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1.
BMC Med Ethics ; 25(1): 61, 2024 May 21.
Artigo em Inglês | MEDLINE | ID: mdl-38773517

RESUMO

Certain organoid subtypes are particularly sensitive. We explore whether moral intuitions about the heartbeat warrant unique moral consideration for newly advanced contracting cardiac organoids. Despite the heartbeat's moral significance in organ procurement and abortion discussions, we argue that this significance should not translate into moral implications for cardiac organoids.


Assuntos
Princípios Morais , Organoides , Humanos , Obtenção de Tecidos e Órgãos/ética , Coração/fisiologia , Miocárdio/citologia
2.
J Med Internet Res ; 26: e54867, 2024 Jul 11.
Artigo em Inglês | MEDLINE | ID: mdl-38990640

RESUMO

BACKGROUND: Electronic informed consent (eIC) is increasingly used in clinical research due to several benefits including increased enrollment and improved efficiency. Within a learning health care system, a pilot was conducted with an eIC for linking data from electronic health records with national registries, general practitioners, and other hospitals. OBJECTIVE: We evaluated the eIC pilot by comparing the response to the eIC with the former traditional paper-based informed consent (IC). We assessed whether the use of eIC resulted in a different study population by comparing the clinical patient characteristics between the response categories of the eIC and former face-to-face IC procedure. METHODS: All patients with increased cardiovascular risk visiting the University Medical Center Utrecht, the Netherlands, were eligible for the learning health care system. From November 2021 to August 2022, an eIC was piloted at the cardiology outpatient clinic. Prior to the pilot, a traditional face-to-face paper-based IC approach was used. Responses (ie, consent, no consent, or nonresponse) were assessed and compared between the eIC and face-to-face IC cohorts. Clinical characteristics of consenting and nonresponding patients were compared between and within the eIC and the face-to-face cohorts using multivariable regression analyses. RESULTS: A total of 2254 patients were included in the face-to-face IC cohort and 885 patients in the eIC cohort. Full consent was more often obtained in the eIC than in the face-to-face cohort (415/885, 46.9% vs 876/2254, 38.9%, respectively). Apart from lower mean hemoglobin in the full consent group of the eIC cohort (8.5 vs 8.8; P=.0021), the characteristics of the full consenting patients did not differ between the eIC and face-to-face IC cohorts. In the eIC cohort, only age differed between the full consent and the nonresponse group (median 60 vs 56; P=.0002, respectively), whereas in the face-to-face IC cohort, the full consent group seemed healthier (ie, higher hemoglobin, lower glycated hemoglobin [HbA1c], lower C-reactive protein levels) than the nonresponse group. CONCLUSIONS: More patients provided full consent using an eIC. In addition, the study population remained broadly similar. The face-to-face IC approach seemed to result in a healthier study population (ie, full consenting patients) than the patients without IC, while in the eIC cohort, the characteristics between consent groups were comparable. Thus, an eIC may lead to a better representation of the target population, increasing the generalizability of results.


Assuntos
Consentimento Livre e Esclarecido , Humanos , Consentimento Livre e Esclarecido/estatística & dados numéricos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Países Baixos , Registros Eletrônicos de Saúde , Projetos Piloto
3.
Eur Heart J ; 44(7): 598-607, 2023 02 14.
Artigo em Inglês | MEDLINE | ID: mdl-36396400

RESUMO

AIMS: To assess the feasibility to comply with the recommended actions of ESC guidelines on general cardiology areas in 102 countries and assess how compliance relates to the country's income level. METHODS AND RESULTS: All recommendations from seven ESC guidelines on general cardiology areas were extracted and labelled on recommended actions. A survey was sent to all 102 ESC national and affiliated cardiac societies (NCSs). Respondents were asked to score recommended actions on their availability in clinical practice on a four-point Likert scale (fully available, mostly/often available, mostly/often unavailable, fully unavailable), and select the top three barriers perceived as being responsible for limiting their national availability. Applicability was assessed overall, per World Bank gross national income (GNI) level, and per guideline.A total of 875 guideline recommendations on general cardiology was extracted. Responses were received from 64 of 102 (62.7%) NCSs. On average, 71·6% [95% confidence interval (CI): 68.6-74.6] of the actions were fully available, 9.9% (95% CI: 8.7-11.1) mostly/often available, 6.7% (95% CI: 5.4-8.0) mostly/often unavailable, and 11·8% (95% CI: 9.5-14.1) fully unavailable. In low-income countries (LICs), substantially more actions were fully unavailable [29·4% (95% CI: 22.6-36.3)] compared with high-income countries [HICs, countries 2.4% (95% CI: 1.2-3.7); P < 0.05]. Nevertheless, a proportion of actions with the lowest availability scores were often fully or mostly unavailable independent of GNIs. Actions were most often not available due to lack of reimbursement and other financial barriers. CONCLUSION: Local implementation of ESC guidelines on general cardiology is high in HICs and low in LICs , being inversely correlated with country gross national incomes.


