Sample records for board approved protocol
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Site Variability in Regulatory Oversight for an International Study of Pediatric Sepsis.
Michelson, Kelly N; Reubenson, Gary; Weiss, Scott L; Fitzgerald, Julie C; Ackerman, Kate K; Christie, LeeAnn; Bush, Jenny L; Nadkarni, Vinay M; Thomas, Neal J; Schreiner, Mark S
2018-04-01
Duplicative institutional review board/research ethics committee review for multicenter studies may impose administrative burdens and inefficiencies affecting study implementation and quality. Understanding variability in site-specific institutional review board/research ethics committee assessment and barriers to using a single review committee (an increasingly proposed solution) can inform a more efficient process. We provide needed data about the regulatory oversight process for the Sepsis PRevalence, OUtcomes, and Therapies multicenter point prevalence study. Survey. Sites invited to participate in Sepsis PRevalence, OUtcomes, and Therapies. Investigators at sites that expressed interest and/or participated in Sepsis PRevalence, OUtcomes, and Therapies. None. Using an electronic survey, we collected data about 1) logistics of protocol submission, 2) institutional review board/research ethics committee requested modifications, and 3) use of a single institutional review board (for U.S. sites). We collected surveys from 104 of 167 sites (62%). Of the 97 sites that submitted the protocol for institutional review board/research ethics committee review, 34% conducted full board review, 54% expedited review, and 4% considered the study exempt. Time to institutional review board/research ethics committee approval required a median of 34 (range 3-186) days, which took longer at sites that required protocol modifications (median [interquartile range] 50 d [35-131 d] vs 32 d [14-54 d)]; p = 0.02). Enrollment was delayed at eight sites due to prolonged (> 50 d) time to approval. Of 49 U.S. sites, 43% considered using a single institutional review board, but only 18% utilized this option. Time to final approval for U.S. sites using the single institutional review board was 62 days (interquartile range, 34-70 d) compared with 34 days (interquartile range, 15-54 d) for nonsingle institutional review board sites (p = 0.16). Variability in regulatory oversight was evident for this minimal-risk observational research study, most notably in the category of type of review conducted. Duplicative review prolonged time to protocol approval at some sites. Use of a single institutional review board for U.S. sites was rare and did not improve efficiency of protocol approval. Suggestions for minimizing these challenges are provided.
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Biometrics IRB best practices and data protection
NASA Astrophysics Data System (ADS)
Boehnen, Christopher; Bolme, David; Flynn, Patrick
2015-05-01
The collection of data from human subjects for biometrics research in the United States requires the development of a data collection protocol that is reviewed by a Human Subjects Institutional Review Board (IRB). The IRB reviews the protocol for risks and approves it if it meets the criteria for approval specified in the relevant Federal regulations (45 CFR 46). Many other countries operate similar mechanisms for the protection of human subjects. IRBs review protocols for safety, confidentiality, and for minimization of risk associated with identity disclosure. Since biometric measurements are potentially identifying, IRB scrutiny of biometrics data collection protocols can be expected to be thorough. This paper discusses the intricacies of IRB best practices within the worldwide biometrics community. This is important because research decisions involving human subjects are made at a local level and do not set a precedent for decisions made by another IRB board. In many cases, what one board approves is not approved by another board, resulting in significant inconsistencies that prove detrimental to both researchers and human subjects. Furthermore, the level of biometrics expertise may be low on IRBs, which can contribute to the unevenness of reviews. This publication will suggest possible best practices for designing and seeking IRB approval for human subjects research involving biometrics measurements. The views expressed are the opinions of the authors.
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Siemionow, Maria Z; Gordon, Chad R
2010-10-01
Preliminary outcomes from the previous nine face transplants performed since 2005 have been encouraging and have therefore led to a rise in the number of medical centers interested in establishing face transplant programs worldwide. However, until now, very little literature has been published providing surgeons the necessary insight on how to (1) prepare a protocol for institutional review board approval and (2) establish a face transplant program. The authors' face transplant team's experience with the institutional review board at the Cleveland Clinic, beginning in 2002, was critically reviewed in a detailed, retrospective manner. The purpose was to identify and define certain criteria necessary for both the institutional review board approval process and face transplant program establishment. In 2002, unprecedented efforts from within the authors' plastic surgery department led to the world's first institutional review board approval for face transplantation, in 2004. As a result, 4 years later, the authors' face transplant team performed the nation's first successful near-total face and maxilla transplant. Every surgical department hoping to establish a face transplant program must realize that this endeavor requires both tremendous financial and long-term commitments by its medical institution. These transplants should be performed only within university-based medical centers capable of orchestrating a specialized, talented, multidisciplinary team. More importantly, facial composite tissue allotransplantation possesses an unmatched level of complexity and therefore requires most centers to prepare a carefully detailed protocol using these institutional review board-based guidelines.
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Code of Federal Regulations, 2010 CFR
2010-01-01
... clinical study involving human subjects under a clinical research protocol approved by an institutional review board. (2) Clinical research has the meaning set forth in 42 U.S.C. 284d(b). (3) Institutional... review a clinical research protocol and approve the initiation of biomedical research involving human...
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Analysis of research ethics board approval times in an academic department of medicine.
Tsang, Teresa S M; Jones, Meaghan; Meneilly, Graydon S
2015-04-01
As part of an ongoing effort to better understand barriers to academic research, we reviewed and analyzed the process of research ethics applications, focusing on ethics approval time, within the Department of Medicine from 2006 to 2011. A total of 1,268 applications for approval to use human subjects in research were included in our analysis. Three variables, risk category (minimal vs. non-minimal risk), type of funding, and year of submission, were statistically significant for prediction of ethics approval time, with risk status being the most important of these. The covariate-adjusted mean time for approval for minimal risk studies (35.7 days) was less than half that of non-minimal risk protocols (76.5 days). Studies funded through a for-profit sponsor had significantly longer approval times than those funded through other means but were also predominantly (87%) non-minimal risk protocols. Further investigations of the reasons underlying the observed differences are needed to determine whether improved training for research ethics board (REB) members and/or greater dialogue with investigators may reduce the lengthy approval times associated with non-minimal risk protocols. © The Author(s) 2015.
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A caution to Native American institutional review boards about scientism and censorship.
Askland, Andrew
2002-01-01
Native American Institutional Review Boards (IRBs) promote the health and welfare of tribes by reviewing protocols for research studies that focus on their tribes. The benefits of approved protocols should not be overstated lest good studies disappoint because they do not satisfy unachievable expectations. IRBs also should avoid the temptation to censor the outcomes of those studies. Science relies on candor and clarity about results and methods to move forward.
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Discovery of Novel Gene Elements Associated with Prostate Cancer Progression
2014-12-01
consent under an Institutional Review Board (IRB) approved protocol at the University of Michigan [SPORE in Prostate Cancer (Tissue/Serum/Urine) Bank IRB...1994-0481]. For the Weill Cornell Medical College patient samples, prostate tissues were collected as part of an IRB- approved protocol at Weill...PCAT-1 or nontargeting short hairpin RNA (shRNA) lentiviral constructs for 48 hours. GFPþ cells were drug -selected using 1 mg/mL puromycin. PCAT-1
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2013-10-01
regulatory and administrative approvals from the US Department of Defense, the Human Research Protection Offices, and the local ethic board. The...submission of the corresponding documents to Health Canada and McGill University Health Center (MUHC) for Canadian regulatory approval (IND/CTA) and Ethics ...the investigator, Dr. Mohan Radhakrishna, submitted amended protocol and ICF to the Institutional (MUHC) Ethics Review Board. • Task 1i (June 11
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Zia, Mohammad I; Heslegrave, Ronald; Newton, Gary E
2011-12-01
The post-trial period is the time period after the end of study drug administration. It is unclear whether post-trial arrangements for patient surveillance are routinely included in study protocols and consents, and whether research ethics boards (REB) consider the post-trial period. The objective was to determine whether trial protocols and consent forms reviewed by the REB describe procedures for post-trial period surveillance. An observational study of protocols of randomised trials of chronic therapies for cardiac conditions, approved by the REB of two academic institutions affiliated with the University of Toronto in Canada (University Health Network and Mount Sinai Hospital) from 1995 to 2007. Plans for patient surveillance in the post-trial period described in the protocol or in the consent form before and after REB approval were recorded. 42 studies were identified including 18 heart failure and 15 coronary artery disease trials. Only four studies planned a clinical visit after trial termination, and an additional three planned a telephone contact after trial completion. Five trials submitted consent forms to the REB with a discussion of the post-trial period. The majority of protocols and consent forms did not discuss plans for post-trial period surveillance. The post-trial period and the REB approval process could be improved by systematic follow-up being described in the protocol and consent form. The small number of trial protocols evaluated in the study may impair the degree to which the results can be generalised.
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Research ethics board approval for an international thromboprophylaxis trial.
Lutz, Kristina; Wilton, Kelly; Zytaruk, Nicole; Julien, Lisa; Hall, Richard; Harvey, Johanne; Skrobik, Yoanna; Vlahakis, Nicholas; Meade, Laurie; Matte, Andrea; Meade, Maureen; Burns, Karen; Albert, Martin; Cash, Bronwyn Barlow; Vallance, Shirley; Klinger, James; Heels-Ansdell, Diane; Cook, Deborah
2012-06-01
Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial. We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF). Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77% completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54% of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits. More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards. Copyright © 2012 Elsevier Inc. All rights reserved.
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Gonorazky, Sergio E
2008-01-01
The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT) requires that an independent ethics committee of sponsors and/or researchers must previously evaluate and approve all the new pharmacological research protocols carried out on human beings. However, due to the lucrative nature of the evaluation, and because the selection of the Independent Ethics Committee is carried out by the sponsors and/or researchers, the assumed autonomy of the former can be reduced to merely a relationship of "service provider-customer". The Institutional Review Board of the Mar del Plata s Community Hospital has evaluated, between 2005 and 2006, thirty three research protocols (with their corresponding information sheets for patients and informed consent forms) previously approved by a non-institutional Independent Ethics Committee. The median number of objections made by the Institutional Review Board, which prompted the previously mentioned protocols to be modified in order to be approved, was of three per protocol. In other words, the accreditation of an Independent Ethics Committee requires a system that guarantees actual independence from the sponsors and/or researchers, as well as management control mechanisms that may lead them into an eventual loss of accreditation. Several measures are proposed in order to correct the deficiencies of the present system.
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Kimberly, Michael B; Hoehn, K Sarah; Feudtner, Chris; Nelson, Robert M; Schreiner, Mark
2006-05-01
To systematically compare standards for compensation and child participant assent in informed permission, assent, and consent forms (IP-A-CFs) approved by 55 local institutional review boards (IRBs) reviewing 3 standardized multicenter research protocols. Sixty-nine principal investigators participating in any of 3 national, multicenter clinical trials submitted standardized research protocols for their trials to their local IRBs for approval. Copies of the subsequently IRB-approved IP-A-CFs were then forwarded to an academic clinical research organization. This collection of IRB-approved forms allowed for a quasiexperimental retrospective evaluation of the variation in informed permission, assent, and consent standards operationalized by the local IRBs. Standards for compensation and child participant assent varied substantially across 69 IRB-approved IP-A-CFs. Among the 48 IP-A-CFs offering compensation, monetary compensation was offered by 33 as reimbursement for travel, parking, or food expenses, whereas monetary or material compensation was offered by 22 for subject inconvenience and by 13 for subject time. Compensation ranged widely within and across studies (study 1, $180-1425; study 2, $0-500; and study 3, $0-100). Regarding child participant assent, among the 57 IP-A-CFs that included a form of assent documentation, 33 included a line for assent on the informed permission or consent form, whereas 35 included a separate form written in simplified language. Of the IP-A-CFs that stipulated the documentation of assent, 31 specified > or =1 age ranges for obtaining assent. Informed permission or consent forms were addressed either to parents or child participants. In response to identical clinical trial protocols, local IRBs generate IP-A-CFs that vary considerably regarding compensation and child participant assent.
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Establishing the first institutional animal care and use committee in Egypt.
Fahmy, Sohair R; Gaafar, Khadiga
2016-04-09
Although animal research ethics committees (AREC) are well established in Western countries, this field is weakly developed and its concept is poorly understood in the Middle East and North Africa region. Our main objective was to introduce the concept and requirements of ethical approaches in dealing with experimental animal in research and teaching in Egypt. Due to its very recent inception, Cairo University, Faculty of Science IACUC decided to operate in accordance with Guide for the Care and Use of Laboratory Animals 8th Edition 2011 (the Guide) since Egypt has not yet compiled its own guide. Fifty protocols were reviewed in 2013-2014. Only ten protocols were reviewed in 2013, but in 2014, forty protocols were reviewed. In 2013 all protocols were approved and in 2014, number of approvals were 35, the number of deferrals were 4, and one refused protocol. Master's theses (MSc) research protocols constituted the majority of the total reviewed protocols. This is attributed to the decision of the Board of the Faculty of Science, Cairo University in September, 2013 that the approval of the IACUC is mandatory before conducting any research involving animals or theses registration. The first IACUC was established in the Cairo University, Faculty of Science, since 2012. The challenges encountered by the committee were diverse, such as the absence of laws that control the use of animal models in scientific research, lack of guidelines (protocols for experimental animals in research) and, mandatory ethical approval for any experimental animal research.
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Carbon Offsets in California: What Role for Earth Scientists in the Policy Process? (Invited)
NASA Astrophysics Data System (ADS)
Cullenward, D.; Strong, A. L.
2013-12-01
This talk addresses the policy structure in California for developing and approving carbon offset protocols, which rely on findings from the environmental and earth sciences communities. In addition to providing an overview of the legal requirements of carbon offsets, we describe a series of case studies of how scientists can engage with policymakers. Based on those experiences, we suggest ways for the earth sciences community to become more involved in climate policy development. California's climate law, known as AB 32, requires that major sectors of the state's economy reduce their emissions to 1990 levels by 2020. As part of AB 32, the California Air Resources Board created a cap-and-trade market to ensure compliance with the statutory target. Under this system, regulated companies have to acquire tradable emissions permits (called 'compliance instruments') for the greenhouse gas emissions they release. The State allocates a certain number of allowances to regulated entities through a mixture of auctions and free transfers, with the total number equal to the overall emissions target; these allowances, along with approved offsets credits, are the compliance instruments that regulated entities are required to obtain by law. One of the key policy design issues in California's cap-and-trade market concerns the use of carbon offsets. Under AB 32, the Air Resources Board can issue offset credits to project developers who reduce emissions outside of the capped sectors (electricity, industry, and transportation)--or even outside of California--pursuant to approved offset protocols. Project developers then sell the credits to regulated companies in California. Essentially, offsets allow regulated entities in California to earn credit for emissions reductions that take place outside the scope of AB 32. Many regulated entities and economists are in favor of offsets because they view them as a source of low-cost compliance instruments. On the other hand, critics argue that some offset protocols award credits for activities that would have occurred anyway; by replacing a company's need to acquire an allowance in the carbon market, critics believe that poorly designed offset protocols increase greenhouse gas emissions. Thus, the effectiveness of the policy approach depends on the scientific integrity of the offset protocols. To date, California has approved offset protocols for emissions reductions in four applications: (1) forestry, (2) urban forestry, (3) livestock, and (4) destruction of ozone-depleting substances. In addition, the State is currently considering protocols that would address (5) methane emissions from mining and (6) greenhouse gas reductions from improved rice cultivation practices. These protocols rely heavily on findings from the environmental and earth sciences communities, especially when the protocol subject involves land use or land use change. Yet, due to budget constraints, the Air Resources Board is relying primarily on third-party protocol developers to design and propose the detailed structures under which offset credits will be issued. Despite the fact that any member of the public may participate in the governance regime that leads to protocol approvals, few scientists or scientific organizations provide input into the policy process. We use case studies from several of the California protocols to illustrate ways scientists can apply their skills to a crucial stage of climate policy development.
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Multicenter Clinical Trial of Keratin Biomaterials for Peripheral Nerve Regeneration
2013-10-01
As soon as the IND is available, our team will be able to obtain final approval for the study protocol from the Copernicus Group, an independent... Copernicus Group, an independent IRB located in Research Triangle Park, North Carolina. Due to the conflict of interest policies at the Wake Forest...School of Medicine, Dr. Li was asked to send the protocol to an independent review board. October 13, 2010: The Copernicus Group granted conditional
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Wao, Hesborn; Mhaskar, Rahul; Kumar, Ambuj; Miladinovic, Branko; Guterbock, Thomas; Hozo, Iztok; Djulbegovic, Benjamin
2014-10-01
To investigate factors, which influence institutional review boards' (IRBs') decision to approve or not approve clinical studies, a nationwide vignette-based online survey of IRB members was conducted. A factorial design was used, whereby seven aspects of each hypothetical study were randomly varied in 15 phrases in each vignette to produce unique vignettes. Participants indicated the degree of study approval and described factors influencing approval decision. Qualitative responses were thematically content analyzed. Sixteen themes were obtained from 208 participants from 42 institutions. Uncertainty, adherence, study design, and harms were frequently and intensely cited to influence study approval. Analysis of two extreme subgroups (approvers vs. nonapprovers) showed that uncertainty influenced approval decisions, odds ratios (OR) = 3.5 (95% confidence interval [CI], 1.3-9.8) and OR = 3.2 (95% CI, 1.1-8.9), respectively, based on theme frequency and theme intensity, ignoring multiple observations per person. Taking into consideration multiple observations per person, similar results were obtained for uncertainty: OR = 8.9 (95% CI, 0.93-85.4). Perceived uncertainty about benefits and harms of a proposed intervention is a key driver in IRB members' approval of clinical trials. This, in turn, calls for improved standardization in the communications of information on benefits and harms in the research protocols considered by the IRBs. Published by Elsevier Inc.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Bernstein, Dr. Ira
This grant was awarded in support of Phase 2 of the University of Vermont Center for Biomedical Imaging. Phase 2 outlined several specific aims including: The development of expertise in MRI and fMRI imaging and their applications The acquisition of peer reviewed extramural funding in support of the Center The development of a Core Imaging Advisory Board, fee structure and protocol review and approval process.
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The Myth, the Truth, the NASA IRB
NASA Technical Reports Server (NTRS)
Covington, M. D.; Flores, M. P.; Neutzler, V. P.; Schlegel, T. T.; Platts, S. H.; Lioyd, C. W.
2017-01-01
The purpose of the NASA Institutional Review Board (IRB) is to review research activities involving human subjects to ensure that ethical standards for the care and protection of human subjects have been met and research activities are in compliance with all pertinent federal, state and local regulations as well as NASA policies. NASA IRB's primary role is the protection of human subjects in research studies. Protection of human subjects is the shared responsibility of NASA, the IRB, and the scientific investigators. Science investigators who plan to conduct NASA-funded human research involving NASA investigators, facilities, or funds must submit and coordinate their research studies for review and approval by the NASA IRB prior to initiation. The IRB has the authority to approve, require changes in, or disapprove research involving human subjects. Better knowledge of the NASA IRB policies, procedures and guidelines should help facilitate research protocol applications and approvals. In this presentation, the myths and truths of NASA IRB policies and procedures will be discussed. We will focus on the policies that guide a protocol through the NASA IRB and the procedures that principal investigators must take to obtain required IRB approvals for their research studies. In addition, tips to help ensure a more efficient IRB review will be provided. By understanding the requirements and processes, investigators will be able to more efficiently prepare their protocols and obtain the required NASA IRB approval in a timely manner.
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The role of the Data and Safety Monitoring Board in a clinical trial: the CRISIS study.
Holubkov, Richard; Casper, T Charles; Dean, J Michael; Anand, K J S; Zimmerman, Jerry; Meert, Kathleen L; Newth, Christopher J L; Berger, John; Harrison, Rick; Willson, Douglas F; Nicholson, Carol
2013-05-01
Randomized clinical trials are commonly overseen by a Data and Safety Monitoring Board comprised of experts in medicine, ethics, and biostatistics. Data and Safety Monitoring Board responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. Data and Safety Monitoring Board decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate Data and Safety Monitoring Board oversight into the design, monitoring, and reporting of randomized trials. Case study, narrative review. The Data and Safety Monitoring Board's role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. The National Institutes of Health-appointed CRISIS Data and Safety Monitoring Board was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested Data and Safety Monitoring Board interim review before opening CRISIS to children below 1 yr of age. The first interim analysis found higher 28-day mortality in one treatment arm. The Data and Safety Monitoring Board maintained trial closure to younger children and requested a second interim data review 6 months later. At this second meeting, mortality was no longer of concern, whereas a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the Data and Safety Monitoring Board elected to examine conditional power and unmask treatment arm identities. On finding somewhat greater efficacy in the placebo arm, the Data and Safety Monitoring Board recommended stopping CRISIS due to futility. The design and operating procedures of a multicenter randomized trial must consider a pivotal Data and Safety Monitoring Board role. Maximum study design flexibility must be allowed, and investigators must be prepared for protocol modifications due to interim findings. The Data and Safety Monitoring Board must have sufficient clinical and statistical expertise to assess potential importance of interim treatment differences in the setting of multiple looks at accumulating data with numerous outcomes and subgroups.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-15
... FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval... approval of proposed information collection by the Board of Governors of the Federal Reserve System (Board... the Public). Board-approved collections of information are incorporated into the official OMB...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-01
... FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval... approval of a proposed information collection by the Board of Governors of the Federal Reserve System... Burdens on the Public). Board-approved collections of information are incorporated into the official OMB...
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Louie, Dexter L; Earp, Brandon E; Blazar, Philip E
2012-07-01
The Internet is available to researchers as a tool for studying long-term outcomes, but no recent research exists on how to best use it. The authors hypothesize that using the Internet can be at least 75% effective in locating patients lost to follow-up. With Institutional Review Board approval, the authors searched for 66 patients lost to follow-up after a period of 10 years or more with no contact. They tested an Internet searching protocol developed in 2004 and developed an alternate protocol. In all, 74% (49/66) of patients were located. Copyright 2012, SLACK Incorporated.
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Ultrasound-Based Guidance for Partial Breast Irradiation Therapy
2011-01-01
and also are inexpensive. b. Collect US data from patient before the PBI treatment at the same time that CT is collected (months 2-14). We...introduces minimal divergence from the original workflow of PBI treatment. We have an approved institutional review board (IRB) protocol to obtain B...irradiation of only the in- volved area of the breast, partial breast irradiation ( PBI ), is as effective as whole breast irradiation [1]. Benefits of PBI
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The Pharmacokinetics and Efficacy of a Low-dose, Aqueous, Intranasal Scopolamine Spray
2017-09-27
In this study , we found no correlation between plasma levels at any time point and the number of head tilts tolerated. However, there was a positive... study protocol was approved by the Naval Medical Research Unit Dayton Institutional Review Board in compliance with all applicable Federal...The study examined both the pharmacokinetic properties and efficacy of a low-dose, aqueous, intranasal scopolamine spray (INSCOP) as an anti-motion
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Cornejo Vucovich, Elsa; Ingram, Maia; Valenica, Celina; Castro Vasquez, Maria del Carmen; Gonzalez-Fagoaga, Eduardo; Geurnsey de Zapien, Jill
2018-01-01
Introduction Northern Mexico has among the highest rates of cardiovascular disease (CVD) and diabetes in the world. This research addresses core gaps in implementation science to develop, test and scale-up CVD risk-reduction interventions in diabetics through a national primary care health system. Methods and analysis The Meta Salud Diabetes (MSD) research project is a parallel two-arm cluster-randomised clinical behavioural trial based in 22 (n=22) health centres in Sonora, Mexico. MSD aims to evaluate the effectiveness of the MSD intervention for the secondary prevention of CVD risk factors among a diabetic population (n=320) compared with the study control of usual care. The MSD intervention consists of 2-hour class sessions delivered over a 13-week period providing educational information to encourage sustainable behavioural change to prevent disease complications including the adoption of physical activity. MSD is delivered within the context of Mexico’s national primary care health centre system by health professionals, including nurses, physicians and community health workers via existing social support groups for individuals diagnosed with chronic disease. Mixed models are used to estimate the effect of MSD by comparing cardiovascular risk, as measured by the Framingham Risk Score, between the trial arms. Secondary outcomes include hypertension, behavioural risk factors and psychosocial factors. Ethics and dissemination This work is supported by the National Institutes of Health, National Heart Lung and Blood Institute (1R01HL125996-01) and approved by the University of Arizona Research Institutional Review Board (Protocol 1508040144) and the Research Bioethics Committee at the University of Sonora. The first Internal Review Board approval date was 31 August 2015 with five subsequent approved amendments. This article refers to protocol V.0.2, dated 30 January 2017. Results will be disseminated via peer-reviewed publication and presentation at international conferences and will be shared through meetings with health systems officials. Trial registration number NCT0280469; Pre-results. PMID:29530914
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-28
... FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval... approval of proposed information collection by the Board of Governors of the Federal Reserve System (Board... docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-24
... Accounting Oversight Board; Order Approving Proposed Board Funding Final Rules for Allocation of the Board's Accounting Support Fee Among Issuers, Brokers, and Dealers, and Other Amendments to the Board's Funding Rules August 18, 2011. I. Introduction On June 21, 2011, the Public Company Accounting Oversight Board (the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-10
... Accounting Oversight Board; Order Approving Proposed Amendment to Board Rules Relating to Inspections March 4, 2010. I. Introduction On July 2, 2009, the Public Company Accounting Oversight Board (the ``Board'' or...'') relating to the Board's rules governing inspections of registered public accounting firms. Notice of the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-19
... MERIT SYSTEMS PROTECTION BOARD Agency Information Collection Activities; Emergency Reinstatement of Previously Approved Collection AGENCY: Merit Systems Protection Board. ACTION: Notice of emergency reinstatement. SUMMARY: The Merit Systems Protection Board (MSPB) is requesting approval from the Office of...
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Protocol Coordinator | Center for Cancer Research
PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. KEY ROLES/RESPONSIBILITIES The Protocol Coordinator II: Provides comprehensive clinical and administrative support to the Brain Tumor Trial Collaborative, Neuro-Oncology Branch, NCI, National Institutes of Health Serves as a liaison with Principal Investigators (PIs), the associated study teams and a variety of offices associated with protocol development and approvals Orchestrates meetings with investigators and other key medical staff to identify required support Coordinates the writing and regulatory review processes that occur in tandem, facilitates the bi-directional dialogue and feedback between various teams, and assists investigators and medical writers on the production/revision of clinical research protocols Assists research staff in coordinating/navigating requirements for special circumstances and facilitates access to necessary services Facilitates initiation of intramural research by providing assistance in obtaining required approvals Coordinates with investigators and medical writers to ensure Institutional Review Board (IRB) and Food and Drug Administration (FDA) stipulations are appropriately addressed in a timely manner Provides consultation and assistance for all aspects of the protocol lifecycle including initial Investigational New Drug (IND) submission, IRB submission, continuing review applications, protocol amendments, annual reports, and protocol inactivation with IRB and FDA Tracks a portfolio of protocols through each lifecycle step; processes and tracks appropriate approvals (e.g., IRB, Data and Safety Monitoring Board, Radiation Safety, Office of Protocol Services, etc.) Provides administrative support to Scientific Review Committees (SRC), reviews proposed protocol documents to ensure they are complete, distributes to reviewers, documents meeting minutes, enters data into the IRIS database, facilitates processes to obtain approval to initiate and continue clinical research Creates, maintains and queries an IRB database of approved amendment descriptions Maintains records of the current protocol(s) version, current Informed Consent document(s), FDA Safe to Proceed designation, etc. for each IND Provides expertise in data management including data collection and analysis Develops procedural manuals for clinical trials protocols Participates in quality improvement and assurance involving International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines This position is located at the National Institutes of Health (NIH) in Bethesda, Maryland.
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12 CFR 918.5 - Approval by Finance Board.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Approval by Finance Board. 918.5 Section 918.5 Banks and Banking FEDERAL HOUSING FINANCE BOARD GOVERNANCE AND MANAGEMENT OF THE FEDERAL HOME LOAN BANKS BANK DIRECTOR COMPENSATION AND EXPENSES § 918.5 Approval by Finance Board. Payments made to directors in compliance with the limits on annual...
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The Real-Time IRB: A Collaborative Innovation to Decrease IRB Review Time.
Spellecy, Ryan; Eve, Ann Marie; Connors, Emily R; Shaker, Reza; Clark, David C
2018-06-01
Lengthy review times for institutional review boards (IRBs) are a well-known barrier to research. In response to numerous calls to reduce review times, we devised "Real-Time IRB," a process that drastically reduces IRB review time. In this, investigators and study staff attend the IRB meeting and make changes to the protocol while the IRB continues its meeting, so that final approval can be issued at the meeting. This achieved an overall reduction in time from submission to the IRB to final approval of 40%. While this process is time and resource intensive, and cannot address all delays in research, it shows great promise for increasing the pace by which research is translated to patient care.
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76 FR 30980 - Annual Board of Directors Meeting; Sunshine Act
Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-27
... 20005. STATUS: Open. CONTACT PERSON FOR MORE INFORMATION: Erica Hall, Assistant Corporate Secretary... III. Approval of the Audit Committee Minutes IV. Approval of the Finance, Budget & Program Committee Minutes V. Approval of the Corporate Administration Committee Minutes VI. Two Board Matters VII. Board...
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Radiation Dose Index of Renal Colic Protocol CT Studies in the United States
Lukasiewicz, Adam; Bhargavan-Chatfield, Mythreyi; Coombs, Laura; Ghita, Monica; Weinreb, Jeffrey; Gunabushanam, Gowthaman; Moore, Christopher L.
2016-01-01
Purpose To determine radiation dose indexes for computed tomography (CT) performed with renal colic protocols in the United States, including frequency of reduced-dose technique usage and any institutional-level factors associated with high or low dose indexes. Materials and Methods The Dose Imaging Registry (DIR) collects deidentified CT data, including examination type and dose indexes, for CT performed at participating institutions; thus, the DIR portion of the study was exempt from institutional review board approval and was HIPAA compliant. CT dose indexes were examined at the institutional level for CT performed with a renal colic protocol at institutions that contributed at least 10 studies to the registry as of January 2013. Additionally, patients undergoing CT for renal colic at a single institution (with institutional review board approval and informed consent from prospective subjects and waiver of consent from retrospective subjects) were studied to examine individual renal colic CT dose index patterns and explore relationships between patient habitus, demographics, and dose indexes. Descriptive statistics were used to analyze dose indexes, and linear regression and Spearman correlations were used to examine relationships between dose indexes and institutional factors. Results There were 49 903 renal colic protocol CT examinations conducted at 93 institutions between May 2011 and January 2013. Mean age ± standard deviation was 49 years ± 18, and 53.9% of patients were female. Institutions contributed a median of 268 (interquartile range, 77–699) CT studies. Overall mean institutional dose-length product (DLP) was 746 mGy · cm (effective dose, 11.2 mSv), with a range of 307–1497 mGy · cm (effective dose, 4.6–22.5 mSv) for mean DLPs. Only 2% of studies were conducted with a DLP of 200 mGy · cm or lower (a “reduced dose”) (effective dose, 3 mSv), and only 10% of institutions kept DLP at 400 mGy · cm (effective dose, 6 mSv) or less in at least 50% of patients. Conclusion Reduced-dose renal protocol CT is used infrequently in the United States. Mean dose index is higher than reported previously, and institutional variation is substantial. PMID:24484064
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Conducting a successful residency research project.
Barletta, Jeffrey F
2008-08-15
The residency research project can be a challenging endeavor for pharmacy residents since they typically have limited experience in this area. Furthermore, as the number of accredited residency programs has increased, so has the demand for preceptors with research experience. This review is intended to assist the resident and preceptor by providing steps and guidance with conducting a successful residency research project. Items such as idea generation, proposing the right type of project, departmental review, and project management skills are discussed and guidance with writing the research protocol is provided. Items that must be addressed in every research protocol are described and a generalized protocol template is presented. In addition, the institutional review board review process is described and tips and pointers for obtaining approval are included. Finally, useful tools and resources are provided that can be used up front or throughout each phase of the research project.
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How to design and write a clinical research protocol in Cosmetic Dermatology*
Bagatin, Ediléia; Miot, Helio A.
2013-01-01
Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment. PMID:23539006
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Sabo, Samantha; Denman Champion, Catalina; Bell, Melanie L; Cornejo Vucovich, Elsa; Ingram, Maia; Valenica, Celina; Castro Vasquez, Maria Del Carmen; Gonzalez-Fagoaga, Eduardo; Geurnsey de Zapien, Jill; Rosales, Cecilia B
2018-03-12
Northern Mexico has among the highest rates of cardiovascular disease (CVD) and diabetes in the world. This research addresses core gaps in implementation science to develop, test and scale-up CVD risk-reduction interventions in diabetics through a national primary care health system. The Meta Salud Diabetes (MSD) research project is a parallel two-arm cluster-randomised clinical behavioural trial based in 22 (n=22) health centres in Sonora, Mexico. MSD aims to evaluate the effectiveness of the MSD intervention for the secondary prevention of CVD risk factors among a diabetic population (n=320) compared with the study control of usual care. The MSD intervention consists of 2-hour class sessions delivered over a 13-week period providing educational information to encourage sustainable behavioural change to prevent disease complications including the adoption of physical activity. MSD is delivered within the context of Mexico's national primary care health centre system by health professionals, including nurses, physicians and community health workers via existing social support groups for individuals diagnosed with chronic disease. Mixed models are used to estimate the effect of MSD by comparing cardiovascular risk, as measured by the Framingham Risk Score, between the trial arms. Secondary outcomes include hypertension, behavioural risk factors and psychosocial factors. This work is supported by the National Institutes of Health, National Heart Lung and Blood Institute (1R01HL125996-01) and approved by the University of Arizona Research Institutional Review Board (Protocol 1508040144) and the Research Bioethics Committee at the University of Sonora. The first Internal Review Board approval date was 31 August 2015 with five subsequent approved amendments. This article refers to protocol V.0.2, dated 30 January 2017. Results will be disseminated via peer-reviewed publication and presentation at international conferences and will be shared through meetings with health systems officials. NCT0280469; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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Time required to initiate outbreak and pandemic observational research.
Rishu, Asgar H; Marinoff, Nicole; Julien, Lisa; Dumitrascu, Mariana; Marten, Nicole; Eggertson, Shauna; Willems, Su; Ruddell, Stacy; Lane, Dan; Light, Bruce; Stelfox, Henry T; Jouvet, Philippe; Hall, Richard; Reynolds, Steven; Daneman, Nick; Fowler, Robert A
2017-08-01
Observational research focused upon emerging infectious diseases such as Ebola virus, Middle East respiratory syndrome, and Zika virus has been challenging to quickly initiate. We aimed to determine the duration of start-up procedures and barriers encountered for an observational study focused upon such infectious outbreaks. At 1 pediatric and 5 adult intensive care units, we measured durations from protocol receipt to a variety of outbreak research milestones, including research ethics board (REB) approval, data sharing agreement (DSA) execution, and patient study screening initiation. The median (interquartile range) time from site receipt of the protocol to REB submission was 73 (30-126) days; to REB approval, 158 (42-188) days; to DSA completion, 276 (186-312) days; and to study screening initiation, 293 (269-391) days. The median time from REB submission to REB approval was 43 (13-85) days. The median time for all start-up procedures was 335 (188-335) days. There is a lengthy start-up period required for outbreak-focused research. Completing DSAs was the most time-consuming step. A reactive approach to newly emerging threats such as Ebola virus, Middle East respiratory syndrome, and Zika virus will likely not allow sufficient time to initiate research before most outbreaks are advanced. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
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Code of Federal Regulations, 2012 CFR
2012-01-01
... Banking FEDERAL HOUSING FINANCE BOARD FEDERAL HOUSING FINANCE BOARD ORGANIZATION AND OPERATIONS PROCEDURES... the Office of Finance approving a transaction, activity, or item that requires Finance Board approval under the Act or a Finance Board rule, regulation, policy, or order. Case-by-Case Determination means a...
