<p>The subject of this thesis is ethical aspects of risk management. It is argued that a model for risk management needs to be developed that acknowledges several ethical aspects and most crucial among these, the individual’s right not to be unfairly exposed to risks.</p><p><i>Article </i>I takes as its starting point the demand frequently expressed in the risk literature for a consistent risk management. Such consistency is often assumed to be in accordance with some kind of cost-benefit analysis. It is maintained that such a model, here called the Standard Model, does not respect the rights of the individual. Two alternative models are outlined in order to better deal with this ethical weakness, the Model of Inviolable Rights and the Model of Procedural Justice. The arguments in the alternative models evolve around the separateness of individuals, rights and fair risk taking. It is claimed that the latter model, which focuses on a fair procedure, seems most fruitful to develop.</p><p><i>Article II</i> is a discussion of the NIMBY (Not In My Backyard) conflict, which is well known from situations of siting potentially risky facilities. Of special concern is to investigate what the ethical premises are behind the negative characterization of the NIMBY concept. It is argued that, contrary to the assumption that the total benefit should outweigh the individual’s cost, individuals in siting scenarios have rights not to be unfairly exposed to risks.</p><p><i>Article III</i>, which is co-authored with Professor Sven Ove Hansson, presents a three party model as a tool for ethical risk analysis. It is argued that ethical dimensions need to be acknowledged in the analysis of risks and that this is best done through a discussion of three parties that are involved in risk decisions – the risk-exposed, the beneficiary, and the decisionmaker. Seven crucial ethical questions are recognized and discussed regarding the relation between these parties. By using examples from the railway sector it is shown how the questions can be used to identify salient ethical features of risk management problems.</p>

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Darbo tikslas – įvertinti pacientų požiūrį į teisę gauti informaciją įstaigose, teikiančiose odontologinės priežiūros (pagalbos) paslaugas. Tyrimo metodika. Tyrimui atlikti buvo panaudotas apklausos tipas - anketinė respondentų apklausa raštu. Pagal Kaune esančių odontologinių įstaigų dydį (pacientų apsilankymų skaičius per metus) buvo atrinkta 1 Kauno miesto privati odontologijos klinika ir 1 Kauno miesto valstybinė gydymo įstaiga. Per šešis mėnesius nuo 2009 metų liepos mėnesio iki 2009 metų gruodžio mėnesio šiose gydymo įstaigose viso buvo išdalintos 860 anketos, grąžintos 798 anketos, iš jų 58 buvo atmestos dėl netinkamo užpildymo. Atsako dažnis buvo 92,8 proc. Analizuotos 740 odontologijos kabinetų pacientų anketos (389 užpildytos privačios gydymo įstaigos pacientų ir 351 - valstybinės gydymo įstaigos pacientų). Statistinė duomenų analizė atlikta naudojant SPSS 13.0 ir MS Excel programą. Rezultatai. Dauguma respondentų teigė, kad jiems odontologas vizito metu pakankamai dėmesio ir laiko skyrė informavimui (apie burnos ir dantų būklę, gydymą, profilaktiką ir pan.). Taip pat dauguma pacientų teigė, jog odontologas suteikė išsamią informaciją apie jų sveikatos būklę, ligos diagnozę, sveikatos priežiūros įstaigoje taikomus ar gydytojui žinomus kitus gydymo ar tyrimo būdus, galimą riziką, komplikacijas, šalutinį poveikį. Beveik pusė respondentų teigė, kad informuoto sutikimo forma skirta pacientams, kad pareikštų savo apsisprendimą susijusį su jų gydymu ar kitomis gydymo... [toliau žr. visą tekstą] / Aim of the study. To evaluate patients’ attitude towards the right to information in the institutions providing dental care (assistance) services. Methods of the study. A questionnaire-based survey was carried out. Based on size of the dental institutions in Kaunas city (number of patient visits per year), one private dental clinic and one public dental clinic of Kaunas city were selected. During the 6-month period from July 2009 till December 2009, 860 questionnaires were distributed in these institutions; 798 were returned and 58 were excluded because of inadequate filling them out. The response rate was 92.8%. A total of 740 questionnaires, completed by patients visiting dental institutions, were analysed (respectively, 389 and 351 questionnaires were completed by patients visiting private or public dental institutions). Statistical analysis of the data was conducted by applying SPSS 13.0 and MS Excel programme. Results. The majority of respondents stated that during the visit to an odontologist, they were given sufficient attention and time for the provision of information on oral health status, treatment, prevention, etc. by their odontologist. Also, the vast majority of patients reported having been provided with comprehensive information on their health status, diagnosis of disease, treatment or examination methods having been applied in health care institutions or other approaches known by their odontologist, possible risk, complications and side effects by their... [to full text]

