BackgroundIn specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent.MethodsHere, we provide a more extensive literature review of possible exceptions to the rule of informed consent and the accompanying arguments based on literature from 1997 onwards, using both Pubmed and PsycINFO in our search strategy.ResultsWe identified three main categories of arguments for (...) the acceptability of a consent waiver: data validity and quality, major practical problems, and distress or confusion of participants. Approval by a medical ethical review board always needs to be obtained. Further, we provide examples of specific conditions under which consent waiving might be allowed, such as additional privacy protection measures.ConclusionsThe reasons legitimized by the authors of the papers in this overview can be used by researchers to form their own opinion about requesting an exception to the rule of informed consent for their own study. Importantly, rules and guidelines applicable in their country, institute and research field should be followed. Moreover, researchers should also take the conditions under which they feel an exception is legitimized under consideration. After discussions with relevant stakeholders, a formal request should be sent to an IRB. (shrink)

The ethical concept of Informed Consent provides individuals with the right and the opportunity to approve of events that will occur regarding his or her own person. In medicine, informed consent is obtained for treatment and for research participation. However, under some circumstances, prospective informed consent cannot be obtained because of the devastating clinical condition of the patient. In emergency circumstances, treatment is never withheld if obtaining informed consent from a critically ill person is not possible or if a (...) delay while seeking surrogates would further endanger life. In emergency research circumstances, waiving informed consent for study participation is fraught with additional ethical considerations. This article will review a presentation given at the June 2, 2006 conference entitled “The Ethics of Research in Emergency Medicine”. (shrink)

The Covid-19 pandemic has led to an unprecedented acceleration of research. Thousands of papers have been published in a very short time across a wide range of academic disciplines. This has already led to instances of research misconduct and articles have been withdrawn from prominent journals very soon after being published. It has also led to calls for the relaxation of generally accepted research ethics rules and rules concerning the protection of personal data during what is claimed (...) to be an exceptional time of crisis where research need to be speeded up and not hampered by rules more suitable to normal times. This chapter will outline some areas of research where there have been calls for the relaxation of research ethics rules, e.g. challenge studies in vaccine development, use of personal health data in epidemiology and the use of data from contact tracing apps. It will explicate and analyse the arguments presented for allowing such relaxation in exceptional times of crisis from a philosophical point of view. And it will ask to what extent the Covid-19 pandemic is an exceptional time of crisis in comparison with other important historical moments in medical research, and how the calls for exception relaxation of general rules fit with the history of research ethics and regulation. It will be argued that (1) the Covid-19 pandemic is far less exceptional than it initially appears, (2) the arguments for a relaxation of research ethics and data protection rules are less than convincing, and (3) the lesson we should really learn from Covid-19 is that adherence to a well justified set of rules can act as a protection against false exceptionalism and a counter to the temptation to bend the rules in crises. (shrink)

This chapter argues that journalism’s ethical frameworks, particularly at moments when it is making its grandest claims to value, collide with those prevalent within universities and particularly with ethical review structures. Working through these tensions requires some accommodation from all sides, and also provides opportunities for learning. The chapter discusses how universities might recognize the ethics systems particular to practices, like journalism, which set out to serve the public good and which produce knowledge in ways distinctive to that practice. Underneath (...) this problem is the more fundamental question of how to establish the boundaries between research and other activities that take place in the university. The chapter proposes, following Spicker’s argument in relation to policy studies, that distinctive ethical criteria must be recognized in different areas of university activity where claims to be producing research are being made. Yet it must also be noted that exceptionalism risks leaving university-based journalists with a weak ethical system. It concludes that journalists within the university have both the opportunity and obligation to extend their practice by using university processes to engage with a wide range of ethical frameworks. (shrink)

Over the last two decades sport-related research has become increasingly influenced by ethical propriety and institutional governance. Whilst there has been thorough consideration of biomedical and associated research in sport and exercise, social research in sport studies has received less attention. In this article, following a brief contextualization of the current climate for research ethics discourse, the planks of an argument for social research in sport without informed consent are addressed. Dealing with ideas linked to (...) ecological validity, impracticality, averting alarm, public interest and ‘leaving only footprints’, a case is made based on two important questions: (a) is the research useful?; and (b) are other research methods available that are fit-for-purpose and allow informed consent to be secured? If the answers are ‘yes’ and ‘no’, respectively, the case should be considered. In such instances the principle of ‘McFee’s friends’ serves as an important source of guidance for researchers. (shrink)

