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1.
Rev Invest Clin ; 71(3): 149-156, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31184330

RESUMO

It is often unclear to the clinical investigator whether observational studies should be submitted to a research ethics committee (REC), mostly because, in general, no active or additional interventions are performed. Moreover, obtaining an informed consent under these circumstances may be challenging, either because these are very large epidemiological registries, or the subject may no longer be alive, is too ill to consent, or is impossible to contact after being discharged. Although observational studies do not involve interventions, they entail ethical concerns, including threats such as breaches in confidentiality and autonomy, and respect for basic rights of the research subjects according to the good clinical practices. In this context, in addition to their main function as evaluators from an ethical, methodological, and regulatory point of view, the RECs serve as mediators between the research subjects, looking after their basic rights, and the investigator or institution, safeguarding them from both legal and unethical perils that the investigation could engage, by ensuring that all procedures are performed following the international standards of care for research. The aim of this manuscript is to provide information on each type of study and its risks, along with actions to prevent such risks, and the function of RECs in each type of study.


Assuntos
Comitês de Ética em Pesquisa/organização & administração , Estudos Observacionais como Assunto/ética , Projetos de Pesquisa , Humanos , Consentimento Livre e Esclarecido/ética , Entrevistas como Assunto/métodos , Sistema de Registros/ética , Pesquisadores/organização & administração , Estudos Retrospectivos
2.
Pediatrics ; 142(Suppl 1): S533-S538, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30171138

RESUMO

Sweden has a long tradition of being at the forefront of the management of extremely preterm infants. In this article, we explore the historical background, ethical discussions, and evidence from national surveys combined with data from quality registers that form the background of the current Swedish guidelines for the care of extremely preterm infants. The current Swedish national guidelines suggest providing active care for preterm infants from 23 weeks' gestation and considering active care from 22 weeks' gestation. The survival of infants in gestational weeks 22 and 23 has increased and now exceed 50% and 60%, respectively; importantly, the Swedish proactive approach to care at the border of viability has not resulted in an increased proportion of functional impairment among survivors.


Assuntos
Gerenciamento Clínico , Viabilidade Fetal/fisiologia , Cuidado do Lactente/ética , Lactente Extremamente Prematuro/fisiologia , Doenças do Prematuro/epidemiologia , Doenças do Prematuro/terapia , Humanos , Cuidado do Lactente/métodos , Cuidado do Lactente/tendências , Recém-Nascido , Sistema de Registros/ética , Taxa de Sobrevida/tendências , Suécia/epidemiologia
3.
Public Health Genomics ; 21(1-2): 18-26, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30227419

RESUMO

OBJECTIVES: Genomic information will increasingly be used to aid in the prevention, diagnosis, and treatment of disease. Several national initiatives are paving the way for this new reality, while also promoting new models of participant-engaged research. We compare the opinions of research participants in a cancer registry, human genetic researchers, and institutional review board (IRB) professionals about the return of individual-level genetic results (ROR). METHODS: Online surveys were administered to participants in a cancer registry (n = 450) and overlapping questions were compared to our previous online national surveys of human genetic researchers (n = 351) and IRB professionals (n = 208). RESULTS: The majority of respondents agreed that researchers have an obligation to return individual results when they would affect a participant's health. While 77% of registry participants favored ROR if the researcher feels the participant might be interested in the results, only 30% of the IRB professionals and 25% of the genetic researchers agreed with this statement. CONCLUSIONS: Significant differences emerged between the stakeholder groups in several ROR scenarios. Policies that are acceptable to participants, researchers and IRBs, and that ensure human subject protections and facilitate research are needed.


