This paper offers a brief guide to implementation research and some of the conceptual and methodological issues it raises. In the course of reviewing investigations of the import of aspects of the 1988 Education Reform Act, it also considers the issues posed for education policy studies in a context where the 'centre' is connected to a dispersed and differentiated periphery.

Implementation research is increasingly common in developing countries as a way of studying the introduction to the population of health interventions that have been proven to be effective elsewhere. Implementation studies are often conducted as cluster randomized trials, a design that raises ethical and conceptual questions different from those in conventional randomized controlled trials. It is often unclear who the subjects of the research are, informed consent may be difficult or impossible to obtain and controversy surrounds (...) the use of comparison clusters that provide substandard care to the population where the research is carried out. An examination of protocols for this type of research reveals uncertainty on the part of researchers themselves about whom or what they are studying and from whom (if anyone) informed consent is required. (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)

Implementing a postcolonial feminist perspective in nursing research related to non‐Western populationsIn this article, I argue that implementing a postcolonial feminist perspective in nursing research transcends the limitations of modern cultural theories in exploring the health problems of non‐Western populations. Providing nursing care in pluralist countries like Canada remains a challenge for nurses. First, nurses must reflect on their ethnic background and stereotypes that may impinge on the understanding of cultural differences. Second, dominant health ideologies that underpin nurses’ (...) everyday practice and the structural barriers that may constrain the utilization of public healthcare services by non‐Western populations must be further examined. Postcolonial feminism is aimed at addressing health inequities stemming from social discriminative practices. I will draw on extant literature and data of an ongoing ethnography exploring the Haitian caregivers’ ways of caring for ageing relatives at home to unveil how the larger social and cultural world has an impact on caregivers’ everyday lives. Marginalized locations represent privileged sites from which health problems, intersecting with power, race, gender, and social classes, can be addressed. Postcolonial feminism provides the analytic lens to look at the impact of these factors in shaping health experiences. It also suggests redirecting nursing cultural research and practice to achieve social justice in the healthcare system. (shrink)

Volume 19, Issue 10, October 2019, Page 101-103.

Researchers and others involved in the research enterprise from 12 African countries met with those working in ethics and oversight in the United States as part of an effort to develop research ethics capacity. Drawing on a wealth of experience among participants, discussions at the meeting revealed five categories of issues that warrant careful attention by those engaged in similar efforts as well as international policymakers and those charged with oversight of research. (1) Principal investigators should build (...) ‘true research teams’ where members of the team are meaningfully involved in decisions regarding the protocol and its implementation. (2)There should be explicit discussion about the ‘standard of care’ at the outset of project planning that includes clarification of the terminology that is being used. (3) While internationally collaborative research may involve populations that have inherent vulnerabilities, it is important to recognize the limitations of host country solutions (such as elaborated consent processes) and look for means to negotiate appropriate protections for those willing to participate. (4) In conducting research involving biological materials it would be prudent to develop material transfer agreements at the outset of the study to clarify expectations and to minimize the likelihood of harm. (5) Those engaged in internationally collaborative research need to be alert to the potential conflicts of interests of host country ethics committees during the approval process and to take measures to manage them if they indeed exist. (shrink)

This article outlines procedures for the feedback of individual research data to participants. This feedback framework was developed in the context of a personalized medicine research project in Canada. Researchers in this domain have an ethical obligation to return individual research results and/or material incidental findings that are clinically significant, valid and actionable to participants. Communication of individual research data must proceed in an ethical and efficient manner. Feedback involves three procedural steps: assessing the health relevance (...) of a finding, re-identifying the affected participant, and communicating the finding. Re-identification requires researchers to break the code in place to protect participant identities. Coding systems replace personal identifiers with a numerical code. Double coding systems provide added privacy protection by separating research data from personal identifying data with a third "linkage" database. A trusted and independent intermediary, the "keyholder", controls access to this linkage database. (shrink)

