An Ethical Justification for Research with Children

This thesis is a contribution to the ethical justification for clinical research with children. A research subject’s participation in a trial is usually justified, in part, by informed consent. Informed consent helps to uphold the moral principle of respect for persons. But children’s limited ability to make informed choices gives rise to a problem. It is unclear what, if anything, justifies their participation in research. Some research ethicists propose to resolve this problem by appealing to social utility, proxy consent, arguments explaining why it is permissible to expose children to some harm, and an argument concerning the appropriate balance between research harms and benefits. I argue that each of these is a necessary part of the justification for research with children, but that the argument concerning harms and benefits is under-developed. It relies on the concept of minimal risk, but minimal risk is inadequately justified. I propose an interpretation of minimal risk. I defend the idea that minimal risk should be interpreted according to the risks of daily life. I reject the most prominent defense of daily life, which claims that daily risks are morally relevant because they replace, rather than add to, the risks a child would ordinarily face. Instead, I propose that these risks are part of a reasonable trade-off between personal safety and our ability to pursue meaningful lives. I then examine whose daily life should be captured in the concept of minimal risk. I reject arguments that minimal risk should refer to healthy children or the subjects of the research (including healthy and sick children) and propose instead that the referent should be children who are not unduly burdened by their lives. I argue that children are not unduly burdened when they fare well and defend the idea that children fare well when they possess sufficiently high degrees of the substantive goods of childhood. I conclude by analyzing a controversial case study using my interpretation of minimal risk. I draw on this case to argue that my interpretation offers clear guidance for research ethics review and contributes to a determination that is more plausible than its rivals

Ethical Contracting for Clinical Trials

The manuscript explores types of contractual review and ethics related to mutual terms as visualized by the Bowtie Risk Assessment. The researcher proposed two ethical crosscheck methods for clinical trials (1) the Four Way Test and (2) the Virtuous Model. Protecting each organization’s interests through bilateral terminology is always appropriate as it is ethical and builds goodwill and camaraderie. When conducting these reviews and considerations through an ethical lens, the legal and financial risks related to unknown factors — force majeure occurrences, out-of-scope needs, unexpected changes, and regulatory issuances — also reduce. Through an ethical lens, the review benefits from working to resolve in good faith and towards a commonality

Improve Days Sales Outstanding With Three Achievable Tricks

Contracting can be tricky. It is easy for an organization to get behind in its financial processes and complete the work before obtaining a payment — or worse, before even a signed contract is in hand. Work before written acceptance is a substantial risk to the company and may result in disapproved work, unplanned discounting, and delayed payments. The business would be wise to consider a clear set of expectations, including periodic financial packages, a preapproval document for scope changes, and clear delegated authority for the team regarding work ahead, approvals, and contracting. Clear, proactive communication and positive relationship management are crucial to mitigating the risk

Quando il crimine è sublime

The article discusses the topic of fascination for crime from a cultural point of view. It’s focused on two aspects: the emotional dimension and the role it assumes in contemporary society. From an emotional standpoint, it is assumed that the “sublime” constitutes the emotional experience to be placed in the center of the process, furthermore, the article draws a parallel between the concepts of the “sublime” (Burke), “awe” (Haidt & Keltner) and the “uncanny” (Freud). Regarding the role played by the fascination for crime and the sublime in contemporary society, the article provides a reflection on the concepts of enjoyment, commodification and collective effervescence, inspired by the thought of Lacan and Maffesoli.L’articolo affronta il tema della fascinazione indotta dal crimine da un punto di vista culturale ponendo l’attenzione su due aspetti: la dimensione emotiva che la caratterizza e il ruolo che essa assume nella società contemporanea. Dal punto di vista delle emozioni, si ipotizza che il “sublime” costituisca l’esperienza emotiva da porre al centro del processo di fascinazione e si propone un’analisi che traccia un parallelismo tra i concetti di “sublime” (Burke), “awe” (Haidt & Keltner) e “perturbante” (Freud). Per quanto riguarda il ruolo assunto dalla fascinazione indotta dal crimine e dal sublime nella società contemporanea, si propone una riflessione intorno ai concetti di godimento, mercificazione e di effervescenza collettiva, ispirata al pensiero di Lacan e di Maffesoli

