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  • About
  • The Global ETD Search service is a free service for researchers to find electronic theses and dissertations. This service is provided by the Networked Digital Library of Theses and Dissertations.
    Our metadata is collected from universities around the world. If you manage a university/consortium/country archive and want to be added, details can be found on the NDLTD website.
61

ISO 9001:2015 implementation at a manufacturing company

Jönsson, Anna, Berglund, Magnus January 2016 (has links)
Martin Ivarsson, manager and part owner at Landeryd’s Mechanical Workshop (LMW), Landeryd, Sweden, initiated this project. This because of a new released ISO 9001 version that LMW has to implement before the 15th of September 2018 to remain certified. Since LMW is ISO 9001:2008 certified the project members only needed to identify the differences among the 2015 and 2008 version to see what LMW has to do to get certified. There are approximately 1.1 million ISO 9001 certificates issued worldwide. An ISO 9001 certification increase organizations ability to satisfy customer needs and customers can rely on that the products and services provided are of consistently good quality. ISO 9001 can also work as a tool to streamline the organization’s processes and make them more efficient. Since the ISO 9001 is reviewed every five year it helps organizations to keep current in an ever- changing world. Landeryd’s Mechanical Workshop has been ISO 9001 certified since 2002 and the “ISO- think” is deeply rooted within the company. LMW is a small owner-controlled company with only 18 employees. ISO 9001:2015 is applicable on different kinds of organizations in various scales. Comparing to previous versions of ISO 9001 the new version is more adaptable. This makes it more beneficial for the organizations but harder for the auditors that certifies. One major conclusion is that LMW will have more freedom of document handling with the new ISO version. This report highlights LMW’s status today in accordance to the new ISO 9001 version, and estimates how much effort that is needed for a successful revision. Readers of this report will benefit from the results, since much is applicable on all types of organizations or companies.
62

Desenvolvimento de métodos alternativos para avaliação de riscos segundo o conceito de supervisão baseada em riscos. / Development of alternative methods for risk assessment in accordance with the concept of risk-based supervision.

Santos, Jordanno Brunno Nicoletta dos 17 November 2011 (has links)
O sistema de fundos de pensão possui papel fundamental na constituição de poupança e desenvolvimento do mercado financeiro e de capitais de um país. As incertezas de sustentabilidade do equilíbrio financeiro no longo prazo direcionam a exigência de uma supervisão robusta sobre os diversos riscos incorridos, não se restringindo apenas ao seu estado de solvência. A presente dissertação procura apresentar modelos baseados na avaliação dos riscos de um fundo de pensão, passando pela situação atuarial, as características dos planos, bem como pelos parâmetros relacionados ao mercado de capitais e formas de gestão dos investimentos. Os modelos propostos nos ajudam a visualizar o risco atuarial justificado pelo aumento da expectativa de vida, o risco de mercado através do reinvestimento e o risco de mercado em função do nível das taxas de juros. Ainda, tendo em conta estes riscos quantificáveis, é efetuada uma aplicação prática com o objetivo de determinação do requisito de capital de um determinado fundo de pensão para a cobertura destes riscos, tendo por base o modelo do projeto europeu de Solvência II, desenvolvido no âmbito da atividade seguradora. / The system of pension funds has a primary role in the formation of savings and financial market development and capital of a country. The uncertainties of financial balance sustainability in the long term drive the requirement for a robust supervision on the various risks involved, not restricted only to its state of solvency. This dissertation seeks to present models based on risk assessment of a pension fund, through the actuarial situation, the characteristics of the plans, as well as the parameters related to capital markets and ways of managing investments. The proposed models help us to see the actuarial risk justified by the increase in life expectancy, market risk through reinvestment and market risk based on the level of interest rates. Still, considering these risks quantifiable, a practical application is made for the purpose of determining the capital requirement of a particular pension fund to cover these risks, based on the model of the European Solvency II project, developed within the ambit of insurance activity.
63

