| 1. |
|
|
| 2. |
- Farisco, Michele, et al.
(författare)
-
Biomedical research involving patients with disorders of consciousness : ethical and legal dimensions
- 2014
-
Ingår i: Annali dell'Istituto Superiore di Sanità. - 0021-2571. ; 50:3, s. 221-228
-
Tidskriftsartikel (refereegranskat)abstract
- The directive 2001/20/UE and the research involving patients with docs. Researchinvolving patients with disorders of consciousness (DOCs) deserves special ethical andlegal attention because of its Janus-faced nature. On the one hand, it raises concernsabout the risk to expose the involved subjects to disproportionate risks not respectingtheir individual dignity, particularly their right to be cared for; on the other hand, researchis an essential tool in order to improve the clinical condition of patients withDOCs. The present paper concerns the ethical and legal dimensions of biomedical researchinvolving patients with disorders of consciousness. In particular, it focuses oninformed consent to experimental treatments, which is a challenging issue both from anethical and legal point of view. The first part reads the Directive 2001/20/EU in the lightof the experimentation of patients with DOCs, and suggests a revision in order to betterassess the issue of informed consent.The particular case of informed consent for observational studies of non-communicativepatients. The second part presents an informed consent form for studies throughvideo-recording of patients unable to communicate their own consent. This form hasbeen elaborated by the bioethics unit of the project “Review of the nosography of vegetativestates: application of methods of behavioral analysis to individuals in coma orvegetative state” developed at the Italian National Institute of Health.Relevance of the suggested form. The paper describes the conceptual framework ofthe form for informed consent to studies through video-recoding, which is a relevantexample of what issues should be included in an informed consent for any type of studiesthrough video-recording of patients unable to express their own consent. The article hasbeen sent on November the 7th 2013, before the adoption of the Regulation (EU) no.536/2014 (and consequent abrogation of the Directive 2001/20/EU) and the release ofthe new edition of the Italian Code of Medical Ethics.
|
|
| 3. |
- Farisco, Michele, et al.
(författare)
-
Clinicians’ attitudes towards patients with disorders of consciousness : a survey
- 2014
-
Ingår i: Neuroethics. - : Springer Berlin/Heidelberg. - 1874-5490 .- 1874-5504. ; 7:1, s. 93-104
-
Tidskriftsartikel (refereegranskat)abstract
- Notwithstanding fundamental methodological advancements, scientific information about disorders of consciousness (DOCs)—e.g. Vegetative State/Unresponsive Wakefulness Syndrome (VS/UWS) and Minimally Conscious State (MCS)—is incomplete. The possibility to discriminate between different levels of consciousness in DOC states entails treatment strategies and ethical concerns. Here we attempted to investigate Italian clinicians’ and basic scientists’ opinions regarding some issues emerging from the care and the research on patients with DOCs. From our survey emerged that Italian physicians working with patients with DOCs give a central role to ethics. Current Italian regulation regarding basic research conducted in patients with DOCs apparently risks to be inadequate to support scientific advancement, and would deserve a different assessment compared to ordinary treatments. We think the results of our survey deserve attention from an international audience because they exemplify the difficulty to define a shared approach to the issues related to patients with DOCs and the necessity to better assess both the ordinary and experimental treatment of patients with DOCs at the ethical and legal level.
|
|
| 4. |
- Farisco, Michele, et al.
(författare)
-
Codici, linee guida e commentari di etica della ricerca: la questione della qualità
- 2014
-
Ingår i: Epidemiologia & Prevenzione. - 1120-9763 .- 2385-1937. ; 38:3-4, s. 268-272
-
Tidskriftsartikel (refereegranskat)abstract
- After an overview of the evolution of ethics laws for medical activities, we suggest a possible classification of documents regarding the ethical conduct of scientific research with human beings. The authors outline the necessity to define formal criteria for the development and the implementation of ethics standards.
|
|
| 5. |
- Farisco, Michele, et al.
(författare)
-
Ethical Frameworks and Comparative Effectiveness Research
- 2015
-
Ingår i: Comparative Effectiveness Research in Health Services. - New York : Springer Science+Business Media B.V.. - 9781489975997 ; , s. 1-37
-
Bokkapitel (refereegranskat)abstract
- The issue of comparative effectiveness research (CER) is assessed from an ethical point of view by comparison with the main ethical frameworks and by analysis of some of the relevant institutional documents. Two main conclusions emerge from the study: no ethical framework seems able to objectively and definitively assess CER; no institutional document, neither national nor international, has specifically assessed the ethical implications of CER. Nevertheless, this vacuum regarding CER raises relevant ethical concerns, thus revealing the necessity and urgency of an ethical evaluation of CER.
|
|
| 6. |
- Farisco, Michele, et al.
(författare)
-
Medical Responsibility and Clinical Guidelines : A Few Remarks from Two Italian Juridical Cases
- 2012
-
Ingår i: Medicine Studies. - : Springer Berlin/Heidelberg. - 1876-4533 .- 1876-4541. ; 3:3, s. 157-169
-
Tidskriftsartikel (refereegranskat)abstract
- PurposeThe aim of this paper is to assess the complex issue of responsibility in clinical practice. The paper focuses mainly on the relationship between personal- and medical-professional responsibility of practitioners and clinical guidelines.MethodsAfter a theoretical review of the different definitions of responsibility in selected bioethical and biojuridical literature, two recent juridical proceedings concerning medical responsibility from Italian Courts are discussed. Subsequently, a theoretical analysis of the definition of clinical practice guidelines is proposed in order to show their feasibility to assess personal- and medical-professional responsibility.ResultsThe definitions of responsibility and the two Italian cases show the theoretical and practical difficulties of shared assessments of both personal-professional and medical-professional responsibility in clinical practice. Clinical practice guidelines cannot be assumed as an objective code of action stating exactly a rule of conduct in all situations, but as a tool suggesting how to decide what to do in different conditions.ConclusionsResponsibility in clinical practice is such a complex issue to deserve a special ethical assessment. The clinician’s personal-professional responsibility cannot be replaced or reduced by clinical practice guidelines, because medicine is as such a relationship focused on the expertize of practitioners. Nonetheless, a shared approach to different clinical conditions is needed in order to avoid a relativist outcome and protect patients’ and even clinicians’ rights. Formal guidelines (that describe not exactly what to do but how to decide what to do) are proposed as potential useful tool to achieve this aim.
|
|
| 7. |
- Farisco, Michele, et al.
