ABSTRACT
Memoria de las ponencias del 1er Congreso de Ética en Investigación, realizado en la Ciudad de Buenos Aires en septiembre de 2022, y organizado por el Comité Central de Ética en Investigación del Ministerio de Salud de esta ciudad. Los dos ejes del Congreso fueron: Desafíos éticos en la investigación durante la pandemia y post-pandemia; y Aporte de las nuevas tecnologías para los procesos de investigación. Se presentan las ponencias del congreso, organizadas en los capítulos: El trabajo de los Comités de Ética en Investigación durante la pandemia; El rol de las comunidades en la investigación; Aporte de las nuevas tecnologías para los procesos de investigación; y Desafíos modernos para la investigación en salud.
Subject(s)
Bioethics , Ethics Committees, Research/trends , Ethics Committees, Research/ethics , Ethics, Research , Ethics , Public Health Systems Research/ethics , COVID-19 , Right to HealthABSTRACT
Presentación de "Estudio Exploratorio de los Marcos de Gobernanza para la Revisión y Supervisión Ética de la Investigación de COVID-19 en América Latina", trabajo descriptivo para identificar si los países de América Latina adoptaron políticas para acelerar la evaluación ética de las investigaciones, a la vez de que aseguraban los estándares éticos para su realización, durante la pandemia.
Subject(s)
Ethics Committees, Research/trends , Ethics Committees, Research/ethics , Ethics, Research , COVID-19/prevention & control , Practice Guideline , Latin AmericaABSTRACT
This Viewpoint discusses the benefits of expanded access research, the usefulness of expanded access data, the issues surrounding cost and transparency, and the adjusted role of institutional review boards.
Subject(s)
Biomedical Research , Compassionate Use Trials , Ethics Committees, Research , Ethics, Research , Ethics Committees, Research/ethics , Compassionate Use Trials/ethics , Biomedical Research/ethicsABSTRACT
Ethics in social science experimentation and data collection are often discussed but rarely articulated in writing as part of research outputs. Although papers typically reference human subjects research approvals from relevant institutional review boards, most recognize that such boards do not carry out comprehensive ethical assessments. We propose a structured ethics appendix to provide details on the following: policy equipoise, role of the researcher, potential harms to participants and nonparticipants, conflicts of interest, intellectual freedom, feedback to participants, and foreseeable misuse of research results. We discuss each of these and some of the norms and challenging situations of each. We believe that discussing such issues explicitly in appendices of papers, even if briefly, will serve two purposes: more complete communication of ethics can improve discussions of papers and can clarify and improve the norms themselves.
Subject(s)
Publications/ethics , Social Sciences/ethics , Ethics Committees, Research/ethics , Ethics, Research , Humans , Randomized Controlled Trials as Topic/ethics , Research Personnel/ethicsABSTRACT
BACKGROUND: During the beginning of the COVID-19 pandemic there was an urgent need for accelerated review of COVID-19 research by Medical Research Ethics Committees (MRECs). In the Netherlands this led to the implementation of so-called 'fast-track-review-procedures' (FTRPs) to enable a swift start of urgent and relevant research. The objective of this study is to evaluate FTRPs of MRECs in the Netherlands during the COVID-19 pandemic and to compare them with the regular review procedures (RRPs). METHODS AND FINDINGS: An explanatory sequential mixed method study was conducted. Online questionnaires and four group interviews were conducted among MREC representatives and investigators of COVID-19 research. In addition, data from a national research registration system was requested. Main outcome measures are differences in timelines, quality of the review and satisfaction between FTRPs and RRPs. The total number of review days was shorter in FTRP (median 10.5) compared to RRPs (median 98.0). Review days attributable to the MRECs also declined in FTRPs (median 8.0 versus 50.0). This shortening can be explained by installing ad hoc (sub)committees, full priority given to COVID-19 research, regular research put on hold, online review meetings and administrative leniency. The shorter timelines did not affect the perceived quality of the review and ethical and legal aspects were not weighted differently. Both MREC representatives and investigators were generally satisfied with the review of COVID-19 research. Weaknesses identified were the lack of overview of COVID-19 research and central collaboration and coordination, the delay of review of regular research, and limited reachability of secretariats. CONCLUSIONS: This study shows that accelerated review is feasible during emergency situations. We did not find evidence that review quality was compromised and both investigators and MRECs were content with the FTRP. To improve future medical ethical review during pandemic situations and beyond, distinguishing main and side issues, working digitally, and (inter)national collaboration and coordination are important.
