Despite significant scholarly debate about knowledge production in the management discipline through the peer-review journal processes, there is minimal discussion about the ethical treatment of the research subject in these publication processes. In contrast, the ethical scrutiny of management research processes within research institutions is often highly formalized and very focused on the protection of research participants. Hence, the question arises of how management publication processes should best account for the interests of the research subject, both in the narrow sense (...) of specific research participants and in the broader understanding of the subject of the research. This question is particularly pertinent in light of significant codification of research ethics within academic institutions, and increasing self-reflection within the management discipline about the “good” of management research and education. Findings from a survey and interviews with management journal editors reveal a complex scenario; many editors believe that a formalized requirement within the journal publication process may have detrimental outcomes and, in fact, diminish the ethical integrity of management scholarship. Building on these findings, this paper argues that ethical concern for the research subject merely in terms of institutional rule compliance and avoidance of harm to individual participants is insufficient, and calls for explicitly positive engagement with both the individual and the collective subject of management research should receive due ethical consideration. An alternative model involving reflexive ethical consideration of research subjects across the publication process—with implications for role of authors, reviewers, editors, and research subjects—is outlined. (shrink)

Launch of clinical investigation represents a substantial escalation in commitment to a particular clinical translation trajectory; it also exposes human subjects to poorly understood interventions. Despite these high stakes, there is little to guide decision-makers on the scientific and ethical evaluation of early phase trials. In this article, we review policies and consensus statements on human protections, drug regulation, and research design surrounding trial launch, and conclude that decision-making is largely left to the discretion of research teams and sponsors. We (...) then review what is currently understood about how research teams exercise this discretion, and close by laying out a research agenda for characterizing the way investigators, sponsors, and reviewers approach decision-making in early phase research. (shrink)

The rapid growth of next-generation genetic sequencing has prompted debate about the responsibilities of researchers toward genetic incidental findings. Assuming there is a duty to disclose significant incidental findings, might there be an obligation for researchers to actively look for these findings? We present an ethical framework for analyzing whether there is a positive duty to look for genetic incidental findings. Using the ancillary care framework as a guide, we identify three main criteria that must be present to give rise (...) to an obligation to look: high benefit to participants, lack of alternative access for participants, and reasonable burden on researchers. Our analysis indicates that there is no obligation to look for incidental findings today, but during the ongoing translation of genomic analysis from research to clinical care, this obligation may arise. (shrink)

Background:Ideas of patient involvement are related to notions of self-determination and autonomy, which are not always in alignment with complex interactions and communication in clinical practice.Aim:To illuminate and discuss patient involvement in routine clinical care situations in nursing practice from an ethical perspective.Method:A case study based on an anthropological field study among patients with advanced cancer in Denmark.Ethical considerations:Followed the principles of the Helsinki Declaration.Findings:Two cases illustrated situations where nurses refused patient involvement in their own case.Discussion:Focus on two ethical issues, (...) namely ‘including patients’ experiences in palliative nursing care’ and ‘relational distribution of power and knowledge’, inspired primarily by Hannah Arendt’s concept of thoughtlessness and a Foucauldian perspective on the medical clinic and power. The article discusses how patients’ palliative care needs and preferences, knowledge and statements become part of the less significant background of nursing practice, when nurses have a predefined agenda for acting with and involvement of patients. Both structurally conditioned ‘thoughtlessness’ of the nurses and distribution of power and knowledge between patients and nurses condition nurses to set the agenda and assess when and at what level it is relevant to take up patients’ invitations to involve them in their own case.Conclusion:The medical and institutional logic of the healthcare service sets the framework for the exchange between professional and patient, which has an embedded risk that ‘thoughtlessness’ appears among nurses. The consequences of neglecting the spontaneous nature of human action and refusing the invitations of the patients to be involved in their life situation call for ethical and practical reflection among nurses. The conditions for interaction with humans as unpredictable and variable challenge nurses’ ways of being ethically attentive to ensure that patients receive good palliative care, despite the structurally conditioned logic of healthcare. (shrink)

