The pre-trial detention of individuals charged with crimes is viewed by many legal scholars as problematic. Standard arguments against it are that it constitutes legal punishment of individuals not yet convicted of crimes, violates the presumption of innocence, and rests on dubious predictions of future crime. I defend modified and restrained forms of pre-trial detention. I argue that pre-trial detention could be made very different than imprisonment, should be governed by strict criteria, and is warranted, when the (...) evidence of danger is convincing. I contend that the presumption of innocence does not preclude us from doing many other things to criminal suspects and defendants that imply their guilt. Finally, I dispute arguments designed to show that pre-trial detention can be justified to prevent absconding or interferences with the course of justice, but not to prevent other, and sometimes much more serious, offenses. (shrink)

In the opening of the article, the author briefly assesses the existing legal regulations of criminal procedure in the Czech Republic adopted as far back as in 1961. He points out to specific imperfections, which justify the need for their recodification. The mainstay of the article is devoted to the very pre-trial proceedings, i.e. checking and investigation. The existing legal regulations are analysed, and selected application problems are mentioned in relation to the recodification under preparation.

Subjective probabilities play a significant role in the assessment of evidence: in other words, our background knowledge, or pre-trial beliefs, cannot be set aside when new evidence is being evaluated. Focusing on homeopathy, this paper investigates the nature of pre-trial beliefs in clinical trials. It asks whether pre-trial beliefs of the sort normally held only by those who are sympathetic to homeopathy can legitimately be disregarded in those trials. The paper addresses several surprisingly unsuccessful attempts to provide (...) a satisfactory justification for ignoring the pre-trial beliefs of the homeopathic community. The ensuing diagnosis of the difficulties here emphasizes that the reason the arguments for choosing the pre-trial beliefs of the conventional community seem insufficient is not the arguments per se. It is rather that there is no cogent argument for choosing the conventional stance which would at the same time rationally persuade a member of the homeopathic community. The paper concludes that, once we understand that this is the predicament, there is no genuine reason to doubt the reasoning that leads us to reject the pre-trial beliefs of the homeopathic community. (shrink)

The process of territorial planning is complicated, because there are different and even opposite interest of persons related with particular territory. Administrative legal regulation of territorial planning in Lithuania underlies emergence of a legal conflict, namely the administrative litigation. Investigation of the administrative dispute applying the pre-litigation procedure allows the parties thereof to save both money and time. This article presents the problematic aspects of the pre-trial investigation of the administrative disputes arising in the area of territorial planning. The (...) article is composed of an introduction, three parts and conclusions. In the first part the characteristics of the disputes arising in the area of territorial planning, the preconditions of origin, and the demand for the pre-trial investigation thereof are analyzed. Legal regulation of pre-trial investigation out-of-court of the disputes arising in the area of territorial planning is revealed in the second part. In the third part key provisions of the reform of the pre-trial investigation out-of-court of the disputes arising in the area of territorial planning are discussed. (shrink)

Existing justifications for exclusionary rules and stays of proceedings in response to pre-trial wrongdoing by police officers and prosecutors are often thought to be counter-productive or disproportionate in their consequences. This article begins to explore whether the concept of standing to blame can provide a fresh justification for such responses. It focuses on a vice related to standing—hypocrisy—and a related vice concerning inconsistent blame. It takes seriously the point that criminal justice agencies, although all part of the State, are (...) in real terms separated from each other, and analyses the so-called separation thesis (or theses). It concludes that hypocrisy and inconsistent blame arguments could plausibly justify exclusion and stays only in relation to lower-level offending, and even there only indirectly. This is in the sense that exclusion and stays are expressions of judicial frustration with other bodies for their failure to take pre-trial wrongdoing seriously. (shrink)

Fluctuations in attentional state and their relation to goal neglect were examined in the current study. Participants performed a variant of the Stroop task in which attentional state ratings were given prior to each trial. It was found that pre-trial attentional state ratings predicted subsequent trial performance, such that when participants rated their current attentional state as highly focused on the current task, performance tended to be high compared to when participants reported their current attentional state as (...) being unfocused on the current task. This effect was larger for incongruent than congruent trials leading to differences in the magnitude of the Stroop effect as a function of pre-trial attentional state. Furthermore, variability in attentional state was correlated with overall levels of performance, and when attentional state was covaried out, the Stroop effect was greatly reduced. These results suggest a link between fluctuations in pre-trial attentional state and goal neglect. (shrink)

Background In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in the marketing authorization deliberation processes. To this date, we know very little about the manner that these regulators put this obligation into action. In this paper, we intend to look into the manner and the extent that ethical issues discovered during inspection have reached the deliberation processes. (...) Methods To gather data, we used the Dutch Medicines Evaluation Board database and first searched for the inspections, and their accompanying site inspection reports and integrated inspection reports, related to central marketing authorization applications of drugs submitted to the European Medicines Agency from 2011 to 2015. We then extracted inspection findings that were purely of ethical nature, i.e., those that did not affect the benefit/risk balance of the study. Only findings graded at least major by the inspectorate were included. Lastly, to identify how many of the ethically relevant findings reach the application deliberation processes, we extracted the relevant joint response assessment reports and reviewed the sections that discussed inspection findings. Results From 2011 to 2015, there were 390 processed applications, of which 65 had inspection reports and integrated inspection reports accessible via the database of the Dutch Medicines Evaluation Board. Of the 65, we found ERFs in 37. The majority of the ERFs were graded as major and half of the time it was informed-consent related. A third of these findings were related to research ethics committee processes and requirements. Of the 37 inspections with ERFs, 30 were endorsed in the integrated inspection reports as generally GCP compliant. Day 150 joint response assessment reports and Day 180 list of outstanding issues were reviewed for all 37 inspections, and none of the ERFs were carried over in any of the assessment reports or list of outstanding issues. Conclusion None of the ethically relevant findings, all of which were graded as major or critical in integrated inspection reports, were explicitly carried over to the joint assessment reports. This calls for more transparency in EMA application deliberations on how ERFs are considered, if at all, in the decision-making processes. (shrink)

