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1.
Dimens Crit Care Nurs ; 41(1): 24-28, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-34817958

RESUMO

Institutional review boards (IRBs) exist to protect the rights and welfare of research participants. Critical care nurses and researchers may interface with IRBs directly or indirectly. Having an understanding of how the IRB process works will help nurses advocate for patients who may also be research participants and will help researchers facilitate approval of their research studies.


Assuntos
Comitês de Ética em Pesquisa , Enfermeiras e Enfermeiros , Cuidados Críticos , Humanos
2.
J Med Internet Res ; 23(12): e25414, 2021 12 22.
Artigo em Inglês | MEDLINE | ID: mdl-34941548

RESUMO

Digital technologies offer unique opportunities for health research. For example, Twitter posts can support public health surveillance to identify outbreaks (eg, influenza and COVID-19), and a wearable fitness tracker can provide real-time data collection to assess the effectiveness of a behavior change intervention. With these opportunities, it is necessary to consider the potential risks and benefits to research participants when using digital tools or strategies. Researchers need to be involved in the risk assessment process, as many tools in the marketplace (eg, wellness apps, fitness sensors) are underregulated. However, there is little guidance to assist researchers and institutional review boards in their evaluation of digital tools for research purposes. To address this gap, the Digital Health Checklist for Researchers (DHC-R) was developed as a decision support tool. A participatory research approach involving a group of behavioral scientists was used to inform DHC-R development. Scientists beta-tested the checklist by retrospectively evaluating the technologies they had chosen for use in their research. This paper describes the lessons learned because of their involvement in the beta-testing process and concludes with recommendations for how the DHC-R could be useful for a variety of digital health stakeholders. Recommendations focus on future research and policy development to support research ethics, including the development of best practices to advance safe and responsible digital health research.


Assuntos
COVID-19 , Lista de Checagem , Comitês de Ética em Pesquisa , Humanos , Estudos Retrospectivos , SARS-CoV-2
3.
Enferm. foco (Brasília) ; 12(4): 794-800, dez. 2021. tab
Artigo em Português | LILACS, BDENF - Enfermagem | ID: biblio-1353377

RESUMO

Objetivo: caracterizar membros de comitês de ética em pesquisa implantados em instituições de ensino superior e em hospitais de uma capital do Nordeste brasileiro. Método: estudo descritivo, por meio de questionário online, aplicado na plataforma Google Forms, tendo como participantes 39 membros efetivos que atuavam em comitês de ética em pesquisa implantados em instituições de ensino superior e em hospitais. Resultados: dos participantes que responderam,59,0% pertenciam ao gênero feminino, 51,2% eram pardos, 54,0% mestres, 49,0% casados, 38,4% pertencem à categoria profissional professor (a), 54,0% dos participantes disseram não haver treinamento inicial, 51% disseram haver formação continuada, 79,5% relataram atuar em comitês de ética em pesquisa na instituição na qual trabalham. Conclusão: os membros dos comitês de ética de uma capital no nordeste brasileiro possuem caraterísticas necessárias para atuarem nesses colegiados, mas há necessidade de redimensionamento em alguns aspectos para que de fato possa haver proteção e garantia aos direitos e interesses dos participantes da pesquisa. (AU)


Objective: To characterize members of research ethics committees located in institutions of higher education and in hospitals in a capital of Northeastern Brazil. Methods: A descriptive study, using an online questionnaire, applied on the Google Forms platform, with 39 effective members who worked on research ethics committees in higher education institutions and hospitals as participants. Results: Of the participants who responded, 59.0% were female, 51.2% were brown, 54.0% masters, 49.0% married, 38.4% belong to the professional category teacher (a), 54, 0% of participants said there was no initial training, 51% said there was continuing training, 79.5% reported working on research ethics committees at the institution where they work. Conclusion: The members of the ethics committees of a capital city in northeastern Brazil have the necessary characteristics to act in these collegiate bodies, but there is a need to resize in some aspects so that in fact there can be protection and guarantee to the rights and interests of the research participants. (AU)


