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2.
MMW Fortschr Med ; 163(7): 10, 2021 04.
Artículo en Alemán | MEDLINE | ID: mdl-33844201
3.
J Indian Soc Pedod Prev Dent ; 39(1): 16-21, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33885382

RESUMEN

Background: Most of the nations have proposed research regulations to protect the rights and welfare of the research participants. Among such regulations are the informed consent and assent. In the present world, informed consent and assent is the cornerstone in health practice. Aims and Objectives: To compare and evaluate the knowledge and attitude toward informed consent and assent for biomedical research involving children among health-care professionals in Belagavi city. Materials and Methods: A cross-sectional questionnaire study was conducted among 300 house surgeons divided into four groups of Medical, Dental, Nursing, and Ayurveda faculty of Belagavi city. A self-administered multiple choice questions were used to evaluate the knowledge and a five-point Likert scale was used to asses attitude regarding informed consent and assent for research involving children. Statistical analysis was done using SPSS version 20. Results: There was statistically significant difference in mean knowledge and attitude among all four groups (P < 0.05), and there was no significant correlation between knowledge and attitude as a whole in each group of professionals (P > 0.05). Conclusion: Emphasis on additional training is the need of the hour for all the faculty participants and also incorporation of study material regarding informed consent and assent for research involving children by the policy makers.


Asunto(s)
Investigación Biomédica , Toma de Decisiones , Niño , Estudios Transversales , Humanos , Consentimiento Informado , Encuestas y Cuestionarios
9.
J Law Med ; 28(2): 462-474, 2021 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-33768752

RESUMEN

With advances in genomic research playing an important role in the development of clinical applications, it is important that ethical guidance for researchers is contemporary and relevant. In this article we analyse the relevant provisions in Australia's National Statement on Ethical Conduct in Human Research (revised in 2018) and consider the guidance it provides for contemporary genomics research. We analyse four key areas: genomic information; biobanking and use of human tissue; consent to participation in genomic research, including specific issues related to participation by children; and return of findings. We conclude that Australia's National Statement is well-placed to provide guidance to Australian researchers on issues relating to genomics, although there is scope for additional guidance on some issues related to consent.


Asunto(s)
Bancos de Muestras Biológicas , Genómica , Australia , Niño , Humanos , Consentimiento Informado , Investigadores
10.
Zhonghua Yu Fang Yi Xue Za Zhi ; 55(3): 289-323, 2021 Mar 06.
Artículo en Chino | MEDLINE | ID: mdl-33706469

RESUMEN

The Vaccine Administration Law of the People's Republic of China and other relevant laws require that vaccine recipients or their guardians be educated about vaccines and how they work, and described in general the methods and contents of such vaccination education. With the new law and "Standard Operational Procedures for Immunization" as foundation documents, and in consultation with experts at home and abroad, the Chinese Preventive Medicine Association developed a consensus statement about informed consent for vaccination. This consensus statement is written for disease control and prevention health care personnel in vaccination services and describes the educational content of informed consent, a theoretical framework for immunization and immunization knowledge, the informed consent processes, principles of planning for vaccination, and an informed consent form. Part Two of the consensus includes influenza vaccine, pneumococcal vaccine, haemophilus influenzae type b containing vaccine, enterovirus type 71 inactivated vaccine, rotavirus vaccine, varicella attenuated live vaccine, herpes-zoster vaccine, human papillomavirus vaccine, rabies vaccine, hemorrhagic fever with renal syndrome vaccine, leptospira vaccine, anthrax vaccine, hepatitis E vaccine, cholera vaccine, typhoid vaccine, and tick-borne encephalitis vaccine.


