The reporting of clinical trial data is necessary not only for doctors to determine treatment efficacy, but also to explore new questions without unnecessarily repeating trials, and to protect patients and the public from dangers when data are withheld. This issue is particularly salient in those trials involving invasive neurosurgical interventions, such as deep brain stimulation (DBS), for ‘treatment refractory’ psychiatric disorders. Using the federal database ClinicalTrials.gov, it was discovered that out of the completed or unknown‐status trials related to psychiatric (...) DBS up to November 2018, only two had submitted results to ClinicalTrials.gov. These results suggest that, despite federal requirements to report clinical trial data, reporting on psychiatric DBS trials is problematically minimal. It is argued that a human rights approach to this problem establishes a legal and ethical foundation for the need to report clinical trial results in this area. (shrink)

Ethics codes of a number of scientific societies across different disciplines promulgate ethical standards for responsible conduct in research and other professional activities. The content of these codes of ethics are compared on key dimensions of research, service or practice, and teaching in terms of the range and specificity of the activities these codes cover, and in the degree to which they are educational, aspirational or regulatory in purpose. The role of professional associations in educating, regulating, monitoring, and sanctioning their (...) membership is also discussed. (shrink)

Chronic disorders of consciousness, particularly the vegetative and the minimally conscious states, pose serious diagnostic challenges to neurologists and clinical psychologists. A look at the concept of “diagnosis” in medicine reveals its social construction: While medical categorizations are intended to describe facts in the real world, they are nevertheless dependent on conventions and agreements between experts and practitioners. For chronic disorders of consciousness in particular, the terminology has proven problematic and controversial over the years. Novel research utilizing functional brain imaging (...) has demonstrated that a substantial number of patients retain their capabilities to communicate by brain activity even when they are incapable of classic verbal and nonverbal responses due to the dysfunction of their motor behavior. Moreover, thorough diagnostic assessments constitute the foundations for suitable rehabilitation measures. Thus, ethical arguments support the claim that the potential of emerging methods for communication via brain activity should be evaluated comprehensively in patients with chronic disorders of consciousness, once the technological methodology for this endeavor progresses to a reliable and affordable stage. (shrink)

Publication ethics is an important aspect of both the research and publication enterprises. It is particularly important in the field of biomedical science because published data may directly affect human health. In this article, we examine publication ethics policies in biomedical journals published in Central and Eastern Europe. We were interested in possible differences between East European countries that are members of the European Union (Eastern EU) and South-East European countries (South-East Europe) that are not members of the European Union.The (...) most common ethical issues addressed by all journals in the region were redundant publication, peer review process, and copyright or licensing details. Image manipulation, editors’ conflicts of interest and registration of clinical trialswere the least common ethical policies. Three aspects were significantly morecommon in journals published outside the EU: statements on the endorsement of international editorial standards, contributorship policy, and image manipulation.On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences amongbiomedical journals’ ethical policies calls for further research and active measuresto harmonize policies across journals. On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences among biomedical journals’ ethical policies calls for further research and active measures to harmonize policies across journals. (shrink)

Publication ethics is an important aspect of both the research and publication enterprises. It is particularly important in the field of biomedical science because published data may directly affect human health. In this article, we examine publication ethics policies in biomedical journals published in Central and Eastern Europe. We were interested in possible differences between East European countries that are members of the European Union and South-East European countries that are not members of the European Union. The most common ethical (...) issues addressed by all journals in the region were redundant publication, peer review process, and copyright or licensing details. Image manipulation, editors’ conflicts of interest and registration of clinical trials were the least common ethical policies. Three aspects were significantly more common in journals published outside the EU: statements on the endorsement of international editorial standards, contributorship policy, and image manipulation. On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences among biomedical journals’ ethical policies calls for further research and active measures to harmonize policies across journals. (shrink)

