scholarly journals La sperimentazione in soggetti in coma: problematiche etiche e giuridiche

2005 ◽  
Vol 54 (2) ◽  
Author(s):  
Adelaide Conti ◽  
Paola Delbon
Keyword(s):  
Clinical Trial ◽  
Human Subjects ◽  
Legal Representative ◽  
Science And Society ◽  
Ethical Guidelines ◽  
Legal Representation ◽  
Legal Questions ◽  
Protection Of Human Rights ◽  
Legal Consent ◽  
Special Protection

L’inclusione di un soggetto in uno studio sperimentale è di regola subordinata al consenso libero e informato dello stesso. Problematiche di ordine etico e giuridico piuttosto complesse emergono quindi quando il soggetto da includere nella ricerca sia incapace di prestare tale consenso, come nel caso di persona in stato di incoscienza. L’inclusione di tale soggetto nella ricerca è dalle norme e dai documenti nazionali e sovranazionali (art. 54 Codice Penale, Convenzione per la protezione dei diritti umani e della dignità dell’essere umano riguardo alle applicazioni della biologia e della medicina, GCP recepite con Decreto Ministeriale 15 luglio 1997, Dichiarazione di Helsinki, Linee Guida Etiche Internazionali per la Ricerca Biomedica che coinvolge Soggetti Umani) subordinata alla sussistenza di una situazione di emergenza, o alla prestazione del consenso da parte del rappresentante legalmente riconosciuto. Si tratta quindi di verificare, ai fini dell’individuazione di uno spazio di praticabilità della ricerca in tali ipotesi, al di fuori delle situazioni di emergenza e rappresentanza legale, la possibilità di ulteriori “criteri di ammissibilità”: l’introduzione delle direttive anticipate e/o la previsione di un “decisore sostitutivo”, e la reversibilità dello stato di coma, ovvero la possibilità di guarigione e/o miglioramento quale condizione legittimante la sperimentazione in quanto pratica volta a recuperare lo stato di coscienza del soggetto. Ogni riflessione circa l’inclusione di un paziente in stato di coma in un protocollo sperimentale deve in definitiva fondarsi sulla considerazione della priorità dell’interesse del paziente stesso rispetto all’interesse della scienza e della società, ancor più se riferita a soggetti incapaci di esercitare un libero consenso rispetto ad un atto di disposizione del proprio corpo, e perciò bisognosi di maggior tutela. ---------- The inclusion of a person in a clinical trial, as a rule, needs his/her free and informed consent. Complex ethical and legal questions emerge when the person to include in a clinical trial in uncapable of giving legal consent, i. e. when he/she is uncounscious. According to national and international rules and documents (art. 54 c.p.; Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine; GCP - D.M. 15 luglio 1997; Declaration of Helsinki (WMA) International Ethical Guidelines for Biomedical Research involving Human Subjects (CIOMS) including such a person in a clinical trial can be justified in emergency or with the consent of patient’s legal representative. We have to verify, in order to pick out a scope for medical research in these hypotheses, apart from emergency and legal representation, the possibility of other “admissibility standards”: advance directives and /or substituted decision-maker, and the reversibility of a coma, i. e. the possibility for the patient to heal or be better as a condition for the conduct of clinical trial as an operation intended to recover patient’s consciousness. All considerations about inclusion of unconscious persons in clinical trials have to be founded in the consideration that the interest of the patient always prevail over those of science and society, much more if the patient is unable to exercise his/her consent to dispose of his/her body, and then in need of special protection.

Nanomedicine First-in-Human Research: Challenges for Informed Consent

2012 ◽  
Vol 40 (4) ◽  
pp. 823-830 ◽  
Author(s):  
Nancy M. P. King
Keyword(s):  
Clinical Trial ◽  
Informed Consent ◽  
Clinical Research ◽  
Human Subjects ◽  
Consent Form ◽  
Human Research ◽  
Research Challenges ◽  
Starting Point ◽  
Human Subjects Protections

First-in-human (FIH) research has several characteristics that require special attention with respect to ethics and human subjects protections. At least some nanomedical technologies may also have characteristics that merit special attention in clinical research, as other papers in this symposium show. This paper considers how to address these characteristics in the consent form and process for FIH nanomedicine research, focusing principally on experimental nanotherapeutic interventions but also considering nanodiagnostic interventions.It is essential, as a starting point, to recognize that the consent form and process are by no means the primary protectors of human subjects (although they are sometimes so regarded). Instead, consideration of the form and content of informed consent becomes relevant only after a clinical trial has been reviewed and deemed scientifically and ethically acceptable.Two convergent types of challenges to informed consent are posed by nanomedicine FIH research. First, some issues appear generally applicable to FIH research, but have specific nanomedicine implications.