‘Client involvement’ has been a mantra within health policies, education curricula and healthcare institutions over many years, yet very little is known about how ‘client involvement’ is practised in home‐care services. The aim of this article is to analyse ‘client involvement’ in practise seen from the positions of healthcare professionals, an elderly person and his relative in a home‐care setting. A sociologically inspired single case study was conducted, consisting of three weeks of observations and interviews. The study has a focus (...) on the relational aspects of home care and the structural, political and administrative frames that rule home‐ care practice. Client involvement is shown within four constructed analytical categories: ‘Structural conditions of providing and receiving home care’; ‘Client involvement inside the home: performing a professional task and living an everyday life’; ‘Client involvement outside the home: liberal business and mutual goal setting’; and ‘Converting a home to a working place: refurnishing a life’. The meaning of involvement is depending on which position it is viewed from. On the basis of this analysis, we raise the question of the extent to which involvement of the client in public home‐care practice remains limited. (shrink)

In their article published in Nanoethics, “Ethical, Legal and Social Aspects of Brain-Implants Using Nano-Scale Materials and Techniques”, Berger et al. suggest that there may be a prima facie moral obligation to improve neuro implants with nanotechnology given their possible therapeutic advantages for patients [Nanoethics, 2:241–249]. Although we agree with Berger et al. that developments in nanomedicine hold the potential to render brain implant technologies less invasive and to better target neural stimulation to respond to brain impairments in the near (...) future, we argue against presenting the development of nanobionic clinical devices in terms of a moral obligation to conduct this research. In the first part of the paper, we consider what a duty to pursue new technologies might mean, and in the second we explore some of the negative consequences of defending such development as a moral obligation based on potential benefit. We argue that promoting the advances available to brain implants through developments in nanotechnology and bionics could contribute to medical rhetoric that indirectly increases the risk of exposing patients to harm when participating in clinical trials. We argue that rather than there being a moral obligation to improve nanobionics implants because of their potential benefit, the pursuit of improved neuro implants must be balanced against the prima facie obligations to protect patients against harm and to promote and protect patient autonomy. (shrink)

Pediatric biobanking is considered important for generating biomedical knowledge and improving health care. However, the inclusion of children’s samples in biobanks involves specific ethical issues. One of the main concerns is how to appropriately engage children in the consent procedure. We suggest that children should be involved through a personalized assent procedure, which means that both the content and the process of assent are adjusted to the individual child. In this paper we provide guidance on how to put personalized assent (...) into pediatric biobanking practice and consider both the content and process of personalized assent. In the discussion we argue that the assent procedure itself is formative. Investing in the procedure should be a requirement for pediatric biobank research. Although personalized assent will require certain efforts, the pediatric community must be aware of its importance. The investment and trust earned can result in ongoing engagement, important longitudinal information, and stability in/for the research infrastructure, as well as increased knowledge among its participants about research activity. Implementing personalized assent will both respect the child and support biobank research. (shrink)

The exportation of unethical practices to low- and middle-income countries has been conceived as a prevalent practice which needs to be examined more closely. Such a practice might point towards the exploitation of vulnerable population groups. We conducted a survey among Mexican research ethics committee members to explore the issue of ethics dumping in Mexico by understanding how its existence and contributing factors and norms are perceived by these ethics committee members. We designed an exploratory survey based on a five-point (...) Likert scale, following an established, validated and published methodology. The questionnaire included both open close-ended questions. The aspects covered in the questionnaire were introductory questions on the existence of ethical issues; general perception on ethics dumping in Mexico; lack of voluntariness, undue inducement, and therapeutic misconception as exploitation risks; existence of exploitative practices; norms facilitating ethics dumping; acceptable levels of benefit to Mexico; boundaries of ethics dumping. The survey was administered to a sample of research ethics committee members from public and private Mexican hospitals in 2016. Most of the ethics committee members believed clinical trials are generally ethically sound, though almost a majority think that ethics dumping is a common occurrence and that it is a serious issue. Most agree that ethics dumping needs to be addressed. They also identified other issues such as ethical issues related to patient participation and ethics committees. Further, most committee members agree that undue inducement and therapeutic misconception affect voluntariness, and that both individuals and communities receive appropriate benefits. From the perspective of Mexican research ethics committee members, ethics dumping commonly exists in Mexican clinical trials, as well as several related issues such as ethical issues on patient participation and ethics committees, as well as voluntariness issues. Further, most members believed these issues need to be addressed. However, most were also of the opinion that clinical trials are generally ethically compliant. This points to the need for further studies on the reasons for these perspectives. (shrink)

