Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 343
Filtrar
1.
S Afr Med J ; 110(8): 816-818, 2020 Jul 29.
Artigo em Inglês | MEDLINE | ID: mdl-32880313

RESUMO

Faecal microbiota transplantation (FMT) has been shown to be an effective treatment for recurrent Clostridioides difficile infection. The purpose of this article, the second of a series of three articles, is to explore the legal framework governing human FMT in South Africa (SA). FMT involves different modes of administration that require different regulatory considerations. The focus of this article is to explore the legal classification of human stool as tissue in terms of the National Health Act 61 of 2003, as well as the regulation of human stool banks as tissue banks. The article concludes with specific recommendations aimed at improving the current regulatory vacuum relating to the regulation of FMT in SA.


Assuntos
Transplante de Microbiota Fecal , Obtenção de Tecidos e Órgãos/legislação & jurisprudência , Bancos de Espécimes Biológicos/legislação & jurisprudência , Fezes , Humanos , África do Sul , Experimentação Humana Terapêutica/ética , Experimentação Humana Terapêutica/legislação & jurisprudência , Obtenção de Tecidos e Órgãos/ética
2.
S Afr Med J ; 110(8): 819-821, 2020 Jul 29.
Artigo em Inglês | MEDLINE | ID: mdl-32880314

RESUMO

The purpose of this article, the last in a series of three exploring the legal framework for the regulation of faecal microbiota transplantation (FMT) in South Africa (SA), is to determine the regulatory framework that applies to microbial-based treatments involving a level of manipulation that exceeds that of basic stool transplantation, e.g. processed FMT-derived products in capsule form. The article highlights the legal requirements for the registration of these products as biological medicines in SA law. Although human stool banks are not regulated in terms of the National Health Act 61 of 2003 (NHA) and regulations, the earlier articles point out that human stool fits the definition of human tissue and human biological material as defined by the NHA. For this reason, stool banks should be considered tissue banks in terms of the NHA and regulations. Healthcare practitioners and researchers involved in FMT banking and transplantation should strive to comply with these regulations in the absence of clear legal direction at present.


Assuntos
Transplante de Microbiota Fecal , Experimentação Humana Terapêutica , Obtenção de Tecidos e Órgãos/legislação & jurisprudência , Bancos de Espécimes Biológicos/legislação & jurisprudência , Fezes , Humanos , África do Sul , Experimentação Humana Terapêutica/ética , Experimentação Humana Terapêutica/legislação & jurisprudência
5.
J Evid Based Med ; 13(2): 173-177, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32445288

RESUMO

The number of research involving human subjects on coronavirus disease 2019 (COVID-19) is surging, bringing challenges to the ethical review committee (ERC) in terms of reviewing speed and special ethical considerations under the pandemic. However, the existing ethical review system and regulations have their limitations to meet the demand for a prompt and efficient epidemic control. Since the research under the public health emergency is different from that carried out in familiar situations to design and implementation, the strategy for a satisfactory ERC response should balance the duty of protecting individual participants as well as the special public needs derived from the disease control. It is suggested that the ethical review-related regulations need to be updated, and a unified supervision system to the overall ERC is required. ERC collaboration, capacity-improving and efficiency-improving measures need to be taken. With respect to the reviewing guidelines, it is suggested that the international norms should be explained with more consideration of the local condition and the exceptional circumstances in this public health emergency. A joint effort needs to be taken for better research conduction.


Assuntos
Betacoronavirus , Infecções por Coronavirus , Comitês de Ética em Pesquisa/organização & administração , Pandemias , Pneumonia Viral , Projetos de Pesquisa , Experimentação Humana Terapêutica/ética , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/terapia , Saúde Global , Humanos , Consentimento Livre e Esclarecido/ética , Pneumonia Viral/diagnóstico , Pneumonia Viral/terapia
6.
Gac Med Mex ; 156(1): 53-59, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32026884

RESUMO

In this essay, the bioethical implications of the recent genetic manipulation in human embryos with CRISPR-Cas9 to eliminate the CCR5 gene and the birth of a pair of discordant twin girls are analyzed. The experiment was disseminated via social media. The main bioethical flaws identified include the justification of the model, the informed consent process and the lack of disclosure of evident conflicts of interest. The consequences of the experiment on the life of the twins that were born were not properly evaluated, such as the impact on their autonomy, the alleged benefits to be received and the future risks of harm during their lifetime. Having manipulated the germ cell line, the effects on their future offspring were not considered. This type of actions negatively affects the way society conceives science. Genetic engineering should be reserved to the basic experimental context or as clinical research for the correction of known serious diseases of genetic origin under strict regulatory and bioethical supervision and using a gradualist approach in accordance with the advances of gene editing techniques.


