Enhancing the International Regulation of Science ...



Enhancing the International Regulation of Science Innovators: Reputation to the Rescue?Sarah DevaneySchool of Law, University of Manchester, Manchester, UKWilliamson Building, Oxford Road, Manchester, M13 9PL, sarah.devaney@manchester.ac.ukEnhancing the International Regulation of Science Innovators: Reputation to the Rescue?This article argues that the use of reputation-affecting regulatory measures can enhance efforts to regulate research in the biotechnology sector at an international level by increasing the inclination to comply and by encouraging the culture of the sector to become one in which ‘science solidarity’ is embedded. It characterises the sector as having a number of features which both make such reputation-affecting measures necessary as well as suggesting that they are likely to be effective. Drawing on examples of regulatory compliance and non-compliance in the sector, this article demonstrates that reputation-affecting measures can complement existing regulatory frameworks and draw on and develop existing cultures within the international community of scientists and stakeholders to enhance the likelihood of compliance with regulatory and scientific norms.Keywords: Reputation; regulatory legitimacy; science solidarity; innovationIntroductionThe potentially transformative effects of research into devastating diseases affecting the health of humans are rarely far from the headlines. In recent times such research has established that the avoidance of such conditions can be achieved through the alteration of our genetic makeup. Such advances are impressive from a scientific perspective, but two examples of their application illustrate ways in which the actions of scientific innovators raise significant challenges for the regulation of such research and therapies at an international level. First, the way in which scientists make breakthroughs in knowledge or application can challenge existing regulatory frameworks, as in the case of the birth in April 2016 of the world’s first baby created from ‘3 parents’. The medical team which facilitated this procedure could not carry it out in their home jurisdiction of the US where the relevant regulator (the Food and Drug Administration (FDA)) had been banned by federal statute in December 2015 from considering applications for such work. The group therefore relocated to Mexico where, in the words of their lead scientist, reproductive endocrinologist John Zhang, ‘there are no rules’. The announcement drew accolades as the first application of ‘mitochondrial replacement therapy’ (MRT) which had resulted in the birth of a live baby. This baby was born to a woman who carried in her mitochondria the genes for a fatal neurological condition which had already led to the death of two of her children at a young age. This was not Zhang’s first foray into MRT in humans. In 2003 he reported brief details of a case in which he used the technique while based in China, providing a fuller account in 2016. While they undoubtedly established Zhang as a scientific pioneer, both instances of his application of MRT have been criticised. The triplet pregnancy established in the Chinese case failed and the therapeutic success in the Mexico case only was achieved through his active non-compliance with regulatory provisions and ethico-scientific norms. It is not just cases of initial breakthroughs by scientific pioneers that can give rise to concern from an international regulatory perspective. Even where such breakthroughs are achieved in compliance with existing regulatory frameworks, proof in principle of a new technology by one researcher or group can lead to innovators in other jurisdictions moving the technology forward in the context of regulatory systems with very different parameters or underpinning norms, or where such systems are completely absent. This was illustrated in the case of the discovery of the gene editing tool CRISPR Cas9, a DNA-cutting technique which can be used to rewrite the DNA sequence of cells by inducing breaks at relevant sites. This discovery quickly led to laboratories worldwide using the technology in a variety of species, making the introduction of a heritable change in mice DNA in just 5 weeks with implications for the active direction of species’ evolution. After application of the technology was announced in rats and monkeys, Jennifer Doudna, one of the scientists involved in the technology’s early discovery, felt she had a responsibility to generate a discussion on the permitted parameters of its use in humans and called for a global pause on germline editing and its regulation. Nevertheless in 2016, teams in China used CRISPR technology on human zygotes. It is not the purpose of this article to consider issues of safety or the ethical acceptability of such technologies. It is also not intended to provide suggestions about how these technologies in particular should be regulated, other than to state that it is possible carefully to craft regulatory approaches which are facilitative of innovation and that the approach discussed here can form part of such a facilitative approach. What these examples illustrate are the challenges which the international development of such technologies pose to two aspects of the oversight and control of such work. The first threat is to the credibility of advances in bioscience. Where such advances are made outside regulatory frameworks, they fall foul of the broad frameworks of scientific norms generally considered to apply to such work. The scientific credibility of such technologies’ application