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1.
Curr Protoc ; 2(1): e354, 2022 Jan.
Article in English | MEDLINE | ID: mdl-35041252

ABSTRACT

The article provides an overview of select methodologies that are commonly used in ELSI ("ethical, legal, and social implications") research. ELSI is a field that focuses on the analysis of the societal implications of cutting-edge biomedical research and technologies. The article aims to provide an accessible reference on well-established research methods that aspiring and seasoned ELSI researchers can rely on as a starting point for exploring how to design and conduct ELSI studies. © 2022 Wiley Periodicals LLC.


Subject(s)
Biomedical Research , Ethics, Research , Humans , Research Personnel
2.
EMBO Rep ; 23(1): e54184, 2022 01 05.
Article in English | MEDLINE | ID: mdl-34897954

ABSTRACT

Human challenge trials to deliberately infect volunteers with SARS-CoV-2 should inspire wider debates about research ethics and participants' motivations to take part in such studies.


Subject(s)
COVID-19 , Pandemics , Ethics, Research , Humans , Pandemics/prevention & control , SARS-CoV-2
4.
J Korean Med Sci ; 36(50): e338, 2021 Dec 27.
Article in English | MEDLINE | ID: mdl-34962112

ABSTRACT

Generating a testable working hypothesis is the first step towards conducting original research. Such research may prove or disprove the proposed hypothesis. Case reports, case series, online surveys and other observational studies, clinical trials, and narrative reviews help to generate hypotheses. Observational and interventional studies help to test hypotheses. A good hypothesis is usually based on previous evidence-based reports. Hypotheses without evidence-based justification and a priori ideas are not received favourably by the scientific community. Original research to test a hypothesis should be carefully planned to ensure appropriate methodology and adequate statistical power. While hypotheses can challenge conventional thinking and may be controversial, they should not be destructive. A hypothesis should be tested by ethically sound experiments with meaningful ethical and clinical implications. The coronavirus disease 2019 pandemic has brought into sharp focus numerous hypotheses, some of which were proven (e.g. effectiveness of corticosteroids in those with hypoxia) while others were disproven (e.g. ineffectiveness of hydroxychloroquine and ivermectin).


Subject(s)
COVID-19/drug therapy , Research Design , SARS-CoV-2 , COVID-19/epidemiology , Ethics, Research , Humans , Peer Review , Pilot Projects , Publishing
5.
BMC Med Ethics ; 22(1): 165, 2021 12 15.
Article in English | MEDLINE | ID: mdl-34911524

ABSTRACT

BACKGROUND: Community engagement is a key component in health research. One of the ways health researchers ensure community engagement is through Community Advisory Boards (CABs). The capacity of CABs to properly perform their role in clinical research has not been well described in many resource limited settings. In this study, we assessed the capacity of CABs for effective community engagement in Uganda. METHODS: We conducted a cross sectional study with mixed methods. We used structured questionnaires and key informant interviews (KII) to collect data from CAB members, trial investigators, and community liaison officers. For quantitative data, we used descriptive statistics while for qualitative data we used content analysis. RESULTS: Seventy three CAB members were interviewed using structured questionnaires; 58.9% males, median age 49 years (IQR 24-70), 71.2% had attained tertiary education, 42.5% never attended any research ethics training, only 26% had a training in human subject protection, 30.1% had training in health research, 50.7% never attended any training about the role of CABs, and 72.6% had no guidelines for their operation. On the qualitative aspect, 24 KIIs cited CAB members to have some skills and ability to understand and review study documents, offer guidance on community norms and expectations and give valuable feedback to the investigators. However, challenges like limited resources, lack of independence and guidelines, and knowledge gaps about research ethics were cited as hindrances of CABs capacity. CONCLUSION: Though CABs have some capacity to perform their role in the Ugandan setting, their functionality is limited by lack of resources to facilitate their work, lack of independence, lack of guidelines for their operations and limited knowledge regarding issues of research ethics and protection of the rights of trial participants.


Subject(s)
Advisory Committees , Ethics, Research , Cross-Sectional Studies , Female , Humans , Knowledge , Male , Middle Aged , Research Personnel
6.
J Law Med Ethics ; 49(2): 269-281, 2021.
Article in English | MEDLINE | ID: mdl-34924060

ABSTRACT

Neuroimaging research regularly yields "incidental findings": observations of potential clinical significance in healthy volunteers or patients, but which are unrelated to the purpose or variables of the study.


Subject(s)
Incidental Findings , Neuroimaging , Brain/diagnostic imaging , Ethics, Research , Humans , Moral Obligations
7.
Enferm. foco (Brasília) ; 12(4): 794-800, dez. 2021. tab
Article in Portuguese | LILACS, BDENF - Nursing | ID: biblio-1353377

ABSTRACT

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)


Subject(s)
Committee Membership , Schools , Bioethics , Ethics Committees, Research , Ethics, Research
8.
BMC Med Ethics ; 22(1): 147, 2021 11 06.
Article in English | MEDLINE | ID: mdl-34742278

ABSTRACT

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.


