Recent policy changes in the European Union have introduced the requirement for publicly funded research to be published in open access. This can be seen as part of a mode of democratic accountability that not only promotes transparency but also, Naomi Hodgson argues, is constituted by visibility and openness. By drawing attention to the way in which the researcher is asked to understand herself in this policy context, Hodgson illustrates how particular technologies of performance measurement and management, and of (...) publication, enter the researcher into this economy of visibility. The understanding of openness as a corrective to the traditional closed access system of publishing and the marketization of academia is challenged, then, in this article, which indicates how these technologies of reading and writing constitute the researcher as a particular figure in the emergent mode of governance. (shrink)

There are increasing concerns that research regulatory requirements exceed those required to manage risks, particularly for low- and negligible-risk research projects. In particular, inconsistent documentation requirements across research sites can delay the conduct of multi-site projects. For a one-year, negligible-risk project examining biobank operations conducted at three separate Australian institutions, we found that the researcher time required to meet regulatory requirements was eight times greater than that required for the approved research activity. In total, 76 business (...) days were required to obtain the necessary approvals, and site-specific processes required twice as long as primary Human Research Ethics Committee and Research Governance Office processes. We describe the impact of this administrative load on the conduct of a one-year, externally-... (shrink)

For many years there has been discussion regarding the problems confronting our current ethics review system. Commentators have identified numerous issues that threaten the sustainability of Australia’s voluntary HREC system. Various ad hoc solutions to these problems have been posed, but have not resulted in any significant advances. However, in recent years, discourse regarding research governance has become prominent in the Australian research environment. The application of research governance principles is gaining momentum amongst the regulators (...) of research, including research institutions and their governing bureaucracies. We argue that this is potentially the most significant development in several years towards creating a sustainable HREC system in Australia. The recognition by research institutions and their governing bureaucracies that the responsibility for overall research governance lies with them, rather than solely with their HRECs, is leading to a range of initiatives which should significantly lessen the burden on Australian ethics committees, and improve their ability to undertake their core task of reviewing the ethical aspects of research proposals. (shrink)

This study examines a significant gap in the role of providing ethical guidance and support for community-based research. University and health-based ethical review committees in New Zealand predominantly serve as ‘gatekeepers’ that consider the ethical implications of a research design in order to protect participants and the institution from harm. However, in New Zealand, community-based researchers routinely do not have access to this level of support or review. A relatively new group, the New Zealand Ethics Committee (NZEC), formed (...) in 2012, responds to the uneven landscape of access for community-based research. By offering ethical approval inclusive of the review of a project’s study design outside institutional settings, NZEC has endeavoured to move beyond a gatekeeping research governance function to that of bridge-building. This change of focus presents rich possibilities but also a number of limitations for providing ethical review outside conventional institutional contexts. This paper reports on the NZEC’s experience of working with community researchers to ascertain the possibilities and tensions of shifting ethics review processes from research governance to a focus on research ethics in community-based participatory research. (shrink)

This paper seeks to address research governance by highlighting the notion of public accountability as a complementary tool for the establishment of an ethical resonance space for emerging technologies. Public accountability can render development and design process of emerging technologies transparent through practices of holding those in charge of research accountable for their actions, thereby fostering ethical engagement with their potential negative consequences or side-effects. Through practices such as parliamentary questions, audits, and open letters emerging technologies could (...) be effectively rendered transparent and opened up to broader levels of scrutiny and debate, thereby contributing to a greater adherence of emerging technologies to ethics and moral consensus. Fundamental democratic practices could thus not only lead to better informed choices in design and development processes, but also contribute to more morally substantive outcomes. (shrink)