is affected by its legality. It is only where the science is developed in accordance with the legal and regulatory provisions of the relevant jurisdiction, as well as within the context of generally accepted scientific norms that they can be said to be scientifically acceptable more broadly. I define this combination of the adherence to widely accepted research norms together with compliance with regulatory provisions and their spirit as ‘science solidarity’. I place solidarity at the core of the duties owed by research bioscientists for two reasons. The first is its emphasis on inter-connectedness with others, a key feature of the sector. The second is its relevance to the concern expressed by research scientists for the views which others hold of them, i.e. their reputation, and what this can mean for a relational regulatory response.The second threat posed by science innovation at an international level is to the legitimacy of regulators and the frameworks over which they preside. A legitimate regulator ‘is perceived as having a right to govern both by those it seeks to govern and by those on whose behalf it purports to govern’ and operates within ‘a generalized perception or assumption that [its actions] are desirable, proper, or appropriate within some socially constructed system of norms, values, beliefs, and definitions’. Where the parameters set by the regulator or regulatory framework are breached without regulatory censure or sanction, confidence in the entitlement and capability of the regulator to regulate will erode.This article takes as its starting point the claim that ‘a focus on ‘technology’ as a regulatory target is less likely to yield useful connections between ideas than a framing that recognises the complex relationship between law, regulation, technology and society.’ I suggest that the challenges illustrated by the two examples above might be overcome through a regulatory focus on cultural and relational interactions and responses amongst research scientists as a group, and between them and other stakeholders in the bioscience sector more broadly. In particular, the question as to whether research scientists’ concern for their reputations can be used effectively to encourage a greater inclination to comply with both regulatory provisions and the norms to which the community adheres will be considered. Adopting a reputation-affecting regulatory approach can reflect the international nature of the norms of scientific research (and the further development of these norms) and the varied regulatory mechanisms which support them.In section 2 the characteristics and culture of the research bioscience sphere are examined. For any regulator to engender the compliance of their regulatees, they must have a keen understanding of and insight into the latter’s interests and priorities. Only then can they deploy compliance mechanisms which are targeted and effective and thus protect their own legitimacy as a regulator. I therefore provide an account of the nature of research bioscience as a regulated sector, highlighting in particular its members’ concern for their reputation. Section 3 considers how developing a regulatory approach which draws on this concern might assist in incentivising compliance with scientific norms and regulatory provisions. I argue that reputation-affecting measures are flexible, responsive, and adaptive to the distinctive nature of the sector. Being closely aligned with the culture, interests and values of the scientific community, they can play a role in improving standards and increasing compliance alongside other complementary mechanisms and approaches. The insights provided here, it is hoped, will contribute to the understanding of cultural issues within the research bioscience sector and how they can be used to influence the behaviour of scientists so that the culture becomes one which is even more inclined to comply with scientific and regulatory norms. 2. Characterising the Culture of Research Bioscience as a Regulated SectorRegulators presiding over an effective, relational regulatory approach need ‘better understanding of regulated organisations, the incentives that drive them, and the consequences of their behaviours’. In this section, the distinctive features of the research bioscience sector and the challenges these pose for international regulation are identified, establishing that pressures to breach regulatory provisions and scientific norms can have a significant influence on the behaviour of those working within the field. Scientific Research NormsFactors which are required for the ethical conduct of research in and for humans have become enshrined in good practice guidelines, policies and regulation at national and international levels. Common factors within these which together constitute accepted research norms include the maintenance of high standards of rigour and integrity in research, ensuring that research is conducted in accordance with appropriate ethical and legal frameworks, respecting the interests of research participants and ensuring that work is carried out in a transparent fashion. Recommendations continue to be developed on how, for example, to improve openness and transparency such as through the publication of data sets as a requirement of funding being awarded; the use of checklists to ensure publications contain details of steps by authors so that others can attempt to reproduce them; and requirements of publication of methods and results of clinical trials whatever their outcome.I argue that the combination of adherence to such good practice norms, together with a commitment to