Social Science & Medicine 113 (2014) 34e41

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Methods of legitimation: How ethics committees decide which reasons count in public policy decision-making Kyle T. Edwards a, b, * a b

Ethox Centre, Nuffield Department of Population Health, University of Oxford, UK Uehiro Centre for Practical Ethics, University of Oxford, UK

a r t i c l e i n f o

a b s t r a c t

Article history: Received 16 July 2013 Received in revised form 15 March 2014 Accepted 30 April 2014 Available online 2 May 2014

In recent years, liberal democratic societies have struggled with the question of how best to balance expertise and democratic participation in the regulation of emerging technologies. This study aims to explain how national deliberative ethics committees handle the practical tension between scientific expertise, ethical expertise, expert patient input, and lay public input by explaining two institutions’ processes for determining the legitimacy or illegitimacy of reasons in public policy decision-making: that of the United Kingdom’s Human Fertilisation and Embryology Authority (HFEA) and the United States’ American Society for Reproductive Medicine (ASRM). The articulation of these ‘methods of legitimation’ draws on 13 in-depth interviews with HFEA and ASRM members and staff conducted in January and February 2012 in London and over Skype, as well as observation of an HFEA deliberation. This study finds that these two institutions employ different methods in rendering certain arguments legitimate and others illegitimate: while the HFEA attempts to ‘balance’ competing reasons but ultimately legitimizes arguments based on health and welfare concerns, the ASRM seeks to ‘filter’ out arguments that challenge reproductive autonomy. The notably different structures and missions of each institution may explain these divergent approaches, as may what Sheila Jasanoff (2005) terms the distinctive ‘civic epistemologies’ of the US and the UK. Significantly for policy makers designing such deliberative committees, each method differs substantially from that explicitly or implicitly endorsed by the institution. Ó 2014 Elsevier Ltd. All rights reserved.

Keywords: United Kingdom United States Assisted reproductive technologies Expertise Legitimacy Ethics committee Deliberative democracy Patient and public involvement

1. Expertise and reasons: a tension in practice Until recently, decisions regarding science and technology policy in democratic societies were frequently made by scientific advisory panels, which tended to operate under what political scientist Alfred Moore (2011) has called a “technocratic model of expert authority” (p. 10). This pattern of decision-making by an elite class of scientific experts was often justified by traditional public understanding of science theories that posited an ignorant, incompetent, and irrational public that hampers the progress of science (Jasanoff, 2005). This technical model of scientific governance focused most heavily on quantitative calculations of risk and benefits to health and safety, suggesting “a presumption of ethical unity on the prioritization of health and welfare” (Moore, 2010b, p. 201). Yet, as perceptions of the public’s capacity to understand and contribute to the dialogue on the proper role of science and

* Ethox Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford OX3 7LF, UK. E-mail addresses: [email protected], [email protected]. http://dx.doi.org/10.1016/j.socscimed.2014.04.043 0277-9536/Ó 2014 Elsevier Ltd. All rights reserved.

technology in society improved, scientists’ and science advisors’ privileged role in the policy-making process came under attack (Wynne, 2006; Abelson et al., 2003). Members of the lay public, although still largely drawn from an elite class of academics and lobbyists, began to question why scientific experts, simply because of their technical expertise, should have the exclusive authority to say what the role of science and technology ought to be in pluralistic, democratic societies (Kelly, 2003). One response to these critiques in many technologicallyadvanced, democratic societies has been the institution of national deliberative ethics committees, particularly in the context of health care and biotechnology. By ‘ethics committee’ throughout this paper, I refer to what Schicktanz and Dusche (2011) term ‘macro level’ institutions, as distinguished from ‘local level’ institutions, like hospital ethics committees, or ‘meso level’ institutions, like research ethics committees, neither of which are considered here (p. 142). I define this type of macro level ethics committee more specifically as a deliberative body tasked with making ethical judgments in a specific (health) policy area for a particular society. Although the composition and process of these