Subject(s)
COVID-19/epidemiology , Ethical Review , Ethics Committees, Research/ethics , Pandemics , Research Personnel/ethics , SARS-CoV-2 , Humans , Netherlands/epidemiologyABSTRACT
BACKGROUND: Biomedical research is overseen by numerous Institutional Review Boards (IRBs) in Singapore but there has been no research that examines how the research review process is perceived by the local research community nor is there any systematic data on perceptions regarding the review process or other research ethics processes and IRB characteristics. The aim of this study was to ascertain general views regarding the overall perceived value of ethics review processes; to measure perceptions about local IRB functions and characteristics; to identify IRB functions and characteristics viewed as important; and to compare these views with those of other international studies. METHODS: An online survey was used with the main component being the IRB-Researcher Assessment Tool (IRB-RAT), a validated tool, to evaluate perceptions of ideal and actual IRB functions and characteristics held by Singaporean researchers and research support staff. Data were analysed descriptively first, with mean and SD of each item of IRB-RAT questionnaire reported, excluding the respondents whose answers were unknown or not applicable. The Wilcoxon Sign Rank test was used to compare the ideal and actual ratings of each IRB-RAT item, while the Mann-Whitney U test was used to compare the ratings of each IRB-RAT item between respondents with different characteristics. The Z-test was used to compare the mean ratings of our cohort with the mean ratings reported in the literature. The correlation between our mean ideal scores and those of two international studies also employing the IRB-RAT was examined. RESULTS: Seventy-one respondents completed the survey. This cohort generally held positive views of the impact of the ethics review process on: the quality of research; establishing and maintaining public trust in research; the protection of research participants; and on the scientific validity of research. The most important ideal IRB characteristics were timeliness, upholding participants' rights while also facilitating research, working with investigators to find solutions when there are disagreements, and not allowing biases to affect reviews. For almost all 45 IRB-RAT statements, the rating of the importance of the characteristic was higher than the rating of how much that characteristic was descriptive of IRBs the respondents were familiar with. There was a significant strong correlation between our study's scores on the ideal IRB characteristics and those of the first and largest published study that employed the IRB-RAT, the US National Validation (USNV) sample in Keith-Spiegel et al. [19]. CONCLUSIONS: An understanding of the perceptions held by Singaporean researchers and research support staff on the value that the ethics review process adds, their perceptions of actual IRB functions and characteristics as well as what they view as central to high functioning IRBs is the first step to considering the aspects of the review process that might benefit from improvements. This study provides insight into how our cohort compares to others internationally and highlights strengths and areas for improvement of Singapore IRBs as perceived by a small sample of the local research community. Such insights provide a springboard for additional research and may assist in further enhancing good relations so that both are working towards the same end.
