Genetics researchers’ and iRB professionals’ attitudes toward genetic research review: a comparative analysis

Science.gov (United States)

Edwards, Karen L.; Lemke, Amy A.; Trinidad, Susan B.; Lewis, Susan M.; Starks, Helene; Snapinn, Katherine W.; Griffin, Mary Quinn; Wiesner, Georgia L.; Burke, Wylie

2012-01-01

Purpose Genetic research involving human participants can pose challenging questions related to ethical and regulatory standards for research oversight. However, few empirical studies describe how genetic researchers and institutional review board (IRB) professionals conceptualize ethical issues in genetic research or where common ground might exist. Methods Parallel online surveys collected information from human genetic researchers (n = 351) and IRB professionals (n = 208) regarding their views about human participant oversight for genetic protocols. Results A range of opinions were observed within groups on most issues. In both groups, a minority thought it likely that people would be harmed by participation in genetic research or identified from coded genetic data. A majority of both groups agreed that reconsent should be required for four of the six scenarios presented. Statistically significant differences were observed between groups on some issues, with more genetic researcher respondents trusting the confidentiality of coded data, fewer expecting harms from reidentification, and fewer considering reconsent necessary in certain scenarios. Conclusions The range of views observed within and between IRB and genetic researcher groups highlights the complexity and unsettled nature of many ethical issues in genome research. Our findings also identify areas where researcher and IRB views diverge and areas of common ground. PMID:22241102

Local IRBs vs. federal agencies: shifting dynamics, systems, and relationships.

Science.gov (United States)

Klitzman, Robert L

2012-07-01

How IRBs relate to federal agencies, and the implications of these relationships, have received little, if any, systematic study. I interviewed 46 IRB chairs, directors, administrators, and members, contacting the leadership of 60 U.S. IRBs (every fourth one in the list of the top 240 institutions by NIH funding), interviewing IRB leaders from 34 (response rate=55%). IRBs describe complex direct and indirect relationships with federal agencies that affect IRBs through audits, guidance documents, and other communications, and can generate problems and challenges. Researchers often blame IRBs for frustrations, but IRBs often serve as the "local face" of federal regulations and agencies and are "stuck in the middle." These data have critical implications for policy, practice, and research.

14 CFR 1230.107 - IRB membership.

Science.gov (United States)

2010-01-01

... human subjects. In addition to possessing the professional competence necessary to review specific... institutional commitments and regulations, applicable law, and standards of professional conduct and practice... information requested by the IRB. (f) An IRB may, in its discretion, invite individuals with competence in...

Das IRB-Modell des Kreditrisikos im Vergleich zum Modell einer logarithmisch normalverteilten Verlustfunktion

OpenAIRE

Vetter, Michael; Cremers, Heinz

2008-01-01

In 2004 the Basel Committee published an extensive revision of the capital charges which creates more risk sensitive capital requirements for banks. The New Accord called International Convergence of Capital Measurement and Capital Standard provides in its first pillar for a finer measurement of credit risk. Banks that have received supervisory approval to use the Internal Ratings-Based (IRB) approach may rely on their own internal estimates of risk components in determining the capital requi...

34 CFR 97.115 - IRB records.

Science.gov (United States)

2010-07-01

... the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.115 IRB records... in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these...

45 CFR 46.107 - IRB membership.

Science.gov (United States)

2010-10-01

... Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.107 IRB membership. (a) Each IRB shall have... respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition...

A caution to Native American institutional review boards about scientism and censorship.

Science.gov (United States)

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.

40 CFR 26.115 - IRB records.

Science.gov (United States)

2010-07-01

... Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26.115 IRB records... in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these...)(5). (b) The records required by this policy shall be retained for at least 3 years, and records...

Institutional Review Boards: Perspectives from the United States

Directory of Open Access Journals (Sweden)

Alvita Nathaniel, Ph.D., FNP-BC, FAANP

2010-12-01

Full Text Available In the U.S., all research must be approved by an Institutional Review Board (IRB that evaluates research protocols for the purpose of protecting human subjects. This paper includes a brief history of the development of public policy that guides institutional review boards in the U.S. and commentary on the responsibilities of a grounded theory researcher interested in applying for approval for a research study.An institutional review board (IRB is a formally constituted committee that approves and monitors biomedical and behavioural research with the purpose of protecting the rights and welfare of research participants. An IRB performs scientific, ethical, and regulatory oversight functions. In the U.S., it is common for grounded theorists to experience frustration with the IRB protocol submission process. Facets of the application process may seem rigid, redundant, and non-applicable. Review board members may not seem to understand or appreciate qualitative methods and delays are common. In addition, a conglomeration of disparate policies and procedures coupled with a variety of types of review boards creates a system that defies description. Nevertheless, a researcher who understands public policy and the responsibilities of institutional review boards can learn to develop research applications that are quickly approved.

Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board

Directory of Open Access Journals (Sweden)

Isabelle Gautier

2017-08-01

Full Text Available Abstract Background 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. Methods 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. Results 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. Conclusion 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.

7 CFR 1c.107 - IRB membership.

Science.gov (United States)

2010-01-01

... Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.107 IRB membership. (a) Each IRB... promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In... knowledgeable about and experienced in working with these subjects. (b) Every nondiscriminatory effort will be...

Working with the institutional review board.

Science.gov (United States)

Byerly, Wesley G

2009-01-15

Working with an institutional review board (IRB) to ensure compliance and ethical conduct of research involving human subjects is discussed. The Department of Health and Human Services (DHHS) and Food and Drug Administration regulations for the conduct of human research are grounded in the principles of the Belmont Report. By establishing the requirements for the function and operation of the IRB, the criteria needed for the review and approval of research, and the requirements for obtaining and documenting informed consent, the federal regulations help ensure the safety, rights and welfare of subjects. In developing research protocols and submissions to the IRB, the investigator should include clear, detailed information that addresses the regulatory requirements for the review and approval of research. Before starting a research study, review and approval by the IRB is required unless the study is determined to be minimal risk and fits one of the defined categories. Some research projects involving observation of public behavior, collection of anonymous surveys of nonvulnerable individuals in which the information is not considered sensitive, and evaluation of standard education practices may be exempt from DHHS regulations. Informed consent is central to the protection of human subjects and is required unless the IRB allows a waiver or alteration of informed consent. Once the study is approved, the investigator must conduct the study as approved by the IRB and continue to meet the regulatory requirements related to modifications, reporting unanticipated events, and continuing review. IRB review is integral to ensuring regulatory compliance and ethical conduct of research involving human subjects. Working closely with the IRB or colleagues who have had experience with the IRB will help junior investigators better understand the IRB submission and review process.

From anonymity to "open doors": IRB responses to tensions with researchers.

Science.gov (United States)

Klitzman, Robert

2012-07-03

Tensions between IRBs and researchers in the US and elsewhere have increased, and may affect whether, how, and to what degree researchers comply with ethical guidelines. Yet whether, how, when, and why IRBs respond to these conflicts have received little systematic attention. I contacted 60 US IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed leaders from 34 (response rate = 55%) and an additional 12 members and administrators. IRBs often try to respond to tensions with researchers and improve relationships in several ways, but range widely in how, when, and to what degree (e.g., in formal and informal structure, content, and tone of interactions). IRBs varied from open and accessible to more distant and anonymous, and in the amount and type of "PR work" and outreach they do. Many boards seek to improve the quantity, quality, and helpfulness of communication with PIs, but differ in how. IRBs range in meetings from open to closed, and may have clinics and newsletters. Memos can vary in helpfulness and tone (e.g., using "charm"). IRBs range considerably, too, in the degrees to which they seek to educate PIs, showing them the underlying ethical principles. But these efforts take time and resources, and IRBs thus vary in degrees of responses to PI complaints. This study, the first to explore the mechanisms through which IRBs respond to tensions and interactions with PIs, suggests that these committees seek to respond to conflicts with PIs in varying ways - both formal and informal, involving both the form and content of communications. This study has important implications for future practice, research, and policy, suggesting needs for increased attention to not only what IRBs communicate to PIs, but how (i.e., the tone and the nature of interactions). IRBs can potentially improve relationships with PIs in several ways: using more "open doors" rather than anonymity, engaging in outreach (e.g., through clinics), enhancing

40 CFR 26.109 - IRB review of research.

Science.gov (United States)

2010-07-01

... 26.109 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26.109 IRB... subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights...

40 CFR 26.1108 - IRB functions and operations.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false IRB functions and operations. 26.1108 Section 26.1108 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN... Exposure of Non-pregnant, Non-nursing Adults § 26.1108 IRB functions and operations. In order to fulfill...

34 CFR 97.109 - IRB review of research.

Science.gov (United States)

2010-07-01

... Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.109 IRB review... subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights...

