The Experts below are selected from a list of 121977 Experts worldwide ranked by ideXlab platform
Todd H. Wagner - One of the best experts on this subject based on the ideXlab platform.
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are central Institutional Review boards the solution the national heart lung and blood institute working group s report on optimizing the irb process
Academic Medicine, 2012Co-Authors: Alice M Mascette, Gordon R Bernard, Donna Dimichele, Jesse A Goldner, Robert A Harrington, Paul A Harris, Hilary S Leeds, Thomas A Pearson, Bonnie W Ramsey, Todd H. WagnerAbstract:The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health convened a working group in June 2011 to examine alternative Institutional Review board (IRB) models. The working group was held in response to proposed changes in the regulations for government-supported rese
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are central Institutional Review boards the solution the national heart lung and blood institute working group s report on optimizing the irb process
Academic Medicine, 2012Co-Authors: Alice M Mascette, Gordon R Bernard, Donna Dimichele, Jesse A Goldner, Robert A Harrington, Paul A Harris, Hilary S Leeds, Thomas A Pearson, Bonnie W Ramsey, Todd H. WagnerAbstract:The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health convened a working group in June 2011 to examine alternative Institutional Review board (IRB) models. The working group was held in response to proposed changes in the regulations for government-supported research and the proliferation of multicenter clinical trials where multiple individual Reviews may be inefficient. Group members included experts in heart, lung, and blood research, research oversight, bioethics, health economics, regulations, and information technology (IT). The group discussed alternative IRB models, ethical concerns, metrics for evaluating IRBs, IT needs, and economic considerations. Participants noted research gaps in IRB best practices and in metrics. The group arrived at recommendations for process changes, such as defining specific IRB performance requirements in funding announcements, requiring funded researchers to use more efficient alternative IRB models, and developing IT systems to facilitate information sharing and collaboration among IRBs. Despite the success of the National Cancer Institute's central IRB (CIRB), the working group, concerned about the creation costs and unknown cost-efficiency of a new CIRB, and about the risk of shifting the burden of dealing with multiple IRBs from sponsors to research institutions, did not recommend the creation of an NHLBI-funded CIRB.
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Costs and Benefits of the National Cancer Institute Central Institutional Review Board
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009Co-Authors: Todd H. Wagner, Christine Murray, Jacquelyn Goldberg, Jeanne Adler, Jeffrey S. AbramsAbstract:Purpose In 2001, the National Cancer Institute (NCI) formed the Central Institutional Review Board (CIRB) to conduct a single human subjects Review for its multisite phase III oncology trials. The goal of this study was to assess whether NCI's CIRB was associated with lower effort, time, and cost in processing adult phase III oncology trials. Methods We conducted an observational study and compared sites affiliated with the NCI CIRB to unaffiliated sites that used their local IRB for Review. Oncology research staff and IRB staff were surveyed to understand effort and timing. Response rates were 60% and 42%, respectively. Analysis of these survey data yielded information on effort, timing, and costs. We combined these data with CIRB operational data to determine the net savings of the CIRB using a societal perspective. Results CIRB affiliation was associated with faster Reviews (33.9 calendar days faster on average), and 6.1 fewer hours of research staff effort. CIRB affiliation was associated with a savin...
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economies of scale in Institutional Review boards
Medical Care, 2004Co-Authors: Todd H. Wagner, Anne Marie E Cruz, Gary L ChadwickAbstract:Background: Research with human subjects is essential for most clinical and social science research. As such, the ethical treatment of subjects, including the role of Institutional Review Boards (IRBs), is of paramount concern. The prevailing system of IRBs in the United States reflects an integrated approach in which research organizations have their own local IRB. Recent regulatory changes and a few high-profile problems have prompted proposals for greater investments in IRBs. Objectives: We conducted regression analyses, looking at how IRB size was associated with IRB costs (economies of scale). Research Design: We studied data from a cross-sectional survey. Subjects: We studied IRBs at Veterans Affairs (VA) and VA-affiliated medical centers (n = 109); 81 (73%) IRB administrators completed the survey. Fourteen of the administrators had missing data and were excluded from final analysis, leaving a sample of 67. Measures: The primary dependent variable was IRB costs in 2001, which we estimated from the survey. Independent variables included IRB size measured as the number of actions (ie, number of initial Reviews, amendments, continuing/annual Reviews, and harms/adverse event reports) Reviewed by the IRB in the last year. Results: The results indicate that very large economies of scale exist, especially for IRBs that handle fewer than 150 actions per year. Conclusions: A discussion of the costs of benefits of having 3000 to 5000 local IRBs in the United States is warranted because other organizational arrangements could be economically and socially advantageous.
