Recent reports and papers on chimeric research highlight the promise of chimeric models of human neuropsychiatric disorders to ameliorate human suffering due to autism spectrum disorders, depression, and schizophrenia. These calls, however, typically do not acknowledge, much less address, criticisms of model creation and validation, or concerns about scientific conduct more generally. The ethical justification for the use of nonhuman animals in research depends on the production of benefits to humans based on such research. But the assessment and production (...) of benefits are highly uncertain and rife with both practical and conceptual challenges. This essay provides a general framework for classifying the benefits of biomedical research and then focuses on two factors that directly impact—and threaten—the production of knowledge in research that models neuropsychiatric disorders. (shrink)

Das Ziel einer so genannten Personalisierten Medizin ist es, verfügbare oder neue Interventionen zielgerichteter einzusetzen, um so ihren Nutzen zu optimieren. Mit dieser Zielsetzung sind an eine Prüfung der Zielerreichung die gleichen Anforderungen zu stellen wie an jede andere Intervention. Der Nutzen ist durch aussagefähige Studien, typischerweise also prospektive, kontrollierte Interventionsstudien, zu belegen. Dort, wo es um den Kern personalisierter Medizin, nämlich die Verbindung von Diagnostik und Behandlung geht, ist genau diese Verbindung in Form einer statistischen Wechselwirkung zu belegen. Enrichment-Designs (...) allein beantworten diese Frage nicht. Die Bewertung von Methoden der personalisierten Medizin ist problemlos in das Konzept evidenzbasierter Medizin einzubinden. (shrink)

It can be argued that there is an ethical requirement to classify correctly what is known and what is unknown in decision situations, especially in the context of biomedicine when risks and benefits have to be assessed. This is because other methods for assessing potential harms and benefits, decision logics and/or ethical principles may apply depending on the kind or degree of uncertainty. However, it is necessary to identify and describe the various epistemic states of uncertainty relevant to such estimates (...) in the first place. Therefore, this paper aims to develop a category system of different epistemic states of uncertainty which, although not exclusively, is primarily intended to be applied to early clinical trials. It is formed on the basis—and various combinations—of three dimensions of uncertainty that represent certain parts of incomplete knowledge: outcome (type of event), probability (of outcome) and evaluation (assessment of outcome). Furthermore, it is argued that uncertainty can arise from three different sources (the structure of the object of research, the state of the evidence, or individual handling of the research and already existing knowledge). The categories developed are applied to actual examples from gene therapy and genome editing to illustrate that they can be helpful for a more precise definition of the respective uncertainties, especially in the context of risk–benefit assessment. The categories allow a differentiated perspective of decision-making situations from the point of view of incomplete knowledge in general, but particularly, for example, in early clinical research, and may thereby support a more acceptable ethical assessment of potential harms and benefits. (shrink)

An axiom of medical research ethics is that a protocol is moral only if it has a “favorable risk-benefit ratio”. This axiom is usually interpreted in the following way: a medical research protocol is moral only if it has a positive expected value -- that is, if it is likely to do more good (to both subjects and society) than harm. I argue that, thus interpreted, the axiom has two problems. First, it is unusable, because it requires us to (...) know more about the potential outcomes of research than we ever could. Second, it is false, because it conflicts with the so-called “soft paternalist” principles of liberal democracy. In place of this flawed rule I propose a new way of making risk-benefit assessments, one that does comport with the principles of liberalism. I argue that a protocol is moral only if it would be entered into by competent subjects who are informed about the protocol. The new rule this eschews all pseudo-utilitarian calculation about the protocol’s likely harms and benefits. (shrink)

It has been presumed within bioethics that the benefits and risks of treatments can be assessed independently of information disclosure to patients as part of the informed consent process. Research on placebo and nocebo effects indicates that this is not true for symptomatic treatments. The benefits and risks that patients experience from symptomatic treatments can be shaped powerfully by information about these treatments provided by clinicians. In this paper we discuss the implications of placebo and nocebo research for risk–benefit (...) assessment and informed consent. (shrink)

For each research protocol that they review, institutional review boards must assess whether the risks of the protocol are acceptable in relation to the potential direct benefits to study participants and/or society. This requirement means that an IRB should first identify risks that are not compensated by direct benefits to the subjects and then judge whether these so-called net risks are acceptable in relation to the benefits to society. We argue that the conventional approach to risk-benefit assessment is (...) not accurate enough to identify all net risks involved in any given protocol. Two relatively new approaches—the component analysis approach and the net risks test—can be of much more use to review boards, especially when used together. (shrink)