Objetivo: Caracterizar a los miembros de los comités de ética en investigación ubicados en instituciones de educación superior y en hospitales de una capital del noreste de Brasil. Métodos: Estudio descriptivo, mediante cuestionario online, aplicado en la plataforma Google Forms, con 39 miembros efectivos que trabajaron en comités de ética en investigación en instituciones de educación superior y hospitales como participantes. Resultados: De los participantes que respondieron, 59,0% eran mujeres, 51,2% morenos, 54,0% maestros, 49,0% casados, 38,4% pertenecen a la categoría profesional docente (a), 54,0% de los participantes dijeron que no había formación inicial, El 51% dijo que había formación continua, el 79,5% informó que trabaja en comités de ética en investigación en la institución donde trabaja. Conclusión: Los miembros de los comités de ética de una ciudad capital en el noreste de Brasil tienen las características necesarias para actuar en estos órganos colegiados, pero es necesario redimensionar en algunos aspectos para que de hecho pueda haber protección y garantía a los derechos y intereses de los participantes en la investigación. (AU)


Assuntos
Membro de Comitê , Instituições Acadêmicas , Bioética , Comitês de Ética em Pesquisa , Ética em Pesquisa
4.
BMC Med Ethics ; 22(1): 147, 2021 11 06.
Artigo em Inglês | MEDLINE | ID: mdl-34742278

RESUMO

BACKGROUND: Research has been an essential part of the COVID-19 pandemic response, including in Latin American (LA) countries. However, implementing research in emergency settings poses the challenge of producing valuable knowledge rapidly while upholding research ethical standards. Research ethics committees (RECs) therefore must conduct timely and rigorous ethics reviews and oversight of COVID-19 research. In the LA region, there is limited knowledge on how countries have responded to this need. To address this gap, the objective of our project is to explore if LA countries developed policies to streamline ethics review and oversight of research in response to the pandemic while ensuring its adherence to ethical standards, and to analyze to what extent these governance frameworks are in accordance with international guidance. METHODS: We conducted a descriptive and exploratory study assessing the COVID-19 research ethics governance frameworks of 19 LA countries, considering 4 dimensions based on international COVID-19 ethics guidance documents: (i) ethics review organizational model adopted, (ii) measures to coordinate between RECs and other research stakeholders, (iii) operational guidance for RECs, and (iv) key ethical issues for review and oversight of COVID-19 research. RESULTS: 10 out of 19 LA countries have some policy to streamline ethics review of COVID-19 research. Of these countries only 6 issued comprehensive documents following international guidance that contemplate strategies with recommendations for concrete actions for a timely and rigorous review. CONCLUSION: LA countries adopted partial strategies and operational guidance that may demonstrate a lack of a comprehensive view of research ethics for the review and oversight of COVID-19 research. Continuing efforts should be directed to strengthen LA countries' research capacity to respond timely and ethically to future health emergencies. Past lessons and the ones from this pandemic should be the basis to develop international standards and operational guidelines for ethics review and oversight of any research for public health emergencies.


Assuntos
COVID-19 , Comitês de Ética em Pesquisa , Ética em Pesquisa , Humanos , América Latina , Pandemias , SARS-CoV-2
5.
Ethics Hum Res ; 43(6): 42-48, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34751515

RESUMO

In the context of emergency research, researchers can ask the institutional review board (IRB) to waive the regulatory requirement that individuals provide informed consent when enrolling in research studies. A requirement of the waiver of informed consent is that the reviewing IRB must review and approve a community consultation and public disclosure plan. It is critical that an IRB serving as the single IRB (sIRB) for multisite research be thoroughly versed in the local context concerns for each participating site to determine whether the site's community is being adequately consulted about the research in which individuals will be enrolled under an exception to the informed consent requirement. We designed an sIRB review model for evaluating site-specific community consultation plans that included a local evaluation and feedback step, and we piloted the model with a four-site, pediatric exception from informed consent (EFIC) clinical trial. We identified three key roles for the model: the sIRB, the investigators, and the representative of the institution's human research protection program (HRPP). We successfully collected the information and local input needed to evaluate each site's community consultation plan and applied the information to a thorough IRB review, despite the geographic distance between the study site and the sIRB.


