BackgroundCase consultation performed by clinical ethics committees (CECs) is a complex activity which should be evaluated. Several evaluation studies have reported stakeholder satisfaction in single institutions. The present study was conducted nationwide and compares clinicians’ evaluations on a range of aspects with the CEC’s own evaluation.MethodsProspective questionnaire study involving case consultations at 19 Norwegian CECs for 1 year, where consultations were evaluated by CECs and clinicians who had participated.ResultsEvaluations of 64 case consultations were received. Cases were complex with multiple (...) ethical problems intertwined. Clinicians rated the average CEC consult highly, being both satisfied with the process and perceiving it to be useful across a number of aspects. CEC evaluations corresponded well with those of clinicians in a large majority of cases. Having next of kin/patients present was experienced as predominantly positive, though practised by only half of the CECs. The educational function of the consult was evaluated more positively when the CEC used a systematic deliberation method.ConclusionsCEC case consultation was found to be a useful service. The study is also a favourable evaluation of the Norwegian CEC system, implying that it is feasible to implement well-functioning CECs on a large scale. There are good reasons to involve the stakeholders in the consultations as a main rule. (shrink)

Reflecting on a three year long exploratory research of ethics committees in the Czech Republic authors discuss the current role and identity of research ethics committees. The research of Czech ethics committees focused on both self-presentation and self-understanding of ECs members, and how other stakeholders (representatives of the pharmaceutical industry) view them. The exploratory research was based on formal and informal communication with the members of the ethics committees. Members of the research team took part at six regular voluntary meetings (...) of the ethics committees' members, organised by the Forum of Czech Ethics Committees, and at three summer schools of medical ethics. There were realised twenty-five semi-structured interviews as well as six focus group sessions and a participant observation of several regular meetings of three ethics committees. On the grounds of experience from the interviews a simple questionnaire survey was realised among the members of the ethics committees. The ethics committees comprise a community of members working voluntarily, without claims to remuneration or prestige; the unifying goal is protection of subjects of research. The principal working methods are dialogue and agreement. The members of the ethics committees thus, among other things, create an informal community, which can be to a certain extent seen as a Kantian ethical community in a weak sense. The phenomenon of ethics committees can also be described by terms of an epistemic community and a community of practice. These concepts, which are borrowed from other authors and areas, are used as a way how to think of ECs role and identity a bit differently and are meant as a contribution to the current international debate on the topic. (shrink)

BackgroundHuman infection studies (HIS) are valuable in vaccine development. Deliberate infection, however, creates challenging questions, particularly in low and middle-income countries (LMICs) where HIS are new and ethical challenges may be heightened. Consultation with stakeholders is needed to support contextually appropriate and acceptable study design. We examined stakeholder perceptions about the acceptability and ethics of HIS in Malawi, to inform decisions about planned pneumococcal challenge research and wider understanding of HIS ethics in LMICs.MethodsWe conducted 6 deliberative focus groups and (...) 15 follow-up interviews with research staff, medical students, and community representatives from rural and urban Blantyre. We also conducted 5 key informant interviews with clinicians, ethics committee members, and district health government officials.ResultsStakeholders perceived HIS research to have potential population health benefits, but they also had concerns, particularly related to the safety of volunteers and negative community reactions. Acceptability depended on a range of conditions related to procedures for voluntary and informed consent, inclusion criteria, medical care or support, compensation, regulation, and robust community engagement. These conditions largely mirror those in existing guidelines for HIS and biomedical research in LMICs. Stakeholder perceptions pointed to potential tensions, for example, balancing equity, safety, and relevance in inclusion criteria.ConclusionsOur findings suggest HIS research could be acceptable in Malawi, provided certain conditions are in place. Ongoing assessment of participant experiences and stakeholder perceptions will be required to strengthen HIS research during development and roll-out. (shrink)

BackgroundBiobanking provides exciting opportunities for research on stored biospecimens. However, these opportunities to advance medical science are fraught with challenges including ethical and legal dilemmas. This study was undertaken to establish perspectives of South African stakeholders on the ethico-legal dimensions of biobanking.MethodsAn in-depth exploratory study was conducted with 25 purposively selected biobankers, clinicians, researchers, postgraduate students in biobanking research, and research ethics committee (REC) members in South Africa. Potential study participants were recruited through known hubs for biobanking in the (...) country, online searches and the snowball sampling technique. A semi-structured face-to-face or Skype interview was arranged. Data was analysed using thematic analysis.ResultsThe emergent themes included: inconsistency in understanding consent models, disconnect between biobank researchers and biosample donors, inadequate processes to support re-consenting minors, inconsistent governance processes for biobanking research; challenges with sample and data sharing, and suboptimal strategies for benefit sharing and return of results. Biobanking practice in general appeared to be inconsistent and fragmented. While the need for consent in research is explicitly outlined in legislative documents, some respondents were unclear on the type of consent model to apply in biosample collection. They also reported inconsistencies in research participants’ understanding of consent. Furthermore, these respondents’ own understanding of consent and consent models were dependent on where they were positioned in biobanking practice (roles occupied). Respondents were unsure about the process to follow to re-consent child participants once the age of majority (≥ 18 years) was reached. It was not surprising that consent was identified as one of the major ethical challenges in biobanking practice. In certain settings, some respondents reported suboptimal governance processes for sample collection. Participants were generally unsure about how to operationalise benefit sharing and how to approach the idea of returning results to research participants and biobank donors.ConclusionThe study findings indicated inconsistencies in stakeholder understanding of ethico-legal considerations related to biobanking in South Africa. A need for ongoing ethics capacity development among stakeholders was identified. Improving understanding of the ethics of biobanking could be facilitated by acknowledging the disconnect created by biosamples in the relationship between biobank researchers and donors. (shrink)

This research focuses on how research ethics committee and integrity board members discuss and decide on solutions to case scenarios that involve a dimension of research ethics or integrity in collaborative settings. The cases involved issues around authorship, conflict of interest, disregard of good scientific practice and ethics review, and research with vulnerable populations (children and neonates). The cases were set in a university, a hospital, or a research institute. In the research, we used a deductive qualitative approach with (...) thematic analysis. Twenty-seven research ethics committee and research integrity board members from 16 European countries and one country outside Europe participated. Participants represented natural and life sciences, social sciences, and humanities. They worked on cases involving ethical/integrity issues in six different constellations. Results show that experts apply key elements of ethical decision making, namely identification of ethical issues, stakeholders, guidelines, solutions, and own positionality, in dealing collaboratively with ethics/ integrity problems, and the nature of the application depends on the complexity of the case. Understanding how individuals knowledgeable in research ethics and integrity, in this case, individuals serving on research ethics committees and integrity boards, approach ethical/ moral issues can help to identify strategies that may be useful in the development of research ethics and integrity training for junior researchers who may benefit from learning professional strategies. (shrink)