Advanced new therapies, such as stem cell and gene therapies and xenotransplantation, represent challenges for regulatory and ethical review. Major drug agencies, such as in the U.S., India, and Europe, have asserted regulatory authority and require ethics review by local ethics review committees, using the same strict requirements as those for standard drug approvals. In spite of this, unapproved and undocumented stem cell clinics flourish in all of these places, suggesting that current approaches do not offer patients sufficient protection. Japan (...) has attempted another approach, requiring approvals at local levels for all regenerative medical procedures, and a faster approval of promising new interventions. The Japanese approach has, however, also been criticized as not striking a proper balance between early access and a proper assessment of safety and effectiveness. For smaller and less-resourced countries, such as Thailand, one major challenge is limited expertise to conduct the evaluation of these advanced new therapies. This article provides an overview of the issues facing regulators and proposes that countries should restrict the early adoption of advanced new therapies to specialized clinics with appropriate scientific and ethical expertise for review. Review in these institutions should focus on expert clinical benefit assessments for individual patients being offered such interventions, independently of whether they are offered as research or therapy. (shrink)

In 2022, students at North American universities with third-dose COVID-19 vaccine mandates risk disenrolment if unvaccinated. To assess the appropriateness of booster mandates in this age group, we combine empirical risk-benefit assessment and ethical analysis. To prevent one COVID-19 hospitalisation over a 6-month period, we estimate that 31 207–42 836 young adults aged 18–29 years must receive a third mRNA vaccine. Booster mandates in young adults are expected to cause a net harm: per COVID-19 hospitalisation prevented, we anticipate (...) at least 18.5 serious adverse events from mRNA vaccines, including 1.5–4.6 booster-associated myopericarditis cases in males (typically requiring hospitalisation). We also anticipate 1430–4626 cases of grade ≥3 reactogenicity interfering with daily activities (although typically not requiring hospitalisation). University booster mandates are unethical because they: (1) are not based on an updated (Omicron era) stratified risk-benefit assessment for this age group; (2) may result in a net harm to healthy young adults; (3) are not proportionate: expected harms are not outweighed by public health benefits given modest and transient effectiveness of vaccines against transmission; (4) violate the reciprocity principle because serious vaccine-related harms are not reliably compensated due to gaps in vaccine injury schemes; and (5) may result in wider social harms. We consider counterarguments including efforts to increase safety on campus but find these are fraught with limitations and little scientific support. Finally, we discuss the policy relevance of our analysis for primary series COVID-19 vaccine mandates. (shrink)

Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption, involve uncertain and potentially high risk, with minimal chance of clinical benefit. Some question whether such trials should be offered, given the risk/benefit imbalance, and whether those who choose to participate are acting rationally. We address these questions through a longitudinal (...) decision-making study nested in a Thai acute HIV research cohort. In-depth interviews revealed central themes about decisions to join. Participants felt they possessed an important identity as members of the acute cohort, viewing their bodies as uniquely suited to both testing and potentially benefiting from HIV cure approaches. While acknowledging risks of ATI, most perceived they were given an opportunity to interrupt treatment, to test their own bodies and increase normalcy in a safe, highly monitored circumstance. They were motivated by potential benefits to themselves, the investigators and larger acute cohort, and others with HIV. They believed their own trial experiences and being able to give back to the community were sufficient to offset participation risks. These decisions were driven by the specific circumstances experienced by our participants. Judging risk/benefit ratios without appreciating these lived experiences can lead to false determinations of irrational decision- making. While this does not minimise vital oversight considerations about risk reduction and protection from harm, it argues for inclusion of a more participant-centered approach. (shrink)

Next SectionThere has been considerable debate surrounding the ethics of sham-controlled trials of procedures and interventions. Critics argue that these trials are unethical because participants assigned to the control group have no prospect of benefit from the trial, yet they are exposed to all the risks of the sham intervention. However, the placebo effect associated with sham procedures can often be substantial and has been well documented in the scientific literature. We argue that, in light of the scientific evidence (...) supporting the benefits of sham interventions for pain and Parkinson's disease that stem from the placebo effect, these sham-controlled trials should be considered as offering potential direct benefit to participants. If scientific evidence demonstrates the positive effect of placebo from sham interventions on other conditions, sham-controlled trials of interventions for the treatment of these conditions should be considered to have prospects of benefit as well. This potential benefit should be taken into account by research ethics committees in risk-benefit analyses, and be included in informed consent documents. (shrink)