Introduction: Little guidance is given to health professionals over how to deal with HIV disclosure complexities in the biomedical setting. Given the paucity of related research in this context, there is also little consideration of the actual effect of HIV disclosure in a given context. Social constructionist theory is an important contribution to disclosure research because it shifts the focus from a biomedical perspective to one that incorporates an individual's experience with HIV infection in a specific context. The task of this study was to develop substantive theory, with the aim of providing a theoretical framework for public health and health care practitioners to better understand HIV disclosure dynamics in the PMTCT setting. Methods: This was a qualitative study which explored the experience of disclosure amongst HIV positive pregnant women in the PMTCT context. Between 5 June – 31 November 2008, a total of 62 participants were recruited from two urban-based PMTCT programmes located within the eThekwini District, KwaZulu-Natal, South Africa. Results: Participants disclosed to two main groups: sexual partners, and family/others. Structural and relationship network factors shaped transmission risk behaviour, subsequent disclosure behaviour and outcomes. The circumstances which placed participants at risk for HIV acquisition also affected the likelihood of disclosure and health behaviour change. HIV and pregnancy diagnoses often occurred concurrently which profoundly impacted on participant's social identities and disclosure behaviour. Current HIV testing protocols within PMTCT settings often recommend disclosure to sexual partners under the assumption that couples will engage in safer behaviours, yet findings from this study indicate that this assumption should be challenged. Discussion: The study findings are synthesized in a conceptual model which offers substantive new theory over the concepts and interrelated factors that were identified to shape HIV disclosure and outcomes in the PMTCT context. The model identifies the following domains: 1) social networks and social support; 2) identity; 3) risk behaviour; 4) HIV and pregnancy diagnoses; and 5) HIV disclosure process to partners and others. Recommendations: Assumed pathways to risk reduction and HIV prevention need to be relooked and reconsidered. The conceptual model provides a proposed framework for future research, intervention design and implementation planning in the PMTCT setting. / Thesis (Ph.D.)-University of KwaZulu-Natal, Durban, 2011.

The overall aim of this thesis was to study participants' understanding of clinical cancer trials, and their motivation for participation. Of particular interest was the question of whether the patients hoped for a cure resulting from the trial. The thesis was based on four studies and used three methods: interviews, a questionnaire, and empirical bioethics. The results of Study I indicated that the participants in phase 1 trials understood most of the information provided, but were unaware of both the very small potential for treatment benefit, and the risk of harm. Patients in phase 3 trials had a good understanding of the trial, except regarding side effects and their right to withdraw. Some found it hard to ask questions and felt they needed more information (Study III). The participants in phase 1 trials were strongly motivated by the generally unrealistic hope for therapeutic benefit (Study I). When the chances of a cure are minuscule, as for participants with end-stage cancer in phase 1 trials, hope can play an important, positive role and offer meaning to one’s remaining life. However, hope for an unrealistic outcome could also deprive patients of an opportunity to spend their remaining lives, as they would otherwise choose (Study II). The participants in phase 3 trials indicated that their motivation for participation was multifaceted; the most common motivations included hope of therapeutic benefit, altruism, access to extra clinical examinations or better care, and a wish to repay society for the help they had received (Study III). After stratifying and analysing the motivation data by gender, age, education and previous experience of trial participation, males and those aged ≥65 years were significantly more motivated to participate out of a desire to reciprocate the help they had received, either because of a sense of duty or because their families or friends considered that they should attend (Study IV). In conclusion, the informed consent process seems to work relatively well, with good results within most subgroups. However, patients with end-stage cancer who are participating in phase 1 trials are a vulnerable group as they have very little potential for treatment benefit coupled with a tangible risk of harm.

