Made available in DSpace on 2016-08-10T10:54:11Z (GMT). No. of bitstreams: 1 EURIPEDES RODRIGUES FILHO.pdf: 1862437 bytes, checksum: 9bbde5e059417e2643ece305cfda4d7a (MD5) Previous issue date: 2014-03-12 / The respect due to the human dignity and autonomy requires that all scientific research involving human subjects may only be conducted with due consent of the participant. It could say that for the Ethics Committee (EC), in Brazil, the most important for verifying the adequacy of the ethics of research projects involving human beings is the Informed Consent (IC) .Therefore, as shown by the literature, it is common ground point between most ethics committees of research centers in the world, the need for obtaining informed consent for any research involving human beings. Therefore, those shown by the literature, it is common ground point between ethics committees of most research centers in the world, the need for Obtaining informed consent for any research Involving human beings. Due to the risks related to privacy and confidentiality of data and that such waiver must be requested by the researcher to the CEP, with justification. Aimed to select, interpret, and critically evaluate studies that were focused understanding and readability of the informed consent; identify factors associated with the process of obtaining valid consent factors; identify the inner relationship between the principle of respect for autonomy and informed consent. The methodological procedures were performed in two stages: the first was used an integrative review to check the guiding question of the study, which to question the readability and understanding of informed consent in research involving humans. Included in the sample selected eleven of this review, national and international articles, four of which were in Portuguese (36.36%), one in Spanish (9.09%) and six in English (54.54%). The second was used content analysis to the verification of changes in guidelines for research involving humans in Brazil, referring to the principle of respect for autonomy of the research participant. From the themes "consent and approval", "document / consent" and "consent process", which allow the inference of the changes brought by the new rules on ethics in research involving human beings. The study results suggest that the informed consent should contain simple vocabulary, clarity of language, considering the socioeconomic, educational and cultural participant. Similarly suppose that the four necessary conditions for an autonomous decision are: intentionality, proper knowledge, the absence of external and internal control and authenticity. Concluded that the IC well understood is the key to autonomous decision making and, that authenticity gives the informed consent the essential nature of validity. It was found that the amount of related to informed consent in research involving humans, studies are still very low in the scientific community. Making is therefore a need for greater mobilization of the scientific and academic community for this matter of major interest to society. / O respeito devido à dignidade humana e à autonomia exige que toda pesquisa científica que envolve seres humanos só poderá ser realizada, com o devido consentimento do participante. Pode-se dizer que, para os Comitês de Ética em Pesquisa (CEP), no Brasil, o documento mais importante para a verificação da adequação da eticidade dos projetos de pesquisas que envolvem seres humanos é o Termo de Consentimento Livre e Esclarecido (TCLE). Por conseguinte, como atesta a literatura pertinente, é ponto pacífico entre a maioria dos comitês de ética dos centros de pesquisas do mundo, a necessidade da obtenção do TCLE para qualquer pesquisa que envolva seres humanos. Excetuam-se os casos especiais previstos nas resoluções e declarações nacionais e internacionais, que tratam da impossibilidade de se obter o TCLE de certos participantes, devido aos riscos relacionados à privacidade e à confidencialidade dos dados e, que essa dispensa deve ser solicitada pelo pesquisador ao CEP, com justificativa. Teve como objetivos selecionar, interpretar e avaliar criticamente os estudos que tiveram como enfoque a compreensão e a legibilidade do Termo de Consentimento Livre e Esclarecido (TCLE); verificar os fatores associados ao processo da obtenção do consentimento válido; explicitar a relação interna entre o princípio do respeito à autonomia e o consentimento livre e esclarecido. Os procedimentos metodológicos foram realizados em dois momentos: no primeiro, utilizou-se da revisão integrativa para a verificação da pergunta norteadora do estudo, que problematizou a legibilidade e a compreensão do consentimento livre e esclarecido na pesquisa que envolve seres humanos. Integram a amostra desta revisão onze artigos selecionados, nacionais e internacionais, dos quais foram quatro em Português (36,36%), um em Espanhol (9,09%) e seis em Inglês (54,54%). No segundo, utilizou-se da análise de conteúdo para a verificação das mudanças ocorridas nas normas de pesquisa que envolve seres humanos no Brasil, referente ao princípio do respeito à autonomia do participante da pesquisa, a partir das categorias temáticas consentimento e assentimento , documento / termo de consentimento e processo de consentimento , que permitem a inferência das mudanças trazidas com a nova norma sobre ética em pesquisa envolvendo seres humanos. Os resultados do estudo sugerem que os Termos de Consentimento Livre e Esclarecido devem conter vocabulário simples e clareza da linguagem, considerando o nível socioeconômico, de escolaridade e cultural do participante. Do mesmo modo supõem que as quatro condições necessárias para uma decisão autônoma são: a intencionalidade, o conhecimento adequado, a ausência de controle externo e interno e a autenticidade. Concluiu-se que o TCLE bem compreendido é a chave para a tomada de decisão autônoma e que a autenticidade confere ao consentimento livre e esclarecido o imprescindível caráter de validade. Constatou-se, também, que a quantidade de estudos relacionados ao consentimento livre e esclarecido em pesquisas que envolvem seres humanos ainda é muito reduzida no meio científico. Perfaz-se, portanto, a necessidade de maior mobilização da comunidade científica e acadêmica para esta temática de relevante interesse à sociedade.