This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: the data protection regime which follows the application of the European Union General Data Protection Regulation, and the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given and revocable and therefore has (...) challenged the concept of ‘broad consent’, which has been widely applied in the context of biobanking. Another source of controversy is the interplay between regulations of research ethics and protection of personal data related to the secondary use of personal data and biological materials. In this case, the GDPR ‘research condition’ provides an alternative to re-consent for the use of previously collected personal data and biological materials. Although the mentioned controversies have been raised in the legal literature, they have not been explicitly addressed from the research ethics perspective. Should consent be regarded as a priority legal basis for personal data processing in health data research? Can broad consent still be a suitable legal ground for biobanking? What should be the role of research ethics provisions that differ from the GDPR standards, and what should be the role and function of research ethics committees in the changing environment of health data research? These are the ongoing controversies to be explored in the paper. (shrink)

Hilden and Gammelgaard's comments on the evaluation and application of statistical trials and on informed consent lead to the same conclusion that there are special circumstances when clinical trials are performed in emergency situations.The decision to comment on the work that H&G responded to was motivated by the wish to manifest the need to reach a consensus on modifying the conditions in which clinical trials should be performed in special circumstances.One unquestionable fact must first be addressed: clinical trials are necessary (...) for acquiring new knowledge and consequent improvements in health care services. At the same time, patient participation should be encouraged under conditions that respect patients' decision making capability.Are these conditions being met at present? An answer to this is given below. (shrink)

German medical schools have not yet sufficiently introduced students to the field of good scientific practice. In order to prevent scientific misconduct and to foster scientific integrity, courses on GSP must be an integral part of the curriculum of medical students. Based on a review of the literature, teaching units and materials for two courses on GSP were developed and tested in a pilot course. The pilot course was accompanied by a pre-post evaluation that assessed students’ knowledge and attitudes towards (...) scientific integrity and scientific misconduct. A syllabus was designed that comprised the following six topics: theoretical foundations of GSP; scientific publishing; empirical data; scientific supervision and teamwork; clinical research; personal interests. The comparison pre versus post-intervention yielded statistically significant changes in regard to the participants’ knowledge and attitude toward all forms of scientific misconduct treated in the course. As the majority of participants was not familiar with the fundamental regulations or guidelines of GSP, it seems crucial to train students in actively applying such norms to real-world conflicts. Students’ unfamiliarity with the fundamentals of GSP can be linked to the fact that many students have already experienced forms of scientific misconduct. Thus, GSP syllabi should be closely adjusted to a student’s realm of experience. All in all, courses on GSP can be seen as a potential means to increase the number of young scholars. (shrink)

This paper offers a critical analysis of several accounts of the placebo effect that have been put forward. While the placebo effect is most often thought of as a control in research and as a deceptive tool in practice, a growing body of research suggests that it ought to be thought of as a powerful phenomenon in its own right. Several accounts that aim to draw boundaries around the placebo effect are evaluated in relation to current evidence and it is (...) argued that none of them adequately capture the variability and potency of the phenomenon. Two accounts, however, that point towards the underlying mechanisms of the placebo effect, are shown to offer promise in terms of developing a more comprehensive account of the placebo effect. (shrink)

This symposium issue of the Journal of Law, Medicine & Ethics indicates that interest in public health law in the United States is enjoying a renaissance. The focus of the articles reflects this renaissance, as they explore the state of public health law in various contexts within the United States. Additionally, all but one of the symposium authors plies his or her trade at a university, institution, or government agency in the United States. My task here is different: I focus (...) on public health law within the context of international relations.Analyzing public health law with an international perspective proves no easy assignment. Examining the role of public health law in the proverbial global village takes the analysis out of the familiar territory of law operating within a single sovereign state. The analysis could take two forms. One could compare different national systems of public health law on specific issues. Such a comparative law approach would be interested in, for example, how the public health laws of the United States and South Africa differ in connection with regulating tobacco consumption. (shrink)

This symposium issue of the Journal of Law, Medicine & Ethics indicates that interest in public health law in the United States is enjoying a renaissance. The focus of the articles reflects this renaissance, as they explore the state of public health law in various contexts within the United States. Additionally, all but one of the symposium authors plies his or her trade at a university, institution, or government agency in the United States. My task here is different: I focus (...) on public health law within the context of international relations.Analyzing public health law with an international perspective proves no easy assignment. Examining the role of public health law in the proverbial global village takes the analysis out of the familiar territory of law operating within a single sovereign state. The analysis could take two forms. One could compare different national systems of public health law on specific issues. Such a comparative law approach would be interested in, for example, how the public health laws of the United States and South Africa differ in connection with regulating tobacco consumption. (shrink)