In this paper, we discuss challenges associated with implementing a policy for Ancillary Care (AC) for related and unrelated (serious) adverse events during an Ebola vaccine trial conducted in a remote area of the Democratic Republic of the Congo. Conducting clinical trials in resourceconstrained settings can raise context-related challenges that have implications for study participants’ health and wellbeing. During the Ebola vaccine study, three participants were injured in road traffic accidents, but there were unexpected difficulties when trying to apply the (...) AC policy. First, because of the nature of the adverse events, the insurer refused to cover the costs. Second, the AC policy did not address treatments by traditional medicine, even though traditional medicines are frequently used and highly trusted in the study community. This highlighted a contrast between the researchers’ well-intentioned AC approach and the participants’ legitimate preferences. The way in which researchers should address their responsibility to provide AC is not straightforward; it requires contextualization. Our experience highlights the importance of involving community representatives and the local ethics committee to ensure development of an AC policy that is culturally and ethically appropriate. Additionally, the insurance contract should clearly stipulate which adverse events are linked to the trial participation, and thus eligible for coverage, to avoid controversies when claims are made. (shrink)

Background Teaching ethical competencies is an essential component of professional and postgraduate curricula. Developing practical–ethical problem-solving competencies as well as appraising program-specific studies and related research ethics are topics typically addressed. However, assessment of these ethical competencies poses a challenge. Written or oral assessment formats addressing relevant learning objectives is mainly limited to knowledge testing alone, often not capturing relevant skills or attitudes pertinent to those competencies. Aim During the reaccreditation of the masters of science program in Nursing Science (...) at Witten/Herdecke University, this challenge was addressed by implementation of an innovative examination format for postgraduate education. Procedure For the module “Ethics in nursing practice and research” a format based on the Objective Structured Clinical Examination format was developed. This assessment method incorporates evaluation of acquired skills and attitudes of nursing students. Conclusion The article demonstrates development and adaption of the OSCE format for this purpose. (shrink)

In this concluding chapter, we want to take a broader perspective and, based on the contributions to this book, identify the key lessons from the NewHoRRIzon project about RRI implementation in general and via Social Labs in particular. From a bird’s eye perspective, the NewHoRRIzon Social Labs can be seen as interventions that depend on and are affected by several interrelated levels which might be separated roughly in the micro-level of Social Labs, the meso level of organisations, and the (...) macro-level of national and European research and innovation systems and policy making. (shrink)

An ethics reflection group is one of a range of ethics support services developed to better handle ethical challenges in healthcare. The aim of this article is to evaluate the implementation process of interdisciplinary ERGs in psychiatric and general hospital departments in Denmark. To our knowledge, this is the first study of ERG implementation to include both psychiatric and general hospital departments. The implementation and evaluation strategies are inspired by action research, using a qualitative approach and (...) systematic text condensation of 28 individual interviews and 4 focus groups with clinicians, ethics facilitators and ward managers. The implementation process was influenced by both structural factors and factors related to clinicians having different values, interests and experiences. Structural barriers and promotors in the process to implement ERG included the following sub-categories: Organizational factors, recruitment and training of ethics facilitators, the deliberation model, planning and recruitment of participants to the ERGs, the support of the ward managers and the project group. Barriers and promotors found among clinicians included the following sub-categories: Expectations and pre-understandings of ERGs, understandings of a physician’s job, challenges experienced by ethics facilitators. At the end of the study, when it was decided that the ERGs should be continued, the implementation strategies were remodeled by the participants to meet new challenges. The study of ERG implementation identified important structural and professional barriers and promotors that are likely to be relevant to anyone wanting to implement ethics support services across various types of healthcare services. (shrink)

With the rise of an innovation agenda in science policy, previous studies have identified a shift in how the state delegates responsibility to funding agencies in order to change the behaviour of the scientific community. This paper contributes to this literature through a micro-level study of how one of Canada’s largest research funding agencies, the Natural Sciences and Engineering Research Council, has changed resource allocation for research over 25 years. Our study foregrounds research funding agencies as (...) key sites for examining the reconfiguration of the relationship between the state and science, as expressed in programmatic and resource allocation decisions. Through analysis of an original dataset compiled from NSERC’s funding and documentary data, we demonstrate the relationship between the introduction of innovation objectives in funding instruments, the adoption of new delegation modes to guide resource allocation, and changes in funding among research fields over time. Our study empirically demonstrates the cumulative effect of programmatic and funding decisions in a major agency, going beyond previous accounts of more general trends at the national level. (shrink)

With the recent Clinical Trials Directive, a degree of harmonisation into research ethics committees across Europe, including the time taken to assess a trial proposal and the kinds of issues a committee should take into account, has been introduced by the European Union . How four different member states—Hungary, Portugal, Sweden and the UK—have chosen to implement the directive is shown. Although this has resulted in four very different ways of structuring RECs, similar themes are present in all four (...) cases, such as centralisation of control over RECs within member states, harmonisation of REC procedures across the EU and increased role of political decision making with regard to such committees. (shrink)

