INTRODUÇÃO: A obtenção de órgãos para pesquisa é essencial para o estudo da neurobiologia da doença mental. Na comunidade científica internacional há uma demanda crescente para a disponibilização de tecido cerebral humano para estudos sobre a neurobiologia das doenças neuropsiquiátricas, com grande interesse no uso desses tecidos para a investigação dos processos biológicos básicos associados às doenças mentais. No cenário atual, entretanto, biobancos de tecido cerebral dedicados às doenças psiquiátricas são extremamente escassos. OBJETIVO: Descrever a frequência de doação de tecido cerebral para pesquisa por familiares de pessoas que cometeram suicídio MÉTODO: Foram incluídas solicitações para doação de encéfalo a familiares de indivíduos que cometeram suicídio com idade entre 18 a 60 anos cuja necropsia foi realizada entre março de 2014 e fevereiro de 2016. Foram excluídos casos com lesões no tecido cerebral devido a trauma na hora da morte. RESULTADOS: Tivemos acesso a 56 casos de suicídio. Destes, 24 estavam dentre os critérios de exclusão do projeto. Foram excluídos do estudo 11 casos por falta de responsáveis para assinar o Termo de Consentimento Livre e Esclarecido (TCLE). Finalmente, dos 21 remanescentes, 9 responsáveis autorizaram a doação de tecido cerebral, em sete casos de fragmento de córtex e dois do encéfalo. CONCLUSÕES: As doações de tecido cerebral para pesquisa são indispensáveis para a elucidação de causas biológicas, e há uma escassez de material biológico disponível para a investigação do sistema nervoso central em doenças neuropsiquiátricas. Neste estudo demostra-se que a doação para pesquisa em nosso meio é possível, com uma proporção de consentimento similar àquela relatada em doenças neurodegenerativas. / INTRODUCTION: Obtaining organs for research is essential to study the neurobiology of mental illness. The international scientific community there is a growing demand for the availability of human brain tissue for studies of the neurobiology of neuropsychiatric diseases, with great interest in the use of these tissues for investigation of basic biological processes associated with mental illness. In the current scenario, however, brain tissue biobanks dedicated to psychiatric disorders are extremely scarce. OBJECTIVES: To describe the frequency of brain tissue donation for research purposes by families of individuals that committed suicide. METHODS: All the requests for brain tissue donation for a brain biorepository made to the families of individuals aged 18-60 years that committed suicide between March 2014 and February 2016 were included. Cases presenting with brain damage due to acute trauma were excluded. RESULTS: Fifty-six suicide cases were reported. 24 fulfilled the exclusion criteria; 11 were excluded because no next of kin was found to sign the informed consent. Finally, of the 21 remaining cases, brain tissue donation was authorized in 9 - – 7 fragments of brain tissue and 2 the entire organ. CONCLUSIONS: The donation of brain tissue for research is essential for the elucidation of the neurobiology of neuropsychiatric illness. In the present study, we report the feasibility of brain tissue donation for research purposes. Moreover, that the rates of this sort of donation is similar to the rates reported for neurodegenerative diseases.