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committees varies immensely, they all promise to bring larger social and public concerns to bear upon rapidly advancing and emerging technologies. Yet these ethics committees, presented as an answer to the un-democratic elements of authority based upon technical expertise, inadvertently created a new challenge in instituting expert authority based upon ethical expertise. The crux of the controversy appears to lie in the process by which ethics committee members assume the authority to categorize reasons or arguments that they assess within their deliberative space as either ‘appropriate’ or ‘inappropriate’. Moore (2010a) has described this move as the practice of making “some kinds of concerns appear legitimately ethical” while making others appear to be “merely political or transient matters of public concern,” such that the latter concerns are rejected or deemphasized (p. 727, emphasis added). Similarly, as part of their analogy of “the moral economy of science,” Alison Harvey and Brian Salter (2012) describe this process as “regulating the currency of the moral economy” by configuring “diverse value positions . as legal or illegal tender” and setting the “exchange rate for trading different values” (pp. 194e198). Yet again, as these new ethical experts began to dominate debates over values, champions of public values and patient voices pushed back, fueling the patient and public involvement (PPI) movement so prominent in UK governance of health care today (Florin and Dixon, 2004; Hogg, 2007). Although the justifications for PPI are many and still quite muddled, one common explanation is that citizens should have a say in which values drive the regulation of science and technology. As more and more individuals sit down around the metaphorical, and often literal, table e the scientist, the bioethicist, the expert patient, and the lay member of the public e a tension arises concerning what it means to make a legitimate public decision: who decides which reasons ought to be voiced and carry force in the public sphere of pluralistic, democratic societies? Here I rely on Sheila Jasanoff’s vague but fitting definition of democracy as “not a singular form of life but a common human urge to self-rule that finds expression in many different institutional and cultural arrangements” (2005, p. 290). I focus on democratic societies because, as Caroline Mullen (2008) notes, there are two “senses of defensibility in decisions on ethics” in this particular political context: whether the decisions are representative of public values and perspectives and whether the decisions withstand ethical scrutiny, which she aptly identifies as a tension between ‘representation’ and ‘reason’. This deliberative decision-making plays out in practice a long line of theoretical controversies concerning which reasons ought to carry weight in the public sphere: John Rawls’ (1997) notion of “public reasons,” Robert Audi’s (2000) formulation of “secular reasons,” and Amy Gutmann and Dennis Thompson’s (2004) requirement of reasons “accessible to all the citizens to whom they are addressed” are all potential criteria when committees pronounce the (il)legitimacy e to borrow from Moore (2010a) e of certain reasons and arguments. In this paper, I aim to contribute to a large and crucial project: determining how this process, of categorizing some reasons as legitimate and others as illegitimate, works in practice. I will present two institutions’ distinct methods for constructing this legitimateeillegitimate divide: the method adopted by the UK’s Human Fertilisation and Embryology Authority (HFEA), which I will argue seeks but fails to “balance” competing reasons, and the method of the US’ American Society for Reproductive Medicine (ASRM), which I will argue seeks to “filter” out problematic reasons. In so doing, I will show that the HFEA and ASRM each resolve the practical tension of which reasons and arguments ought to influence decisions by constructing two very different legitimatee illegitimate divides.

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2. Institutional missions and structures Although both the HFEA and the ASRM play the most significant role in determining the rules for assisted reproductive technologies (ART) at the national level in their respective countries, they represent radically different conceptions of the governance of ART. Based on the recommendations of an appointed committee of inquiry chaired by British philosopher Mary Warnock, British politicians created the HFEA in 1990. During her chairmanship, Warnock argued in the New Scientist, “Increasingly and rightly, people who are not experts expect, as of right, to help determine what is or is not a tolerable society to live in” (as cited in Wilson, 2011). Reflecting this understanding, the HFEA was designed as a statutory body built upon deliberative democracy ideals of representing the range of public perspectives and social values in the deliberation of ART (Wilson, 2011). As a statutory body, the HFEA has the power to produce binding regulations based on this deliberation. The US, on the other hand, has avoided the implementation of federal regulations on ART, the only exception being a Centers for Disease Control and Prevention reporting requirement for “all fertility treatments in which both eggs and sperm are handled” (Centers for Disease Control and Prevention, n.d.). This leaves the ASRM, a professional self-regulating society founded by fertility experts in 1944, with the sole responsibility for designing guidelines for the use of ART. These guidelines, unlike the regulations of the HFEA, lack legal force. In spite of these significant differences, I define both as ‘national deliberative ethics committees’ for the purpose of this comparative project, on the grounds that each institution features central deliberative committees responsible for determining the most authoritative rules for ART in their respective societies. The Human Fertilisation and Embryology Act of 1990 created the HFEA and assigned to it the responsibility of regulating the creation of embryos for use in treatment and research, the use of donated gametes and embryos, and the storage of gametes and embryos (Human Fertilisation and Embryology Authority [HFEA], 2009). It is composed of both a central deliberative committee and supporting staff. The chairman, deputy chairman and between one-third and one-half of the members of its deliberative committee (which I will refer to throughout as ‘the HFEA’ for ease) must be lay and unbiased. This ‘lay and unbiased’ requirement is operationalized as any person who has not been 1) a registered medical practitioner, 2) concerned with keeping or using gametes or embryos outside the body, or 3) concerned with commissioning, funding, or participating in research on keeping or using gametes or embryos outside the body (Department of Health (2008)). Most importantly, the HFEA carries out extensive public consultations when creating or reviewing policy, suggesting that it will in fact carefully consider public input. These consultations collect the views of members of the general public, patients, and other stakeholders through focus groups and an online comment period, after which the HFEA’s support staff analyzes the data both quantitatively and qualitatively to provide an account that feeds into the HFEA’s deliberations. This set of characteristics appeals directly to basic theories of deliberative democracy in attempting both to represent the range of ethical perspectives on issues and to bring into dialogue lay and professional perspectives. As a self-regulating professional association, the ASRM serves a diverse membership of dues-paying professionals, including obstetrician/gynecologists, reproductive endocrinologists, and pediatricians. Its mission statement suggests that the ASRM only engages with the “lay public” in an educative role; there is no suggestion that the ASRM does or ought to accommodate what the general public thinks about the ethics of ART (American Society for Reproductive Medicine [ASRM], 2008). Unsurprisingly, then, there is no practice comparable to the HFEA’s public consultation process.

