Interventions to decrease acquisition and transmission of sexually transmitted diseases among African American women using text messages versus small-group delivery modalities pose distinct research risks and benefits. Determining the relative risk–benefit ratio of studies using these different modalities has relied on the expertise of investigators and their institutional review boards. In this study, African American women participated in focus groups and surveys to elicit and compare risks and benefits inherent in these two intervention delivery modalities, (...) focusing on issues such as convenience, privacy, and stigma of participation. Some risk/benefit variables were implicated in willingness to participate the two intervention modalities. (shrink)

BackgroundThe increasing push to commercialize university research has emerged as a significant science policy challenge. While the socio-economic benefits of increased and rapid research commercialization are often emphasized in policy statements and discussions, there is less mention or discussion of potential risks. In this paper, we highlight such potential risks and call for a more balanced assessment of the commercialization ethos and trends.DiscussionThere is growing evidence that the pressure to commercialize is directly or indirectly associated with adverse (...) impacts on the research environment, science hype, premature implementation or translation of research results, loss of public trust in the university research enterprise, research policy conflicts and confusion, and damage to the long-term contributions of university research.SummaryThe growing emphasis on commercialization of university research may be exerting unfounded pressure on researchers and misrepresenting scientific research realities, prospects and outcomes. While more research is needed to verify the potential risks outlined in this paper, policy discussions should, at a minimum, acknowledge them. (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)

Biotechnology might contribute to solving food safety and security challenges. However, gene technology has been under public scrutiny, linked to the framing of the media and public discourse. The study aims to investigate people’s perceptions and acceptance of food biotechnology with focus on transgenic genetic modification versus genome editing. An online experiment was conducted with participants from the United Kingdom and Switzerland. The participants were presented with the topic of food biotechnology and more specifically with experimentally varied vignettes on (...) transgenic and genetic modification and genome editing. The results suggest that participants from both countries express higher levels of acceptance for genome editing compared to transgenic genetic modification. The general and personal acceptance of these technologies depend largely on whether the participants believe the application is beneficial, how they perceive scientific uncertainty, and the country they reside in. Our findings suggest that future communication about gene technology should focus more on discussing trade-offs between using an agricultural technologies and tangible and relevant benefits, instead of a unidimensional focus on risk and safety. (shrink)

Definition of the problem: The differentiation between ”therapeutic” and ”non-therapeutic” research has found broad acceptance within clinical research, law and medical ethics and is part of national law and international declarations. However, this terminology is problematic on the medical (descriptive) as well as on the ethical (normative) level. Arguments: On theoretical grounds and with an example from clinical practice it is argued that e.g. the terms ”therapeutic research” and ”experimental treatment” are rather manipulative to the patient. Conclusion: In obtaining informed (...) consent from human subjects in medical research the individual risk-benefit-assessment should be pointed out clearly rather than arguing in the category of ”therapeutic” versus ”non-therapeutic” research. (shrink)

Obtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrolment followed, later, by obtaining written consent, have been advocated by some clinicians and bioethicists but have received little empirical attention. We explored women’s and staff views about the consent procedures used during the internal pilot of a trial, where the protocol permitted staff to gain verbal consent at recruitment. Interviews with staff (...) and participating women. Data were analysed thematically and interviews were cross-compared to identify differences and similarities in participants’ views about the consent procedures used. Women and some staff highlighted benefits to obtaining verbal consent at trial enrolment, including expediting recruitment and reducing the burden on those left exhausted by their births. However, most staff with direct responsibility for taking consent expressed extreme reluctance to proceed with enrolment until they had obtained written consent, despite being comfortable using verbal procedures in their clinical practice. To account for this resistance, staff drew a strong distinction between research and clinical care and suggested that a higher level of consent was needed when recruiting into trials. In doing so, staff emphasised the need to engage women in reflexive decision-making and highlighted the role that completing the consent form could play in enabling and evidencing this process. While most staff cited their ethical responsibilities to women, they also voiced concerns that the absence of a signed consent form at recruitment could expose them to greater risk of litigation were an individual to experience a complication during the trial. Inexperience of recruiting into peripartum trials and limited availability of staff trained to take consent also reinforced preferences for obtaining written consent at recruitment. While alternative consent pathways have an important role to play in advancing emergency medicine research, and may be appreciated by potential recruits, they may give rise to unintended ethical and logistical challenges for staff. Staff would benefit from training and support to increase their confidence and willingness to recruit into trials using alternative consent pathways. This qualitative research was undertaken as part of the GOT-IT Trial. Date of registration 26/03/2014. (shrink)

