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)

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)

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)

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 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, 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)

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)

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)

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)

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)

Snap‐shots of live theatre: the use of photography to research governance in operating room nursing The 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)

The research analyzes the process of formation of the ethics committee as a new institution in the system of regulation of genetic research. The external factors of this process are the increasing digitalization of medical and research practices, as well as the special situation that is developing in the field of genomic research and the use of genetic technologies, where issues of philosophy, jurisprudence and administration have generated many fundamentally new, and sometimes unexpected contexts. The author (...) shows the similarity and difference of approaches to the inclusion of the ethics committee in the national regulatory systems of different countries and determines the prospects for further integration of the new institution into normative and administrative-regulatory and law enforcement practices. The research applies all the main methods of system analysis and structural and functional analysis, as well as the comparative legal method. At the stage of generalization of empirical material, the author turns to the means and methods of philosophical phenomenology and phenomenological sociology. The study revealed that the ethics committee may have different institutional and regulatory functions in a variety of management and legal systems. Being hybrid in nature, the ethics committee performs various functions, and in various state legal systems and traditions it can combine elements of legislative, executive and judicial power. At times, the ethics committee may go beyond the scope of both a purely administrative and exclusively legal regulator. All this indicates that the integration of this institution into the legal system and into a variety of social practices is far from being completed. (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)

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)

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)

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)

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’.

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)

Continuing rapid developments in the life sciences offer the promise of providing tools to meet global challenges in health, agriculture, the environment, and economic development; some of the benefits are already being realized. However, such advances also bring with them new social, ethical, legal, and security challenges. Governance questions form an increasingly important part of the discussions about these advances--whether the particular issue under debate is the development of ethical principles for human genome editing, how to establish regulatory systems (...) for the safe conduct of field trials of gene drive-modified organisms, or many others. However there are continuing concerns that the knowledge, tools, and techniques resulting from life sciences research could also enable the development of bioweapons or facilitate bioterrorism. Between June 10 and 13, 2018, more than 70 participants from 30 different countries and 5 international organizations took part in an international workshop, The Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight, in Zagreb, Croatia. Hosted by the Croatian Academy of Sciences and Arts, the workshop was a collaboration among the InterAcademy Partnership, the Croatian Academy, the Croatian Society for Biosafety and Biosecurity, and the U.S. National Academies of Sciences, Engineering, and Medicine. This publication summarizes the presentations and discussions from the workshop."--Publisher's description. (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)

Since the 1980s, two different paradigms have reshaped industrial societies: the Neoliberal paradigm and a Research and Innovation paradigm. Both have been conceptualized and translated into strong policies with massive economic and social consequences. They provide divergent responses to the environmental transition. The Neoliberal paradigm is based on economic models and geopolitical solutions. The Research and Innovation paradigm's goal is to manage knowledge differently in order to reorient the evolution of society. Since the mid-1990s, a version of the (...) Research and Innovation paradigm has led to the design of large-scale research and innovation policies. This book examines how these policies have evolved and how they can be extended and reformed to respond to present and future environmental constraints. It studies the transformation of the conception, organization and role of science and technology in the evolution of industrial societies and explores the future of these developments. The book offers three unique lines of enquiry. The first is to focus not specifically on economics, sociology, political science or history, but on knowledge creation from an institutional and reflexive point of view. The second is to establish a convergence between the British school of science and technology studies and the research trends opened by the work of Michel Foucault. Both introduced trans-disciplinary and policy-oriented research associating case studies, long-term perspectives and theory. The third is to consider climate change as the overwhelming challenge of our time. The book is an insightful guide for students, scholars and researchers across the humanities and social sciences, including philosophy, political science, law, economics, business and media. (shrink)

What is 'legal' about bioethics? What are the ideas and artefacts that bioethics encompasses, and how are they related to law? What is the role of law in bioethics? In this work, Calvin Ho attempts to address these questions in the context of the governance of human pluripotent stem cell research. In essence, he argues that the hybridization of law, through processes, devices and techniques of juridification, has helped to constitute bioethics as a public sphere and an emergent (...) civic epistemology. Drawing on his multi-sited ethnographic fieldwork and on Actor-Network-Theory, Ho explains how the law has, through bioethics, contributed to the scientific and public understanding of human pluripotent stem cell research and its artefacts, particularly the embryo and human-animal combinations. Although the focus of his work is on bioethical developments in Singapore over a period of more than 15 years, parallel developments in key jurisdictions (especially the United States of America and the United Kingdom) and in international science policy are also evaluated. It is through appreciating how it has progressed that bioethics will be better able to engage with future challenges presented by advances in human embryo research and gene editing techniques, among others. (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)