OBJECTIVE: To apply component analysis, a structured approach to the ethical analysis of risks and potential benefits in research, to published emergency research using a waiver of/exception from informed consent. The hypothesis was that component analysis could be used with a high degree of interrater reliability, and that the vast majority of emergency research would comply with a minimal-risk threshold. METHODS: A Medline search and manual search were done to identify studies using a waiver of/exception from informed (...) consent published between July 1996 and December 2000. A review panel of physicians and bioethicists independently classified nontherapeutic procedures in each study as minimal risk, probably minimal risk, or probably more than minimal risk. RESULTS: Seventy studies using a waiver of/exception from informed consent were identified. A majority of reviewers classified nontherapeutic procedures in 62 studies (88.6%) as minimal risk. Reviewers classified nontherapeutic procedures in six studies (8.6%) as minimal risk or probably minimal risk. In two studies (2.9%), nontherapeutic procedures were classified as probably more than minimal risk. The intraclass correlation coefficient was 0.89 (95% CI = 0.85 to 0.93), indicating very high interrater reliability. CONCLUSIONS: Component analysis can be used with high reliability to review emergency research and may improve the consistency of institutional review board review of emergency research. The vast majority of published emergency research performed using a waiver of/exception from consent complies with a properly-applied minimal-risk threshold. A minimal-risk threshold for nontherapeutic procedures protects subjects better than current U.S. regulations while permitting important emergency research to continue. (shrink)

A monomethod bias still prevails in the psychology of religion, with the developing field studying the relationship between religiosity, spirituality and health being almost completely dominated by questionnaire research. This comes as a surprise, because the experiential side of religion, spirituality, can by definition be regarded as inner and private experiences of transcendence that have frequently been described as being of utmost importance. At first glance, from this perspective, standardized questionnaire scales appear to be inappropriate for “measuring the unmeasurable”. (...) Until now, no questionnaire instrument developed for the purpose of assessing spiritual and religious experiences has been qualitatively double-checked for intermethod validity. In order to throw light on whether questionnaire instruments are appropriate for measuring domains of spiritual and transcendental experiences, we tested a newly developed questionnaire instrument, the Exceptional Experience Questionnaire , for intermethod validity by conducting post-questionnaire interviews . This revealed that the EEQ was able to grasp these experiences within reasonable limits. However, two thirds of our interview sample said that the study had changed how they viewed these experiences. These findings suggest that the reactivity of quantitative instruments in grasping spiritual and transcendental domains should be taken into account, especially when devising longitudinal designs and further research is clearly needed. As a consequence, introducing a reflective circle of results stemming from both quantitative and qualitative approaches is recommended as the most useful and appropriate research tool for studying spiritual or mystical experiences, if not all constructs. (shrink)

Background: Emergency exception to informed consent regulation was introduced to provide a venue to perform research on subjects in emergency situations before obtaining informed consent. For a study to proceed, institutional review boards need to determine if the regulations have been met.Aim: To determine IRB members’ experience reviewing research protocols using emergency exception to informed consent.Methods: This qualitative research used semistructured telephone interviews of 10 selected IRB members from around the US in the fall of 2003. IRB (...) members were chosen as little is known about their views of exception to consent, and part of their mandate is the protection of human subjects in research. Interview questions focused on the length of review process, ethical and legal considerations, training provided to IRB members on the regulations, and experience using community consultation and notification. Content analysis was performed on the transcripts of interviews. To ensure validity, data analysis was performed by individuals with varying backgrounds: three emergency physicians, an IRB member and a layperson.Results: Respondents noted that: emergency exception to informed consent studies require lengthy review; community consultation and notification regulations are vague and hard to implement; current regulations, if applied correctly, protect human subjects; legal counsel is an important aspect of reviewing exception to informed-consent protocols; and IRB members have had little or no formal training in these regulations, but are able to access materials needed to review such protocols.Conclusions: This preliminary study suggests that IRB members find emergency exception to informed consent studies take longer to review than other protocols, and that community consultation and community notification are the most difficult aspect of the regulations with which to comply but that they adequately protect human subjects. (shrink)

A monomethod bias still prevails in the psychology of religion, with the developing field studying the relationship between religiosity, spirituality and health being almost completely dominated by questionnaire research. This comes as a surprise, because the experiential side of religion, spirituality, can by definition be regarded as inner and private experiences of transcendence that have frequently been described as being of utmost importance. At first glance, from this perspective, standardized questionnaire scales appear to be inappropriate for “measuring the unmeasurable”. (...) Until now, no questionnaire instrument developed for the purpose of assessing spiritual and religious experiences has been qualitatively double-checked for intermethod validity. In order to throw light on whether questionnaire instruments are appropriate for measuring domains of spiritual and transcendental experiences, we tested a newly developed questionnaire instrument, the Exceptional Experience Questionnaire , for intermethod validity by conducting post-questionnaire interviews . This revealed that the EEQ was able to grasp these experiences within reasonable limits. However, two thirds of our interview sample said that the study had changed how they viewed these experiences. These findings suggest that the reactivity of quantitative instruments in grasping spiritual and transcendental domains should be taken into account, especially when devising longitudinal designs and further research is clearly needed. As a consequence, introducing a reflective circle of results stemming from both quantitative and qualitative approaches is recommended as the most useful and appropriate research tool for studying spiritual or mystical experiences, if not all constructs. (shrink)