Trials with highly unfavourable risk–benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants’ motivations for enrolling in potentially high risk research with no prospect of direct benefit; and (...) third, participants’ understanding of the details of the trials in which they enrol. We argue that the communication concern is relevant to the validity of informed consent and the quality of decision making, that the motivation concern does not identify a genuine problem with either the validity of consent or the quality of decision making and that the understanding concern may not be relevant to the validity of consent but is relevant to the quality of decision making. In doing so, we derive guidance points for researchers recruiting and enrolling participants into their HIV cure trials, as well as the research ethics committees reviewing proposed studies. (shrink)

Ethics has been identified as a central reason for choosing the stepped wedge trial over other kinds of trial designs. The potential advantage of the stepped wedge design is that it provides all arms of the trial with the active intervention over the course of the study. Some groups receive it later than others, but the study intervention is not withheld from any group. This feature of the stepped wedge design seems particularly ethically advantageous in two instances: when the study (...) intervention appears especially likely to be effective and when the consequences of not receiving the intervention may be dire. But despite an increase in the use of the stepped wedge design and appeals to its ethical superiority as the motivation for its selection, there has been limited attention to the stepped wedge trial in the ethics literature. In the following, I examine whether there are persuasive ethical reasons to prefer or to require a stepped wedge trial. I argue that while the stepped wedge design is ethically permissible, it is not morally superior to other kinds of trials. To this end, I examine the ethical justification for providing, withholding, and delaying interventions in research. (shrink)

The length of participant information sheets for research and difficulties in their comprehension have been a cause of increasing concern. We aimed to examine the information sheets in research proposals submitted to an Australian HREC in one year, comparing the results with national recommendations and published data. Information sheets in all 86 research submissions were analysed using available software. The work of Flesch was used for Reading Ease or Readability and that of Flesch and Kincaid for the level of education (...) required for comprehension, the Reading Grade Level. The mean length of 86 information sheets was 3110 words; many had more than 5000 words. Using the Flesch scale of 0 to 100, with 0 meaning most difficult and 100 very easy to read, the mean readability level was 47. The mean length of education needed to easily grasp the information was 11.6 years, equivalent to senior secondary school. Information sheets in research projects submitted to an HREC were often too long to be read in a reasonable time and too difficult to be easily understood. Recommended standards for information sheets were infrequently met. (shrink)

Over the coming century, the accelerating advance of bioenhancement technologies, robotics, and artificial intelligence (AI) may significantly broaden the qualitative range of sentient and intelligent beings. This article proposes a taxonomy of such beings, ranging from modified animals to bioenhanced humans to advanced forms of robots and AI. It divides these diverse beings into three moral and legal categories—animals, persons, and presumed persons—describing the moral attributes and legal rights of each category. In so doing, the article sets forth a framework (...) for extending the concept of personhood well beyond its current boundaries, assigning moral standing to a variety of biological and nonbiological beings. The author concludes that six of the eight subgroups of such beings deserve to be treated as persons or as if they were persons, with full consideration for their presumed interests, rights, obligations, and capabilities for ethically significant agency and patiency. (shrink)

BackgroundIn research ethics, the most basic question would always be, “which is an ethical issue, which is not?” Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus. In this manuscript, we attempted to do just that.MethodsWe extracted (...) the imperatives from five internationally-known ethics guidelines and took note where the imperatives came from. In doing so, we gathered data on how many guidelines support a specific imperative.ResultsWe found that there is no consensus on the majority of the imperatives and that in only 8.2 % of the imperatives were there at least moderate consensus. Of the 12 clusters, Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least.ConclusionThere was a lack of consensus in the majority of imperatives from the five internationally-known ethics guidelines. This may be partly explained by the differences among the guidelines in terms of their levels of specification as well as conceptual/ideological differences. (shrink)