Assuntos
Sistemas CRISPR-Cas , Edição de Genes/ética , Receptores CCR5/genética , Temas Bioéticos , China , Conflito de Interesses , Feminino , Engenharia Genética/classificação , Engenharia Genética/ética , Genoma Humano , Infecções por HIV/prevenção & controle , Humanos , Consentimento Livre e Esclarecido/ética , Editoração/ética , Projetos de Pesquisa , Injeções de Esperma Intracitoplásmicas , Experimentação Humana Terapêutica/ética , Gêmeos Dizigóticos
7.
Trials ; 20(Suppl 2): 704, 2019 Dec 19.
Artigo em Inglês | MEDLINE | ID: mdl-31852488

RESUMO

Typhoidal Salmonella is a major global problem affecting more than 12 million people annually. Controlled human infection models (CHIMs) in high-resource settings have had an important role in accelerating the development of conjugate vaccines against Salmonella Typhi.The typhoidal Salmonella model has an established safety profile in over 2000 volunteers in high-income settings, and trial protocols, with modification, could be readily transferred to new study sites. To date, a typhoidal Salmonella CHIM has not been conducted in a low-resource setting, although it is being considered.Our article describes the challenges posed by a typhoidal Salmonella CHIM in the high-resource setting of Oxford and explores considerations for an endemic setting.Development of CHIMs in endemic settings is scientifically justifiable as it remains unclear whether findings from challenge studies performed in high-resource non-endemic settings can be extrapolated to endemic settings, where the burden of invasive Salmonella is highest. Volunteers are likely to differ across a range of important variables such as previous Salmonella exposure, diet, intestinal microbiota, and genetic profile. CHIMs in endemic settings arguably are ethically justifiable as affected communities are more likely to gain benefit from the study. Local training and research capacity may be bolstered.Safety was of primary importance in the Oxford model. Risk of harm to the individual was mitigated by careful inclusion and exclusion criteria; close monitoring with online diary and daily visits; 24/7 on-call staffing; and access to appropriate hospital facilities with capacity for in-patient admission. Risk of harm to the community was mitigated by exclusion of participants with contact with vulnerable persons; stringent hygiene and sanitation precautions; and demonstration of clearance of Salmonella infection from stool following antibiotic treatment.Safety measures should be more stringent in settings where health systems, transport networks, and sanitation are less robust.We compare the following issues between high- and low-resource settings: scientific justification, risk of harm to the individual and community, benefits to the individual and community, participant understanding, compensation, and regulatory requirements.We conclude that, with careful consideration of country-specific ethical and practical issues, a typhoidal Salmonella CHIM in an endemic setting is possible.


Assuntos
Recursos em Saúde , Experimentação Humana Terapêutica/ética , Febre Tifoide/terapia , Vacinas Tíficas-Paratíficas/administração & dosagem , Países Desenvolvidos/economia , Países em Desenvolvimento/economia , Voluntários Saudáveis , Humanos , Projetos de Pesquisa/legislação & jurisprudência , Salmonella typhi/imunologia , Salmonella typhi/patogenicidade , Experimentação Humana Terapêutica/economia , Experimentação Humana Terapêutica/legislação & jurisprudência , Febre Tifoide/economia , Febre Tifoide/microbiologia , Vacinas Tíficas-Paratíficas/efeitos adversos , Vacinas Tíficas-Paratíficas/economia
8.
Trials ; 20(Suppl 2): 702, 2019 Dec 19.
Artigo em Inglês | MEDLINE | ID: mdl-31852506

RESUMO

Human challenge trials (HCTs) deliberately infect participants in order to test vaccines and treatments in a controlled setting, rather than enrolling individuals with natural exposure to a disease. HCTs are therefore potentially powerful tools to prepare for future outbreaks of emerging infectious diseases. Yet when an infectious disease is emerging, there is often substantial risk and uncertainty about its complications, and few available interventions, making an HCT ethically complex. In light of the need to consider ethical issues proactively as a part of epidemic preparedness, we use the case of a Zika virus HCT to explore whether and when HCTs might be ethically justified to combat emerging infectious diseases. We conclude that emerging infectious diseases could be appropriate candidates for HCTs and we identify relevant considerations and provide a case example to illustrate when they might be ethically acceptable.