The VOICES study involved at least one radical move in the decades-old debates about attention deficit hyperactivity disorder diagnosis and stimulant drug treatments: to systematically investigate young people's perspectives and experiences so that these could be included as evidence in social, ethical and policy deliberations about the benefits and risks of these interventions. The findings reported in this article were both surprising and unsurprising to us as researchers. We were surprised at the consistency of children's positive responses to (...) stimulant medication, and at the robustness of the experience of increased capacity for moral agency with medication. We were unsurprised at the insights many young people have into their own behaviours and that of others.I am hopeful that the perspectives of children reported in this article will inspire a fresh public conversation about the ethics of stimulant drug treatments, as well as further research with children. In order to believe that children's perspectives add something new and valuable to the social discourse, one must first view children as capable of reliably reporting their own experiences as part of a well-designed research study. It seems that Steven Rose does …. (shrink)

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

Actions that financially benefit one person may present risk to another person. For example, the payment incentives of portfolio managers and investors are often asymmetrical such that actions that benefit a portfolio manager can pose financial risk to clients. Despite the presence and potential harm of these asymmetries, few have addressed the question of who exploits these asymmetries and how to mitigate potential harm. Our study examined the effect of selfish personality traits (the Dark Triad) and interpersonal bonding on decision-making (...) for the self, another person, and another person with under reward asymmetry present. Results demonstrated that individuals higher in narcissism and psychopathy made risky decisions for themselves. However, when reward asymmetries were present, all three Dark Triad traits were associated with making riskier decisions for another person in order to benefit the self. There was also a significant interaction between interpersonal closeness generated through bonding and psychopathy such that bonding made the decision-making processes of those high in psychopathy less risky for others. These findings have implications for how different individuals with different relationships make self and other-based financial decisions, and how those decisions change when rewards are asymmetrical. (shrink)

A central principle of bioethics is “subject autonomy,” the acknowledgement of the primacy of the informed consent of the subject of research. Autonomy requires informed consent — the assurance that the research participant is informed about the possible risks and benefits of the research. In fact, informed consent is difficult when a single drug is being tested, although subjects have a baseline understanding of the testing of a pharmacological agent and the understanding that they can stop taking the (...) drug if there were an adverse event. However, informed consent is even less easily achieved in the modern arena of complex new molecular and cellular therapies. In this article, we argue that as science confronts new issues such as transplantation of stem cell products, which may live within the participant for the rest of their lives, researchers must carefully consider and constantly re-examine how they properly inform subjects considering participation trials of these novel therapeutic strategies.For example, the manufacture of a vial of a cell product that consists of a collection of growing cells is very different than the production of a vial of identical pills, which can be presumed to be identical. The scientific concepts on which these cellular approaches are based may seem alien and incomprehensible to a research subject, who thinks of a clinical trial as simply the selection and testing of the most efficacious pharmaceutical agent already proven to work in preclinical animal studies. The research subject would be wrong. (shrink)