abstract: ABSTRACT Whole genome sequencing (WGS) and whole exome sequencing (WES) are two comprehensive genomic tests which use next-generation sequencing technology to sequence most of the 3.2 billion base pairs in a human genome (WGS) or many of the estimated 22,000 protein-coding genes in the genome (WES). The promises offered from WGS/WES are: to identify suspected yet unidentified genetic diseases, to characterize the genomic mutations in a tumor to identify targeted therapeutic agents and, to predict future diseases with the hope of promoting disease prevention strategies and/or offering early treatment. Promises notwithstanding, sequencing a human genome presents several interrelated challenges: how to adequately analyze, interpret, store, reanalyze and apply an unprecedented amount of genomic data (with uncertain clinical utility) to patient care? In addition, genomic data has the potential to become integral for improving the medical care of an individual and their family, years after a genome is sequenced. Current informed consent protocols do not adequately address the unique challenges and complexities inherent to the process of WGS/WES. This dissertation constructs a novel informed consent process for individuals considering WGS/WES, capable of fulfilling both legal and ethical requirements of medical consent while addressing the intricacies of WGS/WES, ultimately resulting in a more effective consenting experience. To better understand components of an effective consenting experience, the first part of this dissertation traces the historical origin of the informed consent process to identify the motivations, rationales and institutional commitments that sustain our current consenting protocols for genetic testing. After understanding the underlying commitments that shape our current informed consent protocols, I discuss the effectiveness of the informed consent process from an ethical and legal standpoint. I illustrate how WGS/WES introduces new complexities to the informed consent process and assess whether informed consent protocols proposed for WGS/WES address these complexities. The last section of this dissertation describes a novel informed consent process for WGS/WES, constructed from the original ethical intent of informed consent, analysis of existing informed consent protocols, and my own observations as a genetic counselor for what constitutes an effective consenting experience. / Dissertation/Thesis / Ph.D. Biology 2013

Submitted by Marlene Santos (marlene.bc.ufg@gmail.com) on 2016-08-10T19:59:22Z No. of bitstreams: 2 Dissertação - Lívia Graziele Rodrigues - 2016.pdf: 1731490 bytes, checksum: 6ab7eea3e0b7851c2ba901f88514b105 (MD5) license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) / Approved for entry into archive by Luciana Ferreira (lucgeral@gmail.com) on 2016-08-15T13:13:35Z (GMT) No. of bitstreams: 2 Dissertação - Lívia Graziele Rodrigues - 2016.pdf: 1731490 bytes, checksum: 6ab7eea3e0b7851c2ba901f88514b105 (MD5) license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) / Made available in DSpace on 2016-08-15T13:13:35Z (GMT). No. of bitstreams: 2 Dissertação - Lívia Graziele Rodrigues - 2016.pdf: 1731490 bytes, checksum: 6ab7eea3e0b7851c2ba901f88514b105 (MD5) license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) Previous issue date: 2016-03-04 / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES / The aim of this study was to evaluate the knowledge of dentists that perform restorative treatment about the Consent Informed (CI) used in your dental clinical practice and to collect data that would allow subsidize the construction of an CI that can be used in this practice dental. For this, a structured questionnaire was applied to Dentists who perform restorative treatment in order to make a diagnosis of use of relationship and knowledge of the importance of informed consent. After distributing 731 questionnaires, 179 professionals returned these questionnaires. Of the respondents, 169 said that the discipline of forensic dentistry was studied for them at graduation, 128 studied the subject of Ethics and Law for graduate school, 139 received lessons on the importance and composition of CI in restorative practice, and 171 of them claim give verbal explanations of treatment for patients. However, 67 of these professionals do not use the CI, but 165 of all respondents believe that the use of this document may endorse the Dentists in a possible lawsuit. When asked about what information should be explicit in the CI, 157 of these professionals felt it necessary to contain the risks inherent in the type of treatment; 150, the limitations of the case; 138, the obligations of the patient; 85, treatment costs and 76 stages of the restorative treatment. The Dentists also said they talk to their patients about risks or needs associated with restorative treatment, and 143 professionals talk about tooth sensitivity; 140, need for endodontic treatment; 141, risk of restoration fracture / facet; 127, decay; 71, pulp necrosis and 66 dental darkening. These findings showed that although many of the interviewees possess some level of knowledge of the importance of the use of this document, 67 professionals do not use in their clinical practice. However, most of them fulfills the requirements of the Consumer Protection Code (CDC) and the Dental Code of Ethics (CEO), providing verbal explanations of treatment to patients. / O objetivo desse estudo foi avaliar o conhecimento de Cirurgiões-dentistas que executam tratamento restaurador sobre o Termo de Consentimento Livre e Esclarecido utilizado (TCLE) em sua prática clínica odontológica e levantar dados que permitissem subsidiar a construção de um TCLE que possa ser utilizado nessa prática odontológica. Para isso, um questionário estruturado foi aplicado aos Cirurgiões-dentistas que executam tratamento restaurador com o intuito de fazer um diagnóstico da relação de uso e conhecimento da importância do TCLE. Após distribuir 731 questionários, 179 profissionais retornaram esses questionários respondidos. Dos respondentes, 169 afirmaram que a disciplina de Odontologia Legal foi cursada por eles na graduação, 128 tiveram a disciplina de Ética e Legislação durante a pós-graduação, 139 receberam aulas sobre a importância e composição do TCLE na prática restauradora, e 171 deles afirmam dar explicações verbais sobre o tratamento para os pacientes. Entretanto, 67 desses profissionais não utiliza o TCLE, mas 165 do total de participantes acreditam que a utilização desse documento pode respaldar o Cirurgião-dentista numa possível ação judicial. Quando questionados sobre quais informações devem estar explícitas no TCLE, 157 desses profissionais julgaram ser necessário conter os riscos inerentes ao tipo de tratamento; 150, as limitações do caso clínico; 138, as obrigações do paciente; 85, os custos do tratamento e 76, as etapas do tratamento restaurador. Os Cirurgiões-dentistas afirmaram ainda que conversam com seus pacientes sobre riscos ou necessidades associadas ao tratamento restaurador, sendo que 143 profissionais falam sobre sensibilidade dental; 140, necessidade de tratamento endodôntico; 141, risco de fratura de restauração/faceta; 127, cárie; 71, necrose pulpar e 66, escurecimento dental. Esses achados demonstraram que, apesar de grande parte dos entrevistados possuírem algum nível de conhecimento da importância da utilização desse documento, 67 profissionais não utilizam em sua prática clínica. Entretanto, a maioria deles cumpre as determinações do Código de Defesa do Consumidor (CDC) e do Código de Ética Odontológica (CEO), oferecendo explicações verbais sobre o tratamento aos pacientes.