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Protocol Coordinator | Center for Cancer Research
PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides comprehensive clinical and administrative support to the National Cancer Institute’s Center for Cancer Research’s (CCR) Protocol Support Office (PSO) for protocol development review, regulatory review, and the implementation process as well as oversees medical writing/editing, regulatory/ compliance, and protocol coordination/navigation and administration. KEY ROLES/RESPONSIBILITIES The Protocol Coordinator III: Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials. Provides deployment of clinical support services for clinical research. Streamlines the protocol development timeline. Provides data and documents collection and compilation for regulatory filing with the U.S. Food and Drug Administration (FDA) and other regulatory authorities.. Provides technical review and report preparation. Provides administrative coordination and general logistical support for regulatory activities. Ensures the provision of training for investigators and associate staff to reinforce and enhance a Good Clinical Practices (GCP) culture. Oversees quality assurance and quality control, performs regulatory review of clinical protocols, informed consent and other clinical documents. Tracks and facilitates a portfolio of protocols through each process step (Institutional Review Board [IRB], Regulatory Affairs Compliance [RAC], Data Safety Monitoring Board [DSMB], Office of Protocol Services). Assists clinical investigators in preparing clinical research protocols, including writing and formatting consent forms. Prepares protocol packages for review and ensures that protocol packages include all of the required material and comply with CCR, NCI and NIH policies. Collaborates with investigators to resolve any protocol/data issues. Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI IRB, and the clinical trial sponsor or the FDA. Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events. Attends and prepares minutes for the Branch Protocol Review Committees. Contacts coordinators at other centers for protocols that are performed there to obtain review committee approvals at those centers, maintains records of these approvals and sends protocol amendments and other reports to the participating centers. Maintains a schedule of all review committee submission deadline dates and meeting dates. Assists clinical investigators in understanding and complying with the entire review process. Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document and tracking system for NCI protocols. Converts protocols from Word format to .pdf with bookmarks. Maintains the .pdf version of the most current approved version of each active clinical protocol on a central server. This position is located in Rockville, Maryland.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-02
... ARCHITECTURAL AND TRANSPORTATION BARRIERS COMPLIANCE BOARD Notice of Intent To Seek OMB Approval...: Architectural and Transportation Barriers Compliance Board. ACTION: 30-day Notice and request for comments. SUMMARY: The Architectural and Transportation Barriers Compliance Board (Access Board) has requested...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-18
... ARCHITECTURAL AND TRANSPORTATION BARRIERS COMPLIANCE BOARD Notice of Intent To Seek OMB Approval...: Architectural and Transportation Barriers Compliance Board. ACTION: Notice and request for comments. SUMMARY: The Architectural and Transportation Barriers Compliance Board (Access Board) plans to request...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-21
... FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB AGENCY: Board of Governors of the Federal Reserve System... of Governors of the Federal Reserve System (Board) under OMB delegated authority, as per 5 CFR 1320...
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Building a Protocol Expressway: The Case of Mayo Clinic Cancer Center
McJoynt, Terre A.; Hirzallah, Muhanad A.; Satele, Daniel V.; Pitzen, Jason H.; Alberts, Steven R.; Rajkumar, S. Vincent
2009-01-01
Purpose Inconsistencies and errors resulting from nonstandard processes, together with redundancies, rework, and excess workload, lead to extended time frames for clinical trial protocol development. This results in dissatisfaction among sponsors, investigators, and staff and restricts the availability of novel treatment options for patients. Methods A team of experts from Mayo Clinic formed, including Protocol Development Unit staff and management from the three Mayo Clinic campuses (Florida, Minnesota, and Arizona), a systems and procedures analyst, a quality office analyst, and two physician members to address the identified deficiencies. The current-state process was intensively reviewed, and improvement steps were taken to accelerate the development and approval of cancer-related clinical trials. The primary goal was to decrease the time from receipt of a new protocol through submission to an approving authority, such as the National Cancer Institute or institutional review board. Results Using the Define, Measure, Analyze, Improve, Control (DMAIC) framework infused with Lean waste-reduction methodologies, areas were identified for improvement, including enhancing first-time quality and processing new studies on a first-in/first-out basis. The project was successful in improving the mean turnaround time for internally authored protocols (P < .001) from 25.00 weeks (n = 41; range, 3.43 to 94.14 weeks) to 10.15 weeks (n = 14; range, 4.00 to 22.14 weeks). The mean turnaround time for externally authored protocols was improved (P < .001) from 20.61 weeks (n = 85; range, 3.29 to 108.57 weeks) to 7.79 weeks (n = 50; range, 2.00 to 20.86 weeks). Conclusion DMAIC framework combined with Lean methodologies is an effective tool to structure the definition, planning, analysis, and implementation of significant process changes. PMID:19564529
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Building a protocol expressway: the case of Mayo Clinic Cancer Center.
McJoynt, Terre A; Hirzallah, Muhanad A; Satele, Daniel V; Pitzen, Jason H; Alberts, Steven R; Rajkumar, S Vincent
2009-08-10
Inconsistencies and errors resulting from nonstandard processes, together with redundancies, rework, and excess workload, lead to extended time frames for clinical trial protocol development. This results in dissatisfaction among sponsors, investigators, and staff and restricts the availability of novel treatment options for patients. A team of experts from Mayo Clinic formed, including Protocol Development Unit staff and management from the three Mayo Clinic campuses (Florida, Minnesota, and Arizona), a systems and procedures analyst, a quality office analyst, and two physician members to address the identified deficiencies. The current-state process was intensively reviewed, and improvement steps were taken to accelerate the development and approval of cancer-related clinical trials. The primary goal was to decrease the time from receipt of a new protocol through submission to an approving authority, such as the National Cancer Institute or institutional review board. Using the Define, Measure, Analyze, Improve, Control (DMAIC) framework infused with Lean waste-reduction methodologies, areas were identified for improvement, including enhancing first-time quality and processing new studies on a first-in/first-out basis. The project was successful in improving the mean turnaround time for internally authored protocols (P < .001) from 25.00 weeks (n = 41; range, 3.43 to 94.14 weeks) to 10.15 weeks (n = 14; range, 4.00 to 22.14 weeks). The mean turnaround time for externally authored protocols was improved (P < .001) from 20.61 weeks (n = 85; range, 3.29 to 108.57 weeks) to 7.79 weeks (n = 50; range, 2.00 to 20.86 weeks). DMAIC framework combined with Lean methodologies is an effective tool to structure the definition, planning, analysis, and implementation of significant process changes.
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76 FR 58303 - Regular Board of Directors Meeting; Sunshine Act
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-20
..., Washington, DC 20005. STATUS: Open. CONTACT PERSON FOR MORE INFORMATION: Erica Hall, Assistant Corporate... Directors Minutes III. Approval of the Special Board of Directors Minutes IV. Approval of the Corporate Administration Committee Minutes V. Approval of the Finance, Budget and Program Committee Minutes VI. Approval of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-21
... Accounting Oversight Board; Order Approving Proposed Rules on Auditing Standard No. 7, Engagement Quality... Accounting Oversight Board (the ``Board'' or the ``PCAOB'') filed with the Securities and Exchange Commission... standards for public company audits, including a requirement for each registered public accounting firm to...
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Clinical evaluation of the Novacor totally implantable ventricular assist system. Current status.
Daniel, M A; Lee, J; LaForge, D H; Chen, H; Billich, J; Miller, P J; Ramasamy, N; Strauss, L R; Jassawalla, J S; Portner, P M
1991-01-01
The totally implantable Novacor left ventricular assist system (LVAS) is currently approaching clinical evaluation. In vivo testing and production are underway with National Institutes of Health (NIH) support. Activity over the past year has focused on manufacturing engineering, preproduction quality assurance, and in vivo experiment completion. Subsequent to successful completion of the NIH-sponsored, 2-year preclinical device readiness test (DRT), a number of refinements were identified and approved by the NIH technical/data review board. Most of these were necessitated by obsolescence or unavailability of electronic components and the decision to use only high reliability military (MIL) qualified electronic components and processes. A few additional refinements were identified to increase design margins, all of which were qualified by accelerated testing. The development of production processes, automated test programs, and MIL compliant environmental stress screening procedures was completed. Production of LVAS subsystems, including core electronic components (hybrids, application-specific integrated circuits, and surface mount boards), was initiated. Animal studies are underway. The clinical trial, at Presbyterian-University Hospital of Pittsburgh and St. Louis University Medical Center, awaits completion of in vivo experiments, protocol development, and Food and Drug Administration approval.
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Kim, Kwan-Ii; Jo, Junyoung
2018-01-01
Male factor subfertility has increasingly been considered the cause of infertility in couples. Many men with male infertility have sperm problems such as oligozoospermia, asthenozoospermia, or teratozoospermia. Because abnormal semen parameters are idiopathic to some extent, no standard therapy has been established to date. Herbal medicine has been reported to have beneficial properties in the treatment of subfertility, especially in improving semen quality both in vivo and in human studies. Therefore, we intend to investigate the effectiveness and safety of treatment using Korean medicine (KM) for infertile male patients with poor semen quality.This will be a single-center, prospective, case-only observational pilot study. About 20 male patients with infertility who visit Conmaul Hospital of Korean Medicine will be recruited. We will follow the standard treatment protocol, which has shown good results in the treatment of male infertility. The protocol is composed mainly of a 10-week herbal decoction treatment; acupuncture and/or pharmacopuncture are added when needed. Semen samples, quality of life, and the scrotal temperatures of infertile men will be observed before and after the 10-week treatment with KM.The study has received ethical approval from the Public Institutional Review Board (approval number: P01-201708-21-008). The findings will be disseminated to appropriate audiences via peer-reviewed publication and conference presentations. Korean Clinical Trial Registry (CRIS), Republic of Korea: KCT0002611.
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76 FR 74831 - Regular Board of Directors Meeting; Sunshine Act
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-01
..., DC 20005. STATUS: Open. CONTACT PERSON FOR MORE INFORMATION: Erica Hall, Assistant Corporate... the Regular Board of Directors Meeting Minutes IV. Approval of the Finance, Budget and Program Committee Meeting Minutes V. Approval of the Corporate Administrative Committee Meeting Minutes VI. Approval...
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77 FR 58416 - Regular Board of Directors Meeting; Sunshine Act
Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-20
..., DC 20005. STATUS: Open. CONTACT PERSON FOR MORE INFORMATION: Erica Hall, Assistant Corporate... Annual Board of Directors Meeting Minutes IV. Approval of the Corporate Administration Committee Meeting Minutes V. Approval of the Finance, Budget & Program Committee Meeting Minutes VI. Approval of the Audit...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-01
... FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval... Reserve System heading, the entry for Agency Information Collection Activities: Announcement of Board... information existed on the exposure of the banking system to those firms as this information was obscured by...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-18
...-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving Proposed Rule Change To Establish Strike Price Intervals and Trading Hours for Options on Index-Linked Securities March 12, 2010. I. Introduction On January 27, 2010, the Chicago Board Options Exchange, Incorporated (``CBOE...
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Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research.
Gilbert, Amy Lewis; Knopf, Amelia S; Fortenberry, J Dennis; Hosek, Sybil G; Kapogiannis, Bill G; Zimet, Gregory D
2015-07-01
The Adolescent Medicine Trials Network Protocol 113 (ATN113) is an open-label, multisite demonstration project and Phase II safety study of human immunodeficiency virus (HIV) preexposure prophylaxis with 15- to 17-year-old young men who have sex with men that requires adolescent consent for participation. The purpose of this study was to examine factors related to the process by which Institutional Review Boards (IRBs) and researchers made decisions regarding whether to approve and implement ATN113 so as to inform future biomedical HIV prevention research with high-risk adolescent populations. Participants included 17 researchers at 13 sites in 12 states considering ATN113 implementation. Qualitative descriptive methods were used. Data sources included interviews and documents generated during the initiation process. A common process for initiating ATN113 emerged, and informants described how they identified and addressed practical, ethical, and legal challenges that arose. Informants described the process as responding to the protocol, preparing for IRB submission, abstaining from or proceeding with submission, responding to IRB concerns, and reacting to the outcomes. A complex array of factors impacting approval and implementation were identified, and ATN113 was ultimately implemented in seven of 13 sites. Informants also reflected on lessons learned that may help inform future biomedical HIV prevention research with high-risk adolescent populations. The results illustrate factors for consideration in determining whether to implement such trials, demonstrate that such protocols have the potential to be approved, and highlight a need for clearer standards regarding biomedical HIV prevention research with high-risk adolescent populations. Copyright © 2015 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-02
...-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a Proposed Rule Change To Adopt Rules Governing S&P 500 Option Variance Basket Trades January 27, 2012. I. Introduction On October 26, 2011, Chicago Board Options Exchange, Incorporated (``Exchange'' or ``CBOE'') filed...
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Federal Register 2010, 2011, 2012, 2013, 2014
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Federal Register 2010, 2011, 2012, 2013, 2014
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...-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving Proposed Rule Change, as Modified by Amendment No. 1 Thereto, To List and Trade CBOE Gold ETF Volatility Index Options May 19, 2010. I. Introduction On March 18, 2010, the Chicago Board Options Exchange, Incorporated (``CBOE...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-10
... Internet Gambling AGENCY: Board of Governors of the Federal Reserve System (``Board'') and Departmental... change, implementing the Unlawful Internet Gambling Enforcement Act of 2006 (the ``Act''). The Board has... currently approved information collection: Title: Prohibition on Funding of Unlawful Internet Gambling. OMB...
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17 CFR 202.190 - Public Company Accounting Oversight Board budget approval process.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 17 Commodity and Securities Exchanges 2 2011-04-01 2011-04-01 false Public Company Accounting... SECURITIES AND EXCHANGE COMMISSION INFORMAL AND OTHER PROCEDURES Public Company Accounting Oversight Board (Regulation P) § 202.190 Public Company Accounting Oversight Board budget approval process. (a) Purpose. These...
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17 CFR 202.190 - Public Company Accounting Oversight Board budget approval process.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 17 Commodity and Securities Exchanges 2 2012-04-01 2012-04-01 false Public Company Accounting... SECURITIES AND EXCHANGE COMMISSION INFORMAL AND OTHER PROCEDURES Public Company Accounting Oversight Board (Regulation P) § 202.190 Public Company Accounting Oversight Board budget approval process. (a) Purpose. These...
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... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66375; File No. SR-CBOE-2011-117] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving Proposed Rule Change Relating to Its Automated Improvement Mechanism February 10, 2012. On December 14, 2011, the Chicago Board...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-01
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1794] Approval for Expanded Manufacturing Authority; Foreign-Trade Subzone 158D Nissan North America, Inc.; (Motor Vehicles) Canton, MS...), the Foreign-Trade Zones Board (the Board) adopts the following Order. Whereas, Nissan North America...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-16
...; Securities Exchange Act of 1934 Release No. 63526/December 10, 2010] Order Approving Public Company... Company Accounting Oversight Board (the ``PCAOB'') to oversee the audits of companies and related matters..., subject to approval by the Commission, auditing and related attestation, quality control, ethics, and...
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IRB Process Improvements: A Machine Learning Analysis.
Shoenbill, Kimberly; Song, Yiqiang; Cobb, Nichelle L; Drezner, Marc K; Mendonca, Eneida A
2017-06-01
Clinical research involving humans is critically important, but it is a lengthy and expensive process. Most studies require institutional review board (IRB) approval. Our objective is to identify predictors of delays or accelerations in the IRB review process and apply this knowledge to inform process change in an effort to improve IRB efficiency, transparency, consistency and communication. We analyzed timelines of protocol submissions to determine protocol or IRB characteristics associated with different processing times. Our evaluation included single variable analysis to identify significant predictors of IRB processing time and machine learning methods to predict processing times through the IRB review system. Based on initial identified predictors, changes to IRB workflow and staffing procedures were instituted and we repeated our analysis. Our analysis identified several predictors of delays in the IRB review process including type of IRB review to be conducted, whether a protocol falls under Veteran's Administration purview and specific staff in charge of a protocol's review. We have identified several predictors of delays in IRB protocol review processing times using statistical and machine learning methods. Application of this knowledge to process improvement efforts in two IRBs has led to increased efficiency in protocol review. The workflow and system enhancements that are being made support our four-part goal of improving IRB efficiency, consistency, transparency, and communication.
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75 FR 74071 - Sunshine Act Meetings
Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-30
... INTER-AMERICAN FOUNDATION BOARD MEETING Sunshine Act Meetings TIME AND DATE: December 13, 2010, 9... Considered [dec221] Approval of the Minutes of the March 29, 2010, Meeting of the Board of Directors. [dec221... Public [dec221] Approval of the Minutes of the March 29, 2010, Meeting of the Board of Directors. [dec221...
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Monera-Penduka, Tsitsi G; Maponga, Charles C; Morse, Gene D; Nhachi, Charles F B
2017-01-01
Lack of regulatory capacity limits the conduct of ethical and rigorous trials of herbal medicines in developing countries. Sharing ethical and regulatory experiences of successful herbal trials may accelerate the field while assuring human subjects protection. The methods and timelines for the ethical and regulatory review processes for the first drug regulatory authority approved herbal trial in Zimbabwe are described in this report. The national drug regulatory authority and ethics committee were engaged for pre-submission discussions. Six applications were submitted. Application procedures and communications with the various regulatory and ethics review boards were reviewed. Key issues raised and timelines for communications were summarized. There was no special framework for the approval of herbal trials. One local institutional review committee granted an exemption. Key issues raised for revision were around pre-clinical efficacy and safety data, standardization and quality assurance of the intervention as well as consenting procedures. Approval timelines ranged between eight and 72 weeks. In the absence of a defined framework for review of herbal trials, approval processes can be delayed. Dialogue between researchers and regulators is important for successful and efficient protocol approval for herbal trials in developing countries. The study was registered prospectively on August 3, 2011 with clinicaltrials.gov (NCT01410058).
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-04
...EPA is taking final action to approve a revision to the California State Implementation Plan (SIP) submitted by the California Air Resources Board (CARB or Board). This revision concerns two regulations that reduce emissions of diesel particulate matter (PM), oxides of nitrogen (NOX), and other pollutants from in-use, heavy-duty diesel-fueled trucks and buses, and drayage trucks. EPA is approving this SIP revision because the Agency has determined that the regulations are consistent with the relevant Clean Air Act requirements, policies and guidance. Final approval of the two regulations and incorporation of them into the California SIP makes them federally enforceable.
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Code of Federal Regulations, 2010 CFR
2010-01-01
... combat money laundering. The Board also may take into account whether the home country supervisor is developing a legal regime to address money laundering or is participating in multilateral efforts to combat money laundering. In approving an application under this paragraph (c)(1)(iii), the Board, after...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-16
... Regulations on Controlling Paperwork Burdens on the Public). Board-approved collections of information are... any information pursuant to this information collection beyond what is made publicly available, no...
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Human subject research: reporting ethics approval and informed consent in 3 chiropractic journals.
Lawrence, Dana J
2011-11-01
To date, there have been no reports of ethics board approval or informed consent within the chiropractic literature or within chiropractic research. The purpose of this study was to assess the reporting of ethics approval and informed consent in articles published during the 2008 volume year of 3 chiropractic research journals included in PubMed. A quantitative assessment of the articles published in each journal for the 2008 volume year was performed. Information collected included if the article involved human subject research, if it reported ethics board approval, and if informed consent was given to subjects. Data were collected as descriptive statistics (frequency counts and percentages). In aggregate, 50 articles of a total of 143 published involved human subject research (35%). 44 reported ethics board approval (88%), and 28 reported that informed consent had been obtained (56%). Forty-five percent of articles published in the Journal of Manipulative and Physiological Therapeutics involved human subject research (39/87), of which 95% reported ethics board approval (37/39) and 64% reported informed consent (25/39); 12.5% of articles from the Journal of the Canadian Chiropractic Association involved human subject research (5/40), of which 80% reported ethics board approval (4/5) and 40% reported informed consent (2/5); and 37.5% of articles published in Chiropractic and Osteopathy involved human subject research (6/16), of which 50% reported ethics board approval (3/6) and 17% reported informed consent (1/6). Overall, most articles reported ethics approval, and more than half reported consent. This was harmonious with research on this topic from other disciplines. This situation indicates a need for continued quality improvement and for better instruction and dissemination of information on these issues to researchers, to manuscript reviewers, to journal editors, and to the readers. Copyright © 2011 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-01-31
... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66235; File No. SR-CBOE-2011-114] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a Proposed Rule Change Relating to Complex Order Processing in Hybrid 3.0 Classes January 25, 2012. I. Introduction On November 29, 2011, the Chicago Board Options...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-24
... under the Clean Air Act (CAA), EPA is taking final action to approve state implementation plan (SIP... the background for this action? II. What action is EPA taking? III. Statutory and Executive Order... proposal to approve Indiana's state board provisions. II. What action is EPA taking? For the reasons...
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[Responsibilities of ethics committees].
von Bergmann, K
1999-01-15
Increasing numbers of clinical research projects are submitted to ethical committees (institutional review boards) for approval. New therapeutic developments have to be evaluated by these committees to protect patients/volunteers. Thus, the responsibility of ethical committees is increasing. The "Nürnberger Kodex" and the "Declaration of Helsinki" are the background for these evaluations. According to the German drug law the physician is obligated by law to submit the protocol to such a committee. In addition, local state physician authorities require such a procedure. Important considerations during the review process besides ethical aspects are the informed consent, which should be written in an understandable form, and the obligations of the insurance.
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[Responsibilities of ethics committees].
von Bergmann, K
2000-05-01
Increasing numbers of clinical research projects are submitted to ethical committees (institutional review boards) for approval. New therapeutic developments have to be evaluated by these committees to protect patients/volunteers. Thus, the responsibility of ethical committees is increasing. The "Nürnberger Kodex" and the "Declaration of Helsinki" are the background for these evaluations. According to the German drug law the physician is obligated by law to submit the protocol to such a committee. In addition, local state physician authorities require such a procedure. Important considerations during the review process besides ethical aspects are the informed consent, which should be written in an understandable form, and the obligations of the insurance.
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78 FR 71725 - Household Movers' Disclosure Requirements
Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-29
... DEPARTMENT OF TRANSPORTATION Surface Transportation Board Household Movers' Disclosure Requirements AGENCY: Surface Transportation Board, DOT. ACTION: Notice of OMB approval of information... approval for its information collection, Household Movers' Disclosure Requirements. See 78 FR 18421-01 (Mar...
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NASA Astrophysics Data System (ADS)
McPhaden, Michael J.
2010-08-01
On 1 July 2010, the first AGU Board of Directors took office. The board is composed of the president, president-elect, immediate past president, general secretary, international secretary, development board chair, six members elected by the Union membership, vice chair of the AGU Council, and the executive director. Two additional members may be nominated by the AGU president and approved by the board. The creation of the board is a result of the new governance structure approved by the AGU membership in November 2009. The board is responsible for the business aspects of the Union, while an expanded AGU Council will focus on science issues. Council members will be introduced in a future issue of Eos.
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Localized radio frequency communication using asynchronous transfer mode protocol
Witzke, Edward L [Edgewood, NM; Robertson, Perry J [Albuquerque, NM; Pierson, Lyndon G [Albuquerque, NM
2007-08-14
A localized wireless communication system for communication between a plurality of circuit boards, and between electronic components on the circuit boards. Transceivers are located on each circuit board and electronic component. The transceivers communicate with one another over spread spectrum radio frequencies. An asynchronous transfer mode protocol controls communication flow with asynchronous transfer mode switches located on the circuit boards.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-11
... eventual approval into the California SIP. For evaluative purposes herein, we also recognize the CARB Board... strategy, designed primarily for the reduction of diesel PM emissions, which has been verified pursuant to...
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Protocol Coordinator | Center for Cancer Research
PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides comprehensive clinical and administrative support to the National Cancer Institute’s Center for Cancer Research’s (CCR), Office of Regulatory Affairs for protocol development review, regulatory review, and the implementation process as well as oversees medical writing/editing, regulatory/ compliance, and protocol coordination/navigation and administration. KEY ROLES/RESPONSIBILITIES - THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL The Protocol Coordinator II: Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials Provides deployment of clinical support services for clinical research Streamlines protocol development timeline Provides data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities Provides administrative coordination and general logistical support for regulatory activities Ensures the provision of training for investigators and associate staff to reinforce and enhance a GCP culture Provides quality assurance and quality control oversight Performs regulatory review of clinical protocols, informed consent and other clinical documents Tracks and facilitates a portfolio of protocols through each process step (IRB, RAC, DSMB, Office of Protocol Services) Assists clinical investigators in preparing clinical research protocols, including writing and formatting protocol documents and consent forms Prepares protocol packages for review and ensures that protocol packages include all of the required material and comply with CCR, NCI and NIH policies Collaborates with investigators to resolve any protocol/data issues Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI Institutional Review Board (IRB) and the clinical trial sponsor or the FDA Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events Attends and prepares minutes for the Branch Protocol Review Committees For protocols that are performed with other research centers: contacts coordinators at other centers to obtain review committee approvals at these centers, maintains records of these approvals at the outside centers in the protocol files, and sends protocol amendments and other reports to the participating centers Maintains a schedule of all review committee submission deadline dates and meeting dates Assists clinical investigators in understanding and complying with the entire review process Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document management and tracking system for NCI protocols Converts protocols from Word format to PDF with bookmarks Maintains the PDF version of the most current approved version of each active clinical protocol on a central server This position has the option to be located in Frederick or Rockville, Maryland.
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75 FR 17462 - Quarterly Rail Cost Adjustment Factor
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-06
... decision may be purchased by contacting the office of Public Assistance, Governmental Affairs, and...-2)] Quarterly Rail Cost Adjustment Factor AGENCY: Surface Transportation Board. ACTION: Approval of rail cost adjustment factor. SUMMARY: The Board has approved the second quarter 2010 Rail Cost...
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Lee, Young Han
2018-04-04
The purposes of this study are to evaluate the feasibility of protocol determination with a convolutional neural networks (CNN) classifier based on short-text classification and to evaluate the agreements by comparing protocols determined by CNN with those determined by musculoskeletal radiologists. Following institutional review board approval, the database of a hospital information system (HIS) was queried for lists of MRI examinations, referring department, patient age, and patient gender. These were exported to a local workstation for analyses: 5258 and 1018 consecutive musculoskeletal MRI examinations were used for the training and test datasets, respectively. The subjects for pre-processing were routine or tumor protocols and the contents were word combinations of the referring department, region, contrast media (or not), gender, and age. The CNN Embedded vector classifier was used with Word2Vec Google news vectors. The test set was tested with each classification model and results were output as routine or tumor protocols. The CNN determinations were evaluated using the receiver operating characteristic (ROC) curves. The accuracies were evaluated by a radiologist-confirmed protocol as the reference protocols. The optimal cut-off values for protocol determination between routine protocols and tumor protocols was 0.5067 with a sensitivity of 92.10%, a specificity of 95.76%, and an area under curve (AUC) of 0.977. The overall accuracy was 94.2% for the ConvNet model. All MRI protocols were correct in the pelvic bone, upper arm, wrist, and lower leg MRIs. Deep-learning-based convolutional neural networks were clinically utilized to determine musculoskeletal MRI protocols. CNN-based text learning and applications could be extended to other radiologic tasks besides image interpretations, improving the work performance of the radiologist.
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Tersmette, Derek Gideon; Engberts, Dirk Peter
2017-01-01
The Committee for Medical Ethics (CME) of Leiden University Medical Center (LUMC) was established as the first medical ethics reviewing committee (MREC) in the Netherlands. In the period 2000-2010 the CME received 2,162 protocols for review. Some of these protocols were never approved. Until now, there has existed neither an overview of these failed protocols nor an overview of the reasons for their failure. This report draws on data from the digital database, the physical archives, and the minutes of the meetings of the CME. Additional information has been obtained from the Central Committee on Research involving Human Subjects (CCRH) and survey-based research. Protocols were itemized based on characteristic features and their reviewing procedures were analyzed. In total, 1,952 out of 2,162 research protocols submitted during 2000-2010 (90.3%) were approved by the CME; 210 of 2,162 protocols (9.7%) were not approved. Of these 210 protocols, 177 failed due to reasons not related to CME reviewing. In 15 cases CME reviewing led to protocol failure, while another 10 protocols were rejected outright. Eight of the 210 submitted protocols without approval had been conducted prior to submission. In the aforementioned period, little protocol failure occurred. For the most part, protocol failure was caused by problems that are not CME related. This type of failure has several identifiable factors, none of which have anything to do with the ethical reviewing procedure by the CME. A mere 1.2% of protocols failed due to ethical review. Unacceptable burden and risks to the subject and an inadequate methodology are the most common reasons for this CME-related protocol failure.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-10
...-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of Proposed Rule Change Regarding Professional Qualifications and Information Concerning Associated Persons November 3... information concerning associated persons. The proposed rule change was published for comment in the Federal...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-26
...-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Approving a Proposed Rule Change Consisting of Amendments To Streamline New Issue Information Submission Requirements Under MSRB Rules G-32..., and market information requirements); and the Electronic Municipal Market Access (``EMMA[supreg...
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76 FR 59483 - Quarterly Rail Cost Adjustment Factor
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-26
... the decision may be purchased by contacting the Office of Public Assistance, Governmental Affairs, and...)] Quarterly Rail Cost Adjustment Factor AGENCY: Surface Transportation Board, DOT. ACTION: Approval of rail cost adjustment factor. SUMMARY: The Board has approved the fourth quarter 2011 Rail Cost Adjustment...
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77 FR 76169 - Quarterly Rail Cost Adjustment Factor
Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-26
....stb.dot.gov . Copies of the decision may be purchased by contacting the Office of Public Assistance...)] Quarterly Rail Cost Adjustment Factor AGENCY: Surface Transportation Board, DOT. ACTION: Approval of rail cost adjustment factor. SUMMARY: The Board has approved the AAR's proposed rebasing calculations and...
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Code of Federal Regulations, 2010 CFR
2010-01-01
... directors approved a plan of conversion? 563b.135 Section 563b.135 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY CONVERSIONS FROM MUTUAL TO STOCK FORM Standard Conversions Plan of Conversion § 563b.135 How do I notify my members that my board of directors approved a plan of conversion? (a...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-02
...-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of Proposed Rule Change Consisting of Establishment of a Subscription to Historical Information and Documents Submitted to... historical information and documents submitted to the MSRB's Short-Term Obligation Rate Transparency System...
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77 FR 31894 - Sunshine Act Meeting Notice, Regular Board of Directors Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-30
...,Washington, DC 20005. STATUS: Open. CONTACT PERSON FOR MORE INFORMATION: Erica Hall, Assistant Corporate... Meeting Minutes V. Approval of the Finance, Budget and Program Committee Meeting Minutes VI. Approval of the Corporate Administration Committee Meeting Minutes VII. Executive Session VIII. Board Elections...
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77 FR 37958 - Quarterly Rail Cost Adjustment Factor
Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-25
..., http://www.stb.dot.gov . Copies of the decision may be purchased by contacting the Office of Public...)] Quarterly Rail Cost Adjustment Factor AGENCY: Surface Transportation Board, DOT. ACTION: Approval of rail cost adjustment factor. SUMMARY: The Board has approved the third quarter 2012 rail cost adjustment...
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75 FR 35877 - Quarterly Rail Cost Adjustment Factor
Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-23
... available on our Web site, http://www.stb.dot.gov . Copies of the decision may be purchased by contacting...-3)] Quarterly Rail Cost Adjustment Factor AGENCY: Surface Transportation Board. ACTION: Approval of rail cost adjustment factor. SUMMARY: The Board has approved the third quarter 2010 rail cost...
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75 FR 58019 - Quarterly Rail Cost Adjustment Factor
Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-23
..., http://www.stb.dot.gov . Copies of the decision may be purchased by contacting the office of Public...)] Quarterly Rail Cost Adjustment Factor AGENCY: Surface Transportation Board, DOT. ACTION: Approval of rail cost adjustment factor. SUMMARY: The Board has approved the fourth quarter 2010 Rail Cost Adjustment...
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75 FR 80895 - Quarterly Rail Cost Adjustment Factor
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-23
..., http://www.stb.dot.gov . Copies of the decision may be purchased by contacting the Office of Public...)] Quarterly Rail Cost Adjustment Factor AGENCY: Surface Transportation Board, DOT. ACTION: Approval of rail cost adjustment factor. SUMMARY: The Board has approved the first quarter 2011 Rail Cost Adjustment...
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76 FR 16037 - Quarterly Rail Cost Adjustment Factor
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-22
..., http://www.stb.dot.gov . Copies of the decision may be purchased by contacting the Office of Public...)] Quarterly Rail Cost Adjustment Factor AGENCY: Surface Transportation Board, DOT. ACTION: Approval of rail cost adjustment factor. SUMMARY: The Board has approved the second quarter 2011 Rail Cost Adjustment...
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78 FR 37660 - Quarterly Rail Cost Adjustment Factor
Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-21
..., http://www.stb.dot.gov . Copies of the decision may be purchased by contacting the Office of Public...)] Quarterly Rail Cost Adjustment Factor AGENCY: Surface Transportation Board, DOT. ACTION: Approval of rail cost adjustment factor. SUMMARY: The Board approves the third quarter 2013 Rail Cost Adjustment Factor...
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76 FR 37191 - Quarterly Rail Cost Adjustment Factor
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-24
... our Web site, http://www.stb.dot.gov . Copies of the decision may be purchased by contacting the...)] Quarterly Rail Cost Adjustment Factor AGENCY: Surface Transportation Board, DOT. ACTION: Approval of rail cost adjustment factor. SUMMARY: The Board has approved the third quarter 2011 Rail Cost Adjustment...
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78 FR 59093 - Quarterly Rail Cost Adjustment Factor
Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-25
...)] Quarterly Rail Cost Adjustment Factor AGENCY: Surface Transportation Board, DOT ACTION: Approval of rail cost adjustment factor. SUMMARY: The Board has approved the fourth quarter 2013 rail cost adjustment factor (RCAF) and cost index filed by the Association of American Railroads. The fourth quarter 2013 RCAF...
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78 FR 17764 - Quarterly Rail Cost Adjustment Factor
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-22
..., http://www.stb.dot.gov . Copies of the decision may be purchased by contacting the Office of Public...)] Quarterly Rail Cost Adjustment Factor AGENCY: Surface Transportation Board, DOT. ACTION: Approval of rail cost adjustment factor. SUMMARY: The Board has approved the second quarter 2013 Rail Cost Adjustment...
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7 CFR 930.59 - Handler diversion privilege.
Code of Federal Regulations, 2010 CFR
2010-01-01
... Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing... limited to: (1) Contribution to a Board-approved food bank or other approved charitable organization; (2... of the Board and that the cost of such supervision is to be paid by the handler. Uniform fees for...
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Dyrbye, Liselotte N; Thomas, Matthew R; Mechaber, Alex J; Eacker, Anne; Harper, William; Massie, F Stanford; Power, David V; Shanafelt, Tait D
2007-07-01
To compare how different institutional review boards (IRBs) process and evaluate the same multiinstitutional educational research proposal of medical students' quality of life. Prospective collection in 2005 of key variables regarding the IRB submission and review process of the same educational research proposal involving medical students, which was submitted to six IRBs, each associated with a different medical school. Four IRBs determined the protocol was appropriate for expedited review, and the remaining two required full review. Substantial variation existed in the time to review the protocol by an IRB administrator/IRB member (range 1-101 days) and by the IRB committee (range 6-115 days). One IRB committee approved the study as written. The remaining five IRB committees had a median of 13 requests for additional information/changes to the protocol. Sixty-eight percent of requests (36 of 53) pertained to the informed consent letter; one third (12 of 36) of these requests were unique modifications requested by one IRB but not the others. Although five IRB committees approved the survey after a median of 47 days (range 6-73), one committee had not responded six months after submission (164 days), preventing that school from participating. The findings suggest variability in the timeliness and consistency of IRB review of medical education research across institutions that may hinder multi-institutional research and slow evidence-based medical education reform. The findings demonstrate the difficulties of having medical education research reviewed by IRBs, which are typically designed to review clinical trials, and suggest that the review process for medical education research needs reform.
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Jansson, Roger L
2003-02-01
Two sets of federal regulations, the "Common Rule" and Food and Drug Administration (FDA) regulations, govern human subject research that is either federally-funded or involves FDA regulated products. These regulations require, inter alia, that: (1) researchers obtain informed consent from human subjects, and (2) that an Institutional Review Board (IRB) independently review and approve the research protocol. Although the federal regulations do not provide an express cause of action against researchers, research subjects should be able to bring informed consent and malpractice actions against researchers by establishing a duty of care and standard of care. Researchers owe human subjects a duty of care analogous to the special relationship between physicians and patients. The federal regulations should provide the minimum standard of care for informed consent in human subject research, and complying with them should be a partial defense. In contrast, expert testimony should establish the standard of care for researcher malpractice, and IRB approval should be a partial defense.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-19
... Authority Foreign-Trade Zone 196 ATC Logistics & Electronics (Cell Phone Kitting) Fort Worth, TX Pursuant to... Foreign-Trade Zones Board (the Board) adopts the following Order: Whereas, ATC Logistics & Electronics... Logistics & Electronics, as described in the application and Federal Register notice, is approved, subject...