The Meaning of the Presumption of Innocence for Pre-trial Detention. An Empirical Approach The presumption of innocence (PoI) is considered to be an important principle for regulating pre-trial detention. The idea is that pre-trial detention should be a last resort. However, pre-trial detention practice demonstrates that pre-trial detention does not function on the basis of a presumption of innocence but rather from a presumption of guilt and dangerousness. It must be concluded that, with regard to (...) pre-trial detention, the PoI has a rather limited normative effect. (shrink)

The lie detector test has long been treated with suspicion by the law. Recently, several authors have called this suspicion into question. They argue that the lie detector test may have considerable forensic benefits, particularly if we move past the classic, false-positive prone, autonomic nervous system-based (ANS-based) control question test, to the more reliable, brain-based, concealed information test. These authors typically rely on a “comparative advantage” argument to make their case. According to this argument, we should not be so suspicious (...) of lie detection evidence if it has comparative advantages over the epistemic methods currently utilised by the legal system. In this article, I add to this growing support by making a novel comparative advantage argument in favour of brain-based lie detection evidence. The argument focuses on the P300 concealed information test (P300 CIT), which has several unique properties, and on the effect it may have on pre-trial bargaining in criminal cases rather than in-court evidence. The thesis is that P300 CIT could allow for innocent defendants to credibly signal their innocence to investigators and prosecutors during pre-trial bargaining more effectively than current proposed methods for doing the same thing. I defend this argument from a number of objections, and suggest that it opens up an interesting avenue in the ongoing debate about the merits of this technology. Although the argument is presented with the criminal law in mind, it could form part of a more general cumulative case in favour of this technology. (shrink)

Over the past decade AIDS research has turned toward the use of pharmacology in HIV prevention, including pre-exposure prophylaxis (PrEP): the use of HIV medication as a means of preventing HIV acquisition in those who do not have it. This paper explores the contradictory reasons offered in support of PrEP—to empower women, to provide another risk-reduction option for gay men—as the context for understanding the social meaning of the experimental trials that appear to show that PrEP works in gay men (...) and heterosexual couples but not single women. The PrEP debates reveal the different ideas about “demedicalization” in the earlier gay health and women’s health movements and highlight the relationship between health activism and critique of research ethics in the context of a global pharmaceutical market. (shrink)

This review discusses the thesis advanced by Sarah Summers in her recent book. In particular it examines the three radical claims that structure her argument. First, that the commonly used analytical distinction between adversarial and inquisitorial traditions in criminal procedure should be abandoned. Secondly, that since the Continental reforms of the 19th century, criminal procedure can best be understood in terms of a single European procedural tradition. Thirdly, that the European Court of Human Rights has misconstrued the logic of that (...) single European procedural tradition by failing to understand that it involves the rejection of a ‘determinative’ pre-trial phase. Each of Summers’ three arguments is subjected to critical analysis and ultimately rejected as innovative and stimulating but flawed. (shrink)

This paper addresses the selective mechanisms by which criminal proceedings produce strong arguments. It does so by focusing on the failing of argument themes (topoi) in the course of criminal proceedings, rather than on their career. In a further step, the notion of failing is bound to learning: different forms of failing point at different ways and places of learning. The study is comparative, relating cases from four different legal regimes (England, USA, Italy and Germany) that are taken from four (...) extensive ethnographic studies in defense lawyer’s firms. We will track down the failures of topoi at three different stages (pre-trial, trial, and deliberation) in our different legal regimes. Failing occurs in all proceedings in various modes and at different stages. We argue that those modes as well as the different stages at which they occur point at the spots in the respective procedures that allow for learning about the inherent conceptions of “good reasons.”. (shrink)

In criminal trials with a jury, judges have many opportunities to engage in adjudicative fact-finding before the jury retires. English law has no conceptual framework for examining this judicial fact-finding which encompasses two categories of collateral fact (preliminary and underlying fact) and foreign law. A third category of collateral fact (conditional fact) is decided by the jury. The article examines the nature of judicial fact-finding and the history and rationale for this allocation of fact-finding responsibility between judge and jury.

My aim is to suggest that there is a case for using a randomised consent design in some neonatal trials. As an example I use the trials of extracorporeal membrane oxygenation (ECMO) in neonates suffering pulmonary hypertension. In some trials the process of obtaining consent has the potential to harm the subject, for example, by disappointing those who end in the control group and by creating additional anxiety at times of acute illness. An example of such were the trials of (...) extracorporeal membrane oxygenation (ECMO) in neonates suffering pulmonary hypertension. Pre-randomised consent could avoid or lessen these harms. However, a number of ethical objections are made to these research designs. They involve denial of information, using people, denial of choice, and "overselling" of allocated treatment. Furthermore, they are the wrong response; better communication might be the answer, for example. I argue that these objections are not completely persuasive. However, they are enough to suggest caution in the use of such designs. (shrink)

The article critically considers the role of NGOs at the US naval base in Guantánamo Bay, Cuba. On the basis of observation of pre-trial hearings for the case against Khalid Sheik Mohammed et al.—those allegedly responsible for the September 11 attacks—the article analyses NGOs as trial monitors of the US military commissions set up to deal with ‘alien unprivileged enemy belligerents’. In spite of continued efforts by human rights NGOs and incremental improvements in the military commissions’ institutional arrangements (...) and practice, the article shows how NGOs have become so much a part of the everyday operation of justice at ‘Gitmo’ that they legitimate the military commissions’ claim to be delivering fair and transparent justice. (shrink)