Made available in DSpace on 2016-04-26T20:21:37Z (GMT). No. of bitstreams: 1 Fernando Loschiavo Nery.pdf: 866232 bytes, checksum: b45520a98956ac52b00124aea476c021 (MD5) Previous issue date: 2013-03-22 / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior / With the discovery of techniques of assisted human reproduction, medicine brought solution to the problem of infertile couples, opening opportunities to various situations never imagined, from which we highlight the issue of posthumous son. The Federal Constitution of 1988 allowed for the inclusion of new families species. The aim of this study was to verify whether the posthumous son has the right to equal treatment, considering the liberty of parents to undertake family planning, represented by informed consent from the clinic assisted human reproduction. To find solution to the problems posed in the study worked through national legislation of medical ethics, with emphasis on informed consent, examining bioethics, the Biolaw, techniques of assisted human reproduction, personality rights, family law, inheritance law, court rulings and foreign law. We conclude that although there is no consensus regarding the beginning of life, the unborn child has received significant expansion of their rights. The genetic material while cryopreserved unfertilized or embryonic, represents a breeding project alive, backed into legal business (informed consent), this document serve physicians responsible for declaration as proof of affiliation legitimate, independent of presumption. For legal and guard the rights of third parties present suggestion "lege ferenda." / Com a descoberta das técnicas de reprodução humana assistida a medicina trouxe solução para o problema dos casais inférteis, abrindo oportunidades a diversas situações nunca imaginadas, entre as quais destacamos a questão do filho póstumo. A constituição de 1988 permitiu a inclusão de novas espécies de famílias. O objetivo desta pesquisa foi de verificar se o filho póstumo possui direito a um tratamento igualitário, considerando a liberdade dos pais ao realizarem o planejamento familiar, representado pelo termo de consentimento informado junto à clínica de reprodução humana assistida. Para encontrar solução aos problemas propostos debruçamos no estudo da legislação nacional, da deontologia médica, com ênfase no consentimento informado, examinando a Bioética, o Biodireito, as técnicas de reprodução humana assistida, os direitos da personalidade, o direito de família, o direito sucessório, as decisões dos tribunais e legislação alienígena. Concluímos que embora não exista um consenso quanto ao início da vida, o nascituro tem recebido ampliação significativa de seus direitos. O material genético criopreservado enquanto não fecundado ou em fase embrionária, representa um projeto de procriação vivo, com o respaldo em negócio jurídico (consentimento informado), servindo este documento por declaração dos médicos responsáveis como prova de filiação legítima, independe da presunção. Para a segurança jurídica e resguardo do direito de terceiros apresentamos sugestão de lege ferenda

