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2.
PLoS One ; 15(6): e0234179, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32479556

RESUMO

Instrumentality-based pro-diversity beliefs (i.e., beliefs that diverse groups outperform homogenous groups in terms of group functioning) have been shown to improve intergroup attitudes. However, such valuing of diversity due to its expected instrumentality holds the risk that outgroups may be devalued in situations when diversity ends up being detrimental to group functioning. Across four experiments, we studied the interplay between instrumentality-based pro-diversity beliefs, actual instrumentality of ethnic diversity, and outgroup attitudes. Our results do not reveal a robust interaction effect between instrumentality-based pro-diversity beliefs and actual instrumentality of diverse groups. Some evidence, however, supports the assumption that instrumentality-based pro-diversity beliefs yielded a weaker positive or even a negative effect on ethnic outgroup attitudes when ethnic diversity was perceived as non-instrumental (i.e., when diversity was perceived as having a negative impact on group functioning). Theoretical contributions, practical implications, and directions for future research are discussed.


Assuntos
Diversidade Cultural , Cultura , Grupos Étnicos , Processos Grupais , Adulto , Atitude , Comércio , Emigrantes e Imigrantes , Retroalimentação Psicológica , Feminino , Alemanha , Humanos , Masculino , Refugiados , Inquéritos e Questionários , Experimentação Humana Terapêutica , Universidades
3.
J Evid Based Med ; 13(2): 173-177, 2020 May.
Artigo em Inglês | MEDLINE | ID: covidwho-343112

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
4.
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
5.
Hist Psychiatry ; 31(2): 217-226, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31928087

RESUMO

After many years of disregard, the use of psychedelic drugs in psychiatric treatment has re-emerged in recent years. The prospect that psychedelics may again be integrated into mainstream psychiatry has aroused interest in long-forgotten research and experience from the previous phase of psychedelic therapy, which lasted from the late 1940s to the 1970s. This article will discuss one large-scale psychedelic therapy programme at Modum Bad Nervesanatorium, a psychiatric clinic which treated 379 inpatients with psychedelic drugs during the years 1961-76. The psychiatrists there initially regarded the psychedelic treatment as efficacious and without serious negative reactions, but reports of long-term harm have since surfaced. This article discusses how insights from Modum Bad might benefit the new generation of psychedelic treatment efforts.


Assuntos
Alucinógenos/história , Dietilamida do Ácido Lisérgico/história , Transtornos Mentais/história , Psiquiatria/história , Experimentação Humana Terapêutica/história , Alucinógenos/efeitos adversos , Alucinógenos/uso terapêutico , História do Século XX , Hospitais Psiquiátricos/história , Humanos , Dietilamida do Ácido Lisérgico/uso terapêutico , Imperícia/história , Transtornos Mentais/tratamento farmacológico , Noruega
6.
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
7.
Hist Psychiatry ; 30(4): 443-456, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31238740

RESUMO

The present study looks into the much-neglected history of neurasthenia in Maoist China in relation to the development of psy sciences. It begins with an examination of the various factors that transformed neurasthenia into a major health issue from the late 1950s to mid-1960s. It then investigates a distinctive culture of therapeutic experiment of neurasthenia during this period, with emphasis on the ways in which psy scientists and medical practitioners manoeuvred in a highly politicized environment. The study concludes with a discussion of the legacy of these neurasthenia studies - in particular, the experiment with the famous 'speedy and synthetic therapy' - and of the implications the present study may have for future historical study of psychiatry and science.


Assuntos
Neurastenia/história , Psiquiatria/história , Psicologia/história , China , Comunismo/história , História do Século XX , Humanos , Neurastenia/terapia , Experimentação Humana Terapêutica/história
8.
Medicine (Baltimore) ; 98(18): e15311, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31045767

RESUMO

INTRODUCTION: The rapid advancement of nanotechnology in recent years has fuelled burgeoning interest in the field of nanoparticle research, particularly its application in cancer management. At present, there seems to be heightened interest in the application of gold nanoparticles (AuNPs) to the management of cancer, encompassing diagnosis, monitoring, and treatment. AuNPs could be used as drug delivery agents that target cancer cells or in gene therapy. These efforts are undertaken in the hope of revolutionizing current methods and strategies for cancer treatment. This review will focus on the current applications of AuNPs in cancer management. OBJECTIVES, DATA SOURCES, STUDY APPRAISAL AND SYNTHESIS METHODS, RESULTS:: objectives, data sources, study eligibility criteria, participants, and interventions, study appraisal and synthesis methods, results are not required, as the study will be a literature review. Just introduction, ethics and dissemination, and conclusion are applicable. ETHICS AND DISSEMINATION: Ethical approval and informed consent are not required, as the study is a literature review and does not involve direct contact with patients or alterations to patient care. CONCLUSION: AuNPs have many properties that are of great value for the diagnosis and treatment of tumors. AuNPs are small in size and can penetrate widely and deposit on the tumor site, bind to many proteins and drugs, target delivery drugs, and have good biocompatibility. The application of AuNPs in the diagnosis and treatment of tumors is very considerable. In the near future, AuNPs will certainly play an important role in the treatment of tumors.


