Search results for "Informed consent"
showing 10 items of 109 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…
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.
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…
Conflicting rationales: leader's experienced ethical challenges in community health care for older people.
2017
BACKGROUND Ethical challenges arise in all types of care, and leaders need to be aware of how to resolve these challenges. Healthcare systems tend to be organised around medical conditions, and the patient is often faced with a series of uncoordinated visits to multiple specialties. Ideally, care should be organised around the patient's needs. AIM The purpose of this article was to highlight some ethical challenges perceived by leaders with responsibility for management and service distribution, finance and ensuring quality of community health services for older people. METHOD This study had a qualitative design with a qualitative content analysis of one focus group with six leaders that me…
The effects of informed consent format on preoperative anxiety in patients undergoing inferior third molar surgery
2013
Objectives: To evaluate the effect of informed consent format on preoperative anxiety of patients. Material and Methods: We performed a prospective study (91 patients) undergoing lower third molar extraction. Patients were distributed into three groups. Informed consent for surgery was obtained through a written document, an oral interview or a video recording. Afterwards, patients were asked about their anxiety level and the effect the informed consent had had on it. Results: Whereas the information conveyed both in oral and written formats relieved the patient to some extent (in a scale of -3 to +3) 0.97±1.21 and 0.29±0.97, respectively), the video recording increased patient’s anxiety in…