Cyclin E1 as a Therapeutic Target in Women with High Grade Serous Ovarian Cancer and Primary Treatment Failure

Science.gov (United States)

2016-09-01

Subtask 1: Submit documents for local IRB and Animal Ethics review. • Submission of institution approved animal protocols and related material for DoD’s...laboratories have submitted animal ethics protocols and received approval from their respective Animal Ethics Committees (Appendix B & Appendix C...targeted ES cells identified positive clones as indicated by the black arrows; (B) chimera mice identified successful germline transmission as

IRB PERSPECTIVES ON THE RETURN OF INDIVIDUAL RESULTS FROM GENOMIC RESEARCH

Science.gov (United States)

Dressler, Lynn G.; Smolek, Sondra; Ponsaran, Roselle; Markey, Janell M.; Starks, Helene; Gerson, Nancy; Lewis, Susan; Press, Nancy; Juengst, Eric; Wiesner, Georgia L.

2012-01-01

Purpose Return of individual research results from genomic studies is a hotly debated ethical issue in genomic research. However, the perspective of key stakeholders—Institutional Review Board (IRB) reviewers—has been missing from this dialogue. This study explores the positions and experiences of IRB members and staff regarding this issue. Methods In depth interviews with 31 IRB professionals at six sites across the United States. Results IRB professionals agreed that research results should be returned to research participants when results are medically actionable but only if the participants wanted to know the result. Many respondents expected researchers to address the issue of return of results (ROR) in the IRB application and informed-consent document. Many respondents were not comfortable with their expertise in genomics research, and only a few described actual experiences in addressing ROR. Although participants agreed that guidelines would be helpful, most were reticent to develop them in isolation. Even where IRB guidance exists (e.g., CLIA lab certification required for return), in practice, the guidance has been overruled to allow return (e.g., no CLIA lab performs the assay). Conclusion An IRB-researcher partnership is needed to help inform responsible and feasible institutional approaches to returning research results. PMID:22241094

How IRBs view and make decisions about coercion and undue influence.

Science.gov (United States)

Klitzman, Robert

2013-04-01

Scholars have debated how to define coercion and undue influence, but how institutional review boards (IRBs) view and make decisions about these issues in actual cases has not been explored. I contacted the leadership of 60 US IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health funding), and interviewed 39 IRB leaders or administrators from 34 of these institutions (response rate=55%), and 7 members. IRBs wrestled with defining of 'coercion' and 'undue inducement', most notably in deciding about participant compensation. IRBs often use these terms synonymously and define undue inducement in varying ways, often wrestling with these issues, relying on 'gut feelings', and seeking compromises. Ambiguities arose, partly reflecting underlying tensions: whether subjects should 'get paid' versus 'volunteer' (ie, whether subjects should be motivated by compensation vs altruism), and whether subjects should be paid differently based on income, given possible resultant selection bias. Lack of consistent standards emerged between and even on single IRBs. Questions arose concerning certain aspects and types of studies; for example, how to view and weigh providing free care in research, whether and how recruitment flyers should mention compensation, and how to avoid coercion in paediatric, developing world, or students research. These data, the first to probe qualitatively how IRBs view and approach questions about coercion, undue influence and participant compensation, and to examine how IRBs have reviewed actual cases, reveal several critical ambiguities and dilemmas, and have vital implications for future practice, education, policy and research.

Structural, mechanical, and electronic properties of TaB2, TaB, IrB2, and IrB: First-principle calculations

International Nuclear Information System (INIS)

Zhao Wenjie; Wang Yuanxu

2009-01-01

First-principle calculations were performed to investigate the structural, elastic, and electronic properties of TaB 2 , TaB, IrB 2 , and IrB. The calculated equilibrium structural parameters, shear modulus, and Young's modulus of TaB 2 are well consistent with the available experimental data, and TaB 2 with P6/mmm space group has stronger directional bonding between ions than WB 2 , OsB 2 , IrN 2 , and PtN 2 . For TaB 2 , the hexagonal P6/mmm structure is more stable than the orthorhombic Pmmn one, while for IrB 2 the orthorhombic Pmmn structure is the most stable one. The high shear modulus of P6/mmm phase TaB 2 is mainly due to the strong covalent π-bonding of B-hexagon in the (0001) plane. Such a B-hexagon network can strongly resist against an applied [112-bar0] (0001) shear deformation. Correlation between the hardness and the elastic constants of TaB 2 was discussed. The band structure shows that P6/mmm phase TaB 2 and Pmmn phase IrB 2 are both metallic. The calculations show that both TaB and IrB are elastically stable with the hexagonal P6 3 /mmc structure. - Elastic constant c 44 of TaB 2 is calculated to be 235 GPa. This value is exceptionally high, exceeding those of WB 2 , OsB 2 , WB 4 , OsN 2 , IrN 2 , and PtN 2 .

