Search results for " consent"
showing 10 items of 148 documents
Opportunities and challenges for drug development: public-private partnerships, adaptive designs and big data
2016
Drug development faces the double challenge of increasing costs and increasing pressure on pricing. To avoid that lack of perceived commercial perspective will leave existing medical needs unmet, pharmaceutical companies and many other stakeholders are discussing ways to improve the efficiency of drug Research and Development. Based on an international symposium organized by the Medical School of the University of Duisburg-Essen (Germany) and held in January 2016, we discuss the opportunities and challenges of three specific areas, i.e., public-private partnerships, adaptive designs and big data. Public-private partnerships come in many different forms with regard to scope, duration and typ…
Recommendations for the implementation of BRCA testing in the care and treatment pathways of ovarian cancer patients
2016
In the last 20 years, following the identification of the BRCA1 and BRCA2 genes (hereinafter referred to as the BRCA genes), preventive pathways have been developed for the identification and clinical management of individuals at high risk of developing breast and ovarian cancer due to the presence of a pathogenic variant in either of these genes. These pathways are aimed at educating high-risk subjects on programs targeted toward early diagnosis and cancer risk reduction. The approval of a novel class of drugs, the PARP enzyme inhibitors, for the treatment of ovarian cancer patients carrying high-risk BRCA pathogenic variants has changed this scenario. BRCA testing, in addition to providin…
Next-generation sequencing in clinical practice: from the patients' preferences to the informed consent process
2016
International audience
Secondary findings from whole-exome/genome sequencing evaluating stakeholder perspectives. A review of the literature
2019
IF 2.004 (2017); International audience; With the development of next generation sequencing, beyond identifying the cause of manifestations that justified prescription of the test, other information with potential interest for patients and their families, defined as secondary findings (SF), can be provided once patients have given informed consent, in particular when therapeutic and preventive options are available. The disclosure of such findings has caused much debate. The aim of this work was to summarize all opinion-based studies focusing on SF, so as to shed light on the concerns that this question generate. A review of the literature was performed, focusing on all PubMed articles repo…
Dissenting voices in a consenting village: lessons from implementation of free, prior and informed consent at a REDD+ pilot in Tanzania
2020
Free, prior and informed consent (FPIC) is a key institutional tool in meeting social safeguards. Its implementation ensures respect of the local people's rights in an intervention. This paper presents a case of FPIC implementation at a REDD+ pilot site. Data were obtained through key informant interviews and focus group discussions with proponents and village members of the Lindi REDD+ project. Findings indicate that the inclusive approach to FPIC by taking the consultations to the hamlet level did not deliver a flawless process. The consent decision was reached by a majority vote, not consensus. There was some dissent, prompting the early establishment of project implementation committees…
Cuestiones varias en torno a la determinación de la filiación por doble paternidad
2018
The article 7.3 of the law 14/2006, of May 26 on technologies of human assisted reproduction establishes the possibility of determining legally the double maternity of married women and not separated legally or of fact, when the not biological mother consents that filiation decides to his favor the respect of the born son of his spouse. In the suppositions not regulated in the mentioned rule the Supreme Court in relation with equal women?s homosexuality in judgment of December 5, 2013 and January 15, 2014 applies the civil code and allows to determine judicially the maternity by means of the exercise of an action of claim for possession of status foreseen in the article 131. In the present …
Informed consent and medical liability
2018
El reconocimiento del derecho a la información del paciente y del deber de obtener su consentimiento ha supuesto un cambio en el modo de ejercer la medicina. La no obtención del consentimiento informado es causa de responsabilidad profesional, aun a pesar de haber cumplido con el resto de obligaciones médicas y cuidados del paciente. El Tribunal Supremo español considera que la obligación de la información es un elemento esencial de la “lex artis”. Este trabajo analiza esta amplia visión de la jurisprudencia española y los casos en los que la infracción del consentimiento informado da lugar a responsabilidad civil. The recognition of the right of patient’s information and of the duty to obt…
Responsabilidad civil médica y reproducción asistida: Dos casos de estudio
2018
El presente trabajo examina los aspectos más relevantes de la responsabilidad civil en materia de reproducción asistida y aborda el estudio de dos casos recientes de especial trascendencia.
La preferencia de la vía civil a la penal para recobrar la posesión en las ocupaciones pacíficas de inmuebles.
2021
En el presente artículo se analizar los motivos por los que en las ocupaciones pacíficas de inmuebles sin consentimiento el recurso a la vía civil es más eficaz que la penal para la recuperación de la posesión. Dos son las causas por los que estimamos preferible la vía civil: la negativa de un sector de la judicatura para aplicar el delito de usurpación de inmuebles del art. 245.2 CP en los casos que no son graves y la no aplicación de la medida cautelar de devolución anticipada de los inmuebles ocupados a sus dueños. La vía civil es la más efectiva para la recuperación de la vivienda ocupada desde que se modificó el interdicto de recobrar la posesión mediante la Ley 5/2018.
El consentimiento informado de los menores de edad en el ámbito sanitario
2021
: El consentimiento informado aparece como un derecho de todo paciente a decidir en el ámbito sanitario. En este marco, es necesario determinar si los menores de edad han de ejercitar este derecho o si, por el contrario, precisan de la intervención de un tercero para llevarlo a cabo. A este respecto, nuestra legislación actual reconoce, con carácter general, el derecho a decidir de este colectivo. No obstante, en ocasiones pueden producirse limitaciones a su ejercicio motivadas bien por la ausencia de capacidad real, bien por el principio de interés superior. En definitiva, se trata de alcanzar el mayor beneficio para los menores de edad en el campo de la salud, evitando que se produzcan pe…