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20 CFR 323.3 - Standards for Board approval of a nongovernmental plan.
Code of Federal Regulations, 2010 CFR
2010-04-01
... payable to an employee who is earning remuneration from railroad or non-railroad employment. Employer... remuneration; (e) The plan confers upon covered employees an enforceable right to the benefits under the plan... has been approved by the Board's Director of Unemployment and Sickness Insurance as a nongovernmental...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-10-26
...-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Approving a Proposed Rule Change To Amend the Real-Time Transaction Reporting System Information System and Subscription Service October 22...'') information system. The proposed rule change was published for comment in the Federal Register on September 12...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-29
... FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval... holding companies (SLHCs) and nongovernmental entities or persons (NGEPs). Estimated annual reporting... Insurance Act (FDI Act), 12 U.S.C. 1831y(b) and (c). The FDI Act authorizes the Federal Reserve to require...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-23
... Gambling AGENCIES: Board of Governors of the Federal Reserve System (``Board'') and Departmental Offices... Unlawful Internet Gambling Enforcement Act of 2006 (the ``Act''). This notice is published jointly by the... Approved Information Collection Title: Prohibition on Funding of Unlawful Internet Gambling. OMB Control...
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76 FR 80448 - Quarterly Rail Cost Adjustment Factor
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-23
...)] Quarterly Rail Cost Adjustment Factor AGENCY: Surface Transportation Board. ACTION: Approval of rail cost adjustment factor. SUMMARY: The Board has approved the first quarter 2012 rail cost adjustment factor (RCAF... decision, which is available on our Web site, http://www.stb.dot.gov . Copies of the decision may be...
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77 FR 58910 - Quarterly Rail Cost Adjustment Factor
Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-24
..., http://www.stb.dot.gov . Copies of the decision may be purchased by contacting the Office of Public...)] Quarterly Rail Cost Adjustment Factor AGENCY: Surface Transportation Board. ACTION: Approval of rail cost adjustment factor. SUMMARY: The Board has approved the fourth quarter 2012 rail cost adjustment factor (RCAF...
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17 CFR 202.11 - Public Company Accounting Oversight Board budget approval process.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Public Company Accounting Oversight Board budget approval process. 202.11 Section 202.11 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION INFORMAL AND OTHER PROCEDURES § 202.11 Public Company Accounting Oversight...
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On May 17, 2017, EPA and the California Air Resources Board (CARB) approved an emissions modification proposed by Volkswagen that will reduce NOx emissions from automatic transmission diesel Passats for model years 2012-2014.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-30
... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61716; File No. SR-CBOE-2010-008] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a Proposed Rule Change Relating to Co- location Service Fees March 16, 2010. Correction In notice document 2010-6184...
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20 CFR 323.3 - Standards for Board approval of a nongovernmental plan.
Code of Federal Regulations, 2012 CFR
2012-04-01
... RAILROAD UNEMPLOYMENT INSURANCE ACT NONGOVERNMENTAL PLANS FOR UNEMPLOYMENT OR SICKNESS INSURANCE § 323.3 Standards for Board approval of a nongovernmental plan. An unemployment or sickness benefit plan qualifies... conditions governing payment of benefits under the Railroad Unemployment Insurance Act. However, a plan will...
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20 CFR 323.3 - Standards for Board approval of a nongovernmental plan.
Code of Federal Regulations, 2011 CFR
2011-04-01
... RAILROAD UNEMPLOYMENT INSURANCE ACT NONGOVERNMENTAL PLANS FOR UNEMPLOYMENT OR SICKNESS INSURANCE § 323.3 Standards for Board approval of a nongovernmental plan. An unemployment or sickness benefit plan qualifies... conditions governing payment of benefits under the Railroad Unemployment Insurance Act. However, a plan will...
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20 CFR 323.3 - Standards for Board approval of a nongovernmental plan.
Code of Federal Regulations, 2013 CFR
2013-04-01
... RAILROAD UNEMPLOYMENT INSURANCE ACT NONGOVERNMENTAL PLANS FOR UNEMPLOYMENT OR SICKNESS INSURANCE § 323.3 Standards for Board approval of a nongovernmental plan. An unemployment or sickness benefit plan qualifies... conditions governing payment of benefits under the Railroad Unemployment Insurance Act. However, a plan will...
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20 CFR 323.3 - Standards for Board approval of a nongovernmental plan.
Code of Federal Regulations, 2014 CFR
2014-04-01
... RAILROAD UNEMPLOYMENT INSURANCE ACT NONGOVERNMENTAL PLANS FOR UNEMPLOYMENT OR SICKNESS INSURANCE § 323.3 Standards for Board approval of a nongovernmental plan. An unemployment or sickness benefit plan qualifies... conditions governing payment of benefits under the Railroad Unemployment Insurance Act. However, a plan will...
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iSAFT Protocol Validation Platform for On-Board Data Networks
NASA Astrophysics Data System (ADS)
Tavoularis, Antonis; Kollias, Vangelis; Marinis, Kostas
2014-08-01
iSAFT is an integrated powerful HW/SW environmentfor the simulation, validation & monitoring of satellite/spacecraft on-board data networks supporting simultaneously a wide range of protocols (RMAP, PTP, CCSDS Space Packet, TM/TC, CANopen, etc.) and network interfaces (SpaceWire, ECSS MIL-STD-1553, ECSS CAN). It is based on over 20 years of TELETEL's experience in the area of protocol validation in the telecommunications and aeronautical sectors, and it has been fully re-engineered in cooperation of TELETEL with ESA & space Primes, to comply with space on-board industrial validation requirements (ECSS, EGSE, AIT, AIV, etc.). iSAFT is highly modular and expandable to support new network interfaces & protocols and it is based on the powerful iSAFT graphical tool chain (Protocol Analyser / Recorder, TestRunner, Device Simulator, Traffic Generator, etc.).
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Time required for institutional review board review at one Veterans Affairs medical center.
Hall, Daniel E; Hanusa, Barbara H; Stone, Roslyn A; Ling, Bruce S; Arnold, Robert M
2015-02-01
Despite growing concern that institutional review boards (IRBs) impose burdensome delays on research, little is known about the time required for IRB review across different types of research. To measure the overall and incremental process times for IRB review as a process of quality improvement. After developing a detailed process flowchart of the IRB review process, 2 analysts abstracted temporal data from the records pertaining to all 103 protocols newly submitted to the IRB at a large urban Veterans Affairs medical center from June 1, 2009, through May 31, 2011. Disagreements were reviewed with the principal investigator to reach consensus. We then compared the review times across review types using analysis of variance and post hoc Scheffé tests after achieving normally distributed data through logarithmic transformation. Calendar days from initial submission to final approval of research protocols. Initial IRB review took 2 to 4 months, with expedited and exempt reviews requiring less time (median [range], 85 [23-631] and 82 [16-437] days, respectively) than full board reviews (median [range], 131 [64-296] days; P = .008). The median time required for credentialing of investigators was 1 day (range, 0-74 days), and review by the research and development committee took a median of 15 days (range, 0-184 days). There were no significant differences in credentialing or research and development times across review types (exempt, expedited, or full board). Of the extreme delays in IRB review, 80.0% were due to investigators' slow responses to requested changes. There were no systematic delays attributable to the information security officer, privacy officer, or IRB chair. Measuring and analyzing review times is a critical first step in establishing a culture and process of continuous quality improvement among IRBs that govern research programs. The review times observed at this IRB are substantially longer than the 60-day target recommended by expert panels. The method described here could be applied to other IRBs to begin identifying and improving inefficiencies.
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AGB Statement on Board Responsibility for the Oversight of Educational Quality
ERIC Educational Resources Information Center
Association of Governing Boards of Universities and Colleges, 2011
2011-01-01
This "Statement on Board Responsibility for the Oversight of Educational Quality," approved by the Board of Directors of the Association of Governing Boards (AGB) in March 2011, urges institutional administrators and governing boards to engage fully in this area of board responsibility. The seven principles in this statement offer suggestions to…
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-29
... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63599; File No. SR-MSRB-2010-16] Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of Amendments to Rule G-5, on Disciplinary Actions by Appropriate Regulatory Agencies, Remedial Notices by Registered Securities Associations; and Rule G-17, on Conduct...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-27
...-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of a Proposed Rule Change To Amend Rule G-34 on CUSIP Numbers, New Issue, and Market Information Requirements September 21... consisting of amendments to Rule G-34 on CUSIP numbers, new issue, and market information requirements. The...
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78 FR 63394 - Approval and Promulgation of Implementation Plans; Idaho: State Board Requirements
Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-24
... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R10-OAR-2013-0548, FRL-9901-76-Region 10] Approval and Promulgation of Implementation Plans; Idaho: State Board Requirements AGENCY: Environmental..., dated June 26, 2013, and Idaho Code Sec. Sec. 59-701 through 705, Ethics in Government Act, and...
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Use of Placebo in Clinical Trials of Psychotropic Medication.
Hasnain, Mehrul; Rudnick, Abraham; Bonnell, Weldon S; Remington, Gary; Lam, Raymond W
2018-05-01
This position paper has been substantially revised by the Canadian Psychiatric Association's Research Committee and approved for republication by the CPA's Board of Directors on March 31, 2017. The original position paper 1 was developed by the Scientific and Research Council and approved by the Board of Directors on October 4, 1996.
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78 FR 79662 - Approval of Subzone Status; VF Jeanswear; Hackleburg, Alabama
Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-31
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-136-2013] Approval of Subzone Status; VF Jeanswear; Hackleburg, Alabama On September 19, 2013, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the Huntsville- Madison County Airport Authority, grantee of FTZ 83, requesting subzone status...
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75 FR 31477 - Neighborworks America; Regular Board of Directors Sunshine Act Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-03
... Corporate Secretary (202) 220-2376; [email protected] . Agenda I. Call To Order. II. Approval of the Minutes. III. Approval of the Minutes. IV. Summary Report of the Audit Committee. V. Summary Report of the Finance... the NHSA Special Board of Directors Meeting. VIII. Summary Report of the Corporate Administration...
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76 FR 67426 - National Advisory Committee on Institutional Quality and Integrity (NACIQI) Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-01
... decisions since October 2010 by the Higher Learning Commission of the North Central Association of Colleges... agency for the approval of nurse education). 2. Maryland State Board of Nursing. (Current Scope: A State agency for the approval of nurse education). 3. New York State Board of Regents, State Education...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-28
..., as Modified by Amendment No. 1, to Reduce the Minimum Size of the Nominating and Governance Committee... proposed rule change to reduce the minimum size of the Nominating and Governance Committee (``NGC'') from... the original proposed rule change, it had not yet obtained formal approval from its Board of Directors...
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Decullier, Evelyne; Lhéritier, Véronique; Chapuis, François
2005-10-17
Clinical trials throughout the world must be evaluated by research ethics committees. No one has yet attempted to clearly quantify at the national level the activity of ethics committees and describe the characteristics of the protocols submitted. The objectives of this study were to describe 1) the workload and the activity of Research Ethics Committees in France, and 2) the characteristics of protocols approved on a nation-wide basis. Retrospective cohort of 976 protocols approved by a representative sample of 25/48 of French Research Ethics Committees in 1994. Protocols characteristics (design, study size, investigator), number of revisions requested by the ethics committee before approval, time to approval and number of amendments after approval were collected for each protocol by trained research assistant using the committee's files and archives. Thirty-one percent of protocols were approved with no modifications requested in 16 days (95% CI: 14-17). The number of revisions requested by the committee, and amendments submitted by the investigator was on average respectively 39 (95% CI: 25-53) and 37 (95% CI: 27-46), per committee and per year. When revisions were requested, the main reasons were related to information to the patient (28%) and consent modalities (18%). Drugs were the object of research in 68% of the protocols examined. The majority of the research was national (80%) with a predominance of single-centre studies. Workload per protocol has been estimated at twelve and half hours on average for administrative support and at eleven and half hours for expertise. The estimated workload justifies specific and independent administrative and financial support for Research Ethics Committees.
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Chlorine transfer hose failure.
Joseph, Giby
2004-11-11
On the morning of 14 August 2002, a 1 in. transfer hose used in a rail tank car unloading operation at DPC Enterprises, near Festus, Missouri, catastrophically ruptured and initiated a sequence of events that led to the release of 48,000 pounds of chlorine--a toxic gas--into neighboring areas. The facility repackages bulk dry liquid chlorine into 1 ton containers and 150 pound cylinders for commercial, industrial, and municipal use in the St. Louis metropolitan area. Fortunately, the wind direction on the day of the release limited the effects of the chlorine plume on the surrounding community. However, 63 people sought hospital treatment due to exposure, and hundreds of others were affected by the release (the community was advised to shelter-in-place for 4 h, and traffic was halted on Interstate 55 for 1.5 h). The US Chemical Safety and Hazard Investigation Board (CSB) investigated this incident for the following reasons: This paper presents the lesson-learned from this incident to help prevent similar occurrences. This paper is based on US Chemical Safety and Hazard Investigation Board Report Number 2002-04-I-MO, which was approved by the Board on 1 May 2003. This paper has not been independently approved by the Board and is published for general informational purposes only. Every effort has been made to accurately present the contents of the Board-approved report in this paper. Any material in the paper that did not originate in the Board-approved report is solely the responsibility of the author and does not represent an official finding, conclusion, or position of the Board. A complete copy of the Board investigation report upon which this paper is based is available on the CSB website at "Completed Investigations."
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-13
...On August 22, 2012, the Farm Credit Administration (FCA) Board authorized the voluntary liquidation of the Farm Credit Finance Corporation of Puerto Rico (FCFCPR) without the appointment of a receiver, and the cancellation of FCFCPR's charter arising out of the voluntary liquidation of the corporation. The Farm Credit Administration (FCA) Board also granted preliminary and final approval of the proposed Plan of Liquidation for the FCFCPR under 12 CFR 627.2795--Voluntary Liquidation of FCA regulations.
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Protocols for second-generation business satellites systems
NASA Astrophysics Data System (ADS)
Evans, B. G.; Coakley, F. P.; El Amin, M. H. M.
The paper discusses the nature and mix of traffic in business satellite systems and describes the limitations on the protocol imposed by the differing impairments of speech, video, and data. A simple TDMA system protocol is presented which meets the requirements of mixed-service operation. The efficiency of the protocol together with implications for allocation, scheduling and synchronisation are discussed. Future-generation satellites will probably use on-board processing. Some initial work on protocols that make use of on-board processing and the implications for satellite and earth-station equipment are presented.
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75 FR 67454 - Notice of Sunshine Act Meeting; Meeting No. 10-05
Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-02
... Business Approval of minutes of August 20, 2010, Board Meeting. New Business 1. Welcome. 2. President's Report. 3. Chairman's Report. A. Board Governance matters, including the creation of the TVA Board... comments to: TVA Board of Directors, Board Agenda Comments, 400 West Summit Hill Drive, Knoxville...
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75 FR 22633 - Proposed Information Collection
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-29
... RECOVERY ACCOUNTABILITY AND TRANSPARENCY BOARD Proposed Information Collection ACTION: Notice of... Board (Board) invites public comments on a revision of a currently approved collection of information (OMB number 0430-0004). [[Page 22634
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Basic Microsurgery Training Using the Laboratory Rat (Rattus norvegicus)
2017-03-23
CHANGES: Have there been any personnel/staffing changes (PI/CI/ AI /TC/lnstructor) since the last IACUC approval of protocol, or annual review? _X_ Yes No If...Include Name, Protocol function - PI/CI/ AI /TC/lnstructor, IACUC approval -Yes/No) Maj Ryan Diepenbrock (PI) IACUC Approval Yes 18Jun 15 DELETIONS...Include Name, Protocol function - PI/CI/ AI /TC/lnstructor, Effective date of deletion) Lt Col Jean Luc Niel (PI) June 2015 Col Bradley Turner (Al)July
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-31
... consisting of amendments to Rule A-3, on membership on the Board, in order to establish a Nominating... Independent Public Finance Advisors to discuss the proposed rule change among other matters. See Memorandum... to the creation of the Nominating Committee of the MSRB. On September 30, 2010, the SEC approved MSRB...
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42 CFR 37.4 - Plans for chest roentgenographic examinations.
Code of Federal Regulations, 2011 CFR
2011-10-01
... name and location of the approved X-ray facility or facilities, and the approximate date(s) and time(s... shall promptly display in a visible location on the bulletin board at the mine its proposed plan or... posted in a visible location on the bulletin board until ALOSH either grants or denies approval of it at...
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42 CFR 37.4 - Plans for chest roentgenographic examinations.
Code of Federal Regulations, 2012 CFR
2012-10-01
... name and location of the approved X-ray facility or facilities, and the approximate date(s) and time(s... shall promptly display in a visible location on the bulletin board at the mine its proposed plan or... posted in a visible location on the bulletin board until ALOSH either grants or denies approval of it at...
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42 CFR 37.4 - Plans for chest roentgenographic examinations.
Code of Federal Regulations, 2010 CFR
2010-10-01
... name and location of the approved X-ray facility or facilities, and the approximate date(s) and time(s... shall promptly display in a visible location on the bulletin board at the mine its proposed plan or... posted in a visible location on the bulletin board until ALOSH either grants or denies approval of it at...
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Code of Federal Regulations, 2010 CFR
2010-07-01
... 34 Education 3 2010-07-01 2010-07-01 false What special considerations must the State board give in approving projects, services, and activities? 403.172 Section 403.172 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF VOCATIONAL AND ADULT EDUCATION, DEPARTMENT OF...
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5 CFR Appendix A to Part 1320 - Agencies With Delegated Review and Approval Authority
Code of Federal Regulations, 2010 CFR
2010-01-01
... Approval Authority A Appendix A to Part 1320 Administrative Personnel OFFICE OF MANAGEMENT AND BUDGET OMB... year the Information Collection Budget allowance set by the Board and OMB for the fiscal year-end. (2... Collection Budget). OMB has notified the Board that it intends to review a specific new proposal for the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-09
... Directors, which CBOE believes will provide it, the Nominating and Governance Committee and the... filing that it needed to obtain, but had not yet obtained, formal approval from its Board of Directors... rule change. The Exchange also noted that it needed to obtain, but had not yet obtained, approval from...
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Costs and inconsistencies in US IRB review of low-risk medical education research.
Kano, Miria; Getrich, Christina M; Romney, Crystal; Sussman, Andrew L; Williams, Robert L
2015-06-01
Advances in communication technologies over the last two decades have transformed the way medical education research is conducted, creating opportunities for multi-institution national and international studies. Although these studies enable researchers to gain broader understandings of educational processes across institutions, they increase the need for multiple institutional review board (IRB) reviews to ensure the protection of human subjects. This study describes the process of obtaining multiple IRB approvals of the same protocol for a multi-site, low-risk, medical education research project in the USA. The burden of obtaining those reviews and their consistency are assessed. The associated time and costs, and implications for the research process are detailed. Following review by the investigators' parent institution IRB, the project team circulated a uniform protocol for conduct of a low-risk, medical education survey to the IRBs of 89 US medical schools for review. The processes and time required to obtain approvals were recorded to estimate associated research team personnel costs. Approval could not be obtained from five IRBs as a result of insurmountable procedural barriers. A total of 67 IRBs eventually deferred to the parent IRB determination. The remaining IRBs required a variety of additional procedural processes before ultimately agreeing with the original determination. The personnel costs associated with obtaining the 84 approvals amounted to US$121,344. Considering the value of multi-site designs to address a range of research questions, enhance participant diversity and develop representative findings, solutions must be found to counter inefficiencies of current IRB review processes for low-risk research, such as that usually conducted in medical education. Although we acknowledge that local review is an essential protective measure for research involving identifiable communities that are uniquely susceptible to social or economic harm, this report suggests that proposals to modernise and streamline IRB review processes for low-risk research are timely and relevant. © 2015 John Wiley & Sons Ltd.
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Clinical issues in caring for former chattel slaves.
Blumhofer, Rebecca D; Shah, Neha; Grodin, Michael A; Crosby, Sondra S
2011-04-01
Over the centuries, slavery has become embedded into the social fabric of Mauritania with generations of abid and bizan (Mauritanian slaves and slave masters, respectively) born and raised knowing nothing but the institution of chattel slavery. Abid fleeing their station in Mauritania come to the USA with unique psychological needs that will affect all of their interactions with the medical community. This paper aims to assist health professionals and others concerned with the welfare of former chattel slaves in competently serving this vulnerable population. Discussion includes an overview of Mauritanian chattel slavery, deduced sequelae of chattel slavery, preliminary recommendations for mental health and medical treatment protocols, and suggestions for future research. A confidential Institutional Review Board (IRB)-approved case report will be used to illustrate these objectives.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-07
... Proposed to the National Board for Education Sciences of the Institute of Education Sciences AGENCY... be proposed to the National Board for Education Sciences of the Institute of Education Sciences... the work of the Institute. The National Board for Education Sciences (Board) must approve the...
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Ultrafast Brain MRI: Clinical Deployment and Comparison to Conventional Brain MRI at 3T.
Prakkamakul, Supada; Witzel, Thomas; Huang, Susie; Boulter, Daniel; Borja, Maria J; Schaefer, Pamela; Rosen, Bruce; Heberlein, Keith; Ratai, Eva; Gonzalez, Gilberto; Rapalino, Otto
2016-09-01
To compare an ultrafast brain magnetic resonance imaging (MRI) protocol to the conventional protocol in motion-prone inpatient clinical settings. This retrospective study was HIPAA compliant and approved by the Institutional Review Board with waived inform consent. Fifty-nine inpatients (30 males, 29 females; mean age 55.1, range 23-93 years)who underwent 3-Tesla brain MRI using ultrafast and conventional protocols, both including five sequences, were included in the study. The total scan time for five ultrafast sequences was 4 minutes 59 seconds. The ideal conventional acquisition time was 10 minutes 32 seconds but the actual acquisition took 15-20 minutes. The average scan times for ultrafast localizers, T1-weighted, T2-weighted, fluid-attenuated inversion recovery (FLAIR), diffusion-weighted, T2*-weighted sequences were 14, 41, 62, 96, 80, 6 seconds, respectively. Two blinded neuroradiologists independently assessed three aspects: (1) image quality, (2) gray-white matter (GM-WM) differentiation, and (3) diagnostic concordance for the detection of six clinically relevant imaging findings. Wilcoxon signed-rank test was used to compare image quality and GM-WM scores. Interobserver reproducibility was calculated. The ultrafast T1-weighted sequence demonstrated significantly better image quality (P = .005) and GM-WM differentiation (P < .001) compared to the conventional sequence. There was high agreement (>85%) between both protocols for the detection of mass-like lesion, hemorrhage, diffusion restriction, WM FLAIR hyperintensities, subarachnoid FLAIR hyperintensities, and hydrocephalus. The ultrafast protocol achieved at least comparable image quality and high diagnostic concordance compared to the conventional protocol. This fast protocol can be a viable option to replace the conventional protocol in motion-prone inpatient clinical settings. Copyright © 2016 by the American Society of Neuroimaging.
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7 CFR 1280.212 - Budget and expenses.
Code of Federal Regulations, 2014 CFR
2014-01-01
... paid from funds received by the Board. (d) With approval of the Secretary, the Board may borrow money..., plans, and projects. Such contributions shall be free from any encumbrance by the donor and the Board...
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7 CFR 1280.212 - Budget and expenses.
Code of Federal Regulations, 2012 CFR
2012-01-01
... paid from funds received by the Board. (d) With approval of the Secretary, the Board may borrow money..., plans, and projects. Such contributions shall be free from any encumbrance by the donor and the Board...
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7 CFR 1280.212 - Budget and expenses.
Code of Federal Regulations, 2010 CFR
2010-01-01
... paid from funds received by the Board. (d) With approval of the Secretary, the Board may borrow money..., plans, and projects. Such contributions shall be free from any encumbrance by the donor and the Board...
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Preparing Protocols for Institutional Review Boards.
ERIC Educational Resources Information Center
Lyons, Charles M.
1983-01-01
Introduces the process by which Institutional Review Boards (IRBs) review proposals for research involving human subjects. Describes the composition of IRBs. Presents the Nuremberg code, the elements of informed consent, the judging criteria for proposals, and a sample protocol format. References newly published regulations governing research with…
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Data Relay Board with Protocol for High-Speed, Free-Space Optical Communications
NASA Technical Reports Server (NTRS)
Wright, Malcolm; Clare, Loren; Gould, Gary; Pedyash, Maxim
2004-01-01
In a free-space optical communication system, the mitigation of transient outages through the incorporation of error-control methods is of particular concern, the outages being caused by scintillation fades and obscurants. The focus of this innovative technology is the development of a data relay system for a reliable high-data-rate free-spacebased optical-transport network. The data relay boards will establish the link, maintain synchronous connection, group the data into frames, and provide for automatic retransmission (ARQ) of lost or erred frames. A certain Quality of Service (QoS) can then be ensured, compatible with the required data rate. The protocol to be used by the data relay system is based on the draft CCSDS standard data-link protocol Proximity-1, selected by orbiters to multiple lander assets in the Mars network, for example. In addition to providing data-link protocol capabilities for the free-space optical link and buffering the data, the data relay system will interface directly with user applications over Gigabit Ethernet and/or with highspeed storage resources via Fibre Channel. The hardware implementation is built on a network-processor-based architecture. This technology combines the power of a hardware switch capable of data switching and packet routing at Gbps rates, with the flexibility of a software- driven processor that can host highly adaptive and reconfigurable protocols used, for example, in wireless local-area networks (LANs). The system will be implemented in a modular multi-board fashion. The main hardware elements of the data relay system are the new data relay board developed by Rockwell Scientific, a COTS Gigabit Ethernet board for user interface, and a COTS Fibre Channel board that connects to local storage. The boards reside in a cPCI back plane, and can be housed in a VME-type enclosure.
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75 FR 29722 - Foreign-Trade Zone 138-Columbus, OH Area; Site Renumbering Notice
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-27
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board Foreign-Trade Zone 138--Columbus, OH Area; Site Renumbering Notice Foreign-Trade Zone 138 was approved by the Foreign-Trade Zones Board on March 13, 1987 (Board Order 351), expanded on February 23, 1994 (Board Order 685), on November 9, 1999 (Board Order 1063...
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Tagliafico, A; Succio, G; Neumaier, C E; Baio, G; Serafini, G; Ghidara, M; Calabrese, M; Martinoli, C
2012-01-01
Objective The purpose of our study was to determine whether a three-dimensional (3D) isotropic resolution fast spin echo sequence (FSE-cube) has similar image quality and diagnostic performance to a routine MRI protocol for brachial plexus evaluation in volunteers and symptomatic patients at 3.0 T. Institutional review board approval and written informed consent were guaranteed. Methods In this prospective study FSE-cube was added to the standard brachial plexus examination protocol in eight patients (mean age, 50.2 years) with brachial plexus pathologies and in six volunteers (mean age, 54 years). Nerve visibility, tissue contrast, edge sharpness, image blurring, motion artefact and acquisition time were calculated for FSE-cube sequences and for the standard protocol on a standardised five-point scale. The visibility of brachial plexus nerve and surrounding tissues at four levels (roots, interscalene area, costoclavicular space and axillary level) was assessed. Results Image quality and nerve visibility did not significantly differ between FSE-cube and the standard protocol (p>0.05). Acquisition time was statistically and clinically significantly shorter with FSE-cube (p<0.05). Pathological findings were seen equally well with FSE-cube and the standard protocol. Conclusion 3D FSE-cube provided similar image quality in a shorter acquisition time and enabled excellent visualisation of brachial plexus anatomy and pathology in any orientation, regardless of the original scanning plane. PMID:21343321
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-10-15
... in their comment that EPA approve a conflict of interest protocol submitted for inclusion in the SIP... that with the inclusion of this protocol in the SIP, EPA would be able to approve Alabama's 1997 annual... the State Implementation Plan (SIP) submissions, submitted by the State of Alabama, through the...
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Central institutional review board review for an academic trial network.
Kaufmann, Petra; O'Rourke, P Pearl
2015-03-01
Translating discoveries into therapeutics is often delayed by lengthy start-up periods for multicenter clinical trials. One cause of delay can be multiple institutional review board (IRB) reviews of the same protocol. When developing the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT; hereafter, NN), the National Institute of Neurological Disorders and Stroke (NINDS) established a central IRB (CIRB) based at Massachusetts General Hospital, the academic medical center that received the NN clinical coordinating center grant. The 25 NN sites, located at U.S. academic institutions, agreed to required CIRB use for NN trials. To delineate roles and establish legal relationships between the NN sites and the CIRB, the CIRB executed reliance agreements with the sites and their affiliates that hold federalwide assurance for the protection of human subjects (FWA); this took, on average, 84 days. The first NN protocol reviewed by the CIRB achieved full approval to allow participant enrollment within 56 days and went from grant award to the first patient visit in less than four months. The authors describe anticipated challenges related to institutional oversight responsibilities versus regulatory CIRB review as well as unanticipated challenges related to working with complex organizations that include multiple FWA-holding affiliates. The authors anticipate that CIRB use will decrease NN trial start-up time and thus promote efficient trial implementation. They plan to collect data on timelines and costs associated with CIRB use. The NINDS plans to promote CIRB use in future initiatives.
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Color Vision Changes and Effects of High Contrast Visor Use at Simulated Cabin Altitudes
2016-06-08
under these conditions. Following Institutional Review Board approval, a reduced oxygen breathing device was used to expose subjects with normal...vision, high contrast visor, reduced oxygen breathing device 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT SAR 18. NUMBER OF...in further degradation of color vision under these conditions. Following Institutional Review Board approval, a reduced oxygen breathing device was
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-06
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-2-2013] Foreign-Trade Zone 196--Fort Worth, TX, Foreign-Trade Subzone 196A--TTI, Inc., Approval of Additional Subzone Site, Fort Worth, TX On January 4, 2013, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by Alliance Corridor, Inc., grantee of...
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Ethical Issues and Practical Challenges in Suicide Research.
Hom, Melanie A; Podlogar, Matthew C; Stanley, Ian H; Joiner, Thomas E
2017-03-01
Research with human subjects represents a critical avenue for suicide prevention efforts; however, such research is not without its ethical and practical challenges. Specifically, given the nature of research with individuals at elevated risk for suicide (e.g., increased concerns regarding participant safety, adverse events, liability, difficulties often arise during the institutional review board (IRB) evaluation and approval process. This paper aims to discuss IRB-related issues associated with suicide prevention research, including researcher and IRB panel member responsibilities, suicide risk assessment and management ethics and procedures, informed consent considerations, preparation of study protocols, and education and training. Points to consider and components to potentially include in an IRB application for suicide-related research are additionally provided. Literature relevant to ethics in suicide research and suicide risk assessment and management was reviewed and synthesized. Suicide research can be conducted in accordance with ethical principles while also furthering the science of suicide prevention. Despite the challenging nature of suicide prevention research, empirically informed solutions exist to address difficulties that may emerge in interfacing with IRBs. There remain areas for improvement in the IRB approval process that warrant further investigation and work.
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Enhancing stewardship of community-engaged research through governance.
Oetzel, John G; Villegas, Malia; Zenone, Heather; White Hat, Emily R; Wallerstein, Nina; Duran, Bonnie
2015-06-01
We explored the relationship of community-engaged research final approval type (tribal government, health board, or public health office (TG/HB); agency staff or advisory board; or individual or no community approval) with governance processes, productivity, and perceived outcomes. We identified 294 federally funded community-engaged research projects in 2009 from the National Institutes of Health's Research Portfolio Online Reporting Tools, Centers for Disease Control and Prevention's Prevention Research Centers, and Native American Research Centers for Health databases. Two hundred (68.0%) investigators completed a survey about governance processes and productivity measures; 312 partners (77.2% of 404 invited) and 138 investigators (69.0% of 200 invited) completed a survey about perceived outcomes. Projects with TG/HB approval had increased likelihood of community control of resources (odds ratios [ORs] ≥ 4.80). Projects with other approvals had decreased likelihood of development or revision of institutional review board policies (ORs ≤ 0.37), having written agreements (ORs ≤ 0.17), and agreements about publishing (ORs ≤ 0.28), data use (ORs ≤ 0.17), and publishing approval (ORs ≤ 0.14). Community-engaged research projects with TG/HB approval had strong stewardship of project resources and agreements. Governance as stewardship protects community interests; thus, is an ethical imperative for communities, especially native communities, to adopt.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-30
... Standards Board (``ASB'') of the American Institute of Certified Public Accountants); and observations from... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63606; File No. PCAOB 2010-01] Public Company.... Introduction On September 15, 2010, the Public Company Accounting Oversight Board (the ``Board'' or the ``PCAOB...
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12 CFR 980.5 - Notice by the Finance Board.
Code of Federal Regulations, 2011 CFR
2011-01-01
....5 Banks and Banking FEDERAL HOUSING FINANCE BOARD NEW FEDERAL HOME LOAN BANK ACTIVITIES NEW BUSINESS... new business activity under § 980.3, the Finance Board may issue to a Bank a notice that: (1... Finance Board's approval of the new business activity, including but not limited to the conditions listed...
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40 CFR 52.241 - Interim approval of enhanced inspection and maintenance program.
Code of Federal Regulations, 2010 CFR
2010-07-01
... AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California... Act (Pub. L. 104-59), the California SIP is approved as meeting the provisions of section 182(c)(3.... (a) [Reserved] (b) Approval. On June 5, 2009, the California Air Resources Board submitted a revision...
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Protocol Development | Division of Cancer Prevention
The chemoprevention Phase I and II consortia must submit Letters of Intent for review and approval prior to the submission and review of the protocol. Letter of Intent (LOI) Process The chemoprevention Phase I and II consortia must submit Letters of Intent for review and approval prior to the submission and review of the protocol. DCP will solicit Letters of Intent from
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Weiss, Jakob; Martirosian, Petros; Notohamiprodjo, Mike; Kaufmann, Sascha; Othman, Ahmed E; Grosse, Ulrich; Nikolaou, Konstantin; Gatidis, Sergios
2018-03-01
The aims of this study were to establish a 5-minute magnetic resonance (MR) screening protocol for prostate cancer in men before biopsy and to evaluate effects on Prostate Imaging Reporting and Data System (PI-RADS) V2 scoring in comparison to a conventional, fully diagnostic multiparametric MR imaging (mpMRI) approach. Fifty-two patients with elevated prostate-specific antigen levels and without prior biopsy were prospectively included in this institutional review board-approved study. In all patients, an mpMRI protocol according to the PI-RADS recommendations was acquired on a 3 T MRI system. In addition, an accelerated diffusion-weighted imaging sequence was acquired using simultaneous multislice technique (DW-EPISMS). Two readers independently evaluated the images for the presence/absence of prostate cancer according to the PI-RADS criteria and for additional findings. In a first reading session, only the screening protocol consisting of axial T2-weighted and DW-EPISMS images was made available. In a subsequent reading session, the mpMRI protocol was assessed blinded to the results of the first reading, serving as reference standard. Both readers successfully established a final diagnosis according to the PI-RADS criteria in the screening and mpMRI protocol. Mean lesion size was 1.2 cm in the screening and 1.4 cm in the mpMRI protocol (P = 0.4) with 35% (18/52) of PI-RADS IV/V lesions. Diagnostic performance of the screening protocol was excellent with a sensitivity and specificity of 100% for both readers with no significant differences in comparison to the mpMRI standard (P = 1.0). In 3 patients, suspicious lymph nodes were reported as additional finding, which were equally detectable in the screening and mpMRI protocol. A 5-minute MR screening protocol for prostate cancer in men with elevated prostate-specific antigen levels before biopsy is applicable for clinical routine with similar diagnostic performance as the full diagnostic mpMRI approach.