Historically, the care of hospitalized children has evolved from being performed in isolation from parents to a situation where the parents and the child are regarded as a unit, and parents and nurses as equal partners in the child’s care. Parents are totally dependent on professionals’ knowledge and expertise, while nurses are dependent on the children’s emotional connection with their parents in order to provide optimal care. Even when interdependency exists, nurses as professionals hold the power to decide whether and (...) to what extent parents should be involved in their child’s care. This article focuses on nurses’ responsibility to act ethically and reflectively in a collaborative partnership with parents. To illuminate the issue of nurses as moral practitioners, we present an observation of contemporary child care, and discuss it from the perspective of the Danish moral philosopher KE Løgstrup and his book The ethical demand. (shrink)

The rapid growth of pharmaceutical markets in the 20th century has increased the demand for human research participants in clinical trials. However, with the globalization of clinical research, most clinical trials are conducted in low-income countries (LICs) with political and economic instability, and lack of basic healthcare, but easy access to human subjects. This paper explores the unique ethical challenges faced during the pre-enrollment phase of cross-cultural research in a country like Pakistan, and how these challenges make the Pakistani population (...) vulnerable to exploitation. It also outlines recommendations regarding conducting research in Pakistan within ethical parameters adopted according to local culture. This discussion is important because researchers must focus on the pre-enrollment phase of the research process for it’s cultural suitability and acceptability so that the research conducted is credible and valid and has social value for the research population. (shrink)

Recital 33 GDPR has often been interpreted as referring to ‘broad consent’. This version of informed consent was intended to allow data subjects to provide their consent for certain areas of research, or parts of research projects, conditional to the research being in line with ‘recognised ethical standards’. In this article, we argue that broad consent is applicable in the emerging field of Computational Social Science (CSS), which lies at the intersection of data science and social science. However, the lack (...) of recognised ethical standards specific to CSS poses a practical barrier to the use of broad consent in this field and other fields that lack recognised ethical standards. Upon examining existing research ethics standards in social science and data science, we argue that they are insufficient for CSS. We further contend that the fragmentation of European Union (EU) law and research ethics sources makes it challenging to establish universally recognised ethical standards for scientific research. As a result, CSS researchers and other researchers in emerging fields that lack recognised ethical standards are left without sufficient guidance on the use of broad consent as provided for in the GDPR. We conclude that responsible EU bodies should provide additional guidance to facilitate the use of broad consent in CSS research. (shrink)

Software plays an important role in contemporary research. Aside from its use for administering traditional instruments like surveys and in data analysis, the widespread use of mobile and web apps for social, medical and lifestyle engagement has led to software becoming a research intervention in its own right. For example, it is not unusual to find apps being studied for their utility as interventions in health and social life. Since the software may persist in use beyond the life of an (...) investigation, this raises questions as to the extent of ethical duties for researchers involved in its production and/or study towards the participants involved. Key factors identified include the extent of affect created by the software, the effect it has on a participant’s life, the length of investigation, cost of maintenance and participant agency. In this article we discuss the issues raised in such situations, considering them in the context of post-research duties of care and suggesting strategies to balance the burden on researchers with the need for ongoing participant support. (shrink)

This article briefly reviews concerns related to the “cultural colonialism” of applying Western biomedical models of research ethics to non-Western groups. The feasibility of alternate ethical models is discussed and found wanting. In practical terms, many academic researchers in the United States are funded by federal agencies and are required to adhere to Title 45, Part 46 of the Code of Federal Regulations , legislation that is clearly grounded in the Western biomedical research tradition. Consequently, the question is not whether (...) this system of ethics should be applied but rather how it can be applied most sensitively, appropriately, and wisely. The remainder of this article discusses of how the authors have attempted to do so in each stage of their own research with Hispanic immigrants to the United States. (shrink)