In April 2018, Japan’s first law regulating clinical research went into effect. The law aimed to strengthen regulations on research integrity and conflicts of interest, which had been limited under existing administrative guidelines; the law also provided stipulations for legal penalties. The scope of the new regulations, however, is limited entirely to studies that evaluate unapproved drugs or the off-label use of approved drugs, and those that receive funding from companies. On the other hand, the law’s application brings (...) numerous complications, including the establishment of new review committees, troublesome procedures for transitioning studies that are currently underway, and ambiguities about the scope of what constitutes best efforts. Thus, the change has led to substantial strain and confusion in the field. This paper offers an overview of the law and its background, and discusses its future prospects from the practical standpoint of managing ethics committees and providing research ethics support in the field. (shrink)

This paper reports on the design and implementation of a multi-phase interactive process among a set of scientists, policy makers, land managers, and community representatives, so as to facilitate communication, mutual understanding, and participative decision making. This was part of the Ecosystem Services Project in Australia. The project sought to broaden public understanding about the natural ecosystems in Australia. The study reported here pertains to one of the project sites--the Goulburn Broken catchment, a highly productive agricultural watershed in the (...) south-east of Australia. The paper demonstrates how, starting from a condition of diversity of ideas and interests among the participants, systematic dialogue and mutual learning could be generated, leading to identification of options for more sustainable land management practices. The concept of "ecosystem services" was used as an integrative tool across disciplines and community perspectives. The concept of scenarios was used to encourage future-focussed thinking among the participants. The idea of "stakeholder jury" was used to promote deliberation. A process of multi-criteria evaluation was used to facilitate convergence of viewpoints, through informed trade-offs and compromises. This experience led to the development of a process for integration research, which helped in harmonising across diverse understandings and values in a transparent and structured manner. (shrink)

Name der Zeitschrift: Studies in Logic, Grammar and Rhetoric Jahrgang: 45 Heft: 1 Seiten: 225-251.

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)

This article presents data from the Growing up with Media study related to the implementation of a risk reduction protocol that resulted in three groups of youth: low-risk youth (no flags), youth flagged because of violence involvement and not clinically referred; and flagged youth who were referred to a team clinician due to additional risk considerations. Data are from 3,979 US youth 14–15 years of age recruited through social media between October 2018-August 2019. Four in ten youth were flagged (...) for review. Findings suggest that this methodology of identifying and reviewing cases appears to be working as intended: Not only did referred youth have more flags than non-referred youth, but post-hoc analyses suggested that these youth also had higher rates of psychosocial problems (e.g., non-victimization adversity, substance use, and depressed mood). The implementation of a risk reduction protocol such as the one described in this article adds a layer of human subject protection beyond the more standard list of websites and hotlines provided to all participants in most studies. This protocol leads the way for future studies to recreate a similar process to address concerning responses collected from survey research. (shrink)

Faculty members in science, technology, engineering, and mathematics disciplines are typically expected to pursue grant funding and publish to support their research or teaching agendas. Providing effective professional development programs on grant preparation and management and on research publications is crucial. This study shares the design and implementation of such a program for Native STEM faculty from two tribal colleges and one public, non-tribal, Ph.D. granting institution during a 3-year period. The overall development and implementation of (...) the program is centered on the six R’s Indigenous framework – Respect, Relationship, Representation, Relevance, Responsibility, and Reciprocity. The role of NAF-STEM and their interactions with the program, as members of the community formed by their participation, impacted the program. Their practices and the program co-emerged over time, each providing structure and meaning for the other. Through such reciprocity, NAF-STEM and the program research team continually refined the program through their mutual engagement. They took on the shared responsibility of the program while they participated in and shaped its practices. The process and results of formative and summative assessment and the impact of COVID-19 on the program are reported. Results of the program offer lessons on the implementation of six R’s framework in professional development at institutions of higher education. (shrink)

Science and Ethics inextricably intertwinedDawson and Yentis argue that research ethics committees have an obligation to consider the science of applications because this is inextricably entwined with ethics. They lament the fact that the recent English ministerial review of RECs suggests that science should be assessed by others for RECs and not by the committee members themselves. In fact, these views are not as incompatible as they might first appear.The plain truth of the matter is that in a maximum (...) membership of 18, at least a third of whom must be lay members, the capacity of each of the 186 RECs currently in the UK to review …. (shrink)

Volume 20, Issue 4, May 2020, Page 80-82.