Assuntos
Cardiologia , Humanos , Inquéritos e Questionários , Sociedades Médicas , Europa (Continente)
4.
Med Health Care Philos ; 27(4): 489-496, 2024 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-39172342

RESUMO

The development of gene therapy has always come with the expectation that it will offer a cure for various disorders, of which hemophilia is a paradigm example. However, although the term is used regularly, it is unclear what exactly is meant with "cure". Therefore, the aim of this paper is to analyse how the concept of cure is used in practice and evaluate which of the interpretations is most suitable in discussions surrounding gene therapy. We analysed how cure is used in four different medical fields where the concept raises discussion. We show that cure can be used in three different ways: cure as normalization of the body, cure as obtaining a normal life, or cure as a change in identity. We argue that since cure is a practical term, its interpretation should be context-specific and the various uses can exist simultaneously, as long as their use is suitable to the function the notion of cure plays in each of the settings. We end by highlighting three different settings in the domain of hemophilia gene therapy in which the term cure is used and explore the function(s) it serves in each setting. We conclude that in the clinical application of gene therapy, it could be better to abandon the term cure, whereas more modest and specified definitions of cure are required in the context of health resource allocation decisions and decisions on research funding.


Assuntos
Terapia Genética , Hemofilia A , Humanos , Terapia Genética/ética , Hemofilia A/terapia , Filosofia Médica
5.
BMC Med Res Methodol ; 23(1): 98, 2023 04 22.
Artigo em Inglês | MEDLINE | ID: mdl-37087415

RESUMO

BACKGROUND: The Utrecht Cardiovascular Cohort - CardioVascular Risk Management (UCC-CVRM) was set up as a learning healthcare system (LHS), aiming at guideline based cardiovascular risk factor measurement in all patients in routine clinical care. However, not all patients provided informed consent, which may lead to participation bias. We aimed to study participation bias in a LHS by assessing differences in and completeness of cardiovascular risk management (CVRM) indicators in electronic health records (EHRs) of consenting, non-consenting, and non-responding patients, using the UCC-CVRM as an example. METHODS: All patients visiting the University Medical Center Utrecht for first time evaluation of a(n) (a)symptomatic vascular disease or condition were invited to participate. Routine care data was collected in the EHR and an informed consent was asked. Differences in patient characteristics were compared between consent groups. We performed multivariable logistic regression to identify determinants of non-consent. We used multinomial regression for an exploratory analysis for the determinants of non-response. Presence of CVRM indicators were compared between consent groups. A waiver (19/641) was obtained from our ethics committee. RESULTS: Out of 5730 patients invited, 2378 were consenting, 1907 non-consenting, and 1445 non-responding. Non-consent was related to young and old age, lower education level, lower BMI, physical activity and haemoglobin levels, higher heartrate, cardiovascular disease history and absence of proteinuria. Non-response increased with young and old age, higher education level, physical activity, HbA1c and decreased with lower levels of haemoglobin, BMI, and systolic blood pressure. Presence of CVRM indicators was 5-30% lower in non-consenting patients and even lower in non-responding patients, compared to consenting patients. Non-consent and non-response varied across specialisms. CONCLUSIONS: A traditional informed consent procedure in a LHS may lead to participation bias and potentially to suboptimal CVRM, which is detrimental for feedback on findings in a LHS. This underlines the importance of reassessing the informed consent procedure in a LHS.