Governança corporativa e normas contábeis das entidades fechadas de previdência complementar no Brasil

Souza, Gilberto Bizerra de 25 June 2012 (has links)
Made available in DSpace on 2016-04-25T18:39:48Z (GMT). No. of bitstreams: 1 Gilberto Bizerra de Souza.pdf: 1472526 bytes, checksum: d785dce81123ecd6c7f0c81ae1c02dd8 (MD5) Previous issue date: 2012-06-25 / The objective of this work is to determine, based on research and analysis of recent articles and publications, and also considering the recent regulations applicable, particularly those issued by the Ministry of Social Security on Corporate Governance and on elaboration and publication of financial statements, what is the current stage of internal control structures of the pension funds. This goal is also working to focus what challenges that those entities should face to build sustainable models of Corporate Governance and of the preparation of its financial statements over the years. The survey was limited to those pension funds who have answered the survey entitled Corporate Governance in pension funds , leaded by Deloitte Consulting and coordinated by the author, during the years of 2009 and 2010, and in this context showed that, on the horizon of two years, respondents pointed out that as a result of the actions of training and awareness, there was a clear improvement in corporate governance environment of pension funds. However, the survey also pointed to a need for constant revisits the structure of internal controls of such entities, with a view to permanently review the risk environment in which they are involved and thus prevent risks are not considered by pension funds. It is therefore concluded that, considering the competition between the pension plans with open pension entities and also with the growing concern of the population with post-employment benefits and well-being in retirement, corporate governance in pension fund entities will be focus of the attention not just of the regulatory entities, but also of all its stakeholders, in particular participants and dependents of those entities / O objetivo deste trabalho é determinar, com base em pesquisas realizadas e análise de publicações e artigos recentes e, também considerando as regulamentações recentes aplicáveis, sobretudo aquelas emanadas pelo Ministério da Previdência Social sobre Governança Corporativa e sobre elaboração e publicação de demonstrações financeiras (também denominadas demonstrações contábeis), qual o estágio atual das estruturas de controles internos das entidades fechadas de previdência complementar. Também é objetivo deste trabalho enfocar quais os desafios que estas entidades, também denominadas fundos de pensão, deverão enfrentar para construir modelos sustentáveis de governança corporativa e de elaboração de suas demonstrações financeiras ao longo dos anos. A pesquisa foi limitada aos fundos de pensão que responderam à pesquisa denominada Governança Corporativa em fundos de pensão , realizada pela empresa de auditoria e consultoria Deloitte e coordenada pelo Autor nos anos 2009 e 2010 e nesse contexto evidenciaram que, no horizonte de dois anos, os respondentes apontaram que, como fruto das ações de treinamento, conscientização e capacitação, houve uma clara melhora no ambiente de Governança Corporativa dos fundos de pensão. Entretanto, a pesquisa também aponta uma necessidade de constante revisita à estrutura de controles internos dessas entidades, a fim de permanentemente revisar o ambiente de riscos no qual estas estão envolvidas e, assim, prevenir a ocorrência de riscos não considerados pelos fundos de pensão. Conclui-se, portanto, que considerando a concorrência das entidades fechadas de previdência complementar com as entidades abertas e também com a crescente preocupação da população com benefícios pós-emprego e bem-estar na aposentadoria, cada vez mais a governança corporativa das entidades fechadas de previdência complementar vai ser foco da atenção não apenas dos órgãos fiscalizadores, mas de todos os seus stakeholders, em particular os participantes e dependentes dessas entidades
64

Capital baseado em risco no mercado de saúde suplementar do Brasil: análise de impacto se adotado o modelo praticado no mercado de seguros