We investigated whether, in the emergency department, educational video-assisted informed consent is superior to the conventional consent process, to inform trauma patients undergoing surgery about the procedure, benefits, risks, alternatives, and postoperative care. We conducted a prospective randomized controlled trial, with superiority study design. All trauma patients scheduled to receive trauma-related debridement surgery in the ED of Kaohsiung Medical University Hospital were included. Patients were assigned to one of two education protocols. Participants in the intervention group watched an (...) educational video illustrating informed consent information, whereas those in the control group read an informed consent document. The primary outcome was knowledge scores and the secondary outcome was assessment of patient satisfaction. A multivariable regression model, with predefined covariates, was used to analyze differences in knowledge scores and patient satisfaction levels between the groups. A total of 142 patients were enrolled, with 70 and 72 assigned to the intervention and control groups, respectively. Mean knowledge scores were higher in the intervention ) than in the control group. By multivariate analysis, the intervention group had significantly greater differences in knowledge scores. Age, injury severity score, and baseline knowledge score significantly affected the differences in knowledge scores. Significant improvements were observed in patients’ perception of statements addressing comprehension of the information provided, helpfulness of the supplied information for decision making, and satisfaction with the informed consent process. Multivariate analysis showed significant correlations between video education and patient satisfaction. Both the educational approach and severity of injury may have an impact on patient understanding during the informed consent process in an emergency environment. Video-assisted informed consent may improve the understanding of surgery and satisfaction with the informed consent process for trauma patients in the ED. Institutions should develop structured methods and other strategies to better inform trauma patients, facilitate treatment decisions, and improve patient satisfaction. The ClinicalTrials.gov Identifier is NCT01338480. The date of registration was April 18, 2011. (shrink)

There is an enduring tension in thinking about the architecture of systems that select behaviours, including evolved organisms. One line of reasoning supports convergence in control systems and conversion of the values of all options into a common currency, in part because this seems the best or only way of trading off costs and benefits associated with outcomes of varying types. A competing consideration supports parallelism or other forms of fragmentation, because of inefficiencies associated with integration, and suspicion towards (...) general-purpose cognitive systems. In addition, recent neuroscience has given particular attention to the question of how partly independent ‘habit based’ and ‘planning based’ decision-systems might interact. The issues here are, at least in part, a special case of the more general integration versus parallelism tension. This tension provides a useful framework for thinking about the implementation of different kinds of sensitivity to risks of various types, the variety of mechanisms by means of which risk sensitivity might be modulated, and how risk might be traded off against other components of value or disincentive. I describe the tension, briefly survey some of the relevant empirical evidence, and conclude with tentative observations on the topic of risk. (shrink)

With the arrival of new methods of genome editing, especially CRISPR/cas 9, new perspectives on germline interventions have arisen. Supporters of germ line genome editing claim that the procedure could be used as a means of disease prevention. As a possible life-saving therapy, it provides benefits that outweigh its risks. Opponents of GGE claim that the medical and societal risks, especially the use of GGE for genetic enhancement, are too high. In our paper, we analyze the (...) class='Hi'>risks and benefits of GGE. We show that the medical risk on an individual level might be reduced by further research in the near future so that they may be outweighed by the benefits. We also show that the societal risks of the procedure, i.e. genetic enhancement, are manageable by establishing a regulative framework before the GGE is implemented. Since the effects of modifying genes for the genepool of a given population are extremely difficult to model, the medical risks on the population level might be too high. (shrink)

Scientists and engineers often are not much interested in theoretical-ethics discussions. Frequently, like Harvard’s Cass Sunstein (2002), they propose “freemarket environmentalism,” basing environmental decisions on cost-benefit analysis and on saving the greatest number of lives for the fewest number of dollars. They say that when society overregulates, by emotively and irrationally rejecting environmental-risk decisions based only on cost-benefit analysis (CBA), it reduces manufacturing jobs, shrinks the economic pie, makes people poorer, and thus causes unnecessary deaths. To avoid these economic problems—that (...) harm everyone—Sunstein (2002, ix, 7) and others argue “for a kind of cost-benefit state” that .. (shrink)