Assuntos
Doenças Cardiovasculares , Sistema de Aprendizagem em Saúde , Humanos , Fatores de Risco , Fatores de Risco de Doenças Cardíacas , Consentimento Livre e Esclarecido
6.
Bioethics ; 37(4): 319-322, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-36905652

RESUMO

The next World Congress of Bioethics will be held in Doha, Qatar. Although this location provides opportunities to interact with a more culturally diverse audience, to advance dialogue between cultures and religions, offer opportunities for mutual learning, there are also huge moral concerns. Qatar is known for violations of human rights - including the treatment of migrant workers and the rights of women - corruption, criminalization of LGBTQI+ persons, and climate impact. Since these concerns are also key (bio)ethical concern we call for a broad debate within the bioethics community whether organizing and attending the World Congress in Qatar is ethically problematic and how ethical concerns should be dealt with.


Assuntos
Bioética , Feminino , Humanos , Catar , Princípios Morais , Direitos Humanos , Ética
7.
Bioethics ; 37(6): 600-609, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-37133893

RESUMO

Despite widespread and worldwide efforts to eradicate vector-borne diseases such as malaria, these diseases continue to have an enormous negative impact on public health. For this reason, scientists are working on novel control strategies, such as gene drive technologies (GDTs). As GDT research advances, researchers are contemplating the potential next step of conducting field trials. An important point of discussion regarding these field trials relates to who should be informed, consulted, and involved in decision-making about their design and launch. It is generally argued that community members have a particularly strong claim to be engaged, and yet, disagreement and lack of clarity exist about how this "community" should be defined and delineated. In this paper, we shed light on this "boundary problem": the problem of determining how boundaries of inclusion and exclusion in (GDT) community engagement should be drawn. As our analysis demonstrates, the process of defining and delineating a community is itself normative. First, we explicate why it is important to define and delineate the community. Second, we demonstrate that different definitions of community are used and intermingled in the debate on GDTs, and argue in favor of distinguishing geographical, affected, cultural, and political communities. Finally, we propose initial guidance for deciding who should (not) be engaged in decision-making about GDT field trials, by arguing that the definition and delineation of the community should depend on the rationale for engagement and that the characteristics of the community itself can guide the effective design of community engagement strategies.


Assuntos
Tecnologia de Impulso Genético , Humanos , Participação da Comunidade , Saúde Pública , Pesquisadores , Dissidências e Disputas
8.
BMC Med Ethics ; 24(1): 44, 2023 06 27.
Artigo em Inglês | MEDLINE | ID: mdl-37370079

RESUMO

BACKGROUND: Pregnant people have been overlooked or excluded from clinical research, resulting in a lack of scientific knowledge on medication safety and efficacy during pregnancy. Thus far, both the opportunities to generate evidence-based knowledge beyond clinical trials and the role of pregnant people in changing their status quo have not been discussed. Some scholars have argued that for rare disease patients, for whom, just like pregnant people, a poor evidence base exists regarding treatments, solidarity has played an important role in addressing the evidence gap. This paper explores whether and how the enactment of solidarity among pregnant people can be stimulated to help address the poor evidence base on medications used during pregnancy. METHOD: We use the concept of solidarity formulated by Prainsack and Buyx and enrich their concept by providing an account for stimulating the enactment of solidarity. Then we apply this account to the case of pregnant people who use medication. RESULTS: Solidarity means enacted commitment on the part of an individual to assisting others with whom the person recognizes a similarity in a relevant respect. Although solidarity cannot be imposed, we argue that the empowerment of people is a crucial concept in understanding how solidarity can be stimulated. Empowerment in the context of pregnant people means creating awareness about their status quo, explaining how scientific research can help close the knowledge gap, and how pregnant people can themselves contribute. In particular, how pregnant people can contribute to the collection of health data to strengthen the evidence base for medications used during pregnancy. CONCLUSIONS: We conclude that acting in solidarity can help change the status quo for pregnant people. Furthermore, we argue that the empowerment of pregnant people and other relevant stakeholders is a way to stimulate the enactment of solidarity. The process of empowerment starts by raising awareness about the lack of evidence on medications used during prengnacy and by explaining to pregnant people how they can contribute to changing the way knowledge is being generated by, for example, sharing data on the health effects of medications.