compliance with regulatory provisions or their spirit, constitute ‘science solidarity’. Solidarity has been described as ‘a deeply relational practice’ which is ‘underpinned by the conviction that all human practices are … both self-interested and other-oriented at the same time’. It is ‘a moral vehicle for injecting legitimate concepts and considerations of community and interconnectedness into ethical and legal analyses’. Solidaristic activities ‘are those by which people or groups express their willingness to accept “costs” (understood widely as any kind of financial, emotional, social or other contributions) to assist others with whom they recognize similarity in a relevant aspect’. Frameworks based on solidarity therefore ‘emphasize the simultaneous importance of personal and collective needs, interests and responsibilities, and focus action on the space where the two overlap’. Science solidarity is similar to, but distinct from and more expansive than the social contract in science which has been defined as ‘the construction of mutually beneficial alignments of interests to ensure that science develops in conjunction with social benefit rather than in opposition to it’. Science solidarity incorporates the social contract but expressly includes a requirement to adhere to regulatory provisions and/or norms as a feature of the development of socially beneficial science. Encouraging a science solidarity culture within the research bioscience sector can help to avoid threats to scientific credibility and regulatory legitimacy.The above examples of advances in the field of genetic manipulation illustrate breaches of and adherence to science solidarity across both research and treatment activities. Both involve research in an area in which applicable formal legal provisions are in an emergent state. Zhang’s description of the Mexican legal position represents a misunderstanding of it, and highlights the regulatory opacity which the US position has engendered. Whatever the mis/understandings of the law, or the provisions’ lack of clarity themselves, Zhang’s actions in undertaking manipulations of ova in the US and the transfer of the resulting embryo into the mother in Mexico represent a determined attempt to circumvent applicable legal provisions, breaching science solidarity. Beyond formal legal provisions there was a failure to comply with other regulatory requirements. In the editorial accompanying Zhang’s 2017 article on the procedure, concerns were expressed about ‘weaknesses and limitations in a number of areas… [and] some uncertainties concerning methodologies and results’ including failure to obtain institutional review board approvals. Zhang’s case additionally involves treatment which, given the new technology being applied, is best described as experimental. Zhang failed to contribute to society’s knowledge and understanding of MRT through his application of it. Studies have suggested that ‘genetic drifting’ or ‘reversion’ (in which maternal mDNA containing mutations increase in the child’s body over time) can occur after deployment of MRT techniques and it has not been possible to rule out the possibility of reversion in this or future cases. Given this long-term uncertainty as to the efficacy of the technique, Zhang has been criticised for a lack of clarity on the long term follow up of the baby. Clear recommendations have been made that such follow up should form part of the application of MRT in order to assess risks and garner as much information as possible from the small numbers of cases in which it is used. Zhang’s actions have been characterised as ‘a perfect lesson in how responsible research should not be performed’ and certainly do little to contribute to science solidarity. In contrast, Doudna has taken active measures to contribute to knowledge about CRISPR by driving the debate with policy makers, regulators and other researchers about how it should be regulated. Other examples of a commitment to enshrining of a culture of science solidarity exist in the wider sector including the public sharing of knowledge in the mapping of the human genome and taking steps to protect patients from potentially dangerous untested new therapies.Regulators therefore need to know that while research norms have the potential to enhance compliance and support international regulation, adherence to them can depend on the inclination, interests and values of the individual researcher. A research culture which values and rewards a commitment to science solidarity can help to influence behaviour away from purely self-interested ends to behaviour which benefits wider society. The tension between such a vision of research culture and the current reality of its myriad pressures will now be considered, before an analysis of how reputation-based regulatory measures can help. Solidarity-Eroding PressuresIt is important for research bioscience regulators to understand how complexities and tensions within the sector can give rise to the sorts of esteem-seeking behaviours which can result in non-compliance with regulatory provisions and good scientific practice. Such behaviours make it a highly challenging area to regulate, with serious implications for both regulatory legitimacy and scientific credibility. The complexities of the research bioscience sector are many and varied. Those which are technological in nature arise due to the emergent state of many aspects of the science. Very few clinical trials in humans have been carried out using stem cells for example, with much more still to be learned about how to control the cells’ behaviour on introduction or