This paper considers the ethics of educational technology in terms of whether or not selected media and methods are beneficial to the teacher and student, or whether other motives and criteria determine the selection. Communications media have proven themselves to be powerful and efficient tools, used like ?dynamite? for getting the most out of a ?quarry?, but the vast scope of their applicability and flexibility may notoriously neglect the unprecedented risks to the user of current online methods ? as (...) one of the areas in which ethical issues arise. Having mentioned en passant any potential benefits of all communications media, their harmful potential is also noted, and, based on this introductory notification, ethical responsibilities of all parties involved in educational media have been examined. The authors? main objective is to centralise the concept of the ?uncritical mass? representing the educationally uninformed general public whose selections of communication technologies can lead to their adoption as educational tools regardless of their educational value. (shrink)

The ability to determine genetic predisposition to cancer represents an opportunity to expand cancer control efforts in a manner that was previously unimaginable. This possibility also forces individual patients, families, health care professionals, and society to confront difficult questions about genetic knowledge. Although genetic testing or screening for cancer risk may hold promise of cancer control benefits, this prospect also raises significant ethical and legal concerns that must inform and shape policy decisions. In “Cancer Genetic Susceptibility Testing,” Benjamin Wilfond (...) and the Cancer Genetic Screening Consortium present a status report and an ambitious agenda for future examination of ethical and policy issues in this embryonic field. The paper provides a provocative and timely discussion of some extremely vexing issues, but it also misses on several critical points. (shrink)

Composed of scientific and technical experts and lay members, thousands of research ethics committees—Institutional Review Boards in the United States—must identify and assess the potential risks to human research subjects, and balance those risks against the potential benefits of the research. IRBs handle risk and its uncertainty by adopting a version of the precautionary principle. To assess scientific merit, IRBs use a tacit ``sanguinity principle,'' which treats uncertainty as inevitable, even desirable, in scientific progress. In balancing human (...) subjects risks and scientific benefits, IRBs use uncertainty as a boundary-ordering device that allows the mediation of the science and ethics aspects of their decisions. One effect is the entangling of methodological and ethical review. Some have suggested these should be more clearly separated, but decisions by research ethics committees depend in part on the negotiating space created by incommensurable approaches to uncertainty. (shrink)

It is almost universally acknowledged that risks have to be weighed against benefits, but there are different ways to perform the weighing. In conventional risk analysis, collectivist risk-weighing is the standard. This means that an option is accepted if the sum of all individual benefits outweighs the sum of all individual risks. In practices originating in clinical medicine, such as ethical appraisals of clinical trials, individualist risk-weighing is the standard. This implies a much stricter criterion for (...) risk acceptance, namely that the risk to which each individual is exposed should be outweighed by benefits for that same individual. The different choices of risk-weighing methods in different policy areas seem to have emerged from traditional thought patterns and social relations, rather than from explicit deliberations on possible justifications for the alternative ways to weigh risks against benefits. It is not obvious how the prevalent differences in risk-weighing practices can be reconstructed in terms of consistent underlying principles of preventive health or social priority-setting. (shrink)

Examining those risk and benefit perceptions utilised in the formation of attitudes and opinions about emerging technologies such as nanotechnology can be useful for both industry and policy makers involved in their development, implementation and regulation. A broad range of different socio-psychological and affective factors may influence consumer responses to different applications of nanotechnology, including ethical concerns. A useful approach to identifying relevant consumer concerns and innovation priorities is to develop predictive constructs which can be used to differentiate applications of (...) nanotechnology in a way which is meaningful to consumers. This requires elicitation of attitudinal constructs from consumers, rather than measuring attitudes assumed to be important by the researcher. Psychological factors influencing societal responses to 15 applications of nanotechnology drawn from different application areas were identified using repertory grid method in conjunction with generalised Procrustes analysis. The results suggested that people differentiate nanotechnology applications based on the extent to which they perceive them to be beneficial, useful, necessary and important. The benefits may be offset by perceived risks focusing on fear and ethical concerns. Compared to an earlier expert study on societal acceptance of nanotechnology, consumers emphasised ethical issues compared to experts but had less concern regarding potential physical contact with the product and time to market introduction. Consumers envisaged fewer issues with several applications compared to experts, in particular food applications. (shrink)