Assuntos
Ensaios Clínicos como Assunto/ética , Doenças Transmissíveis Emergentes/terapia , Epidemias/prevenção & controle , Experimentação Humana Terapêutica/ética , Infecção por Zika virus/terapia , Doenças Transmissíveis Emergentes/epidemiologia , Doenças Transmissíveis Emergentes/virologia , Emergências , Voluntários Saudáveis , Humanos , Vacinas/uso terapêutico , Zika virus/imunologia , Zika virus/patogenicidade , Infecção por Zika virus/epidemiologia , Infecção por Zika virus/virologia
9.
Trials ; 20(Suppl 2): 705, 2019 Dec 19.
Artigo em Inglês | MEDLINE | ID: mdl-31852513

RESUMO

This editorial introduces articles in this Special Issue, which are based on presentations given at the 2017 meeting of the Global Forum of Bioethics in Research meeting. The main themes presented at the meeting were the use of cluster randomized trials, stepped-wedge cluster randomized trials, and controlled human infection models in research conducted in low-resource settings. The editorial sets out which ethical issues may arise in the context of alternative trial designs and describes the articles in this issue that addresses some or more of the ethical issues, such as justification of the research design, risk-benefit evaluations and consent.


Assuntos
Recursos em Saúde , Projetos de Pesquisa/legislação & jurisprudência , Experimentação Humana Terapêutica/ética , Voluntários Saudáveis , Humanos , Experimentação Humana Terapêutica/economia , Experimentação Humana Terapêutica/legislação & jurisprudência
10.
Clin Trials ; 16(5): 473-475, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31368782

RESUMO

Using cases from this symposium, I illustrate a distinction between clinical trials that harm research non-participants' health and clinical trials that reduce a distinct health benefit to research non-participants. This distinction is ethically relevant for the design and justification of clinical trials. The relative stringency of the ethical duty to avoid harm makes it more important, all other things being equal, to avoid harms rather than avoid reduction of benefits. This is especially ethically important as it is often difficult to identify research non-participants who will suffer health harms due to research, let alone obtain their informed consent. In these difficult cases, all other things being equal, we have ethical reason to prefer clinical trials that only reduce non-participants' health benefits to those that only involve harms to non-participants' health. When such trials are not feasible and we are unable to get consent for the significant harms to research non-participants, these (and other) countervailing considerations must be outweighed by substantial social benefits in order for the trial to be ethically justified. Ethical research design must not just be concerned with the magnitude of adverse health effects on research non-participants but also the types of those effects.


Assuntos
Ética em Pesquisa , Experimentação Humana Terapêutica/ética , Ensaios Clínicos como Assunto , Infecções por HIV/prevenção & controle , Humanos , Consentimento Livre e Esclarecido/ética , Mosquiteiros Tratados com Inseticida , Transplante de Órgãos , Medição de Risco
11.
Clin Trials ; 16(5): 447-449, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31368795

RESUMO

This symposium takes a critical look at the ethics of impact on "bystanders" to clinical research. By that we mean study non-participants who nevertheless are at risk of being affected by the study in some way. This introduction suggests some questions to consider while reading through the symposium contributions, and gives a précis of each.


Assuntos
Ensaios Clínicos como Assunto , Consentimento Livre e Esclarecido/ética , Congressos como Assunto , Ética em Pesquisa , Humanos , Risco , Experimentação Humana Terapêutica/ética
12.
Clin Trials ; 16(5): 455-457, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31368799

RESUMO

Research involving human subjects can impose risk on some 'bystanders'- people who are not themselves research subjects but whom the study may affect. We examine the consequences of research for a particular category of bystanders - research subjects' sex partners - in trials testing interventions to reduce (1) HIV transmission (HIV treatment-as-prevention trials) and (2) HIV acquisition (HIV pre-exposure prophylaxis trials). Both types of trials provide useful test cases for assessing whether bystanders to research deserve special consideration in ethics reviews, and potentially some of the benefits and protections that research subjects receive. In HIV treatment-as-prevention trials, there are two groups of people who are alike in many important respects but treated very differently by research ethics: research subjects who contribute data on the primary endpoint of the trial (because some of them have sex with the people receiving the treatment conditions of the trials) - and bystanders who are not enrolled in the trials but who could have contributed primary endpoint data in the same way as the first group. In pre-exposure trials, the sex partners of people participating in pre-exposure prophylaxis trials are bystanders, even though they are necessary for the success of the trial. Research subjects' autonomy is fiercely protected by trial enrolment processes. Bystanders, by contrast, often have no choice but to be affected by the study, because of their relationship to a research subject. In HIV prevention trials, standing by can come with important risks, including the same ones on which the success of the research hinges. It is thus important to consider the ethical obligations to protect bystanders, and the related procedural responsibilities.


