A Central Institutional Review Board for Multi-Institutional Trials

Christian, Michaele C.; Goldberg, Jacquelyn; Killen, Jack; Abrams, Jeffrey S.; McCabe, Mary S.; Mauer, Joan; Wittes, Robert E.

doi:10.1056/nejm200205023461814

Cited by 124 publications

(77 citation statements)

References 11 publications

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“…35 ing viewpoints regarding the role of the REB: "that increased oversight of clinical research is essential" and "that greater protection of research subjects will interfere with medical progress." Christian and coworkers 37 argue that "the burdens associated with securing approval from the local IRB for [multicentre cancer treatment] studies limits [physician-investigators'] interest in participation." Centralized REBs have been proposed as one mechanism to facilitate more rapid, independent review of pharmaceutical company sponsored research and complex multicentre trials.…”

Section: Discussionmentioning

confidence: 99%

“…Centralized REBs have been proposed as one mechanism to facilitate more rapid, independent review of pharmaceutical company sponsored research and complex multicentre trials. [37][38][39] Early success with this approach has recently been reported in the context of multicentre studies of cancer treatment. 37 In this model, the responsibilities and authority of the central and local REBs are formally divided: a central panel of experts with extensive REB experience reviews each protocol and then submits it to the local REB, which may conduct a full review or a more efficient "facilitated review."…”

Section: Discussionmentioning

confidence: 99%

“…37 In this model, the responsibilities and authority of the central and local REBs are formally divided: a central panel of experts with extensive REB experience reviews each protocol and then submits it to the local REB, which may conduct a full review or a more efficient "facilitated review." 37 Such an approach might be useful in reviewing ethically complex protocols involving an exception over a reasonable time frame.…”

Section: Discussionmentioning

confidence: 99%

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Ethical challenges of informed consent in prehospital research

Thompson

2003

CJEM

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Informed consent to participation in research is an important protector of potential subjects' rights and autonomy. Ethical research involving critically ill people is challenging because their medical condition often makes obtaining informed consent impossible. This is especially true in the prehospital setting, where additional barriers to obtaining informed consent exist. A recently published Canadian policy (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans) specifies circumstances under which an exception to the requirement for informed consent may be granted so that vulnerable individuals are not denied the potential benefits of participating in research. This article reviews the rationale for the Tri-Council Policy Statement and illustrates some problems with its application in the context of a Canadian prehospital study on continuous positive airway pressure. A new risk analysis model and a national research ethics board are discussed as possible ways to facilitate interpretation and application of the current exception of informed consent policy. RÉSUMÉLe consentement libre et éclairé avant la participation à un projet de recherche est une garantie de protection importante des droits et de l'autonomie des sujets pressentis. La recherche éthique impliquant des personnes gravement malades représente un défi puisque la gravité de leur état empêche souvent ces personnes de donner leur consentement libre et éclairé. Une telle situation prévaut particulièrement dans le milieu pré-hospitalier où il existe d'autres entraves à l'obtention d'un consentement éclairé. Une politique canadienne publiée récemment (Énoncé de politique des Trois Conseils : Éthique de la recherche avec des êtres humains) précise les circonstances selon lesquelles une exception aux exigences de consentement éclairé pourrait être accordée afin que des individus vulnérables ne se voient pas refuser les bienfaits potentiels de la participation à une recherche. Le présent article passe en revue la synthèse de l'Énoncé de politique des Trois Conseils et illustre certains problèmes liés à son application dans le contexte d'une étude pré-hospitalière canadienne sur la ventilation sous pression positive continue. On discute d'un nouveau modèle d'analyse des risques et de la mise en place d'un comité national d'éthique en recherche comme moyens de faciliter l'interprétation et l'application de l'exception actuelle de la politique de consentement libre et éclairé.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Ethical challenges of informed consent in prehospital research