Background Despite recent developments aimed at creating international guidelines for ethical global health research, critical disconnections remain between how global health research is conducted in the field and the institutional ethics frameworks intended to guide research practice. Discussion In this paper we attempt to map out the ethical tensions likely to arise in global health fieldwork as researchers negotiate the challenges of balancing ethics committees’ rules and bureaucracies with actual fieldwork processes in local contexts. Drawing from our research experiences with (...) an implementation and evaluation project in Jamaica, we argue that ethical research is produced through negotiated spaces and reflexivity practices that are centred on relationships between researchers and study participants and which critically examine issues of positionality and power that emerge at multiple levels. In doing so, we position ethical research practice in global health as a dialectical movement between the spoken and unspoken, or, more generally, between operationalized rules and the embodied relational understanding of persons. Summary Global health research ethics should be premised not upon passive accordance with existing guidelines on ethical conduct, but on tactile modes of knowing that rely upon being engaged with, and responsive to, research participants. Rather than focusing on the operationalization of ethical practice through forms and procedures, it is crucial that researchers recognize that each ethical dilemma encountered during fieldwork is unique and rooted in social contexts, interpersonal relationships, and personal narratives. (shrink)

Large prospective biobanks are being established containing DNA, lifestyle and health information in order to study the relationship between diseases, genes and environment. Informed consent is a central component of research ethics protection. Disclosure of information about the research is an essential element of seeking informed consent. Within biobanks, it is not possible at recruitment to describe in detail the information that will subsequently be collected because people will not know which disease they will develop. It will also be difficult (...) to describe the specific research that will be performed using the biobank, other than to stipulate categories of research or diseases that are not included. Potential subjects can only be given information about the sorts of research that will be performed and by whom. Organisations responsible for biobanks usually argue that this disclosure of information is adequate when seeking informed consent, especially if coupled with a right to withdraw, as it would not be feasible or it would be too expensive to seek consent renewal on a regular basis. However, there are concerns about this ‘blanket consent’ approach’. Consent waivers have also been proposed in which research subjects entrust their consent with an independent third party to decide whether subsequent research using the biobank is consistent with the original consent provided by the subject. (shrink)

Men often make riskier decisions than women across a wide range of real-life behaviors. Whether this sex difference is accentuated, diminished, or stable under stressful conditions is, however, contested in the scientific literature. A critical blind spot lies amid this contestation: Most studies use standardized, laboratory-based, cognitive measures of decision making rather than complex real-life social simulation tasks to assess risk-related behavior. To address this blind spot, we investigated the effects of acute psychosocial stress on risk decision making in men (...) and women using a standardized cognitive measure and a novel task that simulated a real-life social situation. Participants were exposed to either an acute psychosocial stressor or an equivalent control condition. Stressor-exposed participants were further characterized as high- or low-cortisol responders. Results confirmed that the experimental manipulation was effective. On the IGT, participants characterized as low-cortisol responders made significantly riskier decisions than those characterized as high-cortisol responders. Similarly, in the online chatroom, participants characterized as low-cortisol responders were, relative to those in the Non-Stress group, significantly more likely to make risky decisions. Together, these results suggest that at lower levels of cortisol both men and women tend to make riskier decisions in both economic and social spheres. (shrink)

BackgroundGenome-wide association studies (GWAS) provide a powerful means of identifying genetic variants that play a role in common diseases. Such studies present important ethical challenges. An increasing number of GWAS is taking place in lower income countries and there is a pressing need to identify the particular ethical challenges arising in such contexts. In this paper, we draw upon the experiences of the MalariaGEN Consortium to identify specific ethical issues raised by such research in Africa, Asia and Oceania.DiscussionWe explore ethical (...) issues in three key areas: protecting the interests of research participants, regulation of international collaborative genomics research and protecting the interests of scientists in low income countries. With regard to participants, important challenges are raised about community consultation and consent. Genomics research raises ethical and governance issues about sample export and ownership, about the use of archived samples and about the complexity of reviewing such large international projects. In the context of protecting the interests of researchers in low income countries, we discuss aspects of data sharing and capacity building that need to be considered for sustainable and mutually beneficial collaborations.SummaryMany ethical issues are raised when genomics research is conducted on populations that are characterised by lower average income and literacy levels, such as the populations included in MalariaGEN. It is important that such issues are appropriately addressed in such research. Our experience suggests that the ethical issues in genomics research can best be identified, analysed and addressed where ethics is embedded in the design and implementation of such research projects. (shrink)