Silva, Adriana Barbosa Sousa 04 December 2013 (has links)
Made available in DSpace on 2016-04-25T18:39:57Z (GMT). No. of bitstreams: 1 Adriana Barbosa Sousa Silva.pdf: 3488063 bytes, checksum: 14e7038f99ce8aafbd0d18a18b050e1d (MD5) Previous issue date: 2013-12-04 / This paper has the main purpose to determine quantitatively the impact of framing of Health-plan Companies, in regards to sufficiency of solvency margin, if adopted the model of a risk-based capital used in the Insurance Market. We have conducted an exploratory study, based on secondary data available on the ANS - Agência Nacional de Saúde Suplementar (NSA- National Supplemental Health Agency). From a sample of 578 health operators modalities of Medical Group and Medical Cooperatives there were calculated solvency margin requirements of the relevant legislation operators supplemental health and solvency margin requirements for capital model based on current risk of the Brazilian Insurance Market. We performed a descriptive statistical result, segmented by the size of the operator. The results pointed to the need for solvency margin of 5% of the sample, i.e., 30 carriers that were framed in the solvency margin requirements by the legislation applied to health plans companies would no longer be framed if used the model risk-based capital, considering underwriting risk. This impact is higher among carriers of the Medical Group small group, where 15 operators, representing 10% of the mode and size, would no longer be framed. In addition to quantitatively assess the impact of the model adopted in the insurance market, which is more sophisticated and in line with the global trend of risk-based capital, this study sought to raise issues related to risk-based capital and solvency in the supplemental health operators / Essa dissertação tem como principal objetivo verificar quantitativamente qual o impacto no enquadramento das operadoras de planos de saúde, no quesito de suficiência de margem de solvência, se adotado o modelo de capital baseado em risco utilizado no mercado segurador. Foi realizado um estudo exploratório, baseados em dados secundários disponíveis na ANS Agência Nacional de Saúde Suplementar. A partir da amostra composta por 578 operadoras de saúde das modalidades Medicina de Grupo e Cooperativas Médicas, foram calculados os requisitos de margem de solvência pela legislação pertinente às operadoras de saúde suplementar e os requisitos de margem de solvência pelo modelo de capital baseado em risco vigente no mercado segurador brasileiro. Foi realizada uma estatística descritiva dos resultados, segmentada por porte de operadora. Os resultados apontaram para necessidade de margem de solvência para 5% da amostra, ou seja, 30 operadoras que estariam enquadradas nos requisitos de margem de solvência pela legislação aplicada à saúde suplementar deixariam de estar enquadradas se utilizado o modelo de capital baseado em risco, considerando o risco de subscrição. Esse impacto é maior entre as operadoras da modalidade Medicina de grupo de pequeno porte, onde 15 operadoras, que representam 10% da modalidade e porte, deixariam de estar enquadradas. Além de avaliar quantitativamente o impacto do modelo adotado no mercado segurador, que é mais sofisticado e em consonância com a tendência mundial de capital baseado em risco, esse trabalho procurou levantar as questões relacionadas ao capital baseado em risco e solvência nas operadoras de saúde suplementar
65

Desenvolvimento de métodos alternativos para avaliação de riscos segundo o conceito de supervisão baseada em riscos. / Development of alternative methods for risk assessment in accordance with the concept of risk-based supervision.