Assuntos
Ouro/uso terapêutico , Nanopartículas Metálicas/uso terapêutico , Nanotecnologia/métodos , Neoplasias/tratamento farmacológico , Ouro/administração & dosagem , Ouro/química , Humanos , Nanopartículas Metálicas/administração & dosagem , Neoplasias/diagnóstico , Experimentação Humana Terapêutica
11.
Eur Ann Otorhinolaryngol Head Neck Dis ; 136(2): 103-108, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30803860

RESUMO

In France, the so-called "Jardé law" (named for its proposer) on human research, implemented since 2016, defines the regulatory and legal framework for "prospective" studies, formerly known as "biomedical research" or "common care". Three categories are distinguished: type 1 is at-risk drug or non-drug interventional research, type 2 is low-risk, low-burden interventional research, and type 3 is non-interventional research. The decrees of April 12, 2018 precisely define a list of research categories for types 2 and 3, thereby clarifying the regulatory procedures. The Sponsor registers the trial on the database of the National Drug Safety Agency (ANSM), or the European EudraCT database for drug studies, to obtain an identification number. Regulatory procedures are undertaken with the IRB and ANSM and then the Data Protection Commission (CNIL). Retrospective research on previously collected data (other than genetic) does not come under the Jardé law, and is governed by the 1978 data protection law, updated by the application decree of December 2016 and the law No. 2018-493 of June 20, 2018 on protection of personal data. This article presents a clarification of the key methodologic and regulatory steps.


Assuntos
Estudos Clínicos como Assunto/legislação & jurisprudência , Equipamentos e Provisões , Legislação de Medicamentos , Estudos Prospectivos , Estudos Retrospectivos , Experimentação Humana Terapêutica/legislação & jurisprudência , Pesquisa Biomédica/classificação , Pesquisa Biomédica/legislação & jurisprudência , França , Humanos
12.
Mutat Res Genet Toxicol Environ Mutagen ; 836(Pt A): 104-108, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30389152

RESUMO

In the last decades there has been a great progress in understanding the pathological and genetic mechanisms involved in Fanconi anemia (FA), a rare disease characterized by chromosome fragility, congenital malformations, bone marrow failure (BMF) and high cancer predisposition. However, these advances have not gone in parallel with the development of medical treatments, with the exception of improved protocols of hematopoietic stem cell transplant (HSCT). BMF and hematological malignancies are the most important and life threatening conditions the patient suffer during the first and second decade of life, respectively, being HSCT the only curative treatment available. Solid tumors are the third hallmark of the disease, usually with poor prognosis as tumor resection is the only therapeutic option given that patients do not tolerate chemotherapy or radiation. With improved HSCT protocols, FA patient survival has increased, leading to a progressively increased number of solid malignancies in adult patients. Therapeutic research is currently focused in targeted therapies for solid tumors as well as in preventive options in the context of drug repurposing. This review summarizes current therapies and drugs used so far in clinical trials to treat Fanconi anemia, as well as the ones used in FA research with potential for future therapeutic opportunities including drugs that suppress chromosome fragility or are expected to delay the onset of BMF and cancer in Fanconi anemia.


Assuntos
Cromossomos Humanos , Anemia de Fanconi/terapia , Anemia de Fanconi/genética , Terapia Genética , Transplante de Células-Tronco Hematopoéticas , Humanos , Experimentação Humana Terapêutica
14.
J Acquir Immune Defic Syndr ; 79 Suppl 1: S51-S58, 2018 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-30222705

RESUMO

The authors, who took part in designing and conducting the first phase-1 clinical trials of the HIV vaccine between 1991 and 1996, discuss the history of this innovative program, in particular, the conditions under which volunteers were recruited. They recall its multidisciplinary aspects; the team included, along with clinicians who were used to performing such trials, epidemiologists, psychiatrists, psychoanalysts, social psychologists, and a philosopher specialized in ethics. When forming this team, officials at France's National Research Agency on AIDS (ANRS) were careful to identify the volunteers social characteristics and pay heed to their subjective motivations for participating, given the context, namely a rising incidence of HIV infection and the challenges that were undermining confidence in medicine. Important in this context was the application of the Huriet-Sérusclat Act (1988) with its provisions for protecting participants. These clinical trials led to reformulating several ethical questions, for instance, the tension between the need of such trials and the necessity to not expose volunteers to poorly known risks; the importance of precise scientific information for delivering free, informed consent; and the possibility for volunteers to take part on the basis of their autonomy and "risk choice." The network of volunteers, which operated on this basis for nearly 25 years, is a rare example of collaboration between basic research in biomedicine, medical doctors, psychologists, psychoanalysts, and ethicists.


Assuntos
Vacinas contra a AIDS/imunologia , Ensaios Clínicos como Assunto/ética , Infecções por HIV/prevenção & controle , HIV/imunologia , Consentimento Livre e Esclarecido/ética , Pesquisa Biomédica/ética , Feminino , França/epidemiologia , Infecções por HIV/epidemiologia , Infecções por HIV/psicologia , Humanos , Masculino , Motivação , Gravidez , Risco , Assunção de Riscos , Experimentação Humana Terapêutica , Voluntários/psicologia
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
20.
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
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