Subject(s)
Biomedical Research/ethics , Ethics Committees, Research/ethics , Research Personnel/psychology , Social Perception/psychology , Adult , Ethics, Research , Female , Humans , Male , Middle Aged , Singapore , Surveys and QuestionnairesABSTRACT
O encontro virtual do Comitê do CNS de acompanhamento da Covid-19 será transmitido ao vivo na quarta-feira (22/7), às 17h, pelo Facebook e Youtube. A falta de medidas efetivas de proteção à saúde e planos de apoio às pessoas com doenças crônicas e outras patologias, durante a pandemia da Covid-19, serão temas da próxima live do Conselho Nacional de Saúde (CNS) na quarta-feira (22/7), às 17h, com transmissão pelo Facebook e Youtube. Desde o início da pandemia o CNS tem manifestado preocupação com a ausência de medidas protetivas para esta população. A infecção por Covid-19 em pessoas com doenças crônicas e patologias pode representar em torno de 25% a 50%, sendo que estes pacientes apresentam maiores taxas de mortalidade devido à dificuldade de recuperação dos sintomas graves. Para debater o assunto, participarão da live do CNS o diretor do Departamento de Doenças de Condições Crônicas e Infecções Sexualmente Transmissíveis (DCCI/SVS) do Ministério da Saúde, Gerson Pereira, a secretária de Articulação Política da Articulação Nacional de Luta contra a Aids (Anaids), Carla Almeida e a coordenadora da BioRede Brasil (Biored), Priscila Torres. O programa será mediado pelo conselheiro nacional de saúde Artur Custódio, que representa o Movimento de Reintegração das Pessoas Atingidas pela Hanseníase (Morhan) no CNS. O programa também terá representações dos segmentos de gestores, usuários e trabalhadores do SUS, com as participações de Maíra Botelho, diretora do Departamento de Atenção Especializada e Temática, da Secretaria de Atenção Especializada à Saúde do Ministério da Saúde, Eduardo Fróes, conselheiro nacional de saúde pela Associação Brasileira de Linfoma e Leucemia (Abrale) e Laís Souza, representante da Associação Brasileira de Ensino em Fisioterapia (Abenfisio) no CNS, respectivamente. Em abril, o Conselho solicitou ao Ministério da Saúde a apresentação de um plano de apoio para estas pessoas, com o objetivo de reduzir o risco de desenvolvimento de comorbidades e óbitos. O que se tem observado a cada dia são as dificuldades de acesso ao tratamento, baixo diagnóstico, falta de medicamentos e fechamento de atendimento ambulatorial de diferentes especialidades. Entre as medidas efetivas de proteção à saúde das pessoas com doenças crônicas e patologias, recomendadas ao Ministério da Saúde, estão: testagem prioritária, alternativas ao acesso de medicamentos com a estratégia de fornecimento ampliado (para dois ou três meses), enquanto durar o período de isolamento social e construção de protocolos específicos de atendimento a esta população. Essas estratégias devem ser voltadas às pessoas com HIV/Aids, câncer, celíacos, hanseníase, lúpus, doença falciforme, esclerose múltipla, doenças reumáticas, alzheimer, síndrome de down, Transtorno do Espectro Autista (TEA), diabetes, cardiopatas, transplantados, doenças raras, entre outras. Este é o 9º encontro virtual organizado pelo Comitê do CNS de acompanhamento da Covid-19 com transmissão ao vivo.
Subject(s)
Coronavirus Infections/epidemiology , Ethics Committees, Research/organization & administration , Ethics Committees, Research/ethics , Health Research Policy , Clinical Trial Protocol , Healthy Volunteers , Drug Monitoring/ethics , Social Control, Formal/methods , Unified Health System/organization & administration , Pneumonia, Viral/epidemiology , Pandemics/prevention & control , Social Isolation , Epidemiological Monitoring , Noncommunicable Diseases/prevention & control , Noncommunicable Diseases/mortality , Health Services Accessibility/organization & administration , Primary Health Care/organization & administration , HIV , Local Health Systems/organization & administration , Hydroxychloroquine/supply & distribution , Autoimmune Diseases/drug therapy , Hydroxychloroquine/therapeutic use , Pharmaceutical Services/organization & administration , Chronic Disease/prevention & controlABSTRACT