Jordanno Brunno Nicoletta dos Santos 17 November 2011 (has links)
O sistema de fundos de pensão possui papel fundamental na constituição de poupança e desenvolvimento do mercado financeiro e de capitais de um país. As incertezas de sustentabilidade do equilíbrio financeiro no longo prazo direcionam a exigência de uma supervisão robusta sobre os diversos riscos incorridos, não se restringindo apenas ao seu estado de solvência. A presente dissertação procura apresentar modelos baseados na avaliação dos riscos de um fundo de pensão, passando pela situação atuarial, as características dos planos, bem como pelos parâmetros relacionados ao mercado de capitais e formas de gestão dos investimentos. Os modelos propostos nos ajudam a visualizar o risco atuarial justificado pelo aumento da expectativa de vida, o risco de mercado através do reinvestimento e o risco de mercado em função do nível das taxas de juros. Ainda, tendo em conta estes riscos quantificáveis, é efetuada uma aplicação prática com o objetivo de determinação do requisito de capital de um determinado fundo de pensão para a cobertura destes riscos, tendo por base o modelo do projeto europeu de Solvência II, desenvolvido no âmbito da atividade seguradora. / The system of pension funds has a primary role in the formation of savings and financial market development and capital of a country. The uncertainties of financial balance sustainability in the long term drive the requirement for a robust supervision on the various risks involved, not restricted only to its state of solvency. This dissertation seeks to present models based on risk assessment of a pension fund, through the actuarial situation, the characteristics of the plans, as well as the parameters related to capital markets and ways of managing investments. The proposed models help us to see the actuarial risk justified by the increase in life expectancy, market risk through reinvestment and market risk based on the level of interest rates. Still, considering these risks quantifiable, a practical application is made for the purpose of determining the capital requirement of a particular pension fund to cover these risks, based on the model of the European Solvency II project, developed within the ambit of insurance activity.
66

風險基礎資本與涉險值運用在保險監理上之比較 / The Comparison of RBC and VaR in the Insurance Regulation

林姿婷, Lin, Tzy-Ting Unknown Date (has links)
確保保險公司之清償能力是保險監理單位之首要目標,監理單位使用各種不同的監理制度以確保保險公司的財務體質,並防止保單持有人因為保險公司失去清償能力所遭致之損失。在各種監理制度中,RBC監理制度主要是衡量保險公司的資本適足性並且提供監理單位採取相關監理行動的準則;VaR監理制度則是目前銀行業之監理所嘗試採取的新監理方式,而且VaR也被廣泛運用在銀行內部的風險管理系統中,由銀行監理的發展趨勢看來,可以預期保險監理將來也會以VaR監理制度為主。 本研究的主要目的在於探討VaR監理制度適用在保險監理制度上的可行性以及與現行RBC監理制度的比較。在探討VaR監理制度的可行性前,本研究先就VaR監理制度運用在保險監理的前提以及影響保險公司失去清償能力的原因進行探討。 在瞭解影響保險公司失去清償能力的原因後,本研究分別對於在VaR監理制度下保險公司如何分別針對各種不同的風險因子決定所需持有的資本額度。經過相關文獻的探討以及考慮保險業的行業特性,本研究建議市場風險與核保風險可以用VaR計算其資本額度;信用風險由於尚未有十分完善的量化模型,所以本研究建議應以徵信方式因應此一風險,而業務風險則是以規定一固定比率的資本額度因應之。本研究也建議待保險公司累積足夠的VaR使用經驗後,保險監理制度可以開放使用預先承諾法。 在運用VaR於保險監理上時,本研究也建議監理單位必須注意有關VaR的實行風險與模型風險的影響,同時也強調監理單位的檢核與市場制度的力量是VaR監理制度能夠充分運作的必要條件;此外,由於制度實施的初期,無法驗證模型與資料的可用性,所以仍必須輔以最低固定比率的要求,以確保保險公司的清償能力。 在探討VaR運用在保險監理制度上的可行性後,本研究將進一步比較VaR與現行RBC監理制度的比較。本研究主要是由制度實行的難易程度、衡量資本適足的準確性,以及監理的成本三方面進行比較。制度實行的難易程度主要是比較VaR與RBC制度的複雜度與可行性,以及與公司內部風險管理和全球金融監理趨勢的整合程度。衡量資本適足的準確性主要是比較二種制度何者更可以衡量保險公司所面臨的各種風險、清償能力的效力,以及保險公司投資組合的風險分散效果。至於監理的成本則可分為監理者、保險公司與社會成本三方面來探討。 透過本研究的比較結果發現VaR監理制度除了在制度的複雜度與可行性較RBC制度差以外,其他項目皆優於RBC監理制度。除此之外,VaR與RBC都各自有其監理上的道德風險。本研究建議如同銀行監理一般,保險監理制度應朝向VaR監理制度的趨勢前進,以更可以確保保險公司的清償能力以及投保大眾的權益。 / Assuring insurance company solvency has always been the focal point of insurance regulation. Regulators use various methods to promote insurers' financial strength and protect policyholders from losses due to insolvency. Among these methods, risk-based capital (RBC) is used to measure the insurer's capital adequacy and provide the relative action rule for the regulator, and the VaR (value-at-risk) regulation is new regulatory type the bank regulator attempt to adopt. Besides the regulatory application, VaR is also used in bank's risk management system broadly. We can expect the VaR-type regulation will be the new insurance regulation in the future according to the development of bank's regulation. The methodology of this study adopt is literature review. The most important purpose of this study is to explore the feasibility of VaR-type insurance regulation and compare the VaR regulation with current RBC regulation. Before the regulation system examination, this study firstly discusses the presupposition of the VaR regulation application and the causes of insurer insolvency. For the purpose of developing the VaR-type capital requirement in insurance regulation, this study proposes that market and underwriting risk capital requirement can be directly calculated in VaR; credit and business risk capital requirement should be regulated a fixed-rate capital amount. This study also proposes the application of precommitment approach when the regulator assure the insurer accumulate good experience in VaR. In addition, this study also addresses some points for attention of VaR insurance regulation. The other purpose of this study is to compare the RBC and VaR through the regulatory implementation, solvency measurement, and regulatory cost. The result of this study indicates that VaR is superior to RBC in any aspect, besides the complexity and feasibility. In addition, VaR and RBC both have their own regulatory moral hazard. This study suggests VaR should be used in the insurance regulation as other financial regulation in the future.
67