Asunto(s)
Vacunas contra la Influenza , Vacunación , China , Consenso , Humanos , Consentimiento Informado
12.
Ther Umsch ; 78(3): 149-157, 2021 Apr.
Artículo en Alemán | MEDLINE | ID: mdl-33775136

RESUMEN

In search of open minds and shared consent - Information, treatment options and postoperative care from the patient's perspective Abstract. This paper addresses knowledge gaps which are prone to handicap the ongoing communication process between medical / care personnel and patients of breast cancer, due to everyday routine and presumed lack of time. The respective qualitative studies do point to divergent expectations with regards to medical consultations and indicate that patients' satisfaction with therapeutic measures, which were decided in advance, might be improved. Three exemplary aspects of doctor-patient communication are then looked at closer: first the variety of treatment options offered, second the risk of expressing unconscious bias regarding patients' physical appearance and identity, and third the increasingly acknowledged desire of breast cancer patients to consult (… additionally, not alternatively) with other patients that are, or were previously affected by breast cancer and confronted with the decisions this condition entails.


Asunto(s)
Comunicación , Relaciones Médico-Paciente , Humanos , Consentimiento Informado , Satisfacción del Paciente , Cuidados Posoperatorios
13.
Vnitr Lek ; 67(1): 49-55, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33752401

RESUMEN

The issue of a patient´s competence is often solved in practice without a major theoretical concept. Such an approach, focused only on the basis of intuitions and experiences of physicians, however, may lead in some cases to an inadequate assessment of competence of a particular patient. Ultimately, it can happen that the decision of an incompetent person will be respected or that the decision of the competent person will be disrespected. Both possibilities can have ethical as well as legal consequences. This article addresses both theoretical and practical issues of competence in adult patients.


Asunto(s)
Consentimiento Informado , Médicos , Adulto , Humanos , Principios Morales
14.
Recenti Prog Med ; 112(3): 173-181, 2021 03.
Artículo en Italiano | MEDLINE | ID: mdl-33687354

RESUMEN

When a pandemic occurs, scientific research moves fast in order to achieve readily results, such as effective therapies to fight the SARS-CoV-2 and vaccines. But this high-speed science, engaged by the emergency and characterized by the explosion of online publications in preprint form not subject to scrutiny by peer reviewers, carries some risks. And it represents a challenge to maintain research integrity and to comply with those globally recognized standard principles of fairness. Competition and the pressure to publish immediately - a way of encouraging rapid data sharing - can favor the dissemination of incomplete if not erroneous results obtained from partial studies, which feed false news, such as the benefits of a drug, and illusory hopes. It is commonly through press releases that "speed science" disseminates information to an audience that wants to be informed and reassured. Financial and political interests often mix with the urgency to find solutions. Covid-19 has highlighted in particular the risk of a politicization of science at the expense of transparency.


Asunto(s)
Pandemias , Edición/normas , Investigación/normas , Adenosina Monofosfato/análogos & derivados , Adenosina Monofosfato/economía , Adenosina Monofosfato/provisión & distribución , Adenosina Monofosfato/uso terapéutico , Alanina/análogos & derivados , Alanina/economía , Alanina/provisión & distribución , Alanina/uso terapéutico , Antivirales/economía , Antivirales/provisión & distribución , Antivirales/uso terapéutico , Brotes de Enfermedades , Aprobación de Drogas , Unión Europea , Humanos , Gripe Humana/tratamiento farmacológico , Gripe Humana/economía , Gripe Humana/epidemiología , Gripe Humana/prevención & control , Difusión de la Información , Consentimiento Informado , Oseltamivir/economía , Oseltamivir/provisión & distribución , Oseltamivir/uso terapéutico , Revisión de la Investigación por Pares , Publicaciones Periódicas como Asunto , Política , Riesgo , Factores de Tiempo , Estados Unidos
16.
Mayo Clin Proc ; 96(2): 314-321, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-33549253