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the cost of operating Institutional Review boards irbs
Academic Medicine, 2003Co-Authors: Todd H. Wagner, Gary L Chadwick, Aman Bhandari, Daniel K NelsonAbstract:ABSTRACTPurposeRecent reports have claimed that Institutional Review boards (IRBs) are underfunded, yet little is known about the costs of operating IRBs. This study estimated the costs for operating high-volume and low-volume IRBs.MethodIRB costs were calculated from published summary data. Costs w
Jeffrey S. Abrams - One of the best experts on this subject based on the ideXlab platform.
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meeting the challenge the national cancer institute s central Institutional Review board for multi site research
Journal of Clinical Oncology, 2018Co-Authors: Holly A Massett, Linda K Parreco, Sharon Hampp, Lori M Minasian, Jacquelyn Goldberg, M Mooney, Mike Montello, Grace Mishkin, Catasha Davis, Jeffrey S. AbramsAbstract:The National Institutes of Health (NIH) issued a new policy that requires a single Institutional Review board (IRB) of record be used for all protocols funded by the NIH that are carried out at more than one site in the United States, effective January 2018. This policy affects several hundred clinical trials opened annually across the NIH. Limited data exist to compare the use of a single IRB to that of multiple local IRBs, so some institutions are resistant to or distrustful of single IRBs. Since 2001, the National Cancer Institute (NCI) has funded a central IRB (CIRB) that provides human patient Reviews for its extensive national cancer clinical trials program. This paper presents data to show the adoption, efficiencies gained, and satisfaction of the CIRB among NCI trial networks and Reviews key lessons gleaned from 16 years of experience that may be informative for others charged with implementation of the new NIH single-IRB policy.
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Costs and Benefits of the National Cancer Institute Central Institutional Review Board
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009Co-Authors: Todd H. Wagner, Christine Murray, Jacquelyn Goldberg, Jeanne Adler, Jeffrey S. AbramsAbstract:Purpose In 2001, the National Cancer Institute (NCI) formed the Central Institutional Review Board (CIRB) to conduct a single human subjects Review for its multisite phase III oncology trials. The goal of this study was to assess whether NCI's CIRB was associated with lower effort, time, and cost in processing adult phase III oncology trials. Methods We conducted an observational study and compared sites affiliated with the NCI CIRB to unaffiliated sites that used their local IRB for Review. Oncology research staff and IRB staff were surveyed to understand effort and timing. Response rates were 60% and 42%, respectively. Analysis of these survey data yielded information on effort, timing, and costs. We combined these data with CIRB operational data to determine the net savings of the CIRB using a societal perspective. Results CIRB affiliation was associated with faster Reviews (33.9 calendar days faster on average), and 6.1 fewer hours of research staff effort. CIRB affiliation was associated with a savin...
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a central Institutional Review board for multi Institutional trials
The New England Journal of Medicine, 2002Co-Authors: Michaele C Christian, Jacquelyn Goldberg, Jeffrey S. Abrams, Jack Killen, Mary S Mccabe, Joan K Mauer, Robert E WittesAbstract:These are difficult times for the nation's system of protection for human subjects in research.1–10 On the basis of a series of reports, the Office of the Inspector General of the Department of Health and Human Services concluded that Institutional Review boards (IRBs) are now forced to “Review too much, too quickly, with too little expertise,” and with inadequate resources.6 One consequence is that there is minimal, often perfunctory, Review of ongoing research. In addition, IRB members have become disillusioned as a result of both public criticism concerning the perceived failures of the boards and the increasing amount of . . .
Carlos A Camargo - One of the best experts on this subject based on the ideXlab platform.
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variation in Institutional Review board responses to a standard observational pediatric research protocol
Academic Emergency Medicine, 2007Co-Authors: Jonathan M Mansbach, Uchechi Acholonu, Sunday Clark, Carlos A CamargoAbstract:Background: Multicenter studies are becoming more common, and variability in local Institutional Review board (IRB) assessments can be problematic. Objective: To investigate the variability of IRB responses to a multicenter observational study of children presenting to emergency departments. Methods: The authors collected the original IRB applications, subsequent correspondence, and a survey assessing submission timing and response and the nature of IRB queries. The study was conducted as part of the Emergency Medicine Network http://www.emnet-usa.org Results: Of 37 sites initiating the IRB process, 34 (92%) participated in this IRB-approved study. Institutional Review boards returned initial applications in a median of 19 days (IQR, 11–34 d), and 91% considered the protocol to be minimal risk. Of 34 submissions, 13 required no changes, 18 received conditional approvals, and 3 were deferred. The median time from initial submission to final approval was 42 days (IQR, 27–61 d). Seven sites did not participate in patient recruitment: two had Institutional issues, one obtained IRB approval too late for participation, and four sites (12%) reported that IRB hurdles contributed to their lack of participation. Nonetheless, 68% of sites that recruited patients reported that the overall experience made them more likely to participate in future multicenter research. Conclusions: There was substantial variation in IRB assessment of a standard protocol in this study. The burden of the application process contributed to some investigators not participating, but the majority of investigators remain enthusiastic about multicenter research. A national IRB may streamline the Review process and facilitate multicenter clinical research.