This diploma thesis deals with the issue of providing health care to minors in the legislation of the Czech Republic. The area of providing health care has significantly changed in recent years. Nearly half a century old People's Health Care Act from 1966 was substituted by current Health Services Act and other acts, that were enacted during the reform of medical law as a response to the transformation of the traditional paternalistic conception of the relationship between doctor and patient into a partner conception. The issue of health care provision has also been affected by the adoption of the new Civil Code that regulates protection of human personality and interventions into his integrity and includes an agreement on health care as one of the contractual types. Two acts are standing abreast - Civil Code and Health Services Act, whose relation cannot be generally assessed on the basis of the principle lex specialis derogat legi generali, but it is appropriate on this basis to assess relation of particular provisions. This has created doubts for physicians, which one from these two acts with the same legal force they should follow while providing health care. Uncertainty in the area affecting the physical integrity of a person, much less the physical integrity of a minor child as a person...

The aim of this study is to explore the importance of community based social mobilisation strategies in advancing human rights, in particular, strategies that could be used advance exercise of the right to legal capacity for persons with psychosocial disabilities in the face of societal barriers in the African context. The results of the study are aimed at providing useful and practical considerations in addressing the gap that exist in human rights implementation, between the promises of the law and its impact in reality. To this end, secondary desk top data was collected from existing text on the CRPD, mental illness and social mobilisation strategies. The latter was based on an analysis of the mobilisation strategy employed by Tostan in West Africa to successfully challenge female genital mutilation/cutting. Primary data was obtained through focus groups held in Lusaka and at Nsadzu Mental Health Rehabilitation Centre in Chadiza, in rural Zambia. The significance of legal capacity in Zambia was established and three main categories of concern emerged as barriers to the exercise of legal capacity: a) lack of state and community based supports and social networks; b) inadequate training of health and justice system officials; and c) stigma of mental illness and stereotypes. The benefits of social mobilisation in addressing these barriers are manifold, as demonstrated through the Tostan model. / Mini Dissertation (MPhil)--University of Pretoria, 2017. / Centre for Human Rights / MPhil / Unrestricted

Unique characteristics of cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines. Variable interpretation by research ethics committees may further complicate review and conduct. An international web-based survey was administered to corresponding authors of 300 randomly sampled CRT publications. We investigated ethics review and consent practices, investigator experiences with ethics review, and the perceived need for CRT-specific ethics guidelines. The response rate was 64%. Ethics review and consent were under-reported in publications. Ethics approval was obtained in 91%, and consent from individual and cluster level participants in 79% and 82% of trials. Consent varied by level of experimental intervention, data collection, and cluster size. Respondents cited variability among ethics committees (46%), and negative impacts of ethics review on their studies (38%). The majority perceived a need for ethics guidelines (73%), and guidance for ethics committees (70%). CRT-specific ethics guidelines are required to ensure practices meet ethical standards.