Nanomaterials have attracted much interest in the medical field and related applications as their distinct properties in the nanorange enable new and improved diagnosis and therapies. Owing to these properties and their potential interactions with the human body and the environment, the impact of nanomaterials on humans and their potential toxicity have been regarded a very significant issue. Consequently, nanomaterials are the subject of a wide range of cutting-edge research efforts in the medical and related fields to thoroughly probe (...) their potential beneficial utilizations and their more negative effects. We posit that the lack of standardization in the field is a serious shortcoming as it has led to the establishment of methods and results that do not ensure sufficient consistency and thus in our view can possibly result in research outputs that are not as robust as they should be. The main aim of this article is to present how NanoDiaRA, a large FP7 European multidisciplinary project that seeks to investigate and develop nanotechnology-based diagnostic systems, has developed and implemented robust, standardized methods to support research practices involving the engineering and manipulation of nanomaterials. First, to contextualize this research, an overview of the measures defined by different regulatory bodies concerning nanosafety is presented. Although these authorities have been very active in the past several years, many questions remain unanswered in our view. Second, a number of national and international projects that attempted to ensure more reliable exchanges of methods and results are discussed. However, the frequent lack of publication of procedures and protocols in research can often be a hindrance for sharing those good practices. Subsequently, the efforts made through NanoDiaRA to introduce standardized methods and techniques to support the development and utilization of nanomaterials are discussed in depth. A series of semi-structured interviews were conducted with the partners of this project, and the interviews were analyzed thematically to highlight the determined efforts of the researchers to standardize their methods. Finally, some recommendations are made toward the setting up of well-defined methods to support the high-quality work of collaborative nanoparticle-based research and development projects and to enhance standardization processes. (shrink)

Implementation of existing ethical guidelines for international collaborative medical and health research is still largely controversial in sub-Saharan Africa for two major reasons: One, they are seen as foreign and allegedly inconsistent with what has been described as an ‘African worldview’, hence, demand for their strict implementations reeks of ‘bioethical imperialism’. Two, they have other discernible inadequacies – lack of sufficient detail, apparent as well as real ambiguities, vagueness and contradictions. Similar charges exist(ed) in other non-Western societies. Consequently, (...) these guidelines have been correctly judged as an inadequate response to the complex and ever shifting dilemmas met by researchers and research regulators in the field. This paper proposes a framework for effective implementation of existing guidelines without much worry about bioethical imperialism and other inadequacies. This framework is proposed using an analogy of Legal Realism, specifically its key assertions on how, in reality, judicial systems operate using general legal rules to settle specific cases. Legal realists assert that in judicial decision-making, general legal rules do not totally dictate court decisions in specific cases. This analogy is used to coin a new term, ‘Bioethical Realism.’ The framework suggests that local Research Ethics Committees ought to be construed as analogues of judicial courts with the resulting implications. Consequently, just like legal rules are general rules that do not always dictate court decisions, similarly international bioethical guidelines are general ethical rules that should not always dictate local RECs’ decisions and such decisions (ought to) enjoy considerable immunity from outsiders. (shrink)

Intervention studies with developmental samples are difficult to implement, in particular when targeting demographically diverse communities. Online studies have the potential to examine the efficacy of highly scalable interventions aimed at enhancing development, and to address some of the barriers faced by underrepresented communities for participating in developmental research. During the COVID-19 pandemic, we executed a fully remote randomized controlled trial language intervention with third and fourth grade students from diverse backgrounds across the United States. Using this as a (...) case study, we discuss both challenges and solutions to conducting an intensive online intervention through the various phases of the study, including recruitment, data collection, and fidelity of intervention implementation. We provide comprehensive suggestions and takeaways, and conclude by summarizing some important tradeoffs for researchers interested in carrying out such studies. (shrink)