Darbo tikslas. Ištirti gydytojų požiūrį į klinikiniuose tyrimuose dalyvaujančių pacientų teisių apsaugą. Uždaviniai. Įvertinti gydytojų informuotumą apie teisės aktus, reglamentuojančius pacientų, dalyvaujančių klinikiniuose tyrimuose, teisių apsaugą, nustatyti gydytojų nuomonę apie informuoto asmens sutikimo reikšmę jo saugumui, įvertinti pacientų, dalyvaujančių klinikiniuose tyrimuose, teisių pažeidimus ir biomedicininių tyrimų etikos principų įgyvendinimo problemas, gydytojų požiūriu. Tyrimo metodika. 2010 m. buvo atlikta anoniminė anketinė gydytojų apklausa. Buvo išdalinta 200 anketų (atsako dažnis 72 proc.). Tyrime dalyvavo visi gydytojai, įtraukti į N kompanijos, organizuojančios klinikinius tyrimus, gydytojų-tyrėjų duomenų bazę ir dirbantys privačiose ir valstybinėse sveikatos priežiūros įstaigose. Statistinė duomenų analizė atlikta naudojant SPSS 17.0 programinį paketą; naudotas susietų lentelių metodas. Duomenų skirtumų statistinis reikšmingumas buvo vertinamas pagal Chi kvadrato (χ2) kriterijų ir statistinio reikšmingumo lygmenį. Rezultatų skirtumas laikytas statistiškai reikšmingu, jei paklaidos tikimybė p < 0,05, labai reikšmingu – kai p < 0,01, ypač reikšmingu – kai p < 0,001. Rezultatai. Geros klinikinės praktikos taisykles teigė žinantys visi pagrindiniai tyrėjai ir tyrėjai, Helsinkio deklaraciją – 63,6 proc. pagrindinių tyrėjų ir 63,3 proc. tyrėjų bei visi tyrimo koordinatoriai. 50 proc. pagrindinių tyrėjų ir 65,3 proc. tyrėjų nurodė esantys gerai susipažinę... [toliau žr. visą tekstą] / Aim of the study. Investigate physicians' view to protection of patients' rights in clinical trials. Objectives. Evaluate physicians' acknowledge about laws, regulating protection of patients participating in clinical trials; establish physicians' opinion about importance of informed consent to subject’s safety; evaluate violations of patients’ rights and implementation problems of clinical trials ethics principles in Lithuania. Methods. Anonymous physicians’ survey was performed in 2010. 200 questionnaires were distributed (response frequency – 72%). All physicians, working in national and private medical institutions and included in database of N pharmaceutical company organizing clinical trials, were participated. Statistical data analysis was performed by using SPSS 17.0 program package, crosstabs method; statistical significance was evaluated by χ2 criterion and significance level. Result significance was statistically significant if expectation bias p < 0,05, very significant if p < 0,01, extremely significant if p < 0,001. Results. All principal investigators and investigators indicated that they know Good Clinical Practice. 63,6% of principal investigators and 63,3% of investigators and all study coordinators knew Declaration of Helsinki. 50% of principal investigators and 65,3% of investigators were familiarized with Law on ethics of biomedical research. 62,5% of all respondents were read/ heard about Law on the rights of patients and compensation of the damage to... [to full text]