Assuntos
Conhecimentos, Atitudes e Prática em Saúde , Preparações Farmacêuticas , Feminino , Humanos , Gravidez
9.
Clin Trials ; 19(5): 545-560, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-35775421

RESUMO

BACKGROUND: Informed consent is one of the cornerstones of biomedical research with human subjects. Research ethics committees may allow for a modification or a waiver of consent when the research has social value, involves minimal risk, and if consent is impractical to obtain. While the conditions of social value and minimal risk have received ample attention in research ethics literature, the impractical condition remains unclear. There seem to be different interpretations of the meaning of impractical within academic literature. To address this lack of clarity, we performed a systematic review on the interpretation of impractical. METHODS: First, we examined international research ethics guidelines on their usage and interpretation of impractical. Next, we used international ethical guidelines to identify synonyms of the term "impractical." Accordingly, PubMed, Embase, and Web of Science were searched for articles that included "informed consent" and "impractical" or one of its synonyms. RESULTS: We found that there were only a few international ethics guidelines that described what could be considered impractical. Out of 2329 identified academic articles, 42 were included. Impractical was used to describe four different conditions: (1) obtaining informed consent becomes too demanding for researchers, (2) obtaining informed consent leads to invalid study outcomes, (3) obtaining informed consent harms the participant, and (4) obtaining informed consent is meaningless for the participant. CONCLUSION: There are conditions that render conventional informed consent truly impractical, such as untraceable participants or harm for participants. At the same time, researchers have a moral responsibility to design an infrastructure in which consent can be obtained, even if they face hardship in obtaining consent. In addition, researchers should seek to minimize harm inflicted upon participants when harm may occur as a result of the consent procedure. Invalidity of research due to consent issues should not be regarded as impractical but as a condition that limits the social value of research. Further research is essential for when a waiver of informed consent based on impractical is also reasonable.


Assuntos
Pesquisa Biomédica , Consentimento Livre e Esclarecido , Comitês de Ética em Pesquisa , Ética em Pesquisa , Humanos , Pesquisadores
10.
BMC Pregnancy Childbirth ; 22(1): 334, 2022 Apr 18.
Artigo em Inglês | MEDLINE | ID: mdl-35436951

RESUMO

BACKGROUND: Most medications lack evidence-based information about its safety and efficacy during pregnancy and breastfeeding, because pregnant women are often not included in clinical research. Another way to generate evidence is by using a Learning Healthcare System (LHS) approach. In an LHS, care and research are aligned in such a way that it can accelerate evidence generation and outcomes for patients, based on real-life medication use. For the development of an ethically responsible and sustainable LHS, it is of crucial importance to understand what women think of such an alternative approach to knowledge generation. Therefore, this paper explores their views on an LHS for pregnant and breastfeeding women. METHOD: For this qualitative study, we interviewed 20 women during preconception, pregnancy, or nursing to explore their views on an ethically responsible LHS for pregnant and breastfeeding women. The pseudonymized transcripts were analyzed thematically. RESULTS: We identified four main themes describing women's views on LHSs. The first theme describes that respondents were positive about learning healthcare systems, and considered them to function as a central point for information about their medication, which they felt is currently lacking. The second theme shows that respondents want to contribute to and engage in generating new information because they want to help others and contribute to scientific research. Respondents also mentioned that, currently, not every woman is aware of the risks of the lack of evidence for medication used in pregnancy. The third theme shows that respondents regard their healthcare professional as essential for the translation and interpretation of information, regardless of a learning healthcare system. The last theme describes that respondents will trust a learning healthcare system more if the medical community supports it, and when data collection and processing is transparent. CONCLUSION: Women during preconception, pregnancy and nursing agree that an LHS could be a viable alternative to help close the knowledge gap on the safety of medication used during pregnancy and breastfeeding. The obtained insights from our interviews provide valuable stepping-stones for the development of an ethically responsible and sustainable LHS, as well as for the engagement of women in an LHS.


Assuntos
Sistema de Aprendizagem em Saúde , Aleitamento Materno , Feminino , Pessoal de Saúde , Humanos , Masculino , Gravidez , Gestantes , Pesquisa Qualitativa
11.
BMC Health Serv Res ; 22(1): 1320, 2022 Nov 04.
Artigo em Inglês | MEDLINE | ID: mdl-36333803