Background Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet, approaching the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. In this study, we asked, What light does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials? -/- Methods In a systematic search, we identified 30 studies. We (...) began our analysis by applying philosophical frameworks, which were then refined as concepts emerged from the analytical studies, to present a coherent picture of a broad literature. -/- Results Between them, the studies addressed four themes. The first three were the ethical basis for parental informed consent for neonatal and/or perinatal research, the validity of parental consent in this context, and the range of possible options in methods for gaining consent. The last was the issue of risk and the possibility of a double-standard or asymmetry in the current approaches to the requirement for consent for research and consent for clinical treatment. -/- Conclusions In addressing these issues, the analysed studies showed that, whilst there are a variety of possible defences for seeking parental ‘consent’ to neonatal and/or perinatal clinical trials, these are all consistent with the strongly and widely held view that it is important that parents do give (or decline) consent for such research. So far as the method of obtaining consent is concerned, none of the existing consent processes reviewed by the research is satisfactory, and there are philosophical reasons for supposing that at least some parents will fail to give valid consent in a neonatal context. Furthermore, in giving parental ‘consent’ in a perinatal context, parents are authorising infant participation, not giving ‘proxy consent’. Finally, there are reasons for giving weight to both parental ‘consent’ and the infant’s best interests in both research and clinical treatment. However, there are also reasons to treat these factors differently in the two contexts, and this may be partly due to the differing relevance of risk in each case. A significant gap is the lack of any detailed discussion of a process of emergency and/or urgent ‘assent’, in which parents assent or refuse their baby’s participation as best they can during the emergency and later give full consent to continuing participation and follow-up. (shrink)

Increasing ethical attention and debate is focusing on whether individuals who take part in clinical trials should be given access to post-trial care. However, the main focus of this debate has been upon drug trials undertaken in low-income settings. To broaden this debate, we report findings from interviews with individuals (n = 24) who participated in a clinical trial of a closed-loop system, which is a medical device under development for people with type 1 diabetes that automatically adjusts (...) blood glucose to help keep it within clinically recommended ranges. Individuals were recruited from UK sites and interviewed following trial close-out, at which point the closed-loop had been withdrawn. While individuals were stoical and accepting of the requirement to return the closed-loop, they also conveyed varying degrees of distress. Many described having relaxed diabetes management practices while using the closed-loop and having become deskilled as a consequence, which made reverting back to pre-trial regimens challenging. Participants also described unanticipated consequences arising from using a closed-loop. As well as deskilling, these included experiencing psychological and emotional benefits that could not be sustained after the closed-loop had been withdrawn and participants reevaluating their pre- and post-trial life in light of having used a closed-loop and now perceiving this life much more negatively. Participants also voiced frustrations about experiencing better blood glucose control using a closed-loop and then having to revert to using what they now saw as antiquated and imprecise self-management tools. We use these findings to argue that ethical debates about post-trial provisioning need to be broadened to consider potential psychological and emotional harms, and not just clinical harms, that may result from withdrawal of investigated treatments. We also suggest that individuals may benefit from information about potential nonclinical harms to help make informed decisions about trial participation. (shrink)

This paper seeks to argue that although fair trial standards are commonly portrayed as a set of minimum coherent standards applicable across a range of different legal traditions, there is a tension between those standards that accentuate the importance of individual will and autonomy and those that emphasise the importance of accurate outcome through an effective defence. This tension has been managed for the most part by enabling individuals to be represented by legal counsel who present the defence on (...) the basis of their clients’ instructions. Human rights law has recognised the importance of legal assistance at trial and pre-trial stages of criminal procedures. Despite this certain developments in domestic and international criminal processes have led to a growing number of cases being decided without an effective defence being provided by legal counsel. Such cases have been disposed on the basis of defendants’ ‘consent’ and this supposed autonomy has held sway over any effective defence. The paper begins by tracing different dimensions of the fair trial standards and exposes a tension between the need for defendants to exercise autonomy over their case and the need for an effective defence. The paper then argues that the right to counsel has acted as a bridge between these two competing demands. Recent developments are then reviewed which have served to impede counsel from providing an effective defence in the interests of the client’s freedom to choose how her case should be handled. The examples examined are the growing number of cases that are pleaded or diverted out of court with no real examination of the strength of the prosecution case, the emergence of special advocates who do not take instructions from defendants and the increasing tendency for defendants to represent themselves in certain types of cases. The paper concludes by arguing that we need to make a sharper distinction between individual rights and procedural standards and argues for greater attention to be given to the latter on the design of criminal procedure. (shrink)

This is the second paper in a two-part series describing subject and family perspectives from the CENTURY-S (CENtral Thalamic Deep Brain Stimulation for the Treatment of Traumatic Brain InjURY-Safety) first-in-human invasive neurological device trial to achieve cognitive restoration in moderate to severe traumatic brain injury (msTBI). To participate, subjects were independently assessed to formally establish decision-making capacity to provide voluntary informed consent. Here, we report on post-operative interviews conducted after a successful trial of thalamic stimulation. All five msTBI (...) subjects met a pre-selected primary endpoint of at least a 10% improvement in completion time on Trail-Making-Test Part B, a marker of executive function. We describe narrative responses of subjects and family members, refracted against that success. Interviews following surgery and the stimulation trial revealed the challenge of adaptation to improvements in cognitive function and emotional regulation as well as altered (and restored) relationships and family dynamics. These improvements exposed barriers to social reintegration made relevant by recoveries once thought inconceivable. The study’s success sparked concerns about post-trial access to implanted devices, financing of device maintenance, battery replacement, and on-going care. Most subjects and families identified the need for supportive counseling to adapt to the new trajectory of their lives. (shrink)