Background:An ethical, informed consent process requires that potential participants understand the study, their rights, and the risks and benefits. Yet, despite strategies to improve communication, many participants still lack understanding of potential risks and benefits. Investigating attitudes and practices of research nurses can identify ways to improve the informed consent process.Research question:What are the attitudes, practices, and preparedness of nurses involved in the informed consent process regarding communication of risks and benefits?Research design:A survey was (...) developed and administered online to a national purposive sample of 107 research nurses with experience obtaining informed consent for clinical trials. Survey responses stratified by selected work-related characteristics were analyzed.Ethical considerations:Participants were instructed they need not answer each question and could stop at any time. They consented by clicking “accept” on the email which linked to the survey. The study was approved by the Northeastern University Institutional Review Board, Boston, Massachusetts.Findings:Most research nurses used a teach-back method to assess participant comprehension, while 72% relied on their intuition. About one-third did not feel prepared to communicate related statistics. About 20% did not feel prepared to tailor information, and half did not feel competent using supplemental materials to enhance risks and benefits comprehension. Only 70% had received training in the informed consent process which included in-person training, case studies, online courses, feedback during practice sessions, and simulation, such as role playing and viewing videos. Perceived preparedness was significantly associated with greater informed consent experience and training.Conclusion:Research nurses may have inadequate training to encourage, support, and reinforce communication of risks and benefits during the informed consent process. Relevant purposeful education and training should help to improve and standardize the ethical informed consent process. (shrink)

We weigh the presumed benefts of routinely searching all research scans for incidental fndings against its substantial risks, including false-positive and false-negative fndings, and the possibility of triggering unnecessary, costly evaluations and perhaps harmful treatments. We argue that routinely searching for IFs may not maximize benefts and minimize risks to participants.

. Given the importance of the issue of scientific objectivity in our democratic societies and the significant development of citizen science, it is crucial to investigate how citizen science may either undermine or foster scientific objectivity. This paper identifies a variety of epistemic risks and benefits that participation of lay citizens in scientific inquiries may bring. It also discusses concrete actions and pending issues that should be addressed in order to foster objectivity in citizen science programs.

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 question of how to handle incidental findings has sparked a heated debate among neuroimaging researchers and medical ethicists, a debate whose urgency stems largely from the recent explosion in the number of imaging studies being conducted and in the sheer volume of scans being acquired. Perhaps the point of greatest controversy within this debate is whether the magnetic resonance imaging scans of all research participants should be reviewed in an active search for pathology and, moreover, whether this search should (...) be performed by a radiologist. Resistance to routine readings performed by radiologists, as opposed to selective review of those scans on which investigators have spotted a possible IF, has been fueled in part by the obvious and enormous cost — financial and logistical — of engaging radiologists to read massive numbers of scans. This cost would be especially burdensome, even prohibitive, to investigators who are not affiliated with a medical center, because of their limited access to radiologists and other medical expertise. (shrink)

Research in infection biology aims to understand the complex nature of host–pathogen interactions. While this knowledge facilitates strategies for preventing and treating diseases, it can also be intentionally misused to cause harm. Such dual-use risk is potentially high for highly pathogenic microbes such as Risk Group-3 (RG3) bacteria and RG4 viruses, which could be used in bioterrorism attacks. However, other pathogens such as influenza virus (IV) and enterohemorrhagic Escherichia coli (EHEC), usually classified as RG2 pathogens, also demonstrate high dual-use risk. (...) As the currently approved therapeutics against these pathogens are not satisfactorily effective, previous outbreaks of these pathogens caused enormous public fear, media attention and economic burden. In this interdisciplinary review, we summarize the current perspectives of dual-use research on IV and EHEC, and further highlight the dual-use risk associated with evolutionary experiments with these infectious pathogens. We support the need to carry out experiments pertaining to pathogen evolution, including to gain predictive insights on their evolutionary trajectories, which cannot be otherwise achieved with stand-alone theoretical models and epidemiological data. However, we also advocate for increased awareness and assessment strategies to better quantify the risks-versus-benefits associated with such evolutionary experiments. In addition to building public trust in dual-use research, we propose that these approaches can be extended to other pathogens currently classified as low risk, but bearing high dual-use potential, given the particular pressing nature of their rapid evolutionary potential. (shrink)