Assuntos
Comitês de Ética em Pesquisa , Consentimento Livre e Esclarecido , Criança , Revelação , Emergências , Humanos , Encaminhamento e Consulta
6.
Trials ; 22(1): 844, 2021 Nov 25.
Artigo em Inglês | MEDLINE | ID: mdl-34823582

RESUMO

BACKGROUND: Poor participant recruitment is the most frequent reason for premature discontinuation of randomized clinical trials (RCTs), particularly if they are investigator-initiated. The aims of this qualitative study were to investigate (1) the views of clinical trial stakeholders from three different countries regarding reasons for recruitment failure in RCTs and (2) how these compare and contrast with the causes identified in a previous systematic review of RCT publications. METHODS: From August 2015 to November 2016, we conducted 49 semi-structured interviews with a purposive sample of clinical trial stakeholders. This included investigators based in Germany (n = 9), Switzerland (n = 6) and Canada (n = 1) with personal experience of a discontinued RCT and 33 other stakeholders (e.g., representatives of ethics committees, clinical trial units, pharmaceutical industry) in Switzerland. Individual semi-structured qualitative interviews were conducted and analyzed using thematic analysis. RESULTS: Interviewees identified a total of 29 different reasons for recruitment failure. Overoptimistic recruitment estimates, too narrow eligibility criteria, lack of engagement of recruiters/trial team, lack of competence/training/experience of recruiters, insufficient initial funding, and high burden for trial participants were mentioned most frequently. The interview findings largely confirm the previous systematic review on published reasons for recruitment failure. However, eight new reasons for recruitment failure were identified in the interviews, which led to the checklist of reasons for recruitment failure being revised and a new category describing research environment-related factors being added. CONCLUSIONS: This study highlights the diversity of often interlinked reasons for recruitment failure in RCTs. Integrating the findings of this interview study with a previous systematic review of RCT publications led to a comprehensive, structured checklist of empirically-informed reasons for recruitment failure. The checklist may be useful to guide further research on interventions to improve participant recruitment in RCTs and helpful for trial investigators, research ethics committees, and funding agencies when assessing trial feasibility with respect to recruitment.


Assuntos
Comitês de Ética em Pesquisa , Alemanha , Humanos , Seleção de Pacientes , Pesquisa Qualitativa , Suíça
8.
J Int AIDS Soc ; 24 Suppl 7: e25796, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34806302

RESUMO

INTRODUCTION: A major change in the ethics framework for preventive HIV vaccine trials worldwide is the release of the UNAIDS 2021 ethical considerations in HIV prevention trials. This new guidance comes at an exciting time when there are multiple HIV vaccine efficacy trials in the field. Research Ethics Committees (RECs) or Institutional Review Boards are a most likely audience for these guidelines. Our objective is to highlight shifts in ethics recommendations from the earlier 2012 UNAIDS guidance. DISCUSSION: We review recommendations related to four key issues, namely standard of prevention, post-trial access to safe and effective vaccines, enrolment of adolescents and enrolment of pregnant women. We outline implications and make recommendations for the ethics review process, including suggested lines of inquiry by RECs and responses by applicants. CONCLUSIONS: There have been several shifts in the UNAIDS ethics guidance with implications for HIV vaccine researchers submitting applications for initial ethics review or re-certification, and for RECs conducting such reviews. This review may assist RECs in a more efficient and consistent application of ethics recommendations. However, additional tools and training may further help stakeholders comply with new UNAIDS ethics recommendations during protocol development and ethics review.


Assuntos
Vacinas contra a AIDS , Infecções por HIV , Adolescente , Comitês de Ética em Pesquisa , Feminino , Infecções por HIV/prevenção & controle , Humanos , Gravidez , Projetos de Pesquisa , Pesquisadores
9.
Ethics Hum Res ; 43(6): 2-18, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34676693