RESUMO

BACKGROUND: The reimbursement for expensive medicines poses a growing challenge to healthcare worldwide. In order to increase its control over the costs of medicines, the Dutch government introduced the Coverage Lock (CL) policy in 2015. The CL postpones decisions regarding reimbursement of expensive medicines until detailed advice on i.e., cost-effectiveness has been given. The CL has been in place for six years, has raised many questions and concerns, but currently, no evaluation is known to the authors. A better understanding of the effects of the CL on all stakeholders involved may contribute to reflections on the CL process and help find ways to improve it. An evaluation of Dutch policy will also be relevant for other countries that aim to optimize reimbursement procedures for expensive treatments. To perform this evaluation, we focused on the CL procedure for the medicine nusinersen. Nusinersen is the first treatment for spinal muscular atrophy (SMA). Following EMA approval in May 2017, it was placed in the CL. The analysis of cost-effectiveness and added therapeutic value resulted in an advice for reimbursement limited to children younger than 9.5 years at the start of treatment; this was implemented from August 2018 onwards. METHODS: Qualitative stakeholder perspective analysis of the CL procedure focusing on nusinersen with 15 stakeholders. RESULTS: Stakeholders raised key issues of the CL based on their experience with nusinersen: emotional impact of the CL, duration of the CL procedure, appropriateness of the CL procedure for different types of medicines, transparency of the CL, a wish for patient-centred decision-making and the lack of uniformity of access to expensive treatments. DISCUSSION: Stakeholders supported measures to control healthcare expenses and to ensure reasonable pricing. They considered the delay in access to therapies and lack of procedural transparency to be the main challenges to the CL. Stakeholders also agreed that the interests of patients deserve more attention in the practical implementation of the reimbursement decision. Stakeholders suggested a number of adjustments to improve the CL, such as a faster start with conditional reimbursement programs to ensure access and intensify European collaboration to speed up the assessment of the medicine.


Assuntos
Atrofia Muscular Espinal , Oligonucleotídeos , Criança , Humanos , Oligonucleotídeos/uso terapêutico , Atrofia Muscular Espinal/tratamento farmacológico , Análise Custo-Benefício , Políticas
12.
Neurocrit Care ; 36(2): 621-629, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-34611811

RESUMO

BACKGROUND: In some acute care trials, immediate informed consent is not possible, but deferred consent is often considered problematic. We investigated the opinions of patients, proxies, and physicians about deferred consent in an acute stroke trial to gain insight into its acceptability and effects. METHODS: Paper-based surveys were sent to patients who were randomly assigned in the Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage (ULTRA) trial between 2015 and 2018 in two tertiary referral centers and to physicians of centers who agreed or declined to participate. The primary outcome measure was the proportion of respondents who agreed with deferral of consent in the ULTRA trial. Secondary outcomes included respondents' preferred consent procedure for the ULTRA trial, the effect of deferred consent on trust in physicians and scientific research, and the willingness to participate in future research. RESULTS: Eighty-nine of 135 (66%) patients or proxies and 20 of 30 (67%) physicians completed the survey. Of these, 82 of 89 (92%) patients or proxies and 14 of 20 (70%) physicians agreed with deferral of consent in the ULTRA trial. When asked for their preferred consent procedure for the ULTRA trial, 31 of 89 (35%) patients or proxies indicated deferred consent, 15 of 89 (17%) preferred immediate informed consent, and 32 of 89 (36%) had no preference. None of the patients' or proxies' trust in physicians or scientific research had decreased because of the deferred consent procedure. Willingness to participate in future studies remained the same or increased in 84 of 89 (94%) patients or proxies. CONCLUSIONS: A large majority of the surveyed patients and proxies and a somewhat smaller majority of the surveyed physicians agreed with deferred consent in the ULTRA trial. Deferred consent may enable acute care trials in an acceptable manner without decreasing trust in medicine. Future research should investigate factors facilitating the responsible use of deferred consent, such as in-depth interviews, to study the minority of participants who agreed with deferred consent but still preferred immediate informed consent.


Assuntos
Médicos , Acidente Vascular Cerebral , Estudos Transversais , Humanos , Consentimento Livre e Esclarecido , Procurador , Acidente Vascular Cerebral/terapia
13.
J Med Philos ; 46(5): 516-529, 2021 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-34596226

RESUMO

The precautionary principle is often invoked in relation to pregnant women and may be one of the underlying reasons for their continuous underrepresentation in clinical research. The principle is appealing, because potential fetal harm as a result of research participation is considered to be serious and irreversible. In our paper, we explore through conceptual analysis whether and if so how the precautionary principle should apply to pregnant women. We argue that the principle is a decision-making strategy underlying risk-benefit decisions in clinical research, which can be applied to pregnant women. However, the current application is a strong one, leading to the promotion of absolute exclusion or, less often, absolute inclusion of pregnant women. In order to change this paralyzing situation, a shift toward weak precautionary thinking is necessary. Instead of automatic extreme precaution, a balance will be found between harms and potential benefits of including pregnant women in clinical research.