ABSTRACT Patient's Informed Consent, Medicine Doctors' Responsibility, Patient's Protection This diploma thesis analysis the informed consent of patient, which is manifestation of the patient's right to decide about his own health freely. The main aim is to describe what laws is the informed consent based on, what it should contain, in which situations the doctor is allowed to act without the consent and what the consequences of acting without consent, in cases, in which the informed consent is required by law, are. Further problems, which are not adequately treated by the law, are also mentioned, and the obtaining of the informed consent in children and the informed consent in practice were described. It was found out, that registration of complaints should be kept by each medical facility separately in the Czech Republic. Except that, the complaints department is established at each regional office. Czech laws do not impose to register complaints or claims in national unified register. Number of complaints between 2008-2010 were obtained from the Czech Medical Chamber, Control Department of the Ministry of Health, Medical Department of Regional Office and from Prague City Hall. It can be stated, based on the study of all related resources and after comparing of the recquired information with the reality, that even if all regulations are abided, it is impossible for the doctor to inform patient about all risks and possible complications to avoid the complaints completely. The questionnaire survey shows, that the legal awareness of doctors in the issue of informed consent is inadequate and it is important to improve it.

INTRODUÇÃO: Em ensaios clínicos o termo de consentimento livre e esclarecido é fundamental para a preservação da ética na pesquisa clínica e precisa ser lido e assinado pelos pacientes. No entanto, dada a sua complexidade este documento pode não ser entendido pelos mesmos. Para avaliar o entendimento destes sobre a pesquisa realizamos esta investigação. MÉTODOS: Convidamos os sujeitos participantes de ensaios clínicos de hipertensão arterial sistêmica e doença arterial coronária, fase II, III ou IV ambulatoriais e com fármacos, de jan/2002 a dez/2006, para responder questionário estruturado com 29 questões. Estes foram divididos em dois grupos, com uso (grupo I) ou não (grupo II) de placebo, após a randomização. Ao final, 80 pacientes compareceram de 106. Doutros 26 sujeitos, sete se recusaram, nove não foram localizados, oito foram excluídos e dois faleceram. As variáveis de cada questão foram consideradas por freqüência de ocorrência. A comparação entre as médias dos grupos foi realizada pelos testes t de Student ou Wilcoxon. Para avaliar associações utilizou-se o Qui-Quadrado, o teste de Razão de Verossimilhança ou Fisher. Para confirmar as informações, realizou-se também o grupo focal, tendo participado 8 do grupo I e 11 do grupo II. RESULTADOS: Avaliamos 80 sujeitos (grupo I- 47, grupo II- 33). As características sócio demográficas foram similares em ambos. Quanto à motivação para participar da pesquisa, 66,2% atribuíram-na ao benefício próprio, 42,5% pelo bem da ciência, e atendendo ao pedido médico 25,0%, em ambos os grupos. Quanto ao termo de consentimento livre e esclarecido, 50% não entenderam o seu conteúdo e 32,9% sequer o leram, mas o assinaram. No grupo I, 66,7% dos sujeitos não entenderam o significado de placebo e dos que afirmaram ter entendido (n=23) somente doze de fato comprovam o entendimento correto. Foram realizadas associações entre o não entender o significado do termo placebo com as variáveis de interesse para o estudo, e encontramos forte correlação com a escolaridade (p=0,022), evidenciando que quanto menor o nível de instrução menor também o entendimento. Houve também tendência entre ter um companheiro e ler o termo de consentimento livre e esclarecido antes de assinar (p=0,052), e o nível de escolaridade dos sujeitos e conversar sobre o termo de consentimento livre e esclarecido com o pesquisador (p=0,053). No que tange ao grupo focal, este corroborou os resultados e evidenciou que o termo de consentimento livre e esclarecido é considerado difícil pelos pacientes, porém a compreensão é favorecida pela equipe que complementa as informações de maneira clara e dispensa a leitura em virtude do vínculo de confiança estabelecido com esta. CONCLUSÕES: O termo de consentimento livre e esclarecido é pouco compreendido pelos sujeitos e para alguns a confiança no seu médico é crucial para a sua decisão em participar de um ensaio clínico com fármaco; evidenciou-se também influência do nível de instrução dos sujeitos no entendimento do termo placebo. Por outro lado, não houve repercussão na vida dos sujeitos em participar de ensaios clínicos com ou sem placebo, uma vez que a maior motivação para