Background HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania. Methods A total of 1146 women at increased risk of HIV acquisition working (...) as alcohol and food vendors or in bars, restaurants, hotels and guesthouses have been recruited into the MDP301 phase III efficacy and safety trial in Mwanza. During preparations for the trial, participatory community research methods were used to develop a locally-appropriate pictorial flipchart in order to convey key messages about the trial to potential participants. Pre-recorded audio tapes were also developed to facilitate understanding and compliance with gel-use instructions. A comprehension checklist is administered by clinical staff to all participants at screening, enrolment, 12, 24, 40 and 50 week follow-up visits during the trial. To investigate women's perceptions and experiences of the trial, including how well participants internalize and retain key messages provided through a continuous informed consent process, a random sub-sample of 102 women were invited to participate in in-depth interviews conducted immediately after their 4, 24 and 52 week follow-up visits. Results 99 women completed interviews at 4-weeks, 83 at 24-weeks, and 74 at 52 weeks. In all interviews there was evidence of good comprehension and retention of key trial messages including that the gel is not currently know to be effective against HIV; that this is the key reason for conducting the trial; and that women should stop using gel in the event of pregnancy. Conclusions Providing information to trial participants in a focussed, locally-appropriate manner, using methods developed in consultation with the community, and within a continuous informed-consent framework resulted in high levels of comprehension and message retention in this setting. This approach may represent a model for researchers conducting HIV prevention trials among other vulnerable populations in resource-poor settings. Trial registration Current Controlled Trials ISRCTN64716212. (shrink)

In 2004, the first ever multi‐sited clinical trials studied the prospect of HIV biomedical prevention (referred to as pre‐exposure prophylaxis—‘PrEP’). The trials were implemented at several international sites, but many officially closed down before they completed. At most sites, both scientists and community AIDS advocates raised concerns over the ethics and scientific rationales of the trial. Focusing on the Nigerian trial site, we detail the controversy that emerged among mostly Nigerian research scientists who scrutinized the research design and (...) protocol. While some of the disputes, especially those pertaining to community engagement mechanisms, were ultimately resolved in international fora and implemented in later PrEP trials, concerns over science rationales and assumptions were never addressed. We argue that scientific rationales should be treated as ethical concerns and suggest that such concerns should be deliberated at host sites before the trial protocol is finalized. (shrink)

Regulatory offences are a complex phenomenon, presenting problematic aspects both at the level of criminalisation and at the level of enforcement. The literature abounds in works that study the phenomenon. There is, however, an aspect that has remained largely unexplored. It concerns the relationship between the regulatory framework within which the crime occurs and the procedural safeguards that defendants normally enjoy at trial or at the pre-trial stage: defendants tried for regulatory offences are often denied safeguards that are (...) generally considered as important constituents of trial fairness. Relying on a new conceptualisation of regulatory offences, this paper advances a theory that justifies these exceptional rulings. (shrink)

To what extent does the design of statistical experiments, in particular sequential trials, affect their interpretation? Should postexperimental decisions depend on the observed data alone, or should they account for the used stopping rule? Bayesians and frequentists are apparently deadlocked in their controversy over these questions. To resolve the deadlock, I suggest a three‐part strategy that combines conceptual, methodological, and decision‐theoretic arguments. This approach maintains the pre‐experimental relevance of experimental design and stopping rules but vindicates their evidential, postexperimental irrelevance. †To (...) contact the author, please write to: Tilburg Center for Logic and Philosophy of Science, Tilburg University, P.O. Box 90153, 5000 LE Tilburg, The Netherlands; e‐mail: [email protected]. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:A Trial of PatienceChristopher LewisIt seemed like after two weeks, my “flu” symptoms should have resolved. I was not eating, could not hold anything down, and had no energy. It was easy enough for my pediatrician at the time to attribute this to a common virus. This was not sitting well with my parents, however. My mother decided to take me to the emergency room and get me (...) evaluated there. The doctors there assessed me and sent me back home with a medication to help with the nausea. Later that evening, my mom gave me that medication, and it caused a seizure. She called 911, and I was brought by ambulance to the hospital. After an extensive workup, it was determined I was in liver failure related to an aneurysm in my hepatic artery. I was going to require a liver transplant if I were to live. I had to be transferred to another hospital in New York from the hospital near our home in Connecticut. I do not remember any of the details leading up to this after the seizure. I do not remember being told I needed a liver transplant and I do not remember going into surgery.My memories of these events start after the surgery. What I remember is being in the pediatric ICU and being told my mother was able to donate part of her liver to me. I had quite a lengthy recovery after this point. I spent about two months in the hospital and then went to a rehab facility where I would have to learn how to walk again and regain my strength.By the time I was discharged from the rehab facility, I had missed the last half of my 5th-grade year. By the time I was able to return to school, it was already several months into 6th grade. Slowly but surely, life was returning to normal. I was able to get back to doing the things an eleven-year-old should be doing. For twelve years after this initial transplant, I was in great health, my transplant team was happy with how I was doing, and I just required annual checkups after a while. Unfortunately, I saw as a child how fast things can change. This was once again the case. [End Page 126]I was in my last week of college classes, just about to finish my Bachelor’s degree in nursing and looking forward to starting my career as a nurse in the neuro ICU. However, I once again became acutely ill with seemingly flu-like symptoms. After a few days of dealing with these symptoms, my mother brought me to the emergency room. When we got to the emergency room, they did some initial testing and told me I would need to be admitted for antibiotic therapy. The first thought that came to my mind was, “Would I be able to be discharged in time to take my final exams next week?”Once I arrived in my hospital room, I met with my transplant team. They delivered the grave news. The imaging they had done showed that the graft artery from my original liver transplant as a child had failed. The graft had thrombosed and I had infected bilomas in my liver. Now, twelve years later, I would need to be re-listed for another transplant. I was devastated and in disbelief. I recall telling my mother, who was with me at the time, that we should hold off on telling my dad, thinking this could not be possible, and we shouldn’t worry him over something that was not necessarily true. Unfortunately, however, this was my reality. I would go on to wait a little over two years for the perfect liver from a deceased donor.The road to being listed and ultimately having a repeat transplant was not without its challenges and bumps in the road. About three months into my two-year wait for a liver transplant, I received my first offer for a liver. I went through all of the pre-op preparation and the next morning went into the OR and underwent anesthesia. However, I... (shrink)