Assuntos
Tomada de Decisões , Gestantes , Feminino , Humanos , Gravidez , Medição de Risco
14.
Eur J Pediatr ; 179(8): 1205-1211, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32535715

RESUMO

Investigator-initiated clinical trials are crucial for improving quality of care for children and pregnant women as they are often excluded from industry-initiated trials. However, trials have become increasingly time-consuming and costly since the EU Clinical Trial Directive entered into force in 2001. This directive made compliance with ICH-Good Clinical Practice Guidelines (ethical and quality standard for conducting human subject research) mandatory for all clinical trials, regardless of its risk-classification. By discussing two investigator-initiated, 'low-risk' drug trials, we aim to illustrate that compliance with all GCP requirements makes trials very laborious and expensive, while a clear rationale is missing. This discourages clinical researchers to start and carry out investigator-initiated research. However, the forthcoming EU Clinical Trial Regulation (No 536/2014) seems to provide a solution as it allows for less stringent rules for low-risk trials. We want to raise awareness for these developments in both the clinical research community and the European and national regulatory authorities. Implementation of this forthcoming Regulation regulatory policies should be done in such a way that investigator-initiated trials evaluating standard care interventions will become more feasible. This will allow us to obtain evidence on optimal and safe treatments, especially for groups that are underrepresented in medical research. What is Known • Investigator-initiated trials are indispensable for improving care for children and pregnant women as they are often excluded from industry-initiated trials • Trials have become increasingly time-consuming and costly because of mandatory compliance with ICH-GCP guidelines What is New • The forthcoming EU Clinical Trial Regulation allows less stringent rules for low-risk trials • The national legislator and regulatory authorities should recognize the importance of this opportunity and implement the Regulation in such a way that investigator-initiated trials will become more feasible.


Assuntos
Ensaios Clínicos como Assunto/legislação & jurisprudência , União Europeia , Regulamentação Governamental , Projetos de Pesquisa/legislação & jurisprudência , Pesquisadores/legislação & jurisprudência , Experimentação Humana Terapêutica/legislação & jurisprudência , Criança , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/normas , Feminino , Humanos , Guias de Prática Clínica como Assunto , Gravidez , Projetos de Pesquisa/normas , Pesquisadores/ética , Pesquisadores/normas , Risco , Experimentação Humana Terapêutica/ética
15.
Trop Med Int Health ; 24(3): 264-279, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30565381

RESUMO

OBJECTIVES: To systematically review reasons for the willingness to participate in biomedical human subjects research in low- and middle-income countries (LMICs). METHODS: Five databases were systematically searched for articles published between 2000 and 2017 containing the domain of 'human subjects research' in 'LMICs' and determinant 'reasons for (non)participation'. Reasons mentioned were extracted, ranked and results narratively described. RESULTS: Ninety-four articles were included, 44 qualitative and 50 mixed-methods studies. Altruism, personal health benefits, access to health care, monetary benefit, knowledge, social support and trust were the most important reasons for participation. Primary reasons for non-participation were safety concerns, inconvenience, stigmatisation, lack of social support, confidentiality concerns, physical pain, efficacy concerns and distrust. Stigmatisation was a major concern in relation to HIV research. Reasons were similar across different regions, gender, non-patient or patient participants and real or hypothetical study designs. CONCLUSIONS: Addressing factors that affect (non-)participation in the planning process and during the conduct of research may enhance voluntary consent to participation and reduce barriers for potential participants.


OBJECTIFS: Analyser systématiquement les raisons de la volonté de participer à la recherche biomédicale sur les sujets humains dans les PRFI. MÉTHODES: Cinq bases de données ont été systématiquement recherchées pour des articles publiés entre 2000 et 2017 contenant le domaine de la «recherche sur des sujets humains¼ dans les «PRFI¼ et les déterminantes «raisons de la (non) participation¼. Les raisons mentionnées ont été extraites, classées et les résultats décrits de manière narrative. RÉSULTATS: 94 articles ont été inclus, 44 études qualitatives et 51 études à méthodes mixtes. L'altruisme, les avantages pour la santé personnelle, l'accès aux soins de santé, les avantages pécuniaires, les connaissances, le soutien social et la confiance étaient les principales raisons de la participation. Les principales raisons de la non-participation étaient les problèmes de sécurité, les inconvénients, la stigmatisation, le manque de soutien social, les soucis de confidentialité, la douleur physique, les soucis d'efficacité et la méfiance. La stigmatisation était une préoccupation majeure dans le cadre de la recherche sur le VIH. Les raisons étaient similaires dans les différentes régions, le sexe, les participants patients ou non-patients et les modèles d'étude réels ou hypothétiques. CONCLUSIONS: La prise en compte des facteurs qui affectent la (non) participation au processus de planification et au cours de la recherche peut renforcer le consentement volontaire à la participation et réduire les obstacles pour les participants potentiels.


