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The CQUniversity Australia HumanResearchEthics Committee (HREC) is a humanethicsresearch committee registered under the auspices of the National Health and MedicalResearch Council. In 2009 an external review of CQUniversity Australia’s HREC policies and procedures recommended that a lowriskresearch process be available to the institution’s researchers. Subsequently, in 2010 the HumanResearchEthics Committee LowRisk Application Procedure came into operation. This paper examines the applications (...) made under the HumanResearchEthics Committee LowRisk Application Procedure during the course of 2010 and 2011. The paper contributes to the literature analyzing the decision-making processes ofresearch review committees through an analysis of the quantitative data relating to the lowriskresearch applications made and through discourse analysis of the qualitative data represented by the assessment comments of the members of the Committee. (shrink)

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In order to illuminate the potential harms of MRIresearch, we present data obtained by examining MRIresearch proposal files that had been submitted for review to several CanadianResearchEthics Boards. The data reveal that REB review of the studies contained omissions, considerable variability, and sometimes confusion regarding MRIresearch risks andrisk classification. If our findings reflect the general state of REB review of MRIresearch in Canada and elsewhere, there is (...) a pressing need for REBs to be educated about MRI risks in order to responsibly facilitate the disclosure of theseresearch risks in consent forms and during the consent process. Developing a standard template consent form that discloses MRIresearch risks might be a way to ensure attention to and disclosure of risks. (shrink)

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Canada’s Tri-Council Policy Statement: Ethical Conduct forResearch Involving Humans mandates that allresearch involving human subjects be reviewed and approved by aresearchethics board . We have little evidence on how researchers are dealing with this requirement in multisite studies, which involve more than one REB. We retrospectively examined 22 REB submissions for two minimal-risk, multisite studies in leading Canadian institutions. Most REBs granted expedited review to the studies, while one declared the application (...) to be exempt from review. Time between submission and approval ranged greatly, from four to 546 days. We received a total of 155 REB queries for changes and clarifications, most of which asked for further information, clarification, or additional documents. Less than a third of the REB queries were requests for specific changes, and a vast majority had a very limited impact on theresearch projects. Institutions also varied broadly in their description of what was required of local principal investigators. We conclude that the organizational and practical challenges these results imply could deter researchers from embarking on multisiteresearch projects, and that recently proposed changes to the TCPS will not solve these problems. (shrink)

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This scoping review mapsresearchethics and integrity challenges and best practices encountered byresearch actors in the DACH countries (Germany, Austria, and Switzerland), including researchers, funders, publishers,researchethics committees, and policymakers, during the COVID-19 pandemic. The COVID-19 pandemic broughtresearch and, in turn,researchethics and integrity, into public focus. This review identified challenges related to changingresearch environments, diversity inresearch, publication and dissemination trends, scientific literacy and (...) trust in science, recruitment,research redundancy and study termination, placebo and human challenge studies, data management, and informed consent. These challenges are linked to two crucial factors: first, actors in the DACHresearch ecosystem lacked a sound knowledge base to assess the risks and benefits ofresearch during the COVID-19 pandemic. Second, researchers in the DACH region faced pressure from policymakers, funders, and the public to generate relevant, timely, and consistent findings to mitigate the impacts of the COVID-19 pandemic. In addition, this review highlights best practices to mitigate the effects of future crises onresearchethics and integrity, including enhanced cooperation among actors, continuousethics assessments, and support for public scientific literacy. (shrink)

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We consider the implications for the ethical evaluation ofresearch programs of two fundamental changes in the revisedresearch ethical guideline of the Council for International Organizations of Medical Sciences. The first is the extension of scope that follows from exchanging “biomedical” for “health‐related”research, and the second is the new evaluative basis of “social value,” which implies new ethical requirements ofresearch. We use the example of antibiotic resistance interventions to explore the need to consider (...) the instances of what we term the pragmatic risks of such interventions to evaluate the social value of certain kinds of health‐relatedresearch. These (pragmatic) risks severely threaten the social value of interventions in every area where human and social responses significantly impact on their effectiveness. Thus, the social value of health‐relatedresearch needed to demonstrate its effectiveness depends on the extent and successful management of such risks.Research designed to take into account the management of pragmatic risks also gives rise to similar types of risks, and the potential for social value in light of those risks needs to be considered in ethical reviews based on the new guidelines. We argue that, to handle this new expanded task, the international system ofresearch ethical review addressed by the guidelines needs institutional development. (shrink)

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This Open Access book offers a synthetic reflection on the authors’ fieldwork experiences in seven countries within the framework of ‘Authoritarianism in a Global Age’, a major comparativeresearch project. It responds to the demand for increased attention to methodological rigor and transparency in qualitativeresearch, and seeks to advance and practically support fieldresearch in authoritarian contexts. Without reducing the conundrums of authoritarian fieldresearch to a simple how-to guide, the book systematically reflects and reports (...) on the authors’ combined experiences in getting access to the field, assessingrisk, navigating ‘red lines’, building relations with local collaborators and respondents, handling the psychological pressures on field researchers, and balancing transparency and prudence in publishingresearch. It offers unique insights into this particularly challenging area of fieldresearch, makes explicit how the authors handled methodological challenges and ethical dilemmas, and offers recommendations where appropriate. This book is open access under a CC BY 4.0 license. (shrink)