RESUMO

Institutional review boards (IRBs) have been criticized for inconsistency and lack of transparency in decision-making, problems that undermine both trust in their ability to protect human research participants and respect for their decisions among researchers. The absence of robust documentation of their decisions and the inability or unwillingness to share those decisions together represent a missed opportunity for IRBs to learn from one another and advance debates about challenging ethical issues. The concept of IRB precedent, modeled upon the system of legal precedent, has been proposed as a potential solution to these problems. In theory, an IRB faced with a review decision could look back at previous IRB decisions, either its own or those of other boards, made in similar studies or circumstances to guide the present decision. Some IRBs attempt this informally within their institution, but few examples of a structured system of IRB precedent have been described in the literature, and none has been widely adopted. This article describes a pilot project to summarize IRB decisions in a way that could facilitate their use as precedent by creating a documentation tool that meets four criteria-comprehensiveness, validity, searchability, and efficiency. Though this process turned out to be more challenging than expected, we identified key features of such a tool that holds promise for future development and could promote more consistent, robust IRB decision-making and advance discourse in human research ethics.


Assuntos
Comitês de Ética em Pesquisa , Ética em Pesquisa , Humanos , Projetos Piloto , Pesquisadores
10.
Indian J Med Ethics ; VI(4): 321-326, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34666971

RESUMO

This article pertains to the governance of biomedical and health research after the publication of the New Drugs and Clinical Trial Rules, 2019. The new regulations cover all types of research. However, those concerning biomedical and health research may fall short on certain counts regarding: reviewing studies with vulnerable populations, undertaking risk benefit analysis, finding relatedness in case of serious adverse events, and providing compensation. The challenges faced by ethics committees from the inception of a study to its completion are discussed. There is a need for rigorous training of all members involved in the ethics committee's functioning.


Assuntos
Pesquisa Biomédica , Preparações Farmacêuticas , Comitês de Ética em Pesquisa , Humanos
11.
BMC Med Ethics ; 22(1): 132, 2021 09 26.
Artigo em Inglês | MEDLINE | ID: mdl-34565355

RESUMO

BACKGROUND: Over the past two decades, Uganda has experienced a significant increase in clinical research driven by both academia and industry. This has been combined with a broader spectrum of research proposals, with respect to methodologies and types of intervention that need evaluation by Research Ethics Committees (RECs) with associated increased requirement for expertise. We assessed the competencies of REC members regarding review of research protocols with complex and emerging research study designs. The aim was to guide development of a training curriculum to improve the quality of scientific and ethical review. METHODS: This was a cross-sectional study design, with quantitative data collection methods. Research Ethics Committee members completed a structured pre-coded questionnaire on current competence with complex and emerging study design. REC members were asked to outline a list of additional topics for which they needed training. Data from coded questions were entered into Epidata Version 3.1 and then exported to STATA Version14.1 for analysis. Descriptive analysis was performed and findings are presented using percentages and frequencies. RESULTS: We enrolled 55 REC members from 6 RECs who have a total of 97 members. The majority of whom were males (56.4%, n = 31/55). The level of competence for review of selected study design was lowest for Controlled Human Infection Model (10.9%, n = 6) and reverse pharmacology design (10.9%, n = 6), and highest for cluster randomized study design (52.7%, n = 29) and implementation science research (52.7%, n = 29). CONCLUSION: Competence for review of research protocols with complex and emerging study design was low among participating REC members. We recommend prioritising training of REC members on complex and emerging study designs to enhance quality of research protocol review.


Assuntos
Comitês de Ética em Pesquisa , Projetos de Pesquisa , Estudos Transversais , Revisão Ética , Humanos , Masculino , Uganda
13.
Sci Eng Ethics ; 27(5): 62, 2021 09 21.
Artigo em Inglês | MEDLINE | ID: mdl-34546464

RESUMO

In November of 2019, the University of California Santa Cruz hosted a 3-day interdisciplinary conference to commemorate the 200th anniversary of the publication of Frankenstein, by Mary Shelley. A panel of senior researchers convened to discuss the impact of the novel on modern discussions of scientific ethics. The panel featured Nandini Bhattacharya, George Blumenthal, Michael M. Chemers, David Haussler, and Jenny Reardon. In the process, the panelists acted as the Institutional Review Board for a proposal from Victor Frankenstein himself.