Around the world, a growing number of communities are voicing their demands for authority in the governance of research involving them. Many such communities have experienced histories of exploitative, stigmatizing, intrusive research that failed to benefit them. To better understand what strategies communities are developing in order to have a say in research oversight, we conducted a scoping review of the international peer-reviewed and grey literature. Three primary strategies were identified: (1) guidelines; (2) community review boards; (...) and (3) community advisory boards. Guidelines include documents developed by, with, or for communities to outline ethical behavior or conduct in research with or within the community. Community review boards offer ethical review of research protocols, much like traditional research ethics boards, but are community led and focus on community interests. Community advisory boards consist of representatives from a given community and are developed to advise institutions or research teams on community-level ethical matters pertaining to research projects. Initiatives led by Indigenous communities far outnumbered others in the sample, reflecting the legacy of continuous Indigenous resistance to research as a tool of colonialism. In several cases, communities in marginalized neighbourhoods, where harmful and exploitative research practices have taken place, emphasized the significance of community-led governance grounded in shared geographical and social contexts. We discuss some of the beneficial and challenging features of each type of strategy and offer recommendations for stakeholders who wish to support community-led efforts in research ethics. (shrink)

There is growing interest in the contribution of practitioner research towards bodies of knowledge and practice change. A practitioner or group of practitioners may carry out inquiry in order to better understand their own practice and client groups and to assess or improve service effectiveness. There is also increased interest in the place of ethical review (typically encapsulated within requirements to submit to a formal ethics committee) and broader processes of research governance. Drawing on the field of (...) social work this paper seeks to explore how practitioner research should respond to calls for ethical review and greater formal consideration of research projects. We adopt a four-fold discussion. First, we explore the meaning of practitioner research and sketch its progress and the ethical implications thereof within social work; second, we trace the factors accounting for growing interest in ethics review and committees; third, we outline issues raised by practitioner research vis-à-vis ethical review, the role of ethics committees, and processes of research governance. Finally, we suggest how procedures and practices can ensure that ethical principles are considered whilst also fostering practitioner research developments. (shrink)

The objective of this study is to describe researchers', health-care providers' and other stakeholders' views of ethical review and research governance procedures. The study design involved qualitative semi-structured interviews. Participants included 60 individuals who either undertook research in the subspecialty of cancer genetics (n = 40) or were involved in biomedical research in other capacities (n = 20), e.g. research governance and oversight, patient support groups or research funding. While all interviewees observed that (...) oversight is necessary to protect research participants, ethical review and research governance (ERG) arrangements were described negatively throughout these interviews. Interviewees identified a number of problems with ERG, including: over-bureaucratization, over-standardization of information requirements for different types of research, a lack of standardization in the types of information required by different committees for the same research and a lack of consistency in different committees' responses. A number of solutions were proposed including streamlining application procedures and harmonizing committees' responses and information requirements. Recent reports suggest that ethical review procedures and research governance arrangements threaten the possibility of undertaking clinical research in the UK, hence the introduction of the Integrated Research Application System (IRAS) is long overdue. However, while IRAS may solve some of the problems identified by interviewees, it remains to be seen to what extent it will impact upon the very negative perceptions of ethics and research governance procedures reported here. (shrink)

The use of animals in experiments and research remains highly contentious. Laboratory animal research governance provides guidance and regulatory frameworks to oversee the use and welfare of laboratory animals and relies heavily on the replacement, reduction, and refinement principles to demonstrate responsibility. However, the application of the 3Rs is criticized for being too narrow in focus and closing down societal concerns and political questions about the purpose of animal laboratory research. These critiques challenge the legitimacy of (...) responsibility in laboratory animal research governance and call for new approaches. With the advent of the "Responsible Research and Innovation" agenda, we investigate whether the notion of responsibility in the controversial area of animal research governance could be enhanced by examining the 3Rs through RRI. Our analysis reveals RRI has the potential to helpfully augment the 3Rs in three key ways: recognizing the need to include a broader range of experts and publics in animal research governance; emphasizing the importance for animal research scientists of taking societal, and not just role, responsibilities into account; and acknowledging the political questions animal research raises. (shrink)