Assuntos
Ética em Pesquisa , Parceiros Sexuais , Experimentação Humana Terapêutica/ética , Infecções por HIV/prevenção & controle , Infecções por HIV/terapia , Humanos , Consentimento Livre e Esclarecido/ética , Sujeitos da Pesquisa , Medição de Risco
13.
Clin Trials ; 16(5): 450-454, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31368813

RESUMO

This article informally reviews key research ethics guidelines and regulations, academic scholarship, and research studies and finds wide variety in how they consider risk to bystanders in medical research (namely, non-participants whom studies nevertheless place at risk). Some of these key sources give no or very little consideration to bystanders, while others offer them the utmost protection (greater than they offer study participants). This unsettled frontier would benefit from a deeper investigation of the ethics of protecting research bystanders.


Assuntos
Ensaios Clínicos como Assunto , Ética em Pesquisa , Guias como Assunto , Experimentação Humana Terapêutica/ética , Humanos , Consentimento Livre e Esclarecido/ética , Risco , Experimentação Humana Terapêutica/legislação & jurisprudência
14.
Am J Perinatol ; 36(S 02): S41-S47, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31238358

RESUMO

Provisions for post-trial access (PTA) of the experimental intervention are required before the start of a clinical trial. Although there has been ample attention for PTA in the context of preventive vaccine research, discussions on PTA barely include maternal vaccine trials in which mother-infant pairs are exposed to the intervention. In maternal vaccination trials, specific PTA arrangements are required because pregnancy is transient and PTA may apply to the next pregnancy or the child. In this article, we examine the application and adherence to PTA in the context of maternal vaccine trials. We focused on differences between publications before and after 2000 when international ethical guidance documents formalized PTA requirements. Randomized maternal vaccine trials were included after a systematic search for clinical trials in phases II and III with a maternal vaccine as intervention. We used PTA as defined at the time of publication in the World Medical Association's Declaration of Helsinki (DoH) or in the ethical guidelines of the Council for International Organizations of Medical Sciences (CIOMS). In addition, we investigated whether PTA was included in the trial design. Therefore, we contacted principal investigators (PI's) of the publications found in the review to fill out a questionnaire regarding provisions for PTA. Before and after 2000, no trial articles examined in the systematic review described PTA in their trial publication (0/7, 0% and 0/17, 0%, respectively). In addition, more than half of the PI's of the trials found were not familiar with PTA recommendations in international ethical guidelines. Most cases of PTA included making knowledge available by publishing the results of the trial. The revision of the DoH in 2002 and the CIOMS ethical guidelines in 2002 has not resulted in increased PTA provisions for maternal vaccination trials. PTA is a shared responsibility of various stakeholders including sponsors, Institutional Review Boards, regulators, political entities, and researchers. Inclusion of PTA provisions in trial protocols and publications on maternal vaccination trials is essential to increase transparency on the form and content of these provisions.


Assuntos
Ética em Pesquisa , Guias como Assunto , Direitos do Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Experimentação Humana Terapêutica/ética , Vacinação , Códigos de Ética , Feminino , Humanos , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Responsabilidade Social , Terapias em Estudo/ética , Vacinação/ética
16.
AMA J Ethics ; 20(5): 467-474, 2018 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-29763393

RESUMO

Trauma care requires rapid interventions to optimize the chances for survival. Many patients are either in shock or unconscious and are, therefore, unable to provide informed consent even for standard procedures. Research-related interventions must similarly be initiated rapidly with no opportunity to obtain consent from the patient or the patient's legally authorized representative. Federal regulations allow for an exception from informed consent in these circumstances once the investigators complete a process of community consultation and public disclosure. The challenges for investigators include how to define the at-risk community for enrollment in the trial and then how to adequately reach out to that community. Many approaches have been used, with varying success. What constitutes true engagement with the community needs to be further explored.