BackgroundThe concept of benefit sharing to enhance the social value of global health research in resource poor settings is now a key strategy for addressing moral issues of relevance to individuals, communities and host countries in resource poor settings when they participate in international collaborative health research.The influence of benefit sharing framework on the conduct of collaborative health research is for instance evidenced by the number of publications and research ethics guidelines that require prior engagement between stakeholders to determine the (...) social value of research to the host communities. While such efforts as the production of international guidance on how to promote the social value of research through such strategies as benefit sharing have been made, the extent to which these ideas and guidelines have been absorbed by those engaged in global health research especially in resource poor settings remains unclear. We examine this awareness among stakeholders involved in health related research in Kenya.MethodsWe conducted in-depth interviews with key informants drawn from within the broader health research system in Kenya including researchers from the mainstream health research institutions, networks and universities, teaching hospitals, policy makers, institutional review boards, civil society organisations and community representative groups.ResultsOur study suggests that although people have a sense of justice and the moral aspects of research, this was not articulated in terms used in the literature and the guidelines on the ethics of global health research.ConclusionThis study demonstrates that while in theory several efforts can be made to address the moral issues of concern to research participants and their communities in resource poor settings, quick fixes such as benefit sharing are not going to be straightforward. We suggest a need to pay closer attention to the processes through which ethical principles are enacted in practice and distil lessons on how best to involve individuals and communities in promoting ethical conduct of global health research in resource poor settings. (shrink)

In this paper, we investigate the link between audit committees and earnings management providing a more comprehensive simultaneous analysis of the influence of audit committee features using a sample of 485 firm-years from Singapore's publicly traded firms during the 2000 2001 calendar period. Empirical findings indicate firms with a higher proportion of independent audit committee members are more effective at constraining earnings management. Firms with audit committees that are more diligent and/or lack the presence of independent directors serving (...) simultaneously on a substantial number of boards and committees are more effective at constraining earnings management. These findings are robust to alternative income-incentives facing corporate management. Overall, our findings have implications for stakeholders, regulators, and corporate governance. For example, our findings infer policymakers may need to focus on other audit committee characteristics to strengthen the committee's ability to constrain earnings management rather than continue the present fixation with independence. (shrink)

Randomized controlled trial trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions, whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially (...) in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by the onset of learning healthcare systems, as well as an increasing focus on patient-oriented research. However, pragmatic trials have ethical challenges that have not yet been identified or adequately characterized. The present study aims to explore the views of key stakeholders with respect to ethical issues raised by the design and conduct of pragmatic trials. It is embedded within a large, four-year project that seeks to develop guidance for the ethical design and conduct of pragmatic trials. As a first step, this study will address important gaps in the current empirical literature with respect to identifying a comprehensive range of ethical issues arising from the design and conduct of pragmatic trials. By opening up a broad range of topics for consideration within our parallel ethical analysis, we will extend the current debate, which has largely emphasized issues of consent, to the range of ethical considerations that may flow from specific design choices. Semi-structured interviews with key stakeholders, across multiple jurisdictions, identified based on their known experience and/or expertise with pragmatic trials. We expect that the study outputs will be of interest to a wide range of knowledge users including trialists, ethicists, research ethics committees, journal editors, regulators, healthcare policymakers, research funders and patient groups. All publications will adhere to the Tri-Agency Open Access Policy on Publications. (shrink)

The purpose of this article is to examine stakeholder identification and prioritization by managers using the power, legitimacy, and urgency framework of Mitchell et al. (Academy of Management Review 22, 853–886; 1997). We use a multi-method, comparative case study of two large-scale sporting event organizing committees, with a particular focus on interviews with managers at three hierarchical levels. We support the positive relationship between number of stakeholder attributes and perceived stakeholder salience. Managers’ hierarchical level and role have (...) direct and moderating effects on stakeholder identification and perceived salience. We also found that most stakeholders were definitive, dominant, or dormant types – the other five types were rare. Power has the most important effect on salience, followed by urgency and legitimacy. Based on our case study, we offer several ways to advance the theory of stakeholder identification and salience. (shrink)

Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees (RECs). Yet these seem to be lagging behind as a result of the enormous challenges facing these countries, including poor resource availability and lack of capacity. There is thus an urgent (...) need for ongoing capacity and resource development in these regions in general, and in Africa in particular. Similarly, there is a need for research and initiatives that can identify existing capacity and funding and indicate the areas where this needs to be developed.This discussion paper argues that the Mapping African Research Ethics Capacity (MARC) project is a timely initiative aimed at identifying existing capacity. MARC provides a platform and tool on the Council on Health Research for Development's (COHRED) Health Research website (HRWeb), which can be used by RECs and key stakeholders in health research in Africa to identify capacity, constraints and development needs. MARC intends to provide the first comprehensive interactive database of RECs in Africa, which will allow for the identification of key relationships and analyses of capacity. The potential of MARC lies in the mapping of current ethical review activity onto capacity needs. This paper serves as a starting point by providing a descriptive illustration of the current state of RECs in Africa. (shrink)

We present an empirical investigation on how multiple stakeholders can influence and contribute to a standard development process. Based on the analysis of comments submitted by stakeholders developing ISO 26000 standard for social responsibility, we found no significant differences between the ratio of accepted and non-accepted comments among various stakeholder groups; however, we conclude that industry is the most influential stakeholder due to the volume of the comments. We also present a set of processes that stakeholders follow to (...) influence and contribute to standards development, namely to (1) eliminate issues that are controversial and undesirable; (2) link and integrate the standard into a network of other documents and ISO standards; (3) seek consensus by highlighting areas for further dialogue or by addressing their exclusion from the standards development, (4) reinforce issues that are important; and (5) improve the content of the new standard. In conclusion, we provide a set of propositions about multi-stakeholder standards development and compare multi-stakeholder involvement in standards developed through a new committee established in existing standards setting organization [i.e., Committees within the International Organization for Standardization (ISO)] and through new standards setting organizations established for one specific task (i.e., Forest Stewardship Council). We envisage that our study will be a useful platform to monitor and evaluate future developments of ISO 26000 and other multi-stakeholder standards. (shrink)

Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees. The urgent need for continued capacity development in Africa has necessitated research initiatives to identify existing capacity. This discussion paper describes the mapping of RECs in Africa through MARC project, second (...) phase and discusses the findings. MARC provides a platform and tool on COHRED's Health Research HRWeb, which can be used by RECs and key stakeholders in health research in Africa to identify capacity, constraints and development needs. (shrink)