Assuntos
Atitude Frente a Saúde , Pesquisa em Genética/ética , Genômica/ética , Neoplasias/genética , Sistema de Registros/ética , Idoso , Atitude do Pessoal de Saúde , Comitês de Ética em Pesquisa , Ética em Pesquisa , Humanos , Masculino , Pessoa de Meia-Idade , Pesquisadores/psicologia
5.
BMC Med Ethics ; 19(1): 20, 2018 03 07.
Artigo em Inglês | MEDLINE | ID: mdl-29514635

RESUMO

BACKGROUND: There is a growing interest in aggregating more biomedical and patient data into large health data sets for research and public benefits. However, collecting and processing patient data raises new ethical issues regarding patient's rights, social justice and trust in public institutions. The aim of this empirical study is to gain an in-depth understanding of the awareness of possible ethical risks and corresponding obligations among those who are involved in projects using patient data, i.e. healthcare professionals, regulators and policy makers. METHODS: We used a qualitative design to examine Swiss healthcare stakeholders' experiences and perceptions of ethical challenges with regard to patient data in real-life settings where clinical registries are sponsored, created and/or used. A semi-structured interview was carried out with 22 participants (11 physicians, 7 policy-makers, 4 ethical committee members) between July 2014 and January 2015. The interviews were audio-recorded, transcribed, coded and analysed using a thematic method derived from Grounded Theory. RESULTS: All interviewees were concerned as a matter of priority with the needs of legal and operating norms for the collection and use of data, whereas less interest was shown in issues regarding patient agency, the need for reciprocity, and shared governance in the management and use of clinical registries' patient data. This observed asymmetry highlights a possible tension between public and research interests on the one hand, and the recognition of patients' rights and citizens' involvement on the other. CONCLUSIONS: The advocation of further health-related data sharing on the grounds of research and public interest, without due regard for the perspective of patients and donors, could run the risk of fostering distrust towards healthcare data collections. Ultimately, this could diminish the expected social benefits. However, rather than setting patient rights against public interest, new ethical approaches could strengthen both concurrently. On a normative level, this study thus provides material from which to develop further ethical reflection towards a more cooperative approach involving patients and citizens in the governance of their health-related big data.


Assuntos
Pessoal Administrativo/ética , Conscientização , Participação da Comunidade , Conjuntos de Dados como Assunto/ética , Pessoal de Saúde/ética , Obrigações Morais , Direitos do Paciente , Adulto , Idoso , Big Data , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Médicos , Pesquisa Qualitativa , Sistema de Registros/ética , Controle Social Formal , Justiça Social , Participação dos Interessados , Inquéritos e Questionários , Suíça , Confiança
6.
Gac. sanit. (Barc., Ed. impr.) ; 32(1): 92-95, ene.-feb. 2018. tab
Artigo em Espanhol | IBECS | ID: ibc-170159

RESUMO

Los diseños genéticamente informativos, y en particular los estudios de gemelos, constituyen la metodología más utilizada para analizar la contribución relativa de los factores genéticos y ambientales a la variabilidad interindividual. Básicamente, consisten en comparar el grado de similitud, con respecto a una característica o rasgo determinado, entre gemelos monocigóticos y dicigóticos. Además de la clásica estimación de heredabilidad, este tipo de registros permite una amplia variedad de análisis únicos por las características de la muestra. El Registro de Gemelos de Murcia es un registro de base poblacional centrado en el análisis de conductas relacionadas con la salud. Las prevalencias de problemas de salud observadas son comparables a las de otras muestras de referencia de ámbito regional y estatal, lo que avala su representatividad. En conjunto, sus características facilitan el desarrollo de diversas modalidades de investigación, además de diseños genéticamente informativos y la colaboración con distintas iniciativas y consorcios (AU)


Genetically informative designs and, in particular, twin studies, are the most widely used methodology to analyse the relative contribution of genetic and environmental factors to inter-individual variability. These studies basically compare the degree of phenotypical similarity between monozygotic and dizygotic twin pairs. In addition to the traditional estimate of heritability, this kind of registry enables a wide variety of analyses which are unique due to the characteristics of the sample. The Murcia Twin Registry is population-based and focused on the analysis of health-related behaviour. The observed prevalence of health problems is comparable to that of other regional and national reference samples, which guarantees its representativeness. Overall, the characteristics of the Registry facilitate developing various types of research as well as genetically informative designs, and collaboration with different initiatives and consortia (AU)