Considerations of justice and concern for well-being support conducting mental health research and addressing ethical concerns specific to mental health research are critical. We discuss these concerns, provide recommendations to enable the ethical conduct of mental health research, and argue that participants’ interests should be given primary weight in resolving apparent dilemmas. We also comment on provisions of two legislative actions in India relevant to mental health research: Rights of Persons with Disability Act 2016 and the Mental Health Care Act (...) 2017. Both conform to the 2006 United Nations Convention on Rights of Persons with Disabilities of which India is a signatory. Both provide protections and enumerate rights relevant to people with mental health conditions but with differing focus. The commonalities and differences between the three are discussed in the background of international literature on research in mental health conditions. Studies involving deception and future directions for ethical requirements regarding genetic research are discussed. (shrink)

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence will (...) be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world. (shrink)

Ethical codes help guide the methods of research that involves samples gathered from ?at-risk? populations. The current article reviews general as well as specific ethical principles related to gathering informed consent from partner violent offenders mandated to outpatient treatment, a group that may be at increased risk of unintentional coercion in behavioral sciences research due to court mandates that require outpatient treatment without the ethical protections imbued upon prison populations. Recommendations are advanced to improve the process of informed consent within (...) this special population and data supporting the utility of the recommendations in a sample 70 partner violent offenders are provided. Data demonstrate that participants were capable of comprehending all essential elements of consent. (shrink)

We systematically reviewed contemporary literature to create an evidence-informed framework for research studies involving children and adolescents who can assent to participate. We searched seven citation indices to locate peer-reviewed research published in English language journals between 2000 and 2012. After screening 1,231 titles and abstracts for relevance, we assessed levels of evidence, extracted information, and analysed content from 87 articles. Most articles narrowly focused on paediatric assent barriers and facilitators for decision-making about research participation. No articles provided a single, (...) comprehensive ethical framework to guide the development and review of research assent protocols. We developed a 6-step framework that provides guidance to: prepare the child for the assent process; assess the child’s readiness to engage in decision making; discuss the elements of informed consent to the greatest extent possible; seek an initial assent decision; monitor and affirm assent; and respect the child’s role as a research participant. The PAeDS-MoRe framework also supports the creation of process models that address the unique, developmental needs of paediatric sub-groups, and guides the operationalization of jurisdictional requirements for ethical research involving children who are unable to provide free, informed and ongoing consent. (shrink)

Recently the World Health Organization has highlighted the need to strengthen mental health systems following emergencies, including natural and manmade disasters. Mental health services need to be informed by culturally attuned evidence that is developed through research. Therefore, there is an urgent need to establish rigorous ethical research practice to underpin the evidence-base for mental health services delivered during and following emergencies.

Ethics dumping is the practice of undertaking research in a low- or middle-income setting which would not be permitted, or would be severely restricted, in a high-income setting. Whilst Kenya operates a sophisticated research governance system, resource constraints and the relatively low number of accredited research ethics committees limit the capacity for ensuring ethical compliance. As a result, Kenya has been experiencing cases of ethics dumping. This article presents 11 challenges in the context of preventing ethics dumping in Kenya, namely (...) variations in governance standards, resistance to double ethics review, resource constraints, unresolved issues in the management of biological samples, unresolved issues in the management of primary data, unsuitable informed consent procedures, cultural insensitivity, differing standards of care, reluctance to provide feedback to research communities, power differentials which facilitate the exploitation of local researchers and lack of local relevance and/or affordability of the resultant products. A reflective approach for researchers, built around the values of fairness, respect, care and honesty, is presented as a means of taking shared responsibility for preventing ethics dumping. (shrink)

There is too much that we do not know about COVID-19. The longer we take to find it out, the more lives will be lost. In this paper, we will defend a principle of risk parity: if it is permissible to expose some members of society (e.g. health workers or the economically vulnerable) to a certain level of ex ante risk in order to minimize overall harm from the virus, then it is permissible to expose fully informed volunteers to a (...) comparable level of risk in the context of promising research into the virus. We apply this principle to three examples of risky research: skipping animal trials for promising treatments, human challenge trials to speed up vaccine development, and low-dose controlled infection or “variolation.” We conclude that if volunteers, fully informed about the risks, are willing to help fight the pandemic by aiding promising research, there are strong moral reasons to gratefully accept their help. To refuse it would implicitly subject others to still graver risks. (shrink)