This study examines the impact of the Chief Executive Officer ’s interlocking, created through serving on other companies’ audit committees and/or boards, on corporate social responsibility performance of the focal company and that of its linked companies. We find that CEO interlocking positively affects CSR performance of both the focal company and its linked companies. Further analysis shows that interlocks created by the CEO enhance CSR performance and in turn the financial performance of both the focal company and its linked (...) companies. Our findings are robust to a battery of analyses, including Heckman’s selection bias correction, propensity score matching, alternative measures of CSR performance, and CEO interlocks. These findings are important to regulators, company management teams, and other stakeholders with an interest in how the social ties of CEOs influence companies’ CSR performance and in the CSR–financial performance nexus. (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)

Background: Ought nursing homes to establish clinical ethics committees? An answer to this question must begin with an understanding of how a clinical ethics committee might be beneficial in a nursing home context – to patients, next of kin, professionals, managers, and the institution. With the present article, we aim to contribute to such an understanding. Aim: We ask, in which ways can clinical ethics committees be helpful to stakeholders in a nursing home context? We describe in depth a (...) clinical ethics committee case consultation deemed successful by stakeholders, then reflect on how it was helpful. Research design: Case study using the clinical ethics committee’s written case report and self-evaluation form, and two research interviews, as data. Participants and research context: The nursing home’s ward manager and the patient’s son participated in research interviews. Ethical considerations: Data were collected as part of an implementation study. Clinical ethics committee members and interviewed stakeholders consented to study participation, and also gave specific approval for the publication of the present article. Findings/results: Six different roles played by the clinical ethics committee in the case consultation are described: analyst, advisor, support, moderator, builder of consensus and trust, and disseminator. Discussion: The case study indicates that clinical ethics committees might sometimes be of help to stakeholders in moral challenges in nursing homes. Conclusions: Demanding moral challenges arise in the nursing home setting. More research is needed to examine whether clinical ethics committees might be suitable as ethics support structures in nursing homes and community care. (shrink)

ABSTRACT The aim of this study is to determine how stakeholder engagement can be adapted for the conduct of COVID‐19‐related clinical trials in sub‐Saharan Africa. Nine essential stakeholder engagement practices were reviewed: formative research; stakeholder engagement plan; communications and issues management plan; protocol development; informed consent process; standard of prevention for vaccine research and standard of care for treatment research; policies on trial‐related physical, psychological, financial, and/or social harms; trial accrual, follow‐up, exit trial closure and results dissemination; (...) and post‐trial access to trial products or procedures. The norms, values, and practices of collectivist societies in Sub‐Saharan Africa and the low research literacy pose challenges to the conduct of clinical trials. Civil‐society organizations, members of community advisory boards and ethics committees, young persons, COVID‐19 survivors, researchers, government, and the private sector are assets for the implementation and translation of COVID‐19 related clinical trials. Adapting ethics guidelines to the socio‐cultural context of the region can facilitate achieving the aim of stakeholder engagement. (shrink)

Background Rationing and allocation decisions at the clinical level – bedside rationing – entail complex dilemmas that clinicians and managers often find difficult to handle. There is a lack of mechanisms and aids for promoting fair decisions, especially in hard cases. Reports indicate that clinical ethics committees sometimes handle cases that involve bedside rationing dilemmas. Can CECs have a legitimate role to play in bedside rationing? Main text Aided by two frameworks for legitimate priority setting, we discuss how CECs can (...) contribute to enhanced epistemic, procedural and political legitimacy in bedside rationing decisions. Drawing on previous work we present brief case vignettes and outline several potential roles that CECs may play, and then discuss whether these might contribute to rationing decisions becoming legitimate. In the process, key prerequisites for such legitimacy are identified. Legitimacy places demands on aspects such as the CEC’s deliberation process, the involvement of stakeholders, transparency of process, the opportunity to appeal decisions, and the competence of CEC members. On these conditions, CECs can help strengthen the legitimacy of some of the rationing decisions clinicians and managers have to make. Conclusions On specified conditions, CECs can have a well-justified advisory role to play in order to enhance the legitimacy of bedside rationing decisions. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.4 (2002) 389-390 [Access article in PDF] IOM Report on the System for Protecting Human Research Participants Tom L. Beauchamp* In response to society's concerns about the use of human subjects in research, the Department of Health and Human Services commissioned the Institute of Medicine to perform a comprehensive assessment of current systems of research participant protection in the U.S., including recommendations for reform (...) (Committee 2002). Although the committee declared its frustration over the lack of data, it found ample evidence to indicate that there are pivotal weaknesses in the current system. First, it discovered dissatisfaction with the current system from virtually every quarter and at virtually every level. Second, it found evidence that IRBs are under severe strain and performing inadequately. Third, it found that the existing regulatory framework—the IRB system and the Common Rule—has not and probably now cannot react adequately to the constantly evolving research environment. Some of these problems might be handled through federal agencies, but the committee holds that the problems are more extensive and will require additional institutional support and professional attention.The committee found that federal protection requirements should be extended to every research project—private, public, or otherwise. Subjects should be, in this respect, equally protected in privately sponsored research.The committee found that the IRB system is in important respects a failure, especially when it alone is relied upon for ethics reviews in institutions. One set of problems concerns the proper education of IRB members. The committee recommends that all members henceforth be given a specialized knowledge of human research ethics. It finds that IRB deliberations commonly have been dominated by scientists, who often marginalize the perspectives of nonscientist members. It therefore recommends that unaffiliated members, nonscientists, local community representatives, and those representing the participant-perspective comprise at least 25 percent of the membership. It also recommends that no protocol be approved without three-quarters of the voting members concurring. [End Page 389]The committee recommends that institutions distinguish review aimed at (1) scientific merit, (2) conflict of interest, and (3) general Ethics Review. The distinction should more evenly distribute the work of institutional ethics review. The IRB should not conduct the initial scientific review nor should it be spending the bulk of its time purely in examining either scientific merit—as many IRBs now do—or conflict of interest. Instead, the conclusions of the scientific review should be submitted to the IRB for ethics-focused deliberations. Problems of both financial and nonfinancial conflicts of interest should be handled similarly, preferably by a committee properly distanced from the institution's interests.The committee underscores that consent must be understood on the model of an interactive dialogue between research staff and participants and not merely as a signed form or single-disclosure event. Conversations between the participant and the research staff should begin even prior to the point of enrollment and should be reinforced during each stage of the research. The committee finds that informed consent conversations and documents too often are being conceived as risk management tasks gauged to protect the institution from liability.The committee also believes that the system of protections established by a research program should be open to the public in order to foster and maintain the community's trust. Open communication should occur among all relevant stakeholders. The committee notes that currently no centralized system exists for the dissemination of information about clinical trials and other research activities.It urges reconsideration of present policies regarding compensation, finding that many research organizations provide at least short-term medical care for those who are injured, but that few organizations cover all potential risks and that many organizations have no effective policy of compensation. The report holds that providing reasonable compensation for bona fide instances of research harm is the only just system and is necessary to avoid diminished public trust.The committee holds that establishing the appropriate culture in research institutions will require sustained efforts to educate researchers, research administrators, IRB members, and... (shrink)