IntroductionNeurofeedback training is increasingly applied as a therapeutic tool in a variety of disorders, with growing scientific and clinical interest in the last two decades. Different Neurofeedback approaches have been developed over time, so it is now important to be able to distinguish between them and investigate the effectiveness and efficiency characteristics of each specific protocol. In this study we intend to examine the effects of Neurofeedback based on slow brain activity, the so-called Infra-Low Frequency training a recently developed methodology (...) that seems promising for the regulation of the central nervous system.AimsWith this review we intend to summarize the currently existing literature on ILF-Neurofeedback, examine its quality and formulate indications about the clinical effectiveness of ILF-Neurofeedback.MethodsLiterature search was first conducted according to PRISMA principles, described, and then assessed using the MMAT appraisal tool. 18 well-documented studies of ILF-Neurofeedback training in human subjects were picked up and analyzed. Reports include group interventions as well as single case studies.ResultsResearch data indicates good potential for ILF-Neurofeedback to influence brain activity and neurovegetative parameters. From the clinical profile, a salient common observation is a high level of individualization as a specific characteristic of ILF-Training: this feature seems to correlate with effectiveness of ILF-Neurofeedback, but also poses a challenge for researchers in terms of producing controlled and comparable findings; according to this point, some recommendation for future research on ILF-Neurofeedback are proposed. In conclusion, ILF-neurofeedback shows great potential for application for all those conditions in which the regulation of brain activity and neurophysiological processes are crucial. Further research will make it possible to complete the available data and to have a broader overview of its possible applications. (shrink)

BackgroundConcurrent with efforts to establish national and regional biorepositories in Africa is widespread endorsement of ethics committees as stewards of the interests of individual donors and their communities. To date, ethics training programs for IRB members in Botswana have focused on ethical principles and international guidelines rather than on the ethical dimensions of specific medical technologies and research methodologies. Little is known about the knowledge and concerns of current and prospective IRB members in Botswana with respect to export, reuse, storage, (...) and benefit-sharing of biospecimens.MethodsThis qualitative study examined perspectives of IRB members in Botswana about the collection and use of biospecimens in research. Forty-one IRB members representing five committees in Botswana participated in discussions groups in March 2013. Transcriptions of audiotapes and field notes were analyzed to identify issues of concern that might be alleviated through education and capacity-building, and areas that required ongoing discussion or additional regulatory guidance.ResultsAreas of concern included lack of understanding among patients and providers about the use of biospecimens in clinical care and research; reuse of biospecimens, particularly issues of consent, ownership and decision-making; export of specimens and loss of control over reuse and potential benefits; and felt need for regulatory guidance and IRB-member training. Local belief systems about bodily integrity and strong national identity in the construct of benefits may be at odds with initiatives that involve foreign biorepositories or consider such collections to be global public goods.ConclusionEducation is needed to strengthen IRB-member capacity to review and monitor protocols calling for the collection and use of biospecimens, guided by clear national policy on priority-setting, partnerships, review, and oversight. Engagement with local stakeholders is needed to harmonize fundamentally different ways of understanding the human body and community identity with the aims of contemporary biomedicine. (shrink)

This article presents a review of the literature, summarizes current initiatives, and provides a heuristic for assessing the effectiveness of a range of institutional review board collaborative strategies that can reduce the regulatory burden of ethics review while ensuring protection of human subjects, with a particular focus on international research. Broad adoption of IRB collaborative strategies will reduce regulatory burdens posed by overlapping oversight mechanisms and has the potential to enhance human subjects protections.