An offshoot of decision analysis, risk-cost-benefit analysis (RCBA) dominates US policymaking regarding science and technology. In this paper a central normative presupposition of RCBA, called "the linearity assumption" is argued against. This is that there is a linear relationship between the actual probability of fatality and the value of avoiding a social risk or the cost of a social risk. The main object of this essay is to show that the presuppositions underlying the linearity assumption are highly questionable. It is (...) maintained that assessors ought to give more consideration to broadening their interpretations of "unit cost" and "societal risk" and to abandoning their claims about linearity. (shrink)

There is scarce knowledge about the influence of the professional group, education, and age on public perspectives on the risks and benefits of forensic DNA databases. Based on data collected through an online questionnaire applied to 628 individuals in Portugal, this research fills that gap. More than three quarters of the respondents believed that the Portuguese forensic DNA database can help fight crime more efficiently and develop a swifter and more accurate justice, whereas only approximately half thought that (...) it could deter and prevent crime. Lack of security and control over access to data and the future unforeseen misuses of genetic information were the most relevant risks selected by the participants. Health care and life sciences professionals were more likely to agree with all the benefits, as opposed to those working in the field of law enforcement. More educated and older participants disagreed with benefits more often. Concerns with the risks increased with age. (shrink)

Philosophical discussions have critically analysed the methodological pitfalls and epistemological implications of evidence assessment in medicine, however they have mainly focused on evidence of treatment efficacy. Most of this work is devoted to statistical methods of causal inference with a special attention to the privileged role assigned to randomized controlled trials (RCTs) in evidence based medicine. Regardless of whether the RCT’s privilege holds for efficacy assessment, it is nevertheless important to make a distinction between causal inference of intended and unintended (...) effects, in that the unknowns at stake are heterogonous in the two contexts. However, although “lower level” evidence is increasingly acknowledged to be a valid source of information contributory to assessing the risk profile of medications on theoretical or empirical grounds, current practices have difficulty in assigning a precise epistemic status to this kind of evidence because they are more or less implicitly parasitic on the (statistical) methods developed to test drug efficacy. My thesis is that (1) “lower level” evidence is justified on distinct grounds and at different conditions depending on the different epistemologies which one wishes to endorse, in that each impose different constraints on the methods we adopt to collect and evaluate evidence; (2) such constraints ought to be understood to be different in the case of evidence for risk versus benefit assessment for a series of reasons which I will illustrate on the basis of the recent debate on the causal association between acetaminophen (a.k.a. paracetamol) and asthma. (shrink)

Research protocols must have a reasonable balance of risks and anticipated benefits to be ethically and legally acceptable. This article explores three characteristics of research on reproductive genetic technologies that complicate the assessment of the risk-benefit ratio for such research. First, a number of different people may be affected by a research protocol, raising the question of who should be considered to be the subject of reproductive genetic research. Second, such research could involve a wide range of possible (...) harms and benefits, making the evaluation and comparison of those harms and benefits a challenging task. Finally, the risk-benefit ratio for this type of research is difficult to estimate because such research can have unpredictable, long-term implications. The article aims to facilitate the assessment of risk-benefit ratios in research on reproductive genetic technologies by proposing and defending some guidelines for dealing with each of these complicating factors. (shrink)

Authoritarian nationalism is on the rise in many countries around the world, threatening liberal democracies. Many on the left rightly fear that any and all celebrations of national identities risk heightening these dangers. It is questionable, however, whether illiberal nationalism can be defeated politically without some reliance on progressive stories of national identity that advance themes of equality, freedom, and inclusion in ways that resonate with many of the traditions in which those whom progressives seek to mobilize have been raised.