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Ho, Lisa M; Nelson, Rendon C; Delong, David M
2007-05-01
To prospectively evaluate the use of lean body weight (LBW) as the main determinant of the volume and rate of contrast material administration during multi-detector row computed tomography of the liver. This HIPAA-compliant study had institutional review board approval. All patients gave written informed consent. Four protocols were compared. Standard protocol involved 125 mL of iopamidol injected at 4 mL/sec. Total body weight (TBW) protocol involved 0.7 g iodine per kilogram of TBW. Calculated LBW and measured LBW protocols involved 0.86 g of iodine per kilogram and 0.92 g of iodine per kilogram calculated or measured LBW for men and women, respectively. Injection rate used for the three experimental protocols was determined proportionally on the basis of the calculated volume of contrast material. Postcontrast attenuation measurements during portal venous phase were obtained in liver, portal vein, and aorta for each group and were summed for each patient. Patient-to-patient enhancement variability in same group was measured with Levene test. Two-tailed t test was used to compare the three experimental protocols with the standard protocol. Data analysis was performed in 101 patients (25 or 26 patients per group), including 56 men and 45 women (mean age, 53 years). Average summed attenuation values for standard, TBW, calculated LBW, and measured LBW protocols were 419 HU +/- 50 (standard deviation), 443 HU +/- 51, 433 HU +/- 50, and 426 HU +/- 33, respectively (P = not significant for all). Levene test results for summed attenuation data for standard, TBW, calculated LBW, and measured LBW protocols were 40 +/- 29, 38 +/- 33 (P = .83), 35 +/- 35 (P = .56), and 26 +/- 19 (P = .05), respectively. By excluding highly variable but poorly perfused adipose tissue from calculation of contrast medium dose, the measured LBW protocol may lessen patient-to-patient enhancement variability while maintaining satisfactory hepatic and vascular enhancement.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-10
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Docket 28-2012] Foreign-Trade Zone 18--San Jose... to the Foreign-Trade Zones (FTZ) Board (the Board) by the City of San Jose, grantee of FTZ 18...). It was formally filed on April 4, 2012. FTZ 18 was approved by the Board on November 27, 1974 (Board...
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Kost, Rhonda G.; Dowd, Kathleen A.; Hurley, Arlene M.; Rainer, Tyler‐Lauren; Coller, Barry S.
2014-01-01
Abstract The development of translational clinical research protocols is complex. To assist investigators, we developed a structured supportive guidance process (Navigation) to expedite protocol development to the standards of good clinical practice (GCP), focusing on research ethics and integrity. Navigation consists of experienced research coordinators leading investigators through a concerted multistep protocol development process from concept initiation to submission of the final protocol. To assess the effectiveness of Navigation, we collect data on the experience of investigators, the intensity of support required for protocol development, IRB review outcomes, and protocol start and completion dates. One hundred forty‐four protocols underwent Navigation and achieved IRB approval since the program began in 2007, including 37 led by trainee investigators, 26 led by MDs, 9 by MD/PhDs, 57 by PhDs, and 12 by investigators with other credentials (e.g., RN, MPH). In every year, more than 50% of Navigated protocols were approved by the IRB within 30 days. For trainees who had more than one protocol navigated, the intensity of Navigation support required decreased over time. Navigation can increase access to translational studies for basic scientists, facilitate GCP training for investigators, and accelerate development and approval of protocols of high ethical and scientific quality. PMID:24405608
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46 CFR 35.01-55 - Pilot boarding operation.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 46 Shipping 1 2010-10-01 2010-10-01 false Pilot boarding operation. 35.01-55 Section 35.01-55... Requirements § 35.01-55 Pilot boarding operation. (a) The master shall ensure that pilot boarding equipment is... or spreader step on a pilot ladder must be replaced in kind with an approved replacement step or...
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46 CFR 196.95-1 - Pilot boarding operations.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 46 Shipping 7 2011-10-01 2011-10-01 false Pilot boarding operations. 196.95-1 Section 196.95-1... Pilot Boarding Operations § 196.95-1 Pilot boarding operations. (a) The master shall ensure that pilot.... (2) Each damaged step or spreader step on a pilot ladder must be replaced in kind with an approved...
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46 CFR 196.95-1 - Pilot boarding operations.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 46 Shipping 7 2010-10-01 2010-10-01 false Pilot boarding operations. 196.95-1 Section 196.95-1... Pilot Boarding Operations § 196.95-1 Pilot boarding operations. (a) The master shall ensure that pilot.... (2) Each damaged step or spreader step on a pilot ladder must be replaced in kind with an approved...
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46 CFR 35.01-55 - Pilot boarding operation.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 46 Shipping 1 2011-10-01 2011-10-01 false Pilot boarding operation. 35.01-55 Section 35.01-55... Requirements § 35.01-55 Pilot boarding operation. (a) The master shall ensure that pilot boarding equipment is... or spreader step on a pilot ladder must be replaced in kind with an approved replacement step or...
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10 CFR 1023.5 - Duties and responsibilities of the Chair.
Code of Federal Regulations, 2011 CFR
2011-01-01
... cases, including alternative dispute resolution (ADR) proceedings, to administrative judges, hearing...) Authorizing and approving ADR arrangements for Board cases; obtaining non-Board personnel to serve as...-provided personnel and facilities in ADR capacities, for matters before the Board, and for other matters...
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10 CFR 1023.5 - Duties and responsibilities of the Chair.
Code of Federal Regulations, 2010 CFR
2010-01-01
... cases, including alternative dispute resolution (ADR) proceedings, to administrative judges, hearing...) Authorizing and approving ADR arrangements for Board cases; obtaining non-Board personnel to serve as...-provided personnel and facilities in ADR capacities, for matters before the Board, and for other matters...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-27
... either http://www.regulations.gov or http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinical...] Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Continuing Review After Clinical Investigation Approval; Availability AGENCY: Food and Drug Administration...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-11
... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-64189; File No. SR-CBOE-2011-008] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Granting Approval of Proposed... Chicago Board Options Exchange, Incorporated (``CBOE'' or ``Exchange'') filed with the Securities and...
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7 CFR 930.120 - Board membership.
Code of Federal Regulations, 2010 CFR
2010-01-01
... MICHIGAN, NEW YORK, PENNSYLVANIA, OREGON, UTAH, WASHINGTON, AND WISCONSIN Order Regulating Handling... Secretary for approval. If the recommendation is not made by the Board within a reasonable time, the...
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Time Required for Institutional Review Board Review at One Veterans Affairs Medical Center
Hall, Daniel E.; Hanusa, Barbara H.; Stone, Roslyn A.; Ling, Bruce S.; Arnold, Robert M.
2015-01-01
IMPORTANCE Despite growing concern that institutional review boards (IRBs) impose burdensome delays on research, little is known about the time required for IRB review across different types of research. OBJECTIVE To measure the overall and incremental process times for IRB review as a process of quality improvement. DESIGN, SETTING, AND PARTICIPANTS After developing a detailed process flowchart of the IRB review process, 2 analysts abstracted temporal data from the records pertaining to all 103 protocols newly submitted to the IRB at a large urban Veterans Affairs medical center from June 1, 2009, through May 31, 2011. Disagreements were reviewed with the principal investigator to reach consensus. We then compared the review times across review types using analysis of variance and post hoc Scheffé tests after achieving normally distributed data through logarithmic transformation. MAIN OUTCOMES AND MEASURES Calendar days from initial submission to final approval of research protocols. RESULTS Initial IRB review took 2 to 4 months, with expedited and exempt reviews requiring less time (median [range], 85 [23–631] and 82 [16–437] days, respectively) than full board reviews (median [range], 131 [64–296] days; P = .008). The median time required for credentialing of investigators was 1 day (range, 0–74 days), and review by the research and development committee took a median of 15 days (range, 0–184 days). There were no significant differences in credentialing or research and development times across review types (exempt, expedited, or full board). Of the extreme delays in IRB review, 80.0% were due to investigators' slow responses to requested changes. There were no systematic delays attributable to the information security officer, privacy officer, or IRB chair. CONCLUSIONS AND RELEVANCE Measuring and analyzing review times is a critical first step in establishing a culture and process of continuous quality improvement among IRBs that govern research programs. The review times observed at this IRB are substantially longer than the 60-day target recommended by expert panels. The method described here could be applied to other IRBs to begin identifying and improving inefficiencies. PMID:25494359
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2014-10-01
A.J. Mendez, S.L. Groah, J. Kressler. Fasting plasma glucose values may significantly underestimate prevalence of dysfunctional glycemic regulation in...taken corrective actions without undertaking additional protocol changes. There have been no screening issues since protocol amendments were approved...extending approval for the project through September 9, 2015. Enclosed is the dated/stamped Informed Consent Form, approved for one additional year until
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-29
...-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Granting Approval of Proposed Rule Change To Amend Certain Rules Pertaining to Credit Options November 19, 2010. I. Introduction On September 20, 2010, the Chicago Board Options Exchange, Incorporated (``CBOE'' or ``Exchange'') filed with...
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75 FR 69047 - Senior Executive Service: Membership of Performance Review Board
Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-10
... AGENCY FOR INTERNATIONAL DEVELOPMENT Senior Executive Service: Membership of Performance Review Board ACTION: Notice. SUMMARY: This notice lists approved candidates who will comprise a standing roster for service on the Agency's 2010 and 2011 SES Performance Review Boards. The Agency will use this...
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77 FR 66793 - Senior Executive Service: Membership of Performance Review Board
Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-07
... AGENCY FOR INTERNATIONAL DEVELOPMENT Senior Executive Service: Membership of Performance Review Board ACTION: Notice. SUMMARY: This notice lists approved candidates who will comprise a standing roster for service on the Agency's 2012 and 2013 SES Performance Review Boards. The Agency will use this...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-24
...: Federal Reserve Board Clearance Officer--Michelle Shore--Division of Research and Statistics, Board of... delinquency and nonaccrual status of trading securities is not particularly meaningful given that these... proposed disclosure requirements regarding the delinquency and nonaccrual status of trading securities. The...
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78 FR 66715 - Federal Reserve Bank Services
Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-06
... FEDERAL RESERVE SYSTEM [Docket No. OP-1468] Federal Reserve Bank Services AGENCY: Board of Governors of the Federal Reserve System. ACTION: Notice. SUMMARY: The Board of Governors of the Federal Reserve System (Board) has approved the private sector adjustment factor (PSAF) for 2014 of $23.4 million...
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Enhancing Stewardship of Community-Engaged Research Through Governance
Villegas, Malia; Zenone, Heather; White Hat, Emily R.; Wallerstein, Nina; Duran, Bonnie
2015-01-01
Objectives. We explored the relationship of community-engaged research final approval type (tribal government, health board, or public health office (TG/HB); agency staff or advisory board; or individual or no community approval) with governance processes, productivity, and perceived outcomes. Methods. We identified 294 federally funded community-engaged research projects in 2009 from the National Institutes of Health’s Research Portfolio Online Reporting Tools, Centers for Disease Control and Prevention’s Prevention Research Centers, and Native American Research Centers for Health databases. Two hundred (68.0%) investigators completed a survey about governance processes and productivity measures; 312 partners (77.2% of 404 invited) and 138 investigators (69.0% of 200 invited) completed a survey about perceived outcomes. Results. Projects with TG/HB approval had increased likelihood of community control of resources (odds ratios [ORs] ≥ 4.80). Projects with other approvals had decreased likelihood of development or revision of institutional review board policies (ORs ≤ 0.37), having written agreements (ORs ≤ 0.17), and agreements about publishing (ORs ≤ 0.28), data use (ORs ≤ 0.17), and publishing approval (ORs ≤ 0.14). Conclusions. Community-engaged research projects with TG/HB approval had strong stewardship of project resources and agreements. Governance as stewardship protects community interests; thus, is an ethical imperative for communities, especially native communities, to adopt. PMID:25880952
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Bohari, Mohammed H; Sastry, G Narahari
2012-09-01
Efficient drug discovery programs can be designed by utilizing existing pools of knowledge from the already approved drugs. This can be achieved in one way by repositioning of drugs approved for some indications to newer indications. Complex of drug to its target gives fundamental insight into molecular recognition and a clear understanding of putative binding site. Five popular docking protocols, Glide, Gold, FlexX, Cdocker and LigandFit have been evaluated on a dataset of 199 FDA approved drug-target complexes for their accuracy in predicting the experimental pose. Performance for all the protocols is assessed at default settings, with root mean square deviation (RMSD) between the experimental ligand pose and the docked pose of less than 2.0 Å as the success criteria in predicting the pose. Glide (38.7 %) is found to be the most accurate in top ranked pose and Cdocker (58.8 %) in top RMSD pose. Ligand flexibility is a major bottleneck in failure of docking protocols to correctly predict the pose. Resolution of the crystal structure shows an inverse relationship with the performance of docking protocol. All the protocols perform optimally when a balanced type of hydrophilic and hydrophobic interaction or dominant hydrophilic interaction exists. Overall in 16 different target classes, hydrophobic interactions dominate in the binding site and maximum success is achieved for all the docking protocols in nuclear hormone receptor class while performance for the rest of the classes varied based on individual protocol.
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Kohli, Anjalee; Perrin, Nancy A; Remy, Mitima Mpanano; Alfred, Mirindi Bacikenge; Arsene, Kajabika Binkurhorhwa; Nadine, Mwinja Bufole; Heri, Banyewesize Jean; Clovis, Mitima Murhula; Glass, Nancy
2017-03-14
People living in poverty have limited access to traditional financial institutions. Microfinance programmes are designed to meet this gap and show promise in improving income, economic productivity and health. Our Congolese-US community academic research partnership developed two livestock productive asset transfer programmes, Pigs for Peace (PFP) and Rabbits for Resilience (RFR), to address the interlinked health, social and economic well-being of individuals, their families and communities. The community-based randomised controlled trials examine the effectiveness of PFP and RFR to improve health, economic stability, and family and community relationships among male and female adults and adolescents living in 10 rural, postconflict villages of eastern Democratic Republic of Congo. PFP participants include adult permanent residents of rural villages; adolescent participants in RFR include male and female adolescents 10-15 years old living in the selected rural villages. Participants were randomised to intervention or delayed control group. Participants in PFP completed baseline interview prior to intervention and follow-up interview at 6, 12 and 18 months postintervention. In RFR, participants completed baseline interview prior to intervention and follow-up interview at 6, 12 and 18 months postbaseline. The primary outcome of both trials, the change in baseline mental health distress at 18 months in the intervention group (adults, adolescents) compared to control group, is used to calculate sample size. The Johns Hopkins Medical Institute Internal Review Board approved this protocol. A committee of respected Congolese educators and community members (due to lack of local ethics review board) approved the study. The findings will provide important information on the potential for community-led sustainable development initiatives to build on traditional livelihood (livestock raising, agriculture) to have a sustained health, economic and social impact on the individual, family and community. NCT02008708, NCT02008695. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
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Kohli, Anjalee; Perrin, Nancy A; Remy, Mitima Mpanano; Alfred, Mirindi Bacikenge; Arsene, Kajabika Binkurhorhwa; Nadine, Mwinja Bufole; Heri, Banyewesize Jean; Clovis, Mitima Murhula; Glass, Nancy
2017-01-01
Introduction People living in poverty have limited access to traditional financial institutions. Microfinance programmes are designed to meet this gap and show promise in improving income, economic productivity and health. Our Congolese–US community academic research partnership developed two livestock productive asset transfer programmes, Pigs for Peace (PFP) and Rabbits for Resilience (RFR), to address the interlinked health, social and economic well-being of individuals, their families and communities. The community-based randomised controlled trials examine the effectiveness of PFP and RFR to improve health, economic stability, and family and community relationships among male and female adults and adolescents living in 10 rural, postconflict villages of eastern Democratic Republic of Congo. Methods and analysis PFP participants include adult permanent residents of rural villages; adolescent participants in RFR include male and female adolescents 10–15 years old living in the selected rural villages. Participants were randomised to intervention or delayed control group. Participants in PFP completed baseline interview prior to intervention and follow-up interview at 6, 12 and 18 months postintervention. In RFR, participants completed baseline interview prior to intervention and follow-up interview at 6, 12 and 18 months postbaseline. The primary outcome of both trials, the change in baseline mental health distress at 18 months in the intervention group (adults, adolescents) compared to control group, is used to calculate sample size. Ethics and dissemination The Johns Hopkins Medical Institute Internal Review Board approved this protocol. A committee of respected Congolese educators and community members (due to lack of local ethics review board) approved the study. The findings will provide important information on the potential for community-led sustainable development initiatives to build on traditional livelihood (livestock raising, agriculture) to have a sustained health, economic and social impact on the individual, family and community. Trial registration number NCT02008708, NCT02008695. PMID:28292764
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-08
... FTZ 131 zone projects under FTZ 129. FTZ 130 was approved by the Board on September 4, 1986 (51 FR... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [(B-32-2012)] Foreign-Trade Zone 129--Bellingham... to the Foreign-Trade Zones (FTZ) Board (the Board) by the Port of Bellingham, grantee of FTZ 129...
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14 CFR 135.419 - Approved aircraft inspection program.
Code of Federal Regulations, 2010 CFR
2010-01-01
... OPERATING REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT Maintenance, Preventive Maintenance, and Alterations § 135.419 Approved aircraft inspection program. (a... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Approved aircraft inspection program. 135...
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14 CFR 135.419 - Approved aircraft inspection program.
Code of Federal Regulations, 2012 CFR
2012-01-01
... OPERATING REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT Maintenance, Preventive Maintenance, and Alterations § 135.419 Approved aircraft inspection program. (a... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Approved aircraft inspection program. 135...
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14 CFR 135.419 - Approved aircraft inspection program.
Code of Federal Regulations, 2013 CFR
2013-01-01
... OPERATING REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT Maintenance, Preventive Maintenance, and Alterations § 135.419 Approved aircraft inspection program. (a... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Approved aircraft inspection program. 135...
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14 CFR 135.419 - Approved aircraft inspection program.
Code of Federal Regulations, 2014 CFR
2014-01-01
... OPERATING REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT Maintenance, Preventive Maintenance, and Alterations § 135.419 Approved aircraft inspection program. (a... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Approved aircraft inspection program. 135...
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14 CFR 135.419 - Approved aircraft inspection program.
Code of Federal Regulations, 2011 CFR
2011-01-01
... OPERATING REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT Maintenance, Preventive Maintenance, and Alterations § 135.419 Approved aircraft inspection program. (a... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Approved aircraft inspection program. 135...
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77 FR 15142 - Regular Board of Directors Meeting; Sunshine Act
Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-14
... 20005. STATUS: Open. CONTACT PERSON: Erica Hall, Assistant Corporate Secretary, (202) 220- 2376; ehall... Directors Meeting Minutes IV. Approval of the Audit Committee Meeting Minutes V. Approval of the Finance, Budget and Program Committee Meeting Minutes VI. Approval of the Corporate Administration Committee...
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Saade, Charbel; Mayat, Ahmad; El-Merhi, Fadi
2016-01-01
Matching contrast injection timing with vessel dynamics significantly improves vessel opacification and reduces contrast dose in the assessment of pulmonary embolism during computed tomography (CT) pulmonary angiography. The aim of this study was to investigate opacification of the pulmonary vasculature (PV) during CT pulmonary angiography using a patient-specific contrast formula (PSCF) and exponentially decelerated contrast media (EDCM) injection rate. Institutional review board approved this retrospective study. Computed tomography pulmonary angiography was performed on 200 patients with suspected pulmonary embolism using a 64-channel CT scanner. Patient demographics were equally distributed. Patients were randomly assigned to 2 equal protocol groups: protocol A used a PSCF, and protocol B involved the use of a PSCF combined with EDCM. The mean cross-sectional opacification profile of 8 central and 11 peripheral PVs were measured for each patient, and arteriovenous contrast ratio was calculated. Protocols were compared using Mann-Whitney U nonparametric statistics. Jackknife alternative free-response receiver operating characteristic analyses were used to assess diagnostic efficacy. Interobserver variations were investigated using kappa methods. A number of pulmonary arteries demonstrated increases in opacification (P < 0.02) for protocol B compared with A, whereas opacification in all veins was reduced in protocol B (P < 0.03). Subsequently, increased arteriovenous contrast ratio in protocol B compared with A was observed at all anatomic locations (P < 0.0002). An increase in jackknife alternative free-response receiver operating characteristic figure of merit (P < 0.0002) and interobserver variation was observed with protocol B compared with protocol A (κ = 0.3-0.73). Mean contrast volume was reduced in protocol B (29 [4] mL) compared with protocol A (33 [9] mL). Mean effective radiation dose in protocol B (1.2 [0.4] mSv) was reduced by 14% compared with protocol A (1.4 [0.6] mSv). Significant improvements in visualization of the PV can be achieved with a low contrast volume using an EDCM and PSCF. The reduced risk of cancer induction is highlighted.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-04
...-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Granting Approval of Proposed Rule Change To List and Trade Single Stock Dividend Options July 29, 2011. On May 31, 2011, the Chicago Board Options Exchange, Incorporated (``Exchange'' or ``CBOE'') filed with the Securities and Exchange...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-27
...-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Granting Accelerated Approval of Proposed Rule Change To Permit $1 Strikes for Options on Trust Issued Receipts May 20, 2010. I. Introduction On April 13, 2010, the Chicago Board Options Exchange, Incorporated (``CBOE'' or ``Exchange...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-30
... Board Clearance Officer --Michelle Shore, Division of Research and Statistics, Board of Governors of the... survey: Report title: Senior Credit Officer Opinion Survey on Dealer Financing Terms. Agency form number....\\1\\ The purpose of the survey is to provide qualitative and limited quantitative information on (1...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-21
... settlement of electronic debit transactions as the Board considers appropriate and in the public interest. 15... excluded from ``authorization, clearance, and settlement costs.'' In a few instances, the commenters... analysis I. Respondent Information The Board proposed to have respondents provide the name of the card...
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78 FR 70352 - Notice of Government in the Sunshine Regular Board of Directors Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-25
... NEIGHBORHOOD REINVESTMENT CORPORATION Notice of Government in the Sunshine Regular Board of.... Approval of Minutes III. Management Internal Operations Review IV. Non-Network Grant Policy V. MHA... Board XIII. Adjournment Jeffrey T. Bryson, General Counsel/Secretary. [FR Doc. 2013-28325 Filed 11-21-13...
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12 CFR 985.5 - Funding of the OF.
Code of Federal Regulations, 2010 CFR
2010-01-01
... and Banking FEDERAL HOUSING FINANCE BOARD OFFICE OF FINANCE THE OFFICE OF FINANCE § 985.5 Funding of... of Finance, including the costs of indemnifying the members of the OF board of directors, the... for expenses of the Office of Finance and the OF board of directors, according to their approved...
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Code of Federal Regulations, 2011 CFR
2011-10-01
... using an electronic claims management (ECM) system, apply software approved by the Board. (iii) If prospective DUR is not conducted through an ECM system, as part of general compliance monitoring, ensure that...
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Code of Federal Regulations, 2010 CFR
2010-10-01
... using an electronic claims management (ECM) system, apply software approved by the Board. (iii) If prospective DUR is not conducted through an ECM system, as part of general compliance monitoring, ensure that...
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Leonard, Charles E; Tallhamer, Michael; Johnson, Tim; Hunter, Kari; Howell, Kathryn; Kercher, Jane; Widener, Jodi; Kaske, Terese; Paul, Devchand; Sedlacek, Scot; Carter, Dennis L
2010-02-01
To explore the feasibility of fiducial markers for the use of image-guided radiotherapy (IGRT) in an accelerated partial breast intensity modulated radiotherapy protocol. Nineteen patients consented to an institutional review board approved protocol of accelerated partial breast intensity-modulated radiotherapy with fiducial marker placement and treatment with IGRT. Patients (1 patient with bilateral breast cancer; 20 total breasts) underwent ultrasound guided implantation of three 1.2- x 3-mm gold markers placed around the surgical cavity. For each patient, table shifts (inferior/superior, right/left lateral, and anterior/posterior) and minimum, maximum, mean error with standard deviation were recorded for each of the 10 BID treatments. The dose contribution of daily orthogonal films was also examined. All IGRT patients underwent successful marker placement. In all, 200 IGRT treatment sessions were performed. The average vector displacement was 4 mm (range, 2-7 mm). The average superior/inferior shift was 2 mm (range, 0-5 mm), the average lateral shift was 2 mm (range, 1-4 mm), and the average anterior/posterior shift was 3 mm (range, 1 5 mm). This study shows that the use of IGRT can be successfully used in an accelerated partial breast intensity-modulated radiotherapy protocol. The authors believe that this technique has increased daily treatment accuracy and permitted reduction in the margin added to the clinical target volume to form the planning target volume. Copyright 2010 Elsevier Inc. All rights reserved.
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Walker, Sarah; Datta, Ankur; Massoumi, Roxanne L; Gross, Erica R; Uhing, Michael; Arca, Marjorie J
2017-12-01
There is significant diversity in the utilization of antibiotics for neonates undergoing surgical procedures. Our institution standardized antibiotic administration for surgical neonates, in which no empiric antibiotics were given to infants with surgical conditions postnatally, and antibiotics are given no more than 72 hours perioperatively. We compared the time periods before and after implementation of antibiotic protocol in an institution review board-approved, retrospective review of neonates with congenital surgical conditions who underwent surgical correction within 30 days after birth. Surgical site infection at 30 days was the primary outcome, and development of hospital-acquired infections or multidrug-resistant organism were secondary outcomes. One hundred forty-eight infants underwent surgical procedures pre-protocol, and 127 underwent procedures post-protocol implementation. Surgical site infection rates were similar pre- and post-protocol, 14% and 9% respectively, (P = .21.) The incidence of hospital-acquired infections (13.7% vs 8.7%, P = .205) and multidrug-resistant organism (4.7% vs 1.6%, P = .143) was similar between the 2 periods. Elimination of empiric postnatal antibiotics did not statistically change rates of surgical site infection, hospital-acquired infections, or multidrug-resistant organisms. Limiting the duration of perioperative antibiotic prophylaxis to no more than 72 hours after surgery did not increase the rate of surgical site infection, hospital-acquired infections, or multidrug-resistant organism. Median antibiotic days were decreased with antibiotic standardization for surgical neonates. Copyright © 2017 Elsevier Inc. All rights reserved.
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Efficacy evaluation of an anti-caries varnish: protocol for a phase II randomised controlled trial
Tut, Ohnmar; Rothen, Marilynn; Mancl, Lloyd; Gallen, Marcelle; Tanzer, Jason M
2017-01-01
Introduction Dental caries (tooth decay) is a common disease in which the products of sugar metabolism by certain bacteria that populate the tooth surface induce the development and progression of lesions (cavities). This is a phase II single-centre randomised, double-blind, active-controlled, parallel-group trial to assess the efficacy of a combination povidone iodine and sodium fluoride dental varnish to determine if it is superior to a varnish containing only sodium fluoride in the prevention of new caries lesions. The objective of this report is to describe the rationale and protocol for the trial. Methods and analysis The study site is Pohnpei State, Federated States of Micronesia. The study population is 284 children 48–84 months old. The primary outcome will be the surface-level primary molar caries increment (d2-3mfs/DMFS) at 2 years post baseline. The incremental dental caries at 1 year will also be compared between the two interventions. The secondary outcome is the Facial Image Scale after the initial treatment and after the fifth treatment at 1 year that gauges the child’s response to the treatment. Ethics and dissemination The Western Institutional Review Board (designated IRB) and the Institutional Review Board of the College of Micronesia-FSM approved all study procedures. The US Food and Drug Administration (FDA) has issued IND 128835 covering this study. The study results will be published and submitted to the FDA in support of a new drug application. Trialregistration number NCT03082196. PMID:28667230
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75 FR 72843 - National Science Board; Sunshine Act Meetings; Notice
Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-26
.... Electronic Distribution of Initial Chapter Drafts for Board Review. Update on Graphic Design Review of State... Education for Sustainability (SEES), Dr. Timothy Killeen. Approval of Minutes. Chairman's Report. Director's...
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20 CFR 323.5 - Submitting proposed plan for Board approval.
Code of Federal Regulations, 2010 CFR
2010-04-01
... UNEMPLOYMENT INSURANCE ACT NONGOVERNMENTAL PLANS FOR UNEMPLOYMENT OR SICKNESS INSURANCE § 323.5 Submitting... existing plan, to the Director of Unemployment and Sickness Insurance, Railroad Retirement Board, 844 Rush...
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20 CFR 323.5 - Submitting proposed plan for Board approval.
Code of Federal Regulations, 2012 CFR
2012-04-01
... UNEMPLOYMENT INSURANCE ACT NONGOVERNMENTAL PLANS FOR UNEMPLOYMENT OR SICKNESS INSURANCE § 323.5 Submitting... existing plan, to the Director of Unemployment and Sickness Insurance, Railroad Retirement Board, 844 Rush...
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20 CFR 323.5 - Submitting proposed plan for Board approval.
Code of Federal Regulations, 2014 CFR
2014-04-01
... UNEMPLOYMENT INSURANCE ACT NONGOVERNMENTAL PLANS FOR UNEMPLOYMENT OR SICKNESS INSURANCE § 323.5 Submitting... existing plan, to the Director of Unemployment and Sickness Insurance, Railroad Retirement Board, 844 Rush...
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20 CFR 323.5 - Submitting proposed plan for Board approval.
Code of Federal Regulations, 2011 CFR
2011-04-01
... UNEMPLOYMENT INSURANCE ACT NONGOVERNMENTAL PLANS FOR UNEMPLOYMENT OR SICKNESS INSURANCE § 323.5 Submitting... existing plan, to the Director of Unemployment and Sickness Insurance, Railroad Retirement Board, 844 Rush...
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20 CFR 323.5 - Submitting proposed plan for Board approval.
Code of Federal Regulations, 2013 CFR
2013-04-01
... UNEMPLOYMENT INSURANCE ACT NONGOVERNMENTAL PLANS FOR UNEMPLOYMENT OR SICKNESS INSURANCE § 323.5 Submitting... existing plan, to the Director of Unemployment and Sickness Insurance, Railroad Retirement Board, 844 Rush...
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Ebile, Akoh Walter; Ateudjieu, Jerome; Yakum, Martin Ndinakie; Djuidje, Marceline Ngounoue; Watcho, Pierre
2015-09-29
International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. It was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety. In total, 106 (4.9 %) clinical trial protocols were identified from 2173 protocols seen in the archive and 104 (4.8 %) included for review. Seventy six (73.1 %) trials did not include the surveillance of adverse events as part of their objective. A total of 91 (87.5 %) protocols did not budget for adverse event surveillance, 76 (73.1 %) did not have a data safety management board (DSMB), 11(10.6 %) included insurance for participants, 47 (45.2 %) did not include a case definition for serious adverse events, 33 (31.7 %) described procedures to detect adverse events, 33 (31.7 %) described procedure for reporting and 22 (21.2 %) described procedure for investigating adverse events. Most clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols. Clinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee.
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75 FR 46917 - Foreign-Trade Zone 153 - San Diego, California, Site Renumbering Notice
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-04
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board Foreign-Trade Zone 153 - San Diego, California, Site Renumbering Notice Foreign-Trade Zone 153 was approved by the Foreign-Trade Zones Board on October 14, 1988 (Board Order 394, 53 FR 41616, 10/24/88) and expanded on December 16, 1991 (Board Order 548, 56 FR 67057, 12/27/91) and on August 23, 200...
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Practical Guidance and Ethical Considerations for Studies Using Photo-Elicitation Interviews
Bugos, Eva; Frasso, Rosemary; FitzGerald, Elizabeth; True, Gala; Adachi-Mejia, Anna M.
2014-01-01
Photo-elicitation is a qualitative interviewing technique that has gained popularity in recent years. It is the foundation for photovoice projects and is a tool well-suited for community-based participatory research. Photo-elicitation yields rich data, and interview participants say these interviews encourage community awareness and engagement. This article draws on 9 studies, conducted by researchers at 3 institutions (the University of Pennsylvania, the Philadelphia Veterans Affairs Medical Center, and the Geisel School of Medicine at Dartmouth) in partnership with community-based organizations and students, in which 303 participants completed photo-elicitation interviews. We offer 8 practical suggestions for overcoming challenges encountered during photo-elicitation research and for managing ethical concerns about the use of visual data in public health research. Our guidelines can inform study design, protocol development, and institutional review board approval. PMID:25357257
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Finch, Stacia A; Barkin, Shari L; Wasserman, Richard C; Dhepyasuwan, Niramol; Slora, Eric J; Sege, Robert D
2009-12-01
To describe the process and outcomes of local institutional review board (IRB) review for 2 Pediatric Research in Office Settings (PROS) studies. Pediatric Research in Office Settings conducted 2 national studies concerning sensitive topics: (1) Child Abuse Recognition Experience Study (CARES), an observational study of physician decision making, and (2) Safety Check, a violence prevention intervention trial. Institutional review board approval was secured by investigators' sites, the American Academy of Pediatrics, and practices with local IRBs. Practices were queried about IRB rules at PROS enrollment and study recruitment. Pediatric Research in Office Settings practices in 29 states. Eighty-eight PROS practices (75 IRBs). Main Exposure Local IRB presence. Local IRB presence, level of PROS assistance, IRB process, study participation, data collection completion, and minority enrollment. Practices requiring additional local IRB approval agreed to participate less than those that did not (CARES: 33% vs 52%; Safety Check: 41% vs 56%). Of the 88 practices requiring local IRB approval, 55 received approval, with nearly 50% needing active PROS help, many requiring consent changes (eg, contact name additions, local IRB approval stamps), and 87% beginning data collection. Median days to obtain approval were 81 (CARES) and 109 (Safety Check). Practices requiring local IRB approval were less likely to complete data collection but more likely to enroll minority patients. Local IRB review was associated with lower participation rates, substantial effort navigating the process (with approval universally granted without substantive changes), and data collection delays. When considering future reforms, the national human subject protections system should consider the potential redundancy and effect on generalizability, particularly regarding enrollment of poor urban children, related to local IRB review.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-06
...). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve California's Airborne Toxic Control Measure... Resources Board (CARB) for approval to implement and enforce California's Airborne Toxic Control Measure for... Dry Cleaning ATCM California's Airborne Toxic Control Measure for Emissions of Perchloroethylene from...
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78 FR 52893 - Approval and Promulgation of Implementation Plans; State of Iowa
Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-27
... (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve revisions to the State... Board of Health Rules and Regulations. These proposed revisions reflect updates to the Iowa statewide rules previously approved by EPA and will ensure consistency between the applicable local agency rules...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-12
... Promulgation of Implementation Plans; New Mexico; Albuquerque/Bernalillo County: Infrastructure and Interstate... State State citation Title/subject approval/ EPA approval date Explanation effective date New Mexico... Quality Control Board * * * * * * * Part 8 (20.11.8 NMAC) Ambient Air Quality 8/12/2009 September 19, 2012...
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14 CFR 135.335 - Approval of aircraft simulators and other training devices.
Code of Federal Regulations, 2010 CFR
2010-01-01
... OPERATIONS OPERATING REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS AND RULES GOVERNING PERSONS ON BOARD... following requirements: (1) It must be specifically approved for— (i) The certificate holder; and (ii) The..., functional, and other character- istics that are required for approval. (3) Additionally, for aircraft...
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The role of the Data and Safety Monitoring Board in a clinical trial: The CRISIS Study
Holubkov, Richard; Casper, T. Charles; Dean, J. Michael; Anand, K. J. S.; Zimmerman, Jerry; Meert, Kathleen L.; Newth, Christopher J. L.; Berger, John; Harrison, Rick; Willson, Douglas F.; Nicholson, Carol
2012-01-01
Objective Randomized clinical trials are commonly overseen by a data and safety monitoring board (DSMB) comprised of experts in medicine, ethics, and biostatistics. DSMB responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. DSMB decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate DSMB oversight into the design, monitoring, and reporting of randomized trials. Design Case study, narrative review. Methods The DSMB’s role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. Findings The NIH-appointed CRISIS DSMB was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested DSMB interim review before opening CRISIS to children below one year of age. The first interim analysis found higher 28-day mortality in one treatment arm. The DSMB maintained trial closure to younger children, and requested a second interim data review six months later. At this second meeting, mortality was no longer of concern, while a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the DSMB elected to examine conditional power, and unmask treatment arm identities. Upon finding somewhat greater efficacy in the placebo arm, the DSMB recommended stopping CRISIS due to futility. Conclusions The design and operating procedures of a multicenter randomized trial must consider a pivotal DSMB role. Maximum study design flexibility must be allowed, and investigators must be prepared for protocol modifications due to interim findings. The DSMB must have sufficient clinical and statistical expertise to assess potential importance of interim treatment differences in the setting of multiple looks at accumulating data with numerous outcomes and subgroups. PMID:23392377
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-26
...-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Granting Approval of Proposed Rule Change To List and Trade CBOE S&P 500 AM/PM Basis Options July 20, 2012. I. Introduction On May 23, 2012, the Chicago Board Options Exchange, Incorporated (``Exchange'' or ``CBOE'') filed with the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-11
.... Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal...- generated survey. First, under the guidance of Board economists, the Federal Reserve Banks survey business... use online survey tools to collect responses to the survey. The frequency and content of the questions...
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78 FR 26362 - Farm Credit Administration Board; Sunshine Act Meetings
Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-06
... the meeting are: Open Session Approval of Minutes April 11, 2013 New Business Unincorporated Business... May 9, 2013, from 9:00 a.m. until such time as the Board concludes its business. FOR FURTHER...-5090. SUPPLEMENTARY INFORMATION: Parts of this meeting of the Board will be open to the public (limited...