Purposeful infection of healthy volunteers with a microbial pathogen seems at odds with acceptable ethical standards, but is an important contemporary research avenue used to study infectious diseases and their treatments. Generally termed ‘controlled human infection studies’, this research is particularly useful for fast tracking the development of candidate vaccines and may provide unique insight into disease pathogenesis otherwise unavailable. However, scarce bioethical literature is currently available to assist researchers and research ethics committees in negotiating the distinct issues raised by (...) research involving purposefully infecting healthy volunteers. In this article, we present two separate challenge studies and highlight the ethical issues of human challenge studies as seen through a well-constructed framework. Beyond the same stringent ethical standards seen in other areas of medical research, we conclude that human challenge studies should also include: independent expert reviews, including systematic reviews; a publicly available rationale for the research; implementation of measures to protect the public from spread of infection beyond the research setting; and a new system for compensation for harm. We hope these additions may encourage safer and more ethical research practice and help to safeguard public confidence in this vital research alternative in years to come. (shrink)

Dispositional mindfulness and emotion regulation are two psychological constructs closely interrelated, and both appear to improve with the long-term practice of mindfulness meditation. These constructs appear to be related to subcortical, prefrontal, and posterior brain areas involved in emotional processing, cognitive control, self-awareness, and mind wandering. However, no studies have yet discerned the neural basis of dispositional mindfulness that are minimally associated with emotion regulation. In the present study, we use a novel brain structural network analysis approach to study the (...) relationship between structural networks and dispositional mindfulness, measured with two different and widely used instruments [Mindfulness Attention Awareness Scale and Five Facet Mindfulness Questionnaire ], taking into account the effect of emotion regulation difficulties. We observed a number of different brain regions associated with the different scales and dimensions. The total score of FFMQ and MAAS overlap with the bilateral parahippocampal and fusiform gyri. Additionally, MAAS scores were related to the bilateral hippocampus and the FFMQ total score to the right insula and bilateral amygdala. These results indicate that, depending on the instrument used, the characteristics measured could differ and could also involve different brain systems. However, it seems that brain areas related to emotional reactivity and semantic processing are generally related to Dispositional or trait mindfulness, regardless of the instrument used. (shrink)

Researchers should strictly consider the participants’ rights. They are required to document such protections as an ethical approval of the study proposal, the obtaining “informed consent”, the authors’ “conflict of interests”, and the source of “financial support” in the published articles. The purpose of this study was to assess the frequency of reporting ethical issues in human subject articles published in Iranian medical journals during 2009–2013. In this cross-sectional study, we randomly reviewed 1460 human subject articles published in Iranian medical (...) journals during 2009–2013 in two Persian and English language groups. Data collection was carried out by assessing articles, focusing on the documentation “ethics committee approval”, patients’ “informed consent”, “financial support”, “confidentiality”, and “conflict of interest”. Of 1460 evaluated articles, 443 reported “ethics committee approval”, 686 reported “informed consent”, 594 reported “financial support”, and 341 reported “conflict of interest”. 13% of the articles referred to patients’ confidentiality in their text. There was a significant association between these ethical documentations and the year of publication. Articles published in English language journals reported “ethics committee approval”, “financial support”, and “conflict of interest” significantly more than Persian language journals, but the frequency of “informed consent” was similar. Ethical documentation rate in Iranian medical journals is not up to the expected standards of reputable journals which might be related to a lack of awareness and the education of the authors and the journal’s editors. Precise reporting of ethical considerations in medical articles by authors are recommended. It is suggested journals and policymakers pay more attention to reporting this issue while providing standard guidelines in this regard. (shrink)

The randomised controlled trial (RCT) constitutes a quantitative, comparative, controlled study of a particular treatment, and provides invaluable evidence regarding its pharmacotherapeutic efficacy. These studies are generally predicated upon the ethical principle of clinical equipoise. However, this may be insufficient to justify withholding treatment from a control group while assessing drug therapy in a potentially fatal disease. Thus, the criteria for randomisation, informed consent methodology and timing, and consideration of treatment options in such a scenario remain the province of medical (...) ethics. This paper addresses the need for an RCT of ribavirin in the treatment of Crimean Congo haemorrhagic fever, and highlights underlying ethical concerns in light of the current medical, virological and ethical literature. (shrink)