participar é pela expectativa do benefício terapêutico. / INTRODUCTION: To participate in a clinical trial patients have to sign an informed consent, often with misinterpretation words. Herein we addressed the issue of what do patients understand about the informed consent. METHODS: Patients that have participated in clinical trials in our institution were invited to an interview. From a data bank, between 2002 to 2006, patients were contacted by phone call. The questionnaire patients were submitted to was composed of 29 questions. To confirm some data, we did a second interview using the focal technique. Patients were allocated in two groups: Group 1- those that could have taken placebo for the treatment of their illness after a randomization, Group 2- those that did not take placebo during the treatment period but could have taken during the wash-out period. Statistics: were done with the t-Student test, or the Wilcoxon test. To evaluate associations we used the Qui-Square, Similarity test or the Fisher test and we considered a p value of 0,05. RESULTS: 80 patients, 60 (75%) males, age (average in years + SD) of 58.8 + 9.2; 47 in group 1 (58.3 ± 9.0) and 33 in group 2 (59.4 ± 9.8). Except for the job situation, both groups were similar. Of notice is the number of patients that were illiterate or have not completed the primary school. The most quoted motivation to participate was in their own benefit (66.2%), and second to the interest of science (42.5%). It is noteworthy that 50% of patients did not understand the informed consent but even in this case they did sign it. 66% did not understand the meaning of placebo that was correlated to the patients level of education (p= 0.02). Also, 36.2% of patients in group-I were not aware they could have taken tablets with no effect. In 19 patients (eight in group I and 11 in group II) submitted to the focal technique interview, what came out as the more important to their decision making to participate or not in a clinical trial, was the opinion of their assistant doctor. This was stood by almost all (90%) patients in this second interview. CONCLUSION: The informed consent was poorly understood, and for some patients the trust in their assistant doctors is crucial for their agreement to participate in a trial. This raised concerns about long and boring informed consent, and also how important are doctors´ words in the decision making of patients, probably due to their education level.

A pesquisa clínica patrocinada no Brasil vem crescendo cada vez mais e gerando conhecimento científico em diversas áreas da saúde. O desenvolvimento desses ensaios clínicos envolve aspectos que vão além da geração de fármacos e produtos mais avançados. O grande alicerce da pesquisa clínica está também nos pacientes que aceitam participar de um estudo científico. Estes precisam passar por um processo de consentimento que envolve ter conhecimento sobre todos os aspectos que envolvem a sua participação no ensaio clínico. Dentro desse contexto, surge um grande desafio na área que é como realizar o processo de consentimento de maneira adequada. É preciso levar em consideração aspectos como compreensão, motivações, influências, coerção, benefícios, riscos, entre outros aspectos. O objetivo deste trabalho foi identificar quais os fatores vivenciados pelos participantes de pesquisa clínica durante o processo de consentimento. Foram aplicados questionários a respeito da sua percepção no que envolve a participação na pesquisa clínica. Com os dados gerados foi possível desenvolver um conjunto de recomendações visando o aprimoramento do processo de consentimento em projetos de pesquisa clínica. / Clinical research sponsored in Brazil has been increasing and generating scientific knowledge in several areas of health. The development of these clinical trials involves aspects that go beyond the generation of drugs and more advanced products. The key of clinical research is also in patients who accept to participate in a scientific study. These need to undergo a consent process that involves having knowledge about all aspects that involve their participation in the clinical trial. Within this context, a great challenge arises in the area that is how to carry out the consent process in an appropriate way. It is necessary to take into account aspects such as understanding, motivations, influences, coercion, benefits, risks, among other aspects. The objective of this study was to identify the factors experienced by clinical research participants during the consent process. Questionnaires were applied regarding their perception regarding the participation in clinical research. With the data generated, it was possible to develop a set of recommendations aimed at improving the consent process in clinical research projects.