scholarly journals Lessons Learned in Clinical Trial Communication During an Ebola Outbreak: The Implementation of STRIVE

2018 ◽  
Vol 217 (suppl_1) ◽  
pp. S40-S47 ◽  
Author(s):  
Amy Callis ◽  
Victoria M Carter ◽  
Aparna Ramakrishnan ◽  
Alison P Albert ◽  
Lansana Conteh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Community Engagement ◽  
Information Needs ◽  
Human Subjects ◽  
Lessons Learned ◽  
Accurate Information ◽  
Community Acceptance ◽  
Institutional Review ◽  
The Impact

Abstract Communication contributed to 4 important aspects of the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE): recruiting participants, supporting Human Subjects Protection, building trust in the community to support the trial, and mitigating the impact of rumors and misinformation. Communication was particularly important because STRIVE was Sierra Leone’s first vaccine clinical trial and was implemented during a public health emergency. Communication efforts began months prior to trial launch, building awareness and support through sensitization sessions with stakeholders and community leaders. Community engagement activities continued throughout the trial to maintain relationships with leaders and stakeholders and disseminate accurate information, fostering trust in the trial. The communication team led recruitment with hundreds of information sessions for potential participants, facilitating the informed consent process. Communication efforts continued post-enrollment, supporting ongoing voluntary participation in the trial. Informal formative activities during the trial yielded insights on participants’ perceptions and information needs. While Centers for Disease Control and Prevention Institutional Review Board–approved activities and materials did not change, this flexible strategy allowed for responsive interactions with participants. The trial success and its community acceptance illustrated STRIVE’s successful communications efforts, owing in large part to this flexibility and commitment to community engagement. Clinical Trials Registration ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

scholarly journals Reporting of ethical considerations in clinical trials in Chinese nursing journals

2017 ◽  
Vol 26 (4) ◽  
pp. 973-983 ◽  
Author(s):  
Yanni Wu ◽  
Michelle Howarth ◽  
Chunlan Zhou ◽  
Xue Ji ◽  
Jiexia Ou ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Human Subjects ◽  
Journal Citation Report ◽  
Mainland China ◽  
Ethical Guidelines ◽  
Ethical Considerations ◽  
Research Papers ◽  
Technology Journal ◽  
Ethical Approval

Background: It is acknowledged that publishers now require all primary research papers to demonstrate that they have obtained ethical approval for their research. Objectives: To assess the rate of reporting of ethical approval in clinical trials in core nursing journals in mainland China. Research design: A retrospective observational study. Participants: All clinical trials published in all of the 12 core nursing periodicals from 2016 edition China Science and Technology Journal Citation Report (core version) between 2013 and 2016 were retrieved by hand to explicate rate of reporting ethical approval and informed consent. Ethical considerations: The study did not require approval from the research ethics committee as it did not involve human subjects or records. Results: In total, 40,278 papers were published in 12 nursing periodicals between 2013 and 2016. Out of these, 9488 (23.6%) focused on clinical trials. Informed consent obtained from patients or the legally authorized representative was reported in 51.8% of clinical trials. Notably, only 27.4% of clinical trials reported that they had obtained written consent. Furthermore, 25.9% of clinical trials described ethical approval; however, the rate of reporting informed consent and ethical approval in these 12 nursing journals in China during 4 years from 2013 to 2016 improved markedly, with 38.1%, 44.0%, 59.0% and 66.6%, respectively ( p < 0.001), and 17.6%, 21.9%, 28.6% and 35.8%, respectively ( p < 0.001). In addition, both reporting informed consent and reporting written informed consent had a positive significant correlation with the reporting ethical approval ( p < 0.05 or < 0.01). Conclusion: Chinese scientific nursing journals have improved the rate of reporting informed consent and ethical approval in clinical trials during the last 4 years. However, it should be noted that nearly half of clinical trials still did not report either ethical approval or whether informed consent was obtained. Efforts from editors, researchers, sponsors and authors are needed to ensure the transparency of ethical scrutiny and adherence to ethical guidelines in publishing clinical trials in Chinese nursing journals.

scholarly journals PROCEDURAL STATUS OF A LEGAL REPRESENTATIVE IN THE MODERN RUSSIAN CRIMINAL PROCESS

2021 ◽  
Vol 31 (4) ◽  
pp. 669-673
Author(s):  
L.G. Tatyanina ◽  
E.V. Markovicheva
Keyword(s):  
The Other ◽  
Universal Model ◽  
Legal Representative ◽  
Criminal Proceedings ◽  
Criminal Process ◽  
Legal Representation ◽  
Judicial Practice ◽  
The Law ◽  
The One ◽  
Modern Russian