This paper describes the establishment of a research ethics committee in a business school within a university in Ireland. Many of the procedural issues encountered by the Kemmy Business School REC with respect to its modus operandi are outlined. The difficulties faced by business school RECs arising from the need to simultaneously accommodate both academic and corporate stakeholders are discussed in the context of the ethicality of research carried out in the business domain. The experiences of the authors, both (...) of whom have served as respective chairpersons of the Kemmy Business School REC since its inception, inform the discussion. Given the dearth in the literature on research ethics in a business school context, the objective of this paper is to outline the experiences of one business school REC with respect to how it operates in order to assist other committees through the establishment phase and beyond. (shrink)

BackgroundImplementation science research, especially when using participatory and co-design approaches, raises unique challenges for research ethics committees. Such challenges may be poorly addressed by approval and governance mechanisms that were developed for more traditional research approaches such as randomised controlled trials.DiscussionImplementation science commonly involves the partnership of researchers and stakeholders, attempting to understand and encourage uptake of completed or piloted research. A co-creation approach involves collaboration between researchers and end users from the onset, in question framing, research design and delivery, (...) and influencing strategy, with implementation and broader dissemination strategies part of its design from gestation. A defining feature of co-creation is its emergent and adaptive nature, making detailed pre-specification of interventions and outcome measures impossible. This methodology sits oddly with ethics committee protocols that require precise pre-definition of interventions, mode of delivery, outcome measurements, and the role of study participants. But the strict requirements of ethics committees were developed for a purpose – to protect participants from harm and help ensure the rigour and transparency of studies. We propose some guiding principles to help square this circle. First, ethics committees should acknowledge and celebrate the diversity of research approaches, both formally and informally ; without active support, their members may not understand or value participatory designs. Second, ground rules should be established for co-design applications and communicated to committee members and stakeholders. Third, the benefits of power-sharing should be recognised and credit given to measures likely to support this important goal, especially in research with vulnerable communities. Co-design is considered best practice, for example, in research involving indigenous peoples in New Zealand, Australia and Canada. (shrink)

BackgroundThere is growing interest in the collection, storage and reuse of biological samples for future research. Storage and future use of biological samples raise ethical concerns and questions about approaches that safeguard the interests of participants. The situation is further complicated in Africa where there is a general lack of governing ethical frameworks that could guide the research community on appropriate approaches for sample storage and use. Furthermore, there is limited empirical data to guide development of such frameworks. A qualitative (...) study to address this gap was conducted with key stakeholders in Malawi to understand their experiences and perspectives regarding storage and usage of samples for future research.MethodsThis study conducted 13 in-depth interviews with ethics committee members, regulators and researchers, and five focus group discussions with community representatives and clinical trial participants in Malawi. Interviews and focus group discussions were audio-recorded, transcribed verbatim, and thematically analysed.ResultsOn the current regulatory guidelines that governs the collection, storage and reuse of samples in Malawi, participants highlighted their different understanding of it, with some indicating that it prohibited the reuse and sharing of samples, while others believed it permitted.Views on the informed consent model used in Malawi, some stakeholders expressed that the current model limited options for sample contributors regarding future use. Researchers supported storing samples for future use in order to maximize their value and reduce research costs. However, they expressed concern over the exportation of samples highlighting that it could lead to misuse and would not support the development of research capacity within Malawi. They recommended use of broad consent or tiered consent and establishment of biobanks to address these concerns.ConclusionsStudy findings highlighted the need for a review of the current regulatory guideline and the development of infrastructure to support the use of stored biological samples for future use among the research community in Malawi. At the moment, there are ethical and practical concerns arising from the collection, storage and secondary use of biological samples make it hard to reconcile scientific progress and the protection of participants. (shrink)

In July 2020, the H3Africa Ethics and Community Engagement (E&CE) Working Group organised a webinar with ethics committee members and biomedical researchers from various African institutions throughout the Continent to discuss the issue of whether and how biological samples for scientific research may be accessed by commercial entities when broad consents obtained for the samples are silent. 128 people including Research Ethics Committee members (10), H3Africa researchers (46) including members of the E&CE working group, biomedical researchers not associated (...) with H3Africa (27), representatives from the National Institutes of Health (16) and 10 other participants attended the webinar and shared their views. Several major themes emerged during the webinar, with the topics of broad versus explicit informed consent, defining commercial use, legacy samples and benefit sharing prevailing in the discussion. This report describes the consensus concerns and recommendations raised during the meeting and will be informative for future research on ethical considerations for genomic research in the African research context. (shrink)

This study explores the relationship between board environmental committees and corporate environmental performance. We propose that board environmental committees will be positively associated with CEP. Moreover, we argue that the composition of the committee as well as the presence of a sustainability manager will influence this relationship. Our results find support for a positive association between board environmental committees and CEP. Further, the presence of a senior-level environmental manager positively moderates this relationship, but is not effective in isolation. Unexpectedly, (...) no support was found for the influences of stakeholder representation. (shrink)

Background In the course of the COVID-19 pandemic, the biomedical research community’s attempt to focus the attention on fighting COVID-19, led to several challenges within the field of research ethics. However, we know little about the practical relevance of these challenges for Research Ethics Committees. Methods We conducted a qualitative survey across all 52 German RECs on the challenges and potential solutions with reviewing proposals for COVID-19 studies. We de-identified the answers and applied thematic text analysis for the extraction and (...) synthesis of challenges and potential solutions that we grouped under established principles for clinical research ethics. Results We received an overall response rate of 42%. The 22 responding RECs reported that they had assessed a total of 441 study proposals on COVID-19 until 21 April 2020. For the review of these proposals the RECs indicated a broad spectrum of challenges regarding social value, scientific validity, favourable risk–benefit ratio, informed consent, independent review, fair selection of trial participants, and respect for study participants. Mentioned solutions ranged from improved local/national coordination, over guidance on modified consent procedures, to priority setting across clinical studies. Conclusions RECs are facing a broad spectrum of pressing challenges in reviewing COVID-19 studies. Some challenges for consent procedures are well known from research in intensive care settings but are further aggravated by infection measures. Other challenges such as reviewing several clinical studies at the same time that potentially compete for the recruitment of in-house COVID-19 patients are unique to the current situation. For some of the challenges the proposed solutions in our survey could relatively easy be translated into practice. Others need further conceptual and empirical research. Our findings together with the increasing body of literature on COVID-19 research ethics, and further stakeholder engagement should inform the development of hands-on guidance for researchers, funders, RECs, and further oversight bodies. (shrink)