Drowning has been the cause of over 2.5 million preventable deaths in the past decade. Despite the fact that the majority of drownings occur in open water, assessment of water safety competency typically occurs in swimming pools. The assessment of water safety competency in open water environments brings with it a few difficulties, but also promises tremendous benefits. The aim of this position paper is to discuss the benefits and caveats of conducting assessments in open water environments as (...) opposed to closed and controlled environments, and to provide recommendations for evidence-based practice. The first theoretical section discusses the effects of the environment and key variables on various factors of assessment. These discussions are linked to the two perspectives of representative learning design and information processing theory. The second section presents two pilot studies of relevance and provides practical implications for assessment of water safety competency. It seems that a combination of pool-based practice and open water education may be ideal in assessing aquatic skills competency. Assessment in open water presents clear benefits regarding validity, but often poses seemingly unsurmountable barriers, which providers may have reservations about in the absence of clear evidence. Hence this article provides a robust discussion about competency assessment and signals the practical importance of faithfully reproducing the environment in which skilled behavior is most relevant. (shrink)

What I call ‘the standard view’ claims that IRBs should not regard financial payment as a benefit to subjects for the purpose of risk/benefit assessment. Although the standard view is universally accepted, there is little defense of that view in the canonical documents of research ethics or the scholarly literature. This paper claims that insofar as IRBs should be concerned with the interests and autonomy of research subjects, they should reject the standard view and adopt ‘the incorporation (...) view.’ The incorporation view is more consistent with the underlying soft-paternalist justification for risk-benefit assessment and demonstrates respect for the autonomy of prospective subjects. Adoption of the standard view precludes protocols that advance the interests of subjects, investigators, and society. After considering several objections to the argument, I consider several arguments for the standard view that do not appeal to the interests and autonomy of research subjects. (shrink)

In recent years the benefit corporation has emerged as a new organizational form dedicated to legitimizing the pursuit of corporate social responsibility (CSR). Eschewing traditional governmental authority, the benefit corporation derives its moral legitimacy from the values of its owners and the oversight of a third party evaluator. This research identifies the benefit corporation as a new type of gray sector organization (GSO) and applies extant theory on GSOs to analyze its design. In particular, it shows how (...) the theory of GSO accountability can be used to assess the potential of benefit corporations for enhancing CSR. This research first examines the statutes that have established benefit corporations in five states in the US, along with bills in other states, to show how legislation defines their specific public benefits and holds them accountable for delivering these benefits. It then compares the accountability of the benefit corporation with that of other corporate - centric GSOs, e.g., GSOs that closely resemble traditional corporations. It concludes with significant design-based concerns about the utility of the benefit corporation as an effective organization for implementing CSR. (shrink)

Smart grids are rolling out internationally, with the United States nearing completion of a significant USD4-plus-billion federal program funded under the American Recovery and Reinvestment Act. The emergence of smart grids is widespread across developed countries. Multiple approaches to analyzing the benefits of smart grids have emerged. The goals of this white paper are to review these approaches and analyze examples of each to highlight their differences, advantages, and disadvantages. This work was conducted under the auspices of a joint U.S.-China (...) research effort, the Climate Change Working Group Implementation Plan, Smart Grid. We present comparative benefits assessments of smart grid demonstrations in the U.S. and China along with a BA of a pilot project in Europe. In the U.S., we assess projects at two sites: the University of California, Irvine campus, which consists of two distinct demonstrations: Southern California Edison’s Irvine Smart Grid Demonstration Project and the UCI campus itself; and the Navy Yard area in Philadelphia, which has been repurposed as a mixed commercial-industrial, and possibly residential, development. In China, we cover several smart-grid aspects of the Sino-Singapore Tianjin Eco-city and the Shenzhen Bay Technology and Ecology City. In Europe, we look at a BA of a pilot smart grid project in the Malagrotta area west of Rome, Italy, contributed by the Joint Research Centre of the European Commission. The Irvine sub-project BAs use the U.S. Department of Energy Smart Grid Computational Tool, which is built on methods developed by the Electric Power Research Institute. The TEC sub-project BAs apply Smart Grid Multi-Criteria Analysis developed by the State Grid Corporation of China based on the analytic hierarchy process with fuzzy logic. The B-TEC and TNY sub-project BAs are evaluated using new approaches developed by those project teams. JRC has adopted an approach similar to EPRI’s but tailored to the Malagrotta distribution grid. (shrink)

BackgroundResearch ethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis.DiscussionBy looking at decision studies, we see that both procedure-level approaches conflate the various risk-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 the risk-benefit tasks; instead, RECs are meant to evaluate risks and benefits, appraise risk treatment suggestions, and make the final decision.ConclusionAs such, research ethics 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)

Cesario's critiques and suggestions for redesigning social psychology experiments echo Dahl's call for developmental researchers to use experimental and naturalistic methods in a complementary manner for understanding children's development. We provide examples of how naturalistic observations can rectify Cesario's missing flaws for developmental studies investigating children's social biases and help researchers derive theories they can then experimentally test.