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)

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)

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)

The Médecins Sans Frontières ethics review board has been solicited in an unprecedented way to provide advice and review research protocols in an ‘emergency’ mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, ranging from epidemiological research, to behavioural research, infectivity studies and clinical trials with investigational products at early development stages. This article examines the MSF ERB’s experience addressing issues related to both the process of review and (...) substantive ethical issues in this context. These topics include lack of policies regarding blood sample collection and use, and engaging communities regarding their storage and future use; exclusion of pregnant women from clinical and vaccine trials; and the difficulty of implementing timely and high-quality qualitative/anthropological research to consider potential upfront harms. Having noticed different standards across ethics committees, we propose that when multiple ethics reviews of clinical and vaccine trials are carried out during a public health emergency they should be accompanied by transparent communication between the ECs involved. The MSF ERB experience should trigger a broader discussion on the ‘optimal’ ethics review in an emergency outbreak and what enduring structural changes are needed to improve the ethics review process. (shrink)

This paper elucidates and rationalizes the ethical governance system for healthcare AI research, as outlined in the ‘Research Ethics Guidelines for AI Researchers in Healthcare’ published by the South Korean government in August 2023. In developing the guidelines, a four-phase clinical trial process was expanded to six stages for healthcare AI research: preliminary ethics review (stage 1); creating datasets (stage 2); model development (stage 3); training, validation, and evaluation (stage 4); application (stage 5); and post-deployment monitoring (...) (stage 6). Researchers identified similarities between clinical trials and healthcare AI research, particularly in research subjects, management and regulations, and application of research results. In the step-by-step articulation of ethical requirements, this similarity benefits from a reliable and flexible use of existing research ethics governance resources, research management, and regulatory functions. In contrast to clinical trials, this procedural approach to healthcare AI research governance effectively highlights the distinct characteristics of healthcare AI research in research and development process, evaluation of results, and modifiability of findings. The model exhibits limitations, primarily in its reliance on self-regulation and lack of clear delineation of responsibilities. While formulated through multidisciplinary deliberations, its application in the research field remains untested. To overcome the limitations, the researchers’ ongoing efforts for educating AI researchers and public and the revision of the guidelines are expected to contribute to establish an ethical research governance framework for healthcare AI research in the South Korean context in the future. (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)

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)

Human body material removed post mortem is a particularly valuable resource for research. Considering the efforts that are currently being made to study the biochemical processes and possible genetic causes that underlie cancer and cardiovascular and neurodegenerative diseases, it is likely that this type of research will continue to gain in importance. However, post mortem procurement of human body material for research raises specific ethical concerns, more in particular with regard to the consent of the research (...) participant. In this paper, we attempt to determine which consent regime should govern the post mortem procurement of body material for research. In order to do so, we assess the various arguments that could be put forward in support of a duty to make body material available for research purposes after death. We argue that this duty does in practice not support conscription but is sufficiently strong to defend a policy of presumed rather than explicit consent. (shrink)

Biobanking, the large-scale, systematic collection of data and tissue for open-ended research purposes, is on the rise, particularly in clinical research. The infrastructures for the systematic procurement, management and eventual use of human tissue and data are positioned between healthcare and research. However, the positioning of biobanking infrastructures and transfer of tissue and data between research and care is not an innocuous go-between. Instead, it involves changes in both domains and raises issues about how distinctions between (...) research and care are drawn and policed. Based on an analysis of the emergence and development of clinical biobanking in the Netherlands, this article explores how processes of bio-objectification associated with biobanking arise, redefining the ways in which distinctions between research and clinical care are governed. (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)

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)