Affect and marital adjustment in women’s rating of dyspareunic pain

OBJECTIVE: To investigate the extent to which depressive symptomatology, anxiety, and marital adjustment mediate pain ratings in women suffering from dyspareunia. METHOD: Seventy-six women with dyspareunia were administered the depression and anxiety scales of Derogatis\u27s Brief Symptom Inventory and the McGill Pain Questionnaire. They also underwent a manual-visual gynecological examination, an ultrasound, and a colposcopy in an attempt to identify potential evidence and type of organicity. RESULTS: Depressive symptomatology, anxiety, and marital adjustment together accounted for a significant amount of the variance in pain ratings, although only anxiety and marital adjustment were independent predictors of pain ratings in the entire group of women with dyspareunia. When multiple regression analyses were then applied to different diagnostic subgroups of dyspareunia, the independent predictors of pain rating varied depending on the findings from the gynecological examinations. CONCLUSION: Affect and marital adjustment appear to be significant predictors of dyspareunic pain rating, although the independent contribution of psychosocial variables may vary depending on the presence and type of organic findings

Women with provoked vestibulodynia experience clinically significant reductions in pain regardless of treatment : results from a 2-year follow up study

Introduction Provoked vestibulodynia (PVD) is a prevalent genital pain syndrome that has been assumed to be chronic, with little spontaneous remission. Despite this assumption, there is a dearth of empirical evidence regarding the progression of PVD in a natural setting. Although many treatments are available, there is no single treatment that has demonstrated efficacy above others. Aims The aims of this secondary analysis of a prospective study were to (i) assess changes over a 2-year period in pain, depressive symptoms, and sexual outcomes in women with PVD; and (ii) examine changes based on treatment(s) type. Methods Participants completed questionnaire packages at Time 1 and a follow-up package 2 years later. Main Outcome Measures Visual analog scale of genital pain, Global Measure of Sexual Satisfaction, Female Sexual Function Index, Beck Depression Inventory, Dyadic Adjustment Scale, and sexual intercourse attempts over the past month. Results Two hundred thirty-nine women with PVD completed both time one and two questionnaires. For the sample as a whole, there was significant improvement over 2 years on pain ratings, sexual satisfaction, sexual function, and depressive symptoms. The most commonly received treatments were physical therapy, sex/psychotherapy, and medical treatment, although 41.0% did not undergo any treatment. Women receiving no treatment also improved significantly on pain ratings. No single treatment type predicted better outcome for any variable except depressive symptoms, in which women who underwent surgery were more likely to improve. Discussion These results suggest that PVD may significantly reduce in severity over time. Participants demonstrated clinically significant pain improvement, even when they did not receive treatment. Furthermore, the only single treatment type predicting better outcomes was surgery, and only for depressive symptoms, accounting for only 2.3% of the variance. These data do not demonstrate the superiority of any one treatment and underscore the need to have control groups in PVD treatment trials, otherwise improvements may simply be the result of natural progression

La messa alla prova per adulti nel territorio di Milano. Analisi dell’applicazione di una misura innovativa nel panorama sanzionatorio italiano

La legge delega n. 67 del 2014 ha introdotto nell’ordinamento italiano l’istituto della messa alla prova per adulti. Dopo una breve descrizione del contesto in cui si colloca l’introduzione della misura e dopo averne messo in luce le caratteristiche in-novative, si analizzano e discutono i risultati di una ricerca valutativa (SWOT analysis) partecipata dagli attori coinvolti a vario titolo nella gestione dei casi di messa alla prova per adulti nell’ambito territoriale del Tribunale di Milano. Basata su 23 interviste, la ricerca illustra i punti di forza e di debolezza, le minacce e le opportunità legate all’applicazione della misura. Alla luce di quanto emerso, l’articolo si conclude con la presentazione di un vademecum di interventi prioritari per migliorare l’efficacia dell’istituto

A prospective two-year examination of cognitive and behavioral correlates of provoked vestibulodynia outcomes