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Most medicalresearch and a substantial amount of non-medicalresearch, especially that involving human participants, is governed by some kind ofresearchethics committee (REC) following the recommendations of the Declaration of Helsinki for the protection of human participants. The role of RECs is usually seen as twofold: firstly, to make some kind of calculation of the risks and benefits of the proposedresearch, and secondly, to ensure that participants give informed consent. The extent to (...) which the role of the REC includes the former is not uncontroversial. Indeed, the most prevalent debate on the role of RECs sees liberals and strong paternalists arguing over the importance of informed consent given by competent agents versus the significance of making benevolent decisions on behalf of others. On the one hand, liberals argue for the rights of competent adults to decide for themselves the kinds and extents of risks to which they wish to expose themselves. On the other hand, proponents of strong paternalism raise concerns about the likelihood of participants being able to truly understand the complex data involved inresearch. They support a role for RECs in which they exercise duties of benevolence towards patients and participants by limiting the extent to which they can be exposed to significant, permanent and irreversible harms. In this paper, we will argue that when it comes to decisions aboutrisk it is neither possible nor desirable for RECs to adopt either role. (shrink)

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The Tri-Council Policy Statement: Ethical Conduct forResearch Involving Humans was first developed to establish a standard of practice inresearchethics by the three federal agencies responsible for funding institutionalresearch in Canada: Canadian Institutes of HealthResearch, Natural Sciences and EngineeringResearch Council, and Social Sciences and HumanitiesResearch Council. In 2010, a second edition of the policy, known as the TCPS 2, was released with updated information and expanded coverage of (...)researchethics issues. According to the TCPS 2, the Agencies’ mandate is “to promoteresearch that is conducted according to the highest ethical standards,” and the TCPS 2 serves as a benchmark for this with respect for human dignity as its underlying value.Research institutions receiving Agency funding are to comply with this policy statement by formingResearchEthics Boards to review allresearch involving human participants. The intention behind this review requirement is to provide a proportionate assessment of the benefit-to-risk ratio of theresearch, and in that process, to safeguard “respect for persons”, express a “concern for welfare”, and uphold “justice”.Research may not proceed untilethics approval is granted by an institution’s REB. The current study evaluates REB members’ perspectives on their knowledge ofresearchethics, and juxtaposes these perceptions with those of researchers. Specifically, we are interested in the extent to which REB members with less experience read the TCPS 2, and whether those with less experience have decreased confidence in theirethics knowledge. (shrink)

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Current UK legislation is impacting upon the feasibility and cost-effectiveness of medical record-basedresearch aimed at benefiting the NHS and the public heath. Whereas previous commentators have focused on the Data Protection Act 1998, the Health and Social Care Act 2001 is the key legislation for public health researchers wishing to access medical records without written consent. The Act requires researchers to apply to the Patient Information Advisory Group for permission to access medical records without written permission. We present (...) a case study of the work required to obtain the necessary permissions from PIAG in order to conduct a large scale public healthresearch project. In our experience it took eight months to receive permission to access basic identifying information on individuals registered at general practices, and a decision on whether we could access clinical information in medical records without consent took 18 months. Such delays pose near insurmountable difficulties to grant fundedresearch, and in our case £560 000 of public and charitable money was spent onresearch staff while a large part of their work was prohibited until the third year of a three year grant. We conclude by arguing that many of the current problems could be avoided by returning PIAG’s responsibilities toresearchethics committees, and by allowing “opt-out” consent for many public healthresearch projects. (shrink)

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Records the papers and commentaries, with an edited discussion, presented at an international consultation convened by the Council for International Organizations of Medical Sciences (CIOMS) to guide revision of the CIOMS International Ethical Guidelines for BiomedicalResearch Involving Human Subjects. The Guidelines, first issued in 1982 and then revised in 1993, are being updated and expanded to address a number of new and especially challenging ethical issues. These include issues raised by international collaborative trials of drugs in developing countries, (...) especially expensive drugs, and the use of placebo controls in randomized clinical trials. Others arise from the complexity ofresearch in human genetics, including stem-cellresearch, and in reproductive biology. Throughout, particular attention is given to the difficult questions that arose during the heated debate over trials in developing countries, of short-duration zidovudine (AZT) therapy to reduce perinatal transmission of HIV. The International Ethical Guidelines for BiomedicalResearch Involving Human Subjects set out a code ofresearchethics that is widely used by ethical review committees and other bodies responsible for reviewing and overseeing the ethical design of studies and conduct ofresearch. The revision of the Guidelines is being coordinated by CIOMS, in collaboration with WHO. The consultation centered on seven specially commissioned papers, authored by international experts that explore some of the more difficult issues in depth. Each is followed by an invited commentary, often expressing opposing views, and a summary of the issues or conclusions that emerged during the subsequent debate. The first paper, on justice in internationalresearch, deals with the question of whether proposals forresearch to be conducted in a developing country should make provision for future access of the population involved to the interventions under investigation. Also considered are questions that arise whenresearch uses populations in developing countries to investigate interventions that will be of exclusive benefit to the industrialized world. Case studies of recent drug trials and theirresearch protocols are discussed to illustrate circumstances in which use of populations in developing countries is justified or constitutes exploitation. Ethical challenges of the randomized controlled trial are considered in the second paper, which includes a discussion on the equitable distribution of benefits and risks, the use of placebo for controls, and the obligation to ensure that the participation of controls does not compromise their medical care or endanger their health. A paper on informed consent in international healthresearch considers how cultural factors influence communication and language in the informed-consent process and respect for privacy and confidentiality in theresearch. Subsequent papers address issues in geneticsresearch and reproductive biology, including the moral status of fetuses and the use of embryos inresearch, and examine the contribution which international human rights instruments can make in the application of the general principles ofethics toresearch involving human subjects. The final paper gives an overview of capacity building and the role of communities in international biomedicalresearch. (shrink)