Exception from Informed Consent (EFIC) regulations detail specific circumstances in which Institutional Review Boards (IRB) can approve studies where obtaining informed consent is not possible prior to subject enrollment.To better understand how IRB members evaluate community consultation (CC) and public disclosure (PD) processes and results, semi-structured interviews of EFIC-experienced IRB members were conducted and analyzed using thematic analysis.Interviews with 11 IRB members revealed similar approaches to reviewing EFIC studies. Most use summaries of CC activities to determine community members’ attitudes; none (...) reported using specific criteria nor recalled any CC reviews that resulted in modifications to or denials of EFIC studies. Most interviewees thought metrics based on Community VOICES’s domains (feasibility, participant selection, quality of communication, community perceptions, investigator/IRB perceptions) would be helpful.IRB members had similar experiences and concerns about reviewing EFIC studies. Development of metrics to assess CC processes may be useful to IRBs reviewing EFIC studies. (shrink)

Bioethicists have for quite some time discussed the right to know and the right not to know personal health information, such as genetic information acquired in health care and incidental health-related findings in research. Several international ethical guidelines explicitly defend these rights.My own interest in these matters stems from my participation in ethics-related research tied to a longitudinal screening study on Type I diabetes involving young children. A few of the participating parents did not want to be informed (...) if the study revealed their child had a high risk of developing diabetes. This response was troublesome, not least since the information would concern the child's and not the parents’ health. Our inclination was that there cannot be a right not to know that should be granted without qualifications. Furthermore, other contextual factors, e.g., that parents experienced pressure to participate and felt concern about some of the personal data handled in the study, gave reason to question whether autonomous decisions were made regarding participation. The autonomy of their expressed desire not to know was therefore questionable. (shrink)

This paper defends the right not to know personal health information, while it discards the right of research participants to receive individual research results. Disagreement regarding the right not to know stems from two different conceptions of autonomy, leading to opposing normative conclusions. Researchers occasionally have good reason to inform research participants about incidental findings in spite of the absence of a right to know such information. Such decisions have to be made by health care personnel and (...) researchers on a case by case basis, although external support for the decisions may be available. (shrink)

Biomedical research is so important that there is a positive moral obligation to pursue it and to participate in itScience is under attack. In Europe, America, and Australasia in particular, scientists are objects of suspicion and are on the defensive.i“Frankenstein science”5–8 is a phrase never far from the lips of those who take exception to some aspect of science or indeed some supposed abuse by scientists. We should not, however, forget the powerful obligation there is to undertake, support, and (...) participate in scientific research, particularly biomedical research, and the powerful moral imperative that underpins these obligations. Now it is more imperative than ever to articulate and explain these obligations and to do so is the subject and the object of this paper.Let me present the question in its starkest form: is there a moral obligation to undertake, support and even to participate in serious scientific research? If there is, does that obligation require not only that beneficial research be undertaken but also that “we”, as individuals and “we” as societies be willing to support and even participate in research where necessary?Thus far the overwhelming answer given to this question has been “no”, and research has almost universally been treated with suspicion and even hostility by the vast majority of all those concerned with the ethics and regulation of research. The so called “precautionary approach”9 sums up this attitude, requiring dangers to be considered more likely and more serious than benefits, and assuming that no sane person would or should participate in research unless they had a pressing personal reason for so doing, or unless they were motivated by a totally impersonal altruism. International agreements and protocols—for example, the Declaration of Helsinki10 and the CIOMS Guidelines11—have been directed principally at …. (shrink)

Clinical trials in emergency situations present unique challenges, because they involve enrolling individuals who lack capacity to consent in the context of acute illness or injury. The US Department of Health and Human Services and Food and Drug Administration regulations allowing an Exception from Informed Consent in these circumstances contain requirements for community consultation, public disclosure and restrictions on study risks and benefits. In this paper, we analyse an issue raised in the regulations that has received little attention or analysis (...) but is ethically complex. This challenge is when to solicit and honour objections to EFIC trial enrolment, including from non-legally appointed representatives. We address novel questions involving whose objections should be honoured, what level of understanding is necessary for objections to be considered valid and how hard investigators should work to offer an opportunity to object. We present a set of criteria that provide conceptual and practical guidance. We argue that objections should be honoured if they undermine one of the key assumptions that allows for the permissibility of EFIC trials: that individuals would likely not object to enrolment based on their values or preferences. We then clarify the practical implications of this approach through examination of three cases of refusal in an EFIC study. (shrink)