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Unlike the HFEA, in which one committee produces all regulations for ART, ASRM guidelines are created by two separate committees that are part of the larger society: the Practice Committee and the Ethics Committee. All members of the Practice Committee are clinicians or scientific researchers, as opposed to the HFEA’s mix of lay and professional/expert members. The Ethics Committee, on the other hand, is composed of clinicians, attorneys, and academic bioethicists, although physicians tend to make up at least 50 percent of the membership. These two deliberative committees are completely disconnected, generating a division of labor in which it is often unclear who should deal with which issues. While a review of the website suggests that the Practice Committee produces guidelines related to technical best practice and the Ethics Committee handles ethical best practice, both ultimately make significant normative judgments in their decision-making process. For instance, the Practice Committee’s 2012 guideline on multiple embryo transfer argues, “High-order multiple pregnancy (three or more implanted embryos) is an undesirable consequence (outcome) of assisted reproductive technologies . Ideally, the goal of ART is to achieve a singleton gestation,” which clearly amounts to a normative account of the use of ART (Practice Committee of the American Society for Reproductive Medicine, 2013). 3. Methodology In order to interrogate the reasoning processes within these deliberative spaces, a series of interviews were conducted in January and February 2012 with members of the HFEA in London and members of the ASRM’s Ethics and Practice Committees over Skype that aimed to elicit members’ individual reasoning processes and accounts of the dynamics of specific deliberations. The value of these interviews lies in the unique opportunity to urge members to articulate their reasoning at a deeper level than would be possible in the context of a meeting observation. In order to ensure that these individual accounts aligned with actual deliberation, one closed meeting of the HFEA was observed. This served to confirm the analysis of interview data, as it could not itself be used as a source of primary data. As all ASRM meetings are closed and neither the HFEA nor ASRM publishes complete minutes of meetings, this was the only possible ‘check’ on the accuracy of interviewees’ representations. Ethics approval was granted by Princeton University’s Institutional Review Board for Human Subjects and both institutions were informed of the research taking place. Interviews were conducted with three sitting and two former members of the HFEA’s deliberative body and two members of the HFEA’s supporting staff. Members of the staff were interviewed due to their primary role in constructing, carrying out, and presenting the results of public consultations to HFEA members. For the ASRM, interviews were conducted with three members of the Ethics Committee, two members of the Practice Committee, and one member of the public relations staff. Both Ethics Committee and Practice Committee members were interviewed as in practice both make ethical judgments in their decision-making. The public relations staff member was interviewed due to the staff’s role in relaying policy-related news and public inquiries received by the Office of Public Affairs to members of the committees. Given that the HFEA is currently composed of 11 members and 15 members sit on both the ASRM’s Practice Committee and Ethics Committee, the sample size reflects the difficulty of recruiting members. Twelve sitting or former members of the HFEA’s deliberative body were invited using publicly available contact information, of which five participated. Interviews with members of the ASRM’s Ethics and Practice Committees required referral by the