(författare)
-
Misdiagnosis as an ethical and scientific challenge
- 2014
-
Ingår i: Annali dell'Istituto Superiore di Sanità. - 0021-2571. ; 50:3, s. 229-233
-
Tidskriftsartikel (refereegranskat)abstract
- Difficulties of behavioral assessment of consciousness. An astonishingly high rateof misdiagnosis between vegetative state/unresponsive wakefulness syndrome and minimallyconscious state has been detected. This raises the issue of the adequacy of theconsciousness’ assessment in patients with disorders of consciousness. The behavioralassessment of consciousness could be not able to detect covert awareness, which is increasinglyidentified by the instrumental assessment.Ancillary methods. Neurotechnology, particularly neuroimaging, provides relevant dataconcerning the neurological underlying condition of patients with DOCs, but the instrumentalapproach has still to assess some technical issues.Ethical considerations. A correct diagnosis of a DOC is not only an instrumental issue,but also an ethically relevant demand to the scientific community. Finally, an integrationbetween behavioral and instrumental assessments seems to be the most adequate strategyin order to decrease the rate of misdiagnosis.
|
|
| 8. |
- Farisco, Michele, et al.
(författare)
-
On the Stand : Another Episode of Neuroscience and Law Discussion From Italy
- 2014
-
Ingår i: Neuroethics. - Springer : Springer Science and Business Media LLC. - 1874-5490 .- 1874-5504. ; 7:2, s. 243-245
-
Tidskriftsartikel (refereegranskat)abstract
- After three proceedings in which neuro-science was a relevant factor for the final verdict inItalian courts, for the first time a recent case puts inquestion the legal relevance of neuroscientific evidence.This decision deserves international attention in itsunderlining that the uncertainty still affecting neuroscien-tific knowledge can have a significant impact on thelaw. It urges the consideration of such uncertainty andthe development of a shared management of it.
|
|
| 9. |
- Farisco, Michele, et al.
(författare)
-
The Impact of Contemporary Neurotechnology on Diagnosing and Treating Patients with Disorders of Consciousness : A Review
- 2013
-
Ingår i: International Journal of Clinical Therapeutics and Diagnosis. - : SciDoc Publishers LLC. - 2332-2926. ; 1:2, s. 12-19
-
Tidskriftsartikel (refereegranskat)abstract
- Disorders of consciousness, especially Vegetative State, are assessed from a theoretical (historical and ethical) and empirical (neuroscientific) points of view, through a review of the most relevant recent literature. Both the potentiality of neuroscientific investigation and the limitations of its clinical (diagnostic and prognostic) application are underlined, showing the urgency of a collaboration between science, law and ethics in order to define the most appropriate nosography and to ensure the best therapy to patients with disorders of consciousness.
|
|
| 10. |
- Gainotti, Sabina, et al.
(författare)
-
Meeting Patients' Right to the Correct Diagnosis : Ongoing International Initiatives on Undiagnosed Rare Diseases and Ethical and Social Issues
- 2018
-
Ingår i: International Journal of Environmental Research and Public Health. - : MDPI. - 1661-7827 .- 1660-4601. ; 15:10
-
Forskningsöversikt (refereegranskat)abstract
- The time required to reach a correct diagnosis is a key concern for rare disease (RD) patients. Diagnostic delay can be intolerably long, often described as an odyssey and, for some, a diagnosis may remain frustratingly elusive. The International Rare Disease Research Consortium proposed, as ultimate goal for 2017-2027, to enable all people with a suspected RD to be diagnosed within one year of presentation, if the disorder is known. Subsequently, unsolved cases would enter a globally coordinated diagnostic and research pipeline. In-depth analysis of the genotype through next generation sequencing, together with a standardized in-depth phenotype description and sophisticated high-throughput approaches, have been applied as diagnostic tools to increase the chance of a timely and accurate diagnosis. The success of this approach is evident in the Orphanet database. From 2010 to March 2017 over 600 new RDs and roughly 3600 linked genes have been described and identified. However, combination of -omics and phenotype data, as well as international sharing of this information, has raised ethical concerns. Values to be assessed include not only patient autonomy but also family implications, beneficence, non-maleficence, justice, solidarity and reciprocity, which must be respected and promoted and, at the same time, balanced among each other. In this work we suggest that, to maximize patients' involvement in the search for a diagnosis and identification of new causative genes, undiagnosed patients should have the possibility to: (1) actively participate in the description of their phenotype; (2) choose the level of visibility of their profile in matchmaking databases; (3) express their preferences regarding return of new findings, in particular which level of Variant of Unknown Significance (VUS) significance should be considered relevant to them. The quality of the relationship between individual patients and physicians, and between the patient community and the scientific community, is critically important for optimizing the use of available data and enabling international collaboration in order to provide a diagnosis, and the attached support, to unsolved cases. The contribution of patients to collecting and coding data comprehensively is critical for efficient use of data downstream of data collection.
|
|
