Organ Donor Register – different ethnic/faith and age groups were at varying points on the ‘pathway’ to organ donor registration, with large numbers lacking knowledge and remaining at a pre-contemplation stage. Key attitudinal barriers were uncertainties regarding religious permissibility, bodily concerns, lack of trust in health professionals and little priority given to registration, with the varying significance of these factors varying by ethnicity/faith and age. National campaigns focusing on ethnic minorities have had limited impact, whereas characteristics of effective educational interventions are being conducted in a familiar environment; addressing the groups’ particular concerns; delivery by trained members of the lay community; and providing immediate access to registration. Interventions are also required to target those at specific stages of the donation pathway. (2) Hospital studies: family consent to donation – many ICU staff, especially junior nurses, described a lack of confidence in communication and supporting ethnic minority families, often reflecting differences in emotional expression, faith and cultural beliefs, and language difficulties. The continuing high proportion of family donation discussions that take place without the collaboration of a specialist nurse for organ donation (SNOD) reflected consultants’ views of their own role in family consent to donation, a lack of trust in SNODs and uncertainties surrounding controlled donations after circulatory (or cardiac) death. Hospital chaplains differed in their involvement in ICUs, reflecting their availability/employment status, personal interests and the practices of ICU staff. (3) Evaluation: professional development package – a digital versatile disk-based training package was developed to promote confidence and skills in cross-cultural communication (available at: www.youtube.com/watch?v=ueaR6XYkeVM&feature=youtu.be). Initial evaluation produced positive feedback and significant affirmative attitudinal change but no significant difference in consent rate over the short follow-up period with requirements for longer-term evaluation. Limitations: Participants in the focus group study were mainly first-generation migrants of manual socioeconomic groups. It was not permitted to identify non-consenting families for interview with data regarding the consent process were therefore limited to consenting families. Conclusions: The research presents guidance for the effective targeting of donation campaigns focusing on minority ethnic groups and provides the first training package in cultural competence in the NHS. Future work: Greater evaluation is required of community interventions in the UK to enhance knowledge of effective practice and analysis of the experiences of non-consenting ethnic minority families. Funding: The National Institute for Health Research Programme Grants for Applied Research programme

Turning psychology into policy: a case of square pegs and round holes?

This paper problematizes the ways in which the policy process is conceived in published psychological research. It argues that these conceptions of the policy process fail to ade- quately reflect the real-world dynamism and complexity of the processes and practices of social policy-making and implementation. In this context, psychological evidence needs to be seen as one type of evidence (amongst many others). In turn this requires researchers to take account of broader political processes that favour certain types of knowledge and disparage others. Rather than be regarded as objective and scientific, policy in this characterisation is regarded as a motivated form of politics. This multi-layered, multi-level hybrid structure is not immediately amenable to the well-intentioned interventions of psychologists. While the tendency of many psychologists is to overestimate the impact that we can have upon policy formation and implementation, there are examples where psychological theory and research has fed directly into UK policy developments in recent years. This paper draws on the recent Improving Access to Psychological Therapies (IAPT) initiative and the work of personality researcher Adam Perkins on the UK’s social security system to ask whether psychology has a sufficiently elaborated sense of its own evidence base to legitimately seek to influence key national areas of public policy. The article cautions against dramatic changes to policy pre- dicated upon any one reading of the variegated and, at times, contradictory psychological evidence base. It concludes that, in order to meaningfully contribute to the policy develop- ment process in a way which increases equality and social justice, psychologists need to be more strategic in thinking about how their research is likely to be represented and mis- represented in any particular context. Finally some possible directions for psychologists to take for a more meaningful relationship with policy are suggested