ASRM’s Office of Public Affairs; as such, the method and reach of the Office’s invitation is unknown. Indeed, while some previous work has drawn on interviews with HFEA members (Braun et al., 2010; Moore, 2010b), to my knowledge this is the first instance of an academic article drawing on interviews with members of the ASRM’s Practice Committee and Ethics Committee. Furthermore, although the background of each interviewee cannot be tied to the statements in order to preserve anonymity, efforts were made to represent the diversity of member backgrounds, and interviewees from both the HFEA and the ASRM Practice Committee and Ethics Committee included academic philosophers, lawyers, and practitioners. All interviews lasted between 40 and 70 min and were recorded with the consent of interviewees. Interviews were semi-structured and based on a guide that developed through the research process and alongside the analysis of data, in line with the constant comparative method (Glaser, 1965). The initial interview guide for both the HFEA and ASRM was structured around a series of themes meant to illicit the role of the public in the production of regulations/guidelines, including the impact of public input and opinion on decision-making, the structure and flow of deliberation within meetings, and the writing of final regulations or guidelines. Questions were refined after initial analysis of the interviews to focus on public influence on deliberation, with special attention given to the reception of public consultation results in the HFEA interviews and the relationship with the media in the ASRM interviews. Data was analyzed manually using a set of thematic concepts to code the interview transcripts, which captured aspects of the processes, arguments, and considerations surrounding public engagement. Further analysis elicited two categories that capture the key methods of reasoning within the two committees. Forming the structure of this paper, these two categories are balancing, in the case of the HFEA, and filtering, in the case of the ASRM. 4. ‘Balancing’ reasons in the HFEA The first method for determining the legitimacy of arguments that I will explore is the account of ‘balancing’ reasons in deliberations by HFEA members. 4.1. What is balancing? HFEA members invoked the concept of ‘balancing’ various perspectives gathered through the public consultation process when discussing the deliberations in which they engaged. While this metaphor may be clear, the practical manifestations of the act are quite complex. What epistemic work is performed when the HFEA balances different values and perspectives? How do certain arguments ‘win out’ in committee decisions through this act of balancing? As HFEA members tended to use the term unreflectively, a significant portion of my interviews was dedicated to urging members to explain what they meant by ‘balancing.’ For instance, one member initially used the term to describe the deliberation of the 2007 hybrid embryo public consultation results: In the case of hybrid embryos, what you clearly had was a degree of disagreement between the scientists and the scientific community who thought this was clearly important research and that we would be obstructive of them if we regulated or prevented them from doing what they wanted to do, and on the other hand, there were legitimate views from the public that we were encouraging scientists to behave in some kind of hubristic or unconstrained way. So we were balancing different views rather than responding to a single view (HFEA Member 3, emphasis added).

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Another member invoked the term in a general description of the HFEA’s deliberations: The role of the Authority is to take everybody’s opinion and positions and thoughts into account and to balance them, and I think that’s really crucial with everything that is done, to make everybody aware that we are looking at everybody’s perspective and that we’re there not on behalf of any particular group or in order to be swayed by any group but to have very sound reasons based on the whole range of thoughts as to the decision we make and why we make it (HFEA Member 4, emphasis added). These accounts do very little to explain what the committee is actually doing with these consultation results. While it is clear that the members see themselves as listening to a variety of important perspectives, invoking the term ‘balancing’ in this sense seems only to reiterate the fact that the HFEA is considering these views, which we would expect based on the rationale for public consultation. Indeed, this usage of the term, while reassuring the general public, affected publics, and interest groups that all viewpoints are being considered impartially, fails to explain the mechanics of this balancing act. 4.2. The weight of health and welfare concerns When asked to explain the process of ‘balancing’ more concretely, the former HFEA member reasoned: So simply because a particular group has formed which has a clear interest in the matter and campaigns on it and agitates and has material, I don’t think gives them any particular right or weight in terms of their views as opposed to members of the general public. I think in some areas however . it would seem to me that where we do get clear statements from genetic interest groups saying, you know, “We’re the affected parties, we suffer from this particular condition, this is hard for us,” that does weigh with us to a degree, because their direct familiarity with the condition has an importance it might not in some other matter (HFEA Member 3, emphasis added). This account provides a more complex explanation of balancing. By introducing the concept of ‘weight,’ balancing comes to be seen as a process of scaling the relative importance of different perspectives. This account suggests that having a greater interest in the issue at hand does not entail a greater influence in determining the ethical principles and arguments that will be used by the HFEA in its regulatory decision-making. Yet, this member suggests, greater weight may be afforded to interest groups that are also ‘affected’ groups. But what does it mean for a person or group to be ‘affected’ by a regulatory decision and how does this differ from having an ‘interest’ in the outcome of such a decision? While in some contexts being affected might be synonymous with being an interested party, interviewees seemed to understand these two as separate if sometimes overlapping categories. Based on the preceding account, affected persons seem to be those who “suffer from [a] particular condition.” Thus, while a particular religious interest group might be very interested in the outcome of a decision concerning IVF, they are not considered affected; an interest group representing infertile couples, on the other hand, would be considered both interested in the decision and affected by it. Providing another example of the centrality of suffering to this definition of affectedness, one member lauded Parkinson’s disease patients in explaining the legalization of stem cell research for serious diseases:

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And to my surprise, the people that wanted that done, the people who were suffering from Parkinson’s and this and that, came out in force and said they wanted it. I mean, there were demonstrations near Parliament, people in wheelchairs saying, “We want to be given hope. We want this research done” (HFEA Member 5). These members present a particular account of affectedness; religious groups, many of which lobby the HFEA, might claim that they are indeed affected by these decisions, that the HFEA simply endorses the wrong account of affectedness. Yet to the extent that the HFEA operates upon this understanding of affectedness, this method of balancing will privilege certain arguments over others, namely those put forth by affected publics over those of other groups. Balancing, on these accounts, is a particular method for determining which reasons and arguments will carry force in the HFEA’s deliberative decision-making. This method of balancing constructs a legitimateeillegitimate divide in which the reasons that are legitimated by ‘balancing’ are those based upon a certain account of affectedness that privileges the health and welfare concerns of the ‘affected’, the ‘suffering’, or those who may be helped or harmed by novel technologies. It seems, then, that while committees like the HFEA were introduced in order to challenge the narrow account of well-being employed by the technocratic model of science and technology governance, an alternative but still constricted account of well-being may be reproduced within a method designed to represent alterative ethical and social concerns. Where does this leave such alternative concerns? 4.3. Tipping the scales: handling arguments based on the ‘unnatural’ The previous section established that when it reverts to the act of ‘balancing,’ the HFEA may overlook one of society’s most fundamental moral disagreements: whether and when alternative values e such as the preservation of ‘the natural’ or of ‘human dignity’ e ought to override the health and welfare concerns of ‘affected’ persons. In this section, the way the HFEA approaches arguments based upon the ‘unnaturalness’ of certain technologies and procedures is presented as an example of how the HFEA considers such alternative values in its deliberative space. This line of inquiry was introduced in the interviews in order to understand how the HFEA handles this specific challenge, as there is extensive debate in both literature and practice about how to address arguments founded on the ‘unnaturalness’ of reproductive technologies. In responding to whether the HFEA considers arguments based on unnaturalness, one member commented, “Well, I think we do. I’m not sure we do it enough . we call it the ‘yuck factor’ when we’re discussing it” (HFEA Member 2). Although a fairly common reformulation of Leon Kass’s (1997) ‘wisdom of repugnance,’ it is worth noting that the term ‘yuck factor’ carries a negative connotation. This perception of unnaturalness objections and the yuck factor as synonymous also implies that most concerns for the preservation of the natural are gut reactions, in spite of recent suggestions that not all such claims are merely instinctive, superficial responses (Sheehan, 2009; Coady, 2008). As long as these arguments are construed as ‘just’ irrational reactions, and therefore a “kind of nonmoral view” in the terms of Gutmann and Thompson (2004), they may be excluded from the process of balancing reasons and arguments. For example, in describing the HFEA’s consideration of the ‘yuck factor’ response, one member explained: I think all it can really do is feed into discussions in saying we may e personally I don’t have a problem with this, I think why

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even consult, if you can save babies’ lives get on with it e but in a sense the point of the dialogue is to give people like me pause for thought, to think, you know some people really have a problem with this and we have to take that quite seriously (HFEA Member 1).

the previous section. In this section it is argued that the parallel method in the ASRM’s Practice Committee and Ethics Committee deliberations is a process that utilizes an institutional ‘filter’ to legitimate certain reasons. 5.1. What is filtering?

This interviewee suggests that this consideration is more of a moment of reflection, a ‘pause for thought.’ It seems that while the HFEA’s public consultations create a space for such views to be voiced, members may not consider them to be reasons that can or ought to be balanced in the HFEA’s deliberative decision-making. When arguments based on unnaturalness are in fact considered on a deeper level, they may be delegitimized due to the prior commitment to health and welfare embedded within the method of balancing. For example, the previous member explained: I’m not sure that we can say the fact that something’s unnatural is a reason in and of itself, without anything more, not to do something. There would need to be another reason about to do with maybe harming somebody or harming some constituency (HFEA Member 1, emphasis added). This explanation suggests that consultation responses based on ‘unnaturalness’ can be considered legitimate ‘reasons’ if they also incorporate the identification of some ‘harm,’ supporting the theory that the HFEA’s balancing method prioritizes health and welfare concerns. A prime example of such legitimation was illustrated in another member’s discussion of pre-implantation genetic diagnosis (PGD) and its use in creating ‘saviour siblings’: It’s using [embryos] for outcomes that you wouldn’t achieve through nature. And naturally, I think those were the things that were hugely controversial . Well, [arguments based on unnaturalness] certainly weren’t excluded because I think we were very mindful of the fact that it was a quite realistic possibility, in clinical terms, that you could potentially take it to the point where you were creating babies simply for use of their organs (HFEA Member 4). This narrative hints at some of the strong feedback that the HFEA received in its public consultation on PGD that creating savior siblings “goes too far” in commodifying human life and creating unnatural family relationships. Yet this member suggests that these concerns were translated into ones that aligned with the principles of health and welfare; by deciding that respondents who cited ‘unnaturalness’ in this particular issue were actually concerned about the health and welfare of babies who would be born ‘simply for use of their organs,’ alternative social values may have been overlooked, such as how family members ought to relate to one another. Crucially, however, this account implies that it was this imposed alignment that prevented these views from being delegitimized. Although based on the accounts of only five members, the preceding analysis suggests that the HFEA’s method of ‘balancing’ the range of public values belies the way in which this method ultimately ‘tips the scales’. Due to a particular account of affectedness, this method of evaluating reasons renders arguments based on health and welfare concerns legitimate while delegitimizing arguments based on alternative values, like the preservation of the ‘natural’. 5. ‘Filtering’ reasons in the ASRM The central process by which reasons come to be seen as legitimate or illegitimate in the HFEA’s deliberations was discussed in