re-introduction to the body, and thus the risks posed to patients taking part in early trials. Given its use of parts and products of the human body, and in certain domains the human embryo, research bioscience can also give rise to complexities due to ethical, cultural and religious perspectives prevalent in the jurisdiction within which it is undertaken. Further, many research projects involve collaboration across varying jurisdictions, institutions and disciplines, making oversight, whether by the project lead or regulator, particularly challenging. These inherent complexities of the sector give rise to a variety of tensions for those working within it. A key characteristic of the research bioscience sector is that of competition, whether for decreasing amounts of funding for research projects, for publication of results in highly regarded journals, or for other indicators of esteem. Competition can extend from individual scientists, to their employing institutions, and even to national policies on developing regulatory environments which facilitate ground breaking research or which relax regulation to encourage resulting markets. The emerging bioscience sector is one in which it can be particularly difficult to persuade potential funders to support research, particularly where there is a lack of evidence to provide reassurance on potential efficacy and safety risks and value for money. Competition for such funding can affect ‘integrity and impartiality’ through, for example, pressure (whether real or perceived) not to publish results which do not serve the funder’s interests, or to establish parameters of research enquiries which actively serve the funder’s needs.The system of publication of research results is a further major source of tension in the sphere, with publication record having implications for researchers’ ability to obtain employment or funding for new projects. The publication of work in ‘high impact factor’ journals has been perceived to be an indication of high quality, but there is a growing awareness that this is not necessarily always accurate. Cossu et al have warned of the dangers of ‘beautification of data’, that is the prioritising of positive trial data by journals and funders to the extent that important information from negative results does not come to light. Interest on the part of the media in the therapeutic potential for new biotechnologies also gives rise to tensions. A notable characteristic of the research bioscience sector is its ability to generate high profile coverage of key breakthroughs in theory and application, accompanied by the lauding of those who have achieved them. Significant developments are responded to by the awarding of prestigious prizes and awards. This has led to unrealistic expectations of the therapeutic capacity of the technologies and to scientists being lobbied to provide therapies, however experimental, by patients affected by serious diseases. Some scientists, institutes and even governments have shown themselves to be so susceptible to such entreaties for help that they have been willing to bypass existing regulatory provisions, on occasion with devastating results. The effects of the above tensions on those working in the sector are varied. The focus in this article is the resulting pressure to engage in research misconduct in order to become, or be perceived to be, a leader within it. Zhang’s engagement with media interest about his breakthrough despite the flaws in his achievement of it invite conjecture that his reputation as an innovator achieving a “world first” was more important to him than being seen to develop the science in an ethical and compliant manner. The Zhang case is far from the only example of recent major scandals in bioscience research practices. Hwang Woo-Suk fraudulently claimed to have been the first scientist to create human embryonic stem cells through cloning. Haruko Obokata published articles claiming she could turn ordinary body cells into cells similar to embryonic stem cells but these experiments proved impossible to replicate and she was held to have committed scientific misconduct. And Paolo Macchiarini was fired from Sweden’s Karolinska Institute for misconduct after most of the patients subjected to his experimental artificial trachea interventions died. There is evidence that these high profile examples are the tip of the iceberg of poor practice in science ranging from cutting corners in research methods to plagiarism. Of publication retractions between 2001 and 2010, reasons for retraction included publishing misconduct (47%), research misconduct (20%) and questionable data/interpretation (42%). A 2012 analysis found that two-thirds of the 2,047 retractions on a biomedical database were attributable to misconduct, including fraud or suspected fraud (43%), duplication (14%) and plagiarism (10%).ReputationWe know then that the research bioscience sector is, quite apart from its subject matter, highly complex, and that this complexity gives rise to pressures which can result in misconduct. But why is that so? It is suggested here that a major factor influencing the behaviour of those working in the sphere is their concern for their reputation both within and beyond the sector. The results of an online poll of scientific researchers by Nature in 2011 showed that ‘77% say that their personal online reputation is important to them and 88% say that the online reputation of their work is important’. Scientists are deploying a wide range of online and social media methods to maintain their profile, with the poll’s findings suggesting ‘a growing recognition in the scientific community: maintaining a prominent online presence can help researchers to network with colleagues, share resources, raise money and communicate their work.’ Scientists are targeted by publications containing advice on developing and maintaining their reputations not only in relation to the quality of their work, but also ‘their relationships with fellow scientists, their presence in the broader scientific community and their willingness to do what it takes to protect and promote their personal brand.’Reputations then are highly valued by those working in the research science sector – but what should that reputation be for? A survey of non-scientists showed a preference among the public for ‘boring but certain’ results as scientists generating them were seen as ‘smarter, more ethical, a better scientist, more typical, and more likely to get and keep a job.’ In contrast, failings in the replicability of results has been recognised to be ‘fraught with social consequences well beyond the scientific implications of the research’ and ‘can threaten not just the finding but also our status as its discoverer and as a competent scientist.’ However, despite these recognitions that high quality of work can contribute to a strong reputation while failure to maintain high standards can damage it, there is a contradiction in that ‘[t]he present culture in science provides strong incentives for innovation and relatively weak incentives for certainty and reproducibility … This suggests that the recipe for reputation and career success is to prioritize innovative ideas over reproducible evidence.’ The effects of incentives to innovate at all costs can be seen in the behaviour of scientists from high profile fraud cases to low level temptation to breach regulatory provisions and the norms of good scientific practice.In summary we have a sector which the regulator should know is highly pressurised. A culture exists in which its members are highly incentivised to report important breakthroughs, significantly tempted to breach regulatory provisions and sector norms, and inclined to innovate to achieve their aims, including in relation to their response to regulation. Regulators need to use this knowledge in their regulatory approach, and it is the extent to which drawing on reputational concerns can aid in this endeavour to which we now turn.3. Reputation-Affecting Regulation of Research BioscienceIn the previous section it was established that scientists value their own reputations to the extent that the attempt to maintain, protect or enhance them in order to achieve rewards of value to them can have a significant influence on their behaviour. So how can regulators of research bioscience draw on this knowledge to overcome the challenges inherent in the attempt to regulate at an international level and to avoid the threats to scientific credibility and regulatory legitimacy posed by self-interested behaviours? In this section it is argued that adopting reputation-affecting regulatory approaches can complement dynamic regulatory mechanisms allowing or even incentivising scientists to go ‘beyond compliance,’ i.e. beyond the minimum required to comply with defined standards. In doing so, the existing culture of scientific research is infused with a regulatory mechanism to which the sector is already highly sensitised. This mechanism can then actively direct that culture by rewarding those with reputations for commitment to science solidarity including regulatory compliance, honesty and integrity and contributing to supporting others in the scientific community.In making this argument I apply and expand upon Gunningham and Grabosky’s concept of ‘smart regulation’. Smart regulation’s two distinctive elements, which lend themselves to research bioscience regulation, are that it utilises a variety of regulatory mechanisms, and that it harnesses the involvement of numerous regulatory actors beyond formal or governmental regulators, the specific combination of mechanisms and actors being determined according to the sector being regulated. To these two factors I contribute a third reason why reputation-affecting regulation can succeed in the research bioscience sector, which is that such regulation is responsive to the values and interests of those being regulated and thus increases the chances of their compliance with it. A Flexible Regulatory MechanismIn relation to the first of smart regulation’s two key elements, i.e. the preference for ‘complementary instrument mixes over single instrument approaches’, reputation-affecting mechanisms can be wielded in the research bioscience sector in concert with the variety of other regulatory provisions and mechanisms available, to incentivise compliance with those provisions and mechanisms and to enhance compliance with science solidarity. Reputation-affecting strategies can function whether the dominant regulatory approach is one of deterrence or compliance or, as is often the case in smart regulatory approaches, a combination of the two. Deterrence approaches draw on formal mechanisms of punishment to sanction the wrongdoer and set an example to others who may be considering similar breaches. Where regulatees are inclined not to comply if to do so would inhibit the achievement of their own ends, for deterrence strategies to work, ‘the certainty and severity of penalties must be such that it is not economically rational to defy the law’. In Zhang’s case it is evident that regulatory provisions purporting to deter his actions were ineffective, as any normative incentives to comply were disregarded by him in favour of the rewards