Subject(s)
COVID-19 , Ethics Committees, Research , Ethics, Research , Humans , Latin America , Pandemics , SARS-CoV-2
9.
Ethics Hum Res ; 43(6): 2-18, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34676693

ABSTRACT

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.


Subject(s)
Ethics Committees, Research , Ethics, Research , Humans , Pilot Projects , Research Personnel
11.
Rinsho Ketsueki ; 62(8): 1343-1348, 2021.
Article in Japanese | MEDLINE | ID: mdl-34497225

ABSTRACT

Medical ethics are important for medical professionals and can be classified into two subcategories, which are: "Research Ethics," referring to the norms that researchers should follow when engaging in research activities, and "Clinical Ethics," which are mainly norms that should be followed in routine clinical practice. Rules are the basic component of ethics and are an agreement that is enacted after the fact. On the other hand, the development of new medical care strategies requires novelty and originality. Research includes unknown and unpracticed topics; therefore, new problems arise, which are often not possible to deal with by simply following the established rules. Medical professionals need to be ethical so that they can anticipate new problems and make decisions without the rules. This can be done by understanding the background against which the rules have been formed and its preamble.


Subject(s)
Ethics, Medical , Ethics, Research , Humans
12.
Nature ; 597(7875): 153, 2021 09.
Article in English | MEDLINE | ID: mdl-34493844
13.
Am J Bioeth ; 21(10): 1-4, 2021 10.
Article in English | MEDLINE | ID: mdl-34554060
15.
Am J Bioeth ; 21(10): 20-21, 2021 10.
Article in English | MEDLINE | ID: mdl-34554063
16.
Ethics Hum Res ; 43(5): 18-25, 2021 Sep.
Article in English | MEDLINE | ID: mdl-34496156

ABSTRACT

This article provides pragmatic advice for organizations interested in creating a research ethics consultation service (RECS). A robust RECS has the potential to build capacity among investigators to identify and consider the ethical issues they encounter while conducting their research. Determining whether to establish an RECS should begin with an institutional-needs assessment that includes three key questions: What are the current resources available to research teams to navigate ethical concerns that arise from their research? Is there a demand or perceived need for more resources? Is there institutional support (financial and otherwise) to establish and maintain an RECS? If this results in the decision to establish the consultation service, relevant institutional stakeholders must be identified and consulted, and personnel with the requisite skills recruited. The next step is to establish an RECS and build the infrastructure to process and respond to requests. The RECS's long-term sustainability will depend on a stable source of funding and a mechanism to receive constructive feedback to ensure that the service is meeting the institutional needs it set out to address.


Subject(s)
Ethics Consultation , Ethics, Research , Humans
17.
Ethics Hum Res ; 43(5): 42-44, 2021 Sep.
Article in English | MEDLINE | ID: mdl-34496160

ABSTRACT

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.


Subject(s)
COVID-19 , Ethics Committees, Research/standards , Ethics, Research , Biomedical Research/ethics , Biomedical Research/standards , Humans , Informed Consent
20.
BMC Med Ethics ; 22(1): 117, 2021 09 04.
Article in English | MEDLINE | ID: mdl-34481506

ABSTRACT

BACKGROUND: Engagement of people with lived experience and members of the public is an ethically and scientifically essential component of health research. Authentic engagement means they are involved as full partners in research projects. Yet engagement as partnership is uncommon in practice, especially during priority-setting for research projects. What is needed for agenda-setting to be shared by researchers and people with lived experience and/or members of the public (or organisations representing them)? At present, little ethical guidance exists on this matter, particularly that which has been informed by the perspectives of people with lived experience and members of the public. This article provides initial evidence about what they think are essential foundations and barriers to shared decision-making in health research priority-setting and health research more broadly. METHODS: An exploratory, qualitative study was conducted in 2019. 22 semi-structured interviews were performed with key informants from the UK and Australia. RESULTS: Three main types of foundations were thought to be essential to have in place before shared decision-making can occur in health research priority-setting: relational, environmental, and personal. Collectively, the three types of foundations addressed many (but not all) of the barriers to power sharing identified by interviewees. CONCLUSIONS: Based on study findings, suggestions are made for what researchers, engagement practitioners, research institutions, and funders should do in their policy and practice to support meaningful engagement. Finally, key international research ethics guidelines on community engagement are considered in light of study findings.


Subject(s)
Health Priorities , Research Personnel , Australia , Ethics, Research , Humans , Qualitative Research
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