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78 FR 46549 - Approval and Promulgation of Implementation Plans; Idaho: State Board Requirements
Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-01
... such board or body or the head of an executive agency with similar powers be adequately disclosed.'' 42... Requirements Idaho Code Sec. 39-107, Board--Composition--Officers-- Compensation--Powers--Subpoena--Depositions... regard to their knowledge of and interest in solid waste; two (2) members shall be chosen for their...
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75 FR 76953 - Foreign-Trade Zone 238-Dublin, VA Site Renumbering Notice
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-10
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board Foreign-Trade Zone 238--Dublin, VA Site Renumbering Notice Foreign-Trade Zone 238 was approved by the Foreign-Trade Zones Board on August 5, 1999 (Board Order 1047). FTZ 238 currently consists of 1 ``site'' totaling 50 acres in the Dublin area. The...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-23
... Personal Oxygen Concentrator (POC) Devices on Board Aircraft AGENCY: Federal Aviation Administration (FAA... Certain Personal Oxygen Concentrator (POC) Devices on Board Aircraft. Form Numbers: There are no FAA forms... prescribes extensive use of oxygen, brings a POC on board the aircraft. Also, we require passengers who have...
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Innovations in research ethics governance in humanitarian settings.
Schopper, Doris; Dawson, Angus; Upshur, Ross; Ahmad, Aasim; Jesani, Amar; Ravinetto, Raffaella; Segelid, Michael J; Sheel, Sunita; Singh, Jerome
2015-02-26
Médecins Sans Frontières (MSF) is one of the world's leading humanitarian medical organizations. The increased emphasis in MSF on research led to the creation of an ethics review board (ERB) in 2001. The ERB has encouraged innovation in the review of proposals and the interaction between the ERB and the organization. This has led to some of the advances in ethics governance described in this paper. We first update our previous work from 2009 describing ERB performance and then highlight five innovative practices: • A new framework to guide ethics review • The introduction of a policy exempting a posteriori analysis of routinely collected data • The preapproval of "emergency" protocols • General ethical approval of "routine surveys" • Evaluating the impact of approved studies. The new framework encourages a conversation about ethical issues, rather than imposing quasi-legalistic rules, is more engaged with the specific MSF research context and gives greater prominence to certain values and principles. Some of the innovations implemented by the ERB, such as review exemption or approval of generic protocols, may run counter to many standard operating procedures. We argue that much standard practice in research ethics review ought to be open to challenge and revision. Continued interaction between MSF researchers and independent ERB members has allowed for progressive innovations based on a trustful and respectful partnership between the ERB and the researchers. In the future, three areas merit particular attention. First, the impact of the new framework should be assessed. Second, the impact of research needs to be defined more precisely as a first step towards being meaningfully assessed, including changes of impact over time. Finally, the dialogue between the MSF ERB and the ethics committees in the study countries should be enhanced. We hope that the innovations in research ethics governance described may be relevant for other organisations carrying out research in fragile contexts and for ethics committees reviewing such research.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-02
... Statistics, Board of Governors of the Federal Reserve System, Washington, DC 20551. Telecommunications Device... securitized auto loan delinquencies and charge-offs. The accounting changes brought about by the amendments to...
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7 CFR 1219.53 - Budget and expenses.
Code of Federal Regulations, 2012 CFR
2012-01-01
... the Order. (d) With the approval of the Secretary, the Board may borrow money for the payment of... contributions shall be free from any encumbrance by the donor, and the Board shall retain complete control of...
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7 CFR 1219.53 - Budget and expenses.
Code of Federal Regulations, 2010 CFR
2010-01-01
... the Order. (d) With the approval of the Secretary, the Board may borrow money for the payment of... contributions shall be free from any encumbrance by the donor, and the Board shall retain complete control of...
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7 CFR 1219.53 - Budget and expenses.
Code of Federal Regulations, 2014 CFR
2014-01-01
... the Order. (d) With the approval of the Secretary, the Board may borrow money for the payment of... contributions shall be free from any encumbrance by the donor, and the Board shall retain complete control of...
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48 CFR 1913.505-2 - Board order forms in lieu of Optional and Standard Forms.
Code of Federal Regulations, 2011 CFR
2011-10-01
... BROADCASTING BOARD OF GOVERNORS CONTRACTING METHODS AND CONTRACT TYPES SMALL PURCHASES AND OTHER SIMPLIFIED...-case basis, in order to accommodate computer-generated purchase order forms. Exception approval for...
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48 CFR 1913.505-2 - Board order forms in lieu of Optional and Standard Forms.
Code of Federal Regulations, 2010 CFR
2010-10-01
... BROADCASTING BOARD OF GOVERNORS CONTRACTING METHODS AND CONTRACT TYPES SMALL PURCHASES AND OTHER SIMPLIFIED...-case basis, in order to accommodate computer-generated purchase order forms. Exception approval for...
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Poe, J E
1998-01-01
The three original founding healthcare systems and 10 sponsoring religious institutes of Catholic Health Initiatives (CHI) have developed an unprecedented governance model to support their vision of a national Catholic health ministry in the twenty-first century. The new organization spans 22 states; annual revenues exceed $4.7 billion. Religious institutes choose either active or honorary status before consolidating with CHI, depending on their desired involvement in the organization. Currently, nine are active and two are honorary. CHI's civil corporation comprises one representative from each active congregation. These representatives approve major changes in mission or philosophical direction. They control board membership by appointing three to five congregation representatives as sponsorship trustees, who are responsible for approving the remaining members of the Board of Stewardship Trustees. This half-religious, half-lay governing board is responsible for leading CHI. CHI has only two levels of governance, a national board and boards of market-based organizations, for instance a network of facilities with one management structure, or a community board of an individual facility. This avoids multiple administrative layers and approval processes. The organization has a civil identity as CHI and a canonical identity as a public juridic person of pontifical right, called Catholic Health Care Federation (CHCF). The governing board members of CHI, as members of CHCF, serve as the religious sponsors for all CHI health facilities. Some facilities have already been "alienated" (turned over) to CHI by their religious institutes; others will be alienated in the future. CHI's recent consolidation with Sisters of Charity of Nazareth Health System added an 11th sponsor, a sixth geographic region, and two members--one religious and one lay--to the governing board. The governance model assists such growth through the appeal of an equal religious-lay partnership and a flexible sponsorship model.
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[Reporting ethics board approval in German medical theses and journals].
Zenz, Michael; Zenz, Julia; Grieger, Maximilian
2018-06-05
Since 1975, the Declaration of Helsinki of the World Medical Association (WMA) has clearly required ethics committee approval for research into humans. Nevertheless, this Declaration is violated quite often. As many English-language publications have addressed the theme of ethics board approval in theses and other published works, it is now to be investigated in Germany for the first time.From 2013 to 2014, a total of 1,482 medical theses at four selected universities in addition to three German-language scientific journals were reviewed. In 543 theses, reference to ethics approval would have been required according to the criteria of the Declaration of Helsinki.However, ethics approval was stated in only 58.7% of cases, and even less frequently if the prevailing doctoral regulations or instructions did not refer to the necessity of obtaining ethics approval. Theses on pediatrics mentioned ethics approval most frequently (78.6%), whereas the proportion of surgical papers was the lowest (34.9%). Among the journals, Der Nervenarzt mentioned ethics approval most frequently (59.4%) and Der Chirurg least frequently (30%).Our results point to significant deficits in mentioning ethics approval in medical theses and publications. These deficits could easily be compensated for by a thorough approach of the referees of doctoral regulations and by journal reviewers and editors.
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Russia’s Energy Policies and Ukraine’s NATO Candidacy
2008-06-01
Government of Ukraine, “WTO protocol approved una voce nearly,” Web Portal of Ukrainian Government, April 10, 2008, http://www.kmu.gov.ua/control...with Eni into Libya fuels EU security fears.” Financial Times, April 3, 2008, 25. Government of Ukraine. “WTO protocol approved una voce nearly
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Assessing the Effects of Music Listening on Psychobiological Stress in Daily Life.
Linnemann, Alexandra; Strahler, Jana; Nater, Urs M
2017-02-02
Music listening is associated with stress-reducing effects. However, most of the results on music listening and stress were gathered in experimental settings. As music listening is a popular activity of daily life, it is of utmost importance to study the effects of music listening on psychobiological stress in an everyday, daily-life setting. Here, a study protocol is presented that allows the assessment of associations between music listening and psychobiological stress in daily life by noninvasively measuring salivary cortisol (as a marker of the Hypothalamic-Pituitary-Adrenal (HPA) axis) and salivary alpha-amylase (as a marker of the Autonomic Nervous System (ANS)). The protocol includes advice on the study design (e.g., sampling protocol), the materials and methods (e.g., the assessment of psychobiological stress in daily life, the assessment of music listening, and the manual), the selection of participants (e.g., the approval of the institutional review board and inclusion criteria), and the statistical analyses (e.g., the multilevel approach). The representative results provide evidence for a stress-reducing effect of music listening in daily life. Particularly, specific reasons for listening to music (especially relaxation), as well as the presence of others while doing so, increase this stress-reducing effect. At the same time, music listening in daily life differentially affects the HPA axis and ANS functioning, thus emphasizing the need for a multi-dimensional assessment of stress in daily life.
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2014-01-01
Background Single-pass, contrast-enhanced whole body multidetector computed tomography (MDCT) emerged as the diagnostic standard for evaluating patients with major trauma. Modern iterative image algorithms showed high image quality at a much lower radiation dose in the non-trauma setting. This study aims at investigating whether the radiation dose can safely be reduced in trauma patients without compromising the diagnostic accuracy and image quality. Methods/Design Prospective observational study with two consecutive cohorts of patients. Setting: A high-volume, academic, supra-regional trauma centre in Germany. Study population: Consecutive male and female patients who 1. had been exposed to a high-velocity trauma mechanism, 2. present with clinical evidence or high suspicion of multiple trauma (predicted Injury Severity Score [ISS] ≥16) and 3. are scheduled for primary MDCT based on the decision of the trauma leader on call. Imaging protocols: In a before/after design, a consecutive series of 500 patients will undergo single-pass, whole-body 128-row multi-detector computed tomography (MDCT) with a standard, as low as possible radiation dose. This will be followed by a consecutive series of 500 patients undergoing an approved ultra-low dose MDCT protocol using an image processing algorithm. Data: Routine administrative data and electronic patient records, as well as digital images stored in a picture archiving and communications system will serve as the primary data source. The protocol was approved by the institutional review board. Main outcomes: (1) incidence of delayed diagnoses, (2) diagnostic accuracy, as correlated to the reference standard of a synopsis of all subsequent clinical, imaging, surgical and autopsy findings, (3) patients’ safety, (4) radiation exposure (e.g. effective dose), (5) subjective image quality (assessed independently radiologists and trauma surgeons on a 100-mm visual analogue scale), (6) objective image quality (e.g., contrast-to-noise ratio). Analysis: Multivariate regression will be employed to adjust and correct the findings for time and cohort effects. An exploratory interim analysis halfway after introduction of low-dose MDCT will be conducted to assess whether this protocol is clearly inferior or superior to the current standard. Discussion Although non-experimental, this study will generate first large-scale data on the utility of imaging-enhancing algorithms in whole-body MDCT for major blunt trauma. Trial registration Current Controlled Trials ISRCTN74557102. PMID:24589310
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5 CFR Appendix A to Part 1320 - Agencies With Delegated Review and Approval Authority
Code of Federal Regulations, 2011 CFR
2011-01-01
... the Board in advance with a block of control numbers which the Board will assign in sequential order... of automated, electronic, mechanical, or other technological collection techniques or other forms of...
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Code of Federal Regulations, 2010 CFR
2010-01-01
... Steel Guarantee Loans § 400.212 Guarantee. The Board shall adopt a form of Guarantee to be used by the... of the form of Guarantee must be approved and adopted by the Board. [65 FR 70294, Nov. 22, 2000] ...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-29
...: EPA is approving revisions to the Puerto Rico Regulations for the Control of Atmospheric Pollution, submitted to EPA by the Puerto Rico Environmental Quality Board on July 13, 2011. This action approves... of Puerto Rico's Title V Operating Program. Generally the revisions to the regulations involve...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-29
..., published on March 22, 2012, that approved revisions to the Puerto Rico Regulations for the Control of Atmospheric Pollution. Those revisions were submitted to EPA by the Puerto Rico Environmental Quality Board on...] Approval and Promulgation of Implementation Plans and Operating Permits Program; Commonwealth of Puerto...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-25
...-FRL-9754-7] Approval and Promulgation of Air Quality Implementation Plans; Massachusetts and New... (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve State Implementation Plan (SIP... repair network for an on-board diagnostic (OBD2) testing program for model year 1996 and newer vehicles...
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46 CFR 282.21 - Wages of officers and crew.
Code of Federal Regulations, 2010 CFR
2010-10-01
...) Definitions. When used in this part. (1) Base period. The first base period under the wage index system, as... employment of the approved manning complement of the subsidized vessel, including payments required by law to... assessments on crew payrolls. (4) Approved manning complement means the complement approved by the Board for...
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DOE Office of Scientific and Technical Information (OSTI.GOV)
NONE
Thunder Energy Inc. received approval from the Alberta Energy and Utilities Board for modification of an existing gas plant to process sour gas, and also applied for permission to increase the hydrogen sulfide content of its existing pipelines in the Kelsey area. This report presents the views of Thunder Energy, the Board, and various intervenors at a hearing held to consider objections to the plant approval and matters related to the application. Issues considered include the need for sour gas processing, the need for the plant modification as opposed to the feasibility of using existing sour gas processing facilities, environmentalmore » impacts, and the requirements for notification of industry in the area. The report concludes with the Board`s decision.« less
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Insider Deals Are Common among Nonprofit Boards, Study Finds
ERIC Educational Resources Information Center
Panepento, Peter; Fain, Paul
2007-01-01
Almost half of large nonprofit groups make insider deals with board members, and one-third of those deals occur without the prior approval of other board members, according to a new study by the Urban Institute. The study, which is described in a report released on Monday, "Nonprofit Governance in the United States: Findings on Performance…
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-10
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board Foreign-Trade Zone 226--Merced, Madera, Fresno, and Tulare Counties, California; Site Renumbering Notice Foreign-Trade Zone 226 was approved by the Foreign-Trade Zones Board on December 22, 1997 (Board Order 946, 63 FR 778-779, 01/07/98) and expanded on...
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78 FR 45926 - Farm Credit Administration Board; Sunshine Act; Regular Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-30
... to be considered at the meeting are: Open Session Approval of Minutes July 11, 2013 New Business..., Virginia, on August 8, 2013, from 9:00 a.m. until such time as the Board concludes its business. FOR..., Virginia 22102-5090. SUPPLEMENTARY INFORMATION: Parts of this meeting of the Board will be open to the...
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77 FR 74010 - Farm Credit Administration Board; Sunshine Act; Regular Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-12
... to be considered at the meeting are: Open Session Approval of Minutes November 8, 2012 New Business..., Virginia, on December 13, 2012, from 9:00 a.m. until such time as the Board concludes its business. FOR..., Virginia 22102-5090. SUPPLEMENTARY INFORMATION: Parts of this meeting of the Board will be open to the...
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Physician Scientist Research Pathway Leading to Certification by the American Board of Pathology.
Weiss, Sharon W; Johnson, Rebecca L
2016-01-01
In 2014, the American Board of Pathology, in response to the pathology community, approved a physician scientist research pathway. This brief report summarizes the history of and objectives for creating the physician scientist research pathway and the requirements of the American Board of Pathology for the certification of physician scientist research pathway trainees.
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31 CFR 132.1 - Authority, purpose, collection of information, and incorporation by reference.
Code of Federal Regulations, 2012 CFR
2012-07-01
... reference. (a) Authority. This part is issued jointly by the Board of Governors of the Federal Reserve System (Board) and the Secretary of the Department of the Treasury (Treasury) under section 802 of the... Department of the Treasury and assigned OMB control number 1505-0204. The Board has approved the collection...
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31 CFR 132.1 - Authority, purpose, collection of information, and incorporation by reference.
Code of Federal Regulations, 2013 CFR
2013-07-01
... reference. (a) Authority. This part is issued jointly by the Board of Governors of the Federal Reserve System (Board) and the Secretary of the Department of the Treasury (Treasury) under section 802 of the... Department of the Treasury and assigned OMB control number 1505-0204. The Board has approved the collection...
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31 CFR 132.1 - Authority, purpose, collection of information, and incorporation by reference.
Code of Federal Regulations, 2014 CFR
2014-07-01
... reference. (a) Authority. This part is issued jointly by the Board of Governors of the Federal Reserve System (Board) and the Secretary of the Department of the Treasury (Treasury) under section 802 of the... Department of the Treasury and assigned OMB control number 1505-0204. The Board has approved the collection...
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Code of Federal Regulations, 2011 CFR
2011-01-01
... CHANGE IN BANK CONTROL (REGULATION Y) Regulations Financial Holding Companies § 225.89 How to request... holding company and to the financial system generally; (5) Describe the potential adverse effects... effects. (c) Board action. The Board will inform the financial holding company in writing of the Board's...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-23
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Docket 81-2011] Foreign-Trade Zone 99... (grantee of FTZ 99), through the Delaware Economic Development Office, requesting authority to reorganize... December 19, 2011. FTZ 99 was approved by the Board on April 27, 1984 (Board Order 248, 49 FR 19368, 05/07...
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Code of Federal Regulations, 2010 CFR
2010-04-01
... FOR NONCLINICAL LABORATORY STUDIES Protocol for and Conduct of a Nonclinical Laboratory Study § 58.120 Protocol. (a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain, as applicable, the following...
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Zhang, Jun; Lv, Jing; Pang, Shuang; Bai, Xiaohong; Yuan, Fang; Wu, Yubin; Jiang, Hong; Yang, Guanqi; Zhang, Shaoqing
2018-06-01
Henoch-Schönlein purpura nephritis (HSPN) involves the renal impairment of Henoch-Schönlein purpura and can easily relapse into life-threatening late nephropathy in severe cases. Although there is a lack of validated evidence for its effectiveness, Chinese herbal medicine (CHM) is one of the most commonly used methods in China to treat HSPN. It is thus need to report the protocol of a prospective cohort trial using CHM to investigate the effectiveness, safety and advantages for children with HSPN. This large, prospective, multicenter cohort study started in May 2015 in Shenyang. Six hundred children diagnosed with HSPN were recruited from 3 institutions and are followed-up every 2 to 4 weeks till May 2020. Detailed information of participants includes general information, history of treatment, physical examination, and symptoms of TCM is taken face-to-face at baseline. This study has received ethical approval from the ethics committee of institutional review board of the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine (No.2016CS(KT)-002-01). Articles summarizing the primary results and ancillary analyses will be published in peer-reviewed journals. Clinical Trials Registration: NCT02878018.
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A qualitative description of service providers' experiences of ethical issues in HIV care.
Sabone, Motshedisi B; Mogobe, Keitshokile Dintle; Matshediso, Ellah; Shaibu, Sheila; Ntsayagae, Esther I; Corless, Inge B; Cuca, Yvette P; Holzemer, William L; Dawson-Rose, Carol; Baez, Solymar S Soliz; Rivero-Mendz, Marta; Webel, Allison R; Eller, Lucille Sanzero; Reid, Paula; Johnson, Mallory O; Kemppainen, Jeanne; Reyes, Darcel; Nokes, Kathleen; Wantland, Dean; Nicholas, Patrice K; Lingren, Teri; Portillo, Carmen J; Sefcik, Elizabeth; Long-Middleton, Ellen
2018-01-01
Managing HIV treatment is a complex multi-dimensional task because of a combination of factors such as stigma and discrimination of some populations who frequently get infected with HIV. In addition, patient-provider encounters have become increasingly multicultural, making effective communication and provision of ethically sound care a challenge. This article explores ethical issues that health service providers in the United States and Botswana encountered in their interaction with patients in HIV care. A descriptive qualitative design was used to collect data from health service providers and patients using focused group discussions. This article is based on responses from health service providers only. Participants and context: This article is based on 11 focused group discussions with a total sample of 71 service providers in seven US sites and one Botswana site. Ethical considerations: Ethical review boards at all the study sites reviewed the study protocol and approved it. Ethical review boards of the study's coordinating centers, Rutgers University and the University of California at San Francisco, also approved it. The study participants provided a written informed consent to participate. HIV service providers encountered ethical challenges in all the four Beauchamp and Childress' biomedical ethics of respect for patients' autonomy, beneficence, justice, and nonmaleficence. The finding that HIV service providers encounter ethical challenges in their interaction with patients is supported by prior studies. The ethical challenges are particularly prominent in multicultural care and resource-constrained care environments. Provision of HIV care is fraught with ethical challenges that tend to pose different issues depending on a given care environment. It is important that strong partnerships are developed among key stakeholders in HIV care. In addition, health service providers need to be provided with resources so they can provide quality and ethically sound care.
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Brouwer, Patrick A; Brand, Ronald; van den Akker-van Marle, M Elske; Jacobs, Wilco C H; Schenk, Barry; van den Berg-Huijsmans, Annette A; Koes, Bart W; van Buchem, M A; Arts, Mark P; Peul, Wilco C
2015-05-01
Percutaneous laser disc decompression (PLDD) is a minimally invasive treatment for lumbar disc herniation, with Food and Drug Administration approval since 1991. However, no randomized trial comparing PLDD to conventional treatment has been performed. In this trial, we assessed the effectiveness of a strategy of PLDD as compared with conventional surgery. This randomized prospective trial with a noninferiority design was carried out in two academic and six teaching hospitals in the Netherlands according to an intent-to-treat protocol with full institutional review board approval. One hundred fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were included. The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analog scores for back and leg pain, and the patient's report of perceived recovery. Patients were randomly allocated to PLDD (n=57) or conventional surgery (n=58). Blinding was impossible because of the nature of the interventions. This study was funded by the Healthcare Insurance Board of the Netherlands. The primary outcome, Roland-Morris Disability Questionnaire, showed noninferiority of PLDD at 8 (-0.1; [95% confidence interval (CI), -2.3 to 2.1]) and 52 weeks (-1.1; 95% CI, -3.4 to 1.1) compared with conventional surgery. There was, however, a higher speed of recovery in favor of conventional surgery (hazard ratio, 0.64 [95% CI, 0.42-0.97]). The number of reoperations was significantly less in the conventional surgery group (38% vs. 16%). Overall, a strategy of PLDD, with delayed surgery if needed, resulted in noninferior outcomes at 1 year. At 1 year, a strategy of PLDD, followed by surgery if needed, resulted in noninferior outcomes compared with surgery. Copyright © 2015 Elsevier Inc. All rights reserved.
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30 CFR 916.25 - Approval of Kansas abandoned mine land reclamation plan amendments.
Code of Federal Regulations, 2010 CFR
2010-07-01
... approving all, or portions of these amendments, were published in the Federal Register and the State.... House Bill 3009 eliminated the Kansas Mined Land Conservation and Reclamation Board and transferred its...
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30 CFR 916.25 - Approval of Kansas abandoned mine land reclamation plan amendments.
Code of Federal Regulations, 2011 CFR
2011-07-01
... approving all, or portions of these amendments, were published in the Federal Register and the State.... House Bill 3009 eliminated the Kansas Mined Land Conservation and Reclamation Board and transferred its...
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USDOT guidance summary for connected vehicle deployments : human use approval.
DOT National Transportation Integrated Search
2016-07-01
This document provides guidance material in regards to human use approval required for the CV Pilots DeploymentConcept Development Phase. Background is provided on relevant Federal guidance and Institutional Review Boards,including specific reference...
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Gautier, Isabelle; Janiaud, Perrine; Rollet, Nelly; André, Nicolas; Tsimaratos, Michel; Cornu, Catherine; Malik, Salma; Gentile, Stéphanie; Kassaï, Behrouz
2017-08-23
There is a great need for high quality clinical research for children. The European Pediatric Regulation aimed to improve the quality of clinical trials in order to increase the availability of treatments for children. The main purpose of this study was to assess the evolution of both the number and the quality of pediatric trial protocols that were submitted to a French Institutional Review Board (IRB00009118) before and after the initiation of the EU Pediatric Regulation. All protocols submitted to the IRB00009118 between 2003 and 2014 and conducting research on subjects under eighteen years of age were eligible. The quality of randomized clinical trials was assessed according to the guidelines developed by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network and ranked using the Jadad score. Out of 622 protocols submitted to the Institutional Review Board (IRB), 21% (133/622) included children. Among these 133 pediatric protocols, the number of submitted pediatric protocols doubled between the two studied periods. From 2003 to 2008, 47 protocols including 21 institutionally sponsored were submitted to the IRB and from 2009 until 2014, 86 protocols including 48 institutionally sponsored were submitted. No significant trend was observed on the quality of RCTs. The overall median score of RCTs on the Jadad scale was high (3.5), 70.0% of protocols had a Jadad score ≥ 3, and 30.0% had a score < 3. Following the EU Pediatric Regulation, the number of pediatric protocols submitted to the IRB00009118 tends to increase, but no change was noticed regarding their quality.
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78 FR 71724 - Rail Depreciation Studies
Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-29
... DEPARTMENT OF TRANSPORTATION Surface Transportation Board Rail Depreciation Studies AGENCY: Surface Transportation Board, DOT. ACTION: Notice of OMB Approval of Information Collection. SUMMARY... collection, Rail Depreciation Studies. See 78 FR 18676 (Mar. 27, 2013). This collection, codified at 49 CFR...
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76 FR 15991 - Sunshine Act Meetings
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-22
... INTER-AMERICAN FOUNDATION BOARD MEETING Sunshine Act Meetings TIME AND DATE: March 28, 2011, 9 a.m... MATTERS TO BE CONSIDERED: Approval of the Minutes of the December 13, 2010, Meeting of the Board of... Planning Advisory Council [[Page 15992
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Park, Jae Hyun; Putrus, Raphael R; Pruzansky, Dawn P; Grubb, John
2017-03-01
The objective of this study was to identify the board certification protocols that hospital and university-based postgraduate orthodontic programs have in place to prepare residents for the American Board of Orthodontics (ABO) certification examination. An electronic survey was sent to the program directors of each of the 72 postgraduate orthodontic programs in the United States and Canada. The survey consisted of 49 questions about demographics, resident case assignment protocols, and ABO examination preparation methods. The response rate was 81%. Most programs were 30 to 36 months in length (72.7%). Many residents had a case load of 51 to 75 during their first year (50.9%), with an average maximum case load of 70 to 109. There was a positive correlation with both the number of cases that first-year residents start and the length of the program (Spearman correlation coefficient = 0.379; P <0.01) when compared with maximum case load. Approximately 72% of the programs do not offer a written mock board examination; however, 72% reported offering a clinical mock board examination. ABO cases are identified within the first 6 months of most programs. About 88% of respondents believe that residents take advantage of the banking system, and that over the past 5 years ABO Initial Certification Examination applications have increased. Most program directors (89.1%) believe that their program length is sufficient for board preparation. Subjects tested in the written examination are integrated into the didactic curriculum and strengthened with ongoing literature reviews, with a passing rate over 90%. Clinical examination preparation varies, with most programs requiring a mock board examination for graduation. Total participation in both the Initial Certification Examination and banking has increased since 2010; better follow-up protocols are needed to track residents after graduation. Copyright © 2017 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.
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Institutional Review Board approval and innovation in urology: current practice and safety issues.
Sundaram, Varun; Vemana, Goutham; Bhayani, Sam B
2014-02-01
To retrospectively review recent publications describing novel procedures/techniques, and describe the Institutional Review Board (IRB)/ethics approval process and potential ethical dilemmas in their reporting. We searched PubMed for papers about innovative or novel procedures/techniques between 2011 and August 2012. A query of titles/abstracts in the Journal of Urology, Journal of Endourology, European Urology, BJU International, and Urology identified relevant papers. These results were reviewed for human studies that described an innovative technique, procedure, approach, initial series, and/or used new technology. In all, 91 papers met criteria for inclusion; 25 from the Journal of Endourology, 14 from the Journal of Urology, nine from European Urology, 15 from the BJU International and 28 from Urology. IRB/ethics approval was given for an experimental procedure or database in 24% and 22%, respectively. IRB/ethics approval was not mentioned in 52.7% of studies. Published IRB/ethics approvals for innovative techniques are heterogeneous including database, retrospective, and prospective approvals. Given the concept that innovations are likely not in the legal or ethical standard of care, strong consideration should be given to obtaining IRB/ethics approval before the actual procedure, instead of approval to merely report database outcomes. © 2013 The Authors. BJU International © 2013 BJU International.
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Virtual Environment TBI Screen (VETS)
2014-10-01
balance challenges performed on a modified Wii Balance Board . Implementation of this device will enhance current approaches in TBI and mild TBI (i.e...TBI) screen (VETS) device in measuring standing balance . This system consists of software, a Wii balance board , and a large screen television that...Validate Wii ™ Balance Board relative to NeuroCom forceplate ! Running Wii Balance Board validation protocol. ! Milestone Achieved:
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Code of Federal Regulations, 2014 CFR
2014-10-01
... measuring, surveying, photographing, testing, or sampling the property or any designated object or operation... approval of the Board. The party seeking such approval must file an appropriate motion containing an... ensure the agreement is kept confidential. The motion seeking approval may be filed at any time after the...
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Code of Federal Regulations, 2011 CFR
2011-10-01
... measuring, surveying, photographing, testing, or sampling the property or any designated object or operation... approval of the Board. The party seeking such approval must file an appropriate motion containing an... ensure the agreement is kept confidential. The motion seeking approval may be filed at any time after the...
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Code of Federal Regulations, 2013 CFR
2013-10-01
... measuring, surveying, photographing, testing, or sampling the property or any designated object or operation... approval of the Board. The party seeking such approval must file an appropriate motion containing an... ensure the agreement is kept confidential. The motion seeking approval may be filed at any time after the...
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Code of Federal Regulations, 2012 CFR
2012-10-01
... measuring, surveying, photographing, testing, or sampling the property or any designated object or operation... approval of the Board. The party seeking such approval must file an appropriate motion containing an... ensure the agreement is kept confidential. The motion seeking approval may be filed at any time after the...
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Code of Federal Regulations, 2010 CFR
2010-07-01
... unprocessed timber was limited to whichever is less: (i) The higher of the applicant's actual purchase.... (b) Application, review and approval process. To obtain a share of the 50 million board feet exempted.... Applicants were notified of the approving official's decision by letter. If approved, the amount of the...
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ERIC Educational Resources Information Center
US Department of Education, 2010
2010-01-01
The Missouri Board of Nursing approves 34 practical, 35 associate degree, one diploma, and 21 baccalaureate degree nursing programs. Although the Board is responsible for all nursing programs leading to initial licensure, its recognition by the U.S. Department of Education applies only to the 57 professional nursing programs eligible for Federal…
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-12
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Docket T-4-2012] Foreign-Trade Zone 161; Temporary/Interim Manufacturing Authority; Siemens Energy, Inc., (Wind Turbine Nacelles and Hubs); Notice of Approval On April 2, 2012, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board filed an application submitted by the Board of County...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-08
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-72-2013] Foreign-Trade Zone 18--San Jose... Foreign-Trade Zone 18, requesting authority to reorganize the zone to expand its service area under the.... FTZ 18 was approved by the Board on November 27, 1974 (Board Order 103, 39 FR 42031, 12/04/1974) and...
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Deets, M K
1991-06-01
For collaborations that in some way modify involved organizations' assets and organizational or governance issues, negotiations are the responsibility of the congregation and not the healthcare system. Congregational leaders should, however, actively involve the system chief executive officer in the process and should also seek the advice of the system board. The board can be particularly helpful in offering financial, legal, and managerial advice to negotiators. Once an agreement is reached, however, the board must consider whether to approve it. And from this point forward, its involvement in the details of the collaboration will be more active. Because board members must evaluate a proposed collaboration from the perspective of the organization they serve, they may not always take the same view of it as did the congregational leaders. Moreover, what congregational leaders believe to be in the best interests of Catholic healthcare may not be consistent with the legitimate self-interest of some of the many constituencies affected by a collaboration. After negotiators have reached an agreement and the board has approved it, the board must make the necessary financial and organizational changes necessary to achieve the transition to a new corporate entity. In doing so, its goal will be to promote standardization without destroying the member institutions' rich traditions.
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78 FR 14300 - Sunshine Act Meetings Farm Credit Administration Board; Regular Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-05
.... Approval of Minutes February 14, 2013 B. New Business Liquidity and Funding--Final Rule C. Report Ethics..., Virginia, on March 14, 2013, from 9:00 a.m. until such time as the Board concludes its business. FOR...
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7 CFR 930.57 - Secondary inventory reserve.
Code of Federal Regulations, 2010 CFR
2010-01-01
... Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing... OF MICHIGAN, NEW YORK, PENNSYLVANIA, OREGON, UTAH, WASHINGTON, AND WISCONSIN Order Regulating... rules and regulations which the Board, with the approval of the Secretary, may establish. (d) The Board...
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Code of Federal Regulations, 2010 CFR
2010-10-01
... TRANSPORTATION RULES OF PRACTICE PROCEDURES FOR SURFACE TRANSPORTATION BOARD CONSIDERATION OF SAFETY INTEGRATION.... This part is designed to ensure adequate and coordinated consideration of safety integration issues, by... integration plans in connection with its approval and authorization of transactions for which the Board has...
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A Cautious Green Light for Reproductive Studies.
ERIC Educational Resources Information Center
Randal, Judith
1979-01-01
The board that advises the Secretary of HEW on ethics has given a qualified approval for further review of federal funding for research on human embryos conceived in the laboratory. Issues and concerns that influenced the board's decision are addressed. (JMD)
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Acute care research: is it ethical?
Iserson, K V; Mahowald, M B
1992-07-01
Research in acute care is a troubling area for Institutional Review Board (IRB) approval and informed consent. Confusion about ethical and legal requirements has hampered research efforts and subsequent patient benefits. Acute care patients are the relatively few critical care patients who have suffered unexpected events that carry a high probability of mortality or severe morbidity unless immediate medical intervention is provided. We argue that acute care research is justified if the usual ethical requirements for research are modified to reflect the uniqueness of the situation. Our recommendations are to: a) use an explicit definition of acute care as distinct from other modes of critical care; b) eliminate the requirement for informed consent (as it is usually understood); and c) require stringent IRB oversight, regarding the unique ethical problems raised by this area of research. We further suggest that IRB oversight includes review of the protocol by a panel of individuals who represent possible enrollees in the proposed study.
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Domanico, R; Davis, D K; Coleman, F; Davis, B O
2011-01-01
Objective: To test the efficacy of single family room (SFR) neonatal intensive care unit (NICU) designs, questions regarding patient medical progress and relative patient safety were explored. Addressing these questions would be of value to hospital staff, administrators and designers alike. Study Design: This prospective study documented, by means of Institution Review Board-approved protocols, the progress of patients in two contrasting NICU designs. Noise levels, illumination and air quality measurements were included to define the two NICU physical environments. Result: Infants in the SFR unit had fewer apneic events, reduced nosocomial sepsis and mortality, as well as earlier transitions to enteral nutrition. More mothers sustained stage III lactation, and more infants were discharged breastfeeding in the SFR. Conclusion: This study showed the SFR to be more conducive to family-centered care, and to enhance infant medical progress and breastfeeding success over that of an open ward. PMID:21072040
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Gene therapy oversight: lessons for nanobiotechnology.
Wolf, Susan M; Gupta, Rishi; Kohlhepp, Peter
2009-01-01
Oversight of human gene transfer research ("gene therapy") presents an important model with potential application to oversight of nanobiology research on human participants. Gene therapy oversight adds centralized federal review at the National Institutes of Health's Office of Biotechnology Activities and its Recombinant DNA Advisory Committee to standard oversight of human subjects research at the researcher's institution (by the Institutional Review Board and, for some research, the Institutional Biosafety Committee) and at the federal level by the Office for Human Research Protections. The Food and Drug Administration's Center for Biologics Evaluation and Research oversees human gene transfer research in parallel, including approval of protocols and regulation of products. This article traces the evolution of this dual oversight system; describes how the system is already addressing nanobiotechnology in gene transfer: evaluates gene therapy oversight based on public opinion, the literature, and preliminary expert elicitation; and offers lessons of the gene therapy oversight experience for oversight of nanobiotechnology.