Background This article describes the issues encountered when designing a study to evaluate recruitment of minority ethnic groups into clinical cancer research in order to monitor adherence to the principles for good practice set out in the Department of Health, Research Governance Framework, England. Methods (i) A review of routine data sources to determine whether their usefulness as a source of data on prevalence of cancer in the population by ethnic category. (ii) A local case study at (...) one hospital trust to ascertain whether the ethnicity of cancer trial participants was representative of admitted cancer patients. Results (i) The lack of a comparator population makes it problematic to assess recruitment levels by ethnic group in clinical research. (ii) The odds of being in a trial were 30% lower for a member of a minority ethnic group compared to a white cancer patient after adjusting for disease, age and gender, OR 0.70 (0.53 to 0.94). These results differed for each ethnic group; Asian patients did not appear under-represented while Black and Chinese did so. However, there are important caveats to the findings based on the limited recording of ethnicity. Conclusions The lack of available data on the ethnicity of participants in clinical research and the prevalence of cancer in the population according to ethnicity makes it difficult to design a study to monitor representation of minority ethnic groups. This information is necessary to assess adherence to the Research Governance Framework principle that research evidence reflects the diversity of the population. (shrink)

In this paper the author argues that the Academy of Medical Sciences's ‘Review of the regulation and governance of medical research’ has produced a set of muddled recommendations that could increase complexity and uncertainty in research governance rather than reduce it. Issues discussed in the paper include the additional legal burden placed upon the newly proposed Health Research Agency by the plan for a National Research Governance Service and its system of centralized permissions, (...) the consequences that this may have for the research ethics committees in the discharge of their legal duty, and the unanswered questions surrounding the TGN1412 incident. (shrink)

This article focuses on the governance and ethical conduct of research within the domain of social work and social care. Globally, research in this domain appears less well regulated than those in the domains of health care. Within the United Kingdom, the Westminster government is implementing a Research GovernanceFramework for Social Care in England (RGF Social Care). This article locates this development in a broader global context and uses as an example a regionally based implementation to (...) explore some potential issues that arise from the governance and ethical framework in social work and social care. The proposed system is located with English local authorities. Various models are emerging: single department; corporate; dual or multi-council collaborations; cross-sector collaborations. Whatever the merits of the organizational form adopted, the influence of different cultures upon the form of governance and ethical regulation adopted is significant. (shrink)

This paper explores what kind of uncertainty a research program governing solar climate engineering through Stratospheric Aerosol Injection (SAI) needs to account for. Specifically, it tries to answer two central issues with regards to SAI research and it’s ethical evaluation: One, what irreducible uncertainties remain throughout the decision-process, and, two, how do these remaining uncertainties affect the ethical evaluation of SAI research. The main assumption is that decisions on SAI research governance will be made under (...) normative uncertainty, i.e. situations under irreducible knowledge-constraints that arise in concrete, practical decision-contexts. These decision-contexts are multi-lateral and empirically ambiguous, and the decision-makers need to reconcile a plurality of values. While normative uncertainty complicates the ethical evaluation of policy decisions, I argue that moral considerations can be accommodated through the inclusion of recognitional, participatory justice approaches, as well as adaptive and anticipatory governance methods. (shrink)

More recent advancements in digital technologies have significantly alleviated the dissemination of new scientific ideas as well as the storing, searching and retrieval of large amounts of published research findings. While not denying the benefits of this novel ‘economy of memory,’ this paper endeavors to shed light on the ways in which the use of digital technologies may be linked to a distortion of the system of formal publications that facilitates the effective dissemination and collaborative building of scientific knowledge. (...) Through combining three different strands of discussion that are often left separate – those pertaining to the cognitive effects of new technological memory systems, those pertaining to citation and publishing practices, and those regarding the effects of formalizing modes of research governance – it is also shown that this distortion is not merely a consequence of technological developments alone. Rather, such a distortion is inseparable from and potentially aggravated by the spreading of increasingly dysfunctional, formalizing research governance mechanisms. It is argued that these mechanisms run the risk of fostering the proliferation of knowledge practices that are characterized by an increasing degree of superficiality as well as the strategic publication of research that is of a decreasing degree of originality. If left unaddressed, this may pose a serious threat to the efficiency and effectiveness of the formal record of scientific knowledge as a tool for the dissemination of original research. By extension, this may in the long run seriously undermine the capacity of the publicly funded research system more generally. (shrink)

This essay introduces this special issue on virtue ethics in relation to military AI. It describes the current situation of military AI ethics as following that of AI ethics in general, caught between consequentialism and deontology. Virtue ethics serves as an alternative that can address some of the weaknesses of these dominant forms of ethics. The essay describes how the articles in the issue exemplify the value of virtue-related approaches for these questions, before ending with thoughts for further research.