In his Rights Forfeiture and Punishment, Christopher Heath Wellman argues that his preferred ‘strong’ version of rights forfeiture theory makes the moral rights of due process and a fair trial null and void for guilty offenders. They may still possess legal rights to due process, but these are not strong pre-institutional moral rights. I explain here why I disagree with Wellman. I also suggest that he is not entitled, by his own lights, to affirm strong forfeiture theory, at least (...) in our social world. (shrink)

BackgroundPatient skepticism concerning medical innovations can have major consequences for current public health and may threaten future progress, which greatly relies on clinical research.The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in clinical research. Specifically, we sought to evaluate if distrust in pharmaceutical companies and associated psychosocial factors could represent a recruitment bias in clinical trials and thus threaten the applicability of their results.MethodsThis prospective, multicenter survey consisted in the (...) administration of a self-questionnaire to patients during a pulmonology consultation. The 1025 questionnaires distributed collected demographics, socio-professional and basic health literacy characteristics. Patients were asked to rank their level of trust for pharmaceutical companies and indicate their willingness to participate in different categories of research.Logistic regression was used to determine factors contributing to “trust” versus “distrust” group membership and willingness to participate in each category of research.ResultsOne thousand patients completed the survey, corresponding to a response rate of 97.5%. Data from 838 patients were analyzed in this study.48.3% of respondents declared that they trusted pharmaceutical companies, while 35.5% declared distrust. Being female, inactive in the employment market, and not-knowing the name of one’s disease are factors related to declared distrust. Distrust-group membership is associated with unwillingness to participate in certain categories of trials such as pre-marketing and industry-sponsored trials.ConclusionDistrust in pharmaceutical companies is associated with a specific patient profile and with refusal to participate in certain subcategories of trials. This potential recruitment bias may explain the under-representation of certain categories of patients such as women in pre-marketing drug trials. (shrink)

Background Ethical decision‑making and behavior of nurses are major factors that can affect the quality of nursing care. Moral development of nurses to making better ethical decision-making is an essential element for managing the care process. The main aim of this study was to examine and comparison the effect of training in ethical decision-making through lectures and group discussions on nurses’ moral reasoning, moral distress and moral sensitivity. Methods In this randomized clinical trial study with a pre- and post-test (...) design, 66 nurses with moral reasoning scores lower than the average of the community were randomly assigned into three equal groups (n = 22) including two experimental groups and one control group. Ethical decision-making training to experimental groups was provided through the lectures and group discussions. While, the control group did not receive any training. Data were collected using sociodemographic questionnaire, the nursing dilemma test (NDT), the moral distress scale (MDS) and the moral sensitivity questionnaire (MSQ). Unadjusted and adjusted binary logistic regression analysis was reported using the odds ratio (OR) and 95% confidence intervals. Results Adjusted regression analysis showed that the probability of increasing the nursing principle thinking (NPT) score through discussion training was significantly higher than lecture (OR: 13.078, 95% CI: 3.238–15.954, P = 0.008), as well as lecture (OR: 14.329, 95% CI: 16.171–2.005, P < 0.001) and discussion groups compared to the control group (OR: 18.01, 95% CI: 22.15–5.834, P < 0.001). The possibility of increasing moral sensitivity score through discussion training was significantly higher than lecture (OR: 10.874, 95%CI: 6.043–12.886, P = 0.005) and control group (OR: 13.077, 95%CI: 8.454–16.774, P = 0.002). Moreover, the moral distress score was significantly reduced only in the trained group compared to the control, and no significant difference was observed between the experimental groups; lecture group vs. control group (OR: 0.105, 95% CI: 0.015–0.717, P = 0.021) and discussion group vs. control group (OR: 0.089, 95% CI: 0.015–0.547, P = 0.009). Conclusions The results of this study indicate that ethical decision-making training is effective on empowerment of ethical reasoning. Whereas the group discussion was also effective on increasing the ethical sensitivity, it is recommended the training plan provided in this study to be held as workshop for all nurses in health and treatment centers and placed in curricular plan of nursing students. Registration This randomized clinical trial was registered in Iranian Registry of Clinical Trials under code (IRCT2015122116163N5) in 02/07/2016. (shrink)

Data monitoring committees often are employed to review interim findings of randomised controlled trials. Interim findings are kept confidential until the data monitoring committee finds that they provide sufficiently compelling evidence regarding efficacy, typically because they have crossed the pre-defined statistical boundaries, or they raise serious concerns about safety. While this practice is vital to maintaining the scientific integrity of controlled trials and thereby ensuring their social value, it has been criticised as unethical. Commentators argue that withholding interim findings from (...) research participants is deceptive, inconsistent with valid informed consent, and a violation of respect for participants’ autonomy. The present article examines these arguments, focusing specifically on confidential data monitoring for efficacy. This practice need not be deceptive provided its use is disclosed to prospective research participants. In addition, confidential data monitoring does not make research participants worse off than they would be in the clinical setting and represents an acceptable limitation on the options available to prospective research participants. Taken together, these considerations suggest confidential data monitoring, subject to adequate safeguards, is ethically acceptable. (shrink)

Despite their crucial role in the translation of pre-clinical research into new clinical applications, phase 1 trials involving patients continue to prompt ethical debate. At the heart of the controversy is the question of whether risks of administering experimental drugs are therapeutically justified. We suggest that prior attempts to address this question have been muddled, in part because it cannot be answered adequately without first attending to the way labor is divided in managing risk in clinical trials. In what follows, (...) we approach the question of therapeutic justification for phase 1 trials from the viewpoint of five different stakeholders: the drug regulatory authority, the IRB, the clinical investigator, the referring physician, and the patient. Our analysis shows that the question of therapeutic justification actually raises multiple questions corresponding to the roles and responsibilities of the different stakeholders involved. By attending to these contextual differences, we provide more coherent guidance for the ethical negotiation of risk in phase 1 trials involving patients. We close by discussing the implications of our argument for various perennial controversies in phase 1 trial practice. (shrink)