Assuntos
Comitês de Ética em Pesquisa , Pesquisadores , Humanos , Estudos Interdisciplinares
14.
Ethics Hum Res ; 43(5): 2-17, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34496158

RESUMO

Pregnant individuals are often excluded from research without clear justification, even when the research poses minimal risk of harm to the fetus. Little is known about institutional review board (IRB) decision-making practices when reviewing such research. We conducted a survey of current and former IRB personnel in the United States to elicit their interpretations of "minimal risk"-a formal regulatory category-and to identify factors that may influence IRB decisions to approve or disapprove research involving pregnant participants. Study results revealed some consensus among IRB members about the risk level of individual research procedures and hypothetical study vignettes. However, we uncovered important variations not only in the assessment of risk but also in the willingness of IRB members to approve minimal risk research that includes pregnant women. Based on our findings, guidance is needed to assist IRB members in characterizing risk, applying federal regulations, and appropriately ensuring the inclusion or justified exclusion of pregnant people in research.


Assuntos
Comitês de Ética em Pesquisa , Projetos de Pesquisa , Consenso , Feminino , Humanos , Gravidez , Risco , Estados Unidos
15.
Ethics Hum Res ; 43(5): 36-41, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34496159

RESUMO

At electronic dance music events in Belgium in 2013 to 2015, seemingly intoxicated patients were included without their informed consent in an observational toxicology study when the attending physicians determined that they needed treatment with an intravenous line. All included patients received an information letter inviting them to contact the principal investigator (PI) to obtain more information about the study and/or to inform the PI that they wanted to be excluded from it. Overall, 238 patients were included in the study. Nine participants (4%) responded to the information letter, either on their own or through their parent; none of them asked to be excluded from the study. All respondents expressed their gratitude for the information they received. The opt-out study design seemed to be acceptable to the patient-participants, and it provided a fuller picture of the drug-related medical incidents at such music events than what could likely be achieved through a study that includes only people who explicitly choose to participate. These findings may help institutional review boards when evaluating study designs involving recreational drug use, especially at electronic dance music events. Nevertheless, we warn against extrapolation to other settings where informed consent is difficult to obtain.


Assuntos
Dança , Música , Transtornos Relacionados ao Uso de Substâncias , Comitês de Ética em Pesquisa , Humanos , Consentimento Livre e Esclarecido
16.
Ethics Hum Res ; 43(5): 42-44, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34496160

RESUMO

With the rapid spread of SARS-CoV2 has come a rapid proliferation of clinical research studies, resulting in considerable strain on research ethics committees (RECS), which need to review study proposals. RECs are pressured to move through the review process quickly so that studies can get underway to address the pandemic. These committees are also asked to increase efficiency without relaxing the standards for ethical review. RECs are accustomed to external pressure for approval from investigators; however, in the Covid-19 era, this pressure is coming from not only the sponsors and investigators but also many other stakeholders, including world leaders, the community, the media, and professional organizations. Drawing on the authors' experiences on a central REC reviewing complex multicenter Covid-19 studies, this commentary describes challenges that are inherent to Covid-19 research studies, such as the difficulty of obtaining informed consent from patients ill with the highly infectious virus. The commentary recommends several steps that RECs can take to ensure ethical review of research studies during the Covid-19 pandemic and future infectious disease outbreaks.


Assuntos
COVID-19 , Comitês de Ética em Pesquisa/normas , Ética em Pesquisa , Pesquisa Biomédica/ética , Pesquisa Biomédica/normas , Humanos , Consentimento Livre e Esclarecido
17.
BMJ Open ; 11(9): e054213, 2021 09 27.
Artigo em Inglês | MEDLINE | ID: mdl-34580104

RESUMO

In a cluster randomised trial (CRT), intact groups-such as communities, clinics or schools-are randomised to the study intervention or control conditions. The issue of informed consent in CRTs has been particularly challenging for researchers and research ethics committees. Some argue that cluster randomisation is a reason not to seek informed consent from research participants. In fact, systematic reviews have found that, relative to individually randomised trials, CRTs are associated with an increased likelihood of inadequate reporting of consent procedures and inappropriate use of waivers of consent. The objective of this paper is to clarify this confusion by providing a practical and useful framework to guide researchers and research ethics committees through consent issues in CRTs. In CRTs, it is the unit of intervention-not the unit of randomisation-that drives informed consent issues. We explicate a three-step framework for thinking through informed consent in CRTs: (1) identify research participants, (2) identify the study element(s) to which research participants are exposed, and (3) determine if a waiver of consent is appropriate for each study element. We then apply our framework to examples of CRTs of cluster-level, professional-level and individual-level interventions, and provide key lessons on informed consent for each type of CRT.