This study aimed to explore stakeholders’ perspectives on the ethical considerations for returning individual pharmacogenomics research results to people living with HIV. A qualitative approach to investigation involved five focus group discussions with 30 Community representatives, 12 key informant interviews with researchers, and 12 in-depth interviews with research ethics committee members. In total, 54 stakeholders who were involved in pharmacogenomics research and HIV treatment and care contributed to the data collection between September 2021 and February 2022. The study explored (...) five prominent themes: (i) defining the nature of research results to return to participants; (ii) preparing research participants to receive their results; (iii) obtaining informed consent for the return of results; (iv) opinions on health personnel to return the results to participants; and (v) opinions on how research results should be communicated to participants. Respondents identified various strategies for the return of individual results with minimal ethical risks including the setting up of a diverse and independent committee to undertake a risk-benefit assessment based on local context; ongoing discussions about the possible kinds of results and their implications throughout the study; and employing genetic counsellors to communicate results to participants. The strategies identified in this study should be further studied and independently verified. (shrink)

To promote ethical practices, healthcare managers must understand the ethical challenges encountered by key stakeholders. To characterize ethical challenges in Veterans Administration (VA) facilities from the perspectives of managers, clinicians, patients, and ethics consultants. We conducted focus groups with patients (n = 32) and managers (n = 38); semi-structured interviews with managers (n = 31), clinicians (n = 55), and ethics committee chairpersons (n = 21). Data were analyzed using content analysis. Managers reported that the greatest ethical challenge was (...) fairly distributing resources across programs and services, whereas clinicians identified the effect of resource constraints on patient care. Ethics committee chairpersons identified end-of-life care as the greatest ethical challenge, whereas patients identified obtaining fair, respectful, and caring treatment. Perspectives on ethical challenges varied depending on the respondent's role. Understanding these differences can help managers take practical steps to address these challenges. Further, ethics committees seemingly, are not addressing the range of ethical challenges within their institutions. (shrink)

This paper explores an increasingly prevalent element of board-level commitment to sustainability. We propose a theoretical framework under which the existence and associated actions of board-level sustainability committees are motivated by shared value creation, where the interests of a diverse group of stakeholders are satisfied and sufficient profit is achieved. Using hand-collected data, we find that sustainability committees are heterogeneous in focus and vary in their effectiveness. Specifically, we disaggregate the sustainability committee construct based on stakeholder group focus (...) and find that associations between sustainability committees and performance outcomes are stronger when committees focused on a specific stakeholder group are paired with relevant performance outcomes. We generally find that sustainability committees are effective at impacting relevant strengths, but do not mitigate relevant concerns. These results are consistent with the shared value framework, where committees both generate value by pursuing sustainability-related opportunities and protect value by monitoring, but not necessarily mitigating sustainability-related risks. Univariate tests suggest that effective committees are also larger, more independent, and meet more frequently. Finally, we propose a new method to classify industries based on their sensitivity to certain stakeholder groups and find that the effectiveness of committees focused on specific stakeholders is more pronounced in industries that are sensitive to these stakeholders. (shrink)

Fair prioritization of healthcare resources has been on the agenda for decades, but resource allocation dilemmas in clinical practice remain challenging. Can clinical ethics committees be of help? The aim of the study was to explore whether and how CECs handle priority setting dilemmas and contribute to raising awareness of fairness concerns. Descriptions of activities involving priority setting in annual reports from Norwegian CECs were studied and categorized through qualitative content analysis. Three hundred thirty-nine reports from 38 CECs were studied. (...) We found 78 activities where resource use or priority setting were explicitly highlighted as main topics. Of these, 29 were seminars or other educational activities, 21 were deliberations on individual patient cases, whereas 28 were discussions of principled or general cases. Individual patient cases concerned various distributional dilemmas where values were at stake. Six main topics and seven roles for the CEC were identified. CECs handle issues concerning the introduction of new costly drugs, extraordinarily costly established treatment, the application of priority setting criteria, resource use for vulnerable groups, resource constraints compromising practice, and futility of care. The CEC can act as an analyst, advisor, moderator, disseminator, facilitator, watch dog, and guardian of values and laws. In order to fulfil their responsibilities in handling priority setting cases, CECs need knowledge of both the ethics and the institutionalized systems of priority setting. There is potential for developing this aspect of the CECs’ work further. The Norwegian CECs are involved in priority setting decisions where they can play multiple constructive roles. In particular, they advise and raise awareness of ethical aspects in resource allocations; bridge clinical practice with higher-level decisions; and promote fair resource allocation and stakeholder rights and interests. (shrink)

Background Fair prioritization of healthcare resources has been on the agenda for decades, but resource allocation dilemmas in clinical practice remain challenging. Can clinical ethics committees be of help? The aim of the study was to explore whether and how CECs handle priority setting dilemmas and contribute to raising awareness of fairness concerns. Method Descriptions of activities involving priority setting in annual reports from Norwegian CECs were studied and categorized through qualitative content analysis. Results Three hundred thirty-nine reports from 38 (...) CECs were studied. We found 78 activities where resource use or priority setting were explicitly highlighted as main topics. Of these, 29 were seminars or other educational activities, 21 were deliberations on individual patient cases, whereas 28 were discussions of principled or general cases. Individual patient cases concerned various distributional dilemmas where values were at stake. Six main topics and seven roles for the CEC were identified. CECs handle issues concerning the introduction of new costly drugs, extraordinarily costly established treatment, the application of priority setting criteria, resource use for vulnerable groups, resource constraints compromising practice, and futility of care. The CEC can act as an analyst, advisor, moderator, disseminator, facilitator, watch dog, and guardian of values and laws. Discussion In order to fulfil their responsibilities in handling priority setting cases, CECs need knowledge of both the ethics and the institutionalized systems of priority setting. There is potential for developing this aspect of the CECs’ work further. Conclusions The Norwegian CECs are involved in priority setting decisions where they can play multiple constructive roles. In particular, they advise and raise awareness of ethical aspects in resource allocations; bridge clinical practice with higher-level decisions; and promote fair resource allocation and stakeholder rights and interests. (shrink)

For many decades, access to human biological samples, such as cells, tissues, organs, blood, and sub-cellular materials such as DNA, for use in biomedical research, has been central in understanding the nature and transmission of diseases across the globe. However, the limitations of current ethical and regulatory frameworks in sub-Saharan Africa to govern the collection, export, storage and reuse of these samples have resulted in inconsistencies in practice and a number of ethical concerns for sample donors, researchers and research ethics (...) committees. This paper examines stakeholders’ perspectives of and responses to the ethical issues arising from these research practices. (shrink)