運用選擇權訂價模型評估存款保險差別費率之合理性 / Using the Option Pricing Model to Evalation Rationality of Risk- based Variable Rate of Deposit Insurance

胡慧珠, Hui-Chu Hu Unknown Date (has links)
本研究結果的重點如下:一、各樣本金融機構經由模型計算出的費率差異 頗大,顯示財務結構的不同,確實應課收不同保費。而現行的單一費率對 於好壞金融機構收取的費率一視同仁無法反應金融機構其經營風險的差異 ,也就無法避免低風險金融機構補貼高風險金融機構的弊病。因此應實施 差別費率較為合理。二、根據研究結果顯示,若以金融機構性質為分類, 其費率估計負擔由低至高依序為:一般民營銀行、國家行局、省市屬行庫 、民營中小企業銀行、信託投資公司、外商銀行、信用合作社、漁會信用 部、農會信用部。而此法的一大優點在於可對個別機構評估其相對風險性 的高低,即可依各自經營情況、組織結構分別評估其風險,以達精算上的 合理性。三、由各家樣本金融機構應負擔之估計存保費率可知,只要金融 機構資產結構稍有不同,便會使存保公司的負擔不同。換言之,因金融機 構體質的互異,其為存保公司所帶來的承保風險也有別,為避免資源配置 不當的缺失,實施以個別金融機構風險為基礎的差別費率是較公平、合理 的方式。四、承保比率亦是影響費率估計的一項因素,由實證可知承保比 率對費率估計有顯著的影響。即承保比率高的金融機構,其估計費率與全 部承保時的差異較小;承保比率低者,其估計費率與全部承保時的差異較 大。
68

風險基礎資本制實施對壽險業資本與風險之影響 / The Impact of RBC on the Capital and Risk in the Life Insurance Industry