The European Union Data Protection Regulation will have profound implications for public health, health services research and statistics in Europe. The EU Commission's Proposal was a breakthrough in balancing privacy rights and rights to health and healthcare. The European Parliament, however, has proposed extensive amendments. This paper reviews the amendments proposed by the European Parliament Committee on Civil Liberties, Justice and Home Affairs and their implications for health research and statistics. The amendments eliminate most innovations brought by the (...) Proposal. Notably, derogation to the general prohibition of processing sensitive data shall be allowed for public interests such as the management of healthcare services, but not health research, monitoring, surveillance and governance. The processing of personal health data for historical, statistical or scientific purposes shall be allowed only with the consent of the data subject or if the processing serves an exceptionally high public interest, cannot be performed otherwise and is legally authorised. Research, be it academic, government, corporate or market research, falls under the same rule. The proposed amendments will make difficult or render impossible research and statistics involving the linkage and analysis of the wealth of data from clinical, administrative, insurance and survey sources, which have contributed to improving health outcomes and health systems performance and governance; and may illegitimise efforts that have been made in some European countries to enable privacy-respectful data use for research and statistical purposes. If the amendments stand as written, the right to privacy is likely to override the right to health and healthcare in Europe. (shrink)

Although much has been written globally about the key issues of corporate governance in REITs, there are not enough studies inspired by the systematic literature review method. This study reviews the literature on corporate governance in real estate investment trusts (REITs) published after 2004 and addresses three interrelated research questions. We examined 77 peer-reviewed journal articles using a systematic literature review approach. We found that there has been a rise in studies since 2010, with a brief decrease (...) in 2015 and 2017 before increasing again in 2016. Moreover, the vast majority of the studies were published in the areas of economics/econometrics/finance and business/management/accounting. In addition, most of the papers are single-country studies, and the minority are multi-country. The majority of the papers are focused on the USA and Asia. Similarly, the majority of these analyses concentrate on developed countries and ignore emerging and frontier markets.Keywordscorporate governance, real estate investment trusts, REITs, systematic literature review, SLR. (shrink)

BackgroundResearch has been an essential part of the COVID-19 pandemic response, including in Latin American (LA) countries. However, implementing research in emergency settings poses the challenge of producing valuable knowledge rapidly while upholding research ethical standards. Research ethics committees (RECs) therefore must conduct timely and rigorous ethics reviews and oversight of COVID-19 research. In the LA region, there is limited knowledge on how countries have responded to this need. To address this gap, the objective of our (...) project is to explore if LA countries developed policies to streamline ethics review and oversight of research in response to the pandemic while ensuring its adherence to ethical standards, and to analyze to what extent these governance frameworks are in accordance with international guidance.MethodsWe conducted a descriptive and exploratory study assessing the COVID-19 research ethics governance frameworks of 19 LA countries, considering 4 dimensions based on international COVID-19 ethics guidance documents: (i) ethics review organizational model adopted, (ii) measures to coordinate between RECs and other research stakeholders, (iii) operational guidance for RECs, and (iv) key ethical issues for review and oversight of COVID-19 research.Results10 out of 19 LA countries have some policy to streamline ethics review of COVID-19 research. Of these countries only 6 issued comprehensive documents following international guidance that contemplate strategies with recommendations for concrete actions for a timely and rigorous review.ConclusionLA countries adopted partial strategies and operational guidance that may demonstrate a lack of a comprehensive view of research ethics for the review and oversight of COVID-19 research. Continuing efforts should be directed to strengthen LA countries' research capacity to respond timely and ethically to future health emergencies. Past lessons and the ones from this pandemic should be the basis to develop international standards and operational guidelines for ethics review and oversight of any research for public health emergencies. (shrink)

In twentieth century Europe and the USA, industrial relations, labour, and workers' rights issues have been handled through collective bargaining and industrial agreements between firms and unions, with varying degrees of government intervention from country to country. This industrial relations landscape is currently undergoing fundamental change with the emergence of transnational industrial relations systems that complement existing national industrial relations systems. Despite the significance of this ongoing change, existing research has only started to explore the implications of this change (...) for how workers' rights are governed around the globe. This paper addresses this gap by outlining an agenda for future research into the transnational governance of workers' rights. Fulfilling such a research agenda would be both challenging, as it requires combining the so far divergent industrial relations and business ethics research streams, and rewarding, as it provides ample scope for promising future research. (shrink)

This paper examines the UK’s response to a recent European Clinical Trials Directive, namely the Department of Health, Central Office for Research Ethics Committee guidance, Governance Arrangements for NHS Research Ethics Committees. The revisions have been long awaited by researchers and research ethics committee members alike. They substantially reform the ethical review system in the UK. We examine the new arrangements and argue that though they go a long way toward addressing the uncertainty surrounding ethics committee (...) function, the system favours the facilitation of research over the protection of the dignity and welfare of research participants. (shrink)