Schools have been the main context for physical activity and sedentary behavior interventions among adolescents, but there is inconsistent evidence on whether they also improve dimensions of the health−related quality of life. The aim of this study was to evaluate the effects of a school-based active lifestyle intervention on dimensions of HRQoL. A secondary aim was to verify whether sex, age, and HRQoL at baseline were moderators of the intervention effect. A cluster-randomized controlled trial was conducted at three control (...) and three intervention schools in Florianopolis, Brazil. All students from 7th to 9th grade were invited to participate. A school year intervention, designed primarily to increase PA and reduce SB, included strategies focused on teacher training on PA, SB, and nutrition, and availability of teaching materials related to these contents; environmental improvements ; and education strategies, with the availability of folders and posters regarding PA, SB, and nutrition. Participants and the research staffs were not blinded to group assignment, but a standardized evaluation protocol was applied at baseline and after the intervention using the KIDSCREEN−27 to assess HRQoL across five dimensions. Mixed linear models were performed to evaluate the effect of the Movimente intervention on the five HRQoL dimensions. Of the 921 students who answered the questionnaire at baseline, 300 and 434 completed the study in control and intervention groups, respectively. The results revealed no significant effects of the intervention on any HRQoL dimensions. A reduction of the school environment dimension was observed in both the control and intervention groups. Sensitivity analyses showed that students in the highest baseline tertiles of HRQoL in any dimension had a reduction in their respective scores from pre- to post-intervention in both school groups. In conclusion, our results demonstrated no intervention effect on HRQoL dimensions and those students with the highest levels of HRQoL at baseline on all dimensions reduced from pre to post-intervention.Clinical Trial RegistrationThe trial is registered at the Clinical Trial Registry. (shrink)

Current treatments for chronic pain have limited benefit. We describe a resilience intervention for individuals with chronic pain which is based on a model of viewing chronic pain as dysregulated homeostasis and which seeks to restore homeostatic self-regulation using strategies exemplified by survivors of extreme environments. The intervention is expected to have broad effects on well-being and positive emotional health, to improve cognitive functions, and to reduce pain symptoms thus helping to transform the suffering of pain into self-growth. A total (...) of 88 Veterans completed the pre-assessment and were randomly assigned to either the treatment intervention or control. Fifty-eight Veterans completed pre- and post-testing. The intervention covered resilience strengths organized into four modules: engagement, social relatedness, transformation of pain and building a good life. A broad set of standardized, well validated measures were used to assess three domains of functioning: health and well-being, symptoms, and cognitive functions. Two-way Analysis of Variance was used to detect group and time differences. Broadly, results indicated significant intervention and time effects across multiple domains: Pain decreased in present severity [F = 5.02, p < 0.05, η2p = 0.08], total pain over six domains [F = 14.52, p < 0.01, η2p = 0.21], and pain interference [F = 6.82, p < 0.05, η2p = 0.11]; Affect improved in pain-related negative affect [F = 7.44, p < 0.01, η2p = 0.12], fear [F = 7.70, p < 0.01, η2p = 0.12], and distress [F = 10.87, p < 0.01, η2p = 0.16]; Well-being increased in pain mobility [F = 5.45, p < 0.05, η2p = 0.09], vitality [F = 4.54, p < 0.05, η2p = 0.07], and emotional well-being [F = 5.53, p < 0.05, η2p = 0.09] Mental health symptoms and the cognitive functioning domain did not reveal significant effects. This resilience intervention based on homeostatic self-regulation and survival strategies of survivors of extreme external environments may provide additional sociopsychobiological tools for treating individuals with chronic pain that may extend beyond treating pain symptoms to improving emotional well-being and self-growth.Clinical Trial Registration: Registered with ClinicalTrials.gov. (shrink)

This article examines the relationship between bioethics and the therapeutic standards in HIV prevention research in the developing world, focusing on the closure of the pre-exposure prophylaxis (PrEP) trials in the early 2000s. I situate the PrEP trials in the historical context of the vertical transmission debates of the 1990s, where there was protracted debate over the use of placebos despite the existence of a proven intervention. I then discuss the dramatic improvement in the clinical management of HIV and the (...) treatment access movement, and consider how these contexts have influenced research practice. I argue that as HIV prevention trials oblige researchers to observe the rate at which vulnerable people under their care acquire HIV, there is an obligation to provide antiretroviral treatment to seroconverters and other health care benefits that fall within the scope of researchers' entrustment, both to avoid exploitation and to enact reciprocal justice. I argue against propositions that the obligations to provide specific benefits are vague, fall only upon researchers and sponsors, and create injustices by privileging the few over the many. Finally, I contend that the realisation of a broader standard of care in HIV prevention research broadens the role of research from being a simple tool to produce knowledge to a complex intervention that can play a part in the reduction of health disparities. (shrink)

BackgroundMental illness among Malaysian children is gradually reaching a fundamentally alarming point as it persistently shows increasing trend. The existing literature on the etiologies of children’s mental illness, highlights the most common cause to be ineffective or impaired parenting. Thus, efforts to combat mental illness in children should focus on improving the quality of parenting. Documented interventional studies focusing on this issue, particularly in Malaysia, are scarce and commonly report poor treatment outcomes stemming from inconvenient face-to-face instructions. Consequently, proposing an (...) accessible online and digital-assisted parenting program is expected to reach a larger number of parents, as it can overcome substantial barriers. Hence, this study aims to develop a universal digital-assisted preventive parenting intervention called DaPI, that aims to enhance mental health of children in Malaysia.MethodsA total of 200 parents of children aged 10–14 years will be recruited and randomized into two groups either intervention or waitlist-control based on a 1:1 ratio for a duration of 8 weeks. Those in the intervention group will receive eight sessions of the DaPI program that focus mainly on parenting and children’s mental health. The primary outcome of this study will essentially focus on the changes in parent-reported parenting behavior and parental self-efficacy. The secondary outcome will be changes in children’s mental health. Assessments will be arranged pre- and post-intervention as well as at the 1-month follow-up. Analyses will be conducted using a paired t-test and multivariate analysis of covariance.DiscussionThe expected outcome will be the establishment of DaPI in promoting children’s mental health by targeting changes in parenting behavior and parental self-efficacy in Malaysia. Findings from this study will be beneficial for policymakers to invest in parenting programs that could provide support to parents in enhancing their child’s overall development.Clinical trial registration[www.irct.ir], identifier [IRCT20211129053207N1]. (shrink)