This paper defends a principle I call Equal Treatment, according to which the rationality of a belief is determined in precisely the same way as the rationality of any other state. For example, if wearing a raincoat is rational just in case doing so maximizes expected value, then believing some proposition P is rational just in case doing so maximizes expected value. This contrasts with the popular view that the rationality of belief is determined by evidential support. It also contrasts (...) with the common idea that in the case of belief, there are two different incommensurable senses of rationality, one of which is distinctively epistemic. I present considerations that favor Equal Treatment over these two alternatives, reply to objections, and criticize some arguments for Evidentialism. I also show how Equal Treatment opens the door to a distinctive kind of response to skepticism. (shrink)

Researchers sometimes engage in various forms of dishonesty and unethical behavior, which has led to regulatory efforts to ensure that they work according to acceptable standards. Such regulation is a difficult task, as research is a diverse and dynamic endeavor. Researchers can disagree about what counts as good and acceptable standards, and these standards are constantly developing. This paper presents and discusses recent changes in research integrity and ethics regulation in Norway, Denmark, and Sweden. Recognizing that research (...) norms are developed through practice and are therefore unsuited for comprehensive national regulation, the Scandinavian countries focus on empowering the research community to regulate itself instead, except for the most severe cases of misconduct. This empowerment takes the form of giving research institutions tools and investigatory powers while also holding them responsible for ensuring that both the institution and individual researchers are up to date on relevant norms. In this way, the Scandinavian governments seek to avoid some of the challenges found in more legalistic approaches, which risk lagging behind the continuous development of research norms and can be insensitive to the fact that different disciplines have different norms. While the new approach in Scandinavian has several potential benefits, it also involves potential trade-offs and limitations. The new laws can create confusion about what researchers are allowed to do. Another issue is that it only addresses the fundamental drivers of misconduct to a limited extent. (shrink)

In response to the COVID-19 pandemic, states have funneled exceptional amounts of public funding into research and development of diagnostics, treatments and vaccines to help fight the virus. In th...

The aim of the article is to explain the relationship between the ethical evaluation of scientific research involving personal data and the assessment of compliance with data protection law. The article presents the mutual relationship between the protection of personal data and scientific activity from a dogmatic perspective, the legal regulation of the processing of personal data in scientific research, and the so-called research exceptions that apply when data are processed for scientific research. It also (...) covers the importance of meeting the ethical requirements of scientific research in order to profit from the indicated exceptions. Finally, it provides a comparison between the ethical and the legal systems of personal data protection in research (objectives, criteria, authorities, and procedures). (shrink)

Global health emergencies such as the COVID-19 pandemic are contexts in which it is critical to draw upon learning from prior research and to conduct novel research to inform real-time decision-making and pandemic responses. While research is vitally important, however, emergencies are radically non-ideal contexts for its conduct, due to exceptional uncertainty, urgency, disruption, health needs, and strain on existing health systems, amongst other challenges. This generates novel ethical challenges and a broader conception of research ethics (...) is necessary to effectively address the complexity of pandemic research contexts. Going beyond traditional approaches to research ethics centring on the design of specific studies, this broader conception requires consideration of fundamental questions relating to the exercise of power and influence throughout research pathways, and a broader attention to both salient ethical issues, and the ethical responsibilities of stakeholders. These include important questions about responsibilities to gather evidence and generate knowledge systematically during emergencies, to implement policy responses in ways that are amenable to evaluation, and even potential moral obligations to participate in research. In situations of heightened uncertainty, additional questions arise about what constitutes sufficient evidence to justify the development and implementation of policy responses, and the responsibilities of scientific and social science researchers involved in policy-making processes. The four cases in this chapter prompt reflection on evolving and at times competing values and responsibilities of policy-makers, regulators, health authorities and researchers during the design and conduct of research, and proposed early implementation of research findings. These cases highlight issues arising when conducting research of national importance in a pandemic, where researchers are required to liaise with authorities responsible for pandemic responses and address complex ethical issues, including protecting the interests of participants and publics when tensions arise between prioritising the completion of research and accelerating the rollout of novel health interventions. This chapter invites reflection on the practical ethical implications of commitments to undertake research during emergencies, including the nature and scope of the relevant responsibilities of a range of stakeholders. (shrink)

Review boards responsible for vetting the ethical conduct of research have been criticised for their costliness, unreliability and inappropriate standards when evaluating some non-medical research, but the basic value of mandatory ethical review has not been questioned. When the standards that review boards use to evaluate research proposals are applied to review board practices, it is clear that review boards do not respect researchers or each other, lack merit and integrity, are not just and are not beneficent. (...) The few benefits of mandatory ethical review come at a much greater, but mainly hidden, social cost. It is time that responsibility for the ethical conduct of research is clearly transferred to researchers, except possibly in that small proportion of cases where prospective research participants may be so intrinsically vulnerable that their well-being may need to be overseen. (shrink)