Introduction : La prise de décision concernant la préservation de la fertilité dans un contexte de prise en charge urgente de cancer du sein est complexe. Les objectifs de ce travail étaient de définir les attentes et les besoins des patientes en matière d’information, de concevoir un outil d’aide à la décision en ligne et d’évaluer sa validité apparente et son influence sur le choix éclairé des patientes.Méthodologie : Trois méthodes de recherche ont été menées pour répondre aux hypothèses : un focus group de cinq patientes pour l’étude qualitative, l’élaboration d’un outil d’aide à la décision selon la méthode d’Ottawa et une étude randomisée monocentrique. Cette dernière a été menée auprès de patientes âgées de 18 à 40 ans, adressées pour préservation de la fertilité dans un contexte de cancer du sein, randomisées au sein du groupe IRIS (information standard) ou du groupe DECISIF (avec outil d’aide à la décision en ligne). La mesure du choix éclairé était évaluée selon trois critères, à l’aide d’un questionnaire : les connaissances, l’attitude, et la mise en place ou non de techniques de préservation de la fertilité.Résultats : L’étude qualitative a permis de mettre en évidence que l’information transmise aux femmes et l’annonce de l’infertilité potentielle était à parfaire. L’outil d’aide à la décision en ligne a été élaboré suivant les recommandations des patientes et des professionnels de santé impliqués qui ont confirmé sa validité apparente. En ce qui concerne l’étude quantitative, au total 125 patientes ont été inclues et randomisées dans le groupe IRIS (n=65) ou DECISIF (n=60). Il a été mis en évidence une amélioration des connaissances dans le groupe DECISIF (8.6/10 (±1.34)) par rapport au groupe IRIS (6.49/10 (±1.89)). Dans les deux groupes, les patientes ont une attitude favorable envers la préservation de la fertilité (96 %). La décision finale n’est pas influencée par l’appartenance à un groupe ou un autre. Ainsi, à l’issue de la consultation de préservation de la fertilité, 73.6 % (92/125), soit 69.2 % (45/65) des patientes du groupe IRIS et 78.3 % (47/60) des patientes du groupe DECISIF vont choisir de conserver leurs ovocytes, embryons et/ou tissu ovarien. La proportion de choix éclairé était statistiquement plus élevée dans le groupe DECISIF que dans le groupe IRIS (respectivement 75 % versus 38.5 %, p<0.001). Par ailleurs, le niveau de conflit décisionnel chez les patientes du groupe DECISIF était moins élevé que chez celles du groupe IRIS (respectivement 14.4 (±2.94) versus 15.1 (±2.18), p=0.13).Conclusion : Nous avons conçu un outil d’aide à la décision en ligne pour accompagner les femmes atteintes d’un cancer du sein dans leur prise de décision concernant la préservation de la fertilité. Notre travail de recherche a permis de valider scientifiquement cet outil qui améliore les connaissances des patientes et leur autonomie de décision sans influencer leur attitude envers la préservation de la fertilité. / Introduction: Decision-making regarding fertility preservation in the context of urgent breast cancer management is complex. The objectives of this study were to define patients' expectations and information needs, develop an online decision support tool, and assess its apparent validity and influence on patients' informed choice.Methodology: Three research methods were used to address the hypotheses: a focus group of five patients for the qualitative study, the development of a decision support tool using the Ottawa method and a randomized, single-centre study. The latter was conducted with patients aged 18 to 40 years referred for fertility preservation in the context of breast cancer, randomized to the IRIS group (standard information) or the DECISIF group (with online decision support tool). The measurement of informed choice was evaluated according to three criteria using a questionnaire: knowledge, attitude, and whether fertility preservation techniques were available.Results: The qualitative study revealed that the information provided to women and the announcement of potential infertility needed to be improved. The online decision support tool was developed based on recommendations from the patients and health professionals involved, who confirmed its apparent validity. For the quantitative study, a total of 125 patients were included and randomized to the IRIS (n=65) or DECISIF (n=60) group. Better knowledge was found in the DECISIF group (8.6/10 (±1.34)) compared to the IRIS group (6.49/10 (±1.89)). In both groups, patients had a positive attitude towards fertility preservation (96%). The final decision was not influenced by membership in one group or another. Thus, at the end of the fertility preservation consultation, 73.6% (92/125), i.e. 69.2% (45/65) of patients in the IRIS group and 78.3% (47/60) of patients in the DECISIF group, chose to keep their oocytes, embryos and/or ovarian tissue. The proportion of informed choice was statistically higher in the DECISIF group than in the IRIS group (respectively 75% versus 38.5%, p<0.001). In addition, the level of decision-making conflict among patients in the DECISIF group was lower than in the IRIS group (respectively 14.4 (±2.94) versus 15.1 (±2.18), p=0.13).Conclusion: We have developed an online decision support tool to assist women with breast cancer in making decisions about fertility preservation. We have now validated this tool, which improves patients' knowledge and decision-making autonomy without influencing their attitude towards fertility preservation.