郭純芳, Kuo, Chun Fang Unknown Date (has links)
行政院會於民國八十八年十二月十六日通過保險法修正草案,修正草案中針對強化之監理機制與增進保戶大眾之權益係以強化其資本適足性為其修法目標,所採之方法即建立風險基礎資本額制(Risk-based Capital, RBC)。而保險法修正案於民國九十年六月二十六日業已經立法院三讀通過,然RBC制度將於民國九十二年中實施。台灣保險監理機關的確有必要對於壽險公司之投資效率及經營上的安全作一考量,所以便引入美國監理關協會(National Association of Insurance Commissioners, NAIC)早於1993年便推動的風險基礎資本額制。   本文檢視美國壽險業者在風險基礎資本額制實施後,其資本結構與資產風險是否產生顯著之變化,研究保險公司之冒險行為之增減,以作為台灣監理機關未來施行RBC制度的參考。然基於此,本文利用三階段最小平方法來分析壽險業者其風險、資本與風險基礎資本制度的關係,實證結果發現RBC ratio較高的業者在風險基礎資本額制實施後,雖然增加風險但也同時調高資本比率,另一方面,RBC ratio較低之保險公司不僅僅增加公司整體風險外,也降低資本比率。 / The risk-based capital requirements developed by the National Association of Insurance Commissioners (NAIC) were intended to raise the safety net for insurers and provide regulators with the authority to intervene when capital falls below a minimum standard of capital adequacy that is related to risk. The paper examines the simultaneous impact of RBC had on life insurer’s both capital and risk. We employed a three stage least squares (3SLS) model to analyze the relationship between life insurer’s capital, risk and the risk-based capital requirements. The results suggest that life insurers with lower RBC ratio would not only increase their capital ratio but also increase their company-wide risk. Besides, the life insurers with higher RBC ratio would reduce the capital ratio and increase the risk.
69

Essays on Soft Budget Constraints¡BTop- Management Compensation¡BOwnership Structure and Banking Governance

Chang, Ching-ming 27 September 2004 (has links)
Abstract This dissertation explores two interrelated aspects of banking crises and bank regulations in perspective of regulator¡¦s soft budget constraints (SBCs in brief) and bank top management compensation. First, this paper models, in a game of incomplete information, bank behavior during banking crises when asymmetric information exists between regulators and banks. Here, I show that the situation creates the incentives for banks to roll over their defaulting loans to disguise their financial statements. Although a prudential regulator may mitigate this incentive by offering a ¡§slack¡¨ rescue packages, the bank¡¦s reputational concern may cause them to reject rescue offers. In this instance, regulators may be forced to offer amounts of recapitalization that will meet the amount necessary to restore banks to solvency. Otherwise, banks may have to gamble for resurrection, or wait until the banking crises become severe, and then more banks become insolvent, regulators have to offer optimal rescue packages subject to SBCs. New findings include (1) During banking crises, the optimal regulatory policies, on the one hand, may cause regulators have to offer rescue or bailout packages subject to different SBCs, on the other hand, mitigate banker¡¦s moral hazard. The more severe the crises will be, the greater soft budget constrained to regulators. (2) The potential severity of banking crises can be measured by the ratios, getting from net worth over the total amount of recapitalization offered by regulators and recovered from nonperforming loans. (3) As banking crises become severe, the cost of rescue becomes larger than that of bailout, the best regulatory policy is to intervene; On the contrary, if a situation labeled ¡§ too-many-to-fail¡¨ arises, the regulators may offer to rescue distressed banks subject to SBC. (4)As Bayesian equilibrium cost of regulator in crises is increasing, a random creative ambiguity for regulators to offer bailout or rescue plans may be the optimal policy to mitigate the expectation of SBC for banks . Second, this paper also shows that in the circumstances of universal banking or bank holding company, concentrating bank regulation on bank capital ratios and risk-based deposit insurance may be ineffective in controlling banker¡¦s risk-taking and moral hazard. Here, this paper follows, a more direct mechanism of influencing bank risk-taking incentives, in which the insurance premium scheme incorporate features of top management compensation. In a model of universal banking with two-periods and three-subsidiaries or departments, bank owner pre-commits to regulators to pick an optimal management compensation structure that induces the first-best value-maximizing investment choices by a bank¡¦s management. Findings include (1) If insurance premium is not fairly priced, the incentives are created for banks to have a ¡§regulatory arbitrage¡¨ by segregating its nonperforming assets from the investment bank, and shift it to the commercial bank, that increases the deposit-insurer an additional risk liability, and aggravates the risk-shifting within the universal bank; and vice versa. (2) Given management contracts{ fixed salary, a bonus paid, a fraction of equity of the bank} and { fixed salary, a penalty , a fraction of equity}for bank and security investment department respectively ; and a capitalization level corresponding must exceed the lower risky investment outcome , here bonus paid larger than 0, a penalty larger than 0, a fraction of equity between 0 and 1, then the investment policies implemented by managers, is less risky than when manger¡¦s interests are fully aligned with the equity interests. (3) Given a fairly priced insurance premium, and capitalization level corresponding must exceed the lower risky investment outcome, then the optimal management compensation structure can internalize the cost of moral hazard and induce the Pareto-optimal and department-equilibrium investment policies, thus mitigate moral hazard under universal banking. Finally, the state-owned and half-state-owned banks have experienced the institution-induced ineffectiveness; and the latter suffer from poor business performance level, partially because of the issues of ownership structure. This paper shows the investment policy with moral hazard under these banks incorporated with optimal compensation structures, and given capitalization level corresponding must exceed the lower risky investment outcome, then the optimal policies induced, that will improve their business performance level. This paper also shows that as the controlling shareholders have power over banks in excess of their cash flow rights, the incentives will be created for them to expropriate the minority shareholders. And, when the incentives for expropriation exists, the investment policy will be distorted with the managerial bias induced by their private benefits, and deteriorate morale of the banks. The regulatory mandatory requirements of one-share-one-vote principle may be proposed, instead.
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Le soin courant et le standard de soin dans l'encadrement juridique de la recherche biomédicale / Usual care and standard of usual care under the legal framework for biomedical research