The doctrine of clinical equipoise is appealing because it appears to permit physicians to maintain their therapeutic obligation to offer optimal medical care to patients while conducting randomized controlled trials (RCTs). The appearance, however, is deceptive. In this article we argue that clinical equipoise is defective and incoherent in multiple ways. First, it conflates the sound methodological principle that RCTs should begin with an honest null hypothesis with the questionable ethical norm that participants in these trials should never be randomized (...) to an intervention known to be inferior to standard treatment. Second, the claim that RCTs preserve the therapeutic obligation of physicians misrepresents the patient-centered orientation of medical care. Third, the appeal to clinical equipoise as a basic principle of risk-benefit assessment for RCTs is incoherent. Finally, the difficulties with clinical equipoise cannot be resolved by viewing it as a presumptive principle subject to exceptions. In the final sections of the article, we elaborate on the non-exploitation framework for the ethics clinical research and indicate issues that warrant further inquiry. (shrink)

We read with great interest Garland, Morain and Sugarman’s manuscript on the obligations of clinicians to participate in pragmatic clinical trials (PCTs) (Garland, Morain and Sugarman 2023). We bel...

I ask whether weapons research is ever justified. Weapons research is identified as the business of the engineer. It is argued that the engineer has responsibility for the uses to which the tools that he designs can be put, and that responsibility extends to the use of weapons. It is maintained that there are no inherently defensive weapons, and hence there is no such thing as ‘defensive’ weapons research. The issue then is what responsibilities as a professional (...) the engineer has in regard to such research. An account is given to ground the injunction not to provide the means to harm as a duty for the engineers. This account is not, however, absolutist, and as such it allows justifiable exceptions. The answer to my question is thus not that weapons research is never justified but there must be a strong assurance that the results will only be used as a just means in a just cause. (shrink)

Exceptional human experiences (EHEs) have garnered increasing research attention, particularly with regard to the characteristics and potential functional aspects of these experiences. The current study sought to replicate and expand upon previous research on EHEs by using a mixed-methods approach to examine the characteristics of EHEs in a large adult sample. The participants were 869 healthy adults who completed a survey that allowed participants to share both quantitative ratings and qualitative descriptions of EHEs. The results revealed that 96.7% (...) of respondents had experienced at least one EHE, and EHEs were generally rated as having a positive impact on the participants' lives. Participants reported a variety of EHEs, with two primary themes emerging in the qualitative analysis: perception and function of EHEs. The results suggest that EHEs may serve a positive, functional purpose in the lives of those who experience them. (shrink)

While most high school students will obtain future social class positions consistent with their class backgrounds, a handful of students are exceptions to this rule, being either upwardly mobile working-class students or downwardly mobile middle-class students. Highlighting predominant patterns, research typically ignores such students precisely because they are exceptions to the rule. This article, based on ethnographic research among white and Mexican American high school girls in California's Central Valley, foregrounds the experience of upwardly mobile working-class (...) students showing how race/ethnicity, class, and gender intersect in the lives of these young women, shaping their educational mobility. Using a comparative approach, this article examines the similarities and differences between white and Mexican American working-class girls' experiences of mobility. The article first describes the various contingencies leading to the girls' mobility, then explores their subjective experience of mobility, in both cases noting the girls' different experiences according to their race/ethnicity. (shrink)

This essay surveys the situation of Italian women life scientists from the late nineteenth to the mid-twentieth century. It follows the path that took women from being an exceptional presence to becoming a common, yet not equal, presence in the Italian science departments. Very different proportions of women occupied the three ranks in the academic hierarchy—students, research staff and professors. From the late nineteenth century onwards, women started to enrol in Italian universities. Initially, the second most popular department among (...) female students—outdone only by the humanities—was that of mathematics, physics and natural sciences. Concerning women among research staff, a brief statistical analysis reveals the growing proportion of the female workforce in academic institutions and brings into view poorly known female assistants and technicians. The most difficult career step for women was to gain a tenured university position. A comparison between bacteriologist Giuseppina Cattani’s ‘failure’ to gain such a position and the ultimately successful strategy of zoologist and limnologist Rina Monti, who became one of the very first female university professors in Europe, illustrates the opportunities as well as the obstacles women naturalists encountered on the way into the academia. These experiences and those of others show that well into the twentieth century the support of powerful male mentors continued to be indispensable for women scientists. Positions in peripheral institutes or specializations in emerging research fields, in particular hydrobiology, entomology and cytogenetics, provided opportunities for Italian women to work their way up to professorships. (shrink)

In the past decade, policy-makers in science have been concerned with harmonizing research integrity standards across Europe. These standards are encapsulated in the European Code of Conduct for Research Integrity. Yet, almost every European country today has its own national-level code of conduct for research integrity. In this study we document in detail how national-level codes diverge on almost all aspects concerning research integrity – except for what constitutes egregious misconduct. Besides allowing for potentially unfair responses (...) to joint misconduct by international collaborations, we argue that the divergences raise questions about the envisaged self-regulatory function of the codes of conduct. (shrink)