Assuntos
Pesquisa Biomédica , Participação do Paciente , Países em Desenvolvimento , Acessibilidade aos Serviços de Saúde/normas , Humanos , Consentimento Livre e Esclarecido/normas
16.
BMC Pregnancy Childbirth ; 19(1): 65, 2019 Feb 11.
Artigo em Inglês | MEDLINE | ID: mdl-30744577

RESUMO

BACKGROUND: Bioethicists argue that inclusion of pregnant women in clinical research should be more routine to increase the evidence-base for pregnant women and foetuses. Yet, it is unknown whether pregnant women and others directly involved are willing to be routinely included. Therefore, we first need to establish what these stakeholders think about research participation in regular pregnancy-related research. However, studies on their views are scarce. In our study, we piggy-backed on a relatively conventional RCT, the APOSTEL VI study, to identify the views of stakeholders on inclusion of pregnant women in this study. METHODS: We conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed pregnant women (n = 14) recruited for the APOSTEL VI study, in addition to healthcare professionals (n = 14), Research Ethics Committee members (RECs) (n = 5) and regulators (n = 7) involved in clinical research in pregnant women. RESULTS: Three themes characterise stakeholders' views on inclusion of pregnant women in the APOSTEL VI study. Additionally, one theme characterises stakeholders' interest in inclusion of pregnant women in clinical research in general. First, pregnant women participate in the APOSTEL VI study for potential individual benefit and secondarily for altruistic motives, contrary to hypothetical studies. Second, a gatekeeping tendency hampers recruitment of pregnant women who might be eligible and willing, and questions about pregnant women's decisional capacities surface. Third, healthcare professionals sometimes use the counselling conversation to steer pregnant women in a direction. Fourth, all stakeholders are hesitant about inclusion of pregnant women in clinical research in general due to a protective sentiment. CONCLUSIONS: Pregnant women are willing to participate in the APOSTEL VI study for potential individual benefit and altruistic motives. However, an underlying protective sentiment, resulting in gatekeeping and directive counselling, sometimes hampers recruitment in the APOSTEL VI study as well as in clinical research in general. While bioethicists claim that inclusion of pregnant women should be customary, our study indicates that healthcare professionals, regulators, RECs and pregnant women themselves are not necessarily interested in inclusion. Advancing the situation and increasing the evidence-base for pregnant women and foetuses may require additional measures such as investing in the recruitment and feasibility of RCTs and stimulating pregnant women's decisional capacities.


Assuntos
Pesquisa Biomédica/ética , Estudos Clínicos como Assunto/psicologia , Gestantes/psicologia , Sujeitos da Pesquisa/psicologia , Adulto , Estudos Clínicos como Assunto/ética , Tomada de Decisões , Feminino , Grupos Focais , Humanos , Motivação , Gravidez , Estudos Prospectivos , Pesquisa Qualitativa
17.
J Med Ethics ; 45(11): 736-741, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31375547

RESUMO

There is a growing consensus that the offer of a reasonable compensation for oocyte donation for reproductive treatment is acceptable if it does not compromise voluntary and altruistically motivated donation. However, how to translate this 'reasonable compensation' in practice remains unclear as compensation rates offered to oocyte donors between different European Union countries vary significantly. Clinics involved in oocyte donation, as well as those in other medical contexts, might be encouraged in calculating a more consistent and transparent compensation for donors if the elements that constitute a reasonable compensation are explicated. In doing so, lessons can be learnt from living organ donation and medical research participation. Practices in which the elements of a reasonable compensation for the individuals involved have already been more defined in the literature. By means of analogical reasoning, we will outline the different components of a reasonable compensation and subsequently apply these to the context of oocyte donation. We will argue that oocyte donors should first of all be reasonably reimbursed direct expenses related to the donation, without standard remuneration of lost wages. Second, donating oocytes requests a serious time investment, therefore donors are entitled to suitable compensation for their time spent and efforts made. Finally, we will explain that a reasonable compensation consisting of these two components allows for altruism to remain the key value of oocyte donation for reproductive treatment. However, if we acknowledge that donors' motives are more complex and often include reasons from self-interest, the reasonable compensation may be complemented with modest (non)monetary benefits.