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Gocho, Kiyoko; Akeo, Keiichiro; Itoh, Naoko; Kameya, Shuhei; Hayashi, Takaaki; Katagiri, Satoshi; Gekka, Tamaki; Ohkuma, Yasuhiro; Tsuneoka, Hiroshi; Takahashi, Hiroshi
2016-12-01
To report the clinical features of Japanese patients at Stage 1 and 2 of central areolar choroidal dystrophy (CACD). Five family members had comprehensive ophthalmic examinations including adaptive optics (AO) retinal imaging. Mutation analysis of the PRPH2 gene was performed by Sanger sequencing. The protocol conformed to the tenets of the Declaration of Helsinki and was approved by the institutional review board of The Jikei University School of Medicine. Four family members had a heterozygous PRPH2 mutation, p.R172Q; however, one member with a mutation did not show any ophthalmological abnormalities. Two patients had mild parafoveal retinal dystrophy and a reduction of cone density determined by AO analysis. The results indicate that the parafoveal cone photoreceptors can be affected even at the early stage of CACD. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:1115-1126.]. Copyright 2016, SLACK Incorporated.
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Alam, Fahad; LeBlanc, Vicki R; Baxter, Alan; Tarshis, Jordan; Piquette, Dominique; Gu, Yuqi; Filipkowska, Caroline; Krywenky, Ashley; Kester-Greene, Nicole; Cardinal, Pierre; Au, Shelly; Lam, Sandy; Boet, Sylvain; Clinical Trials Group, Perioperative Anesthesia
2018-04-21
The proportion of older acute care physicians (ACPs) has been steadily increasing. Ageing is associated with physiological changes and prospective research investigating how such age-related physiological changes affect clinical performance, including crisis resource management (CRM) skills, is lacking. There is a gap in the literature on whether physician's age influences baseline CRM performance and also learning from simulation. We aim to investigate whether ageing is associated with baseline CRM skills of ACPs (emergency, critical care and anaesthesia) using simulated crisis scenarios and to assess whether ageing influences learning from simulation-based education. This is a prospective cohort multicentre study recruiting ACPs from the Universities of Toronto and Ottawa, Canada. Each participant will manage an advanced cardiovascular life support crisis-simulated scenario (pretest) and then be debriefed on their CRM skills. They will then manage another simulated crisis scenario (immediate post-test). Three months after, participants will return to manage a third simulated crisis scenario (retention post-test). The relationship between biological age and chronological age will be assessed by measuring the participants CRM skills and their ability to learn from high-fidelity simulation. This protocol was approved by Sunnybrook Health Sciences Centre Research Ethics Board (REB Number 140-2015) and the Ottawa Health Science Network Research Ethics Board (#20150173-01H). The results will be disseminated in a peer-reviewed journal and at scientific meetings. NCT02683447; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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Combustible dusts: a serious industrial hazard.
Joseph, Giby
2007-04-11
After investigating three fatal explosions in manufacturing plants, the U.S. Chemical Safety and Hazard Investigation Board (CSB) has concluded: The explosive hazard of combustible dust is not well known, and helping industry to understand this hazard is a priority. Prompted by these three incidents in North Carolina, Kentucky and Indiana and the need to increase the hazard awareness, CSB is conducting a study to examine the nature and scope of dust explosion risks in industry and to identify initiatives that may be necessary to more effectively prevent combustible dust fires and explosions. Such initiatives may include regulatory action, voluntary consensus standards, or other measures that could be taken by industry, labor, government, and other parties. A critical task of the dust study is analyzing past incidents to determine the severity of the problem within industry. The analysis is focusing on the number of incidents, injuries and fatalities, industrial sectors affected, and regulatory oversight. This paper presents the preliminary findings from CSBs analysis of combustible dust incidents over the past 25 years. This paper has not been approved by the Board and is published for general informational purposes only. Every effort has been made to accurately present the contents of any Board-approved report mentioned in this paper. Any material in the paper that did not originate in a Board-approved report is solely the responsibility of the authors and does not represent an official finding, conclusion, or position of the Board.
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2014-01-01
When guidelines are approved by APA, they become association policy, and it is imperative that they remain current. The revision of guidelines poses several challenges to the association. These challenges range from the availability and allocation of resources to support the complicated processes involved in developing and updating these policies to the lack of a clearly defined process that includes identification of tasks, assignments of responsibilities, and so forth. For this reason, the APA Board of Directors asked the Policy and Planning Board (P&P) to work with the boards of the four directorates (i.e., the Education Directorate, the Practice Directorate, the Public Interest Directorate, and the Science Directorate) to create a proposal that would (a) make recommendations with regard to how the review and revision of guidelines documents might best be accomplished in accordance with the APA Strategic Plan and existing policies and procedures and (b) make suggestions regarding the association resources that might be required. The Board of Directors approved the proposed review process in December 2013. 2014 APA, all rights reserved
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Should Society Allow Research Ethics Boards to Be Run As For-Profit Enterprises?
Emanuel, Ezekiel J; Lemmens, Trudo; Elliot, Carl
2006-01-01
Background to the debate: An important mechanism for protecting human research participants is the prior approval of a clinical study by a research ethics board, known in the United States as an institutional review board (IRB). Traditionally, IRBs have been run by volunteer committees of scientists and clinicians working in the academic medical centers where the studies they review are being carried out. However, for-profit organizations are increasingly being hired to conduct ethics reviews. Proponents of for-profit IRBs argue that these IRBs are just as capable as academic IRBs at providing high-quality ethics reviews. Critics argue that for-profit IRBs have a conflict of interest because they generate their income from clients who have a direct financial interest in obtaining approval. PMID:16848618
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-13
....gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default...] Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval; Availability AGENCY: Food and Drug Administration, HHS...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-19
... RECOVERY ACCOUNTABILITY AND TRANSPARENCY BOARD Agency Information Collection Activities: Renewal... Management and Budget and 30- day public comment period. SUMMARY: The Recovery Accountability and... Recovery Accountability and Transparency Board, Office of Management and Budget, New Executive Office...
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DOT National Transportation Integrated Search
1997-03-01
This information bulletin provides general information on Surface Transportation Board (STB) procedures for obtaining approval to operate a railroad. It focuses primarily on those procedures that are most useful in helping potential and established s...
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78 FR 71724 - Recordations, Water Carrier Tariffs, and Agricultural Contract Summaries
Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-29
... DEPARTMENT OF TRANSPORTATION Surface Transportation Board Recordations, Water Carrier Tariffs, and Agricultural Contract Summaries AGENCY: Surface Transportation Board, DOT. ACTION: Notice of OMB Approval of..., Control Number 2140-0025 (2) Water Carrier Tariffs, Control Number 2140-26 (3) Agricultural Contract...
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75 FR 81287 - Mortgagee Review Board: Administrative Actions
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-27
...: Administrative Actions AGENCY: Office of the Assistant Secretary for Housing--Federal Housing Commissioner, Department of Housing and Urban Development (HUD). ACTION: Notice. SUMMARY: In compliance with Section 202(c... actions taken by HUD's Mortgagee Review Board against HUD-approved mortgagees. FOR FURTHER INFORMATION...
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75 FR 3479 - Mortgagee Review Board: Administrative Actions
Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-21
...: Administrative Actions AGENCY: Office of the Assistant Secretary for Housing-Federal Housing Commissioner, Department of Housing and Urban Development (HUD). ACTION: Notice. SUMMARY: In compliance with Section 202(c... actions taken by HUD's Mortgagee Review Board against HUD-approved mortgagees. FOR FURTHER INFORMATION...
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77 FR 11149 - Mortgagee Review Board: Administrative Actions
Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-24
...: Administrative Actions AGENCY: Office of the Assistant Secretary for Housing--Federal Housing Commissioner, Department of Housing and Urban Development (HUD). ACTION: Notice. SUMMARY: In compliance with Section 202(c... actions taken by HUD's Mortgagee Review Board against HUD-approved mortgagees. FOR FURTHER INFORMATION...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-01
... UNITED STATES INSTITUTE OF PEACE Meeting AGENCY: United States Institute of Peace. Date/Time... Peace Act, Public Law 98-525. Agenda: September 22, 2011 Board Meeting; Approval of Minutes of the One Hundred Fortieth Meeting (June 23-24, 2011) of the Board of Directors; Chairman's Report; President's...
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Code of Federal Regulations, 2010 CFR
2010-01-01
... activity that is complementary to a financial activity? 225.89 Section 225.89 Banks and Banking FEDERAL... CHANGE IN BANK CONTROL (REGULATION Y) Regulations Financial Holding Companies § 225.89 How to request approval to engage in an activity that is complementary to a financial activity? (a) Prior Board approval...
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By-Laws | Center for Cancer Research
The NIH Fellows Editorial Board (FEB) offers a free and confidential editorial service for NIH fellows. The Board members edit manuscripts, abstracts, book chapters, clinical protocols, and grant submissions and offer suggestions for grammar, structure, and style, but not for scientific content. The Board provides valuable training and editorial experience to its members for
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-26
... Recovery.gov . The FederalReporting.gov Recipient Registration System (FRRS) was developed to protect the... RECOVERY ACCOUNTABILITY AND TRANSPARENCY BOARD Agency Information Collection Activities: Renewal of Currently Approved Collection; Comment Request AGENCY: Recovery Accountability and Transparency...
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75 FR 19465 - Sunshine Act; Meeting Notice
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-14
... news media following the Board meeting. STATUS: Open. Agenda Old Business Approval of minutes of February 11, 2010, Board Meeting. New Business 1. Chairman's Report. 2. President's Report. 3. Report of..., and Ethics Committee. A. Designation of Corporate Secretary 6. Report of the Community Relations and...
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iBoard/CDX User Guide for Nonfederal Individuals and Company/Organization Points of Contact
This user guide describes the process that individuals or company/organization points of contact (POCs) must follow to submit non-EPA personnel data through the EPA’s Central Data Exchange (CDX) iBoard application for review and approval.
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25 CFR 36.41 - Standard XIV-Textbooks.
Code of Federal Regulations, 2010 CFR
2010-04-01
... Standard XIV—Textbooks. (a) Each school shall establish a textbook review committee composed of teachers, parents, and students, and school board members. Appointment to the textbook review committee shall be subject to school board approval. (b) The textbook review committee shall establish a procedure and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-01
... the applicant's gender and ethnic group and (2) The Research Assistant Candidate Survey of Interests... operational responsibilities. Currently, the University of Michigan's Survey Research Center (SRC) includes...: Acting Federal Reserve Board Clearance Officer: Cynthia Ayouch-- Division of Research and Statistics...
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7 CFR 1212.45 - Reimbursement and attendance.
Code of Federal Regulations, 2010 CFR
2010-01-01
... RESEARCH, PROMOTION, CONSUMER EDUCATION AND INDUSTRY INFORMATION ORDER Honey Packers and Importers Research, Promotion, Consumer Education, and Industry Information Order Honey Packers and Importers Board § 1212.45... compensation but will be reimbursed for reasonable travel expenses, as approved by the Board, that they incur...
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Viscogliosi, Chantal; Asselin, Hugo; Basile, Suzy; Couturier, Yves; Drolet, Marie-Josée; Gagnon, Dominique; Torrie, Jill; Levasseur, Mélanie
2017-01-01
Introduction Indigenous elders have traditionally played an important role in maintaining social cohesion within their communities. Today, part of this role has been taken over by government social and healthcare services, but they are having limited success in addressing social challenges. Increasing elders’ social participation and intergenerational solidarity might foster community development and benefit young people, families, communities and the elders themselves. However, knowledge of the contribution of elders’ social participation and intergenerational solidarity to wellness is scattered and needs to be synthesised. This protocol presents a scoping review on the social participation of indigenous elders, intergenerational solidarity and their influence on individual and community wellness. Methods and analysis This scoping review protocol is based on an innovative methodological framework designed to gather information from the scientific and grey literature and from indigenous sources. It was developed by an interdisciplinary team including indigenous scholars/researchers, knowledge users and key informants. In addition to searching information databases in fields such as public health and indigenous studies, an advisory committee will ensure that information is gathered from grey literature and indigenous sources. Ethics The protocol was approved by the Ethics Review Board of the Université du Québec en Abitibi-Témiscamingue and the First Nations of Quebec and Labrador Health and Social Services Commission. Discussion The comprehensive synthesis of the scientific and grey literature and indigenous sources proposed in this protocol will not only raise awareness within indigenous communities and among healthcare professionals and community organisations, but will also enable decision-makers to better meet the needs of indigenous people. Conclusion The innovative methodological framework proposed in this scoping review protocol will yield richer information on the contribution of elders to community wellness. This work is an essential preliminary step towards developing research involving indigenous communities, drawing on the social participation of elders and intergenerational solidarity. PMID:28501814
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2016-10-01
USAMRMC ORP HRPO. Ethics board approval from UBC has been approved by HRPO, and U of Cincinnati is under review. The University of Hamburg is working...UBC ethics committee approval was established, and USAMRMC ORP HRPO approval was provided October 20, 2015. Additional continuing review approval in...operations, and once translated to German will be submitted to its ethics committee. The CRFs have been translated into German and will be submitted
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21 CFR 814.19 - Product development protocol (PDP).
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Product development protocol (PDP). 814.19 Section...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.19 Product development protocol (PDP). A class III device for which a product development protocol has been declared completed by FDA under...
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21 CFR 814.19 - Product development protocol (PDP).
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Product development protocol (PDP). 814.19 Section...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.19 Product development protocol (PDP). A class III device for which a product development protocol has been declared completed by FDA under...
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[Local approval procedures act as a brake on RCTs].
van der Stok, E P; Huiskens, J; Hemmes, B; Grünhagen, D J; van Gulik, T M; Verhoef, C; Punt, C J A
2016-01-01
Large multicentre randomised controlled trials (RCTs) in the Netherlands are increasingly being impeded by major differences between local approval procedures. However, no national agenda exists as yet to improve this situation. The existence of major local differences in processing time and documentation required has been reported previously but little is known about the costs incurred and whether or not specific certifications and research contracts are mandatory. The current study evaluated these aspects of local procedures for obtaining approval of two oncological multicentre RCTs. Retrospective, descriptive. All local procedures for obtaining approval of two randomised clinical trials were evaluated: the CAIRO5 and CHARISMA trials initiated by the Dutch Colorectal Cancer Group (DCCG). We objectified time between approval by the Medical Ethics Review Committee (METC) and final approval by the Board of Directors (RvB), the type and number of documents needed, and costs charged. The median time interval between the approval by the Medical Ethics Review Committee and the approval by the Board of Directors was 90 days (range 4-312). The number of documents required per centre ranged from 6-20. The costs charged ranged from € 0-€ 1750, and amounted to € 8575 for all procedures combined. No costs were charged by the majority of the centres. The approval procedures for multicentre clinical trials in the Netherlands demonstrate major differences. Processing times, documentation required and costs are unpredictable; greater uniformity is highly desirable in this context.
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Code of Federal Regulations, 2010 CFR
2010-10-01
... permanent steel bulkheads. CSC safety approval plate means the safety approval plate specified in Annex I of... tank tops, decks, bulkheads, frames, plating, or ladders, or used for filling voids or fitting around... cargo on board a vessel. Portable magazine means a strong, closed, prefabricated, steel or wooden...
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Navigating the IRB: The Ethics of SoTL
ERIC Educational Resources Information Center
Martin, Ryan C.
2013-01-01
This chapter discusses Institutional Review Boards (IRBs) as they apply to the SoTL. Specifically, it describes when SoTL projects must receive IRB approval, why they must get IRB approval, the review process, and some special issues of concern with regard to SoTL.
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78 FR 2719 - BNSF Railway Company-Lease Exemption-Norfolk Southern Railway Company
Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-14
... DEPARTMENT OF TRANSPORTATION Surface Transportation Board [Docket No. FD 35689] BNSF Railway Company--Lease Exemption--Norfolk Southern Railway Company AGENCY: Surface Transportation Board, DOT... exemption from the prior approval requirements of 49 U.S.C. 11323-25 for BNSF Railway Company (BNSF) to...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-30
... $50 billion in total assets and nonbank systemically important financial institutions, subject to annual supervisory stress tests and semi- annual company-run stress tests; ``other financial companies... Board informed as to--(i) its financial condition, [and] systems for monitoring and controlling...
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5 CFR 6801.109 - Prior approval for compensated outside employment.
Code of Federal Regulations, 2010 CFR
2010-01-01
... SYSTEM SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE BOARD OF GOVERNORS OF THE FEDERAL... designee) and the concurrence of the Board's Designated Agency Ethics Official before engaging in... employment or business relationship involving the provision of personal services by the employee. It includes...
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Code of Federal Regulations, 2010 CFR
2010-10-01
... a contract from the policy in FAR 3.601, after the Procurement Review Board and the agency ethics... agency ethics official, the Procurement Review Board, and written approval by the Assistant Secretary for... director of the cognizant program office to the HCA. In the procurement request, the director must describe...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-17
... maintain their ALLL. Although Financial Accounting Standards Board (FASB) Accounting Standards Update No... investment amounts by impairment measurement method for only three segments: consumer credit cards, all other... recorded investment amounts by impairment measurement method for five loan categories: commercial real...
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77 FR 24555 - Sunshine Act Meeting Notice
Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-24
... news media following the Board meeting. Status: Open. Agenda Chairman's Welcome. Old Business Approval of minutes of February 16, 2012, Board Meeting New Business 1. Report from President and CEO 2. Financial Update 3. Report of the Finance, Rates, and Portfolio Committee A. Proposed contract with Holtec...
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75 FR 51169 - Notice of Sunshine Act Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-18
... questions from the news media following the Board meeting. STATUS: Open. Agenda Old Business Approval of minutes of June 10, 2010, Board Meeting. New Business 1. Welcome. 2. President's Report. 3. Chairman's... Regulation Committee. A. Enterprise Risk Management Policy. 7. Report of the Customer and External Relations...
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Connect Computer Education to Policies.
ERIC Educational Resources Information Center
Kimmelman, Paul
1985-01-01
The computer phenomenon has made rapid inroads into school curricula, often without proper board guidance or approval. Accordingly, this pamphlet discusses why and how computer education should be provided in schools and sets forth guidelines for school board policy regarding computers. An umbrella policy is proposed, defining "computer literacy"…
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75 FR 13296 - Sunshine Act Meetings
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-19
... INTER-AMERICAN FOUNDATION BOARD MEETING Sunshine Act Meetings TIME AND DATE: March 29, 2010; 9:00...). MATTERS TO BE CONSIDERED: Approval of the Minutes of the December 14, 2009, Meeting of the Board of... Operations Report RedEAmerica Status Advisory Council Membership and Attendance at Meetings Status of...
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Sudore, Rebecca L; Barnes, Deborah E; Le, Gem M; Ramos, Roberto; Osua, Stacy J; Richardson, Sarah A; Boscardin, John; Schillinger, Dean
2016-01-01
Introduction Advance care planning (ACP) is a process that allows patients to identify their goals for medical care. Traditionally, ACP has focused on completing advance directives; however, we have expanded the ACP paradigm to also prepare patients to communicate their wishes and make informed decisions. To this end, we created an ACP website called PREPARE (http://www.prepareforyourcare.org) to prepare diverse English-speaking and Spanish-speaking older adults for medical decision-making. Here, we describe the study protocol for a randomised controlled efficacy trial of PREPARE in a safety-net setting. The goal is to determine the efficacy of PREPARE to engage diverse English-speaking and Spanish-speaking older adults in a full spectrum of ACP behaviours. Methods and analysis We include English-speaking and Spanish-speaking adults from an urban public hospital who are ≥55 years old, have ≥2 chronic medical conditions and have seen a primary care physician ≥2 times in the last year. Participants are randomised to the PREPARE intervention (review PREPARE and an easy-to-read advance directive) or the control arm (only the easy-to-read advance directive). The primary outcome is documentation of an advance directive and/or ACP discussion. Secondary outcomes include ACP behaviour change processes measured with validated surveys (eg, self-efficacy, readiness) and a broad range of ACP actions (eg, choosing a surrogate, identifying goals for care, discussing ACP with clinicians and/or surrogates). Using blinded outcome ascertainment, outcomes will be measured at 1 week and at 3, 6 and 12 months, and compared between study arms using mixed-effects logistic regression and mixed-effects linear, Poisson or negative binomial regression. Ethics and dissemination This study has been approved by the appropriate Institutional Review Boards and is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of this study will be disseminated to academic and community stakeholders. Trial registration numbers NCT01990235; NCT02072941; Pre-results. PMID:27401363
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Sudore, Rebecca L; Barnes, Deborah E; Le, Gem M; Ramos, Roberto; Osua, Stacy J; Richardson, Sarah A; Boscardin, John; Schillinger, Dean
2016-07-11
Advance care planning (ACP) is a process that allows patients to identify their goals for medical care. Traditionally, ACP has focused on completing advance directives; however, we have expanded the ACP paradigm to also prepare patients to communicate their wishes and make informed decisions. To this end, we created an ACP website called PREPARE (http://www.prepareforyourcare.org) to prepare diverse English-speaking and Spanish-speaking older adults for medical decision-making. Here, we describe the study protocol for a randomised controlled efficacy trial of PREPARE in a safety-net setting. The goal is to determine the efficacy of PREPARE to engage diverse English-speaking and Spanish-speaking older adults in a full spectrum of ACP behaviours. We include English-speaking and Spanish-speaking adults from an urban public hospital who are ≥55 years old, have ≥2 chronic medical conditions and have seen a primary care physician ≥2 times in the last year. Participants are randomised to the PREPARE intervention (review PREPARE and an easy-to-read advance directive) or the control arm (only the easy-to-read advance directive). The primary outcome is documentation of an advance directive and/or ACP discussion. Secondary outcomes include ACP behaviour change processes measured with validated surveys (eg, self-efficacy, readiness) and a broad range of ACP actions (eg, choosing a surrogate, identifying goals for care, discussing ACP with clinicians and/or surrogates). Using blinded outcome ascertainment, outcomes will be measured at 1 week and at 3, 6 and 12 months, and compared between study arms using mixed-effects logistic regression and mixed-effects linear, Poisson or negative binomial regression. This study has been approved by the appropriate Institutional Review Boards and is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of this study will be disseminated to academic and community stakeholders. NCT01990235; NCT02072941; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
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ERIC Educational Resources Information Center
Hartel, R. W.; Iwaoka, W. T.
2016-01-01
For the past 15 years, Institute of Food Technologists (IFT) has mandated assessment of undergraduate student learning outcomes as the basis for approving food science (FS) programs. No longer is a check-off course system sufficient to be an IFT-approved program. The 4 steps to gaining IFT approval include developing learning outcomes for all…
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Physician scientist research pathway leading to certification by the American Board of Pathology.
Weiss, Sharon W; Johnson, Rebecca L
2016-06-01
In 2014, the American Board of Pathology, in response to the pathology community, approved a physician scientist research pathway (PSRP). This brief report summarizes the history of and objectives for creating the physician scientist research pathway and the requirements of the American Board of Pathology for the certification of physician scientist research pathway trainees. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.
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Campbell, Eric G; Vogeli, Christine; Rao, Sowmya R; Abraham, Melissa; Pierson, Roz; Applebaum, Sandra
2015-09-01
For the past decade, more attention and concern has been directed toward financial relationships between the life science industry and physicians. Relationships between industry and institutional review board (IRB) members represent an important subclass that has the potential to broadly influence decisions regarding medical research. To study the nature, extent, and perceived consequences of industry relationships among IRB members in academic health centers and to compare our results with findings from 2005. A survey mailed to IRB members from the 115 most research-intensive medical schools and teaching hospitals in the United States from January 16 through May 16, 2014. The survey included questions identical to those used in 2005. Data analysis was conducted from June through October 2014. The frequency of industry relationships among IRB members and the perceived effect of those relationships on IRB-related activities. We found no significant change in the percentage of IRB members with an industry relationship from 2005 through 2014 (2005: 37.2%; 95% CI, 32.7%-42.0%; 2014: 32.1%; 95% CI, 28.0%-36.4%; P = .09). However, since 2005, the percentage of members who felt another member did not properly disclose a financial relationship decreased from 10.8% (95% CI, 8.0%-14.4%) to 6.7% (95% CI, 4.7%-9.4%) (P = .04), as did the percentage who felt pressure from their institution or department to approve a protocol (2005: 18.6%; 95% CI, 15.0%-22.9%; 2014: 10.0%; 95% CI, 7.6%-13.0%; P < .001). The percentage of members with a conflict of interest who voted on protocols with which they have a conflict has not changed, although the percentage who said they always disclose relationships increased significantly from 54.9% in 2005 (95% CI, 42.2%-66.9%) to 80.0% in 2014 (95% CI, 65.3%-89.4%) (P = .01). We also found evidence of anti-industry bias in the presentation of protocols to the IRB. The results show significant positive progress in the reporting and management of conflicts of interest among IRB members in academic health centers since 2005 after adjusting for other factors. Additional attention should be focused on deterring IRB members from inappropriately voting on or presenting protocols in a biased manner.
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Freeman, Anne; Stanko, Patrick; Berkowitz, Lily N; Parnell, Neanta; Zuppe, Anastasia; Bale, Tracy L; Ziolek, Tracy; Epperson, C Neill
2017-01-01
The 2015 National Institutes of Health (NIH) policy that sex be considered as a biological variable (SABV) is now a critical part of the peer-review process for NIH funding as well as publication in several high-impact scientific journals. We sought to determine the degree to which biomedical researchers at the University of Pennsylvania already consider SABV or gender in their research. We reviewed 240 research protocols approved by the University of Pennsylvania Investigational Review Board (IRB) consecutively submitted between January and July 2016. Each protocol was searched for the terms sex, gender, male, female, man, and woman and justifications related to the population under study. A PubMed search was conducted to determine the current state of knowledge regarding potential sex and/or gender differences with respect to protocol topic. Data were summarized using descriptive statistics. Of the 165 (68.8%) protocols that included one of the search terms, only 24 (14.5%) provided justification for the choice of the sex/gender of the population studied. Sixty-three percent ( n = 151) of the protocols focused on topics for which the extant literature supports at least a moderate degree of sex/gender differences in some aspect of the disorder/condition being studied. Of these, only three (2.0%) indicated that the investigator would consider sex or gender impact on their primary outcomes. Review of a subset of IRB protocols submitted at a major research institution suggests that very few investigators are considering sex or gender as important variables in their clinical research at the stage of protocol development. IRBs are in an excellent position to encourage investigators to consider SABV and gender in order to enhance the rigor of research design, maximize the importance of the resulting knowledge, and ensure that subject selection is equitable. These findings serve as the basis for developing an intervention at the level of IRB protocol development and submission that will promote consideration of SABV and/or gender, factors with critical import to patient safety and efficacy of interventions.
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By-Laws | Center for Cancer Research
The NIH Fellows Editorial Board (FEB) offers a free and confidential editorial service for NIH fellows. The Board members edit manuscripts, abstracts, book chapters, clinical protocols, and grant submissions and offer suggestions for grammar, structure, and style, but not for scientific content. The Board provides valuable training and editorial experience to its members for academic as well as nonacademic scientific careers.
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Alahuhta, S; Mellin-Olsen, J; Blunnie, W P; Knape, J T A
2007-06-01
The mission of the Section and Board of Anaesthesiology of the European Union of Medical Specialists (EUMS/UEMS) is to harmonize training and medical practice in all European countries to continuously improve the quality of care. The need for continuous medical education in the field of anaesthesiology has long been recognized. However, specialty-based competencies are not the only requirements for successful medical practice. The need to acquire medical, managerial, ethical, social and personal communication skills on top of specialty-based competencies has developed into the principle of continuous professional development, which embraces both objectives. The Section and Board of Anaesthesiology of the EUMS/UEMS has approved a proposal of its Standing Committee on Continuous Medical Education/Continuous Professional Development to adopt the following charter on the subject.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Rosenthal, M.D.; Saum-Manning, L.; Houck, F.
Volume I of this Review traces the origins of the Model Additional Protocol. It covers the period from 1991, when events in Iraq triggered an intensive review of the safeguards system, until 1996, when the IAEA Board of Governors established Committee 24 to negotiate a new protocol to safeguards agreement. The period from 1991-1996 set the stage for this negotiation and shaped its outcome in important ways. During this 5-year period, many proposals for strengthening safeguards were suggested and reviewed. Some proposals were dropped, for example, the suggestion by the IAEA Secretariat to verify certain imports, and others were refined.more » A rough consensus was established about the directions in which the international community wanted to go, and this was reflected in the draft of an additional protocol that was submitted to the IAEA Board of Governors on May 6, 1996 in document GOV/2863, Strengthening the Effectiveness and Improving the Efficiency of the Safeguards System - Proposals For Implementation Under Complementary Legal Authority, A Report by the Director General. This document ended with a recommendation that, 'the Board, through an appropriate mechanism, finalize the required legal instrument taking as a basis the draft protocol proposed by the Secretariat and the explanation of the measures contained in this document.'« less
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A PCIe Gen3 based readout for the LHCb upgrade
NASA Astrophysics Data System (ADS)
Bellato, M.; Collazuol, G.; D'Antone, I.; Durante, P.; Galli, D.; Jost, B.; Lax, I.; Liu, G.; Marconi, U.; Neufeld, N.; Schwemmer, R.; Vagnoni, V.
2014-06-01
The architecture of the data acquisition system foreseen for the LHCb upgrade, to be installed by 2018, is devised to readout events trigger-less, synchronously with the LHC bunch crossing rate at 40 MHz. Within this approach the readout boards act as a bridge between the front-end electronics and the High Level Trigger (HLT) computing farm. The baseline design for the LHCb readout is an ATCA board requiring dedicated crates. A local area standard network protocol is implemented in the on-board FPGAs to read out the data. The alternative solution proposed here consists in building the readout boards as PCIe peripherals of the event-builder servers. The main architectural advantage is that protocol and link-technology of the event-builder can be left open until very late, to profit from the most cost-effective industry technology available at the time of the LHC LS2.
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2016-10-01
approval and initiated advertising , recruitment, participant screening, participant enrollment, and the study protocol. All start up subtasks have been...be made to enroll these during the next reporting period. Advertisement , recruitment, screening, and enrollment are ongoing as we work toward the...Regulatory Approvals 100% Completed. • Task 3: Start up 100% Completed. Milestone: Protocol ready to begin—Completed • Task 4: Advertisement 40
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Department of Clinical Investigation Annual Research Progress Report, Fiscal Year 1993. Volume 1
1993-10-01
monocytes, total periphernuclear cells, and alveolar macrophages from four study groups : patients with concurrent Mycobacterium tuberculosis (MTBI and...research design, similar to the Solomon Four Group design will be utilized to determine if the educational intervention provided has an impact on nurses...members with approved protocols: 173 Number of approved protocols held by this group : 230 Drug evaluation/comparison studies : 94 (Does not include
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-17
... the conflict resolution section that would allow the Governor of Indiana to delegate the decision on... revision consists of nine Metropolitan Planning Organization (MPO) board resolutions, one MPO Memorandum of.... The MPO board resolutions are for the Delaware- Muncie Metropolitan Plan Commission, the Evansville...
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Research Ethics: Institutional Review Board Oversight of Art Therapy Research
ERIC Educational Resources Information Center
Deaver, Sarah P.
2011-01-01
By having their research proposals reviewed and approved by Institutional Review Boards (IRBs), art therapists meet important ethical principles regarding responsibility to research participants. This article provides an overview of the history of human subjects protections in the United States; underlying ethical principles and their application…
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77 FR 76078 - Regular Board of Directors Sunshine Act Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-26
..., DC 20005. STATUS: Open. CONTACT PERSON FOR MORE INFORMATION: Erica Hall, Assistant Corporate... Regular Board of Directors Meeting Minutes IV. Approval of the Finance, Budget & Program Committee Meeting... Corporate Secretary. [FR Doc. 2012-31163 Filed 12-21-12; 4:15 pm] BILLING CODE 7570-02-P ...
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76 FR 55138 - Sunshine Notice; Board of Directors Meeting; September 22, 2011
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-06
... 2013 Budget. 3. Recommendations of the Ad-Hoc Board Committee on Governance. 4. Finance Project--India. 5. Finance Project--Nigeria. 6. Finance Project--Thailand. 7. Finance Project--Kenya. 8. Approval of... obtained from Connie M. Downs at (202) 336-8438. Connie M. Downs, Corporate Secretary, Overseas Private...
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12 CFR 211.5 - Edge and agreement corporations.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 12 Banks and Banking 2 2013-01-01 2013-01-01 false Edge and agreement corporations. 211.5 Section... Edge and agreement corporations. (a) Board Authority. The Board shall have the authority to approve: (1) The establishment of Edge corporations; (2) Investments in agreement corporations; and (3) A member...
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12 CFR 211.5 - Edge and agreement corporations.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 12 Banks and Banking 2 2011-01-01 2011-01-01 false Edge and agreement corporations. 211.5 Section... Edge and agreement corporations. (a) Board Authority. The Board shall have the authority to approve: (1) The establishment of Edge corporations; (2) Investments in agreement corporations; and (3) A member...
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12 CFR 211.5 - Edge and agreement corporations.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 12 Banks and Banking 2 2012-01-01 2012-01-01 false Edge and agreement corporations. 211.5 Section... Edge and agreement corporations. (a) Board Authority. The Board shall have the authority to approve: (1) The establishment of Edge corporations; (2) Investments in agreement corporations; and (3) A member...
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12 CFR 211.5 - Edge and agreement corporations.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 12 Banks and Banking 2 2014-01-01 2014-01-01 false Edge and agreement corporations. 211.5 Section... Edge and agreement corporations. (a) Board Authority. The Board shall have the authority to approve: (1) The establishment of Edge corporations; (2) Investments in agreement corporations; and (3) A member...
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77 FR 4061 - Board of Governors; Sunshine Act Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2012-01-26
... Financial Performance. 6. Quarterly Report on Service Performance. 7. Tentative Agenda for the March 21...--Discussion of prior agenda items and Board Governance. Thursday, February 9 at 8:30 a.m. (Open) 1. Approval... of Wednesday's closed session agenda. CONTACT PERSON FOR MORE INFORMATION: Julie S. Moore, Secretary...
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76 FR 6163 - Board of Governors; Sunshine Act Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-03
... Financial Performance. 6. Quarterly Report on Service Performance. 7. Tentative Agenda for the March 21-22... prior agenda items and Board Governance. Wednesday, February 9 at 8:30 a.m. (Open) 1. Approval of.... Continuation of Tuesday's closed session agenda. CONTACT PERSON FOR MORE INFORMATION: Julie S. Moore, Secretary...
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29 CFR 1952.150 - Description of the plan as initially approved.
Code of Federal Regulations, 2011 CFR
2011-07-01
... Section 1952.150 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... Labor has entered into an agreement with the State Board of Health whereby the State Board of Health is to assist the Department of Labor in the administration and enforcement of occupational health...
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29 CFR 1952.150 - Description of the plan as initially approved.
Code of Federal Regulations, 2010 CFR
2010-07-01
... Section 1952.150 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... Labor has entered into an agreement with the State Board of Health whereby the State Board of Health is to assist the Department of Labor in the administration and enforcement of occupational health...
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75 FR 28806 - Sunshine Act Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-24
... meeting are: Open Session A. Approval of Minutes May 13, 2010. B. New Business--Regulations Advance Notice... June 10, 2010, from 9 a.m. until such time as the Board concludes its business. FOR FURTHER INFORMATION.... SUPPLEMENTARY INFORMATION: Parts of this meeting of the Board will be open to the public (limited space...
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75 FR 47809 - Farm Credit Administration Board; Sunshine Act; Regular Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-09
...: Open Session A. Approval of Minutes July 8, 2010. B. New Business Joint and Several Liability Debt... business. FOR FURTHER INFORMATION CONTACT: Roland E. Smith, Secretary to the Farm Credit Administration..., McLean, Virginia 22102-5090. SUPPLEMENTARY INFORMATION: This meeting of the Board will be open to the...
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75 FR 67720 - Farm Credit Administration Board; Sunshine Act; Regular Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-03
...: Open Session A. Approval of Minutes October 14, 2010 B. New Business Advance Notice of Proposed... concludes its business. FOR FURTHER INFORMATION CONTACT: Roland E. Smith, Secretary to the Farm Credit... Drive, McLean, Virginia 22102-5090. SUPPLEMENTARY INFORMATION: This meeting of the Board will be open to...
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ERIC Educational Resources Information Center
Ewell, Peter T.
2006-01-01
Board members are accustomed to looking after the financial health of their institutions by reviewing budgets, revenue projections, capital needs, or the approval of specific expenditures. At many institutions the board only rarely gets to look directly at the heart of the academic enterprise: the quality of teaching and learning. However, growing…
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-17
... Promulgation of Air Quality Implementation Plans; Delaware, State Board Requirements AGENCY: Environmental... revision to the Delaware State Implementation Plan (SIP) submitted by the Delaware Department of Natural Resources and Environmental Control (DNREC) on January 11, 2013. The SIP revision addresses requirements of...