Assuntos
Humanos , Gêmeos/genética , Estudos em Gêmeos como Assunto/métodos , Registros/normas , Sistema de Registros/ética , Sistema de Registros/normas , Estudos em Gêmeos como Assunto/ética , Genética Médica/métodos , Genética Comportamental/ética , Genética Comportamental/métodos
8.
BMC Med Ethics ; 18(1): 53, 2017 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-28915865

RESUMO

BACKGROUND: Research into personal health data holds great potential not only for improved treatment but also for economic growth. In these years many countries are developing policies aimed at facilitating such research often under the banner of 'big data'. A central point of debate is whether the secondary use of health data requires informed consent if the data is anonymised. In 2013 the Danish Minister of Health established a new register collecting data about all ritual male childhood circumcisions in Denmark. The main purpose of the register was to enable future research into the consequences of ritual circumcision. DISCUSSION: This article is a study into the case of the Danish Circumcision Registry. We show that such a registry may lead to various forms of harm such as 1) overreaching social pressure, 2) stigmatization, 3) medicalization of a religious practice, 4) discrimination, and 5) polarised research, and that a person may therefore have a strong and legitimate interest in deciding whether or not such data should be collected and/or used in research. This casts doubt on the claim that the requirement of informed consent could and should be waived for all types of secondary research into registries. We finally sketch a new model of informed consent - Meta consent - aimed at striking a balance between the interests in promoting research and at the same time protecting the individual. Research participants may have a strong and legitimate interest in deciding whether or not their data should be collected and used for registry-based research whether or not their data is anonymised.


Assuntos
Comportamento Ritualístico , Circuncisão Masculina/estatística & dados numéricos , Anonimização de Dados/ética , Anonimização de Dados/legislação & jurisprudência , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Sistema de Registros/ética , Dinamarca , Ética Médica , Humanos , Masculino , Consentimento dos Pais/ética , Consentimento dos Pais/legislação & jurisprudência , Religião e Medicina , Estigma Social
9.
J Clin Epidemiol ; 91: 87-94, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28757260

RESUMO

OBJECTIVES: The decision to make protocols of phase III randomized controlled trials (RCTs) publicly accessible by leading journals was a landmark event in clinical trial reporting. Here, we compared primary outcomes defined in protocols with those in publications describing the trials and in trial registration. STUDY DESIGN AND SETTING: We identified phase III RCTs published between January 1, 2012, and June 30, 2015, in The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, and The BMJ with available protocols. Consistency in primary outcomes between protocols and registries (articles) was evaluated. RESULTS: We identified 299 phase III RCTs with available protocols in this analysis. Out of them, 25 trials (8.4%) had some discrepancy for primary outcomes between publications and protocols. Types of discrepancies included protocol-defined primary outcome reported as nonprimary outcome in publication (11 trials, 3.7%), protocol-defined primary outcome omitted in publication (10 trials, 3.3%), new primary outcome introduced in publication (8 trials, 2.7%), protocol-defined nonprimary outcome reported as primary outcome in publication (4 trials, 1.3%), and different timing of assessment of primary outcome (4 trials, 1.3%). Out of trials with discrepancies in primary outcome, 15 trials (60.0%) had discrepancies that favored statistically significant results. Registration could be seen as a valid surrogate of protocol in 237 of 299 trials (79.3%) with regard to primary outcome. CONCLUSION: Despite unrestricted public access to protocols, selective outcome reporting persists in a small fraction of phase III RCTs. Only studies from four leading journals were included, which may cause selection bias and limit the generalizability of this finding.