he anticipated for succeeding in the treatment. As a result, the legitimacy of the extant framework and the regulator with oversight over it has been threatened.As well as failing in relation to Zhang as an individual, the framework in place is also failing in relation to the wider community of regulatees. Deterrence actions are intended to have ‘both a ‘reminder’ and a ‘reassurance’ function’ for those to whom they apply, ‘reminding them to review their own compliance status and reassuring them that if they invested in compliance efforts, their competitors who cheated would probably not get away with it’. Other scientists working in the area but adhering to the FDA guidelines prohibiting such research on human embryos were understandably indignant that Zhang’s team had simply side-stepped regulatory provisions which they themselves had complied with (as well as bemoaning the wider damage such actions were causing to the practice of compliant research as a whole) On the other hand, overly strong deterrence actions might be resisted by the community of medical scientists if seen as overly adversarial thus reducing any inclination to respond positively to attempts to encourage the development of a reputation for science solidarity.In contrast to the deterrence approach, a compliance strategy ‘seeks to prevent harm rather than punish an evil. Its conception of enforcement centres upon the attainment of the broad aims of legislation, rather than sanctioning its breach. Recourse to the legal process here is rare, a matter of last resort, since compliance strategy is concerned with repair and results, not retribution.’ Where reputation-affecting approaches are being used within such a system, regulators and other stakeholders can reward compliant behaviour with reputation-enhancing measures such as access to funding, publication in esteemed journals and licenses allowing innovative work to be undertaken. Similar challenges to those facing deterrence appear here however, and as Gunningham notes ‘there is considerable evidence that cooperative approaches may actually discourage improved regulatory performance amongst better actors if agencies permit lawbreakers to go unpunished. This is because even those who are predisposed to be “good apples” may feel at a competitive disadvantage if they invest money in compliance at a time when others are seen to be ‘getting away with it’.It is likely that reputation-affecting mechanisms would be deployed in conjunction with a combination of deterrence and compliance approaches. This is because it has been found that regulators will ‘gain better results by developing more sophisticated strategies which employ a judicious blend of persuasion and coercion, the actual mix being adjusted to the particular circumstances and motivations of the entity with whom they are dealing.’ Reputation-affecting mechanisms are adaptable to either approach. For example, naming and shaming could work for extreme cases including regulators notifying funders of serious transgressions. Reputation enhancing activities would likely form the bulk of the approach however, on the basis of their capacity to bring wider rewards and thus instil a greater willingness for compliance with the principle of science solidarity. Adaptive to the Parties InvolvedThe second feature of smart regulation which can assist in the international regulation of bioscience and which correlates with reputation-affecting regulation is the use of parties beyond the regulator as ‘surrogate regulators’, with the advantage of achieving regulatory outcomes at lower cost. It is argued here that because reputation-affecting mechanisms are adaptive to the parties involved, this approach is appropriate for the bioresearch sector, which involves the actions, contributions, aims and interests of a wide variety of parties who can influence the manner in which research is undertaken and the norms to which it adheres in doing so. This can be done by developing a regulatory culture in the sector which incentivises adherence to science solidarity norms by providing reputation-enhancing responses where compliance is evident. Not only that but reputation-affecting mechanisms can be used to steer the culture’s norms to a stronger focus on compliance as opposed to one where non-compliance appears to regulatees to be an option which will help them enhance their reputation. In this sense, a reputation-based regulatory approach incorporates not only a descriptive but also a normative account of science solidarity.Meidinger argues that a regulatory cultural perspective ‘focuses on the understandings that are negotiated and enacted by actors in regulatory arenas. It tends to presume that those understandings are important in their own right, and are not simply reducible to other factors, such as pregiven material interests or powers’. Further, it ‘can be understood as a necessary medium for social interaction that both constrains group behaviour and creates possibilities for new forms of social behaviour’. Culture can often be identified through the behaviours of members of the group, becoming manifest in ‘what they enact in their daily lives’.As Meidinger observes, ‘the groups involved in regulatory policy and practice are… ordinarily larger than regulatory agencies’, something which he terms ‘regulatory communities’, stating, ‘Members of the community frequently influence each other, act with reference to each other, and desire each other’s respect. Therefore, as well as being arenas for the pursuit of pre-existent interests, regulatory communities appear to have the capacity to be “constitutive” – that