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Researchethics committees (RECs) have a crucial role in protecting children inresearch. However, studies on REC members’ perspectives on paediatricresearch are scarce. We conducted a qualitative study to explore Swedish scientific REC members’ perspectives on ethical aspects in applications involving children with severe health conditions. The REC members considered promoting participation, protecting children and regulatory adherence to be central aspects. The results underscored the importance of not neglecting ill children’s rights to adapted information and (...) participation. REC members supported a contextual and holistic approach to vulnerability andrisk, which considers the child’s and parents’ psychological wellbeing and the child’s integrity, both short and long term. The ethical complexity of paediatricresearch requires continuous ethical competence development within RECs. (shrink)

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Stem cells are likely to be used as an alternate source of biological material for neural transplantation to treat Parkinson’s disease in the not too distant future. Among the several ethical criteria that must be fulfilled before proceeding with clinicalresearch, a favourable benefit torisk ratio must be obtained. The potential benefits to the participant and to society are evaluated relative to the risks in an attempt to offer the participants a reasonable choice. Through examination of preclinical (...) studies transplanting stem cells in animals and the transplantation of fetal tissue in patients with Parkinson’s disease, a current set of potential benefits and risks for neural transplantation of stem cells in clinicalresearch of Parkinson’s disease are derived. The potential benefits toresearch participants undergoing stem cell transplantation are relief of parkinsonian symptoms and decreasing doses of parkinsonian drugs. Transplantation of stem cells as a treatment for Parkinson’s disease may benefit society by providing knowledge that can be used to help determine better treatments in the future. The risks toresearch participants undergoing stem cell transplantation include tumour formation, inappropriate stem cell migration, immune rejection of transplanted stem cells, haemorrhage during neurosurgery and postoperative infection. Although some of these risks are general to neurosurgical transplantation and may not be reduced for participants, the potentialrisk of tumour formation and inappropriate stem cell migration must be minimised before obtaining a favourable potential benefit torisk calculus and to provide participants with a reasonable choice before they enrol in clinical studies. (shrink)

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Current UK legislation is impacting upon the feasibility and cost-effectiveness of medical record-basedresearch aimed at benefiting the NHS and the public heath. Whereas previous commentators have focused on the Data Protection Act 1998, the Health and Social Care Act 2001 is the key legislation for public health researchers wishing to access medical records without written consent. The Act requires researchers to apply to the Patient Information Advisory Group for permission to access medical records without written permission. We present (...) a case study of the work required to obtain the necessary permissions from PIAG in order to conduct a large scale public healthresearch project. In our experience it took eight months to receive permission to access basic identifying information on individuals registered at general practices, and a decision on whether we could access clinical information in medical records without consent took 18 months. Such delays pose near insurmountable difficulties to grant fundedresearch, and in our case £560 000 of public and charitable money was spent onresearch staff while a large part of their work was prohibited until the third year of a three year grant. We conclude by arguing that many of the current problems could be avoided by returning PIAG’s responsibilities toresearchethics committees, and by allowing “opt-out” consent for many public healthresearch projects. (shrink)

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With the advancement of human microbiomeresearch, it is inevitable that a growing number of biobanks will include a collection of microbiota specimens to characterize the microbial communities that inhabit the human body and explore the relationships between the microbiota and their human hosts. Biobanks of human microbiota and their associated genetic information may become a valuable health resource. But, this area ofresearch also presents ethical and social problems, some of which are distinct from those faced by (...) biobanks that store human tissue samples. This paper examines four core issues which are considered highly relevant to microbiome biobanking: the nature of human microbiome samples and how different understandings have an impact on benefit/risk evaluation, privacy, informed consent, and returning the result to participants. We argue that these issues should be addressed early on in microbiomeresearch projects and also call for adjusting or developing new governance mechanism to better accommodate these changes. (shrink)

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Risks and burdens in the study participation, as well as an adequaterisk-benefit balance, are key concepts for the evaluation of clinical studies byresearchethics committees. An adequate assessment and continuous monitoring to ensure compliance of risks and burdens in clinical trials have long been described as a central task inresearchethics. However, there is currently no uniform and solid theoretical approach torisk assessment by RECs. Regulatory standards ofresearch (...) class='Hi'>ethics such as the Declaration of Helsinki provide only minimal guidance on howrisk decisions are considered. Due to discrepancies in the existing literature and guidance documents, adequaterisk assessment by RECs remains to be elusive. In this article, we address current definitions ofrisk and present our own concept of aggregaterisk definition. Moreover, we highlight the concept of benefit, the standard of reasonableness with respect toethics literature and different approaches ofrisk-benefit assessment. In order to present a comprehensive theoretical approach ofrisk assessment by RECs, further understanding of the definitions ofrisk may improve adequate decision-making tasks by RECs. To improve the process ofrisk assessment by RECs, a dynamic framework will be illustrated, showing step-by-steprisk assessment functions. This approach may be a promising tool to ensure adequacy inrisk assessment by RECs. (shrink)