Assuntos
Ensaios Clínicos Fase III como Assunto/ética , Viés de Publicação , Publicações/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Sistema de Registros/ética , Humanos , Disseminação de Informação/ética , Avaliação de Resultados da Assistência ao Paciente , Relatório de Pesquisa
10.
Regen Med ; 12(6): 705-719, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28721755

RESUMO

Numerous US businesses that engage in direct-to-consumer advertising of stem cell interventions that are not US FDA-approved also recruit clients by listing 'pay-to-participate' studies listed on ClinicalTrials.gov . Individuals considering enrolling in such studies and NIH officials responsible for overseeing the database need to be aware that some businesses are using the registry to promote unapproved stem cell interventions that study subjects are charged to receive. Inclusion of such studies in ClinicalTrials.gov reveals that the database needs better screening tools. In particular, screening should evaluate whether studies submitted to the registry have been reviewed and permitted to proceed by the FDA in the case of clinical studies requiring FDA clearance in addition to institutional review board approval.


Assuntos
Ensaios Clínicos como Assunto/ética , Bases de Dados Factuais , Controle Social Formal , Ensaios Clínicos como Assunto/legislação & jurisprudência , Internet , National Institutes of Health (U.S.) , Sistema de Registros/ética , Transplante de Células-Tronco , Estados Unidos
13.
J Med Toxicol ; 13(3): 255-258, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28540608

RESUMO

Optimizing care in medical toxicology necessitates designing and conducting ethical research. Nevertheless, the context of medical toxicology can make clinical research ethically challenging for a variety of reasons: medical toxicology is typified by relative rare conditions; making precise and rapid diagnoses is often fraught with uncertainty; emergent and urgent clinical exigencies make consent difficult or impossible; and some exposures are stigmatized or related to illegal activities that can compromise collecting accurate data from patients. In this paper, we examine some of the ethical issues in medical toxicology research that are especially salient in effort to promote optimal research in the field. The particular issues to be addressed are as follows: (1) rare conditions and orphan agents, (2) randomization and control arms, (3) inclusion and exclusion criteria, (4) outcome measures, (5) consent, (6) confidentiality, (7) registries, (8) oversight, and (9) transparency and reporting. Thinking about these ethical issues prospectively will help researchers and clinicians appropriately navigate them.


Assuntos
Pesquisa Biomédica/ética , Toxicologia/ética , Confidencialidade/ética , Definição da Elegibilidade/ética , Determinação de Ponto Final/ética , Comitês de Ética em Pesquisa/ética , Humanos , Consentimento Livre e Esclarecido/ética , Produção de Droga sem Interesse Comercial/ética , Seleção de Pacientes/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Doenças Raras/diagnóstico , Doenças Raras/epidemiologia , Doenças Raras/terapia , Sistema de Registros/ética
14.
BMJ Open ; 7(2): e013351, 2017 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-28148535

RESUMO

PURPOSE: Recruitment to trials is often difficult. Many trials fail to meet recruitment targets resulting in underpowered studies which waste resources and the time of those who participated. While there is evidence that many people are willing to take part in research, particularly if it involves a condition from which they suffer, researchers are unable to easily contact such people often relying on busy clinicians to identify them. Many clinicians perceive themselves as too busy to take part in research activities. The Scottish Health Research Register SHARE adopts an approach which asks the public to consent to their data held in National Health Service databases to be used to determine their suitability for research projects. Additionally, participants can consent for spare blood, left after routine venepuncture to be automatically identified in the laboratory and stored for future research studies. PARTICIPANTS: Anyone over the age of 16 years in Scotland can participate. Participants are approached through a range of methods including directly at outpatient clinics and general practitioners practices, leaflets with hospital letters and personal email from employers. FINDINGS TO DATE: SHARE has recruited around 130 000 people. SHARE has demonstrated that it can quickly and efficiently recruit to studies, over 20 until now. In addition, it can be used to administer questionnaire studies by email and recruit to patient and public involvement groups. FUTURE PLANS: SHARE continues to steadily recruit with the ambition of eventually achieving 1 000 000 people in Scotland. We are steadily increasing the number of data sets we use for identifying participants. We are adding a mobile app which will facilitate dissemination about research and allow the collection of physiological and activity data if desired. We anticipate that SHARE will soon become the main source of health research recruitment in Scotland.