Mudanças na legislação que protege participantes de pesquisa clínica no Brasil pode abrir espaço para um sistema vinculado ao governo e sem autonomia A proteção aos direitos dos participantes de pesquisa clínicas no Brasil será tema da próxima live do Conselho Nacional de Saúde (CNS), na quinta-feira 17/09, às 17h. O programa virtual será transmitido pelo Facebook e Youtube do CNS. Com a participação da deputada federal Margarida Salomão, da pesquisadora da Fundação Oswaldo Cruz (Fiocruz) Margareth Dalcolmo e do membro do Comitê de Ética e Pesquisa (CEP) de Porto Alegre Oscar Paniz, a live vai abordar o Projeto de Lei nº 7.082, que pode reduzir os diretos dos pacientes de pesquisas e fragilizar a independência da Comissão Nacional de Ética em Pesquisa (Conep) do CNS. O PL está em tramitação na Câmara dos Deputados e, se aprovado, altera uma característica exemplar e quase única do sistema brasileiro, que garante o acesso, pós estudo, dos produtos que se mostrarem eficazes e seguros para o participante de pesquisa pelo tempo que for necessário, sem custos. O projeto ainda desvincula a Conep do CNS ao instituir o Sistema Nacional de Ética em Pesquisa Clínica com Seres Humanos, sob coordenação da Secretaria de Ciência, Tecnologia e Insumos Estratégicos (SCTIE) do Ministério da Saúde, o que poderá representar a flexibilização de regras éticas para os laboratórios e patrocinadores de medicamentos, abrindo espaço para um sistema vinculado ao governo e sem autonomia. A live será moderada pelo coordenador da Conep, Jorge Venâncio, com a participação do infectologista e professor da Universidade Federal de Minas Gerais (UFMG) Dirceu Greco e dos conselheiros nacionais de saúde Aníbal Machado e Neilton Araújo, que também é membro da mesa diretora do CNS. O debate envolve uma discussão em torno da formulação de princípios universais dos direitos humanos e da bioética, que embasam os sistemas de regulação da ética em pesquisa em todo o mundo na garantia da proteção à vida.
Subject(s)
Ethics Committees, Research/legislation & jurisprudence , Ethics Committees, Research/organization & administration , Ethics Committees, Research/ethics , Clinical Protocols , Healthy Volunteers , Unified Health System/organization & administration , Social Control, Formal , Health Research Policy , BrazilABSTRACT
There has been a good deal of discussion in the literature regarding which subjects are vulnerable in the context of clinical trials. There has been significantly less discussion regarding when and how to include vulnerable subjects in clinical trials. This lack of guidance is a particular problem for trials covered by the US regulations, which mandate strict requirements on the inclusion of three groups: pregnant women/fetuses, prisoners, and children. For the past 30 years, funders, investigators, and institutional review boards have frequently responded to these regulations by excluding pregnant women/fetuses, prisoners, and children from clinical trials. More recent work has emphasized the extent to which a default of exclusion can undermine the value of clinical trials, especially pragmatic trials. A default of exclusion also has the potential to undermine the interests of vulnerable groups, in both the short and the long term. These concerns raise the need for guidance on how to satisfy existing US regulations, while minimizing their negative impact on the value of clinical trials and the interests of vulnerable groups. The present manuscript thus describes a six-step decision procedure that institutional review boards can use to determine when and how to include vulnerable subjects in clinical trials, including pragmatic trials, that are covered by US regulations.