Snap‐shots of live theatre: the use of photography to research governance in operating room nursingThe use of photography is an underreported method of research in the nursing literature. This paper explores its use in an ethnographic research project, the fieldwork of which was undertaken by the first author. The aim was to examine the governance of operating room nursing in the clinical setting and the theoretical orientation was the work of Michel Foucault. The focus of (...) this paper is on how photography was used as a means of data generation. To establish some context we begin by drawing on writers from sociology and anthropology to provide an overview of the status of vision and visual research methods in contemporary social research. We then move to a brief discussion of the uses of photography in social research and the limitations imposed by ethical considerations of its use in clinical nursing settings. As well, the process and approach involved in this research project, and issues of analysis are discussed. Three ‘snap‐shots’ of operating room nursing, taken by participants, are presented. Each is analysed in terms of its contributions to the research process as well as its substantive contribution to the theoretical framework and the research aims. (shrink)

Background Research ethics is intertwined with and depends on building robust and responsive research governance systems alongside researchers. Globally there has been substantial investment in agriculture, nutrition, and health (ANH) research motivated by the need to improve health outcomes, such as micronutrient deficiencies in Sub-Saharan Africa. Although there has been a notable focus on ethical issues inherent in ANH studies, there has been scanty research examining researchers’ attitudes related to ANH research. This study was (...) conducted to explore the perspectives of researchers who conducted an agronomic biofortification study in Malawi. Methodology In-depth interviews were conducted with a purposive sample of ten ANH researchers. Interviews were conducted online via Zoom, audio-recorded, transcribed verbatim, and thematically analysed using the Leadership, Ethics, Governance and Systems Framework. Results Four core aspects emerged: Leadership: The relevance of building ethics leadership and ethical competence among researchers. Ethics: There is a need to develop a framework that operationalises core ethical values that can guide the implementation of ANH research. Governance: Research guidelines were perceived to be too generic to guide ANH research. Systems: Researchers’ recommended the establishment of a specialised ANH research ethics committee. Conclusions The findings highlight the significance of building ethics leadership and supporting ethical competency amongst researchers. Researchers recommended the development of tailored approaches rather than utilising generic governance systems and frameworks that are drawn from medical research and thus not fit for purpose in this field. In Malawi, specialised ethics review committees are needed to guide ANH research. (shrink)

How could it happen that the very processes intended to assure ethical research in Australia might, themselves, undermine good research practice?This paper describes one PhD candidate’s recent experiences of multicentre review for a Human Research Ethics Committee approved, low/negligible risk, qualitative study, at the crossroad of health services research and organisational research.A retrospective review of international literature about multi-centre review processes revealed that many of these experiences were not unique and might have been expected, notwithstanding (...) Australian efforts at harmonisation of multi-centre review. This paper examines not only the burden of red-tape that was applied to a small doctoral study, but also the way in which the red-tape threatened the anonymity of potential study participants and risked exposing them to undue pressure and distress.These experiences support the view that harmonisation initiatives have not yet developed as the Australian National Health and Medical Research Council may have hoped and that further attention is needed to harmonise research governance processes. (shrink)

Ensuring that research is of high quality and is based on sound ethical principles is not easy; it requires a fine balance between adequate oversight and suitable facilitation. The current state of research ethics governance is an ideal environment to maintain a governance ‘ratchet’ rather than produce a well-organized and carefully thought out ‘dial’.