O presente trabalho construiu-se a partir dos novos paradigmas que permeiam a relação médico-paciente. Se o profissional não mais se encontra em uma posição de superioridade (ao menos do ponto de vista fático) em face de seu paciente, que por sua vez está mais sensível em virtude das transformações oriundas da sociedade de massa, o elemento informação ganhou contornos importantíssimos, inserindo-se no núcleo principal da prestação, ao lado dos cuidados relativos à saúde propriamente ditos. Nesse contexto, foi proposta uma nova visão do dever de informar na relação médico-paciente, tratando a informação como uma obrigação autônoma, que gera de per se em caso de ausência ou vício responsabilização civil. A reparação, em tal perspectiva, surge a partir da violação do direito à liberdade: se a autodeterminação é um atributo da personalidade do paciente, a afronta a esse direito acarreta danos indenizáveis. Os limites do dever de informar, assim, desempenham relevante papel, pois demarcam a tênue linha que distingue a informação viciada (que ensejará responsabilização civil) daquela transmitida diligentemente. Assim, o conteúdo e a extensão da informação foram abordados, confrontando-se aspectos subjetivos, objetivos e buscando uma solução ao mesmo tempo viável (do ponto de vista prático), jurídica e justa. Como o trabalho trata essencialmente do dever de informar na relação médico-paciente e das consequências jurídicas derivadas do inadimplemento dessa obrigação, foram destrinchados todos os elementos que compõem esse complexo vínculo, passando por sua evolução histórica, pelos princípios, valores e direitos que permeiam e iluminam esta relação e, finalmente, pelos sujeitos que a compõem. Aspectos processuais atinentes à prova do cumprimento do dever de informação foram, ainda, examinados. Diversas questões polêmicas, tais como recusa de tratamento, direito a não saber, privilégio terapêutico, dentre outros, foram também debatidos. / This study is based on the new paradigms that permeate the doctor-patient relationship. If the medical professional no longer holds a superior position (at least from the factual point of view) vis a vis the patient who, on the other hand, is more aware to changes originating from doctor-patient relationship in the mass society, information availability has gained highly important contours, inserting itself into the core of services rendered, together with health care services themselves. In this context, this study proposes a new vision of the duty to inform in a doctor-patient relationship, treating information as an autonomous obligation, that, per se, results in liability in the case of its absence or flaws. The compensation, in such perspective, arises from breach of the right to autonomous choice: if self-determination is a characteristic of the patients personality, the disrespect of this right results in damages subject to indemnification. Therefore, the limits of the duty to inform perform a relevant role since they demarcate the fine line that distinguishes flawed information (that can incur liabilities) from that transmitted diligently. Thus, the contents and the extension of the information were addressed, comparing subjective and objective aspects and seeking a solution at the same time viable (from the practical viewpoint), legal and just. Since this study essentially deals with the duty to inform in the doctorpatient relationship and of the legal consequences derived from noncompliance of this duty, all factors that compose this complex link were carefully examined, reviewing its historical evolution, the principles, values and rights that permeate and elucidate this relationship and, finally, the parties involved. Legal evidential procedures related to fulfillment of the duty to inform were also examined. Various controversial topics such as the refusal to undergo treatment, the right to not be informed, therapeutic privilege, among others, were also discussed.

What role should trust have in biobank research? Is it a scarce resource to be cultivated, or does its moral significance lie elsewhere? How does it relate to the researcher’s individual responsibility? In this thesis I draw four general conclusions. First, trust is still very much present in at least some biobanking settings, notably in Sweden, but possibly also internationally. Second, a morally relevant conception of trust entails that to be trustworthy, researchers must consider the normative expectations that people have of them, and renegotiate expectations that are mistaken. Third, this conception differs from “public trust” assessed through surveys. The main use of the latter is to legitimate policy, not to identify moral duties. Fourth, in spite of ethics review, guidelines and informed consent procedures, ethical issues will always arise during the course of a research project. Researchers can therefore never avoid their individual moral responsibility. Ensuring that one is adequately trusted is one step towards conducting morally acceptable research. Study I indicates that few Swedes refuse storage of samples in healthcare-associated biobanks and their use in research. Study II suggests that people are somewhat more willing to donate samples than surveys indicate, especially when approached face-to-face by health care personnel. Relationships of trust might thus be important in people’s decision-making. Study III investigates trust as a moral concept. The trustee is often in a unique position to determine what the other’s trust amounts to. When it is mistaken, the trustee has an obligation to counteract it, compensate for it, or renegotiate the expectations that cannot be met. In Study IV, I critique the feasibility of guaranteeing the trustworthiness of the research apparatus through formal measures such as ethics review and guidelines. Not only are there limitations of such measures to consider. They also risk blinding researchers to ethical issues that are not covered by the rules, fostering moral complacency, and alienating researchers to ethics.

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.

<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>

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]