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49 CFR 1155.28 - Appellate procedures.
Code of Federal Regulations, 2010 CFR
2010-10-01
... Applications for a Land-Use-Exemption Permit § 1155.28 Appellate procedures. General rule. Petitions to modify, amend, or revoke land-use-exemption permits shall be decided in accordance with the Board's normal... amendment. (b) The Board will approve or deny petitions to modify, amend, or revoke a land-use-exemption...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-19
... National Ambient Air Quality Standards; Indiana PSD; Indiana State Board Requirements AGENCY: Environmental... from Indiana addressing EPA's requirements for the prevention of significant deterioration (PSD... (PSD elements), or EPA-R05-OAR-2012-0988 (state board requirements), by one of the following methods: 1...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-13
... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-67152; File No. SR-CBOE-2012-013] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Granting Approval of a Proposed Rule Change To Adopt Self-Trade Prevention Modifiers on the CBOE Stock Exchange June 7, 2012. I...
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77 FR 11496 - Renewal of Department of Defense Federal Advisory Committees
Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-27
... the Secretary of Defense, who are not full-time or permanent part-time federal employees, shall be... special government employee members. With the exception of travel and per diem for official Board related travel, Board members shall serve without compensation. The Secretary of Defense may approve the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-20
...: Cynthia Ayouch, Acting Federal Reserve Board Clearance Officer (202-452-3829), Division of Research and... disclosure: 8 hours; and Advertising: 30 minutes. Number of respondents: 1,107. General description of report... calculated. They also contain rules about advertising deposit accounts and overdraft services. Current...
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77 FR 58870 - Meeting of the CJIS Advisory Policy Board
Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-24
... policy issues and appropriate technical and operational issues related to the programs administered by... with approval of the Designated Federal Officer (DFO). Any member of the public may file a written statement with the Board. Written comments shall be focused on the APB's current issues under discussion and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-18
... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69124; File Nos. SR-CBOE-2013-016; SR-ISE-2013... Securities Exchange, LLC; Order Granting Accelerated Approval of Proposed Rule Changes To Permit the Minimum... Security March 12, 2013. I. Introduction On January 31, 2013, Chicago Board Options Exchange, Incorporated...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-01
... Personal Oxygen Concentrator (POC) Devices on Board Aircraft AGENCY: Federal Aviation Administration (FAA.... Title: Use of Certain Personal Oxygen Concentrator (POC) Devices on Board Aircraft. Form Numbers: There... physician statement describing the oxygen therapy needed, to determine whether an inflight diversion to an...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-18
... Business October 12, 2010. I. Introduction On August 25, 2010, the Municipal Securities Rulemaking Board... contributions and prohibitions on municipal securities business. The proposed rule change was published for... prohibitions on municipal securities business.\\4\\ Under Rule G-37, certain contributions to elected officials...
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78 FR 51726 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-21
... thereby indirectly acquire Peoples Community State Bank, Doniphan, Missouri. Board of Governors of the... FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company...
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Code of Federal Regulations, 2010 CFR
2010-01-01
... board of directors of the Bank has specifically approved such acceptance by formal resolution, and the... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Collateral. 950.7 Section 950.7 Banks and Banking FEDERAL HOUSING FINANCE BOARD FEDERAL HOME LOAN BANK ASSETS AND OFF-BALANCE SHEET ITEMS ADVANCES...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-17
... purpose of the survey is to provide qualitative and limited quantitative information on credit...--Division of Research and Statistics, Board of Governors of the Federal Reserve System, Washington, DC 20551... Opinion Survey on Bank Lending Practices. Agency form number: FR 2018. OMB control number: 7100-0058...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-10
....C. 552(b)(4)). Abstract: This voluntary survey collects qualitative and limited quantitative..., Division of Research and Statistics, Board of Governors of the Federal Reserve System, Washington, DC 20551... extension for three years, with revision, of the following survey: Report title: Senior Credit Officer...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-28
... Accounting Oversight Board Budget and Annual Accounting Support Fee for Calendar Year 2011 The Sarbanes-Oxley Act of 2002, as amended (the ``Sarbanes-Oxley Act''), established the Public Company Accounting... through registration of public accounting firms and standard setting, inspection, and disciplinary...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-20
... Accounting Oversight Board Budget and Annual Accounting Support Fee for Calendar Year 2013 The Sarbanes-Oxley Act of 2002, as amended (the ``Sarbanes-Oxley Act''),\\1\\ established the Public Company Accounting... through registration of public accounting firms and standard setting, inspection, and disciplinary...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-01-18
... Accounting Oversight Board Budget and Annual Accounting Support Fee for Calendar Year 2012 The Sarbanes-Oxley Act of 2002, as amended (the ``Sarbanes-Oxley Act''),\\1\\ established the Public Company Accounting... through registration of public accounting firms and standard setting, inspection, and disciplinary...
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77 FR 15382 - Notice of Sunshine Act Meetings
Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-15
... INTER-AMERICAN FOUNDATION BOARD MEETING Notice of Sunshine Act Meetings TIME AND DATE: March 26...). MATTERS TO BE CONSIDERED: [ssquf] Approval of the Minutes of the December 12, 2011, Meeting of the Board... Perception Report [ssquf] Next Meetings [ssquf] Executive Session PORTIONS TO BE OPEN TO THE PUBLIC: [ssquf...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-18
... RECOVERY ACCOUNTABILITY AND TRANSPARENCY BOARD Agency Information Collection Activities: Renewal of Currently Approved Collection; Comment Request Correction In notice document 2012-30952, appearing on page 76097, in the issue of Wednesday, December 26, 2012, make the following correction: In the...
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40 CFR 52.283 - Interstate Transport.
Code of Federal Regulations, 2013 CFR
2013-07-01
...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California § 52.283 Interstate Transport. (a) Approval. On November 16, 2007, the California Air Resources Board submitted the “Interstate Transport State... Act section 110(a)(2)(D)(i) for the State of California (September 21, 2007)” (“2007 Transport SIP...
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40 CFR 52.283 - Interstate Transport.
Code of Federal Regulations, 2012 CFR
2012-07-01
...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California § 52.283 Interstate Transport. (a) Approval. On November 16, 2007, the California Air Resources Board submitted the “Interstate Transport State... Act section 110(a)(2)(D)(i) for the State of California (September 21, 2007)” (“2007 Transport SIP...
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40 CFR 52.283 - Interstate Transport.
Code of Federal Regulations, 2014 CFR
2014-07-01
...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California § 52.283 Interstate Transport. (a) Approval. On November 16, 2007, the California Air Resources Board submitted the “Interstate Transport State... Act section 110(a)(2)(D)(i) for the State of California (September 21, 2007)” (“2007 Transport SIP...
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40 CFR 52.241 - Inspection and maintenance program.
Code of Federal Regulations, 2011 CFR
2011-07-01
... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California § 52.241 Inspection and maintenance program. (a) [Reserved] (b) Approval. On June 5, 2009, the California Air Resources Board submitted a revision to the California Motor Vehicle Inspection and Maintenance Program (2009 I/M Revision) to satisfy...
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40 CFR 52.241 - Inspection and maintenance program.
Code of Federal Regulations, 2014 CFR
2014-07-01
... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California § 52.241 Inspection and maintenance program. (a) [Reserved] (b) Approval. On June 5, 2009, the California Air Resources Board submitted a revision to the California Motor Vehicle Inspection and Maintenance Program (2009 I/M Revision) to satisfy...
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40 CFR 52.241 - Inspection and maintenance program.
Code of Federal Regulations, 2013 CFR
2013-07-01
... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California § 52.241 Inspection and maintenance program. (a) [Reserved] (b) Approval. On June 5, 2009, the California Air Resources Board submitted a revision to the California Motor Vehicle Inspection and Maintenance Program (2009 I/M Revision) to satisfy...
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40 CFR 52.241 - Inspection and maintenance program.
Code of Federal Regulations, 2012 CFR
2012-07-01
... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California § 52.241 Inspection and maintenance program. (a) [Reserved] (b) Approval. On June 5, 2009, the California Air Resources Board submitted a revision to the California Motor Vehicle Inspection and Maintenance Program (2009 I/M Revision) to satisfy...
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Connected Vehicle Pilot Deployment Program Phase 1 : Human Use Approval Summary : New York City
DOT National Transportation Integrated Search
2016-08-04
The New York City (NYC) Connected Vehicle (CV) Pilot Deployment will be the largest deployment of connected vehicle technology to date. The purpose of the human use approval activity is to apply the Institutional Review Board (IRB) process to the NYC...
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24 CFR 4001.05 - Approval of mortgagees.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 24 Housing and Urban Development 5 2010-04-01 2010-04-01 false Approval of mortgagees. 4001.05 Section 4001.05 Housing and Urban Development Regulations Relating to Housing and Urban Development (Continued) BOARD OF DIRECTORS OF THE HOPE FOR HOMEOWNERS PROGRAM HOPE FOR HOMEOWNERS PROGRAM HOPE for...
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7 CFR 1150.140 - Duties of the Board.
Code of Federal Regulations, 2014 CFR
2014-01-01
... develop and submit to the Secretary for approval, promotion, research, and nutrition education plans or... for approval, budgets on a fiscal period basis of its anticipated expenses and disbursements in the administration of this subpart, including probable costs of promotion, research and nutrition education plans or...
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7 CFR 1150.140 - Duties of the Board.
Code of Federal Regulations, 2012 CFR
2012-01-01
... develop and submit to the Secretary for approval, promotion, research, and nutrition education plans or... for approval, budgets on a fiscal period basis of its anticipated expenses and disbursements in the administration of this subpart, including probable costs of promotion, research and nutrition education plans or...
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7 CFR 1150.140 - Duties of the Board.
Code of Federal Regulations, 2013 CFR
2013-01-01
... develop and submit to the Secretary for approval, promotion, research, and nutrition education plans or... for approval, budgets on a fiscal period basis of its anticipated expenses and disbursements in the administration of this subpart, including probable costs of promotion, research and nutrition education plans or...
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Addressing risks to advance mental health research.
Iltis, Ana S; Misra, Sahana; Dunn, Laura B; Brown, Gregory K; Campbell, Amy; Earll, Sarah A; Glowinski, Anne; Hadley, Whitney B; Pies, Ronald; Dubois, James M
2013-12-01
Risk communication and management are essential to the ethical conduct of research, yet addressing risks may be time consuming for investigators and institutional review boards may reject study designs that seem too risky. This can discourage needed research, particularly in higher-risk protocols or those enrolling potentially vulnerable individuals, such as those with some level of suicidality. Improved mechanisms for addressing research risks may facilitate much needed psychiatric research. To provide mental health researchers with practical approaches to (1) identify and define various intrinsic research risks, (2) communicate these risks to others (eg, potential participants, regulatory bodies, and society), (3) manage these risks during the course of a study, and (4) justify the risks. As part of a National Institute of Mental Health-funded scientific meeting series, a public conference and a closed-session expert panel meeting were held on managing and disclosing risks in mental health clinical trials. The expert panel reviewed the literature with a focus on empirical studies and developed recommendations for best practices and further research on managing and disclosing risks in mental health clinical trials. No institutional review board-review was required because there were no human subjects. Challenges, current data, practical strategies, and topics for future research are addressed for each of 4 key areas pertaining to management and disclosure of risks in clinical trials: identifying and defining risks, communicating risks, managing risks during studies, and justifying research risks. Empirical data on risk communication, managing risks, and the benefits of research can support the ethical conduct of mental health research and may help investigators better conceptualize and confront risks and to gain institutional review board-approval.
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Detection of Banned and Restricted Ozone-Depleting Chemicals in Printed Circuit Boards
DOE Office of Scientific and Technical Information (OSTI.GOV)
Lee, Richard N.; Wright, Bob W.
2008-12-01
A study directed toward the detection of halogenated solvents in the matrix of circuit boards has recently been completed. This work was undertaken to demonstrate the potential for reliable detection of solvents used during the fabrication of printed circuit boards (PCB). Since many of these solvents are now, or soon will be, restricted under the terms of legislation enacted in response to the Montreal Protocol and other international agreements, the work described here, conducted over a period of more that 4 years, has provided guidance for the development of chromatographic system and analytical protocol to assure compliance with regulations introducedmore » to control, or ban, industrial solvents associated with adverse environmental impact.« less
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The Satisfaction and Use of Research Ethics Board Information Systems in Canada.
Detlor, Brian; Wilson, Michael J
2015-10-01
This article reports findings from a national survey of Research Ethics Board (REB) personnel across Canada on the satisfaction and use of information systems that support the review and administration of research ethics protocols. Findings indicate that though a wide variety of REB systems are utilized, the majority fall short of desired characteristics. Despite these shortcomings, most respondents are satisfied with their current REB systems. Satisfaction is dependent on the volume of protocols processed in relation to the robustness of the system. Boards with higher volumes are more satisfied with full-fledged systems; however, the satisfaction of REBs with lower volumes is not affected by the robustness of the REB system used. Recommendations are provided. © The Author(s) 2015.
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Lungu, Eugen; Grondin, Philippe; Tétreault, Patrice; Desmeules, François; Cloutier, Guy; Choinière, Manon; Bureau, Nathalie J
2018-06-09
Chronic lateral epicondylosis (CLE) of the elbow is a prevalent condition among middle-aged people with no consensus on optimal care management but for which surgery is generally accepted as a second intention treatment. Among conservative treatment options, ultrasound (US)-guided fenestration has shown encouraging results that should be explored before surgery is considered. The primary objective of this study is to compare the efficacy of US-guided fenestration with open-release surgery in patients with failure to improve following a minimum 6 months of conservative treatment. This study protocol entails a two-arm, single-blinded, randomised, controlled design. Sixty-four eligible patients with clinically confirmed CLE will be assigned to either US-guided fenestration or open-release surgery. Fisher's exact test will be used to compare the proportion of patients reporting a change of 11/100 points or more in the Patient Rated Tennis Elbow Evaluation score at 6 months, according to an intention-to-treat analysis. Secondary analyses will compare the two treatment groups in terms of pain and disability, functional limitations at work, pain-free grip strength, medication burden, patients' global impression of change and level of satisfaction at 6 weeks, 3, 6 and 12 months, using mixed linear models for repeated measures or Fisher's exact test, as appropriate. Finally, recursive partitioning analyses will investigate US and elastography parameters as predictors of treatment success at 6 and 12 months. This data will contribute to evidence-based treatment guidelines for CLE and explore the value of imaging biomarkers to improve risk stratification plans and assist clinicians. The study has been approved by the Research Ethics Board of our institution on 23 March 2016 (REB 15.327). In case of important protocol modifications, a new version of the protocol with appropriate amendments will be submitted to the REB for approval. Study results will be published in peer-reviewed journals and presented at local, national and international conferences. NCT02710682. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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Lien, Victoria Peixin; Ong, Hwee Kuan; Er, Pei Ling; Hao, Ying; Khan, Shariq Ali; Liu, Christopher Weiyang
2017-01-01
Introduction Frail patients have decreased physiological reserves and consequently, they are unable to recover as quickly from surgery. Frailty, as an entity, is a risk factor of increased morbidity and mortality. It is also associated with a longer time to discharge. This trial is undertaken to determine if a novel prehabilitation protocol (10-day bundle of interventions—physiotherapy, nutritional supplementation and cognitive training) can reduce the postoperative length of stay of frail patients who are undergoing elective abdominal surgery, compared with standard care. Methods and analysis This is a prospective, single-centre, randomised controlled trial with two parallel arms. 62 patients who are frail and undergoing elective abdominal surgery will be recruited and randomised to receive either a novel prehabilitation protocol or standard care. Participants will receive telephone reminders preoperatively to encourage protocol compliance. Data will be collected for up to 30 days postoperatively. The primary outcome of the trial will be the postoperative length of stay and the secondary outcomes are the postoperative complications and functional recovery during the hospital admission. Ethics and dissemination This study has been approved by the Singapore General Hospital Institutional Review Board (CIRB Ref: 2016/2584). The study is also listed on ClinicalTrials.gov (Trial number: NCT02921932). All participants will sign an informed consent form before randomisation and translators will be made available to non-English speaking patients. The results of this study will be published in peer-reviewed journals as well as national and international conferences. The data collected will also be made available in a public data repository. Trial registration number NCT02921932 (ClinicalTrials.gov) PMID:28778994
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Madden, Victoria J; Catley, Mark J; Grabherr, Luzia; Mazzola, Francesca; Shohag, Mohammad; Moseley, G Lorimer
2016-01-01
Background. Nd:YAP laser is widely used to investigate the nociceptive and pain systems, generating perpetual and laser-evoked neurophysiological responses. A major procedural concern for the use of Nd:YAP laser stimuli in experimental research is the risk of skin damage. The absorption of Nd:YAP laser stimuli is greater in darker skin, or in pale skin that has been darkened with ink, prompting some ethics boards to refuse approval to experimenters wishing to track stimulus location by marking the skin with ink. Some research questions, however, require laser stimuli to be delivered at particular locations or within particular zones, a requirement that is very difficult to achieve if marking the skin is not possible. We thoroughly searched the literature for experimental evidence and protocol recommendations for safe delivery of Nd:YAP laser stimuli over marked skin, but found nothing. Methods. We designed an experimental protocol to define safe parameters for the use of Nd:YAP laser stimuli over skin that has been marked with black dots, and used thermal imaging to assess the safety of the procedure at the forearm and the back. Results. Using thermal imaging and repeated laser stimulation to ink-marked skin, we demonstrated that skin temperature did not increase progressively across the course of the experiment, and that the small change in temperature seen at the forearm was reversed during the rest periods between blocks. Furthermore, no participant experienced skin damage due to the procedure. Conclusion. This protocol offers parameters for safe, confident and effective experimentation using repeated Nd:YAP laser on skin marked with ink, thus paving the way for investigations that depend on it.
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Takase, Naoto; Matsumoto, Koji; Onoe, Takuma; Kitao, Akihito; Tanioka, Maki; Kikukawa, Yoshitaka; Yamaguchi, Satoshi; Fujiwara, Kiyoshi; Negoro, Shunichi
2015-06-01
Platinum agents are essential for treating gynecological malignancies, particularly ovarian cancer. However, multiple carboplatin doses may cause hypersensitivity reactions (HSRs). Carboplatin desensitization prevents life-threatening HSRs and promotes the successful completion of planned chemotherapy. Since January 2010, carboplatin desensitization was performed at our institution. Solutions with 1/1000, 1/100, and 1/10 dilutions of carboplatin and an undiluted solution were prepared in 250 mL of 5% glucose. Each solution was administered as a 1-h intravenous infusion (4-step 4-h protocol). This retrospective analysis was approved by the institutional review board. From January 2010 to December 2013, 20 patients with gynecological malignancies (median age 62 years, range 43-74 years) received desensitization treatment. The International Federation of Gynecology and Obstetrics stages at presentation were I, II, III, and IV in 1, 1, 15, 13 patients, respectively. During first-line and second-line treatments, 3 and 17 patients, respectively, experienced carboplatin-induced HSRs. The median carboplatin cycle number was 11 (range 2-16). In the first desensitization cycle, 17 (85%) patients completed treatment without adverse events, 2 experienced Grade 1 HSRs but completed treatment, and 1 experienced Grade 3 HSR and discontinued treatment. The first desensitization cycle completion rate was 95%. Of 83 desensitization cycles administered, 79 (95.2%) were completed. No treatment-related deaths occurred. Most patients completed the planned chemotherapy. Our protocol could be conducted safely with shorter duration and simpler procedures than previous protocols. Carboplatin desensitization seems beneficial for patients with a history of carboplatin-induced HSRs; however, the risk of HSR recurrence still remains. Desensitization should therefore be performed only by well-trained staff.
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Management of persistent postconcussion symptoms in youth: a randomised control trial protocol
Reed, Nick; Greenspoon, Dayna; Iverson, Grant L; DeMatteo, Carol; Fait, Philippe; Gauvin-Lepage, Jérôme; Hunt, Anne; Gagnon, Isabelle J
2015-01-01
Introduction Current management of concussion consists of early education, rest until symptom free, with gradual return to school and physical activity protocols. Although this management strategy is effective for most youth who sustain a concussion, it is not an appropriate strategy for youth with persistent postconcussion symptoms. Prolonged rest and periods of restricted activity may place youth at risk for secondary issues and contribute to the chronicity of postconcussion symptoms. The purpose of this study is to evaluate the efficacy of an active rehabilitation protocol for youth who are slow to recover from concussion. It is hypothesised that an active rehabilitation intervention can reduce persistent postconcussion symptoms, improve function and facilitate return to activity. This article describes the research protocol. Methods and analysis This is a randomised clinical trial with blinded outcome measurement. Participants will be recruited and randomly assigned to 1 of 2 treatment groups, an active rehabilitation intervention or a standard care education group. Both groups will receive standard care education. However, the active rehabilitation group will participate in an additional low-intensity exercise programme consisting of aerobic, coordination and visualisation exercises. Both the active rehabilitation and the standard care education interventions will be 6 weeks in duration. The primary outcome measure is postconcussion symptoms. Secondary outcome measures include functional recovery (cognitive, motor, psychosocial and emotional functioning) and return to activity. Outcome measures will be administered preintervention and postintervention. The primary outcome measure will also be repeated 2 weeks into the intervention period. Ethics and dissemination This study has been approved by the Holland Bloorview Kids Rehabilitation Hospital research ethics board (REB # 13-459). The findings from this study will be shared with the general public, sport associations, relevant brain injury organisations and healthcare professionals. Trial registration number NCT02257749. PMID:26231756
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Abdullah, Hairil Rizal; Lien, Victoria Peixin; Ong, Hwee Kuan; Er, Pei Ling; Hao, Ying; Khan, Shariq Ali; Liu, Christopher Weiyang
2017-08-04
Frail patients have decreased physiological reserves and consequently, they are unable to recover as quickly from surgery. Frailty, as an entity, is a risk factor of increased morbidity and mortality. It is also associated with a longer time to discharge. This trial is undertaken to determine if a novel prehabilitation protocol (10-day bundle of interventions-physiotherapy, nutritional supplementation and cognitive training) can reduce the postoperative length of stay of frail patients who are undergoing elective abdominal surgery, compared with standard care. This is a prospective, single-centre, randomised controlled trial with two parallel arms. 62 patients who are frail and undergoing elective abdominal surgery will be recruited and randomised to receive either a novel prehabilitation protocol or standard care. Participants will receive telephone reminders preoperatively to encourage protocol compliance. Data will be collected for up to 30 days postoperatively. The primary outcome of the trial will be the postoperative length of stay and the secondary outcomes are the postoperative complications and functional recovery during the hospital admission. This study has been approved by the Singapore General Hospital Institutional Review Board (CIRB Ref: 2016/2584). The study is also listed on ClinicalTrials.gov (Trial number: NCT02921932). All participants will sign an informed consent form before randomisation and translators will be made available to non-English speaking patients. The results of this study will be published in peer-reviewed journals as well as national and international conferences. The data collected will also be made available in a public data repository. NCT02921932 (ClinicalTrials.gov). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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Fossey, Robyn; Kochan, David; Winkler, Erin; Pacyna, Joel E.; Olson, Janet; Thibodeau, Stephen; Connolly, John J.; Harr, Margaret; Behr, Meckenzie A.; Prows, Cynthia A.; Cobb, Beth; Myers, Melanie F.; Leslie, Nancy D.; Namjou-Khales, Bahram; Milo Rasouly, Hila; Wynn, Julia; Fedotov, Alexander; Chung, Wendy K.; Gharavi, Ali; Williams, Janet L.; Pais, Lynn; Holm, Ingrid; Aufox, Sharon; Smith, Maureen E.; Scrol, Aaron; Leppig, Kathleen; Jarvik, Gail P.; Wiesner, Georgia L.; Li, Rongling; Stroud, Mary; Smoller, Jordan W.; Sharp, Richard R.; Kullo, Iftikhar J.
2018-01-01
We examined the Institutional Review Board (IRB) process at 9 academic institutions in the electronic Medical Records and Genomics (eMERGE) Network, for proposed electronic health record-based genomic medicine studies, to identify common questions and concerns. Sequencing of 109 disease related genes and genotyping of 14 actionable variants is being performed in ~28,100 participants from the 9 sites. Pathogenic/likely pathogenic variants in actionable genes are being returned to study participants. We examined each site’s research protocols, informed-consent materials, and interactions with IRB staff. Research staff at each site completed questionnaires regarding their IRB interactions. The time to prepare protocols for IRB submission, number of revisions and time to approval ranged from 10–261 days, 0–11, and 11–90 days, respectively. IRB recommendations related to the readability of informed consent materials, specifying the full range of potential risks, providing options for receiving limited results or withdrawal, sharing of information with family members, and establishing the mechanisms to answer participant questions. IRBs reviewing studies that involve the return of results from genomic sequencing have a diverse array of concerns, and anticipating these concerns can help investigators to more effectively engage IRBs. PMID:29301385
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Kotecha, Jyoti A; Manca, Donna; Lambert-Lanning, Anita; Keshavjee, Karim; Drummond, Neil; Godwin, Marshall; Greiver, Michelle; Putnam, Wayne; Lussier, Marie-Thérèse; Birtwhistle, Richard
2011-10-01
To describe the challenges the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) experienced with institutional research ethics boards (IREBs) when seeking approvals across jurisdictions and to provide recommendations for overcoming challenges of ethical review for multisite and multijurisdictional surveillance and research. The CPCSSN project collects and validates longitudinal primary care health information (relating to hypertension, diabetes, depression, chronic obstructive lung disease, and osteoarthritis) from electronic medical records across Canada. Privacy and data storage security policies and processes have been developed to protect participants' privacy and confidentiality, and IREB approval is obtained in each participating jurisdiction. Inconsistent interpretation and application of privacy and ethical issues by IREBs delays and impedes research programs that could better inform us about chronic disease. The CPCSSN project's experience with gaining approval from IREBs highlights the difficulty of conducting pan-Canadian health surveillance and multicentre research. Inconsistent IREB approvals to waive explicit individual informed consent produced particular challenges for researchers. The CPCSSN experience highlights the need to develop a better process for researchers to obtain timely and consistent IREB approvals for multicentre surveillance and research. We suggest developing a specialized, national, centralized IREB responsible for approving multisite studies related to population health research.
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The Southern California Earthquake Survival Program
Harris, J.M.
1989-01-01
In July 1988, the Los Angeles County Board of Supervisors directed the Chief Administrative Office to develop an educational program aimed at improving earthquake preparedness among Los Angeles County residents. the board recognized that current earthquake education efforts were not only insufficient, but also often confusing and costly. The board unanimously approved the development of a program that would make earthquake preparedness a year-long effort by encouraging residents to take a different precaution each month.
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Code of Federal Regulations, 2010 CFR
2010-10-01
... essential service is required to meet foreign-flag competition and to promote U.S. foreign commerce; (b) The... him to operate in an essential service in such manner as may be necessary to meet competitive... economical conversion into an auxiliary naval vessel, or approved by the Board and Navy Department as...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-29
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1671] Approval for Processing Authority, Foreign-Trade Zone 196, ATC Logistics & Electronics (Personal Navigation Devices), Fort Worth... & Electronics, an operator of Foreign-Trade Zone 196, has requested processing authority within FTZ 196 in Fort...
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Code of Federal Regulations, 2010 CFR
2010-10-01
... other similar places open to persons on board. Anti-exposure suit means a protective suit designed for use by rescue boat crews and marine evacuation system parties. Approval series means the first six... subpart of subchapter Q of this chapter, the approval series corresponds to the number of the subpart. A...
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Code of Federal Regulations, 2013 CFR
2013-10-01
... other similar places open to persons on board. Anti-exposure suit means a protective suit designed for use by rescue boat crews and marine evacuation system parties. Approval series means the first six... subpart of subchapter Q of this chapter, the approval series corresponds to the number of the subpart. A...
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EPA and CARB approve an emissions modification proposed by Volkswagen (VW) to reduce nitrogen oxides emissions from model year 2009-2014, generation 1, 2.0 liter diesel Jetta, Golf, Beetle, and Audi A3 vehicles.
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76 FR 4094 - Submission for OMB Review; Comment Request
Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-24
...). Title: Trademark Trial and Appeal Board (TTAB) Actions. Form Number(s): PTO 2120, 2151, 2153, and 2188 through 2190. Agency Approval Number: 0651-0040. Type of Request: Revision of a currently approved... a petition to cancel the registration of that mark. Individuals or entities may file an appeal from...
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14 CFR 135.93 - Autopilot: Minimum altitudes for use.
Code of Federal Regulations, 2011 CFR
2011-01-01
... specifications to allow the use, to touchdown, of an approved flight control guidance system with automatic... REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT Flight... than 500 feet or less than twice the maximum altitude loss specified in the approved Aircraft Flight...
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14 CFR 135.93 - Autopilot: Minimum altitudes for use.
Code of Federal Regulations, 2012 CFR
2012-01-01
... specifications to allow the use, to touchdown, of an approved flight control guidance system with automatic... REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT Flight... than 500 feet or less than twice the maximum altitude loss specified in the approved Aircraft Flight...
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14 CFR 135.93 - Autopilot: Minimum altitudes for use.
Code of Federal Regulations, 2014 CFR
2014-01-01
... specifications to allow the use, to touchdown, of an approved flight control guidance system with automatic... REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT Flight... than 500 feet or less than twice the maximum altitude loss specified in the approved Aircraft Flight...
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14 CFR 135.93 - Autopilot: Minimum altitudes for use.
Code of Federal Regulations, 2013 CFR
2013-01-01
... specifications to allow the use, to touchdown, of an approved flight control guidance system with automatic... REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT Flight... than 500 feet or less than twice the maximum altitude loss specified in the approved Aircraft Flight...
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14 CFR 135.93 - Autopilot: Minimum altitudes for use.
Code of Federal Regulations, 2010 CFR
2010-01-01
... specifications to allow the use, to touchdown, of an approved flight control guidance system with automatic... REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT Flight... than 500 feet or less than twice the maximum altitude loss specified in the approved Aircraft Flight...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-25
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1798] Approval for Expansion of Manufacturing Authority, Foreign-Trade Subzone 29F, Hitachi Automotive Systems Americas, Inc., (Automotive... requested an expansion of the scope of manufacturing authority on behalf of Hitachi Automotive Systems...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-27
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1803] Approval for Manufacturing Authority; Foreign-Trade Zone 26; Makita Corporation of America; (Hand-Held/Stationary Power Tool and Gasoline/Electric-Powered Lawn and Garden Product Manufacturing); Buford, GA Pursuant to its authority...
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78 FR 4124 - Approval of Subzone Status, Coamo Property & Investments, LLC, Coamo, PR
Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-18
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-107-2012] Approval of Subzone Status, Coamo Property & Investments, LLC, Coamo, PR On October 9, 2012, the Executive Secretary of the Foreign-Trade... the proposed operator, Coamo Property & Investments, LLC, in Coamo, Puerto Rico. The application was...
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7 CFR 2201.23 - Funding for the Program.
Code of Federal Regulations, 2010 CFR
2010-01-01
... the Program and operate the Program accordingly. (b) Credit Risk Premium—(1) Establishment and approval. The Board may establish and approve the acceptance of credit risk premiums with respect to a..., credit risk premiums shall be accepted from a non-Federal source on behalf of a Borrower. (2) Credit risk...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-19
... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Approval of Noise Compatibility... the noise compatibility program (NCP) submitted by the Chicago Executive Airport Board of Directors... Noise Abatement Act, herein referred to as ``the Act'') and 14 CFR part 150. On March 1, 2010, the FAA...
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12 CFR 225.12 - Transactions not requiring Board approval.
Code of Federal Regulations, 2010 CFR
2010-01-01
... Merger Act. The merger or consolidation of a subsidiary bank of a bank holding company with another bank... application under this subpart if it determines that the merger or consolidation would have a significant adverse impact on the financial condition of the bank holding company, or otherwise requires approval...
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75 FR 13598 - Regular Board of Directors Meeting; Sunshine Act
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-22
... 20005. STATUS: Open. CONTACT PERSON FOR MORE INFORMATION: Erica Hall, Assistant Corporate Secretary... of the Corporate Administration Committee IV. Approval of the Minutes V. Summary Report of the Audit Committee VI. Approval of the Minutes VII. Summary Report of the Finance, Budget and Program Committee VIII...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-07
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1810] Approval for Manufacturing Authority, Foreign-Trade Zone 22, Baxter Healthcare Corporation, (Pharmaceutical and Biological Intravenous Product Manufacturing), Chicago, IL Pursuant to its authority under the Foreign-Trade Zones Act of June 18...
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13 CFR 108.510 - SBA approval of NMVC Company's Investment Adviser/Manager.
Code of Federal Regulations, 2010 CFR
2010-01-01
... Investment Adviser/Manager. 108.510 Section 108.510 Business Credit and Assistance SMALL BUSINESS... and Compensation § 108.510 SBA approval of NMVC Company's Investment Adviser/Manager. You may employ an Investment Adviser/Manager who will be subject to the supervision of your board of directors...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-08
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-132-2012] Approval of Subzone Status; Pepsi Cola Puerto Rico Distributing, LLC, Toa Baja, Puerto Rico On December 7, 2012, the Executive Secretary... activation limit of FTZ 7, on [[Page 20888
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-21
..., supporting statements and approved collection of information instrument(s) are placed into OMB's public... revision, of the following reports: Report title: Report of Changes in Organizational Structure, Annual... organizational information with the Federal Reserve. The Federal Reserve uses information to assess an FBO's...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-27
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1834] Approval for Expanded Manufacturing Authority; Foreign-Trade Subzone 7M; Amgen Manufacturing Limited (Biotechnology and Healthcare Products); Juncos, Puerto Rico Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934...
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50 CFR 300.45 - Vessel Monitoring System.
Code of Federal Regulations, 2013 CFR
2013-10-01
... installers may be obtained from the Regional Administrator or the Administrator. (d) Hardware and software specifications. The VMS unit installed and carried on board a vessel to comply with the requirements of this section must consist of hardware and software that is approved by the Administrator and approved by NMFS...
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50 CFR 300.45 - Vessel Monitoring System.
Code of Federal Regulations, 2012 CFR
2012-10-01
... installers may be obtained from the Regional Administrator or the Administrator. (d) Hardware and software specifications. The VMS unit installed and carried on board a vessel to comply with the requirements of this section must consist of hardware and software that is approved by the Administrator and approved by NMFS...
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50 CFR 300.45 - Vessel Monitoring System.
Code of Federal Regulations, 2014 CFR
2014-10-01
... installers may be obtained from the Regional Administrator or the Administrator. (d) Hardware and software specifications. The VMS unit installed and carried on board a vessel to comply with the requirements of this section must consist of hardware and software that is approved by the Administrator and approved by NMFS...
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Kijowski, Richard; Blankenbaker, Donna G; Munoz Del Rio, Alejandro; Baer, Geoffrey S; Graf, Ben K
2013-05-01
To determine whether the addition of a T2 mapping sequence to a routine magnetic resonance (MR) imaging protocol could improve diagnostic performance in the detection of surgically confirmed cartilage lesions within the knee joint at 3.0 T. This prospective study was approved by the institutional review board, and the requirement to obtain informed consent was waived. The study group consisted of 150 patients (76 male and 74 female patients with an average age of 41.2 and 41.5 years, respectively) who underwent MR imaging and arthroscopy of the knee joint. MR imaging was performed at 3.0 T by using a routine protocol with the addition of a sagittal T2 mapping sequence. Images from all MR examinations were reviewed in consensus by two radiologists before surgery to determine the presence or absence of cartilage lesions on each articular surface, first by using the routine MR protocol alone and then by using the routine MR protocol with T2 maps. Each articular surface was then evaluated at arthroscopy. Generalized estimating equation models were used to compare the sensitivity and specificity of the routine MR imaging protocol with and without T2 maps in the detection of surgically confirmed cartilage lesions. The sensitivity and specificity in the detection of 351 cartilage lesions were 74.6% and 97.8%, respectively, for the routine MR protocol alone and 88.9% and 93.1% for the routine MR protocol with T2 maps. Differences in sensitivity and specificity were statistically significant (P < .001). The addition of T2 maps to the routine MR imaging protocol significantly improved the sensitivity in the detection of 24 areas of cartilage softening (from 4.2% to 62%, P < .001), 41 areas of cartilage fibrillation (from 20% to 66%, P < .001), and 96 superficial partial-thickness cartilage defects (from 71% to 88%, P = .004). The addition of a T2 mapping sequence to a routine MR protocol at 3.0 T improved sensitivity in the detection of cartilage lesions within the knee joint from 74.6% to 88.9%, with only a small reduction in specificity. The greatest improvement in sensitivity with use of the T2 maps was in the identification of early cartilage degeneration. © RSNA, 2013.