The research aims to investigate the characteristics and risks associated with the handling of sensitive data in the implementation of public policies within the digital government model. To achieve this, a hypothetical-deductive method and bibliographic and documentary procedures are employed, proposing an interdisciplinary discussion on technological advancement, data protection, transparency, and public policies. The justification revolves around the importance of a comprehensive, cohesive system that genuinely protects sensitive personal data, considering the need to keep pace with technological developments and (...) maintain a minimum level of security in the digital age at both national and international levels. There is no doubt that the judicious and strategic use of data has the potential to drive substantial improvements in policy evaluation, decision-making, and the relationship between government and citizens. However, dealing with personal data also means addressing risks with responsibility, transparency, and respect for individual rights. (shrink)

Does organizational governance contribute to academic quality? Two top research universities are observed in-depth: Berkeley and the MIT. Three key factors are listed that help generate consistent and lasting high performance. Priority is allocated to self-evaluation and to the development of talent. Values and norms such as community membership, commitment to the affectio societatis, mutual respect and trust strongly regulate the behaviors of the faculty. Complex inner organizational processes are at work making integration and differentiation compatible. Each of (...) these factors contributes to produce top academic quality in a synergetic way. (shrink)

Global health research partnerships are increasingly taking the form of consortia of institutions from high-income countries and low- and middle-income countries that undertake programs of research. These partnerships differ from collaborations that carry out single projects in the multiplicity of their goals, scope of their activities, and nature of their management. Although such consortia typically aim to reduce health disparities between and within countries, what is required for them to do so has not been clearly defined. This article (...) takes a conceptual approach to explore how the governance of transnational global health research consortia should be structured to advance health equity. To do so, it applies an account called shared health governance to derive procedural and substantive guidance. A checklist based on this guidance is proposed to assist research consortia determine where their governance practices strongly promote equity and where they may fall short. (shrink)

Biobanks are proliferating rapidly worldwide because they are powerful tools and organisational structures for undertaking medical research. By linking samples to data on the health of individuals, it is anticipated that biobanks will be used to explore the relationship between genes, environment and lifestyle for many diseases, as well as the potential of individually-tailored drug treatments based on genetic predisposition. However, they also raise considerable challenges for existing legal frameworks and research governance structures. This book critically examines (...) the current governance structures in place for biobanks in England and Wales. It shows that the technologies, techniques and practices involved in biobanking do not always conform neatly to existing legal principles and frameworks that apply to other areas of medical research. Using a socio-legal approach, including interview data gathered from the scientific community, this book provides unique insights and makes recommendations about appropriate governance mechanisms for biobanking in the future. It also explores the issues around the secondary use of information, such as consent and how to protect privacy, when biobanks are accessed by a number of different third parties. These issues have relevance both within England and Wales and to a wide international audience, as well as for other areas where large datasets are used.--Back cover. (shrink)

Publication date: 2 May 2019 Source: Author: Rosemary O. Obasi This paper presents a number of research opportunities in corporate governance in Nigeria. Corporate governance has come along with changes in Nigeria regulatory framework for financial reporting and corporate governance code during the recent years. The researcher identified some important areas where research can help advance our knowledge and provide relevant information for policy makers. These research areas include audit firm governance, corporate level (...) of compliance on corporate governance; Public sector code of governance; adoption of Not-for-profit governance code by such organisations in Nigeria. The research questions that were raised are of global interest, but the Nigeria environment provides some distinctive natural experimental settings to address these questions. (shrink)

I argue that the title question needs to be taken seriously because there are important questions about how the scientific agenda should be set. Natural answers to the question – declarations of the proper autonomy of science or expressions of faith in market forces – are found inadequate. Instead, I propose a form of democracy with respect to scientific research that will avoid the obvious dangers of a tyranny of ignorance. I conclude with some modest proposals about how the (...) ideal of a democratic science might be implemented and with a response to common objections. (shrink)

Performance evaluation in research is more and more based on numbers of publications, citations, and impact factors. In the wake of New Public Management output control has been introduced into research governance without taking into account the conditions necessary for this kind of control to work efficiently. It is argued that to evaluate research by output control is counterproductive. It induces to substitute the ‘taste for science’ by a ‘taste for publication’. Instead, input control by careful (...) selection and socialization serves as an alternative. (shrink)