Subject(s)
Clinical Trials as Topic/legislation & jurisprudence , Research Subjects/legislation & jurisprudence , Vulnerable Populations/legislation & jurisprudence , Biomedical Research/legislation & jurisprudence , Child , Clinical Trials as Topic/ethics , Decision Making , Ethics Committees, Research/ethics , Ethics Committees, Research/legislation & jurisprudence , Female , Fetus , Humans , Male , Pragmatic Clinical Trials as Topic/ethics , Pragmatic Clinical Trials as Topic/legislation & jurisprudence , Pregnancy , Pregnant Women , Prisoners , United StatesABSTRACT
BACKGROUND: This is a multi-method, in-depth, three part qualitative study exploring the regulation and practice of secondary research with tissue and data in a high-income country. We explore and compare the perspectives of researchers, research ethics committees (RECs) and other relevant professionals (e.g. pathologists and clinicians). We focus on points of contention because they demonstrate misalignment between the expectations, values and assumptions of these stakeholders. METHODS: This is a multi-method study using observational research, focus groups and interviews with 42 participants (conducted 2016-2017) and analyzed using thematic analysis. RESULTS: Results are arranged under the following themes: consent; balancing the social value of the research with consent requirements; and harm. Our findings demonstrate different perspectives on the review process, styles of ethical reasoning and issues of concern. First, researchers and RECs disagreed about whether the cost of re-consenting patients satisfied the criterion of impracticability for consent waivers. Second, most researchers were skeptical that secondary research with already collected tissue and data could harm patients. Researchers often pointed to the harm arising from a failure to use existing material for research. RECs were concerned about the potential for secondary research to stigmatize communities. Third, researchers adopted a more consequentialist approach to decision-making, including some willingness to trade off the benefit of the research against the cost of getting consent; whereas RECs were more deontological and typically considered research benefit only after it had been established that re-consent was impractical. CONCLUSION: This research highlights ways in which RECs and researchers may be talking past each other, resulting in confusion and frustration. These finding provide a platform for realignment of the expectations of RECs and researchers, which could contribute to making research ethics review more effective.
Subject(s)
Ethics Committees, Research , Informed Consent/ethics , Ethics Committees, Research/ethics , Ethics, Research , Focus Groups , Humans , Qualitative Research , Research Design , Research Personnel/ethics , Tissue Banks/ethicsABSTRACT
Embedded pragmatic clinical trials (ePCTs) present an opportunity to improve care for people living with dementia (PLWD) and their care partners, but they also generate a complex constellation of ethical and regulatory challenges. These challenges begin with participant identification. Interventions may be delivered in ways that make it difficult to identify who is a human subject and therefore who needs ethical and regulatory protections. The need for informed consent, a core human subjects protection, must be considered but can be in tension with the goals of pragmatic research design. Thus it is essential to consider whether a waiver or alteration of informed consent is justifiable. If informed consent is needed, the question arises of how it should be obtained because researchers must acknowledge the vulnerability of PLWD due in part to diminished capacity and also to increased dependence on others. Further, researchers should recognize that many sites where ePCTs are conducted will be unfamiliar with human subjects research regulations and ethics. In this report, the Regulation and Ethics Core of the National Institute on Aging Imbedded Pragmatic Alzheimer's disease (AD) and AD-related dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory discusses key ethical and regulatory challenges for ePCTs in PLWD. A central thesis is that researchers should strive to anticipate and address these challenges early in the design of their ePCTs as a means of both ensuring compliance and advancing science. J Am Geriatr Soc 68:S37-S42, 2020.
Subject(s)
Dementia/epidemiology , Ethics Committees, Research/legislation & jurisprudence , Informed Consent/legislation & jurisprudence , Pragmatic Clinical Trials as Topic/ethics , Research Subjects , Ethics Committees, Research/ethics , Humans , National Institute on Aging (U.S.) , Patient Selection , Research Design , Research Personnel , Research Subjects/legislation & jurisprudence , United StatesABSTRACT
There is growing evidence that human genetics plays a significant role in shaping human responses to infectious diseases. For instance, individuals' genetic susceptibility or resistance to infectious disease is likely to affect disease transmission. Yet little attention has been paid to the ethical, legal, and social implications of research in genomics and infectious disease, despite the unique ethical issues that arise in this arena. This article presents results from a pilot study exploring ethics in research on human genetics and response to HIV and other infectious diseases and is focused on perspectives from expert stakeholders. Whereas chairs of institutional review boards, biobank directors, and researchers in genomics and infectious disease expressed similar views about research privacy in the context of a public health emergency, they expressed different perspectives about the role that public health considerations ought to play in the return of individual results to research participants. These perspectives highlight the need to emphasize the importance of broad dialogue for helping various parties navigate the ethically complex current and future challenges of genomics and infectious disease research.