The ability to exchange samples and data is crucial for the rapidly growth of biobanking. However, sharing is based on the assumption that the donor has given consent to a given use of her or his sample. Biobanking stakeholders, therefore, must choose 1 of 3 options: obtain general consent enabling multiple future uses before taking a sample from the donor, try to obtain consent again before sharing a previously obtained sample, or look for a legally endorsed way to share a (...) sample without the donor's consent. In this study, we present the results of 36 semistructured qualitative interviews with Swiss biobanking stakeholders regarding these options and the role of ethics committees in the process of authorizing sharing. Our results show that despite a lack of legal or guideline-based barriers to general consent, some stakeholders and ethics committees have reservations about this method of consent. In most cases, however, a general consent form is already in use. Many interviewees describe processes involving the ethics committees as time-consuming and cumbersome and their requirements as too demanding for donors/patients. Greater awareness of donors' opinions and preferences and the content of guidelines and recommendations could therefore be helpful for a better justified perspective of biobanking stakeholders and ethical committee members, equally. Finally, it may be necessary to differentiate between procedures governing future samples, where general consent is clearly desirable, and the use of old yet still relevant samples, where the option of using them without consent can be highly beneficial for research. (shrink)

Purpose We examine the levels of post-trial responsibility ascribed to different stakeholders, following a community-based clinical trial and how the ‘responsibility’ is understood. Methods We employed photovoice, unstructured observations and key informant interviews to gain insights into contexts of access to care following transition to the public health system post trial. We used an inductive narrative analysis to explore experiences and understandings of post-trial access. Results In their photovoice stories, many participants expressed a sense of abandonment after the trial. This (...) was viewed as a contributing factor to failing to re-engage with care available in the public health system. This led to the experiences of loss as some trial participants defaulted and died. Research investigators, department of health participants and sponsor agreed that PTA was especially important for communities in resource-limited settings. The government has an obligation towards its citizens while researchers have a responsibility to ensure a smooth transition of patients to public clinics. Sponsors have a responsibility to ensure that the trial is conducted in accordance with the protocol and post-trial agreements are in place and adhered to. Research partnerships among stakeholders were affected by power imbalances making it difficult to negotiate and plan for post-trial care responsibilities. Conclusions The research community still struggles with understanding the scope of PTA responsibilities. Power dynamics between public health actors and research sponsors need to be managed to ensure that government involvement is not tokenistic. The responsibility of trial participants and ethics committees needs to be investigated further. Data are available upon request. (shrink)

The field of global health has reached a critical juncture, where both its visibility and the complexity of its challenges are unprecedented. The World Health Organization, as the only global health actor possessing both democratic and formal legal legitimacy, is best positioned to capitalize on this new, precarious situation in public health and respond with the governance innovation that is needed to bring the increasingly chaotic network of activities and entities affecting health outcomes under the fold of a centralized, standard-setting (...) agency. One such proposed innovation to guide normative and strategic coordination in global health is the creation of a Committee C of the World Health Assembly that would promote consensus building and multi-stakeholder decision-making within the unique convening power of the World Health Organization. (shrink)

The explosion of interest in responsible corporate citizenship since 1995 has reminded many of the earlier rapid development of interest in environmental management issues. Active stakeholders and lobby groups have successfully exerted pressures on management for improved corporate behaviour. The paper looks at some recent initiatives and draws conclusions about the imprecise terminologies in use. It moves on to consider tools to better manage business risk exposures within the corporation. The example of the Business Ethics Strategic Survey is described, together (...) with the attendant benefits it can deliver to company chairmen, Audit Committees and investment fund managers. (shrink)

Objectives To analyse the perspective of clinical research stakeholders concerning post-trial access to study medication. Methods Questionnaires and informed consents were sent through e-mail to 599 ethics committee (EC) members, 290 clinical investigators (HIV/AIDS and Diabetes) and 53 sponsors in Brazil. Investigators were also asked to submit the questionnaire to their research patients. Two reminders were sent to participants. Results The response rate was 21%, 20% and 45% in EC, investigators and sponsors’ groups, respectively. 54 patients answered the questionnaire (...) through their doctors. The least informative item in the consent form was how to obtain the study medication after trial. If a benefit were demonstrated in the study, 60% of research participants and 35% of EC answered that all patients should continue receiving study medication after trial; 43% of investigators believed the medication should be given to participants, and 40% to subjects who participated and benefited from treatment. For 50% of the sponsors, study medication should be assured to participants who had benefited from treatment. The majority of responders answered that medication should be provided free by sponsors; investigators and sponsors believed the medication should be kept until available in the public health sector; EC members said that the patient should keep the benefit; patients answered that benefits should be assured for life. Conclusions Due to the study limitations, the results cannot be generalised; however, the data can contribute to discussion of this complex topic through analysing the views of stakeholders in clinical research in Brazil. (shrink)

BackgroundThe landscape of clinical research has evolved over the past decade. With technological advances, the practice of using electronic informed consent (eIC) has emerged. However, a number of challenges hinder the successful and widespread deployment of eIC in clinical research. Therefore, we aimed to investigate the views of various stakeholders on the potential advantages and challenges of eIC.MethodsSemi-structured interviews were conducted with 39 participants from 5 stakeholder groups from across 11 European countries. The stakeholder groups included physicians, patient (...) organization representatives, regulator representatives, ethics committee members, and pharmaceutical industry representatives, and all were involved in clinical research. Interviews were analyzed using the framework method.ResultsInterviewees identified that a powerful feature of eIC is its personalized approach as it may increase participant empowerment. However, they identified several ethical and practical challenges, such as ensuring research participants are not overloaded with information and offering the same options to research participants who would prefer a paper-based informed consent rather than eIC. According to the interviewees, eIC has the potential to establish efficient long-term interactions between the research participants and the research team in order to keep the participants informed during and after the study. Interviewees emphasized that a personal interaction with the research team is of utmost importance and this cannot be replaced by an electronic platform. In addition, interviewees across the stakeholder groups supported the idea of having a harmonized eIC approach across the European Member States.ConclusionsInterviewees reported a range of design and implementation challenges which needs to be overcome to foster innovation in informing research participants and obtaining their consent electronically. It was considered important that the implementation of eIC runs alongside the face-to-face contact between research participants and the research team. Moreover, interviewees expect that eIC could offer the opportunity to enable a personalized approach and to strengthen continuous communication over time. If successfully implemented, eIC may facilitate the engagement of research participants in clinical research. (shrink)