We are living in an algorithmic age where mathematics and computer science are coming together in powerful new ways to influence, shape and guide our behaviour and the governance of our societies. As these algorithmic governance structures proliferate, it is vital that we ensure their effectiveness and legitimacy. That is, we need to ensure that they are an effective means for achieving a legitimate policy goal that are also procedurally fair, open and unbiased. But how can we ensure (...) that algorithmic governance structures are both? This article shares the results of a collective intelligence workshop that addressed exactly this question. The workshop brought together a multidisciplinary group of scholars to consider barriers to legitimate and effective algorithmic governance and the research methods needed to address the nature and impact of specific barriers. An interactive management workshop technique was used to harness the collective intelligence of this multidisciplinary group. This method enabled participants to produce a framework and research agenda for those who are concerned about algorithmic governance. We outline this research agenda below, providing a detailed map of key research themes, questions and methods that our workshop felt ought to be pursued. This builds upon existing work on research agendas for critical algorithm studies in a unique way through the method of collective intelligence. (shrink)

Behavioral research suggests that rule-governed behavior should be less sensitive to environmental changes and thus more resistant to extinction (disconfirmation) than contingency-governed behavior. The opposite is implied in Davey's discussion of ontogenetic and phylogenetic contributions to fear development. The generality of the behavioral findings and their apparent inconsistency with the present article should be further explored with more sensitive research paradigms.

This paper offers a conceptually novel contribution to the understanding of the distinctive governance challenges arising from the increasing reliance on formalized knowledge in the governance of research activities. It uses the current Australian research governance system as an example – a system which exhibits a comparatively strong degree of formalization as to its knowledge mechanisms. Combining theoretical reflections on the political-administrative and epistemic dimensions of processes of formalization with analyses of interview data gathered at (...) Australian universities, it is suggested that such a strong reliance on formalized knowledge has rather ambivalent governance ramifications. On the one hand, it allows for a seemingly rational and efficient form of the control and coordination of research activities. Yet on the other hand, it also increases the risk that knowledge is used in governance contexts in superficial, unconsidered and ultimately unreasonable ways. It is further suggested that there are a range of indications that precisely such use elicits and reinforces a range of dysfunctional behaviors on part of relevant individual and organizational actors in the public science system. (shrink)

Genomic and biobank research has undergone exponential growth in Africa. Traditionally this resulted in exploitative research practices in the form of so-called ‘parachute research’ with little or no consideration for capacity building. However there has been a recent growth of research and consortia where capacity building and equitable research have been a key objective of the research, and attention is now focused on the governance of this research. The importance of solidarity in (...) genomic biobank research in high income countries is well established and such an ethos reflects the communal based worldviews prevalent in many African communities. However, if the governance of the research is to foster equitable research practices, there must be some reciprocal benefit. This chapter will explore the impact that reciprocity will have on solidarity and how this may manifest in a governance framework in Africa. Particular focus will be given to capacity building and benefit sharing to enable the research to develop for the benefit of the local population, in a manner that promotes trust and fairness. This chapter will conclude with some recommendations on how to ensure reciprocity is enshrined in a governance framework for genomic biobank research in Africa. (shrink)

Despite ample research on corporate governance (CG) and corporate social responsibility (CSR), there is a lack of consensus on the nature of the relationship between these two concepts and on how this relationship manifests across institutional contexts. Drawing on the national business systems approach, this article systematically reviews 218 research articles published over a 27-year period to map how CG–CSR research has evolved and progressed theoretically and methodologically across different institutional contexts. To shed light on the (...) full gamut of the CG–CSR relationship, we categorize and explore the nature of this relationship along two strands: (a) CSR as a function of CG and (b) CG as a function of CSR. Through this review, we identify key themes where CG–CSR research has lagged and account for under-explored contexts in this domain. Finally, we put forth a comprehensive agenda for progressing future research in the field. (shrink)