Germany is an interesting case with respect to the governance of reprogenetics. It has a strong profile in the technosciences and high aims regarding the global bioeconomy, yet her regulation of human genetics, reproductive medicine and embryo research has for a long time been rather restrictive. German biopolitical exceptionalism has often been explained by reference to Catholicism and the legacy of the Nazi past. The Germans, so goes the common story, have learnt the lessons of history and translated them (...) into unconditional respect for human dignity, which in turn translates into unconditional protection of human life, including the human embryo, and the firm repudiation of any eugenic distinction between ‘life worth to live’ and ‘life not worth to live’. This, however, is not the whole story. Alongside deontological strictness we find another strand of governing body politics and reprogenetics in Germany, the rule-and-exception model, running from the mid-1970s abortion law via the 2002 Stem Cell Act to the 2011 regulation of pre-implantation genetic diagnosis. In contrast to the former, that strongly draws on Kant and his concept of human dignity, the latter bears resemblances to Carl Schmitt's concept of state of exception. The article will show that the rule-and-exception model builds the exception into the rule and transforms the meaning and mandate of ethics, namely from safeguarding ethical standards to deciding about the exception. Given that the exception has now tended to become the rule, the question is whether the lessons of history will govern German reprogenetics for much longer. (shrink)

One of the distinguishing features of mathematics is the exceptional level of consensus among mathematicians. However, an analysis of what mathematicians agree on, how they achieve this agreement, and the relevant historical conditions is lacking. This paper is a programmatic intervention providing a preliminary analysis and outlining a research program in this direction.First, I review the process of ‘negotiation’ that yields agreement about the validity of proofs. This process most often does generate consensus, however, it may give rise to (...) another kind of disagreement: whether the original and new proof are effectively the same, leading to potential disagreement about the validity of the original proof.Second, I historicize the phenomenon of consensus. I show that in earlier European mathematics and other mathematical cultures, consensus about the validity of arguments was substantially weaker or conceived differently than it is today. This means that contemporary consensus about the validity of mathematical proofs should be explained by historical changes in mathematical practice.Finally, I conjecture what brought about the contemporary form of mathematical consensus. Since a sharp rise in consensus occurs around the turn of the 20th century, it makes sense to explain this consensus by the concurrent formalization of mathematics. However, this explanation has a major flaw: it explains a really existing phenomenon (consensus) by something that hardly ever happens (writing proofs in formal languages). I will therefore explain the ways in which formalization does enter mathematical practice so as to account for contemporary forms of mathematical consensus. (shrink)

Offering cash payments to research subjects is a common recruiting method but there is significant debate about whether and in what amount such payments are appropriate. This paper is concerned with exploitation and whether there should be a lower limit on the amount researchers can pay their subjects. When subjects participate in research as a way to make money, fairness requires that researchers pay them a fair wage. This call for the establishment of a lower limit meets resistance (...) in two places: (1) denial that the payments offered by researchers are wages for participation; and (2) concern about undue inducement. This paper critically examines these arguments for and against a lower limit. It shows that the need for a lower limit cannot be avoided by adopting a non-wage payment model and that concerns about undue inducement are unjustified in all trials except those that present greater than minimal risk. This analysis suggests the following compromise position: there should be an unconditional lower limit on payment amounts so that researchers cannot offer less than a fair wage, and when researchers cannot satisfy this limit because fairness requires a problematically large payment, then researchers should offer no payment at all. (shrink)

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to (...) give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only.. Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject’s life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject’s participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject’s consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject’s autonomy and rights it is necessary to add to them two other conditions: the emergency research could not be conducted using other research participants capable of giving informed consent; and informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible. A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible. (shrink)

While research on children is supported by many professional guidelines, international declarations and domestic legislation, when it is undertaken on children with no possibility of direct benefit it rests on shaky moral foundations. A number of authors have suggested that research enrolment is in the child's best interests, or that they have a moral duty or societal obligation to participate. However, these arguments are unpersuasive. Rather, I will propose in this paper that research participation by children seems (...) most reasonable when considered as an act of solidarity; a form of identification with, and provision of practical assistance to, those who are less well off. This is an articulation of the view that many children, and their parents, seem to take seriously the suffering of others, and wish to assist in advancing other children's wellbeing. Perhaps, by fostering an environment in which children are encouraged to take solidarity seriously, participation in research which holds out substantial hope of benefit to those less well off would come to be perceived as a behavioural norm rather than an exceptional practice. (shrink)