There are two critical steps in determining whether a medical experiment involving human subjects can be conducted in an ethical manner: assessing risks and potential benefits and obtaining potential subjects’ informed consent. Although an extensive literature on both of these aspects exists, virtually nothing has been written about human experimentation for which the objective is not to prevent, cure, or mitigate a disease or condition, but to enhance human capabilities. One exception is a 2004 article by Rebecca Dresser on preimplantation (...) genetic modification — one of the most controversial enhancement technologies — in which she states, “Under existing research ethics principles, it would be unethical for investigators to perform modifications exposing embryos expected to develop into healthy children to significant risk in exchange for a possible physical or mental enhancement.” But Dresser does not explain why such an experiment would be unethical under existing principles, and her conclusion is not self-evident. (shrink)

Human infection challenge studies (HCS) have been proposed as a means to accelerate SARS-CoV2 vaccine development and thereby help to mitigate a prolonged global public health crisis. A key criterion for the ethical acceptability of SARS-CoV2 HCS is that potential benefits outweigh risks. Although the assessment of risks and benefits is meant to be a standard part of research ethics review, systematic comparisons are particularly important in the context of SARS-CoV2 HCS in light of the significant potential benefits and (...) harms at stake as well as the need to preserve public trust in research and vaccines. In this paper we explore several considerations that should inform systematic assessment of SARS-CoV-2 HCS. First, we detail key potential benefits of SARS-CoV-2 HCS including, but not limited to, those related to the acceleration of vaccine development. Second, we identify where modelling is needed to inform risk-benefit (and thus ethical) assessments. Modelling will be particularly useful in (i) comparing potential benefits and risks of HCS with those of vaccine field trials under different epidemiological conditions and (ii) estimating marginal risks to HCS participants in light of the background probabilities of infection in their local community. We highlight interactions between public health policy and research priorities, including situations in which research ethics assessments may need to strike a balance between competing considerations. (shrink)

In 2004 Emanuel et al. published an influential account of exploitation in international research, which has become known as the 'fair benefits account'. In this paper I argue that the thin definition of fairness presented by Emanuel et al, and subsequently endorsed by Gbadegesin and Wendler, does not provide a notion of fairness that is adequately robust to support a fair benefits account of exploitation. The authors present a procedural notion of fairness – the fair distribution of the benefits of (...) research is to be determined on a case-by-case basis by the parties involved in each study. The fairness of the distribution of benefits is not assessed against an independent normative standard. Emanuel et al.'s account of fairness provides a framework for objecting only to transactions that occur without the fully informed consent of the weaker party. As a result, a debate about exploitation collapses into a debate about consent. This is problematic because, as the proponents of the fair benefits framework acknowledge, neither the trial participants' consent nor the host community's consent preclude exploitation. Attempts to stipulate normative standards of fairness to protect research subjects in developing countries have been controversial and divisive, and it is therefore understandable that bioethicists would be tempted to develop accounts of exploitation that are independent of such prescriptive principles. I conclude, however, that the utility of the fair benefits model of exploitation as a policy tool will ultimately depend on whether a substantive principle of fairness can be developed to underpin it. (shrink)

Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first (...) propose a categorization of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs. (shrink)

This paper focuses on the question of whether DNA patents help or hinder scientific discovery and innovation. While DNA patents create a wide variety of possible benefits and harms for science and technology, the evidence we have at this point in time supports the conclusion that they will probably promote rather than hamper scientific discovery and innovation. However, since DNA patenting is a relatively recent phenomena and the biotechnology industry is in its infancy, we should continue to gather evidence about (...) the effects of DNA patenting on scientific innovation and discovery as well the economic, social, and legal conditions relating to intellectual property in biotechnology. We should give the free market, the courts, researchers, and patent offices a chance to settle issues related to innovation and discovery, before we seek legislative remedies, since new laws proposed at this point would lack adequate foresight and could do more harm than good. However, we should be open to new laws or regulations on DNA patents if they are required to in order to deal with some of the biases and limitations of the free market. (shrink)