This chapter contains sections titled: Knowing the Difference Between One's Ass and First Base Self‐Important Dork Personal Ethics and Professional Ethics The Philosophical Foundations of Bioethics Clinical Bioethics and Some Major Players Risk Versus Benefit Autonomy Inside the Outside Influences of Your Ink Memory Remodeling.

A series of studies investigated the capacity of children between the ages of 7 and 12 to give free and informed consent to participation in psychological research. Children were reasonably accurate in describing the purpose of studies, but many did not understand the possible benefits or especially the possible risks of participating. In several studies children's consent was not affected by the knowledge that their parents had given their permission or by the parents saying that they would not (...) be upset if the children refused. In contrast, other studies found that children were much more likely to stop their participation if the experimenter said explicitly that she would not be upset if they stopped. We suggest that experimenters should pay more attention to describing the possible risks and benefits of participation in research, and that they should also make it clearer to children that they are free to stop once they have begun. (shrink)

Accurate estimation of risk and benefit is integral to good clinical research planning, ethical review, and study implementation. Some commentators have argued that various actors in clinical research systems are prone to biased or arbitrary risk/benefit estimation. In this commentary, we suggest the evidence supporting such claims is very limited. Most prior work has imputed risk/benefit beliefs based on past behavior or goals, rather than directly measuring them. We describe an approach – forecast analysis – that would enable direct and (...) effective measure of the quality of risk/benefit estimation. We then consider some objections and limitations to the forecasting approach. (shrink)

This issue of the Report, like many others, was assembled with an eye more to diversity of topics and themes than to commonality. But as also often happens, some topics and themes arise anyway. Two pieces in this issue discuss the disclosure of information that's uncovered in the course of genetic testing and try to develop some guidance for physicians and researchers. A third offers an historical look at changing practices.

The concept of ‘human dignity’ sits at the heart of international human rights law and a growing number of national constitutions and yet its meaning is heavily contested and contingent. I aim to supplement the theoretical literature on dignity by providing an empirical study of how the concept is used in the specific context of legal discourse on sex work. I will analyse jurisprudence in which commercial sex was declared as incompatible with human dignity, focussing on the South African Constitutional (...) Court case of S v Jordan and the Indian Supreme Court case of Budhadev Karmaskar v State of West Bengal. I will consider how these courts conceptualise dignity and argue that their conclusions on the undignified nature of sex work are predicated on particular sexual norms that privilege emotional and relational intimacy. In light of the stigma faced by sex workers I will explore how a discourse, proclaiming sex work as beneath human dignity, may impact on the way that sex workers are perceived and represented culturally, arguing that it reinforces stigma. I will go on to examine how sex workers subvert the notion that commercial sex is undignified, and resist stigma, by campaigning for the right to sell sex with dignity. I will demonstrate that an alternative legal approach to dignity and sex work is possible, where the two are not considered as inherently incompatible, concluding with thoughts on the risks and benefits of using ‘dignity talk’ in activism and campaigns for sex work law reform. (shrink)

In this consensus report by a diverse group of academics who conduct and/or are concerned about social and behavioral genomics (SBG) research, the authors recount the often‐ugly history of scientific attempts to understand the genetic contributions to human behaviors and social outcomes. They then describe what the current science—including genomewide association studies and polygenic indexes—can and cannot tell us, as well as its risks and potential benefits. They conclude with a discussion of responsible behavior in the context of (...) SBG research. SBG research that compares individuals within a group according to a “sensitive” phenotype requires extra attention to responsible conduct and to responsible communication about the research and its findings. SBG research (1) on sensitive phenotypes that (2) compares two or more groups defined by (a) race, (b) ethnicity, or (c) genetic ancestry (where genetic ancestry could easily be misunderstood as race or ethnicity) requires a compelling justification to be conducted, funded, or published. All authors agree that this justification at least requires a convincing argument that a study's design could yield scientifically valid results; some authors would additionally require the study to have a socially favorable risk‐benefit profile. (shrink)