Assuntos
Serviços Médicos de Emergência/ética , Consentimento Livre e Esclarecido/ética , Experimentação Humana Terapêutica/ética , Pesquisa Biomédica/ética , Humanos , Seleção de Pacientes/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Projetos de Pesquisa
17.
J Med Ethics ; 44(1): 3-8, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27573153

RESUMO

The West African Ebola epidemic has set in motion a collective endeavour to conduct accelerated clinical trials, testing unproven but potentially lifesaving interventions in the course of a major public health crisis. This unprecedented effort was supported by the recommendations of an ad hoc ethics panel convened in August 2014 by the WHO. By considering why and on what conditions the exceptional circumstances of the Ebola epidemic justified the use of unproven interventions, the panel's recommendations have challenged conventional thinking about therapeutic development and clinical research ethics. At the same time, unanswered ethical questions have emerged, in particular: (i) the specification of exceptional circumstances, (ii) the specification of unproven interventions, (iii) the goals of interventional research in terms of individual versus collective interests, (iv) the place of adaptive trial designs and (v) the exact meaning of compassionate use with unapproved interventions. Examination of these questions, in parallel with empirical data from research sites, will help build pragmatic foundations for disaster research ethics. Furthermore, the Ebola clinical trials signal an evolution in the current paradigms of therapeutic research, beyond the case of epidemic emergencies.


Assuntos
Ensaios de Uso Compassivo , Desastres , Surtos de Doenças , Análise Ética , Doença pelo Vírus Ebola/terapia , Experimentação Humana Terapêutica/ética , Terapias em Estudo , África Ocidental , Ética em Pesquisa , Doença pelo Vírus Ebola/epidemiologia , Humanos , Saúde Pública , Projetos de Pesquisa
18.
J Med Ethics ; 44(4): 270-276, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29127137

RESUMO

Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption (ATI), involve uncertain and potentially high risk, with minimal chance of clinical benefit. Some question whether such trials should be offered, given the risk/benefit imbalance, and whether those who choose to participate are acting rationally. We address these questions through a longitudinal decision-making study nested in a Thai acute HIV research cohort.In-depth interviews revealed central themes about decisions to join. Participants felt they possessed an important identity as members of the acute cohort, viewing their bodies as uniquely suited to both testing and potentially benefiting from HIV cure approaches. While acknowledging risks of ATI, most perceived they were given an opportunity to interrupt treatment, to test their own bodies and increase normalcy in a safe, highly monitored circumstance. They were motivated by potential benefits to themselves, the investigators and larger acute cohort, and others with HIV. They believed their own trial experiences and being able to give back to the community were sufficient to offset participation risks.These decisions were driven by the specific circumstances experienced by our participants. Judging risk/benefit ratios without appreciating these lived experiences can lead to false determinations of irrational decision- making. While this does not minimise vital oversight considerations about risk reduction and protection from harm, it argues for inclusion of a more participant-centered approach.


Assuntos
Vacinas contra a AIDS , Pesquisa Biomédica , Ensaios Clínicos como Assunto/ética , Infecções por HIV/tratamento farmacológico , Experimentação Humana Terapêutica/ética , Suspensão de Tratamento/ética , Adulto , Fármacos Anti-HIV , Tomada de Decisões , Feminino , Infecções por HIV/transmissão , Conhecimentos, Atitudes e Prática em Saúde , Pesquisa sobre Serviços de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Participação do Paciente , Direitos do Paciente , Medição de Risco , Carga Viral/efeitos dos fármacos
19.
Clin Pharmacol Ther ; 103(4): 566-569, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29285748

RESUMO

The European Medicines Agency (EMA) in 2017 issued a revised guideline on nonclinical and clinical aspects of first-in-human (FIH) and early clinical trials (CTs). External input was solicited during a draft comment phase, and although some industry suggestions were adopted, others were not. We agree that subject safety is of utmost priority, and believe that minimizing risk must be balanced with efficient and informative study designs to bring new medicines to patients.


Assuntos
Ensaios Clínicos como Assunto , Desenvolvimento de Medicamentos , Indústria Farmacêutica , Controle de Medicamentos e Entorpecentes/métodos , Guias como Assunto , Experimentação Humana Terapêutica , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/legislação & jurisprudência , Ensaios Clínicos como Assunto/normas , União Europeia , Humanos , Experimentação Humana Terapêutica/ética , Experimentação Humana Terapêutica/legislação & jurisprudência
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...