Subject(s)
Communicable Diseases/genetics , Ethics Committees, Research/ethics , Genomics/ethics , Privacy , Public Health/ethics , Stakeholder Participation , Cohort Studies , Humans , Middle Aged , Pilot Projects , ResearchABSTRACT
United States regulations for the protection of human research subjects prescribe parameters for documentation of valid informed consent, which include the stipulation that the process be in a "language understandable to the subject." While significant energy has been devoted to improving the readability of consent documents, supplemental educational tools, and nuanced measurements of individual decisional capacity, there is little guidance about how to best meet the informational needs of adults with decisional capacity who do not speak English. This article reviews the institutional review board policies from the twenty-one research centers that received the most funding from the National Institutes of Health in 2018 and compares their guidelines for obtaining informed consent from non-English speakers. Inconsistent practices suggest the need for more assertive federal direction on what parameters constitute valid consent for this population. These practices also indicate a reluctance to directly engage the ethical underpinnings of consent policies for non-English speakers.
Subject(s)
Communication Barriers , Consent Forms/standards , Ethics Committees, Research/ethics , Informed Consent/ethics , Research Subjects , Translating , Comprehension , Documentation , Humans , LanguageABSTRACT
Ante la pandemia de COVID-19 es un deber moral realizar investigaciones que generen evidencia para mantener, promover y mejorar la atención de la salud, la toma de decisiones y la definición de políticas para el manejo y mitigación de la pandemia. Es necesario adaptar y buscar alternativas a los procesos ordinarios de revisión ética a fin de reducir al máximo los obstáculos prácticos para la realización de las investigaciones para dar una respuesta eficiente a los tiempos y necesidades de la emergencia sanitaria. Este documento ofrece orientación y estrategias a las autoridades de salud y a los comités de ética de la investigación para poner en práctica procesos rápidos y rigurosos de revisión y supervisión éticas de las investigaciones con seres humanos relacionadas con COVID-19.
Faced with the COVID-19 pandemic, we have the moral duty to conduct research that generates evidence to maintain, promote and improve health care delivery and decision-making, and to define policies for managing and mitigating the pandemic. In order to efficiently respond to this health emergency, it is necessary to adapt existing ethics review procedures and search for alternatives to reduce as much as possible the practical obstacles to conducting research. This document offers health authorities and ethics review committees guidance and strategies with which to implement rapid and rigorous ethics review and oversight processes for COVID-19-related research with human subjects.
Subject(s)
Humans , Pneumonia, Viral/prevention & control , Bioethics , Coronavirus Infections/prevention & control , Ethics, Research , Pandemics/prevention & control , Betacoronavirus , Ethics Committees, Research/ethicsABSTRACT
The use of crowd workers as research participants is fast becoming commonplace in social, behavioral, and educational research, and institutional review boards are encountering more and more research protocols concerning these workers. In what sense are crowd workers vulnerable as research participants, and what should ethics reviewers look out for in evaluating a crowdsourced research protocol? Using the popular crowd-working platform Amazon Mechanical Turk as the key example, this article aims to provide a starting point for a heuristic for ethical evaluation. The first part considers two reputed threats to crowd workers' autonomy-undue inducements and dependent relationships-and finds that autonomy-focused arguments about these factors are inconclusive or inapplicable. The second part proposes applying Alan Wertheimer's analysis of exploitation instead to frame the ethics of crowdsourced research. The article then provides some concrete suggestions for ethical reviewers based on the exploitation framework.