Thompson

2003

CJEM

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“…Furthermore, centralized review boards facilitate access to expert panels comprised of representatives from a variety of disciplines. It is possible that a national review board responsible for vetting the ethical standards of research protocols coupled with local autonomy for overseeing adherence to ethical conduct could effectively enhance efficiencies while ensuring research subjects are protected (18)(19)(20). However, there are also drawbacks to a unified review system.…”

Section: Possibilities For Improvementmentioning

confidence: 99%

Ethics application protocols for multicentre clinical studies in Canada: A paediatric rheumatology experience

Matheson

Huber

Warner

et al. 2012

Paediatrics and Child Health

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“…Future plans include consideration of the creation of a common IRB review platform, modeled after the National Cancer Institute's Centralized IRB initiative. 9 Standardizing approaches to recruitment and data collection across multiple sites can be onerous, since collaborators may all approach a multisite study with different ideas for the study design. The HMORN has vast experience with recruiting and retaining a wide array of different study populations for multisite studies.…”

Section: Research Review and Implementationmentioning

confidence: 99%

The Coordinated Clinical Studies Network: A Multidisciplinary Alliance to Facilitate Research and Improve Care.

Greene¹

2005

permj

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The NIH Roadmap is a major effort to reshape the US health research enterprise to accelerate medical discovery and to do so in such a way that actually hastens population health improvement through research. The Roadmap's ultimate goal resonates with the HMO Research Network, a consortium of integrated health care systems that uses its collective scientific capabilities to integrate research, practice, and policy for the improvement of health and health care among diverse populations. (See page 6 for abstracts from the HMO Research Network annual conference.) As such, the HMO Research Network was ideally suited to propose a new consortium project as a part of the NIH Roadmap, the Coordinated Clinical Studies Network (CCSN). The CCSN was funded in 2004 to create a path-breaking research facility that leverages several distinctive features of the HMO Research Network: the multidisciplinary scientific capabilities of its researchers; the ability to rapidly move clinical research findings into care delivery; its large, diverse patient populations; and a commitment to placing its findings in the public domain. Among the goals of the CCSN are to augment the capacity and infrastructure for conducting research, and to use considerable investments in health informatics to improve the scope and efficiency of research data collection. The NIH Roadmap is a revolutionary step toward a new paradigm for research and responds to both a compelling social need and rapid technological advances in biomedicine. The CCSN's participation in the Roadmap Initiative is a unique opportunity for researchers, clinicians, and our patients.effort on the part of the National Institutes of Health (NIH), dubbed the NIH Roadmap. The Roadmap is designed to accelerate progress on pressing scientific questions, synergistically leverage the NIH research agenda to address these questions, remove impediments to efficiently conducting research, and facilitate uptake in everyday clinical practice. Roadmap activities are vast initiatives (http://nihroadmap.nih.gov). Each is based in the director's office and administered through a single designated institute. However, each initiative involves all institutes of NIH and importantly, each one is funded from agreed-upon contributions from individual institutes' budgets. Research Partnerships with Community PartnersAn important pillar in the NIH Roadmap is the initiative, "Re-engineering the Clinical Research Enterprise." This endeavor is designed to spur new research partnerships between researchers and community practices that care for large, diverse patient populations.1 This initiative resonated with the members of the HMO Research Network (HMORN), a consortium of 14 health plans situated across all regions of the US, including six Kaiser Permanente (KP) Regions. All of the HMORN members have formal, recognized research capabilities, and a commitment to using their collective scien- Integrating and Expanding the Research EnterpriseThe US national landscape for conducting clinical and health service...

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A Central Institutional Review Board for Multi-Institutional Trials

Cited by 124 publications

References 11 publications

Ethical challenges of informed consent in prehospital research

Ethical challenges of informed consent in prehospital research

Ethics application protocols for multicentre clinical studies in Canada: A paediatric rheumatology experience

The Coordinated Clinical Studies Network: A Multidisciplinary Alliance to Facilitate Research and Improve Care.

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