Between December 2020 and March 2021, the US Food and Drug Administration and the European Medicines Agency issued Emergency Use Authorizations and Conditional Marketing Authorizations for the distribution of the first COVID-19 vaccines. Although these vaccines were thoroughly assessed before their approval, regulators required companies to continue ongoing placebo-controlled clinical trials in order to gather further reliable scientific information on their safety and efficacy, as well as to start new studies to evaluate additional candidates. The aim of this paper is (...) to present and discuss the ethical issues raised by the tension between the need to continue these types of clinical trials and the obligations related to the protection of the rights and well-being of research participants. Specifically, we question whether—how, and to what extent—fundamental principles governing research involving human beings can be applied to the current pandemic situation. We argue that continuing ongoing placebo-controlled clinical trials can be considered ethically justifiable only if all participants are adequately informed of any developments that may affect their willingness to remain enrolled, including the current situation of resource scarcity and the prioritization criteria established for vaccination. However, we also argue that currently approved vaccines, which are considered safe and effective enough to be administered to millions of people as part of the vaccination campaign, necessarily represent the “best proven intervention” currently available and, therefore, should be used as comparators in future studies instead of placebo. (shrink)

Concerns about exploiting the poor or economically disadvantaged in clinical research are widespread in the bioethics community. For some, any research that involves economically disadvantaged individuals is de facto ethically problematic. The economically disadvantaged are thought of as “venerable” to exploitation, impaired decision making, or both, thus requiring either special protections or complete exclusion from research. A closer examination of the worries about vulnerabilities among the economically disadvantaged reveals that some of these worries are empirically or logically untenable, while others (...) can be better resolved by improved study designs than by blanket exclusion of poorer individuals from research participation. The scientific objective to generate generalisable results and the ethical objective to fairly distribute both the risks and benefits of research oblige researchers not to unnecessarily bar economically disadvantaged subjects from clinical research participation. (shrink)

Different immunotherapeutic approaches are in the pipeline for the treatment of drug dependence. “Drug vaccines” aim to induce the immune system to produce antibodies that bind to drugs and prevent them from inducing rewarding effects in the brain. Drugs of abuse currently being tested using these new approaches are opioids, nicotine, cocaine, and methamphetamine. In human clinical trials, “cocaine and nicotine vaccines” have been shown to induce sufficient antibody levels while producing few side effects. Studies in humans, determining how these (...) vaccines interact in combination with their target drug, are underway. However, although vaccines can become a reasonable treatment option for drugs of abuse, there are several disadvantages that must be considered. These include i) great individual variability in the formation of antibodies, ii) the lack of protection against a structurally dissimilar drug that produces the same effects as the drug of choice, and iii) the lack of an effect on the drug desire that may predispose an addict to relapse. In addition, a comprehensive overview of several crucial ethical issues has not yet been widely discussed in order to have not only a biological approach to immunotherapy of addiction. Overall, immunotherapy offers a range of possible treatment options: the pharmacological treatment of addiction, the treatment of overdoses, the prevention of toxicity to the brain or the heart, and the protection of the fetus during pregnancy. So far, the results obtained from a small-scale experiment using vaccines against cocaine and nicotine suggest that a number of important technical challenges still need to be overcome before such vaccines can be approved for clinical use. (shrink)

OBJECTIVE: Questions have been posed about the competence of persons with serious mental illness to consent to participate in clinical research. This study compared competence-related abilities of hospitalized persons with schizophrenia with those of a comparison sample of persons from the community who had never had a psychiatric hospitalization. METHODS: The study participants were administered the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), a structured instrument designed to aid in the assessment of competence to consent to clinical research. The (...) scores of 27 persons who met DSM-IV criteria for schizophrenia who were long-stay patients on a state hospital research ward were compared with those of 24 individuals from the community who were of similar age, gender, race, and socioeconomic status. RESULTS: Significant differences were found between the patients and the community sample on three measures of competence-related abilities: understanding, reasoning, and appreciation. Degree of psychopathology and cognitive functioning were significantly negatively correlated with understanding and appreciation among the patients with schizophrenia. Length of hospitalization was significantly negatively correlated with all measures of decision-making capacities. CONCLUSIONS: The generally poor performance of the long-stay patients with chronic schizophrenia highlights the difficulties this group is likely to encounter in providing consent to research. However, variation across the sample points to the need for individualized assessment and for validated techniques for facilitating decision making in the face of decisional impairments. (shrink)