This book offers clinicians a long-awaited comprehensive paradigm for assessing object relations functioning in disturbed younger and older adolescents. It gives a clear sense of how object relations functioning is manifest in different disorders, and illuminates how scores on object relations measures are converted into a therapeutically relevant diagnostic matrix and formulation. Outlining the process of object relations assessment, Kelly presents vividly detailed cases of a range of disorders including anorexia nervosa, borderline states, depressive disorders, and trauma. The cases (...) portray the vicissitudes of object relations functioning and disruption that result in a unique structural developmental composite for a given adolescent. A major concern is demonstrating the utility and validity of two object representation measures--The Mutuality of Autonomy Scale and The Social Cognition Object Relations Scale --that are the main ones employed in the assessment of adolescents. MOA and SCORS scores facilitate a multidimensional understanding of the nuances of an adolescent's object relations functioning, and provide clinicians with organized, theory-based data leading to clear, specific treatment directions and guidelines and appropriate therapeutic programming. The book addresses the following questions: * Is individual psychotherapy indicated--will this adolescent benefit from an insight-oriented approach? * What are the likely directions that transference parameters will take in the treatment? * What types of countertransference reactions are likely to be anticipated in a given patient? * Is medication likely to be helpful in making this adolescent more accessible for treatment? Focusing only on adolescents, covering both the TAT and the Rorschach, and utilizing object relations theory as its major interpretive foundation, the book offers practitioners an alternative to general references based on a more actuarial, nomothetic, and atheoretical interpretive approach. It reflects one school of contemporary thought in projective assessment--one that advocates a more phenomenological, theory-based approach to test application and interpretation. (shrink)

There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally-sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants' motivations and the influence of payments on research subjects' behaviour and (...) risk assessment. Admittedly, the available research in this field is limited, but the research that has been conducted suggests that financial rewards do not distort research subjects' behaviour or blind them to the risks involved with research. Therefore, I conclude that research sponsors should prioritise the prevention of exploitation in international research by providing greater benefits to research participants. (edited). (shrink)

Bacterial conjugation, wherein DNA is transferred between cells through direct contact, is highly prevalent in complex microbial communities and is responsible for spreading myriad genes related to human and environmental health. Despite their importance, much remains unknown regarding the mechanisms driving the spread and persistence of these plasmids in situ. Studies have demonstrated that transferring, acquiring, and maintaining a plasmid imposes a significant metabolic burden on the host. Simultaneously, emerging evidence suggests that the presence of a conjugative plasmid can also (...) provide both obvious and unexpected benefits to their host and local community. Combined, this highlights a continuous cost‐benefit tradeoff at the population level, likely contributing to overall plasmid abundance and long‐term persistence. Yet, while the metabolic burdens of plasmid conjugation, and their causes, are widely studied, their attendant potential advantages are less clear. Here, we summarize current perspectives on conjugative plasmids’ metabolic burden and then highlight the lesser‐appreciated yet critical benefits that plasmid‐mediated metabolic burdens may provide. We argue that this largely unexplored tradeoff is critical to both a fundamental theory of microbial populations and engineering applications and therefore warrants further detailed study. (shrink)

The issue of assessing priorities is one that has become the subject of much debate in the National Health Service particularly in the wake of various documents on priorities from central Government. It has become even more so with the prospect of real cuts in expenditure. Economists claim that their science, or perhaps more accurately art can assist in determining not only how best to achieve various ends but also whether and to what extent competing objectives should be pursued. Such (...) choices cannot be made in the absence of some ethical considerations and it is important that health service decision makers (and in particular the medical profession) are aware if the relationship between economics (and especially cost-benefit analysis) and medical ethics. (shrink)

Diabetes self-management is a crucial part in the management of diabetic patients. Most randomized controlled clinical trials reported significant benefits by diabetes self-management education on DSM behaviors and metabolic control. Although the randomized clinical trials are the gold standard method in assessing the effectiveness of any intervention, including DSME interventions, the outcomes of these studies may reflect exaggerated effects; because in most of these studies, subjects in control group receive usual care with no any DSME. The lack of such education (...) in the control group had many drawbacks: make blindness impossible; at which non blinded studies may result in false-positive findings; it may be unethical to recruit patients for participation in DSME studies as control subjects, most of these studies with long periods of follow up, without any direct benefit to them during the study period; the lack of direct benefit to control subjects in any clinical trial may results in high attrition rate. The high attrition rate in clinical trials especially in the control group can lower the statistical power of the study results; thus, the DSME program would appear to have positive effects even if the program had no real benefit. This problem of the DSME exaggerated effects can be solved partially through providing control subjects with education about some DSM behaviors or comparing the effect of DSME through different educational approaches. (shrink)