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AOA Approval of ACGME Internship and Residency Training.
Duffy, Thomas; Martinez, Bulmaro
2011-04-01
Since the 1970s, the American Osteopathic Association (AOA) has provided a means for osteopathic physicians to apply for approval of their postdoctoral training in programs accredited by the Accreditation Council for Graduate Medical Education (ACGME). Osteopathic physicians who trained in ACGME programs need this approval to meet AOA licensure and board certification requirements. The AOA approves ACGME residency training with several different approval processes. Approval of the first year of postdoctoral training occurs through Resolution 42, specialty approval (for specialties in which the first year of training is part of the residency), or federal or military training approval. For residency training, the AOA verifies successful completion of an ACGME training program before approving the training. The AOA is using customer surveys and online applications to improve the review process for applicants.
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Janke, Leandro; Lima, André O S; Millet, Maurice; Radetski, Claudemir M
2013-01-01
In Brazil, Solid Waste Disposal Sites have operated without consideration of environmental criteria, these areas being characterized by methane (CH4) emissions during the anaerobic degradation of organic matter. The United Nations organization has made efforts to control this situation, through the United Nations Framework Convention on Climate Change (UNFCCC) and the Kyoto Protocol, where projects that seek to reduce the emissions of greenhouse gases (GHG) can be financially rewarded through Certified Emission Reductions (CERs) if they respect the requirements established by the Clean Development Mechanism (CDM), such as the use of methodologies approved by the CDM Executive Board (CDM-EB). Thus, a methodology was developed according to the CDM standards related to the aeration, excavation and composting of closed Municipal Solid Waste (MSW) landfills, which was submitted to CDM-EB for assessment and, after its approval, applied to a real case study in Maringá City (Brazil) with a view to avoiding negative environmental impacts due the production of methane and leachates even after its closure. This paper describes the establishment of this CDM-EB-approved methodology to determine baseline emissions, project emissions and the resultant emission reductions with the application of appropriate aeration, excavation and composting practices at closed MSW landfills. A further result obtained through the application of the methodology in the landfill case study was that it would be possible to achieve an ex-ante emission reduction of 74,013 tCO2 equivalent if the proposed CDM project activity were implemented.
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Code of Federal Regulations, 2012 CFR
2012-10-01
... 45 Public Welfare 1 2012-10-01 2012-10-01 false Hearing. 16.11 Section 16.11 Public Welfare... BOARD § 16.11 Hearing. (a) Electing a hearing. If the appellant believes a hearing is appropriate, the... appeal file). The Board will approve a request (and may schedule a hearing on its own or in response to a...
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Code of Federal Regulations, 2014 CFR
2014-10-01
... 45 Public Welfare 1 2014-10-01 2014-10-01 false Hearing. 16.11 Section 16.11 Public Welfare... BOARD § 16.11 Hearing. (a) Electing a hearing. If the appellant believes a hearing is appropriate, the... appeal file). The Board will approve a request (and may schedule a hearing on its own or in response to a...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-15
... of the reference to the ``Secretary'' in Article VII, Section 1. Lastly, the Chief Financial Officer.... The Board approves the appointment of a Chief Financial Officer in the form of a Board resolution annually. In addition, the Chief Financial Officer will delegate to certain Exchange employees the powers...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-15
... of the reference to the ``Secretary'' in Article VII, Section 1. Lastly, the Chief Financial Officer.... The Board approves the appointment of a Chief Financial Officer in the form of a Board resolution annually. In addition, the Chief Financial Officer will delegate to certain Exchange employees the powers...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-04
.... Irwin-Knott, President, National Association of Independent Public Finance Advisors (``NAIPFA''), dated... staggered and, each year, one class would be nominated and elected to the Board of Directors. Rule A-3 would... nominated for term extensions by a Special Nominating Committee formed pursuant to Rule A- 6, on committees...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-02
... Collection; Comments Requested: Notice of Appeal to the Board of Immigration Appeals From a Decision of a DHS.... Overview of This Information Collection (1) Type of Information Collection: Revision of a currently approved collection. (2) Title of the Form/Collection: Notice of Appeal to the Board of Immigration Appeals...
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78 FR 57854 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-20
... acquire 100 percent of the voting shares of Metropolitan National Bank, Little Rock, Arkansas. Board of... FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company...
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78 FR 34660 - Farm Credit System Insurance Corporation Board; Regular Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-10
... Performance Open Session A. Approval of Minutes April 11, 2013 B. Business Reports FCSIC Financial Report Report on Insured and Other Obligations Quarterly Report on Annual Performance Plan C. New Business Mid... June 13, 2013, from 1:00 p.m. until such time as the Board concludes its business. FOR FURTHER...
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Long Range Plan for Information Systems from the State Board of Education.
ERIC Educational Resources Information Center
Texas Education Agency, Austin.
The Information Systems Long Range Plan specifically addresses Goal four of the Texas State Board of Education's (SBOE's) "Long-Range Plan for Public School Education" dealing with efficient management and organization of the educational system. To facilitate this goal, the SBOE in 1986 approved and directed the Texas Education Agency to…
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Regulating the Use of Theatrical Movies in the Classroom: Academic Freedom Issues.
ERIC Educational Resources Information Center
Bjorklun, Eugene C.
1995-01-01
Explores whether using a review board to approve the use of a movie infringes on a teacher's right to academic freedom. Also examines, in the absence of such a policy, whether teachers can be disciplined for showing movies that some parents, board members, or administrators regard as inappropriate. (68 footnotes) (MLF)
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-22
... Pollution, submitted to EPA by the Puerto Rico Environmental Quality Board on July 13, 2011. This action...)(2).) List of Subjects 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation... Control of Atmospheric Pollution submitted on July 13, 2011 by the Puerto Rico Environmental Quality Board...
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A New Approach to Teacher Education and Teacher Certification.
ERIC Educational Resources Information Center
Washington Office of the State Superintendent of Public Instruction, Olympia. Div. of Teacher Education and Certification.
New certification standards adopted by the Washington State Board of Education in 1971 were designed to develop teacher education programs that ensure the highest quality of professional performance by teachers prepared within them. Teacher education programs under the new standards are approved by the State Board of Education only when three…
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-30
.... ARS 49-478(B) establishes the compositional requirements of the county Air Quality Hearing Boards... County Code 17.04.190 (``Composition'') generally mirrors the language or ARS 49-478 but also includes... membership requirement of ARS 49-478 to interests in persons subject to enforcement orders. However, this...
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77 FR 5015 - Proposed Agency Information Collection Activities; Comment Request
Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-01
... by the Board under conditions set forth in 5 CFR 1320 Appendix A.1. Board-approved collections of... extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB... Affairs, Office of Management and Budget, New Executive Office Building, Room 10235 725 17th Street NW...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-29
..., Division of Research and Statistics, Board of Governors of the Federal Reserve System, Washington, DC 20551... FR Y-14 series of reports are authorized by section 165 of the Dodd-Frank Wall Street Reform and... large BHCs' quantitative projections of balance sheet, income, losses, and capital across a range of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-24
... in implementing the New Mexico Air Quality Control Act, the joint Air Quality Control Board (AQCB... Department in implementing the New Mexico Air Quality Control Act, the joint Air Quality Control Board (AQCB... Promulgation of Implementation Plans; New Mexico; Albuquerque/Bernalillo County; Fees for Permits and...
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12 CFR 211.4 - Permissible activities and investments of foreign branches of member banks.
Code of Federal Regulations, 2014 CFR
2014-01-01
... foreign branches of member banks. 211.4 Section 211.4 Banks and Banking FEDERAL RESERVE SYSTEM BOARD OF... requirements; and (C) Shares of automated electronic-payments networks, professional societies, schools, and...) Investment in subsidiaries. With the Board's prior approval, acquire all of the shares of a company (except...
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12 CFR 211.4 - Permissible activities and investments of foreign branches of member banks.
Code of Federal Regulations, 2013 CFR
2013-01-01
... foreign branches of member banks. 211.4 Section 211.4 Banks and Banking FEDERAL RESERVE SYSTEM BOARD OF... requirements; and (C) Shares of automated electronic-payments networks, professional societies, schools, and...) Investment in subsidiaries. With the Board's prior approval, acquire all of the shares of a company (except...
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12 CFR 211.4 - Permissible activities and investments of foreign branches of member banks.
Code of Federal Regulations, 2012 CFR
2012-01-01
... foreign branches of member banks. 211.4 Section 211.4 Banks and Banking FEDERAL RESERVE SYSTEM BOARD OF... requirements; and (C) Shares of automated electronic-payments networks, professional societies, schools, and...) Investment in subsidiaries. With the Board's prior approval, acquire all of the shares of a company (except...
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76 FR 62457 - National Science Board; Sunshine Act Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-07
... Board's Subcommittee on Facilities, pursuant to NSF regulations (45 CFR 614), The National Science Foundation Act (42 U.S.C. 1862n-5), and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives.... SUBJECT MATTER: Chairman's remarks, approval of minutes of prior meetings, discussion of Mid-Scale...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-29
... effects that a prolonged economic downturn could have on their capital adequacy and ability to continue to operate and remain credit intermediaries during times of economic and financial stress. In 2009, the Board... whether large BHCs had capital sufficient to weather a more-adverse-than-anticipated economic environment...
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77 FR 61753 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Federal Register 2010, 2011, 2012, 2013, 2014
2012-10-11
... Financial Corporation, and thereby indirectly acquire Peoples State Bank, both in Many, Louisiana. Board of... FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company...
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Financial planning for major initiatives: a framework for success.
Harris, John M
2007-11-01
A solid framework for assessing a major strategic initiative consists of four broad steps: Initial considerations, including level of analysis required and resources that will be brought to bear. Preliminary financial estimates for board approval to further assess the initiative. Assessment of potential partners' interest in the project. Feasibility analysis for board green light.
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76 FR 14971 - Proposed Agency Information Collection Activities; Comment Request
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-18
... examination or were to receive a copy of a Suspicious Activity Report (SAR; FR 2230; OMB No. 7100-0212). In... the Board under conditions set forth in 5 CFR part 1320 Appendix A.1. Board-approved collections of.... E-mail: [email protected] . Include docket number in the subject line of the message...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-10
...: Cynthia Ayouch, Acting Federal Reserve Board Clearance Officer (202-452-3829), Division of Research and... Systems Surveys: Ad Hoc Payments Systems Survey, Currency Quality Sampling Survey, Currency Quality Survey, and Currency Functionality Survey. Agency form number: FR 3054a, FR 3054b, FR 3054c, and FR 3054d. OMB...
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78 FR 57838 - Foreign-Trade Zone 15-Kansas City, Missouri, Area; Site Renumbering Notice
Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-20
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board Foreign-Trade Zone 15--Kansas City, Missouri, Area; Site Renumbering Notice Foreign-Trade Zone 15 was approved by the Foreign-Trade Zones Board on... War Road, Carthage; Site 7 (1,567 acres)--Richards-Gebaur Memorial Airport/ Industrial Park, 1540...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-10
...--Division of Research and Statistics, Board of Governors of the Federal Reserve System, Washington, DC 20551.... 5. Report title: Supervisory and Regulatory Survey. Agency form Number: FR 3052. OMB Control Number: 7100-0322. Frequency: On occasion.\\1\\ \\1\\ The Federal Reserve conducts the survey as needed up to 24...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-01
... capability for non- vital laboratory room electrical loads that provides an engineered control to reduce..., approximately two orders of magnitude higher than our evaluation guideline for selecting safety class controls. Approval of the DSA included recognition of weaknesses in the facility's control set and the need to...
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78 FR 9749 - Notice of Sunshine Act Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-11
... to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and... to approve the 2013 budget of the Public Company Accounting Oversight Board and will consider the related annual accounting support fee for the Board under Section 109 of the Sarbanes-Oxley Act of 2002...
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77 FR 54655 - Genesee & Wyoming Inc.-Control-RailAmerica, Inc., et al.
Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-05
... & Wyoming Inc.--Control--RailAmerica, Inc., et al. AGENCY: Surface Transportation Board. ACTION: Decision No... August 6, 2012, by Genesee and Wyoming Inc. (GWI) and RailAmerica, Inc. (RailAmerica). The application seeks Board approval under 49 U.S.C. 11323-11325 of the acquisition of control of RailAmerica, a...
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76 FR 16776 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-25
...-chartered stock commercial bank. Board of Governors of the Federal Reserve System, March 22, 2011. Robert... FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company...
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75 FR 5080 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-01
... thereby acquire Commercial Bank, both in Bassett, Nebraska. Board of Governors of the Federal Reserve... FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company...
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77 FR 19665 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-02
... Minnesota state-chartered commercial bank. Board of Governors of the Federal Reserve System, March 28, 2012... FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company...
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77 FR 66463 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-05
... savings bank to a state chartered commercial bank. Board of Governors of the Federal Reserve System... FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company...
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76 FR 51033 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-17
..., Evansville, Indiana, from a federally chartered savings bank to a state chartered commercial bank. Board of... FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company...
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77 FR 35384 - Farm Credit System Insurance Corporation Board; Regular Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-13
..., 2012, from 1:00 p.m. until such time as the Board concludes its business. FOR FURTHER INFORMATION... Performance Open Session A. Approval of Minutes April 24, 2012 (Regular Meeting) B. Business Reports FCSIC Financial Reports Report on Insured Obligations Quarterly Report on Annual Performance Plan C. New Business...
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78 FR 73859 - Farm Credit System Insurance Corporation Board; Regular Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-09
...: Open Session A. Approval of Minutes September 12, 2013 B. Business Reports September 30, 2013 Financial... Credit Administration in McLean, Virginia, on December 12, 2013, from 1:00 p.m. until such time as the Board concludes its business. FOR FURTHER INFORMATION CONTACT: Dale L. Aultman, Secretary to the Farm...
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Protocols for Automated Protist Analysis
2011-12-01
Report No: CG-D-14-13 Protocols for Automated Protist Analysis December 2011 Distribution Statement A: Approved for public...release; distribution is unlimited. Protocols for Automated Protist Analysis ii UNCLAS//Public | CG-926 RDC | B. Nelson, et al. | Public...Director United States Coast Guard Research & Development Center 1 Chelsea Street New London, CT 06320 Protocols for Automated Protist Analysis
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Variability of the institutional review board process within a national research network.
Khan, Muhammad A; Barratt, Michelle S; Krugman, Scott D; Serwint, Janet R; Dumont-Driscoll, Marilyn
2014-06-01
To determine the variability of the institutional review board (IRB) process for a minimal risk multicenter study. Participants included 24 Continuity Research Network (CORNET) sites of the Academic Pediatric Association that participated in a cross-sectional study. Each site obtained individual institutional IRB approval. An anonymous questionnaire went to site investigators about the IRB process at their institution. Twenty-two of 24 sites (92%) responded. Preparation time ranged from 1 to 20 hours, mean of 7.1 hours. Individuals submitting ≤3 IRB applications/year required more time for completion than those submitting >3/year (P < .05). Thirteen of 22 (59%) study sites received approval with "exempt" status, and 6 (27%) approved as "expedited" studies. IRB experiences were highly variable across study sites. These findings indicate that multicenter research projects should anticipate barriers to timely study implementation. Improved IRB standardization or centralization for multicenter clinical studies would facilitate this type of practice-based clinical research.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Morgan, Earl W.
A Question of Authority. This article deals with a certain scenario and several reviewers are to give their opinion. This one is in regards to - Suspending an IACUC approved animal use activity is about the last thing a research institution wants to do. Consider the predicament that the Great Eastern University IACUC faced when Dr. Janet Jenkins, the Attending Veterinarian, suspended all animal use activity on an approved protocol of Dr. Roy Maslo. Jenkins had the IACUCs authority to temporarily suspend a protocol, subject to review by a quorum of the full committee. She alleged that Maslo used micemore » from his breeding colony, not purchased rats, to begin a new study. Jenkins saw Maslos technicians bringing mouse cages to a procedure room and setting up for a minor survival surgery. She asked them to wait until she clarified things as she felt confident that the protocol called for rats. She called Maslo and asked him if the study had been approved for mice, to which he responded affirmatively. Still not feeling quite assured, she went to her office, reviewed the protocol, and found only rat studies described. She also called the IACUC office to see if there were any approved amendments which she may not have received, and was told that there were none. By the time she returned, one procedure was completed. Understandably upset, she informed the technicians and Maslo that any further activity on the protocol was suspended until the issue was resolved. Jenkins informed the IACUC chairman who in turned called an emergency meeting of the committee.« less
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Experience with Canada's First Policy on Concussion Education and Management in Schools.
Hachem, Laureen D; Kourtis, George; Mylabathula, Swapna; Tator, Charles H
2016-07-01
In response to the rising incidence of concussions among children and adolescents, the province of Ontario recently introduced the Ontario Policy/Program Memorandum on Concussions (PPM No. 158) requiring school boards to develop a concussion protocol. As this is the first policy of its kind in Canada, the impact of the PPM is not yet known. An electronic survey was sent to all high school principals in the Toronto District School Board 1 year after announcement of the PPM. Questions covered extent of student, parent, and staff concussion education along with concussion management protocols. Of 109 high school principals contacted, 39 responded (36%). Almost all schools provided concussion education to students (92%), with most education delivered through physical education classes. Nearly all schools had return to play (92%) and return to learn (77%) protocols. Although 85% of schools educated staff on concussions, training was aimed at individuals involved in sports/physical education. Only 43.6% of schools delivered concussion education to parents, and many principals requested additional resources in this area. One year after announcement of the PPM, high schools in the Toronto District School Board implemented significant student concussion education programs and management protocols. Staff training and parent education required further development. A series of recommendations are provided to aid in future concussion policy development.
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Study protocol for the Cities Changing Diabetes programme: a global mixed-methods approach.
Napier, A David; Nolan, John J; Bagger, Malene; Hesseldal, Louise; Volkmann, Anna-Maria
2017-11-08
Urban living has been shown to affect health in various ways. As the world is becoming more urbanised and almost two-thirds of people with diabetes now live in cities, research into the relationship between urban living, health and diabetes is key to improving the lives of many. The majority of people with diabetes have type 2 diabetes, a subset linked to overweight and obesity, decreased physical activity and unhealthy diets. Diabetes has significant consequences for those living with the condition as well as their families, relationships and wider society. Although care and management are improving, complications remain common, and diabetes is among the leading causes of vision loss, amputation, neuropathy and renal and cardiovascular disease worldwide. We present a research protocol for exploring the drivers of type 2 diabetes and its complications in urban settings through the Cities Changing Diabetes (CCD) partnership programme. A global study protocol is implemented in eight collaborating CCD partner cities. In each city, academic institutions, municipal representatives and local stakeholders collaborate to set research priorities and plan implementation of findings. Local academic teams execute the study following the global study protocol presented here. A quantitative Rule of Halves analysis obtains measures of the magnitude of the diabetes burden, the diagnosis rates in each city and the outcomes of care. A qualitative Diabetes Vulnerability Assessment explores the urban context in vulnerability to type 2 diabetes and identifies social factors and cultural determinants relevant to health, well-being and diabetes. The protocol steers the collection of primary and secondary data across the study sites. Research ethics board approval has been sought and obtained in each site. Findings from each of the local studies as well as the result from combined multisite (global) analyses will be reported in a series of core scientific journal papers. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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Life-threatening asthma and anaphylaxis in schools: a treatment model for school-based programs.
Murphy, Kevin R; Hopp, Russell J; Kittelson, Eleanor B; Hansen, Geri; Windle, Mary L; Walburn, John N
2006-03-01
Pediatric asthma is the No. 1 chronic disease in childhood and is responsible for significant morbidity and mortality. In Nebraska, the number of asthma-related deaths is greater than the national average, and in 1998, 2 students died of acute asthma attacks while attending school in the Omaha public schools (OPSs). In response, we designed and implemented a program to respond to this problem. To implement and study a school-based program for the treatment of life-threatening asthma and anaphylaxis in the OPSs. The Emergency Response to Life-Threatening Asthma or Systemic Allergic Reactions (Anaphylaxis) Protocol was designed and evaluated in 78 OPSs from 1998 to 2003. Nurses and school staff were trained in the protocol, which required the use of nebulized albuterol and/or intramuscular epinephrine in conjunction with an emergency response procedure. Outcomes were measured by improvement in acute care in schools and survival of students. In the 5 years of evaluation, 98 students were treated successfully. One student died. Of those treated with the protocol, equal numbers had at school both asthma action plans (AAPs) and metered-dose inhalers (MDIs), MDIs only, or neither AAPs nor MDIs. As a result of the program, there has been an increased awareness from parents, teachers, and physicians about the necessity of an emergency response program. In 2002, an outcome of the OPS program resulted in the formation of Attack on Asthma Nebraska to ensure that Nebraska schools have the education, training, and medications to respond to anyone experiencing a life-threatening asthma or anaphylaxis attack at school. The following year, a revised protocol was approved by the Nebraska State Board of Education for use in all Nebraska schools. Emergency response protocols provide protection for children while in school. This program should serve as a national model for other school-based programs for children and adolescents with asthma and anaphylaxis.
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Dillman, Jonathan R.; Goodsitt, Mitchell M.; Christodoulou, Emmanuel G.; Keshavarzi, Nahid; Strouse, Peter J.
2014-01-01
Purpose To retrospectively compare image quality and radiation dose between a reduced-dose computed tomographic (CT) protocol that uses model-based iterative reconstruction (MBIR) and a standard-dose CT protocol that uses 30% adaptive statistical iterative reconstruction (ASIR) with filtered back projection. Materials and Methods Institutional review board approval was obtained. Clinical CT images of the chest, abdomen, and pelvis obtained with a reduced-dose protocol were identified. Images were reconstructed with two algorithms: MBIR and 100% ASIR. All subjects had undergone standard-dose CT within the prior year, and the images were reconstructed with 30% ASIR. Reduced- and standard-dose images were evaluated objectively and subjectively. Reduced-dose images were evaluated for lesion detectability. Spatial resolution was assessed in a phantom. Radiation dose was estimated by using volumetric CT dose index (CTDIvol) and calculated size-specific dose estimates (SSDE). A combination of descriptive statistics, analysis of variance, and t tests was used for statistical analysis. Results In the 25 patients who underwent the reduced-dose protocol, mean decrease in CTDIvol was 46% (range, 19%–65%) and mean decrease in SSDE was 44% (range, 19%–64%). Reduced-dose MBIR images had less noise (P > .004). Spatial resolution was superior for reduced-dose MBIR images. Reduced-dose MBIR images were equivalent to standard-dose images for lungs and soft tissues (P > .05) but were inferior for bones (P = .004). Reduced-dose 100% ASIR images were inferior for soft tissues (P < .002), lungs (P < .001), and bones (P < .001). By using the same reduced-dose acquisition, lesion detectability was better (38% [32 of 84 rated lesions]) or the same (62% [52 of 84 rated lesions]) with MBIR as compared with 100% ASIR. Conclusion CT performed with a reduced-dose protocol and MBIR is feasible in the pediatric population, and it maintains diagnostic quality. © RSNA, 2013 Online supplemental material is available for this article. PMID:24091359
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-30
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-32-2013] Approval of Subzone Status; Teva Pharmaceuticals USA, Inc.; North Wales, Chalfont, Kutztown and Sellersville, Pennsylvania On March 18, 2013, the... activation limit of FTZ 35, on behalf of Teva Pharmaceuticals USA, Inc., in North Wales, Chalfont, Kutztown...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-22
.... SUMMARY: EPA is proposing to approve revisions to the Puerto Rico Regulations for the Control of Atmospheric Pollution, submitted to EPA by the Puerto Rico Environmental Quality Board (PREQB) on July 13... de Leon Avenue, Stop 22, Santurce, Puerto Rico 00909. FOR FURTHER INFORMATION CONTACT: Kirk J. Wieber...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-19
... Agreement Between India and the International Atomic Energy Agency Memorandum for the Secretary of State... Government of India and the International Atomic Energy Agency for the Application of Safeguards to Civilian Nuclear Facilities, as approved by the Board of Governors of the International Atomic Energy Agency on...
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46 CFR 108.540 - Survival craft muster and embarkation arrangements.
Code of Federal Regulations, 2013 CFR
2013-10-01
... OFFSHORE DRILLING UNITS DESIGN AND EQUIPMENT Lifesaving Equipment § 108.540 Survival craft muster and... minutes from the time the instruction to board is given. (e) Each davit-launched and free-fall survival... ladder as follows: (1) Each embarkation ladder must be approved under approval series 160.117 or be a...
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12 CFR 208.76 - What Federal Reserve approvals are necessary for financial subsidiaries?
Code of Federal Regulations, 2010 CFR
2010-01-01
... for financial subsidiaries? 208.76 Section 208.76 Banks and Banking FEDERAL RESERVE SYSTEM BOARD OF... SYSTEM (REGULATION H) Financial Subsidiaries of State Member Banks § 208.76 What Federal Reserve approvals are necessary for financial subsidiaries? (a) Notice requirements. (1) A state member bank may not...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-05
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1654] Approval for Expansion of Subzone 22F, Abbott Molecular, Inc. (Pharmaceutical and Molecular Diagnostic Products), Chicago, IL, Area... manufacturing authority on behalf of Abbott Molecular, Inc., within FTZ 22F in Des Plaines and Elk Grove Village...
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14 CFR 125.329 - Minimum altitudes for use of autopilot.
Code of Federal Regulations, 2014 CFR
2014-01-01
... specifications to allow the use, to touchdown, of an approved flight control guidance system with automatic... CAPACITY OF 6,000 POUNDS OR MORE; AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT Flight Operations... than 500 feet or less than twice the maximum altitude loss specified in the approved Airplane Flight...
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14 CFR 125.329 - Minimum altitudes for use of autopilot.
Code of Federal Regulations, 2012 CFR
2012-01-01
... specifications to allow the use, to touchdown, of an approved flight control guidance system with automatic... CAPACITY OF 6,000 POUNDS OR MORE; AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT Flight Operations... than 500 feet or less than twice the maximum altitude loss specified in the approved Airplane Flight...
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14 CFR 125.329 - Minimum altitudes for use of autopilot.
Code of Federal Regulations, 2013 CFR
2013-01-01
... specifications to allow the use, to touchdown, of an approved flight control guidance system with automatic... CAPACITY OF 6,000 POUNDS OR MORE; AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT Flight Operations... than 500 feet or less than twice the maximum altitude loss specified in the approved Airplane Flight...
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14 CFR 125.329 - Minimum altitudes for use of autopilot.
Code of Federal Regulations, 2011 CFR
2011-01-01
... specifications to allow the use, to touchdown, of an approved flight control guidance system with automatic... CAPACITY OF 6,000 POUNDS OR MORE; AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT Flight Operations... than 500 feet or less than twice the maximum altitude loss specified in the approved Airplane Flight...
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14 CFR 125.329 - Minimum altitudes for use of autopilot.
Code of Federal Regulations, 2010 CFR
2010-01-01
... specifications to allow the use, to touchdown, of an approved flight control guidance system with automatic... CAPACITY OF 6,000 POUNDS OR MORE; AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT Flight Operations... than 500 feet or less than twice the maximum altitude loss specified in the approved Airplane Flight...
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21 CFR 56.109 - IRB review of research.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false IRB review of research. 56.109 Section 56.109 Food... REVIEW BOARDS IRB Functions and Operations § 56.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research...
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21 CFR 56.109 - IRB review of research.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 1 2014-04-01 2014-04-01 false IRB review of research. 56.109 Section 56.109 Food... REVIEW BOARDS IRB Functions and Operations § 56.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research...
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15 CFR 400.32 - Procedure for review of request for approval of manufacturing or processing.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 15 Commerce and Foreign Trade 2 2010-01-01 2010-01-01 false Procedure for review of request for approval of manufacturing or processing. 400.32 Section 400.32 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued) FOREIGN-TRADE ZONES BOARD, DEPARTMENT OF COMMERCE...
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78 FR 13625 - Approval of Subzone Status; Sea World, Inc.; Guaynabo, Puerto Rico
Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-28
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-138-2012] Approval of Subzone Status; Sea World, Inc.; Guaynabo, Puerto Rico On December 12, 2012, the Executive Secretary of the Foreign-Trade... Sea World, Inc., in Guaynabo, Puerto Rico. The application was processed in accordance with the FTZ...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-23
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1822] Approval for Manufacturing Authority; Foreign-Trade Zone 177; Hoosier Stamping & Mfg. Corp. (Wheel Assemblies and Accessories); Chandler, IN Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-29
... does states. Enacted in 1967, the New Mexico Air Quality Control Act allowed the establishment of the... approve a revision to the Albuquerque/ Bernalillo County, New Mexico State Implementation Plan (SIP) to... any state. The Albuquerque/ Bernalillo Air Quality Control Board (AQCB) is responsible for the portion...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-21
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1820] Approval for Expansion of Manufacturing Authority, Foreign-Trade Subzone 78A, Nissan North America, Inc. (Electric Passenger Vehicles..., Nissan North America, Inc. (NNA), operator of Subzone 78A, at the NNA manufacturing facilities in Smyrna...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-12
...: (i) To oversee OCC's governance processes; (ii) to approve and oversee OCC's business strategies... place for a number of years, it has not previously submitted those as proposed rule changes pursuant to... accountability, and to align OCC with current best practices in corporate governance. The Board Charter addresses...
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77 FR 48127 - Approval of Subzone Status; Shimadzu USA Manufacturing, Inc., Canby, OR
Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-13
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-52-2012] Approval of Subzone Status; Shimadzu USA Manufacturing, Inc., Canby, OR On May 8, 2012, the Executive Secretary of the Foreign-Trade Zones... subzone status subject to the existing activation limit of FTZ 45, on behalf of Shimadzu USA Manufacturing...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-24
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1669] Approval for Manufacturing Authority, Foreign-Trade Zone 7, CooperVision Caribbean Corporation (Contact Lenses), Juana Diaz, Puerto Rico Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-29
...] Approval and Promulgation of Implementation Plans; California; South Coast; Contingency Measures for 1997...) contingency measure requirements for the 1997 annual and 24-hour national ambient air quality standard (NAAQS... Contingency Measures for the 2007 PM 2.5 SIP'' (dated October 2011), which the California Air Resources Board...
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New Evaluation System Wins Approval
ERIC Educational Resources Information Center
Barrett, Laura
2011-01-01
All Massachusetts school districts will have to adopt new evaluation systems based on a state framework that was approved by the Board of Elementary and Secondary Education on June 28. The new system will be phased in over three years, beginning with Level 4 schools--those designated "underperforming" by the state--in the 2011-12 school…
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-22
..., Incorporated; Order Approving a Proposed Rule Change Relating to Co- Location Service Fees I. Introduction On... to co-location services and related fees. The proposed rule change was published for comment in the... of the equipment to the Exchange's servers, at no additional charge. This ``co-location service...
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30 CFR 944.15 - Approval of Utah regulatory program amendments.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 816/817.61; 850; Memorandum of Agreement between the Board and Division of Oil, Gas, and Mining and... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Approval of Utah regulatory program amendments..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944...
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30 CFR 944.15 - Approval of Utah regulatory program amendments.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 816/817.61; 850; Memorandum of Agreement between the Board and Division of Oil, Gas, and Mining and... 30 Mineral Resources 3 2011-07-01 2011-07-01 false Approval of Utah regulatory program amendments..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944...
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30 CFR 944.15 - Approval of Utah regulatory program amendments.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 816/817.61; 850; Memorandum of Agreement between the Board and Division of Oil, Gas, and Mining and... 30 Mineral Resources 3 2012-07-01 2012-07-01 false Approval of Utah regulatory program amendments..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944...
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30 CFR 944.15 - Approval of Utah regulatory program amendments.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 816/817.61; 850; Memorandum of Agreement between the Board and Division of Oil, Gas, and Mining and... 30 Mineral Resources 3 2013-07-01 2013-07-01 false Approval of Utah regulatory program amendments..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944...
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30 CFR 944.15 - Approval of Utah regulatory program amendments.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 816/817.61; 850; Memorandum of Agreement between the Board and Division of Oil, Gas, and Mining and... 30 Mineral Resources 3 2014-07-01 2014-07-01 false Approval of Utah regulatory program amendments..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-19
... implementation of any SIP provision, the state has responsibility for ensuring adequate implementation of such... Responsibilities of Department. The Montana Board of Environmental Review (BER) oversees the Montana DEQ, including... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R08-OAR-2010-0298; FRL-9308-5] Approval and...
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,; ,; ,; ,
1989-01-01
This gazetteer lists antarctic names approved by the United States Board on Geographic Names and by the Secretary of the Interior. The Board is the interagency body created by law to standardize and promulgate geographic names for official purposes. As the official standard for names in Antarctica, the gazetteer assures accuracy and uniformity for the specialist and the general user alike. Unlike the last (1981) edition, now out of print, the book contains neither historical notes nor textual descriptions of features. The gazetteer contains names of features in Antarctica and the area extending northward to the Antarctic Convergence that have been approved by the Board as recently as mid-1989. It supersedes previous Board gazetteers for the area. For each geographic feature, the book contains the name, cross references if any, and latitude and longitude. Coverage corresponds to that of maps at the scale of 1:250,000 or larger for islands, coastal Antarctica, and mountains and ranges of the continent. Much of the interior of Antarctica, an ice plateau, has been mapped at a smaller scale and is nearly devoid of features and toponyms. All of the names are for natural features; scientific stations are not listed. For the names of submarine features, reference should be made to the Gazetteer of Undersea Features, U.S. Board on Geographic Names (1981).
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Honest broker protocol streamlines research access to data while safeguarding patient privacy.
Silvey, Scott A; Silvey, Scott Andrew; Schulte, Janet; Smaltz, Detlev H; Smaltz, Detlev Herb; Kamal, Jyoti
2008-11-06
At Ohio State University Medical Center, The Honest Broker Protocol provides a streamlined mechanism whereby investigators can obtain de-identified clinical data for non-FDA research without having to invest the significant time and effort necessary to craft a formalized protocol for IRB approval.
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40 CFR 721.4472 - Phenyl, alkyl, hydroxyalkyl substituted imidazole (generic).
Code of Federal Regulations, 2010 CFR
2010-07-01
... percent), and (c). (ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c... protocol. (3) TSCA Good Laboratory Practice Standards at 40 CFR part 792. (4) Using methodologies generally..., the person must obtain approval of test protocols from EPA by submitting written protocols. EPA will...
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Multiprocessor shared-memory information exchange
DOE Office of Scientific and Technical Information (OSTI.GOV)
Santoline, L.L.; Bowers, M.D.; Crew, A.W.
1989-02-01
In distributed microprocessor-based instrumentation and control systems, the inter-and intra-subsystem communication requirements ultimately form the basis for the overall system architecture. This paper describes a software protocol which addresses the intra-subsystem communications problem. Specifically the protocol allows for multiple processors to exchange information via a shared-memory interface. The authors primary goal is to provide a reliable means for information to be exchanged between central application processor boards (masters) and dedicated function processor boards (slaves) in a single computer chassis. The resultant Multiprocessor Shared-Memory Information Exchange (MSMIE) protocol, a standard master-slave shared-memory interface suitable for use in nuclear safety systems, ismore » designed to pass unidirectional buffers of information between the processors while providing a minimum, deterministic cycle time for this data exchange.« less
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Hesseling, P B; Katayi, E; Wharin, P; Bardin, R; Kouya, F; Palmer, D; Glenn, M; Kruger, M
2017-10-31
There is little published information on effective treatment of Kaposi's sarcoma (KS) in children in low-income countries. We prospectively treated 12 patients with an institutional review board-approved protocol consisting of four monthly courses of doxorubicin (Adriamycin), bleomycin and vincristine sulphate (ABV), with highly active antiretroviral therapy (HAART) plus co-trimoxazole prophylaxis for those who were HIV-positive, with additional vincristine if remission was not achieved after 4 months. Maintenance HAART plus co-trimoxazole was given to all HIV-positive patients. A fine-needle aspirate and CD4+ count were done if possible, and staging was performed according to Mitsuyasu. Eight of ten HIV-positive patients with stage III - IVB disease, and both HIV-negative patients with stage I disease, were in remission after 473 - 1 490 (mean 939) days. One patient died after absconding during treatment, and one died from neutropenia-related pulmonary infection. ABV with or without HAART is an effective treatment option for children with KS.