Spelling suggestions: "subject:"clinician investigator"" "subject:"clinician investigators""
1 |
Ethos and Regula in Contemporary Clinical ResearchJanuary 2012 (has links)
abstract: With new trends in drug development and testing, it must be determined whether the current state of balance of ethos (the moral norm) and regula (the legal framework) can successfully protect patients while keeping the door to scientific innovation open. The rise of the Clinician Investigator (CI) in both academic and private research introduces a challenge to the protection of subjects in the conflicting dual role of physician and scientist. Despite the constant evolution of regulation and ethical standards, questions about the roles' combined effectiveness in relation to this challenge persist. Carl Elliot describes the suicide of a patient-subject enrolled in an industry-funded physician-run anti-psychotic pharmaceutical drug trial in a 2010 Mother Jones article. Elliot provides a personal account of discrepancies seen in the ethical principles of beneficence, respect for subjects and justice. Through analysis of the problems presented in the case as a model for potential dangers in clinical research, the effectiveness of ethics and law in protecting human subjects is examined. While the lag between ethical standard and regulation has historically shown to cause similar issues, the misconception of current regulation and ethical standards may be contributing to the decrease in subject protections. After IRB approval of subject protections in the research protocol, CIs have been shown to downgrade their responsibility to maintaining ethos through the course of the trial. And, despite their experience in patient-centered ethos as a physician, CIs may be inclined to substitute these values for the ethos of a researcher, with the goal to avoid therapeutic misconception. Maintaining personal responsibility for subjects beyond regulatory structure, and promoting the welfare of the subjects in regards to the ethical standard of research investigators, will provide added security for subjects and decrease opportunity for exploitation in future research. / Dissertation/Thesis / M.S. Biology 2012
|
2 |
Les projets de séquençage génétique en oncologie pédiatrique : les enjeux éthiques reliés au double rôle de l’hémato-oncologueGoudie, Catherine 08 1900 (has links)
La recherche est imbriquée dans les soins cliniques en oncologie, de sorte que la dualité de rôles (clinicien, investigateur) est une réalité connue des oncologues. Vu l'importance de la génomique pour guider les soins en oncologie pédiatrique, la plupart des patients sont enrôlés dans des études génomiques au Québec. En pratique, l'oncologue, par sa présence aux réunions d'oncogénomique, participe avec les chercheurs à l'interprétation des résultats génétiques ainsi qu'aux décisions de divulgation au patient.
Ce projet vise à identifier et caractériser les enjeux éthico-légaux soulevés par la dualité de rôles de l'oncologue durant ce partage de résultats génétiques en amont du patient.
Un questionnaire incluant six vignettes narratives a été diffusé électroniquement à tous les oncologues pédiatres du Québec. Des entrevues semi-dirigées ont été effectuées avec un sous-groupe de participants. Vingt-huit oncologues ont complété le questionnaire et cinq oncologues ont participés aux entrevues. Les niveaux de confort des oncologues étaient influencés par le type de résultat génétique, par le contenu discuté lors du consentement et par le rôle de l'oncologue envers le patient (oncologue traitant ou non). Le fait d'être informé d'un résultat génétique de recherche suffisait pour déclencher un sentiment de responsabilité par rapport à celui-ci.
La dualité de rôles est incontournable et donne à l’oncologue un accès privilégié à l'information génétique, au-delà de ce à quoi aura accès le patient. Les responsabilités et les devoirs de l’oncologue dans le cadre de la relation thérapeutique sont au centre des enjeux éthiques et légaux soulevés par la dualité de rôles. / Research is heavily integrated in oncology care, with oncologists well acquainted with the concept of duality of roles (doctor, researcher). Given the importance of genomics in pediatric oncology, most patients are offered genomic sequencing via research initiatives in Quebec. Practical experience reveals that oncologists, by attending molecular tumour board meetings, participate with the research team in the interpretation of genetic research results and decisions regarding disclosure to patients. This project aims to identify and characterise the ethical and legal issues related to the duality of roles of oncologists during this process of genetic information sharing, prior to informing the patient.
A questionnaire including six narrative case vignettes was electronically distributed to all pediatric oncologists in Quebec. A semi-structured interview was then conducted with a sub-group of participants.
Twenty-eight oncologists completed the questionnaire and five oncologists participated in the interviews. Oncologists' comfort levels were influenced by the type of genetic result, by the content of prior consent discussions and by their specific role regarding the patient (treating oncologist or not). The state of becoming aware of a result was sufficient to trigger a feeling of responsibility regarding that genetic research result.
Duality of roles is inevitable and provides the oncologist with privileged access to genetic information, above what will be accessible to the patient. Responsibilities and duties of the oncologist in the setting of a therapeutic relationship are central to the ethical and legal issues raised by the duality of roles.
|
Page generated in 0.0865 seconds