The terminology of filtering is appropriated directly from the account of an Ethics Committee member, although accounts from other members below support the fitness of the term for describing the process: There may not be a policy fix for everything, particularly in reproduction where we think it’s very important to let people make their own decisions. So we constantly evaluate our policy proposals through the filter of, ‘Does this make it any harder for our members’ patients to get treatment than it already is?’ And if it is, you’ll have to tell us what huge, social problem is being solved by this. In most cases, there is not one (ASRM Ethics Committee Member 2). This account suggests that the ASRM actively prioritizes the principle of “let[ting] people make their own decisions,” and has constructed an institutional filter that ensures a constant awareness of guideline alternatives’ effects on patients’ reproductive autonomy. I will start by examining this prioritization of reproductive autonomy before turning to the constraint that “huge, social problem[s]” and the resulting public outcry impose upon this filter. 5.2. Preserving reproductive autonomy This principle of reproductive autonomy appears to be based upon a more general account of individual liberty that posits the right of individuals to make their own decisions so long as they do not harm others. Substantiating this relationship, the same Ethics Committee member asserted: We hold very strongly that reproductive decisions ought to be made by individuals and if they need medical treatment then those decisions should be made in consultation with their physician. We don’t think it’s their neighbor’s business, we don’t think it’s their sister’s business, we don’t think it’s the government’s business, we don’t think it’s bureaucrats’ business, we don’t think it’s Nightline’s business. We think it’s the business of the people contemplating having the children (ASRM Ethics Committee Member 2). Another Ethics Committee member, also implying a constant filter in deliberations, noted the importance of maintaining the reproductive autonomy of infertile citizens vis-à-vis the autonomy of fertile citizens: So you will hear continually in the meetings, wait a minute we don’t ask people who don’t have fertility problems to do x, y or z, why should we be willing to put an extra burden on people who happen to have fertility problems? (ASRM Ethics Committee Member 1). Practice Committee members also stressed the central role of the patient in reproductive decision-making: The patient has to be involved and informed, and her decisionmaking process has to shape what is the best practice for that individual (ASRM Practice Committee Member 1).

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And we don’t want to be deaf to [public] concerns. But our mission is to our patients first and to our practitioners next . So if there is somebody who falls out of that relationship, they are entitled to an opinion but I’m not sure they’re entitled to drive the conversation (ASRM Practice Committee Member 2). Thus the basis for filtering out reasons and arguments that make it harder for patients to get the treatment they want appears to be a strong commitment to reproductive autonomy. 5.3. A caveat: the marketability of decisions While a commitment to preserving reproductive autonomy would on its face seem to result in few guidelines restricting the use of ART, members of both the ASRM’s Practice Committee and Ethics Committee crucially suggested that some decisions do indeed require imposing limits. Members presented such limits as necessary in order to maintain a positive public image by creating guidelines that fall within the bounds of public acceptability. Thus, although the public is not directly consulted as in the HFEA, it is frequently considered in the abstract in order to ascertain the public acceptability of guideline alternatives, or what can be ‘sold’ to the public: I think [considering public opinion] is pretty high on our list of priorities because to represent our members fairly we need to have buy-in from the larger community (ASRM Practice Committee Member 2, emphasis added). [The ASRM employs me] to say here’s what the media’s paying attention to and maybe that means we need to do something about it or maybe it means we don’t. And also to say yeah, that may be what the data say but that’s going to be an ugly sell for us (ASRM Public Relations Staff Member, emphasis added). This discourse of ‘buying’ and ‘selling’, a kind of marketing language and strategy, illustrates the pronounced concern for marketability of guidelines. To demonstrate how this discourse plays out in practice, I will first examine the Ethics Committee’s 2007 “Financial compensation of oocyte donors” report, which sets out guidelines for egg donor compensation (Ethics Committee of the American Society for Reproductive Medicine, 2007). The report explains how a 1993 study calculated the just payment for egg donors by multiplying the average time committed to the donation process, 56 h, by the average rate that men receive for sperm donation, under the assumption that sperm donation requires a one hour time commitment (Siebel and Kiessling, 1993). Using this equation and the average payment to sperm donors in 2000, $60e$75, the committee calculated that a payment of $3360e$4200 would be appropriate for egg donors. This calculation was made without any reference to the principles underlying and justifying the payment of $60e$75 for sperm donation. When asked why sperm donation compensation was taken as something of an ‘ethical given,’ Ethics Committee members responded: No one seemed to have any trouble with paying a sperm donor $75 . that had been on the scene for a long time and nobody seemed to object to it (ASRM Ethics Committee Member 3, emphasis added). What was said was, “Look, payment for sperm donors is accepted. Let’s start from there. If that’s acceptable, is there some way we can move from there?” (ASRM Ethics Committee Member 1, emphasis added).