Discussions about the merits and shortcomings of non-inferiority trials are becoming increasingly common in the medical community and among regulatory agencies. However, criticisms targeting the ethical standing of non-inferiority trials have often been mistargeted. In this article we review the ethical standing of trials of non-inferiority. In the first part of the article, we outline a consequentialist position according to which clinical trials are best conceived as epistemic tools aimed at fostering the proper ends of medicine. According to this view, (...) clinical trials are means to ends, and thus their moral status depends both on how well they perform as means to reach desired ends and on which ends they are meant to achieve. Building upon this normative framework in the next two sections we analyze the specific ethical issues raised by non-inferiority trials. By making it clear that clinical trials are just epistemic tools – i.e. means to certain ends – it is possible not only to clarify the conceptual debate over a fundamental issue in clinical research, but also to identify which ethically relevant considerations ought to be addressed in setting up a non-inferiority trial. (shrink)

The establishment of MyCohort in 2005 showed that there is a growing interest on the part of the Malaysian government in the creation of biobanks in the country. This project can be considered as the biggest and most comprehensive cohort study in Malaysia, where hundreds of thousands of human samples are stored for epidemiological and biomedical research. However, little is known about the current issues or the situation related to biobank research in Malaysia. There are pressing issues that need answers (...) such as the governance of the national biobank as well as other privately owned biobanks in the nation, the public perspectives and perceptions regarding biobanks, and other matters such as the ethical, legal, and social issues related to biobank research. This article will highlight the status and issues related to biobank research in Malaysia and provide suggestions on future research practices that we feel need to be seriously considered. These suggestions are designed to advance and enlighten researchers’ knowledge, as well as provide the public with information on issues associated to biobanking. Good governance increases public knowledge and trust, and religious acceptance of biobank research and accountability can lead to increased participation in biobank research. The direct implications of the discussion about the ethical, legal, and social issues of biobanks are pertinent for the foundation of knowledge relating to biobanks, as well as the forward gestures for future medicine for mankind. (shrink)

BackgroundConsenting for retrospective medical records-based research (MR) and leftover tissue-based research (TR) continues to be controversial. Our objective was to survey Saudis attending outpatient clinics at a tertiary care hospital on their personal preference and perceptions of norm and current practice in relation to consenting for MR and TR.MethodsWe surveyed 528 Saudis attending clinics at a tertiary care hospital in Saudi Arabia to explore their preferences and perceptions of norm and current practice. The respondents selected one of 7 options from (...) each of 6 questionnaires.ResultsRespondents' mean (SD) age was 33 (11) years, 42% were males, 56% were patients, 84% had ≥ secondary school education, and 10% had previously volunteered for research. Respectively, 40% and 49% perceived that the norm is to conduct MR and TR without consent and 38% and 37% with general or proposal-specific consent; the rest objected to such research. There was significant difference in the distribution of choices according to health status (patients vs. companions) for MR (adjusted Kruskal-Wallis test P = 0.03) but not to age group, gender, education level, or previous participation in research (unadjusted P = 0.02 - 0.59). The distributions of perceptions of current practice and norm were similar (unadjusted Marginal Homogeneity test P = 0.44 for MR and P = 0.89 for TR), whereas the distributions of preferences and perceptions of norm were different (adjusted P = 0.09 for MR and P = 0.02 for TR). The distributions of perceptions of norm, preferences, and perceptions of current practice for MR were significantly different from those of TR (adjusted P < 0.009 for all).ConclusionsWe conclude that: 1) there is a considerable diversity among Saudi views regarding consenting for retrospective research which may be related to health status, 2) the distribution of perceptions of norm was similar to the distribution of perceptions of current practice but different from that of preferences, and 3) MR and TR are perceived differently in regard to consenting. (shrink)