Assuntos
Ética em Pesquisa , Projetos de Pesquisa , Comitês de Ética em Pesquisa , Humanos , Consentimento Livre e Esclarecido , Ensaios Clínicos Controlados Aleatórios como Assunto , Pesquisadores
18.
BMC Med Ethics ; 22(1): 133, 2021 09 28.
Artigo em Inglês | MEDLINE | ID: mdl-34583718

RESUMO

BACKGROUND: Using an effective method for evaluating Institutional Review Board (IRB) performance is essential for ensuring an IRB's effectiveness, efficiency, and compliance with applicable human research standards and organizational policies. Currently, no empirical research has yet been published in China evaluating IRB performance measures by the use of a standardized tool. This study was therefore conducted to develop a Chinese version of the IRB Researcher Assessment Tool (IRB-RAT), assess the psychometric properties of the Chinese version (IRB-RAT-CV), and validate the tool for use in China. METHODS: In this cultural adaptation, cross-sectional validation study, the IRB-RAT-CV was developed through a back-translation process and then distributed to 587 IRB staff members and researchers in medical institutions and schools in Hunan Province that review biomedical and social-behavioral research. Data from the 470 valid questionnaires collected from participants was used to evaluate the reliability, content validity, and construct validity of the IRB-RAT-CV. RESULTS: Participants' ratings of their ideal and actual IRB as measured by the IRB-RAT-CV achieved Cronbach's alpha 0.989 and 0.992, Spearman-Brown coefficient 0.964 and 0.968, and item-total correlation values ranging from 0.631 to 0.886 and 0.743 to 0.910, respectively. CONCLUSION: The IRB-RAT-CV is a linguistically and culturally applicable tool for assessing the quality of IRBs in China.


Assuntos
Comparação Transcultural , Comitês de Ética em Pesquisa , China , Estudos Transversais , Psicometria , Reprodutibilidade dos Testes , Inquéritos e Questionários
19.
AORN J ; 114(4): 309-318, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34586652

RESUMO

Perioperative nurses are responsible for generating and using evidence to improve patient care. To protect human participants during research activities, government regulations enacted after widely publicized research misconduct specify that institutions receiving federal funds must have an institutional review board (IRB) comprising at least five members. Board members have many responsibilities, including completing a thorough review of each section of the application and attachments (eg, consent documents). To expedite the IRB approval processes, applicants should create and submit a well-written application. Applicants should understand that the application addresses the important ethical concepts of respect for persons, beneficence, and justice. Quality improvement activities (ie, local activities that seek to improve patient care or clinical outcomes) differ from research activities that focus on creating new knowledge. Depending on the purpose, design, and generalizability of a quality improvement project, the applicant may need to submit the project to the IRB for approval.


Assuntos
Comitês de Ética em Pesquisa , Consentimento Livre e Esclarecido , Termos de Consentimento , Humanos
20.
Washington, D.C.; PAHO; 2021-09-22. (PAHO/HSS/BIO/21-0009).
em Inglês | PAHO-IRIS | ID: phr-54869

RESUMO

In 2018, the Member States of the Pan American Health Organization (PAHO) evaluated their progress on integrating ethics in distinct areas of health, and deemed it essential that a systemic approach be promoted so that research is always conducted ethically. To strengthen research ethics systemically, PAHO has developed research ethics indicators that address the core components of a national research ethics system. The indicators allow to identify advances on each component, evaluate progress toward strengthening systems, and develop a plan of action for each country based on the indicators not yet reached. This indicator-based strategy could be useful beyond the Region and be a model for other countries and regions to strengthen their national research ethics systems and catalyze research ethics.


Assuntos
Ética , Bioética , Ética em Pesquisa , Comitês de Ética em Pesquisa , Pesquisa , Sistemas de Saúde , Sistemas Nacionais de Saúde
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