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As these justifications illustrate, there was no perceptible public disapproval of the presence and level of compensation for sperm donors. Thus, in determining a just compensation level for egg donors, the ASRM took something that was already “acceptable” e that it knew could be ‘sold’ to the public e as a starting point for its ethical reasoning. In other words, the empirical conclusion that the majority of people accept sperm donor compensation was cast as a legitimate reason for the moral permissibility of compensation for gametes more generally; the questions of why the majority of people accepting something makes it morally permissible and why egg donation ought to be treated like sperm donation were left aside. Indeed, turning to a second example of the practical utilization of this marketing discourse, the inability to ‘sell’ a position can trump the reasoned deliberation of ethical principles in ASRM deliberations. In response to negative media coverage in late 2011 of a sperm donor who was discovered to have 150 offspring (Mroz, 2011; Hanrahan, 2011), a member of the Practice Committee explained, I mean medically and scientifically, the fact that this guy has 150 kids feels icky and creepy, but it’s not a big deal. Because, you know it raises one of the huge taboos in our culture about incest but it’s not really incest because [donor conceived half-siblings] don’t know that they’re related. And the medical consequences of them even reproducing together later are far less than most people realize. Most people think that if you have a baby with your cousin it’s going to have three heads and around the world there’s lots of consanguinity that is meaningless . but it’s almost impossible to articulate in a sound bite what I just tried to tell you, that this isn’t really important and you should just move on. You can’t say that because then you sound too laissez-faire (ASRM Practice Committee Member 2, emphasis added). This member suggests that, while single-generation, incidental consanguinity may not raise serious ethical problems, the inability to capture this reasoning in a “sound bite” that would convince the larger public is a legitimate reason to maintain the ASRM’s current guideline of a 10-family limit on the number of families a sperm donor can help create. In other words, the concern for public acceptability legitimates the consideration of ‘reasons’ based upon the marketability of policy alternatives in the ASRM’s deliberative decision-making process alongside more traditional ethical principles. Thus this marketability caveat occasionally results in the adoption of restrictive guidelines e such as limiting the use of sperm donations e that seem to impinge upon reproductive autonomy in the immediate context. Why does the ASRM feel this compulsion to ‘sell’ its guidelines? To explore this, I will use the case of Nadya Suleman, commonly referred to as ‘Octomom’ and frequently invoked by interviewees, another instance in which the ASRM publicly supported specific limits on reproductive autonomy in the face of public outcry (Duke, 2009; Saul, 2009). Suleman’s birth to octuplets after California-based fertility doctor Michael Kamrava transferred twelve embryos in one cycle of IVF produced a massive and largely negative public response that reflected poorly on the ASRM. Explaining the fallout from the Suleman controversy, one member of the Practice Committee noted, “We don’t want to be embarrassed like this again. It’s common to hear the phrase in meetings, ‘We don’t want another Octomom’ ” (ASRM Practice Committee Member 2). Indeed, this member noted that while “the move towards more conservative numbers of embryo transfer, eSET [elective single embryo transfer], in this country was well on its way before the Suleman octuplets,” the committee did “fast-track