The article reveals the features of the normative consolidation of the procedural status of a legal representative in the Russian criminal process. The authors focus their attention on the problems of investigative and judicial practice related to the shortcomings of the current legislation. The most important issues that need to be addressed as soon as possible have been identified. Particular attention is drawn to the need to resolve problems arising from conflicts between a legitimate representative and a person represented by him/her, which gives rise, on the one hand, to grounds for appealing against decisions made, and on the other, to a conflict between the parties, which may affect their subsequent relationship. The absence of a single rule regulating the rights of legal representatives raises questions in practice about the possibility of their participation in individual investigative and procedural actions, applications, etc. Attention is drawn to the lack of regulation in the law of the duties of a legal representative in criminal proceedings, which creates controversial situations when assessing their behavior, especially when deciding on their removal from participation in the case. The article concludes that it is necessary to develop a single, universal model of legal representation in criminal proceedings.

scholarly journals LEGAL ASPECTS OF CLINICAL TRIALS IN POLAND

2017 ◽  
Vol 28 (1) ◽  
pp. 67-84
Author(s):  
Katarzyna Syroka-Marczewska
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Reactions ◽  
Legal Aspects ◽  
Science And Society ◽  
Medicinal Products ◽  
Safety And Efficacy ◽  
Pharmacodynamic Effects ◽  
Trial Participants

A clinical trial is each trial conducted in humans to discover or confirm the clinical, pharmacological, including pharmacodynamic, effects of action of one or more investigational medicinal products, or to identify the adverse reactions to one or more investigational medicinal products, or to monitor absorption, distribution, metabolism and excretion of one or more investigational medicinal products, taking into consideration their safety and efficacy. It ought to be remembered that clinical trials may be conducted with the use of medicinal products. Clinical trials must be conducted in a way which is in line with the primary principle that clinical trial participants’ rights, safety, health, and welfare override the interest of science and society.

scholarly journals Recommendations for Supporting Prospective Study Registration in the Basic Experimental Studies in Humans And Alternative Procedures for Results Dissemination

2021 ◽  
Author(s):  
David Thomas Mellor ◽  
Nicole Pfeiffer
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Study ◽  
Human Subjects ◽  
Behavioral Outcomes ◽  
Experimental Studies ◽  
Basic Research ◽  
Health Related ◽  
Alternative Procedures ◽  
Definition Of

Recently, the NIH has modified the definition of clinical trial so that it applies to a much broader range of studies that previously were classified as clinical research but not specifically as trials. This definition, below, specifically includes research where behavioral outcomes are a focus of the study: “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”With the addition of behavioral outcomes, many studies that previously would not have been “clinical trials” are now so classified. Research studies that meet both criteria for “clinical trial” and “basic research” are now referred to as basic experimental studies in humans (BESH). The purpose of this whitepaper is to analyze and investigate ways that existing infrastructure could be improved to support these new requirements in ways that benefit all stakeholders.

scholarly journals Revised CIOMS International Ethical Guidelines for Biomedical Research

10.5912/jcb66 ◽  
1969 ◽  
Vol 10 (2) ◽  
Author(s):  
Jane Gregory
Keyword(s):  
Medical Association ◽  
Biomedical Research ◽  
Human Subjects ◽  
Ethical Principles ◽  
World Medical Association ◽  
Ethical Guidelines ◽  
National Policies ◽  
Low Resource ◽  
Declaration Of Helsinki ◽  
The World

The revised CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects supersede the previous 1993 Guidelines and consist of a statement of general ethical principles, a preamble and 21 guidelines with extensive commentaries. The Guidelines provide advice on the implementation in practice of the World Medical Association (WMA) Declaration of Helsinki and are designed to be of use, particularly to low-resource countries, in defining national policies and regulations on the ethics of biomedical research. The Guidelines are available on the CIOMS website.

scholarly journals Analyzing the Ethical Implications of Research Using Leaked Data

2020 ◽  
Vol 53 (3) ◽  
pp. 505-509
Author(s):  
Anne E. Boustead ◽  
Trey Herr
Keyword(s):  
Human Subjects ◽  
Public Domain ◽  
Ethical Challenges ◽  
Ethical Guidelines ◽  
Data Breach ◽  
The Public ◽  
Ethical Implications ◽  
Research Questions ◽  
Conducting Research ◽  
Insight Into

ABSTRACTAlthough information made public after a data breach can provide insight into difficult research questions, use of these data raises ethical questions not directly addressed by current ethical guidelines. This article develops a framework for identifying and managing risks to human subjects when conducting research involving leaked data. We contend that researchers who seek to use leaked data should identify and address ethical challenges by considering the process through which the data were originally released into the public domain.

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