BackgroundMany authors choose to work with professional medical writers when reporting the results of clinical trials. We conducted a systematic review to examine the relationship between professional medical writing support (PMWS) and the quality, ethics and timeliness of publications reporting clinical trials.MethodsUsing terms related to ‘medical writer’ and ‘observational study’, we searched MEDLINE and Embase (no date limits), as well as abstracts and posters from meetings of the International Society for Medical Publication Professionals (ISMPP; 2014–2018). We also hand-searched the journals (...) Medical Writing and The Write Stuff (2014–2018) and the bibliographies of studies identified in the electronic searches. We screened the results to identify studies that compared the quality, ethics and timeliness of clinical trial publications written with and without declared PMWS.ResultsOur searches identified 97 potentially relevant studies, of which 89 were excluded during screening and full paper review. The remaining eight studies compared 849 publications with PMWS with 2073 articles developed without such support. In these eight studies, PMWS was shown to be associated with increased adherence to Consolidated Standards of Reporting Trials (CONSORT) guidelines (in 3/3 studies in which this was assessed), publication in journals with an impact factor (one study), a higher quality of written English (one study), and a lower likelihood of reporting non-pre-specified outcomes (one study). PMWS was not associated with increased adherence to CONSORT for Abstracts guidelines (one study) or with the impact of published articles (mean number of citations per year, mean number of article views per year and Altmetric score; one study). In studies that assessed timeliness of publication, PMWS was associated with a reduced time from last patient visit in clinical trials to primary publication (one study), whereas time from submission to acceptance showed inconsistent results (two studies).ConclusionsThis systematic review of eight observational studies suggests that PMWS is positively associated with measures of overall quality of reporting of clinical trials and may improve the timeliness of publication.Video abstract. (MP4 161000 kb). (shrink)

The ethical pre-condition of randomised controlled trials is, at present, the presence of equipoise. This refers to an opinion of the investigator that there is uncertainty as to the merits of the treatments being compared. It is argued that since the decision to enrol is the potential subject’s, the investigator’s opinion is not ethically relevant. It is proposed instead that equipoise be patient-centred, and that a trial is in equipoise for a patient when enrolling gives them the same chance (...) of a good outcome as not enrolling. It is shown that trial enrolment is normally easily the best strategy for achieving a good outcome, and that trials currently thought to be unethical may be in patient-centred equipoise. This is so for three reasons: (1) patients in trials receive superior care, (2) trial enrolment minimises the risk of being a victim of a therapeutic disaster and (3) health professionals make mistakes, and a 50% chance of receiving the worse treatment until a trial reports is always better than any chance of receiving the worse treatment indefinitely. It is concluded that so long as the standard of professional conduct is the furtherance of patients’ objective interests randomised controlled trials are ethical. (shrink)

Community engagement is increasingly emphasized in biomedical research, as a right in itself, and to strengthen ethical practice. We draw on interviews and observations to consider the practical and ethical implications of involving Community Health Workers (CHWs) as part of a community engagement strategy for a vaccine trial on the Kenyan Coast. CHWs were initially engaged as an important network to be informed about the trial. However over time, and in response to community advice, they became involved in (...) trial information sharing and identifying potential participants; thereby taking on roles that overlapped with those of employed fieldworkers (FWs). While CHWs involvement was generally perceived as positive and appreciated, there were challenges in their relations with FWs and other community members, partly related to levels and forms of remuneration. Specifically, payment of CHWs was not as high as for FWs and was based on ‘performance’. This extrinsic motivation had the potential to crowd out CHWs intrinsic motivation to perform their pre-existing community roles. CHWs remuneration potentially also contributed to CHWs distorting trial information to encourage community members to participate; and to researchers encouraging CHWs to utilize their social connections and status to increase the numbers of people who attended information giving sessions. Individual consent processes were protected in this trial through final information sharing and consent being conducted by trained clinical staff who were not embedded in study communities. However, our experiences suggest that roles and remuneration of all front line staff and volunteers involved in trials need careful consideration from the outset, and monitoring and discussion over time. (shrink)

Tremendous development in recent medical science and the consequent discoveries resulting in successful prevention and also cure of different diseases are shared by clinical research involving the human volunteers. Preceding the trials in the human subjects, and to ensure safety, the proposed drug and other interventions are either tested in animals (vivo) or in laboratory (vitro) to evaluate initial safe starting dose for the human beings and to key out the benchmarks for the clinical monitoring for the potential unfavorable effects. (...) These pre human trials might not necessarily protect against the untoward effects in the human beings as happened in the case of thalidomide tragedy, which caused disability and killed thousands of babies born to the mothers, those who took this medicine. Use of healthy human volunteers in the preliminary experiments or phase I clinical trials either reduces or excludes risks of subsequent undesirable effects in the future trails (1). Phase-1 trials are conducted in order to test the safety, reactions and immunogenicity of vaccines in volunteers. Novel treatments for the cancer are first tested in phase 1 trials enrolling the patients with advanced disease, who have exhausted the standard treatment options. Phase-1 oncology trials are the pivot point in the translation of new cancer therapies from bench to bedside. Nevertheless, these trials remain ethically controversial. The controversy stems from the fact that, classically, phase-1 oncology clinical trials involve first-in-human testing of experimental treatment candidates in patients with a terminal diagnosis, who typically have exhausted standard treatment options. Commentators on the ethics of phase-1 clinical trials make diametrically opposed claims about the prospect of direct medical benefit from participation in these trials-benefits that can be attributed to receiving the experimental treatment intervention. One camp of benefit skeptics, inhabited mainly by bioethicists, characterizes this form of research as lacking any reasonable prospect of direct medical benefit. They see an ethical cloud hovering over phase-1 trials, because the vast majority of patients volunteer for phase-1 trials out of a motivation to receive medical benefit. In the view of these skeptics, such patients therefore harbor a ‘therapeutic misconception’ about research participation. This misconception calls into question the validity of informed consent and thereby undercuts the ethical basis of these trials (2). In this paper, I will discuss the ethical justification of the participation of human volunteers in phase-1 trials. (shrink)