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Clinicalresearchethics consultation has emerged in the last 15 years as a service to those involved in the conduct of clinicalresearch who face challenging issues for which more than one course of action may be justified. To respond to a growing field and need for opportunities to share knowledge and experience, the ClinicalResearchEthics Consultation Collaborative, established in 2014, holds monthly webinars for its 90 members to present their most challenging cases to (...) each other and engage in substantive discussion. Every year, the group selects the four most interesting cases with accompanying commentaries for publication in the American Journal of Bioethics. This timely book brings together these cases and commentaries under a range of common themes for the first time, creating a permanent collection in book format that encourages and supports readers to gain a better understanding of the ethical challenges that they may face, and providing them with a convenient and reflective resource to reference in their own deliberations. Key Features- Comprehensive collection of cases and commentaries, chosen to reflect the range of issues faced by clinical researchers and oversight committees and illustrate the diversity of analysis that can arise. Supplemented by short introductions to each section. Focus on ethical rather than regulatory issues. Essential Reading for graduate students in bioethics and post-doctoral bioethics fellows, and useful for all participants in training grants that are funded by either NIH or NSF Presenting challenging cases to stimulate reflection, the book provides invaluable guidance to clinicians in training and in practice and to investigators, bioethics consultants, regulators, and oversight bodies. (shrink)

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A core tenet ofresearchethics is that risks assumed byresearch participants are reasonable, balanced, and minimized in relation to benefit to the individual and to society. It is also generally accepted that people who cannot give their own informed consent ought only to be exposed to low risks inresearch, unless there is a compensating potential for direct benefit.However, there is no consensus on whether individuals should be able to voluntarily consent to high net (...)risk inresearch—or, in other words, toresearch that is not justified by direct benefits to the individual and must be justified by benefits to others in society. The Belmont Report—perhaps the most canonical document inresearchethics—does not... (shrink)

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As the artificial intelligence (AI)ethics field is currently working towards its operationalisation,ethics review as carried out byresearchethics committees (RECs) constitutes a powerful, but so far underdeveloped, framework to make AIethics effective in practice at theresearch level. This article contributes to the elaboration ofresearchethics frameworks forresearch projects developing and/or using AI. It highlights that these frameworks are still in their infancy and in need (...) of a structure and criteria to ensure AIresearch projects advance in a way that respects norms and principles. This article proposes to draw from the European Union’s AI Act currently in development to shape these frameworks. Although, in the current form of the draft (as of August 2023), the obligations of the AI Act do not apply to scientificresearch, it is most likely that they will still have a strong impact on AIresearch considering the need to anticipate market placement or to test new tools in real world conditions. This article investigates what therisk-based approach in the AI Act implies forresearchethics and highlights some AI Act obligations of particular value to implement forethics review processes. (shrink)

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Data Stewardship is a novel governance mechanism in the context of artificial intelligence (AI) development in healthcare. This paper examines whether the conceptual tool of stewardship can remedy inadequacies of ‘AIethics’ which has fundamental problems of accountability, legitimacy and trustworthiness. A modern secular conceptual explanation of stewardship involves taking a balanced account of the interests of society, and the core element of answerability. This conception of stewardship lends itself to legal mechanisms involving fiduciary duties, which introduces accountability mechanisms (...) into AI development. The separation of AI development from the permanent enclosure of health data presents a useful lever to counter unethical behaviour and ensure societal engagement. Stewardship offers some promise to remedy the inadequacies of AIethics, but there are risks that a narrow technical conception of data stewardship, without fiduciary duties and decoupled from beneficiaries, will be insufficient to drive the required fundamental change. (shrink)

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ResearchEthics, Volume 18, Issue 1, Page 51-63, January 2022. Aboriginal and Torres Strait Islander peoples in Australia, have historically experiencedresearch as another means of colonialization and oppression. Although there are existing frameworks, guidelines and policies in place that respond to this history, therisk of exploitation and oppression arising fromresearch still raises challenging ethical questions. Since the 1990s the National Health and MedicalResearch Council in Australia has developed specific sets of (...) guidelines that governresearch with these populations in an attempt to redress injustices of the past. The current guidelines: Ethical Conduct inResearch with Aboriginal and Torres Strait Islander Peoples and Communities: Guidelines for Researchers and Stakeholders, 2018, emphasis six core values which are bound together by “spirit and integrity.” The values are reflected through respect for cultural inheritance, and genuine negotiation of partnerships between researchers, other stakeholders, and communities. We examine whether these guidelines can lead toresearch andresearch practices that redress some of the ongoing traumas of colonialization and racism. We draw upon Margaret Urban Walker’s formulation of restorative justice, based upon her “pragmatics of repair” which relies upon “voice, validation and vindication” and at its core, the restoration of relationships. (shrink)