In recent years there has been an increase in research conducted in the Middle East, with a corresponding increase in the challenges faced by members of the Research Ethics Committees. This study compares the structures of Omani and Jordanian RECs and investigates the perceptions of the challenges affecting the work of the REC members in Oman and Jordan. A convenience sample of 34 Omani and 66 Jordanian participants from 21 universities was recruited in this cross-sectional study. Almost 70% disagreed that (...) the members of RECs are unqualified, providing comments without justification; half believed that members have limited experience in research, and almost three-quarters that they have different opinions regarding some ethical issues. No significant differences were found between Omani and Jordanian REC members regarding their perception of the challenges, except for the perception that reviewing proposals is a time-consuming task and that multi-REC centres are less available. The regression model showed that there were significantly more male members of Jordanian RECs, and that Jordanian members were less likely to receive formal training. In conclusion, the current structure of RECs and the challenges faced by members need to be re-evaluated by decision makers to improve the overall quality of research activities, and to ensure that current REC members’ practices adhere to international standards. (shrink)

In Jordan, research ethics committees exist in most health settings. However, little is known about Jordanian public views regarding the ethics of clinical research. This study aimed to evaluate Jordanian public understanding and attitudes about ethics in clinical research. A questionnaire was used to collect information that included demographics, public knowledge, and attitudes towards ethics in clinical research. It was administered via face-to-face interviews in two major cities in Jordan from 1st June to 15th August 2017. Of the 2315 respondents, (...) 2.33% were found to have poor knowledge, 22.16% had fair knowledge, and 75.51% had good knowledge of ethics in clinical research. Furthermore, 75.81% of respondents had positive attitudes towards ethics in research. However, only 45.23% reported that they trust clinical researchers in Jordan. Even though a large majority of respondents were aware of key features of research ethics, efforts are needed to address negative perceptions and knowledge deficits. (shrink)

The main question explored by the book is: How can cross-border access to human genetic resources, such as blood or DNA samples, be governed in such a way as to achieve equity for vulnerable populations in developing countries? The book situates the field of genomic and genetic research within global health and research frameworks, describing the concerns that have been raised about the potential unfairness in exchanges during recent decades. Access to and sharing in the benefits of human biological resources (...) are aspects not regulated by any international legal framework such as the Convention on Biological Diversity, which applies only to the exchange of plants, animals and microorganisms, as well as to associated traditional knowledge. Examples of genetic research perceived as exploitative are provided in order to illustrate the legal vacuum concerning the global governance of human genetic resources. The main conclusions drawn from the legal and ethical analysis are: - Benefit sharing is crucial in order to avoid the exploitation of developing countries in human genetic research. - With functioning research ethics committees, undue inducement is less of a concern in genetic research than in other areas of medical research (e.g. clinical trials). - Concerns remain over research involving indigenous populations; accordingly, recommendations are provided. In drawing these conclusions, the book addresses in detail a highly pressing topic in global bioethics and international law. In this regard, it combines bioethical arguments with jurisprudence, in particular with reference to the law of equity and the legal concepts of duress (coercion), unconscionable dealing, and undue inducement. (shrink)

Experimental design is one aspect of a scientific method. A well-designed, properly conducted experiment aims to control variables in order to isolate and manipulate causal effects and thereby maximize internal validity, support causal inferences, and guarantee reliable results. Traditionally employed in the natural sciences, experimental design has become an important part of research in the social and behavioral sciences. Experimental methods are also endorsed as the most reliable guides to policy effectiveness. Through a discussion of some of the central concepts (...) associated with experimental design, including controlled variation and randomization, this chapter will provide a summary of key ethical issues that tend to arise in experimental contexts. In addition, by exploring assumptions about the nature of causation and by analyzing features of causal relationships, systems, and inferences in social contexts, this chapter will summarize the ways in which experimental design can undermine the integrity of not only social and behavioral research but policies implemented on the basis of such research. (shrink)