Face perception is crucial in all social animals. Recent studies have shown that pre-stimulus oscillations of brain activity modulate the perceptual performance of face vs. non-face stimuli, specifically under challenging conditions. However, it is unclear if this effect also occurs during simple tasks, and if so in which brain regions. Here we used magnetoencephalography and a 1-back task in which participants decided if the two sequentially presented stimuli were the same or not in each trial. The aim of the (...) study was to explore the effect of pre-stimulus alpha oscillation on the perception of face and non-face stimuli. Our results showed that pre-stimulus activity in the left occipital face area modulated responses in the intra-parietal sulcus at around 170 ms after the presentation of human face stimuli. This effect was also found after participants were shown images of motorcycles. In this case, the IPS was modulated by pre-stimulus activity in the right OFA and the right fusiform face area. We conclude that pre-stimulus modulation of post-stimulus response also occurs during simple tasks and is therefore independent of behavioral responses. (shrink)

Previous studies have explored the impact of magic tricks on different basic cognitive processes yet there is a need of examining effectiveness of a cognitive training program through magic tricks for children with attention deficit hyperactivity disorder. The present study examines the effectiveness and feasibility of the MAGNITIVE program, a manualized intervention for cognitive training through the learning of magic tricks. A total of 11 children with ADHD participated in separated groups of two different community settings, and were assessed at (...) pre-treatment, post-treatment, and a 3-month later follow-up in different tasks involving processing speed, sustained attention, selective attention, and mental flexibility. Using non parametric statistical analyses and Reliable Change Index, the results showed that these children receiving MAGNITIVE particularly improved their performance in sustained attention, shifting attention, and mental flexibility, changes were also observed in processing speed performance yet further research is needed in terms of selective attention and inhibition, given the great individual differences within this sample. Changes were maintained when the program was finished. In terms of viability, the study proved a good treatment integrity in different contexts, adherence to the curriculum, and high levels of engagement satisfaction. In this second clinical trial, MAGNITIVE program appears to be a feasible training program for children with ADHD, as an alternative for medication when possible. (shrink)

Background: COVID-19 has taken many lives worldwide and due to this, millions of persons are in grief. When the grief process lasts longer than 6 months, the person is in risk of developing Complicated Grief Disorder. The CGD is related to serious health consequences. To reduce the probability of developing CGD a preventive intervention could be applied. In developing countries like Mexico, the psychological services are scarce, self-applied interventions could provide support to solve this problem and reduce the health impact (...) even after the pandemic has already finished.Aims: To design and implement a self-applied intervention composed of 12 modules focused on the decrease of the risk of developing CGD, and increasing the life quality, and as a secondary objective to reduce the symptomatology of anxiety, depression, and increase of sleep quality. The Intervention Duelo COVID follows the principles of User Experience and is designed according to the needs and desires of a sample of the objective participants, to increase the adherence to the self-applied intervention, considered one of the main weaknesses of online interventions.Methods: A Randomized Controlled Trial will be conducted from the 22nd of December of 2020 to the first of June 2021. The participants will be assigned to an intervention with elements of Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, Mindfulness and Positive Psychology. The control group will be a wait-list condition, that will receive the intervention 1.5–2 months after the pre-measurement were taken. The Power Size Calculation conducted through G*Power indicated the need for a total of 42 participants, which will be divided by 21 participants in each group. The platform will be delivered through responsive design assuring with this that the intervention will adapt to the screen size of cellphones, tablets, and computers.Ethics and Dissemination: The study counts with the approval of the Research Ethics Committee of the Autonomous University of Ciudad Juárez, México, and it is registered in Clinical Trials. The article is sent and registered in clinical trials before the recruitment started. The results will be reported in future conferences, scientific publications, and media. (shrink)

BackgroundAcrophobia is a specific phobia characterized by a severe fear of heights. The purpose of the present study was to investigate the efficacy of two therapies that may ameliorate symptoms of acrophobia and anxiety sensitivity, i.e., virtual reality exposure therapy (VRET) and eye movement desensitization and reprocessing (EMDR) therapy with a Waiting List Control Condition (WLCC).MethodsWe applied a three-armed randomized controlled pre-post-test design with 45 female adolescent students. Students who met DSM-5 criteria for acrophobia were randomly assigned to either VRET (...) (N = 15;Mage = 17.26; SD = 1.32), EMDR (N = 15;Mage = 17.15; SD = 1.57), or a WLCC (N = 15;Mage = 17.50; SD = 1.26). The study groups were evaluated one week before the intervention and one week after the last intervention session regarding symptoms of acrophobia (Severity Measure for Acrophobia) and anxiety sensitivity (Anxiety Sensitivity Index).ResultsThe data showed that both the application of VRET and EMDR therapy were associated with significantly reduced symptoms of acrophobia (d = 1.03 for VRET and d = 1.08 for EMDR) and anxiety sensitivity (d = 1.15 for VRET and d = 1.13 for EMDR) in comparison to the Waiting List.LimitationsThe sample consisted only of adolescent women. Due to the recognizable differences between the two interventions, the therapists and the participants were not blind to the conditions.ConclusionThe results suggest that both VRET and EMDR are interventions that can significantly improve symptoms of acrophobia and anxiety sensitivity in female adolescents.Clinical Trial Registrationhttps://www.irct.ir/trial/57391, identifier: IRCT20210213050343N1. (shrink)