Risks and burdens in the study participation, as well as an adequate risk-benefit balance, are key concepts for the evaluation of clinical studies by research ethics 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 in research ethics. However, there is currently no uniform and solid theoretical approach to risk assessment by RECs. Regulatory standards of research ethics such as the Declaration (...) of Helsinki provide only minimal guidance on how risk decisions are considered. Due to discrepancies in the existing literature and guidance documents, adequate risk assessment by RECs remains to be elusive. In this article, we address current definitions of risk and present our own concept of aggregate risk definition. Moreover, we highlight the concept of benefit, the standard of reasonableness with respect to ethics literature and different approaches of risk-benefit assessment. In order to present a comprehensive theoretical approach of risk assessment by RECs, further understanding of the definitions of risk may improve adequate decision-making tasks by RECs. To improve the process of risk assessment by RECs, a dynamic framework will be illustrated, showing step-by-step risk assessment functions. This approach may be a promising tool to ensure adequacy in risk assessment by RECs. (shrink)

To judge from the rash of recent law review articles, it is a miracle that research with human subjects in the U.S. continues to draw breath under the asphyxiating heel of the rent-seeking, creativity-stifling, jack-booted bureaucrethics that is the current system of research ethics oversight and review. Institutional Review Boards, sometimes called Research Ethics Committees, have been accused of perpetrating “probably the most widespread violation of the First Amendment in our nation's history,” resulting in a “disaster, not only for academics, (...) but for the whole nation.” One member of the President's Council on Bioethics went so far as to assert, “There has been no greater damage to academic freedom in the United States in my lifetime. And my lifetime encompasses McCarthy and it encompasses political correctness, both.” Locked in the bureaucratic “iron cage” of IRB oversight, critics charge that researchers have been transformed into a vulnerable, exposed population, subject to domination, that has been likened in one case to a kind of “Tuskegee in reverse.”. (shrink)

Dual-track assessment directs research ethics committees to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.Research guidelines around the world recognise that clinical research is ethical only when the risks to participants (...) are reasonable.1 Appropriate implementation of this requirement is vital to protecting research participants and allowing research to proceed when it poses acceptable risks. Unfortunately, as the US National Bioethics Advisory Commission notes: “current regulations do not further elaborate how risks and potential benefits are to be assessed, and little additional guidance is available to IRBs.”1The NBAC, as well as numerous commentators, recommend that research ethics committees , ethics review committees and institutional review boards should adopt what may be called dual-track risk assessment.2–5 Yet, dual-track assessment unnecessarily divides research interventions into two different categories before assessing their risks and relies on the unclear distinction between therapeutic and non-therapeutic interventions. As a result, dual-track assessment provides RECs with confusing guidance and has the potential to block valuable research that poses acceptable risks. This paper describes one alternative, the net risks test, and argues that this approach offers a better method for assessing research risks, one that puts RECs in a position to protect participants without blocking appropriate research studies.BACKGROUNDClinical research exposes participants to interventions and procedures to gather systematic data that may be used to improve overall health and well-being. To ensure that research is ethical, RECs must ensure that the risks and burdens to participants are not excessive and that …. (shrink)

AbstractDuring the Covid-19 pandemic, ethicists and researchers proposed human challenge studies as a way to speed development of a vaccine that could prevent disease and end the global public health crisis. The risks to healthy volunteers of being deliberately infected with a deadly and novel pathogen were not low, but the benefits could have been immense. This essay is a history of the three major efforts to set up a challenge model and run challenge studies in 2020 and 2021. The (...) pharmaceutical company Johnson and Johnson, the National Institutes of Health in the United States, and a private-public partnership of industry, university, and government partners in Britain all undertook preparations. The United Kingdom’s consortium began their Human Challenge Programme in March of 2021.Beyond documenting each effort, the essay puts these scientific and ethical debates in dialogue with the social, epidemiological, and institutional conditions of the pandemic as well as the commercial, intellectual, and political systems in which medical research and Covid-19 challenge studies operated. It shows how different institutions understood risk, benefit, and social value depending on their specific contexts. Ultimately the example of Covid-19 challenge studies highlights the constructedness of such assessments and reveals the utility of deconstructing them retrospectively so as to better understand the interplay of medical research and research ethics with larger social systems and historical contexts. (shrink)