The gifted education research area is rapidly expanding in Sweden. In the context of very limited research nationally, demands are increasing for steering documents and addressing of student and teacher needs in practice. However, Swedish research on students that are ‘twice exceptional’—students classified as being both gifted and disabled (for instance, through a neurodevelopmental disorder such as ADHD)—is nearly non-existent. In this study, we present an exploratory single case study of a female student in school year seven (...) based on semi-structured individual interviews with the student and her two guardians regarding her educational situation. The data were first inductively coded and triangulated in collaboration between three of the authors. A fourth author later independently and deductively coded one-third of the data based on the previously inductively determined thematic structure and conducted a consensus interrater reliability check, exceeding 85% percent agreement. The three main themes are as follows: (1) multiplex perspectives on academic outcomes and expectations, (2) the intersection between twice exceptionality and academic work, and (3) information and perceptions about twice exceptionality. The results indicate several educational challenges and opportunities for twice exceptional students. Further research is needed regarding twice exceptional students in Sweden. (shrink)

We surveyed 1005 postdoctoral fellows by questionnaire about ethical matters related to biomedical research and publishing; 33% responded. About 18% of respondents said they had taken a course in research ethics, and about 31% said they had had a course that devoted some time to research ethics. A substantial majority stated willingness to grant other investigators, except competitors, access to their data before publication and to share research materials. Respondents’ opinions about contributions justifying authorship of (...) class='Hi'>research papers were mainly consistent but at variance with those of many biomedical journal editors. More than half said they had observed what they considered unethical research practices. To increase the chances of getting a grant funded, 27% said they were willing to select or omit data to improve their results; to make publication of their work more likely or to benefit their career, 15% would select or omit data and 32% would list an undeserving author. Of respondents who thought they had been unfairly denied authorship on a paper, or been listed with or asked to list an undeserving author, 75% said they would be willing to list an undeserving author (P<0.001). Having taken a course dealing with research ethics had no effect on stated willingness to select or omit data or to fabricate data in the future, but was positively associated with willingness to grant undeserved authorship (P<0.04). Although these results do not controvert research demonstrating the effectiveness of ethics courses during professional education, they indicate that the research environment is a powerful component of a trainee’s experience and ethical development. (shrink)

Literature on the ethics of researching refugees, both as participants and partners, presents strong arguments for why anonymity is the safer option in the event of questionable consent. However, blanket anonymity, without asking refugee interviewees if they wish to be anonymous, may cause more harm than good in certain contexts. One such context which this article will explore is the context of Israel, where a working Refugee Status Determination (RSD) system has yet to be established. This case study highlights that, (...) even in extreme circumstances where identity exposure can create risks, there may be a case for allowing identity exposure and perhaps an obligation on the part of the researcher to publish a name if this is the strong wish of the interviewee. This article builds on literature addressing confidentiality of identities (Duvell et al., 2010; Giordano et al., 2007; Kelly, 2009; Lahman et al., 2011; Lee, 1993; Mackenzie et al., 2007; Pittaway et al., 2010) and literature addressing informed consent (Hugman et al., 2011; Mackenzie et al., 2007; Pittaway et al., 2010; Zion et al., 2010). Primary sources demonstrating the use of waiving anonymity were collected between 2007 and 2012. Data were collected from refugee and activist civil society publications, television and newspaper media reports, participatory observation in the Israeli Knesset, and in-depth interviews with refugees and asylum seekers from South Sudan, Sudan, DR Congo, Liberia and Eritrea living in Tel Aviv, Jerusalem and Eilat. (shrink)

Largely unacknowledged by historians of the human sciences, late-19th-century psychical researchers were actively involved in the making of fledgling academic psychology. Moreover, with few exceptions historians have failed to discuss the wider implications of the fact that the founder of academic psychology in America, William James, considered himself a psychical researcher and sought to integrate the scientific study of mediumship, telepathy and other controversial topics into the nascent discipline. Analysing the celebrated exposure of the medium Eusapia Palladino by German-born (...) Harvard psychologist Hugo Münsterberg as a representative example, this article discusses strategies employed by psychologists in the United States to expel psychical research from the agenda of scientific psychology. It is argued that the traditional historiography of psychical research, dominated by accounts deeply averse to its very subject matter, has been part of an ongoing form of ‘boundary-work’ to bolster the scientific status of psychology. (shrink)

In this article, I argue that distinguishing ‘evolutionary’ from ‘Darwinian’ medicine will help us assess the variety of roles that evolutionary explanations can play in a number of medical contexts. Because the boundaries of evolutionary and Darwinian medicine overlap to some extent, however, they are best described as distinct ‘research traditions’ rather than as competing paradigms. But while evolu- tionary medicine does not stand out as a new scientific field of its own, Darwinian medicine is united by a number (...) of distinctive theoretical and methodological claims. For example, evolutionary medicine and Darwinian medicine can be distinguished with respect to the styles of evolutionary explanations they employ. While the former primarily involves ‘forward looking’ explanations, the latter depends mostly on ‘backward looking’ explanations. A forward looking explanation tries to predict the effects of ongoing evolutionary processes on human health and disease in contem- porary environments (e.g., hospitals). In contrast, a backward looking explanation typically applies evolutionary principles from the vantage point of humans’ distant biological past in order to assess present states of health and disease. Both approaches, however, are concerned with the prevention and control of human diseases. In con- clusion, I raise some concerns about the claim that ‘nothing in medicine makes sense except in the light of evolution’. (shrink)