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Social Science relies heavily on the use of ethnography and other forms of qualitative study,research that may place the researcher as well as their subjects at significant ethicalrisk. In Canada,ResearchEthics Boards are responsible for protectingresearch participants during these studies. But how much ethical oversight ought theResearchEthics Boards be entitled to? Are they repressing valuable qualitative studies or are the Social Science simply rebelling against new but appropriate (...) control mechanisms not formerly applied to them? This paper evaluates how well the changes made in the TCPS 2 respond to the concerns of Social Scientists as presented in the literature. (shrink)

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Several foundational documents of bioethics mention the special obligation researchers have to vulnerableresearch participants. However, the treatment of vulnerability offered by these documents often relies on enumeration of vulnerable groups rather than an analysis of the features that make such groups vulnerable. Recent attempts in the scholarly literature to lend philosophical weight to the concept of vulnerability are offered by Luna and Hurst. Luna suggests that vulnerability is irreducibly contextual and that Institutional Review Boards (ResearchEthics (...) Committees) can only identify vulnerable participants by carefully examining the details of the proposedresearch. Hurst, in contrast, defines the vulnerable as those especially atrisk of incurring the wrongs to which allresearchethics participants are exposed. We offer a more substantive conception of vulnerability than Luna but one that gives rise to a different rubric of responsibilities from Hurst's. While we understand vulnerability to be an ontological condition of human existence, in the context ofresearchethics, we take the vulnerable to beresearch subjects who are especially prone to harm or exploitation. Our analysis rests on developing a typology of sources of vulnerability and showing how distinct sources generate distinct obligations on the part of the researcher. Our account emphasizes that the researcher's first obligation is not to make theresearch participant even more vulnerable than they already are. To illustrate our framework, we consider two cases: that of a vulnerable population involved in internationalresearch and that of a domestic population of people with diminished capacity. (shrink)

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A generation ago, we adopted a national system for the protection of human subjects inresearch. Today, that system is facing new challenges. Many argue that the system has failed to evolve in concert with dramatic changes in theresearch environment. Accordingly, efforts are underway to reform the existing process to make it both more efficient and more effective. At the same time, many are also reexamining the system in more fundamental ways — going well beyond considerations of (...) policies and compliance and raising questions that go to the very foundations of what constitutes an ethical conduct of humanresearch.Experimentation involving human subjects is a necessary step in the process of translating scientific discovery and technological advancement into procedures and products that offer the prospect of better lives for all of us. It helps us to better understand why we do the things we do and believe what we believe. (shrink)

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In this paper we argue the need to reimagineresearchethics frameworks to include notions of environmental sustainability. While there have long been calls for healthcareethics frameworks and decision-making to include aspects of sustainability, less attention has focused on howresearchethics frameworks could address this. To do this, we first describe the traditional approach toresearchethics, which often relies on individualised notions ofrisk. We argue that we need to broaden this notion of individual (...) class='Hi'>risk to consider issues associated with environmental sustainability. This is becauseresearch is associated with carbon emissions and other environmental impacts, both of which cause climate change health hazards. We introduce how bioethics frameworks have considered notions of environmental sustainability and draw on these to help develop a framework suitable for researchers. We provide a case study of data-driven healthresearch to apply our framework. (shrink)

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

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The foundations ofresearchethics are riven with fault lines emanating from a fear that ifresearch is too closely connected to weighty social purposes an imperative to advance the common good throughresearch will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature ofresearch, an incomplete focus on actors who bear important moral responsibilities, and a system ofethics and oversight highly attuned to (...) the dangers ofresearch but largely silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations ofResearchEthics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promoteresearch that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure thatresearch is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connectingresearch to the goals of a just social order grounds a framework for assessing and managingresearchrisk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceivingresearchethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and internationalresearch. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

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Reigning regulatory frameworks for biomedicalresearch impose on researchers andresearchethics committees an obligation to protectresearch participants from risks that are unnecessary, disproportionate to potentialresearch benefits, and non-minimized. Where theresearch has no potential to produce results of direct benefit to the subjects and the subjects are unable to give consent, these requirements are strengthened by an additional condition, that risks should not exceed a certain minimal threshold. In this article, I (...) address the question of whether there should be limits of permissible risks in non-therapeuticresearch involving competent and healthy subjects. Some commentators argue that competent and informed individuals should have a right to participate even in extremely riskyresearch and thatresearchethics committees should never reject studies because they are too dangerous. To use David Shaw's expression, competent volunteers should have ‘a right to participate in high-riskresearch’. I argue that this idea is ill-founded, as it does not take into account the social mission and complex collaborative nature ofresearch practice as well as the inequity of power between researchers and subjects. Imposition of limits on permissible risks for healthy volunteers is justified by the need to protectresearch enterprise and the need to protect the weaker party, namely the subjects. Also, I suggest that the best way to set boundaries onresearch risks is to leave the judgment ofrisk acceptability toresearchethics committees. (shrink)

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We identify three distinct ethical problems that can arise withrisk displacement.Risk displacement is the shifting of extantrisk from one or more individuals to other individual(s) such that the reduction ofrisk to the first group is causally implicated in increasingrisk to the second group. These problems are: concentration ofrisk in inequitable ways; transfer ofrisk to already vulnerable or disadvantaged populations; and exercise of undue influence over potential (...) class='Hi'>research participants. The first two arise in both public policy andresearch initiatives, whereas the third is a special concern that only applies toresearch initiatives. We argue that when one or more of these is of high magnitude, then the study or policy intervention may be ethically wrong. Finally, we conclude that although somerisk displacement is ethically permissible, researchers and policymakers still have ethical reasons to reduce the magnitude of these problems. (shrink)