:In a recent paper in Cambridge Quarterly of Healthcare Ethics on the necessary conditions for morally responsible animal research David DeGrazia and Jeff Sebo claim that the key requirements for morally responsible animal research are an assertion of sufficient net benefit, a worthwhile-life condition, and a no-unnecessary-harm condition. With regards to the assertion of sufficient net benefit, the authors claim that morally responsible research offers unique benefits to humans that outweigh the costs and harms to humans and animals. (...) In this commentary we will raise epistemic, practical, and ethical challenges to DeGrazia and Sebo’s emphasis on benefits in the prospective assessment of research studies involving animals. We do not disagree with DeGrazia and Sebo that, at the theoretical level, the benefits of research justify our using animals. Our contribution intends to clarify, at the practical level, how we should understand benefits in the prospective assessment and moral justification of animal research. We argue that ASNB should be understood as an assessment of Expectation of Knowledge Production in the prospective assessment and justification of animal research. EKP breaks down into two further claims: that morally responsible research generates knowledge worth having and that morally responsible research is designed and executed to produce generalizable knowledge. We understand the condition called knowledge worth having as scientists’ testing a hypothesis that, whether verified or falsified, advances an important interest, and production of generalizable knowledge in terms of scientific integrity. Generalizable knowledge refers to experimental results that generalize to a larger population beyond the animals studied. Generalizable scientific knowledge is reliable, replicable, and accurately descriptive. In sum, morally responsible research will be designed and carefully executed to successfully test a hypothesis that, whether verified or falsified, advances important interests. Our formulation of EKP, crucially, does not require further showing that an experiment involving animals will produce societal benefits. (shrink)

Much of the contemporary debate about the propriety of non-therapeutic circumcision of male infants and boys revolves around the question of risks vs. benefits. With its headline conclusion that the benefits outweigh the risks, the current circumcision policy of the American Academy of Pediatrics [AAP] (released 2012) is a typical instance of this line of thought. Since the AAP states that it cannot assess the true incidence of complications, however, critics have pointed out that this conclusion is unwarranted. In this (...) paper it is argued that the AAP’s conclusion is untenable not only for empirical reasons related to lack of data, but also for logical and conceptual reasons: the concept of risk employed—risk of surgical complications—is too narrow to be useful in the circumcision debate. Complications are not the only harms of circumcision: the AAP and other parties debating the pros and cons of circumcision should conceptualize their analysis more broadly as risk of harm vs. prospect of benefit, thereby factoring in the value of the foreskin to the individual and the physical and ethical harms of removing it from a non-consenting child. (shrink)

The expanded use of genetic testing raises key ethical and policy questions about possible benefits and harms for those receiving disease‐risk information. As predictive testing for Huntington’s was initiated in a clinical setting, survey research posing hypothetical test scenarios suggested that the vast majority of at‐risk relatives wanted to know whether they carried a disease‐causing mutation. However, only a small minority ultimately availed themselves of this opportunity. Many at‐risk individuals concluded that a positive test result would be too psychologically overwhelming. (...) A substantial literature suggests that individuals are often more resilient than anticipated in coping with many different health‐related stresses. Much of my own work in the field has been through the Risk Evaluation & Education for Alzheimer’s Disease study (REVEAL), a series of randomized clinical trials assessing the impact of genetic susceptibility testing on asymptomatic individuals at risk for Alzheimer’s disease. Our experience in developing and implementing four successive, multisite trials provides some potentially useful lessons for the field. More people will be asking for their personal genetic information. Better understanding will help us decide when access is appropriate and how best to disclose results in a manner that supports adjustment to test findings and promotes use of genetic information to improve human health. (shrink)

One argument against using cost-benefit analysis to justify policies aimed at promoting human life and health or protecting the environment is that it requires putting a price on priceless goods. This distorts the value of these goods, and it can affect their value by cheapening them. This argument might be rejected by a moral consequentialist who believes that a rational agent should always be able to reflect on his values, even priceless goods, and assess their costs and their importance. (...) This article defends the argument against cost-benefit analysis and suggests that a proper understanding of priceless goods shows that they also raise difficulties for consequentialist moral theories. (shrink)