Ethics guidance increasingly recognises that researchers and sponsors have obligations to consider provisions for post-trial access to interventions that are found to be beneficial in research. Yet, there is little information regarding whether and how such plans can actually be implemented. Understanding practical experiences of developing and implementing these plans is critical to both optimising their implementation and informing conceptual work related to PTA. This viewpoint is informed by experiences with developing and implementing PTA plans for six large-scale (...) multicentre HIV prevention trials supported by the HIV Prevention Trials Network. These experiences suggest that planning and implementing PTA often involve challenges of planning under uncertainty and confronting practical barriers to accessing healthcare systems. Even in relatively favourable circumstances where a tested intervention medication is approved and available in the local healthcare system, system-level barriers can threaten the viability of PTA plans. The aggregate experience across these HIV prevention trials suggests that simply referring participants to local healthcare systems for PTA will not necessarily result in continued access to beneficial interventions for trial participants. Serious commitments to PTA will require additional efforts to learn from future approaches, measuring the success of PTA plans with dedicated follow-up and further developing normative guidance to help research stakeholders navigate the complex practical challenges of realising PTA. (shrink)

The Kingdom of Saudi Arabia passed a Law and Implementing Regulations of Ethics of Research on Living Creatures in 14/09/1431 Hijri. We have performed an ethical analysis of this law and, accordingly, this paper discusses the major components, key strengths, and weaknesses of this law. The Saudi system considers Islamic Shariah in addition to international research ethics guidelines. The Law and its Implementing Regulations contain all ethical requirements for research. We conclude that this law can serve as (...) an example, not only for other Arab countries in the region that have similar values and social structure to the Kingdom of Saudi Arabia, but also for other Islamic countries. (shrink)

There is growing interest in tissue procurement for cancer research through autopsy. Establishing an autopsy/tissue donation programme for breast cancer research within an academic medical centre i...

The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) has been the focal point of many different criticisms regarding the ethics of the study ever since publication of the trial's findings in 2010 and 2012. In this article, we focus on a concern that the technical design and implementation details of the study were ethically flawed. While the federal Office Human Research Protections focused on the consent form, rather than on the study design and implementation, OHRP's critiques (...) of the consent form reveal views about the study design and implementation that we believe are fundamentally flawed. These criticisms about the design and implementation of SUPPORT, if generalized, become relevant concerns about these aspects of many comparative effectiveness research studies.Our analytical approach will be to use SUPPORT as a prime example of comparative effectiveness research and show why it challenges some prevailing assumptions about the riskiness of research. We will address five aspects of the study design and implementation: 1) randomization, 2) treatment by protocol, 3) choice of endpoints, 4) lack of a “standard care” control group, and 5) the use of altered oximeters. Examining these aspects will allow us to answer two specific central questions. The first is a methodological question with ethical implications: was the study designed in such a way as to answer the primary study question? The second question is whether the study design added or decreased risk to the babies enrolled in the study compared to babies who were not in the study. (shrink)

Researchers and technologists involved in the development of weapon systems can take their work to such extremes as to cause unplanned injury or death to others and lasting damage to the environment, reviewed here. In some cases innocent human casualties and ecological harm may actually be programmed and achieved. An analysis is proffered, attributing blame, and indicating efforts to correct the situation. The ethics involved are “complexified”, moral boundaries are exceeded, and humanity is transgressed as it develops solutions to the (...) problem. The license to make mistakes becomes more limited with the passing of the years.. (shrink)

The embedding and promotion of social change is faced with aparadoxical challenge. In order to mainstream an approach to socialchange such as responsible research and innovation and makeit into a practical reality rather than an abstract ideal, we need tohave conceptual clarity and empirical evidence. But, in order to beable to gather empirical evidence, we have to presuppose that theapproach already exists in practice. This paper proposes a social labmethodology that is suited to deal with this circularity. Themethodology combines (...) the defining features of social labs emergingfrom the literature such as agility and real-world focus withestablished theories and approaches such as action research andexperiential learning. Thereby it enables the parallel investigationand propagation of RRI. The framework thus constructed provides atheoretical embedding of sociallabs and overcomes some of theknown limitations of the constitutive approaches. (shrink)