Many are calling for concrete mechanisms of oversight for health research involving artificial intelligence (AI). In response, institutional review boards (IRBs) are being turned to as a familiar model of governance. Here, we examine the IRB model as a form of ethics oversight for health research that uses AI. We consider the model's origins, analyze the challenges IRBs are facing in the contexts of both industry and academia, and offer concrete recommendations for how these committees might be (...) adapted in order to provide an effective mechanism of oversight for health‐related AI research. (shrink)

Given the increasing importance attached to both corporate social responsibility (CSR) and corporate governance, this study investigates the association between these two complimentary mechanisms used by companies to enhance relations with stakeholders. Consistent with both legitimacy and stakeholder theory and controlling for industry profile, firm size, stockholder power/dispersion, creditor power/leverage, and economic performance, our analysis of the annual reports for a sample of 222 listed companies suggests that firms providing more CSR information: have better corporate governance ratings; are (...) larger; belong to higher profile industries; and are more highly leveraged. Our findings support the limited prior research suggesting a link between corporate governance quality and CSR disclosure in company annual reports and suggest that, rather than mandating specific disclosures, regulators might be better served focussing on corporate governance quality as a way of increasing CSR disclosures. (shrink)

Although governance and stakeholder practices have been widely researched in both the private and public sectors, governance still remains a fuzzy concept when it comes to corporate foundations (CFs). The latter target social creation, fulfilling societal needs and expectations. Using a multiple case study design in respect of 16 French CFs, this qualitative research contributes to the theoretical discussion around stakeholder engagement, examining how governance processes are implemented. Our results point out that involving the foundation's stakeholders (...) is a roundabout way to engage in dialogue with and involve the company's stakeholders. New relationships and value propositions are then developed that have nothing to do with the company's core competencies. This study makes a major contribution to the CF' governance field by highlighting an imbalance between the impact of internal and external stakeholders, with an overinvestment of internal staff (employees and managers). The governance mechanisms are based on a three-stage process (project submission, selection phase and final approval), in which external stakeholder involvement is limited. Finally, the analysis identifies that upward accountability practices are put in place (mainly toward the company), while horizontal accountability is respected but not publicly disclosed. (shrink)

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges (...) and explore how public involvement can meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance. (shrink)

In the past decade, there has been an increase in genomic research and biobanking activities in Africa. Research initiatives such as the Human Heredity and Health in Africa Consortium are contributing to the development of scientific capacity and infrastructure to support these studies on the continent. Despite this growth, genomic research and biobanking have raised important ethical challenges for key research stakeholders, including members of research ethics committees. One of these is the limited ethical and (...) regulatory frameworks to guide the review and conduct of genomic studies, particularly in Africa. This paper is a reflection on a series of consultative activities with research ethics committees in Africa which informed the development of an ethics and governance framework for best practices in genomic research and biobanking in Africa. The paper highlights the engagement process and the lessoned learned. (shrink)

This study aims to provide an overview of RECs (research ethics committees) in Chinese universities, encompassing both medical and non-medical studies. The primary objective is to identify major challenges faced by RECs in Chinese universities and draw meaningful implications from the findings. The investigation focuses on 42 comprehensive Chinese universities, and the results reveal that while all universities have implemented RECs in various forms, only 28.6% explicitly stipulate ethical review requirements for non-medical disciplines. Furthermore, RECs in Chinese universities encounter (...) various challenges, including insufficient attention to research ethics review, inadequate ethics review systems and regulations, a lack of education and training, and lacking ethics review for non-medical research. This paper proposes recommendations for establishing robust RECs in Chinese universities, seeking to enhance ethical governance in research. By addressing the challenges identified, these recommendations aim to strengthen ethical oversight, foster a culture of responsible research, and uphold the highest ethical standards across diverse academic disciplines. (shrink)

This article considers the process of ethical review of research on human subjects at a very large multinational consumer products company. The commercial context of this research throws up unique challenges and opportunities that make the ethics of the process of oversight distinct from mainstream medical research. Reflection on the justification of governance processes sheds important, contrasting light on the ethics of governance of other forms and context of research.