The European Union Data Protection Regulation will have profound implications for public health, health services research and statistics in Europe. The EU Commission's Proposal was a breakthrough in balancing privacy rights and rights to health and healthcare. The European Parliament, however, has proposed extensive amendments. This paper reviews the amendments proposed by the European Parliament Committee on Civil Liberties, Justice and Home Affairs and their implications for health research and statistics. The amendments eliminate most innovations brought by the (...) Proposal. Notably, derogation to the general prohibition of processing sensitive data shall be allowed for public interests such as the management of healthcare services, but not health research, monitoring, surveillance and governance. The processing of personal health data for historical, statistical or scientific purposes shall be allowed only with the consent of the data subject or if the processing serves an exceptionally high public interest, cannot be performed otherwise and is legally authorised. Research, be it academic, government, corporate or market research, falls under the same rule. The proposed amendments will make difficult or render impossible research and statistics involving the linkage and analysis of the wealth of data from clinical, administrative, insurance and survey sources, which have contributed to improving health outcomes and health systems performance and governance; and may illegitimise efforts that have been made in some European countries to enable privacy-respectful data use for research and statistical purposes. If the amendments stand as written, the right to privacy is likely to override the right to health and healthcare in Europe. (shrink)

According to most substantive axiological theories – theories telling us which things are good and bad – pleasure is nonderivatively good. This seems to imply that it is always good, even when directed towards a bad object, such as another person’s suffering. This implication is accepted by the Mainstream View about misdirected pleasures: it holds that when someone takes pleasure in another person’s suffering, his being pleased is good, although his being pleased by suffering is bad. This view gains some (...) of its popularity from the advantages of an axiological theory that is structured in the way advocated by Brentano. However, I argue that we should reject the Mainstream View, in favour of an alternative suggested by Aristotle: this distinguishes between nonderivative goodness and exceptionless goodness. When it is good, being pleased is good nonderivatively – but it is not always good. The aim of the paper is to show how a Brentano-style theory can be modified to accommodate this alternative view, and how that supports a case for accepting it. (shrink)

This paper advances a new criterion of a vulnerable population in research. According to this criterion, there are consent-based and fairness-based reasons for calling a group vulnerable. The criterion is then applied to the case of people with serious illnesses. It is argued that people with serious illnesses meet this criterion for reasons related to consent. Seriously ill people have a susceptibility to “enticing offers” that hold out the prospect of removing or alleviating illness, and this susceptibility reduces their (...) ability to safeguard their own interests. This explains the inclusion of people with serious illnesses in the Belmont Report’s list of populations needing special protections, and supports the claim that vulnerability is the rule, rather than the exception, in biomedical research. (shrink)

The view that research with competent adults requires valid consent to be ethical perhaps finds its clearest expression in the Nuremberg Code, whose famous first principle asserts that “the voluntary consent of the human subject is absolutely essential.” In a similar vein, the United Nations International Covenant on Civil and Political Rights states that “no one shall be subjected without his free consent to medical or scientific experimentation.” Yet although some formulations of the consent principle allow no exceptions, (...) others hold that informed consent is not always strictly necessary for ethical research. The U.S. federal regulations known as the “Common Rule,” which govern research with human subjects, lists several conditions for waiving consent. However, neither guidance documents on the ethics of clinical research nor the literature in bioethics contains a general justification of research without consent. The purpose of this paper is to advance a justificatory framework that will explain why research without consent is permissible in paradigmatic cases and that can be useful in analyzing cases about which there is disagreement. We argue that research without consent can be justified on two grounds: if it stands to infringe no right of the participants and obtaining consent is impracticable, or if the gravity of the rights infringement is minor and outweighed by the expected social value of the research and obtaining consent is impracticable. (shrink)

ABSTRACT In this paper, I support the claim that placing certain restrictions on public access to possible new treatments is morally problematic under some exceptional circumstances. Very ill patients may find that all available standard treatments are unacceptable, either because they are ineffective or have serious adverse effects, and these patients may understandably be desperate to try something new even if this means stepping into the unknown. Faced with certain death, it is rational to want to try something new and (...) to chance a dire outcome. Restricting possible new treatments to research trials may put these treatments scientifically, geographically or economically out of reach of these patients. For those who can get access, research restrictions could weaken, though not necessarily eliminate, the value of consent participants of such trials are able to give. Some participants may therefore be exploited for scientific purposes in the name of public interest. There are nonetheless compelling reasons for keeping some restrictive regulation in this area. (shrink)