As national and state health care policy -making becomes contentious and complex, there is a need for a forum to debate and explore public concerns and values in health care, give voice to local citizens, to facilitate consensus among various stakeholders, and provide feedback and direction to health care institutions and policy makers. This paper explores the role that regional health care ethics committees can play and provides two contrasting examples of Networks involved in facilitation of public input into and (...) the development of health care policies and adoption of state-wide practices. (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 recently published Report of theAHAG on the Operation of NHS Research Ethics Committees advocates major reforms of the NHS research ethics committees system. The main implications of the proposed changes and their probable effects on the major stakeholders are described.The Ad Hoc Advisory Group on the operation of NHS research ethics committees, set up in November 2004 by Lord Warner on behalf of the Department of Health, submitted its report in June 2005.1 The report advocates major reforms of the (...) research ethics committee system. The primary aim of the report is to streamline the processes around the approval of research projects and to pursue conformity of governance across Europe. Implicit in the report is the contention that failure to achieve this objective would be harmful to everyone with vested interests in improving health and social care. Moreover, it is stated that the reforms will enhance the mechanisms that protect the interests of all parties concerned.1Being mindful of two published critiques of the Warner Report, we suggest that its alleged benefits should not be taken at face value.2,3 In fact, the reformed system will give rise to moral failings akin to those of the existing system, but will differ from the existing system in its effect on the stakeholders. Thus, whereas the outgoing system has given each stakeholder a unique mixture of benefit and harm, the incoming system offers benefit only to sponsors and researchers and nothing but detriment to participants in research and consumers of its products.In the light of this conclusion, we finally suggest that the Warner Report be construed not merely as an ill-considered document, but rather as an ideological reflection of a long-established hegemonic contract fine-tuning itself to contemporary global challenges.To avoid …. (shrink)

To promote ethical practices, healthcare managers must understand the ethical challenges encountered by key stakeholders. To characterize ethical challenges in Veterans Administration facilities from the perspectives of managers, clinicians, patients, and ethics consultants. We conducted focus groups with patients and managers ; semi-structured interviews with managers, clinicians, and ethics committee chairpersons. Data were analyzed using content analysis. Managers reported that the greatest ethical challenge was fairly distributing resources across programs and services, whereas clinicians identified the effect of resource constraints (...) on patient care. Ethics committee chairpersons identified end-of-life care as the greatest ethical challenge, whereas patients identified obtaining fair, respectful, and caring treatment. Perspectives on ethical challenges varied depending on the respondent's role. Understanding these differences can help managers take practical steps to address these challenges. Further, ethics committees seemingly, are not addressing the range of ethical challenges within their institutions. (shrink)

The need to understand the systems that support ethical health research has long been recognized, but there are limited descriptions of actual health research ethics (HRE) systems. Using participatory network mapping methods, we empirically defined Malaysia's HRE system. 13 Malaysian stakeholders identified 4 overarching and 25 specific HRE system functions and 35 actors internal and 3 external to the Malaysian HRE system responsible for those functions. Functions requiring the most attention were: advising on legislation related to HRE; optimizing research value (...) to society; and defining standards for HRE oversight. Internal actors with the greatest potential for more influence were: the national network of research ethics committees; non-institution-based research ethics committees; and research participants. The World Health Organization, an external actor, had the largest untapped potential for influence overall. In summary, this stakeholder-driven process identified HRE system functions and actors that could be targeted to increase HRE system capacity. (shrink)

BackgroundMedical researchers in resource-constrained settings must make difficult moral decisions about the provision of ancillary care to participants where additional healthcare needs fall outside the scope of the research and are not provided for by the local healthcare system. We examined research stakeholder perceptions and experiences of ancillary care in biomedical research projects in Malawi. MethodsWe conducted 45 qualitative in-depth interviews with key research stakeholders: researchers, health officials, research ethics committee members, research participants and grants officers from international (...) research funding organisations. Thematic analysis was used to analyse and interpret the findings. FindingsAll stakeholders perceived the provision of ancillary care to have potential health benefits to study participants in biomedical research. However, they also had concerns, particularly related to the absence of guidance to support it. Some suggested that consideration for ancillary care provision could be possible on a case-by-case basis but that most of the support from research projects should be directed towards strengthening the public health system, emphasising public good above individual or personal benefits. Some researchers and ethics committee members raised concerns about potential tensions in terms of funding, for example balancing study demands with addressing participants’ additional health needs.ConclusionOur findings highlight the complexities and gaps in the guidance around the provision of ancillary care in Malawi and other resource-constrained settings more generally. To promote the provision of ancillary care, we recommend that national and international guidelines for research ethics include specific recommendations for resource-constrained settings and specific types of research. (shrink)

BACKGROUND: There is a growing interest in aggregating more biomedical and patient data into large health data sets for research and public benefits. However, collecting and processing patient data raises new ethical issues regarding patient's rights, social justice and trust in public institutions. The aim of this empirical study is to gain an in-depth understanding of the awareness of possible ethical risks and corresponding obligations among those who are involved in projects using patient data, i.e. healthcare professionals, regulators and policy (...) makers. METHODS: We used a qualitative design to examine Swiss healthcare stakeholders' experiences and perceptions of ethical challenges with regard to patient data in real-life settings where clinical registries are sponsored, created and/or used. A semi-structured interview was carried out with 22 participants (11 physicians, 7 policy-makers, 4 ethical committee members) between July 2014 and January 2015. The interviews were audio-recorded, transcribed, coded and analysed using a thematic method derived from Grounded Theory. RESULTS: All interviewees were concerned as a matter of priority with the needs of legal and operating norms for the collection and use of data, whereas less interest was shown in issues regarding patient agency, the need for reciprocity, and shared governance in the management and use of clinical registries' patient data. This observed asymmetry highlights a possible tension between public and research interests on the one hand, and the recognition of patients' rights and citizens' involvement on the other. CONCLUSIONS: The advocation of further health-related data sharing on the grounds of research and public interest, without due regard for the perspective of patients and donors, could run the risk of fostering distrust towards healthcare data collections. Ultimately, this could diminish the expected social benefits. However, rather than setting patient rights against public interest, new ethical approaches could strengthen both concurrently. On a normative level, this study thus provides material from which to develop further ethical reflection towards a more cooperative approach involving patients and citizens in the governance of their health-related big data. (shrink)