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HumanResearchEthics Committee (HREC) reviewers often provide similar feedback across applications, which suggests that the problem lies in researcher awareness of key issues rather than novel, unsolvable challenges. If common problems can be addressed before lodgement by applicants referencing clear evidence-based supports (e.g., FAQs on common application shortcomings), it would improve efficiency for HREC members and expedite approvals. We aim to inform such supports by analysing the patterns in the most frequent feedback made by HREC members during (...) review processes. We collected every instance (_N_ = 4,195) of feedback made on _N_ = 197 ‘low-risk’ protocols by all HREC staff (_N_ = 16) at one institution over the course of a full year (2019). Reflexive thematic analysis to identify themes (and content analysis to determine relative frequency) revealed that the top three themes are consistent with existing literature: Consent, Administrative, and Methodological concerns. However, we identified important new themes that are not captured in previousresearch, including ‘Risk to Researchers’, ‘Commercial benefit, scope and scale’, ‘Diversity’ (covering issues of cultural sensitivity, language and accessibility), as well as fair right to a complaints process. Our thorough exploration of information-rich primary data marks an important methodological improvement over previous studies and offers a theoretical contribution to understanding themes that have heretofore been overlooked in theethics review process. By identifying the common challenges experienced in HREC review we can better inform tailored supports to applicants (by extension reducing workload burdens on HREC systems) and reduce their perceived barriers to engaging in challenging but meaningfulresearch. (shrink)

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The authors report the first Italian experience of aresearchethics committee (REC) audit focused on the evaluation of the REC’s compliance with standard operating procedures, requirements in insurance coverage, informed consent, protection of privacy and confidentiality, predictable risks/harms, selection of subjects, withdrawal criteria and other issues, such as advertisement details and justification of placebo. The internal audit was conducted over a two-year period (March 2009–February 2011) divided into quarters to better value the influence of the new insurance (...) coverage regulation that came into effect in March 2010 (Ministerial Decree of 14 July, 2009) and expand the requirements to safeguard participants in clinical drug trials including other critical items as information and consent and the risks to benefits ratio. Out of a total of 639 REC’s opinions andresearch studies, 316 were reviewed. Regarding the insurance policy requirements, Auditor/REC non-compliance occurred only in one case. The highest number of Auditor/REC non-compliance was in regard to information and consent, which should have incurred a suspended decision rather than a favorable opinion. This internal audit shows the importance and the difficulty of the review process. For this reason, specific courses for members of theresearchethics committee and for those who aspire to become auditors will be provided. There may also be efforts to improve the standard operating procedures already in place. (shrink)

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Urban communities experiencing marginalization often disproportionately bear the risks and burdens ofresearch and are left out ofresearchethics governance processes. To address this, many communities have created place-based and community-ledresearchethics governance initiatives to ensure that community voice is included in discussions surroundingresearch conduct. Place-based strategies in the Vancouver Downtown Eastside, the Bronx, and the Philadelphia Promise Zone successfully mobilize community perspectives inresearchethics, filling in a significant (...) gap in our current system of institutionalresearchethics review and oversight. These cases demonstrate that place-basedresearchethics governance has the potential to account for the community-level risks posed byresearch projects and to ensure communities receive more felt benefits. Place-based communities sidestep simplistic notions of identity based on single shared features and make space for intersectional analyses and diverse community viewpoints to be considered. Such communities have a unique claim to expertise given their shared experience of place, which grants them the ability to see problematic assumptions embedded in scientific projects as well as community-level concerns withinresearch. Despite this, many marginalized communities are excluded from currentresearchethics oversight processes. This exclusion demands critical examination and a way forward to facilitate the integration of place-based community oversight strategies withinresearchethics governance. (shrink)

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ResearchEthics Boards (REBs) at universities are chaired and staffed by researchers who serve to enforce codes ofethics by scrutinizingresearch proposals. Yet there is widespread dissatisfaction with the REB approval process. This article examines the sources of that dissatisfaction, the place for codes ofethics in the conducting ofresearch, the evidence forrisk toresearch participants as the basis for those codes, and the effectiveness of REBs in protecting (...) class='Hi'>research participants. We offer suggestions for how REB chairs, members, and researchers can improve the REB approval process so that it is fair and responsive. (shrink)

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The ethical parameters of businessresearch, especially that undertaken by doctoral candidates, are an under researched area. This exploratoryresearch analysesresearchethics in the business and management contexts as espoused in perceived lowriskethics applications from business doctoral candidates in light of the principles of Australianresearchethics guidelines. Applications are also analysed in terms of power relationships, methods of access and informed consent, pressure to completeresearch expeditiously, conflict (...) of interest and cross-cultural understandings. Findings suggest thatresearch design, personal relationships with participants and nuanced understandings of the contextual dimensions ofrisk may be of concern in the proposedresearch. However, a reflexive process also questions the cultural and other assumptions of both researchers andethics administrators underlying these concerns. (shrink)

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The online version of the original article can be found under doi:10.1007/s11948-007-9045-2.