Note de l'éditeur : This article may not exactly replicate the final version published in the journal. It is not the copy of record. / Cet article ne constitue pas la version officielle, et peut différer de la version publiée dans la revue.Background: Provoked vestibulodynia (PVD) is a common genital pain disorder in women that is associated with sexual dysfunction and lowered sexual satisfaction. A potentially applicable cognitive-behavioral model of chronic pain and disability is the fear-avoidance model (FAM) of pain. The FAM posits that cognitive variables, such as pain catastrophizing, fear, and anxiety lead to avoidance of pain-provoking behaviors (eg, intercourse), resulting in continued pain and disability. Although some of the FAM variables have been shown to be associated with PVD pain and sexuality outcomes, the model as a whole has never been tested in this population. An additional protective factor, pain self-efficacy (SE), is also associated with PVD, but has not been tested within the FAM model. Aims: Using a 2-year longitudinal design, we examine (1) whether initial levels (T1) of the independent FAM variables and pain SE were associated with changes in pain, sexual function, and sexual satisfaction over the 2-year time period; (2) the prospective contribution of changes in cognitive-affective (FAM) variables to changes in pain, and sexuality outcomes; and (3) whether these were mediated by behavioral change (avoidance of intercourse). Methods: A sample of 222 women with PVD completed self-report measures of FAM variables, SE, pain, sexual function, and sexual satisfaction at time 1 and at a 2-year follow-up. Structural equation modeling with Latent Difference Scores was used to examine changes and to examine mediation between variables. Main Outcomes: Questionnaires included the Pain Catastrophizing Scale, McGill Pain Questionnaire, Trait Anxiety Inventory, Pain Self-Efficacy Scale, and Global Measure of Sexual Satisfaction, Female Sexual Function Index. Results: Participants who reported higher SE at T1 reported greater declines in pain, greater increases in sexual satisfaction, and greater declines in sexual function over the 2 time points. The overall change model did not support the FAM using negative cognitive-affective variables. Only increases in pain SE were associated with reductions in pain intensity. The relationship between changes in SE and changes in pain was partially mediated through changes in avoidance (more intercourse attempts). The same pattern of results was found for changes in sexual satisfaction as the outcome, and a partial mediation effect was found. There were no significant predictors of changes in sexual function other than T1 SE. Discussion: Changes in both cognitive and behavioral variables were significantly associated with improved pain and sexual satisfaction outcomes. However, it was the positive changes in SE that better predicted changes in avoidance behavior, pain, and sexual satisfaction. Cognitive-behavior therapy is often focused on changing negative pain-related cognitions to reduce avoidance and pain, but the present results demonstrate the potential importance of bolstering positive self-beliefs as well. Indeed, before engaging in exposure therapies, SE beliefs should be assessed and potentially targeted to improve adherence to exposure strategies

Painful sex (dyspareunia) in women: prevalence and associated factors in a British population probability survey.

ObjectiveTo estimate the prevalence of painful sex among women in Britain, and to explore associated sexual, relationship and health factors that should be considered in assessment.DesignMulti-stage, clustered and stratified population probability sample survey, using computer-assisted self-interview. Sample frame was the British Postcode Address File.SettingParticipants interviewed at home between 2010 and 2012.SampleA total of 15 162 adults aged 16-74 years (8869 women). Data reported from 6669 sexually active women.MethodsAge-adjusted logistic regressions to examine associations between painful sex and indicators of sexual, relational, mental and physical health.Main outcome measurePhysical pain as a result of sex for ≥3 months in the past year, plus measures of symptom severity.ResultsPainful sex was reported by 7.5% (95% CI 6.7-8.3) of sexually active women, of whom one-quarter experienced symptoms very often or always, for ≥6 months, and causing distress. Reporting painful sex was strongly associated with other sexual function problems, notably vaginal dryness (age adjusted odds ratio 7.9; 6.17-10.12), anxiety about sex (6.34; 4.76-8.46) and lacking enjoyment in sex (6.12; 4.81-7.79). It was associated with sexual relationship factors [such as not sharing same level of interest in sex (2.56; 1.97-3.33)], as well as with adverse experiences such as non-volitional sex (2.17; 1.68-2.80). Associations were also found with measures of psychological and physical health, including depressive symptoms (1.68; 1.28-2.21).ConclusionPainful sex is reported by a sizeable minority of women in Britain. Health professionals should be supported to undertake holistic assessment and treatment which takes account of the sexual, relationship and health context of symptoms.Tweetable abstractPainful sex-reported by 7.5% of women in Britain-is linked to poorer sexual, physical, relational and mental health