BackgroundThe Transparency and Openness Promotion Guidelines describe modular standards that journals can adopt to promote open science. The TOP Factor is a metric to describe the extent to which journals have adopted the TOP Guidelines in their policies. Systematic methods and rating instruments are needed to calculate the TOP Factor. Moreover, implementation of these open science policies depends on journal procedures and practices, for which TOP provides no standards or rating instruments.MethodsWe describe a process for assessing journal policies, procedures, (...) and practices according to the TOP Guidelines. We developed this process as part of the Transparency of Research Underpinning Social Intervention Tiers Initiative to advance open science in the social intervention research ecosystem. We also provide new instruments for rating journal instructions to authors, manuscript submission systems, and published articles according to standards in the TOP Guidelines. In addition, we describe how to determine the TOP Factor score for a journal, calculate reliability of journal ratings, and assess coherence among a journal’s policies, procedures, and practices. As a demonstration of this process, we describe a protocol for studying approximately 345 influential journals that have published research used to inform evidence-based policy.DiscussionThe TRUST Process includes systematic methods and rating instruments for assessing and facilitating implementation of the TOP Guidelines by journals across disciplines. Our study of journals publishing influential social intervention research will provide a comprehensive account of whether these journals have policies, procedures, and practices that are consistent with standards for open science and thereby facilitate the publication of trustworthy findings to inform evidence-based policy. Through this demonstration, we expect to identify ways to refine the TOP Guidelines and the TOP Factor. Refinements could include: improving templates for adoption in journal instructions to authors, manuscript submission systems, and published articles; revising explanatory guidance intended to enhance the use, understanding, and dissemination of the TOP Guidelines; and clarifying the distinctions among different levels of implementation.Research materials are available on the Open Science Framework: https://osf.io/txyr3/. (shrink)

The Global Code of Conduct for Research in Resource-Poor Settings (GCC) aims to stop the export of unethical research practices from higher to lower income settings. Launched in 2018, the GCC was immediately adopted by European Commission funding streams for application in research that is situated in lower and lower-middle income countries. Other institutions soon followed suit. This article reports on the application of the GCC in two of the first UK-funded projects to implement this new code, (...) one situated in India and one in Pakistan. Through systematic ethics evaluation of both projects, the practical application of the GCC in real-world environments was tested. The findings of this ethics evaluation suggest that while there are challenges for implementation, application of the GCC can promote equity in international research collaborations. (shrink)

Lee emphasizes the need to better understand the moral relationship between researchers and participants connoted by precision medicine, with the framework of “the gift” offering bioethics a...

In October 2013, the Declaration of Helsinki was revised a seventh time in its 50 year history. While it is the most widely accepted set of ethical principles for the protection of patients participating in medical research, the Declaration of Helsinki has also been subject of constant controversy. In particular, its paragraph on the use of placebo controls in clinical trials divides the research community into active-control and placebo orthodox proponents, both continuously demanding revisions of the Declaration of (...) Helsinki in favour of their position. The goal of the present project is to compare the mainly theoretical controversy with regulatory implementation. We distributed a questionnaire to national drug regulatory authorities from different countries to collect information on the authorities’ respective approaches to interpretation and implementation of the Declarations’ placebo paragraph in the conduct of medical research. Our findings suggest that the majority of drug regulatory authorities have established a practice of a middle ground, allowing placebo controls in some instances. Various interpretations of “serious harm” and “methodological reasons” are proposed as well as safeguards to avoid abuse of the option to use placebo-controls. Leaving the placebo paragraph open to various interpretation is a result of the Declaration of Helsinki’s character as a guidance document. With the current version controversy will continue. The Declaration should be continued to be strengthened to enforce the appreciation of conducting medical research with the highest ethical standard. (shrink)

This article examines capacity development for collective action and institutional change through the implementation of Corporate Social Responsibility (CSR) initiatives. We integrate Hargrave and Van de Ven’s (2006, Academy of Management Review31(4), 864–888) Collective Action Model with capacity development literature to develop a framework that can be used to clarify the nature of CSR involvement in capacity development, help identify alternative CSR response options, consider expected impacts of these options on stakeholders, and highlight trade-offs across alternative CSR investments. Our (...) framework encompasses CSR program investments in the capacities of individuals, organizations, and collaborations, as also their impact on the larger enabling environment. We then use this framework to provide descriptive evidence of two implementations: (1) The PhD Project, whose mission is to increase the diversity of corporate America by increasing the diversity of business school faculty, and (2) Involve, the community involvement program at KPMG, one of the Big Four Accounting firms. We discuss implications of our framework for managerial practice and future research. (shrink)