is, to be forums in which appropriate individual and collective behavior (and interests) are defined and redefined.’As we have seen, the research bioscience sector is characterised by interactions between and the desire to influence key members of its regulatory community such as researchers themselves, their employing institutions, research funders, journal reviewers and editors, regulators, the media, policy makers and the public. Where scientists wish to maintain a reputation with them, each of these parties can play a role as one of smart regulation’s surrogate regulators by setting expectations on scientists to adhere to science solidarity norms and regulatory provisions. And each can have a role in setting the parameters of what makes a ‘good’ reputation in science by withholding rewarding behaviour unless researchers behave in a way which promotes good scientific practice and adheres to regulatory norms and provisions.For example, research funders could make it a requirement of an award of funding that researchers publish their findings whether positive or negative, that they engage with the public to disseminate their findings comprehensively and accurately, and that they comply with all applicable regulatory provisions. Journal editors may make it a requirement of publication of work that research has been compliant with the regulation of the jurisdiction/s within which funding was provided and that a full account of methods and outcomes are made available. Where applicable, regulators may make it a condition of issuing licenses for research work that full publication of results is made and public engagement activities are undertaken. And each of these parties to the endeavour to ensure scientific and research norms are complied with should be communicating with each other so that where breaches occur, this has a negative effect on the reputation of the researcher in future attempts to publish, obtain funding etc. Solidaristic practices can also be incorporated into such a framework. Those organisations funding and directing innovative research would be under a duty to direct research for the benefit of society as a whole, rather than being driven solely by profit considerations. Further, the aspects of solidarity which impose a duty to share knowledge and advances in the field and ‘to report fully, honestly and regularly, on the performance of those tasks they have been given, to their stakeholders and the wider public’ might be chosen to be guiding principles of research. This could be achieved through a requirement, either in guidance or in the terms of the licence granted that research results be published on the regulator’s website. In this way, reputation-affecting measures can use cultural knowledge as a source of power to actively mould the culture of the sector to enhance the chances of maintaining scientific credibility and regulatory legitimacy. Responsive to the Regulatees’ Values and InterestsExtending beyond the two aspects of smart regulation just discussed, the third facet of reputation-affecting regulatory approaches which can assist in the international regulation of bioscience is the fact that it is responsive to the particular values and interests of regulatees. The fact that subjects of law and/or regulation might be sensitised to the views which others hold of them in a way which can affect their behaviour is not new and has been explored in theoretical analysis of the effect of anticipated shame and/or embarrassment on the decision as to whether to break the law or breach regulatory provisions.Braithwaite defines shaming as ‘all societal processes of expressing social disapproval which have the intention or effect of invoking remorse in the person being shamed and/or condemnation by others who become aware of the shaming’. His theory of reintegrative shaming suggests that ‘emotional responses to disapproval are critical to explaining the effect that regulatory action has on subsequent compliance.’ Shame is seen as ‘a response to social pressures that are exterior to individuals and constraining. The individual feels shame as a result of others’ decision to reject. If others do not reject in the face of the same actions, no shame is felt.’ It is suggested that the shame response occurs where the individual is morally engaged, as they recognise that certain values have been breached. Shaming can thus have a deterrent effect for morally engaged individuals who constrain their actions to avoid a loss of respect by those whose opinions they value.Grasmick and Bursick say shame can be seen as ‘a form of potential self-imposed, or reflective punishment’ whereas embarrassment relates to the views of others whose opinions the individual values and is a ‘socially imposed punishment’. In a similar way to loss of reputation, ‘[m]ore long-term consequences of embarrassment might include a loss of valued relationships and perhaps a restriction in opportunities to achieve other valued goals over which significant others have some control.’ Such potential costs can be taken into account in an individual’s decision as to whether or not to comply with regulatory provisions.Reputation contains aspects similar to those of shame and embarrassment but goes beyond these in its overtly instrumental nature. Individuals who value their reputation do so, at least in significant part, due to the consequential gains which a strong reputation can bring. The fear of damage to reputation focuses on the losses which will flow from this such as reduced access to supportive funding. As a result reputation is a highly effective regulatory mechanism as it is responsive to the values and interests of the specific regulatee.Where it is being used as an enforcement mechanism, reputation has shades of shaming but in this instance it can be more effective. First, it is a more targeted mechanism as threats to damage reputation can provide a ready-made incentive to comply which correlates with the distinct values and aims of the regulatee. Secondly, it does not have to rely on there being a moral basis to the individual’s compliance. Reintegrative shaming theory relies greatly on the capacity of moral persuasion to incentivise compliance. This ‘stems from a broader social premise, one derived from control theory, that the reason individuals do not commit crime is because they have commitments to shared moral norms and social institutions.’ Where there are no such commitments to shared moral norms, Braithwaite acknowledges that this approach will be ineffective. In contrast, reputation-affecting mechanisms can function effectively to influence behaviour even if regulatees are only incentivised to comply because it is in their own interests to do so. No system of regulation can ever guarantee total compliance with its provisions and some individuals will remain impervious to regulatory intervention based on reputation where the value they place on their own reputation depends on alternative values to those embodied by science solidarity. Zhang himself is a case in point. The FDA has taken steps to require his regulatory compliance through publicly available enforcement letters, yet he continues to offer MRT procedures through a company with headquarters in the Ukraine but operating internationally.While it is therefore acknowledged that a regulatory system which uses reputation-affecting mechanisms will not alter the behaviour of all regulatees in the desired manner, it can contribute to the development of a culture in which it is instrumentally beneficial for most to contribute to science solidarity.ConclusionThe challenges of international regulation of biotechnologies are well rehearsed and the vulnerabilities of the sector to misconduct are far from unrecognised. Without effective enforcement mechanisms, regulation will fail to be effective and efficient, losing community confidence. No system of regulation can ever guarantee total compliance with its provisions, but without an effective method which incentivises compliance with scientific norms and regulatory provisions, the sector is vulnerable to more widespread practice of misconduct discussed in this article. What is missing from current regulatory approaches is an explicit recognition of and response to the motivations of the actors involved. It is argued that influencing the culture so that it becomes important to have a reputation for compliance with science solidarity can help to reduce instances of misconduct.Reputation enhances existing regulatory frameworks – for those who might be tempted to breach such frameworks, it provides an added incentive, tied in with their interests and values, to determine whether such breach will help them achieve their own aims. In jurisdictions where such frameworks are absent, it can still incentivise compliance with the spirit of much international regulatory effort and the principle of science solidarity to develop safe, high quality science which results in therapeutic benefits. In the sphere of research bioscience, we have seen that researchers act in innovative ways, not only in relation to the science, but in relation to regulatory provisions too. This means that if they are intent upon breaching or avoiding regulatory provisions, they will be able to find ways to do so. What the proposals in this article intend to achieve is a shoring up of regulatory provisions and norms of good scientific practice through a mechanism which is reflective of the priorities and concerns of existing community culture, so that the likelihood of them being complied with increases. It advocates that the existing informal propensity to develop and protect reputation in the research bioscience sector should be taken advantage of by those parties involved in regulatory activities within it to enhance compliance with its norms.The beauty of reputation as a regulatory mechanism is its flexibility, adaptability and responsiveness. It is flexible enough to be used in conjunction with either deterrence or compliance strategies and as an adjunct either to formal regulatory provisions or to cultural norms within the sector. It is adaptive to the relationships the reputation holder develops with stakeholders within and beyond the sector; and it is responsive to the importance of those reputations to the holder. Through its application across the culture of the sector, reputation transcends jurisdictional boundaries and thus has the capacity to incentivise compliance at least with good practice norms, even where formal regulation is inconsistent or absent.A resort to reputation-affecting mechanisms can contribute to efforts to maintain scientific credibility by incentivising behaviours which enhance safety, transparency and accuracy in science as well as contributing to maintaining trust in the sector. It can assist scientists in achieving their own goals such as ensuring fair credit for discoveries, and fair allocation of funding, and maintaining their own reputations. Finally, it can protect the legitimacy of regulation and the regulators who preside over it, and ensure that innovative therapies are developed in a way which maintains the credibility of the science behind them. ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download