Review of multicenter studies by multiple institutional review boards: characteristics and outcomes for perinatal studies implemented by a multicenter network

Abramovici, Adi; Salazar, Ashley; Edvalson, Tonya; Gallagher, Nancy; Dorman, Karen; Tita, Alan T.N.

doi:10.1016/j.ajog.2014.07.058

Cited by 7 publications

(6 citation statements)

References 21 publications

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“…Prior reports have identified great variability in requests arising from IRB protocol review. [5][6][7][8][9][10] These evaluations can include requests for clarification of, or changes to, the protocol, additional safety testing, alterations in patient population included, changes in inclusion or exclusion criteria, and alteration of wording of consent form. For multicenter protocols, variation in requests from different local IRBs typically results in further delays while differences are adjudicated through the coordinating center.…”

Section: Discussionmentioning

confidence: 99%

“…4 Such an approach may also reduce variability of decisions of IRBs at different institutions and improve consistency in informed consent documents. [5][6][7][8][9][10] However, there has been hesitancy by many medical schools and medical centers/hospitals to use sIRBs. 2,11,12 Stated concerns included adequacy of review, uncertainty that sIRB would recognize and/or address local considerations, concern with expertise of sIRB members, and concern for local institutional liability following central review.…”

Section: Introductionmentioning

confidence: 99%

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The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials

et al. 2018

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Background/aims: Timely review of research protocols by institutional review boards leads to more rapid initiation of clinical trials, which is critical to expeditious translation from bench to bedside. This observational study examined the impact of a single institutional review board on time and efforts required to initiate clinical trials by the National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network. Methods: Collection of data from the same six main clinical sites for three current clinical trials and two past clinical trials, including time from institutional review board submission to approval, pages submitted, consent form length, number of required attachments, other regulatory requirements, order of review at central or local sites, and language in documents at individual participating sites. Results from two past clinical trials were also included. Results: While time required for actual institutional review board submission's review and initial approval was reduced with use of a single institutional review board for multicenter trials (from a mean of 66.7-24.0 days), total time was increased (to a mean of 111.2 or 123.3 days). In addition to single institutional review board approval, all institutions required local approval of some components (commonly consent language and use of local language), which varied considerably. The single institutional review board relied on local institutions for adding or removing personnel, conflict of interest review, and auditing of activities.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials

et al. 2018

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“…Researchers also report frustration with many aspects of multisite ethics review, including delays, the increased time, effort and cost to address changes, lack of cooperation between ethics boards, and the lack of standardization in ethics review [4,31,35]. Unfortunately, the research community is experiencing major issues with the way ethics boards respond to multisite research protocols that may negatively impact researchers, potential and current research participants, and the public [2,8,[36][37][38].…”

Section: The Status Quo: Research Ethics Review By Local Boardsmentioning

confidence: 99%

Multisite Research Ethics Review: Problems and Potential Solutions

Ferguson

Master

2018

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Large scale, multisite clinical research trials have been increasing in frequency. As it stands currently, a research project performed at multiple institutions requires ethics review at each institution. While local (institutional) review may be necessary in some instances, repetitive reviews may require unnecessary changes and not serve to further protect participants. Multiple ethics reviews of a single study have been shown to delay research and require, in some cases, significant resources in order to fulfill the requests of individual ethics boards. This literature review discusses the conceptual issues and outlines empirical research surrounding multisite ethics review from different jurisdictions, as well as alternative methods to streamline the ethics review process including reciprocal review, centralized review, and a proposed modification to the centralized review process.

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“…For all multicenter studies, whether pragmatic or explanatory, oversight by numerous local IRBs can pose challenges. [39][40][41][42][43] Variability across institutions in approaches and interpretation of regulations are important contributors to the slow pace and expense of large trials, and it has been argued that review by multiple IRBs may paradoxically reduce protections to participants. 44 For pragmatic trials, particularly those that use cluster-wide implementation of an intervention, variability across institutions in the interpretation of regulations, such as the criteria for waiving informed consent, can result not only in delays but also in irresolvable impasses.…”

Section: Institutional Review Boardsmentioning

confidence: 99%

Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative

Dember

Archdeacon

Krishnan³

et al. 2016

JASN

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Pragmatic clinical trials are conducted under the real-world conditions of clinical care delivery. As a result, these trials yield findings that are highly generalizable to the nonresearch setting, identify interventions that are readily translatable into clinical practice, and cost less than trials that require extensive research infrastructures. Maintenance dialysis is a setting especially well suited for pragmatic trials because of inherently frequent and predictable patient encounters, highly granular and uniform data collection, use of electronic data systems, and delivery of care by a small number of provider organizations to approximately 90% of patients nationally. Recognizing the potential for pragmatic trials to generate much needed evidence to guide the care of patients receiving maintenance dialysis, the Kidney Health Initiative assembled a group of individuals with relevant expertise from academia, industry, and government to provide the nephrology community with information about the design and conduct of such trials, with a specific focus on the dialysis setting. Here, we review this information, and where applicable, use experience from the ongoing Time to Reduce Mortality in End Stage Renal Disease Trial, a large cluster-randomized, pragmatic trial evaluating hemodialysis session duration, to illustrate challenges and solutions to operational, ethical, and regulatory issues.

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Review of multicenter studies by multiple institutional review boards: characteristics and outcomes for perinatal studies implemented by a multicenter network

Cited by 7 publications

References 21 publications

The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials

The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials

Multisite Research Ethics Review: Problems and Potential Solutions

Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative

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