In spite of accruing concerted scholarly and managerial interest since the 1950s in corporate social responsibility (CSR), its implementation is still a growing topic as most of it remains academically unexplored. As CSR continues to establish a stronger foothold in organizational strategies, understanding its implementation is needed for both academia and industry. In an attempt to respond to this need, we carry out a systematic review of 122 empirical studies on CSR implementation to provide a status quo (...) of the literature and inform future scholars. We develop a research agenda in the form of an integrated framework of CSR implementation that pronounces its multi-dimensional and multi-level nature and provides a snapshot of the current literature status of CSR implementation. Future research avenues relating to multi-level studies, theoretically supported research models, developing economy settings, and more are recommended. Practitioners can also benefit through utilizing the holistic framework to attain a bird’s eye view and proactively formulate and implement CSR strategies that can be facilitated by collaborations with CSR scholars and experts. (shrink)

Despite the evidence showing the promise of HIV treatment as prevention (TasP) in reducing HIV incidence, a variety of ethical questions surrounding the implementation and “scaling up” of TasP have been articulated by a variety of stakeholders including scientists, community activists and government officials. Given the high profile and potential promise of TasP in combatting the global HIV epidemic, an explicit and transparent research priority-setting process is critical to inform ongoing ethical discussions pertaining to TasP.

This article contributes to the concept of social values by presenting analytical tools that explore how social values are classified, re-presented and interpersonally performed in the construction of identities. I approach social values as classificatory systems of acceptability and desirability that are collectively generated. The meanings of social values are embedded in culture and in power imbalanced social relations; they constantly undergo reformulation in identification processes and are also used to define the social order. I suggest that social values can (...) be analysed in relation to aspects of representation and interpersonal positioning that are also involved in the construction of identities: Value classifications involve compartmentalising moral orders into e.g. good, desirable, important, necessary; value projects are concerned with how value classifications and content occupy roles and become oriented to action; and value positioning is concerned with how narrators align with value classifications and projects as well as with individuals and groups seen to share or reject such classifications and projects. (shrink)

The tutelage of our mentors as scientists included the analogy that writing a good scientific paper was an exercise in storytelling that omitted unessential details that did not move the story forward or that detracted from the overall message. However, the advice to not get lost in the details had an important flaw. In science, it is the many details of the data themselves and the methods used to generate and analyze them that give conclusions their probative meaning. Facts may (...) sometimes slow or distract from the clarity, tidiness, intrigue, or flow of the narrative, but nevertheless they are important for the assessment of what was done, the trustworthiness of the science, and the meaning of the findings. Nevertheless, many critical elements and facts about research studies may be omitted from the narrative and become hidden from scholarly scrutiny. We describe a “baker’s dozen” shortfalls in which such elements that are pertinent to evaluating the validity of scientific studies are sometimes hidden in reports of the work. Such shortfalls may be intentional or unintentional or lie somewhere in between. Additionally, shortfalls may occur at the level of the individual or an institution or of the entire system itself. We conclude by proposing countermeasures to these shortfalls. (shrink)

The design and implementation of clinical ethics support is attracting increasing attention. Often, the characteristics and aims of clinical ethics support are translated into practice in a top-down, programmatic manner. These characteristics and aims then remain a constant feature of the clinical ethics support functions within the organisation. We argue that the characteristics of clinical ethics support should be reflected in the implementation strategy. Inspired by dialogical, pragmatic and hermeneutic perspectives on clinical ethics support in general and moral (...) case deliberation in particular, we argue for a dialogical approach to implementing clinical ethics support, based on open, ongoing discussion with healthcare professionals about how they conceive clinical ethics support. Based on research and experience with various moral case deliberation implementation projects in mental healthcare, we present a theoretical framework for dialogical implementation and heuristic guidelines for implementing moral case deliberation in mental healthcare, which take into account the dialogical characteristics of moral case deliberation and some specific features of mental healthcare. (shrink)

This article examines capacity development for collective action and institutional change through the implementation of Corporate Social Responsibility initiatives. We integrate Hargrave and Van de Ven's, 864-888) Collective Action Model with capacity development literature to develop a framework that can be used to clarify the nature of CSR involvement in capacity development, help identify alternative CSR response options, consider expected impacts of these options on stakeholders, and highlight trade-offs across alternative CSR investments. Our framework encompasses CSR program investments in (...) the capacities of individuals, organizations, and collaborations, as also their impact on the larger enabling environment. We then use this framework to provide descriptive evidence of two implementations: The PhD Project, whose mission is to increase the diversity of corporate America by increasing the diversity of business school faculty, and Involve, the community involvement program at KPMG, one of the Big Four Accounting firms. We discuss implications of our framework for managerial practice and future research. (shrink)