Matei, Mihaela 07 December 2016 (has links)
La législation relative à la recherche biomédicale est fondée historiquement sur le principe selon lequel la recherche et le soin constituent deux activités distinctes. Perçu comme le garant éthique de tout encadrement normatif de la recherche, ce principe a conduit en France à la création d’un cadre juridique spécifique pour les pratiques médicales expérimentales. En pratique cependant, un protocole de recherche biomédicale est souvent constitué d’actes de recherche intriqués avec les interventions du soin. La distinction entre les pratiques médicales et les interventions expérimentales peut être brouillée par l’objet de la recherche (le soin courant), par la méthodologie employée (l’évaluation en conditions réelles) ou encore par le faible niveau de l’intervention ajoutée par le protocole. Tant les dispositifs juridiques passés que les modèles présents occultent cette évidence en invoquant la séparation du soin et de la recherche. Pourtant la coexistence du soin avec la recherche a créé des tensions que le cadre juridique actuel ne peut résoudre. Il est manifeste que ces dernières n'ont été évacuées en rien par la création de deux régimes juridiques distincts, l'un relatif au soin et l'autre relatif à larecherche biomédicale. De plus, la séparation nette au plan normatif entre les deux activités a empêché l’indispensable réflexion sur l’articulation entre les obligations qui relèvent de la relation médicale et celles qui sont liées à la recherche, telle l'obligation d'assurer la continuité des soins. Le législateur, soucieux de garantir cette frontière, ne traite pas spécifiquement de ces questions. Il est dès lors essentiel de déterminer avec précision le contenu et l’étendue des obligations de soigner ainsi que de mieux encadrer le « soin courant » et le « standard de soin» dans le contexte de la recherche biomédicale. Dans ces conditions, le paradigme juridique centré sur la distinction soin-recherche a-t-il encore un sens? / A biomedical research protocol includes both medical and research interventions. Since its origins, the legal framework has ignored this evidence under the pretext that research and care are two distinct activities. That is why it is all the more essential to determine the nature and the scope of the duty of care and the standard of care used in the context of biomedical research. In parallel, there is a need to distinguish, from a regulatory perspective, this "standard of care" from any equivalent notions used in the context of usual care.

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