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[its] eSET document” in response to the media attention. Another member of the Practice Committee explained: I think we have to be very careful because if there’s a big outlier, like this Octomom, someone in the government might decide that they’re going to regulate what we do. And I think on the one hand, it would be good for the outliers that are not compliant, but I think on the other hand, for the vast number of clinics that are complying, do you want a politician saying you can’t put two embryos back? (ASRM Practice Committee Member 1, emphasis added). This account captures the very real and perpetual fear within the ASRM that the government will step in if the fertility sector fails to properly respond to public outcry. Thus the need to produce publicly acceptable guidelines stems from this strong desire to avoid government regulation. Regardless of whether ASRM members’ primary concern is their own professional autonomy or their patients’ autonomy, this account captures the general belief amongst committee members that self-regulation of the fertility sector is far more conducive to reproductive autonomy than governmental regulation; politicians, it is implied, will eliminate the important possibility of clinical variation. Thus, maintaining a positive public image, or at the very least ‘flying under the radar’ of public opinion by suppressing “outliers” like Octomom, is necessary in order to maintain the fragile integrity of the fertility sector’s self-regulatory system. Indeed, it seems that the very term ‘Octomom’ has become a benchmark for public acceptability in the filtering process of the ASRM’s deliberations: invoking the phrase “We don’t want another Octomom” in discussing guideline options filters out those that might result in a similar public relations disaster. Yet, condemning Octomom and attempting to prevent future higher-order multiple births clearly sends the message that such multiple births are not an acceptable reproductive choice. In this sense, the response to Octomom can be interpreted as a sacrifice of certain “extreme” choices to safeguard reproductive autonomy more broadly. This is why this phenomenon is best understood as a marketability ‘caveat’ rather than a constraint on the process of filtering out reasons incompatible with reproductive autonomy: it is a method of instituting limits to support, however ironically, the principle of reproductive autonomy by preserving self-regulation. 6. Discussion Before presenting the conclusions of this analysis, it is necessary to restate the key limitations of this study. The small sample size suggests caution in interpreting these results as representative of the decision-making processes of the HFEA and ASRM. The general coherence of the explanations of reasoning and decision-making from different members of the same committee may moderate these concerns somewhat; more than one interviewee has been cited at various points in the analysis to illustrate this concurrence. Still, it must be recognized that the theories of balancing and filtering developed here are conceptual interpretations of committee dynamics based on a small number of interviews. This study found that members of the HFEA and the ASRM employ different approaches in rendering reasons or arguments either ‘legitimate’ or ‘illegitimate’. While the HFEA retains a precommitment to health and welfare concerns in its method of balancing, the ASRM has enshrined the principle of reproductive autonomy in its filtering method. Breaking these methods of legitimation down further, both the process (balancing and filtering) and the ‘good’ to be attained (health/welfare and reproductive autonomy) differ.

The overt differences between the two institutions’ structures and missions provide some explanation for these procedural and substantive disparities. As a self-regulating professional organization, the ASRM does not have the same duty as the HFEA to appear impartial or neutral in its reasoning method: it is free to openly commit to reproductive autonomy as the ultimate or overriding ‘good’ that it seeks to achieve through the process of ‘filtering’. The HFEA, on the other hand, as a statutory body producing binding regulations, must appear impartial in its decision-making. Indeed, that is what ‘balancing’ is meant to suggest: consideration of competing values and conceptions of the ‘good’ without a predetermined commitment to any one in particular. Yet a more complex analysis of the process of ‘balancing’ reasons within the committee suggests that priority is given to health and welfare concerns. Returning to the debate about competing accounts of technical and ethical expertise discussed at the beginning of this paper, the empirical findings presented here contribute a novel account of how the tensions between scientific experts, ethicists, and lay persons are played out and resolved in practice. While the deliberative democracy underpinnings of the HFEA would suggest a greater role for previously overlooked values and perspectives, many alternative, non-expert perspectives that are not rooted in health and welfare concerns may still be excluded or delegitimized by the HFEA’s method of reasoning. On the other hand, while the ASRM does not seek to engage in public consultation to determine how its practitioners ought to treat patients, it is in fact quite reactive to a rough abstraction of the public as measured by media attention to ART guidelines and specific patient cases. Beyond the institutional differences, the divergence between the ways in which the HFEA and ASRM deliberate about the legitimacy of particular reasons may reflect broader ‘civic epistemologies,’ or “institutionalized practices by which members of a given society test and deploy knowledge claims used as a basis for making collective decisions,” as Jasanoff (2005, p. 255) suggests. Without wishing to overgeneralize, ‘filtering’ and ‘balancing’ may represent processes specific to US professional self-regulation and UK expert deliberation that flesh out Jasanoff’s characterizations of these nation’s styles of regulatory science. Importantly, however, this study has attempted to advance Jasanoff’s position in answering her call for “new theoretical resources to bring the missing public back into studies of science and democracy” (p. 249). While Jasanoff examines the HFEA in detail, her work fails to consider the ASRM and the influential way in which an abstract conception of the public by this institution affects professional guidelines for ART in the US. Furthermore, the elaboration herein of the differential ways in which the HFEA considers claims made by affected and unaffected publics updates and nuances Jasanoff’s position that the UK’s expert deliberative style fails broadly to consider the public voice. While this paper has focused on an empirical question, something may be said briefly in conclusion about the normative implications of these findings. While this paper has articulated two processes for reasoning in the regulation of ART, future work must focus on whether and why we find these particular accounts, and each committee’s enactment of authority based upon that account, justified in a liberal democratic society. The next step in this line of inquiry, then, must be the formulation of a robust theory of legitimate authority for national deliberative ethics committees. The detailed account of these two institutions’ methods of legitimation points toward the right direction for this next stage: by starting within these key points of tension surrounding what legitimate reasoning requires, future work may improve upon former theories.

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Acknowledgment The author gratefully acknowledges the time and cooperation of members of the Human Fertilisation and Embryology Authority and the American Society for Reproductive Medicine, the support of Elizabeth M. Armstrong, Michael Dunn, Julian Savulescu and Imogen Goold, and the insightful comments from four anonymous reviewers.

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