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variation in Institutional Review board responses to a standard protocol for a multicenter clinical trial
Academic Emergency Medicine, 2001Co-Authors: Thomas O Stair, Carlos A Camargo, Greg Koski, Caitlin R Reed, Michael S RadeosAbstract:Abstract. Multicenter clinical trials require approval by multiple local Institutional Review boards (IRBs). The Multicenter Airway Research Collaboration mailed a clinical trial protocol to its U.S. investigators and 44 IRBs ultimately Reviewed it. Objective: To describe IRB responses to one standard protocol and thereby gain insight into the advantages and disadvantages of local IRB Review. Methods: Two surveys were mailed to participants, with telephone follow-up of nonrespondents. Survey 1 was mailed to 82 investigators across North America. Survey 2 was mailed to investigators from 44 medical centers in 17 U.S. states. Survey 1 asked about each investigator's local IRB (e.g., frequency of meetings, membership), whereas survey 2 asked about IRB queries and concerns related to the submitted clinical trial. Results: Both surveys had 100% response rate. Investigators submitted applications a median of 58 days (interquartile range [IQR], 40-83) after receipt of the protocol, and IRB approval took an additional 38 days (IQR, 26-62). Although eight applications were approved with little or no changes, IRBs requested an average of 3.5 changes per site. Changes involved study logistics and supervision for 45%, the research process for 43%, and the consent form for 91%. Despite these numerous requests, all eventually approved the basic protocol, including inclusion criteria, intervention, and data collection. Conclusions: The IRBs showed extreme variability in their initial responses to a standard protocol, but ultimately all gave approval. Almost all IRBs changed the consent form. A national, multicenter IRB process might streamline ethical Review and warrants further consideration.
Tracy Ziolek - One of the best experts on this subject based on the ideXlab platform.
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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
Clinical Trials, 2019Co-Authors: Michael P Diamond, Esther Eisenberg, Hao Huang, Christos Coutifaris, Richard S Legro, Karl R Hansen, Anne Z Steiner, Marcelle I Cedars, Kurt T Barnhart, Tracy ZiolekAbstract: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 beds...
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time to Institutional Review board approval with local versus central Review in a multicenter pragmatic trial
Clinical Trials, 2018Co-Authors: Mark D Neuman, Lakisha J Gaskins, Tracy ZiolekAbstract:Background/aims:Central Institutional Review board (IRB) Review will be required for National Institutes of Health–funded multisite human subjects research as of January 2018, with similar requirements extending to most US multisite human research in 2020. Nonetheless, little is known regarding the relative efficiency of central versus local IRB Review for multicenter studies. We compared the amount of time required for central versus local IRB Review and approval for sites in one ongoing multicenter randomized trial.Methods:The REGAIN Trial (Regional versus General Anesthesia for Promoting Independence after Hip Fracture; clinicaltrials.gov number: NCT02507505) is an ongoing randomized trial comparing standard-care spinal anesthesia to standard-care general anesthesia for patients undergoing hip fracture surgery. After approval of the protocol by the sponsor IRB, each participating US site opted either to submit the protocol for local IRB Review or to designate the sponsor IRB as the IRB of record (i.e. ...
Robert T Schooley - One of the best experts on this subject based on the ideXlab platform.
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breaking the camel s back multicenter clinical trials and local Institutional Review boards
Annals of Internal Medicine, 2001Co-Authors: William J Burman, Randall Reves, David L Cohn, Robert T SchooleyAbstract:Clinical research has undergone remarkable and beneficial expansion in the past 25 years, but with this growth has come an unprecedented increase in workload for the human subjects protection system. Recently, a major change in federal oversight of local Institutional Review boards (IRBs) became evident. Although it was not announced publicly, in 1998 and 1999 federal regulatory actions against local IRBs increased threefold. Particularly notable was the marked increase in regulatory actions taken against the IRBs of academic medical centers (1 in 1997 compared with 14 in 1999). Ironically, this apparent federal crackdown began at the same time that two federal Review panels called for major changes in the regulations governing local IRBs. A key factor in the current crisis in the function of local IRBs is the ascendance of multicenter clinical trials as the dominant form of clinical research. Local IRBs were not designed to handle the initial evaluation and ongoing Review required by the rapidly increasing number of multicenter clinical trials. Furthermore, local IRB Review of the thousands of safety reports from multicenter clinical trials monopolizes resources without promoting patient safety. Instead of rigid enforcement of outmoded regulations that do not contribute to patient safety, the responsibilities of the local IRB in the oversight of multicenter clinical trials must be systematically evaluated.
