Protecting the vulnerable: testing times for clinical research ethics

Schüklenk, Udo

doi:10.1016/s0277-9536(00)00075-7

Cited by 69 publications

(53 citation statements)

References 8 publications

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“…The male to female ratio was 1. [15][16][17] . It has never been a function of the committee to harass researchers although such a belief is also reflected elsewhere [11][12] .…”

Section: Resultsmentioning

confidence: 99%

Knowledge about the research and ethics committee at Makerere University, Kampala

Ibingira¹,

Ochieng²

2014

Afr H. Sci.

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Background: All research involving human participants should be reviewed by a competent and independent institutional research and ethics committee. Research conducted at Makerere University College of Health Sciences should be subjected to a rigorous review process by the ethics committee in order to protect human participants' interests, rights and welfare. Objective: To evaluate researchers' knowledge about the functions and ethical review process of the College of Health Sciences research and ethics committee. Methods: A cross sectional study. 135 researchers consented to participate in the study, but 70 questionnaires were answered giving a 52% response. Results: Age ranged between 30 to 61 years, majority of participants 30-39 years. Most of the respondents do agree that the REC functions include Protocol review 86%, protection of research participants 84.3%, and monitoring of ongoing research. During ethical review, the RECpays special attention to scientific design [79.7%] and ethical issues [75.3%], but less to the budget and literature review. More than 97% of the respondents believe that the REC is either average or very good, while 2.8% rank it below average. Conclusion: Respondents knew the major functions of the committee including protection of the rights and welfare of research participants, protocol review and monitoring of on going research, and the elements of protocol review that are given more attention include ;scientific design and ethical issues. Overall performance of the REC was ranked as average by respondents. The committee should limit delays in approval and effectively handle all functions of the committee.

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“…The male to female ratio was 1. [15][16][17] . It has never been a function of the committee to harass researchers although such a belief is also reflected elsewhere [11][12] .…”

Section: Resultsmentioning

confidence: 99%

Knowledge about the research and ethics committee at Makerere University, Kampala

Ibingira¹,

Ochieng²

2014

Afr H. Sci.

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“…However, several points are targets of debates, particularly the informed consent and the appropriate benefits and standards of care. Reflections on the guidelines for conducting medical research in developing countries have received attention in recent years [11][12][13][14] . The research activity in Thoracic Surgery in Brazil initiates a critical reflection, a reflection that may provide the bases for planning and implementing, by the academic community and / or the government, actions for induction of research, funding, human resources training, assistance to emerging groups, etc.…”

Section: Results Results Results Resultsmentioning

confidence: 99%

Perfil da atividade de pesquisa encaminhada ao Congresso Brasileiro de Cirurgia Torácica - Tórax 2009

Coelho

Silva

2010

Rev. Col. Bras. Cir.

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OBJETIVO: Contribuir para o melhor conhecimento da atividade de pesquisa em Cirurgia Torácica no Brasil. MÉTODOS: Estudo prospectivo observacional dos resumos publicados nos Anais do Congressos Brasileiro de Cirurgia Torácica - Tórax 2009, para descrição quantitativa e qualitativa da distribuição geográfica e do tipo das instituições de origem dos resumos, dos tipos de estudos e dos temas abordados. RESULTADOS: Foram publicados 182 resumos, sendo 174 (95,60%) intervencionistas. Houve três resumos provenientes de instituições estrangeiras, todos provindos de uma mesma instituição italiana. Quanto aos tipos de estudos, foram observados 108 estudos clínicos, 67 relatos de caso e sete estudos experimentais. No cômputo geral, a ressecção pulmonar (14,29%) é o tema mais freqüente, seguidos de câncer pulmonar, hiperidrose e afecções traqueais (10,44%), trauma torácico (7,14%) e mediastino (6,04%). As instituições públicas participaram com 68,16% dos resumos avaliados, as instituições privadas 11,17% e as chamadas institucionais com 20,67%, sendo que as Pontifícias Universidades Católicas (11,00%) e as Santas Casas (7,70%) tiveram participação significativa na pesquisa em Cirurgia Torácica no Brasil. CONCLUSÃO: As instituições públicas são as principais responsáveis pela atividade de pesquisa em Cirurgia Torácica no Brasil, a qual está mais concentrada no estado de São Paulo (34,07%). Um terço desta atividade é representada por relatos de caso e, embora haja grande variação de assuntos abordados, a ressecçãos pulmonar é o tema mais freqüente.

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“…The current emphasis of research guidelines on individual autonomy -the protection of the vulnerable -is primarily a reaction to historical tragedies. [5][6][7][8][9] It draws on the ethical tradition of deontological morality: the question of whether research treats participants as they ought to be treated or as they have a right to be treated. 5,10 This accords with the Hippocratic obligation to benefit the individual patient and its hallmarks are consent to participation and the right to non-interference.…”

Section: Ethics Of Public Health Research In Lowincome Countriesmentioning

confidence: 99%

Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia

Osrin

Azad²,

Fernandez

et al. 2009

Bull World Health Org

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Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of -and responsibility for -group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.Une traduction en français de ce résumé figure à la fin de l'article. Al final del artículo se facilita una traducción al español. ‫املقالة.‬ ‫لهذه‬ ‫الكامل‬ ‫النص‬ ‫نهاية‬ ‫يف‬ ‫الخالصة‬ ‫لهذه‬ ‫العربية‬ ‫الرتجمة‬

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Protecting the vulnerable: testing times for clinical research ethics

Cited by 69 publications

References 8 publications

Knowledge about the research and ethics committee at Makerere University, Kampala

Knowledge about the research and ethics committee at Makerere University, Kampala

Perfil da atividade de pesquisa encaminhada ao Congresso Brasileiro de Cirurgia Torácica - Tórax 2009

Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia

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