In recent years, there has been a particular emphasis placed on conducting randomized controlled trials (RCTs) that compare the relative efficacy of psychosocial and pharmacological interventions. This article addresses relevant ethical considerations in the conduct of these treatment trials, with a focus on RCTs with children. Ethical concerns, including therapeutic misconception, treatment preference, therapeutic equipoise, structure of treatments, and balancing risks versus benefits, are introduced through a clinical scenario and discussed as they relate to psychotherapy versus (...) medication RCTs. In each case, suggestions are made for researchers seeking to minimize the impact of these ethical concerns on research participants. (shrink)

In this paper the coherence of the precautionary principle as a guide to public health policy is considered. Two conditions that any account of the principle must meet are outlined, a condition of practicality and a condition of publicity. The principle is interpreted in terms of a tripartite division of the outcomes of action . Such a division of outcomes can be justified on either “consequentialist” or “deontological” grounds. In the second half of the paper, it is argued that the (...) precautionary principle is not necessarily opposed to risk–cost–benefit analysis, but, rather, should be interpreted as suggesting a lowering of our epistemic standards for assessing evidence that there is a link between some policy and “special bad” outcomes. This suggestion is defended against the claim that it mistakes the nature of statistical testing and against the charge that it is unscientific or antiscientific, and therefore irrational. (shrink)

Objectives: There are indications that institutional review board members do not find it easy to assess the risks and benefits in medical experiments, although this is their principal duty. This study examined how IRB members assessed the risk/benefit ratio of a specific phase II breast cancer clinical trial.Participants and methods: The trial was evaluated by means of a questionnaire administered to 43 members of IRBs at six academic hospitals and specialised cancer centres in the Netherlands. The questionnaire addressed: (...) identification and estimation of inconvenience, toxicity, psychosocial distress, and benefits of trial participation to patients; identification and estimation of benefits to future patients and medical science; assessment of the trial’s RBR; and assessment of its ethical acceptability.Results: Most IRB members expected trial participation to involve fairly or very serious inconvenience, fairly severe to sometimes life-threatening toxicity, and serious psychological and social consequences. Conversely, the perceived likelihood of benefits to patients was modest. Most regarded the study as important, and the balance between risks and benefits to be favourable, and believed that the protocol should be approved. The IRB members’ final judgement on the trial’s ethical acceptability was significantly correlated with their RBR assessment of the protocol.Conclusions: Because most patients who participate in clinical trials hope this will prolong their lives, it is suggested that patient information should better describe the anticipated benefits—for example, the likelihood of prolonging life. This would allow patients to make decisions regarding participation based on realistic expectations. (shrink)

The Helsinki Declaration, first published in 1964, is the universally accepted standard for ethical behavior in research involving human subjects. The Declaration was formulated in response to the abuses of human subjects by the scientists in Nazi Germany and to update the Nuremberg Code. Amended in 1975, 1983, 1989, 1996, and 2000, the Declaration provides the foundation for the United States federal regulations for research involving human subjects.To conform to standards developed in the Declaration, a researcher must fulfill the following: (...) respect the autonomy of the individual; promote and safeguard the individual’s health; provide informed consent without coercion; take special measures with vulnerable populations; compare new therapies to the best current therapies; have a thorough scientific knowledge of the subject; assess risk versus benefit of the intervention; perform studies that will ultimately benefit the population involved in the research; accurately report their findings; and fully disclose ethical concerns in their research protocols. (shrink)

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