RESUMEN

OBJECTIVE: To determine at which phase in the recruitment process for participation in clinical research studies do health literacy and other patient characteristics influence recruitment outcomes. PATIENTS AND METHODS: Using a sample of 5872 patients hospitalized with cardiovascular disease approached for participation in the Vanderbilt Inpatient Cohort Study from October 2011 through December 2015, we examined the independent association of patients' health literacy with two steps in their research participation decision-making process: (1) research interest - willingness to hear more about a research study; and (2) research participation - the decision to enroll after an informed consent discussion. Best practices for effective health communication were implemented in recruitment approaches and informed consent processes. Using logistic regression models, we determined patient characteristics independently associated with patients' willingness to hear about and participate in the study. RESULTS: In unadjusted analyses, participants with higher health literacy, and those who were younger, female, or had more education had higher levels of both research interest and research participation. Health literacy remained independently associated with both outcomes in multivariable models, after adjustment for sociodemographic factors. CONCLUSION: Because identical variables predicted both research interest and eventual consent, efforts to recruit broad populations must include acceptable methods of approaching potential participants as well as explaining study materials.


Asunto(s)
Investigación Biomédica , Enfermedades Cardiovasculares/terapia , Alfabetización en Salud , Consentimiento Informado , Participación del Paciente , Factores de Edad , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Factores Sexuales , Tennessee
18.
Stroke ; 52(4): 1527-1531, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-33588599

RESUMEN

Informed consent is a key concept to ensure patient autonomy in clinical trials and routine care. The coronavirus disease 2019 (COVID-19) pandemic has complicated informed consent processes, due to physical distancing precautions and increased physician workload. As such, obtaining timely and adequate patient consent has become a bottleneck for many clinical trials. However, this challenging situation might also present an opportunity to rethink and reappraise our approach to consent in clinical trials. This viewpoint discusses the challenges related to informed consent during the COVID-19 pandemic, whether it could be acceptable to alter current consent processes under these circumstances, and outlines a possible framework with predefined criteria and a system of checks and balances that could allow for alterations of existing consent processes to maximize patient benefit under exceptional circumstances such as the COVID-19 pandemic without undermining patient autonomy.


Asunto(s)
Consentimiento Informado/normas , Pandemias , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/terapia , Anciano , Humanos , Masculino , Accidente Cerebrovascular/epidemiología , Factores de Tiempo
19.
Br Dent J ; 230(3): 114, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-33574507
20.
AJOB Neurosci ; 12(1): 57-67, 2021 01.
Artículo en Inglés | MEDLINE | ID: mdl-33528320

RESUMEN

Intracranial electrophysiological research methods, including those applying electrodes on the cortical surface or in deep structures, have become increasingly important in human neuroscience. They also pose novel ethical concerns, as human studies require the participation of neurological patients undergoing surgery for conditions such as epilepsy and Parkinson's disease. Research participants in this setting may be vulnerable to conflicts of interest, therapeutic misconception, and other threats to valid recruitment and consent. We conducted semi-structured interviews with investigators from NIH-funded studies involving recording or stimulation inside the human skull. We elicited perspectives on study recruitment and consent procedures, and analyzed transcripts using a modified grounded theory approach. We interviewed 26 investigators from 19 separate intracranial electrophysiology studies, who described two study types: opportunity studies (n = 15) and experimental trials (n = 4). Respondents described significant heterogeneity in recruitment and consent procedures, even among studies employing similar techniques. In some studies, clinician-investigators were specifically barred from obtaining consent, while in other studies clinician-investigators were specifically required to obtain consent; regulatory guidance was inconsistent. Respondents also described various models for subject selection, the timing of consent, and continuing consent for temporally extended studies. Respondents expressed ethical concerns about participants' vulnerability and the communication of research-related risks. We found a lack of consensus among investigators regarding recruitment and consent methods in human intracranial electrophysiology. This likely reflects the novelty and complexity of such studies and indicates a need for further discussion and development of best practices in this research domain.


Asunto(s)
Electrofisiología , Consentimiento Informado , Malentendido Terapéutico , Encéfalo , Humanos , Proyectos de Investigación , Investigadores
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