Assuntos
Pesquisa Biomédica , Seleção de Pacientes , Sistema de Registros , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Bancos de Sangue , Conjuntos de Dados como Assunto , Registros Eletrônicos de Saúde , Feminino , Financiamento Governamental , Humanos , Consentimento Livre e Esclarecido , Masculino , Registro Médico Coordenado , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Sistema de Registros/ética , Escócia , Adulto Jovem
16.
Am J Transplant ; 17(6): 1439-1446, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28066999

RESUMO

The Scientific Registry of Transplant Recipients (SRTR) serves to collect data on organ transplants performed in the United States. Although the infectious diseases data are limited and include mostly pretransplant serologies and other nonspecific infection-related outcomes, this multicenter data collection allows for insightful national data and the ability to monitor trends over time. We reviewed the published concise reports for each organ type in SRTR reports containing data from 2005 to 2014, and summarized our findings with respect to cytomegalovirus (CMV), Epstein-Barr virus, posttransplant lymphoproliferative disorder (PTLD), hepatitis B virus (HBV), hepatitis C virus (HCV), HIV, general infection, and prophylaxis. Our review highlights a few developments. While rates of donor-recipient CMV serology combinations remain fairly constant over time, there are generally more seronegative donors and recipients among living donor transplants. There has been a reduction in PTLD for pediatric transplant recipients. There has also been a slight reduction in anti-HBV core antibody-positive donor organs and stable reporting of HCV-positive donor organs and HIV-positive recipients.


Assuntos
Doenças Transmissíveis/etiologia , Transplante de Órgãos/efeitos adversos , Sistema de Registros/ética , Transplantados , Humanos , Fatores de Risco
20.
Acad Med ; 91(5): 690-5, 2016 05.
Artigo em Inglês | MEDLINE | ID: mdl-26466377

RESUMO

PROBLEM: Efforts to evaluate and optimize the effectiveness of medical education have been limited by the difficulty of designing medical education research. Longitudinal, epidemiological views of educational outcomes can help overcome limitations, but these approaches require "bigger data"-more learners, sources, and time points. The rich data institutions collect on students and residents can be mined, however, ethical and practical barriers to using these data must first be overcome. APPROACH: In 2008, the authors established the Research on Medical Education Outcomes (ROMEO) Registry, an educational data registry modeled after patient registries. New York University School of Medicine students, residents, and fellows provide consent for routinely collected educational, performance, quality improvement, and clinical practice data to be compiled into a deidentified, longitudinal database. As of January 2015, this registry included 1,225 residents and fellows across 12 programs (71% consent rate) and 841 medical students (86% consent rate). Procedures ensuring voluntary informed consent are essential to ethical enrollment and data use. Substantial resources are required to provide access to and manage the data. OUTCOMES: The registry supports educational scholarship. Seventy-two studies using registry data have been presented or published. These focus on evaluating the curriculum, quality of care, and measurement quality and on assessing needs, competencies, skills development, transfer of skills to practice, remediation patterns, and links between education and patient outcomes. NEXT STEPS: The authors are working to integrate assessment of relevant outcomes into the curriculum, maximize both the quantity and quality of the data, and expand the registry across institutions.


Assuntos
Competência Clínica , Educação de Graduação em Medicina/normas , Internato e Residência/normas , Melhoria de Qualidade , Sistema de Registros/ética , Sistema de Registros/normas , Acesso à Informação/ética , Currículo/normas , Humanos , Armazenamento e Recuperação da Informação/ética , Armazenamento e Recuperação da Informação/métodos , Estudos Longitudinais , New York , Garantia da Qualidade dos Cuidados de Saúde
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