Purpose: Patients living with advanced heart failure experience dyspnea, fatigue, poor quality of life, depression and cognitive impairment which may threaten their ability to provide informed consent to undergo heart transplant (HTx) or mechanical support (LVAD). Using qualitative and quantitative methods, we asked how patients with advanced heart failure make decisions regarding HTx and LVAD. The variables chosen to reflect the elements of consent included quality of life and symptom severity (voluntariness), depression and cognitive impairment (capacity) and treatment preferences (decision-making). Methods: 76 patients enrolled in the quantitative arm completed the Minnesota Living with Heart Failure Questionnaire; Visual Analog scales for dyspnea, fatigue and overall health; Beck Depression Inventory; Montreal Cognitive Assessment; Standard Gamble and Time Tradeoff. Qualitative methods were used to discover concepts, relationships and decision-making processes described by 17 of the 76 patients considering HTx and LVAD. Results: Patients reported poor quality of life and high symptom severity scores which compelled them to consider surgery as a way to relieve unpleasant symptoms and improve quality of life. Although 30% of patients had evidence of depression and/or cognitive impairment, no patient was deemed incapable of decision-making. Patients were willing to take considerable risk (35%) and trade considerable time (4months) to improve their health. While heart failure-related concepts were important to the decision, entrustment emerged as the meaningful process for decision-making. Conclusions: Patients who participated in this study were capable of decision-making and understood the risks associated with the surgery. Voluntariness was diminished by disease but not absent, and decisions were free of coercion. These results suggest the entrustment model of decision-making is the dominant process for patients considering high-risk surgical procedures and meets criteria for informed consent. Understanding the process of decision-making will help clinicians support and enable treatment decisions made by patients living with advanced heart failure.

La problématique du consentement éclairé en santé mentale demeure au coeur des préoccupations des cliniciens, médecins spécialistes et médecins experts. Le travail auprès des cérébrolésés ou des patients souffrant de troubles mentaux graves, tout comme les questions qui me sont adressées depuis près de 20 ans par les médecins spécialistes, juristes ou résidents en psychiatrie, m’ont amenée à y réfléchir davantage. J’ajouterais que le constat personnel d’une compréhension des comportements, attitudes, motivations et jugements des patients vulnérables qui s’est modifiée au fil des ans, et le constat de l’importance de la notion du consentement vs le flou de sa définition et la fragilité des paramètres établis pour l’évaluer et la définir ont ravivé cette réflexion. La présente étude n’a aucunement pour but d’élaborer quelque règle de conduite que ce soit, ni de définir ce que devrait être le consentement éclairé en psychiatrie, mais plutôt d’explorer les dilemmes éthiques et les questionnements cliniques auxquels sont confrontés les médecins psychiatres afin de raviver une réflexion éthique qui semble s’estomper au profit de procédures juridiques et administratives. / In the mental health field, the topic of informed consent has always been among the most important problems to address for clinicians and psychiatrists. My clinical work with head injured patients and patients with severe mental health disorder, as well as all the questions addressed by physicians, residents or lawyers for the last decade lead me to think about it more deeply. Moreover, the personal observation of cognitively impaired patients and the fact that the concept of informed consent is so present compared to the lack of parameters to assess it has lead me to think about it otherwise. This study does not pretend to lead the actions or clinical behaviour, nor as it pretend to find a better definition of the concept of informed consent. It is only a way to explore some aspects of the complexity and clinical difficulties over the legal and administrative frame in which the medical field is evolving.

Le regime juridique instaure par le legislateur quebecois en matiere de consentement aux soins pour le majeur inapte merite d'etre revise. La determination de cette inaptitude produit des effets importants. Le constat d'inaptitude prive la personne majeure de son droit de prendre une decision a l'egard de sa sante, une des spheres les plus personnelles et privees de sa vie. Cette these utilise une approche transdisciplinaire, puisant a la fois dans le droit et la bioethique, pour evaluer de facon critique: l'encadrement de la determination de cette inaptitude, la determination juridique de cette inaptitude et les dispositions pertinentes du Code civil du Quebec qui s'appliquent en matiere de consentement aux soins lorsque cette inaptitude est constatee par le medecin. L'auteur conclut que l'objectif vise par le legislateur quebecois, le respect de la personne, n'est que partiellement atteint.

Source: Masters Abstracts International, Volume: 46-01, page: 0344. Adviser: Patricia Dolan Mullen. Includes bibliographical references (leaves xx-xx).