The purpose of this dissertation is to identify some of the most pressing problems in the dominant contemporary approach to research ethics, and to devise an alternative approach that avoids these problems. I contend that the fundamental ethical values invoked in human research are often appealed to in contradictory or ambiguous ways, or in ways that do not adequately capture or do not show an adequate understanding of the specific ethical concerns of human research. One significant problem in this domain (...) is that values for ethical research are often unreflectively imported from medical therapy, producing ill-suited guidelines that cannot capture the different ethical situations that arise in the context of research. Furthermore, ethical guidelines in this area are often not developed with a sufficient understanding of the deep philosophical issues that they invoke. I suggest that we can address these problems through examining the fundamental ethical concerns of research on a philosophical level. This method will reveal severe problems with the approach to two of the ethical values underlying research; beneficence and respect for autonomy (or respect for persons). Once the nature of these problems has been revealed, and with reference to ethical problems that typically arise in the domain of research, I construct a coherent philosophical foundation for research ethics, which both avoids these deep-seated problems and better captures the ethical issues that arise in the domain of human research. I argue that we need to radically depart from the values of beneficence and autonomy/respect for persons as they are currently understood in the guidelines. We need an idea of beneficence that is clearly distinct from that which is used in the therapeutic medical context from which this notion is currently drawn. I also contend that we need to move away from autonomy as a central value in research ethics. I posit an alternative choice-based approach to informed consent which is concerned both with respecting agents’ freedom of choice, and also with their wellbeing, as providing a good means of protecting and promoting the interests of the individual research subject. Although these two imperatives are often thought to clash on a fundamental level, I will show that, in research ethics, they can be reconciled with minimal conflict. Though this represents a departure from the ethics of medical therapy, this approach is far more suited to the context of research. This theoretical basis for informed consent can help to clarify the ethical problems that are specific to this domain and provide us with relevant ethical guidance in research ethics. (shrink)

In the first half of this dissertation, I develop a heuristic methodology for analyzing scientific solutions to the problem of underdetermination. Heuristics are rough-and-ready procedures used by scientists to construct models, design experiments, interpret evidence, etc. But as powerful as they are, heuristics are also error-prone. Therefore, I argue that they key to prudently using a heuristic is the articulation of meta-heuristics---guidelines to the kinds of problems for which a heuristic is well- or ill-suited. Given that heuristics will introduce certain (...) errors into our scientific investigations, I emphasize the importance of a particular category of meta-heuristics involving the search for robust evidence. Robustness is understood to be the epistemic virtue bestowed by agreement amongst multiple modes of determination. The more modes we have at our disposal, and the more these confirm the same result, the more confident can we be that a result is not a mere artifact of some heuristic simplification. Through an analysis of case-studies in the philosophy of biology and clinical trials, I develop a principled method for modeling and evaluating heuristics and robustness claims in a qualitative problem space. The second half of the dissertation deploys the heuristic methodology to address ethical and epistemological issues in the science of clinical trials. To that end, I develop a network model for the problem space of clinical research, capable of representing the various kinds of experiments, epistemic relationships, and ethical justifications intrinsic to the domain. I then apply this model to ongoing research with the antibacterial agent, moxifloxacin, for the treatment of tuberculosis, tracking its development from initially successful and promising in vitro and animal studies to its disappointing and discordant performance across five human efficacy trials. Given this failure to find a robust result with moxifloxacin across animal and human studies, what should researchers now do? While my final analysis of this case does not definitively answer that question, I demonstrate how my methodology, unlike a statistical meta-analysis, helps to clarify the directions for further research. (shrink)