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This is the third in a series of five papers on the role, remit and function ofresearchethics committees which are intended to provide for REC members a broad understanding of the most important issues inresearchethics and governance. This paper examines the role ofethics committees in balancing the social value of theresearch it reviews against the risks it imposes on those who take part. Theethics committee's role in (...) assessing the social value ofresearch goes well beyond checking its scientific validity and this assessment may affect the risksethics committees are prepared to ask of subjects not only for their own potential personal interests but importantly and inevitably in the name of science. However, their function is importantly restricted by the wider regulatory and governance environment in which they work. (shrink)

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Institutional review boards (IRBs) have a reputation for impedingresearch. This reputation is understandable inasmuch as many studies are poorly designed, exploit participants, or do not ask a relevant question , and it is entirely proper that IRBs should reject such proposals. However, IRBs also frequently reject or tamper with perfectly sound and relevant studies in the name of protecting participants from harm, in accordance with the widely accepted message that “clinicalresearch is justified only when participants are (...) protected from excessive risks”. Here, I argue that IRBs should never reject a study because it poses too high arisk to participants, and that their role should be confined to ensuring that risks and any potential benefits are fully explained to potential participants. Everyone should have the right to participate inresearch without paternalistic decisions aboutrisk being made on their behalf. (shrink)

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Therisk of creating cerebral organoids/assembloids conscious enough to suffer is a recurrent concern in organoidresearchethics. On one hand, we should, apparently, avoid discovering how to distinguish between organoids that it would be permissible (non-conscious) and impermissible (conscious) to use inresearch, since if successful we would create organoids that suffer. On the other, if we do not, therisk persists thatresearch might inadvertently continue to cause organoids to suffer. Moreover, since (...) modeling some brain disorders may require inducing stress in organoids, it is unclear how to eliminate therisk, if we want to develop effective therapies. We are committed to harm avoidance but hamstrung by a presumption that we should avoidresearch that might tell us clearly when suffering occurs. How can we negotiate this challenge and maximize the therapeutic benefits of cerebral organoidresearch? The author interrogates the challenge, suggesting a tentative way forward. (shrink)

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In this paper the authors argue thatresearchethics committees should not be paternalistic by rejectingresearch that posesrisk to people competent to decide for themselves. However it is important they help to ensure valid consent is sought from potential recruits and protect vulnerable people who cannot look after their own best interests. The authors first describe the tragic deaths of Jesse Gelsinger and Ellen Roche. They then discuss the following claims to support their case: (...) competent individuals are epistemologically and ethically in the best position to say which risks are reasonable for them, so RECs should be no more restrictive than the “normal” constraints on people taking risks with themselves; RECs do not judge individual competence ; individual liberty is mostly limited by what serves the public interest, and RECs do not determine public interest; RECs may have a paternalistic role in preventing exploitation of competent people vulnerable to the use of incentives, and in protecting the interests of incompetent people; however, the moral and political authority of RECs has not been established in this respect. (shrink)

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Gain-of-functionresearch involves experimentation that aims or is expected to increase the transmissibility and/or virulence of pathogens. Suchresearch, when conducted by responsible scientists, usually aims to improve understanding of disease causing agents, their interaction with human hosts, and/or their potential to cause pandemics. The ultimate objective of suchresearch is to better inform public health and preparedness efforts and/or development of medical countermeasures. Despite these important potential benefits, GOFresearch can pose risks regarding biosecurity and (...) biosafety. In 2014 the administration of US President Barack Obama called for a “pause” on funding of GOF experiments involving influenza, SARS, and MERS viruses in particular. With announcement of this pause, the US Government launched a “deliberative process” regarding risks and benefits of GOFR to inform future funding decisions—and the US National Science Advisory Board for Biosecurity was tasked with making recommendations to the US Government on this matter. As part of this deliberative process the National Institutes of Health commissioned this Ethical Analysis White Paper, requesting that it provide review and summary of ethical literature on GOFR, identification and analysis of existing ethical and decision-making frameworks relevant to the evaluation of risks and benefits of GOFR, decision-making about the conduct of GOF studies, and the development of US policy regarding GOFR, and development of an ethical and decision-making framework that may be considered by NSABB when analyzing information provided by GOFRrisk-benefit assessment, and when crafting its final recommendations. The ethical and decision-making framework ultimately developed is based on the idea that there are numerous ethically relevant dimensions upon which any given case of GOFR can fare better or worse :research imperative, proportionality, minimization of risks, manageability of risks, justice, good governance, evidence, and international outlook and engagement. Rather than drawing a sharp bright line between GOFR studies that are ethically acceptable and those that are ethically unacceptable, this framework is designed to indicate where any given study would fall on an ethical spectrum—where imaginable cases of GOFR might range from those that are most ethically acceptable, at one end of the spectrum, to those that are most ethically problematic or unacceptable, at the other. The aim should be that any GOFR pursued should be as far as possible towards the former end of the spectrum. (shrink)