Assuntos
Pesquisa Biomédica/economia , Doação de Oócitos/economia , Transplante de Órgãos/economia , Remuneração , Altruísmo , Pesquisa Biomédica/ética , Humanos , Motivação , Doação de Oócitos/ética , Transplante de Órgãos/ética
19.
Bioethics ; 33(3): 367-373, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30341918

RESUMO

As early as 2002, CIOMS stated that pregnant women should be presumed eligible for participation in research. Despite this position and calls of other well-recognized organizations, the health needs of pregnant women in research remain grossly under-researched. Although the presumption of eligibility remains unchanged, the revision of the 2002 CIOMS International ethical guidelines for biomedical research involving human subjects involved a substantive rewrite of the guidance on research with pregnant women and related guidelines, such as those on fair inclusion and vulnerability. However, close reading of the guidelines reveals morally relevant different approaches to fair inclusion of pregnant women and other under-represented groups, such as children and incompetents. Where CIOMS sets out that children and adolescents must be included unless a good scientific reason justifies their exclusion, no such claim of having to justify exclusion appears in the guideline on pregnant women. Instead, CIOMS claims that research relevant to pregnant women's health needs must be promoted. This paper analyses how and to what extent the guideline on pregnant women differs from other guidance on fair inclusion in the document. Accordingly, the paper evaluates to what extent the current phrasing may contribute to fair inclusion of pregnant women in research. We will conclude that a system change towards a learning health system is essential to break down the status quo of knowledge generation in the field of medication use during pregnancy and argue that the CIOMS guidelines allow for this system change.


Assuntos
Pesquisa Biomédica/ética , Guias como Assunto , Experimentação Humana/ética , Cooperação Internacional , Organizações , Gestantes , Justiça Social , Adolescente , Criança , Ética em Pesquisa , Feminino , Política de Saúde , Necessidades e Demandas de Serviços de Saúde , Humanos , Consentimento Livre e Esclarecido , Conhecimento , Seleção de Pacientes/ética , Preparações Farmacêuticas , Gravidez
20.
Dev World Bioeth ; 18(2): 68-75, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-27761986

RESUMO

To address the burden of maternal morbidity and mortality in low- and middle-income countries (LMICs), research with pregnant women in these settings is increasingly common. Pregnant women in LMIC-context may experience vulnerability related to giving consent to participate in a clinical trial. To recognize possible layers of vulnerability this study aims to identify factors that influence the decision process towards clinical trial participation of pregnant women in an urban middle-income setting. This qualitative research used participant observation, in-depth interviews, and focus group discussion with medical staff and pregnant women eligible for trial participation, at a regional hospital in Accra, Ghana. Besides lack of familiarity with modern scientific concepts, specific factors influencing the decision-making process were identified. These include a wide power difference between health provider and patient, and a different perception of risk through externalization of responsibility of risk management within a religious context as well as a context shaped by authority. Also, therapeutic misconception was observed. The combination of these factors ensued women to rely on the opinion of the medical professional, rather than being guided by their own motivation to participation. Although being a (pregnant) woman per se should not render the label of being vulnerable, this study shows there are factors that influence the decision process of pregnant woman towards trial participation in a LMIC context that can result in vulnerability. The identification of context-specific factors that can create vulnerability facilitates adaptation of the design and conduct of research in a culturally competent manner.


Assuntos
Pesquisa Biomédica/ética , Tomada de Decisões , Renda , Consentimento Livre e Esclarecido , Poder Psicológico , Gestantes , Relações Profissional-Paciente , Adulto , Cultura , Ética em Pesquisa , Feminino , Gana , Humanos , Motivação , Seleção de Pacientes , Pobreza , Gravidez , Pesquisa Qualitativa , Religião , Sujeitos da Pesquisa , Risco , População Urbana , Populações Vulneráveis , Adulto Jovem
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