The present work is concerned with a phenomenon referred to as contextual cueing. In visual search, if a searched-for target object is consistently encountered within a stable spatial arrangement of distractor objects, detecting the target becomes more efficient over time, relative to non-repeated, random arrangements. This effect is attributed to learned target-distractor spatial associations stored in long-term memory, which expedite visual search. This Thesis investigates four aspects of contextual cueing: Study 1 tackled the implicit-explicit debate of contextual cueing from a (...) new perspective. Previous studies tested explicit access to learned displays by applying a recognition test, asking observers whether they have seen a given display in the previous search task. These tests, however, typically yield mixed findings and there is an on-going controversy whether contextual cueing can be described as an implicit or an explicit effect. The current study applied the new perspective of metacognition to contextual cueing and combined a contextual cueing task with metacognitive ratings about the clarity of the visual experience, either of the display configuration or the target stimulus. Bayesian analysis revealed that there was an effect of repeated context on metacognitive sensitivity for configuration, but not target, ratings. It was concluded that effects of contextual memory on metacognition are content-specific and lead to increased metacognitive access to the display configuration, but not to the target stimulus. The more general implication is that from the perspective of metacognition, contextual cueing can be considered as an explicit effect. Study 2 aimed at testing how explicit knowledge affects memory-guided visual search. Two sets of search displays were shown to participants: explicit and implicit displays. Explicit displays were introduced prior to the search experiment, in a dedicated learning session, and observers should deliberately learn these displays. Implicit displays, on the other hand, were first shown in the search experiment and learning was incidental through repeated exposure to these displays. Contextual cueing arising from explicit and implicit displays was assessed relative to a baseline condition of non-repeated displays. The results showed a standard contextual cueing effect for explicit displays and, interestingly, a negative cueing effect for implicit displays. Recognition performance was above chance for both types of repeated displays; however, it was higher for explicit displays. This pattern of results confirmed – in part – the predictions of a single memory model of attention-moderated associative learning, in which different display types compete for behavior and explicit representations block the retrieval of implicit representations. Study 3 investigates interactions between long-term contextual memory with short-term perceptual hypotheses. Both types of perceptual memory share high similarities with respect to their content, therefore the hypothesis was formulated that they share a common memory resource. In three experiments of interrupted search with repeated and non-repeated displays, it was shown that contextual cueing expedites performance in interrupted search; however, there was no interaction of contextual cueing with the generation or the confirmation of perceptual hypotheses. Rather, the analysis of fixational eye movements showed that long-term memory exerts its influence on search performance upon the first glance of a given display, essentially affecting the starting point of the search process. The behavior of approaching the target stimulus is then a product of generating and confirming perceptual hypotheses with these processes being unaffected by long-term contextual memory. It was concluded that long-term and short-term memory representations of the same search display are independent and exhibit additive effects on search performance. Study 4 is concerned with the effects of reward on perceptual learning. It was argued that rewarding repeated displays in a contextual cueing paradigm leads to an acceleration of the learning effect; however, it was not considered whether reward also has an effect in non-repeated displays. In these displays, at least the target position is kept constant while distractor configurations are random across repetitions. Usually this is done in order to account for target position-specific probability learning in contextual cueing. However, it is possible that probability learning itself is modulated by reward. The current experiment introduced high or low reward to repeated and importantly, also non-repeated displays. It was shown that reward had a huge effect on non-repeated displays, indicating that rewarding certain target positions, irrespective of the distractor layout, facilitates RT performance. Interestingly, reward effects were even larger for non-repeated compared to repeated displays. It was concluded that reward has a strong effect on probability-, and not context learning. (shrink)

The fourth amendment to the German Medicinal Products Act (Arzneimittelgesetz) states that nontherapeutic research in incompetent populations is permissible under the condition that potential research participants expressly declare their wish to participate in scientific research in an advance research directive. This article explores the implementation of advance research directives in Germany against the background of the international legal and ethical framework for biomedical research. In particular, it addresses a practical problem that arises from the disclosure requirement for advance research directives. (...) We show that, if the disclosure standard for advance research directives is set at a token level, nontherapeutic research in incompetent populations becomes practically impossible. To resolve this issue, we suggest the disclosure standard be set at a type level. (shrink)

This collection presents six case studies on the ethics of mental health research, written by scientific researchers and ethicists from around the world. We publish them here as a resource for teachers of research ethics and as a contribution to several ongoing ethical debates. Each consists of a description of a research study that was proposed or carried out and an in-depth analysis of the ethics of the study.