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Artificial intelligence (AI) and machine learning (ML) are transforming healthcare, offering promising tools for diagnostics, predictive modeling, and personalized treatment. However, the successful deployment of AI in clinical settings faces significant challenges, including ethical concerns and the “AI-chasm”—the gap between AI’s technical performance in controlled environments and its real-world deployment. Building on existing ethical frameworks, we propose a three-phase validationresearch model for AI in healthcare in which each phase identifies specific ethical risks and outlines the role of interdisciplinary (...) oversight bodies responsible for mitigating them. We argue that AI models should not only demonstrate technical accuracy, but must also be integrated into healthcare systems in a manner that respects fundamental ethical principles. By embedding ethical oversight throughout theresearch and validation process, this framework seeks to close the AI-chasm and promote the responsible adoption of AI in healthcare. (shrink)

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: Despite its mandate on minimizing harms in clinical trials, the Common Rule provides little guidance as to how IRBs should evaluaterisk. The Common Rule and derivative commentaries tend to conceptualizerisk review as an expert-based endeavor aimed at an objective and universal evaluation of possible harm; they also have tended to locaterisk in theresearch activity itself rather than in the context of theresearch. These views ofrisk conflict with scholarship (...) showing thatrisk evaluations are socially determined even among experts, that the context of harms can influence how persons evaluate risks, and that forums that approachrisk assessment as a technical endeavor bracket from discussion the numerous values that groundrisk judgments. Possible reforms are proposed for clinical trialrisk review that would render it more inclusive of the different types of risks encountered and more attuned to the priorities of trial subjects. (shrink)

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Inresearchethics there is a canon regarding what ethical rules ought to be followed by investigators vis-à-vis their treatment of subjects and a canon regarding what fundamental ethical principles apply to the endeavor. What I aim to demonstrate here is that several of the rules find no support in the principles. This leaves anyone who would insist that we not abandon those rules in the difficult position of needing to establish that we are nevertheless justified in believing (...) in the validity of the rules. I conclude by arguing that this is not likely to be accomplished.The rules I call into question are the rules requiring:– that studies be designed in a scientifically valid way– that risks to subjects be minimized– that subjects be afforded post-trial access to experimental interventions– that inducements paid to subjects not be counted as a benefit to them– that inducements paid to subjects not be ‘undue’– that subjects must remain free to withdraw from the study at any time for any reason without penaltyBoth canons, the canon on principles and the canon on rules, are found in the overlap among ethical pronouncements that are themselves canonical: the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, CIOMS's International Ethical Guidelines for BiomedicalResearch Involving Human Subjects, and NBAC's 2001 report, Ethical Issues in InternationalResearch: Clinical Trials in Developing Countries. (shrink)

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In this case, the investigator should be allowed to enroll incompetent adults into this study, with certain safeguards. If an incompetent adult has an agent or a legally authorized representative (...

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One of the central problems concerningresearch with children is the delineation of appropriate levels ofrisk exposure. In the U.S. Code of Federal Regulations, the "minimalrisk" concept serves as an anchoring measure for allowablerisk. While the regulations sought to promote a balance between scientific advances and the protection of children's vulnerable status, ambiguities in the language of the regulations and the regulatory definition of "minimalrisk" have given rise to a great deal (...) of confusion.Researchethics boards and the medical community espouse a multitude of varying opinions regarding the interpretation and application of the federal regulations with more recentresearch demonstrating an apparent increase inrisk without corresponding benefit in pediatricresearch. Informed by ethical theory, law, and science, this project analyzes the apparent increase in allowablerisk, calls for a reassessment of the concept of "minimalrisk," and recommends modifications to the federal regulations. (shrink)

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BackgroundResearchethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the NetRisk Test and the Component Analysis.DiscussionBy looking at decision studies, we see that both procedure-level approaches conflate the variousrisk-benefit tasks, i.e.,risk-benefit assessment,risk-benefit evaluation,risk treatment, and decision making. This conflation makes the RECs’risk-benefit task confusing, if not impossible. We further realize that RECs are not meant (...) to do all therisk-benefit tasks; instead, RECs are meant to evaluate risks and benefits, appraiserisk treatment suggestions, and make the final decision.ConclusionAs such,researchethics would benefit from looking beyond the procedure-level approaches and allowing disciplines like decision studies to be involved in the discourse on RECs’risk-benefit task. (shrink)

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Lack of supportive workplaces may be depriving babies and mothers of the health advantages of breastfeeding. This citizen science pilot project set out to engage women in photographing and sharing information on the available facilities for breastfeeding and expressing and storing breastmilk in Australian workplaces. While some useful insights were gained, the project failed in the sense that 234 people ‘liked’ the project Facebook page set up to recruit participants, but only nine photographs were submitted. The heaviest loss of participation (...) occurred after theethics committee requirements were explained, in particular, the requirement for employer consent to take a photograph, or alternatively, for a participant to agree to bear therisk of taking a photo without permission. Theethics committee also made stipulations about the formality of language to be used. Thus, the project’s potential role as an enabler for health action was neutered. We argue that theethics requirements worked contrary to our purpose and possibly acted to reinforce the powerlessness some women experience at work. (shrink)

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Key messages Theresearch environment has changed since clinical equipoise was first proposed 30 years ago New trial designs—such as umbrella and basket trials, adaptive platform trials, and cluster randomised trials—raise new ethical challenges for evaluating the state of scientific uncertainty and communicating about risks with patients and participants Clinical equipoise needs to evolve We propose the design of specific guidelines to provideethics committees and trialists with instructions for how to evaluate equipoise in the context of new (...) designs and biomarkers and how to optimise communication with participants. (shrink)

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