Although guidelines to regulate user involvement in research have been advocated and implemented for several years, literature still describes the process as challenging. In this qualitative study, we take a critical view on guidelines that are developed to regulate and govern the collaboration process of user involvement in research. We adapt a social constructivist view of guidelines and our aim is to explore how guidelines construct the perception of users and researchers and thus the process of involvement. Twenty‐two (...) guidelines published between 2006 and 2019 were analyzed iteratively. The analysis focuses on values which are emphasized in the guidelines on the distribution of entities, knowledge, and tasks between users and researchers. The analysis indicates that users and researchers are constructed differently; researchers are mainly constructed as responsible initiators and caretakers, while users are constructed as powerless and vulnerable. The guidelines portray the collaboration process as harmonious and assume a normative perspective. In doing so, challenges described in the literature related to power imbalances are not addressed. Based on these findings, we ask if these guidelines might function to maintain existing power imbalances between users and researchers. (shrink)

Recent scandals allegedly linked to CEO compensation have brought executive compensation and perquisites to the forefront of debate about constraining executive compensation and reforming the associated corporate governance structure. We briefly describe the structure of executive compensation, and the agency theory framework that has commonly been used to conceptualize executives acting on behalf of shareholders. We detail some criticisms of executive compensation and associated ethical issues, and then discuss what previous research suggests are likely intended and unintended consequences (...) of some widely proposed executive compensation reforms. We explicitly discuss the following recommendations for reform: require greater independence of compensation committees, require executives to hold equity in the corporation, require greater disclosure of executive compensation, increase institutional investor involvement in corporate governance (including executive compensation), and require firms to expense stock options on their income statements. We provide a brief summary discussion of ethical issues related to executive compensation, and describe possible future research. (shrink)

The Toronto experience suggests that there may be several general lessons for academic health sciences complexes to learn from the Olivieri/Apotex affair regarding the ethics, independence, and integrity of clinical research sponsored by for profit enterprises. From a local perspective, the OAA occurred when there already was a focus on the complex and changing relationships among the University of Toronto, its medical school, the fully affiliated teaching hospitals, and off campus faculty because of intertwined interests and responsibilities. The OAA (...) became a catalyst that accelerated various systemic reforms, particularly concerning academic/industry relations. In this article, the evolving governance framework for the Toronto academic health sciences complex is reviewed and these policy and process reforms discussed. These reforms have created collaborative activity among research ethics boards and contract research offices of the partner institutions, and allowed the joint university/hospital ethics centre to play a role in governance and policy, while respecting the missions and mandates of the involved institutions. Although few of the policies are dramatically innovative, what is arguably novel is the elaboration of an overarching governance framework that aims to move ethics to a central focus in the academic complex. Time alone will tell how sustainable and effective these changes are. (shrink)

Responsible Research and Innovation (‘RRI’) is a cross-cutting priority for scientific research in the European Union and beyond. This paper considers whether the way such research is organised and delivered lends itself to the aims of RRI. We focus particularly on international consortia, which have emerged as a common model to organise large-scale, multi-disciplinary research in contemporary biomedical science. Typically, these consortia operate through fixed-term contracts, and employ governance frameworks consisting of reasonably standard, modular components (...) such as management committees, advisory boards, and data access committees, to co-ordinate the activities of partner institutions and align them with funding agency priorities. These have advantages for organisation and management of the research, but can actively inhibit researchers seeking to implement RRI activities. Conventional consortia governance structures pose specific problems for meaningful public and participant involvement, data sharing, transparency, and ‘legacy’ planning to deal with societal commitments that persist beyond the duration of the original project. In particular, the ‘upstream’ negotiation of contractual terms between funders and the institutions employing researchers can undermine the ability for those researchers to subsequently make decisions about data, or participant remuneration, or indeed what happens to consortia outputs after the project is finished, and can inhibit attempts to make project activities and goals responsive to input from ongoing dialogue with various stakeholders. Having explored these challenges, we make some recommendations for alternative consortia governance structures to better support RRI in future. (shrink)