The caliber of recent discourse regarding geneticallymodified organisms (GMOs) has suffered from a lack of consensuson terminology, from the scarcity of evidence upon which toassess risk to health and to the environment, and from valuedifferences between proponents and opponents of GMOs. Towardsaddressing these issues, we present the thesis that GM should bedefined as the forcible insertion of DNA into a host genome,irrespective of the source of the DNA, and exclusive ofconventional or mutation breeding.Some defenders of the commercial use of GMOs (...) have referred to thescientific work of GMO critics as ``junk science.'''' Such a claim isfalse and misleading, given that many papers critical of both theutility and safety of GMOs have been published in peer reviewedjournals by respected scientists. In contrast, there is a dearthof peer reviewed work to substantiate the frequently heardassertions of either safety or utility in GMOs. The polarity,which now characterizes much of the public discourse on GMOs,reflects not simply scientific disagreement, but alsodisagreement in underlying value assumptions. Value differencesstrongly affect the assessment of both benefit and harm fromGMOs. (shrink)

In research involving pregnant women and fetuses, a number of questions arise concerning the balancing of risks and benefits. In research that holds out a prospect of direct benefit for the woman, how much risk to the fetus is permissible? How should the principle of minimizing risks be applied when there are two subjects—pregnant woman and fetus? Should risks for each of them be minimized? What if minimizing risks for one increases risks for the other? These and other questions (...) are not addressed in the current federal regulations for the protection of human subjects. This paper reviews the current regulations, attempts to identify issues that need to be addressed, considers alternative viewpoints concerning those issues, and argues for particular views. It concludes with a set of proposed guidelines for balancing risks and benefits in research involving pregnant women and fetuses. (shrink)

The Assess Model of Intellectual Capital and a Company's Value Added Cohesion Nowadays intangible assets are especially important in every company and can help to increase a company's value added. The importance is so huge that many companies invest more money in intellectual capital than in material assets. Why has this happened? Scientists answer this question very quickly and easily - many companies have already been disappointed and damaged by their materials, goods, equipment, buildings, cars, machinery that cost a lot (...) of money but do not give effective productivity. On the contrary, intellectual capital that usually costs only the salary of an employee brings significant benefits. The research purpose is to evaluate the cohesion between intellectual capital and a company's value added and to provide the model of this cohesion. The methods used are analysis of scientific literature, GBN matrix method, expert evaluation, average comparison method, and Kendall's coefficient of concordance. Scientific aims: to reveal the cohesion between intellectual capital and a company's value added; to introduce a model of a company's value added and its intellectual capital; to demonstrate the results of expert evaluation on the model of intellectual capital and a company's value. The findings are as follows: intellectual capital is considered as a unit of social capital, communicational capital, and psychological capital; intellectual capital has a huge influence for the growth of a company's value added; employee motivation is the most important factor either for the growth of intellectual capital or a company's value added. Conclusions: expert evaluation was performed in order to investigate the importance of intellectual capital factors for the growth of intellectual capital itself and a company's value added. Experts were taken from two areas: business environment and academic environment. It is possible that experts from other environments could answer the questions in a completely different way, and this model could be improved even more. (shrink)

BackgroundOnline assessment of narrative production and comprehension became an important component of language assessment during the COVID-19 pandemic. This study aimed to establish quantitative measures of narrative macrostructure in the production and comprehension of adult Irish-English bilinguals in an online assessment.MethodsA total of 30 Irish-English bilingual adults participated in an online assessment of oral narrative production and comprehension. Narratives were elicited using LITMUS-MAIN for Irish and English. Story-tell elicitation method was used for all stories. Twenty participants (...) produced Baby Birds and Baby Goats story pairs while 10 participants produced Cat and Dog story pairs. Quantitative measures of story structure, comprehension score, and the overall number of Internal State Terms in production and comprehension were compared across the story pairs, languages, and the output type.ResultsA general linear model indicated no differences in either story structure or story comprehension scores across languages for both sets of stories. Combined analysis for all participants and stories indicated no difference in the story structure scores or comprehension scores across the languages or the story pairs. While the overall number of ISTs was the same across languages, a higher number of ISTs was observed in comprehension relative to production in both languages for Cat and Dog story pair only, but not for Baby birds and Baby goats' stories. The major benefit of using online assessment was the accessibility of participants. The major drawback was the inability to control the environment and the quality of the internet connection.Conclusion and implicationsWhile online assessment increased the availability of participants, which is a significant factor in rural Ireland characterized by low population density and the high percentage of Irish speakers, the availability of stable internet connection limited the applicability of online assessment. Measures of narrative macrostructure were stable across the languages and the story pairs. This is important because of high variability in exposure to Irish, frequent code-switching, and a high number of morphosyntactic errors due to rapid language change that characterizes Irish-English bilinguals. Identifying reliable measures of language performance for Irish-English adult speakers is an important step toward establishing developmental norms for Irish-English bilinguals. (shrink)