Subject(s)
Crowdsourcing/ethics , Ethics Committees, Research/ethics , Personal Autonomy , Research Subjects , Research , HumansABSTRACT
A central pillar of the Belmont Report is that a bright line must be drawn between medical practice and biomedical research. That line may have been brighter 50 years ago. Today, the typical physician is likely to work for a corporation or health system that styles itself as a learning health system. Such systems increasingly emphasize the (research-like) use of data to measure quality, encourage efficiency, ensure safety, and guide a standardized approach to clinical care. While these activities are not considered research, they pose many of the same risks or conflicts of loyalty. In research, the doctor's fiduciary loyalty to the patient is compromised by a loyalty to the scientific process. In learning health systems, the doctor's loyalty is compromised by loyalty to the system and its metrics. In this world, it is not clear that research-as conceptualized by the Belmont Report, codified in the Common Rule, and overseen by IRBs-is a uniquely risky activity deserving of such uniquely strict oversight. Perhaps, instead, the divided loyalties and conflicts of interest faced by everyday clinicians working in learning health systems demand a protective framework similar to the one that we now have for the activities that we designate as "research." This article compares the risks of the various activities that might be called "research" and suggests a unified system of oversight for all of them.
Subject(s)
Biomedical Research/ethics , Ethics, Medical , Physicians/ethics , Research Personnel/ethics , Conflict of Interest , Ethics Committees, Research/ethics , Ethics Committees, Research/standards , Ethics, Research , Humans , Learning Health System/ethicsABSTRACT
Public trust in research depends on implementation of research protections. Genetic and psychiatric research may elicit "exceptionalism," the belief that these types of research deserve special protections. Genetic information has been viewed as different from other health information. Psychiatric research has been scrutinized based on concerns about the impact of psychiatric illness on individuals' abilities to make decisions. This study compared four stakeholder groups' attitudes toward research safeguards. Psychiatric genetic researchers and institutional review board chairs received structured surveys. Individuals with mental illness and family members participated in semistructured interviews. Paired sample t-tests were used to compare mean ratings of importance of safeguard procedures for genetic versus nongenetic research on physical versus mental illnesses. All groups provided higher ratings for the importance of safeguards for genetic research and for mental illness. Individuals with mental illness and family members rated the importance of safeguards more highly than researchers and chairs did. Results of generalized linear models showed significant effects of gender and ethnicity.
Subject(s)
Ethics Committees, Research/ethics , Genetic Research , Mental Disorders/genetics , Research Subjects , Stakeholder Participation , Female , Humans , Male , Middle Aged , Research Personnel , Surveys and QuestionnairesABSTRACT
Scanty evidence exists about the safety and effectiveness of drugs-and of their efficacious dosing-that women may need to treat acute and chronic health issues during their pregnancies. This lack of evidence puts pregnant women and their fetuses at risk of harm from the use or avoidance of drugs during pregnancy. In light of the protectionist approach in regulations governing research with pregnant women and fetuses, trial sponsors, researchers, clinicians, and institutional review boards (IRBs) have been reluctant to include pregnant women in clinical drug trials, applying ethical reasoning for exclusions that reflects a default exclusionary approach. Yet in recent years, many clinicians, researchers, bioethicists, and professional societies have called for a reexamination of the routine practice of excluding pregnant women from clinical research. This paper proposes a practical approach to an ethical framework for IRBs that supports fair inclusion, rather than routine exclusion, of pregnant women in clinical research. This guidance will aid IRBs in ethically including and appropriately protecting pregnant women in research.
Subject(s)
Biomedical Research/ethics , Ethics Committees, Research/ethics , Patient Selection , Pregnant Women , Female , Humans , Patient Safety , PregnancyABSTRACT
In the past decade, there has been an increase in genomic research and biobanking activities in Africa. Research initiatives such as the Human Heredity and Health in Africa (H3Africa) Consortium are contributing to the development of scientific capacity and infrastructure to support these studies on the continent. Despite this growth, genomic research and biobanking have raised important ethical challenges for key research stakeholders, including members of research ethics committees. One of these is the limited ethical and regulatory frameworks to guide the review and conduct of genomic studies, particularly in Africa. This paper is a reflection on a series of consultative activities with research ethics committees in Africa which informed the development of an ethics and governance framework for best practices in genomic research and biobanking in Africa. The paper highlights the engagement process and the lessoned learned.