Background In April 2019, our hospital transitioned to an electronic patient record system and patient portal. MyGOSH enables young people aged 12 years or older and their parents to access results, documentation, appointments, and to communicate with their care team. Aims A focus group was conducted to explore the ethical and legal considerations of young people and their parents using a patient portal from the perspective of hospital Ethics Committee members. Participants and research context Members of the hospital Paediatric (...) Bioethics Centre were recruited. Written informed consent was provided by all participants. Research design The focus group discussion was recorded, transcribed verbatim and analysed using thematic analysis. Ethical considerations Health Research Authority Research Ethics Committee Approval was granted by London Southeast REC. Results Four themes, and sub-themes, were identified: granting access – complexities of assessing competence/capacity, exclusion from MyGOSH due to non-disclosure of diagnosis, and truth-telling; inequalities resulting in inequities – complexities of inequity in access; responding to change – providing support and managing expectations; engagement, empowerment and understanding – data safety, empowering young people to take ownership of their health data, a one-size fits all system may not meet the needs of all families, and early engagement with young people/parents. Discussion Giving families portal access can increase engagement, empowering them to be more involved in care, yet poses challenges for all. Complexities exist in the assessment for portal access, and supporting and managing user expectations whilst providing an equitable service. Conclusions Ongoing support is required for all stakeholders following patient portal implementation to navigate the ethical and legal complexities, and to promote equity and portal utility for patient benefit. (shrink)

Ethical guidance for genomic research is increasingly sought and perceived to be necessary. Although there are pressing ethical issues in genomic research – concerning for example the recruitment of patients/participants; the process of taking consent; data sharing; and returning results to patients/participants – there is still limited useful guidance available for researchers/clinicians or for the research ethics committees who review such projects. This report outlines the ethical principles and guidance for genomic research co-produced with stakeholders during two workshops which took (...) place in the UK between November 2016 and May 2017. The stakeholders involved in these workshops included: healthcare professionals, genomic research teams, academics, patients, biobank managers, and representatives from the Health Research Authority, NHS Research Ethics Committees, patient support groups, pharmaceutical industry, and health policy think tanks. The co-produced principles and guidance are specifical... (shrink)

Questions have been raised over the acceptability of conducting human challenge studies in low and middle income countries. Most of these concerns are based on theoretical considerations and there exists little data on the attitudes of stakeholders in these countries. This study examines the view of researchers and REC members in Thailand regarding the design and conduct of challenge studies in the country. A questionnaire was developed based on ethical frameworks for human challenge studies. The target respondents included those who (...) had experience with health-related research at universities, non-university hospitals, and research institutes. A total of 240 respondents completed the on-line survey. In general, the respondents felt that the ethical issues raised by human challenge studies in LMICS do not differ significantly from those in high income countries, including: scientific rationale, safety, appropriate risks, and robust informed consent process. In contrast, issues that have been described as important for human challenge studies in LMICs were rated as having lower importance, including: a publicly available rationale, national priority, and community engagement. Responses did not vary significantly between researchers in different fields, nor between researchers and REC members. These findings provide an important perspective for assessing existing frameworks for human challenges studies in LMICs. (shrink)

This book approaches the problems and circumstances confronting blacks in the context of black values, the black community, and the role of government. ^BContents:: The Black Community's Values as a Basis for Action; The Community as Agent of Change; and The Government's Role in Meeting New Challenges.

In lieu of an abstract, here is a brief excerpt of the content:Martin Heidegger and OntologyEmmanuel Levinas (bio)The prestige of Martin Heidegger 1 and the influence of his thought on German philosophy marks both a new phase and one of the high points of the phenomenological movement. Caught unawares, the traditional establishment is obliged to clarify its position on this new teaching which casts a spell over youth and which, overstepping the bounds of permissibility, is already in vogue. For once, (...) Fame has picked one who deserves it and, for that matter, one who is still living. Anyone who has studied philosophy cannot, when confronted by Heidegger’s work, fail to recognize how the originality and force of his achievements, stemming from genius, are combined with an attentive, painstaking, and close working-out of the argument—with that craftsmanship of the patient artisan in which phenomenologists take such pride. In this study, it is important for us to understand, above all, the true intentions of our author, to illuminate what he thinks really needs to be said, and to surmise what is most critical for him.To get to the heart of Heidegger’s system, it seems fitting to begin with a problem that is generally familiar. We choose the problem of knowledge, a deeper understanding of which takes us to the very threshold of Heidegger’s thought. For this problem, central to modern philosophy, is one of the main obstacles of modern philosophy that Heidegger wishes to surmount. Neo-Kantianism, which takes knowledge as the philosophical problem of the first rank, is the movement against which Heidegger rebels with all his strength. We have, thus, every chance of gaining access to his thought by the main door, so to speak. Once inside the system we will try to trace its outlines, 2 reserving, for a second part of our work, the determination of Heidegger’s place in the history of ideas, especially in the phenomenological movement, as well as of his relations with the philosopher to whom he owes so much—Edmund Husserl. 31In its most general form, the problem of the theory of knowledge has a critical significance. It consists in delineating a domain where knowledge can be certain and in determining the criteria for the legitimate scope of knowledge. But this problem, as normal and as simple as it may appear, has deeper roots. That knowledge should need a criterion at all presupposes that truth is not identical to all that is known and that the course [End Page 11] of things can fail to correspond with the course of thought. “How does knowledge correspond to being?” is a more profound formulation of the problem of knowledge.But we are not going to touch anymore on the primordial phenomenon that generates the problem. The problem of correspondence between thing and thought presupposes a free activity of thought and its isolation in relation to the object. It is precisely this presupposition which renders their harmony and even their contact problematic. “How does the subject take leave of itself to attain the object?” is what the problem of knowledge, in the last analysis, boils down to. Its true source is thus the concept of “subject” as elaborated by modern philosophy. The cogito presided over the subject’s birth. The cogito was the affirmation of the privileged nature of the subject’s immanent sphere, of its unique place in existence; hence, the cogito was the specificity of the subject’s connection to the rest of reality, the sui generis nature which opens up the passage from immanence to transcendence, the passage from ideas contained in the thinking substance to 4 their “formal existence.”The concept of the subject, understood as a substance having a specific position in the entire domain of being, presents us with difficulties of two kinds. First, how do we understand this leave-taking from the self which the thinking substance brings about and which displays an entirely original aspect? Indeed, we could say that thought, in reaching out toward objects, does not actually take leave of itself, since its objects—considered as ideas and contents of thought—are, in a certain sense, already within it. In order to make sense of this paradox, Descartes... (shrink)

This study examines how the CSR committee and CSR-linked executive compensation jointly affect CSR performance as governance mechanisms. Prior studies provided mixed results on the CSR committee’s effect on CSR performance. We posit that a CSR committee has both a direct and an indirect positive effect on CSR performance, with CSR-linked compensation playing the role of mediator in the relationship. We base our analysis on a sample of 164 Canadian firms covering the period 2012–2018, for a total (...) of 952 firm-year observations. We propose a regression-based approach for our mediation research design. Our findings reveal that CSR-linked compensation mediates the CSR committee’s positive effect on performance, but the type of mediation depends on whether the performance is social or environmental. We provide evidence of both direct and indirect effects on environmental performance but only a positive indirect effect on social performance. These results suggest that demands from the firm’s internal and external stakeholders are treated differently, with the former receiving priority. (shrink)