From anonymity to “open doors”: IRB responses to tensions with researchers

Directory of Open Access Journals (Sweden)

Klitzman Robert

2012-07-01

Full Text Available Abstract Background Tensions between IRBs and researchers in the US and elsewhere have increased, and may affect whether, how, and to what degree researchers comply with ethical guidelines. Yet whether, how, when, and why IRBs respond to these conflicts have received little systematic attention. Findings I contacted 60 US IRBs (every fourth one in the list of the top 240 institutions by NIH funding, and interviewed leaders from 34 (response rate = 55% and an additional 12 members and administrators. IRBs often try to respond to tensions with researchers and improve relationships in several ways, but range widely in how, when, and to what degree (e.g., in formal and informal structure, content, and tone of interactions. IRBs varied from open and accessible to more distant and anonymous, and in the amount and type of “PR work” and outreach they do. Many boards seek to improve the quantity, quality, and helpfulness of communication with PIs, but differ in how. IRBs range in meetings from open to closed, and may have clinics and newsletters. Memos can vary in helpfulness and tone (e.g., using “charm”. IRBs range considerably, too, in the degrees to which they seek to educate PIs, showing them the underlying ethical principles. But these efforts take time and resources, and IRBs thus vary in degrees of responses to PI complaints. Conclusions This study, the first to explore the mechanisms through which IRBs respond to tensions and interactions with PIs, suggests that these committees seek to respond to conflicts with PIs in varying ways – both formal and informal, involving both the form and content of communications. This study has important implications for future practice, research, and policy, suggesting needs for increased attention to not only what IRBs communicate to PIs, but how (i.e., the tone and the nature of interactions. IRBs can potentially improve relationships with PIs in several ways: using more “open doors” rather

Potential North American Clinical Trials Network (NACTN) for Treatment of Spinal Cord Injury: A Consortium of Military, Veterans Administration, and Civilian Hospitals

National Research Council Canada - National Science Library

Grossman, Robert G

2008-01-01

.... In anticipation of approval, all NACTN personnel met in February 2008 to discuss the riluzole protocol/safety study, and the centers are working with local IRBs and ORP to fulfill all regulatory...

Sustaining engagement and partnership: model of enhancing cultural capital among nonaffiliated IRB members.

Science.gov (United States)

Hung, Yvonne; Ayala, Armida; Morales, Francisco; Frierman-Hunt, Gina; Moreno, Alva; Nwachuku, Ijeoma

2013-07-01

Although federal regulations require the presence of at least one nonaffiliated member on the roster of an institutional review board (IRB), little research exists about how to foster their participation and satisfaction. Guided by principles of justice and diversity, the Kaiser Permanente Southern California IRB adapted the sociological concept of "cultural capital" to develop training and support with its nonaffiliated IRB members. Using in-depth qualitative interviews with four past and current nonaffiliated IRB members, we describe how our initial and ongoing activities enhanced their ability to analyze, communicate, and complete the ethical review of research. This case study is situated in the gaps of existing research about nonaffiliated IRB members by providing insights into how to sustain their engagement while protecting the rights of research volunteers, particularly from vulnerable communities.

An IRB Transformation: Increasing Quality and Efficiency Using Existing Resources

Science.gov (United States)

Andrews, Joseph E., Jr.; Moore, J. Brian; Means, Paula; Weinberg, Richard

2012-01-01

In an effort to increase review-quality and efficiency, research administration at Wake Forest School of Medicine initiated a change in the operational structure of the Institutional Review Board (IRB) via a reconfiguring of the boards and rescheduling of the convened meetings. The number of IRB Panels was doubled and each panel/board began…

Ethical Considerations Related to Return of Results from Genomic Medicine Projects: The eMERGE Network (Phase III) Experience

Science.gov (United States)

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

An Analysis of Information Technology Adoption by IRBs of Large Academic Medical Centers in the United States.

Science.gov (United States)

He, Shan; Botkin, Jeffrey R; Hurdle, John F

2015-02-01

The clinical research landscape has changed dramatically in recent years in terms of both volume and complexity. This poses new challenges for Institutional Review Boards' (IRBs) review efficiency and quality, especially at large academic medical centers. This article discusses the technical facets of IRB modernization. We analyzed the information technology used by IRBs in large academic institutions across the United States. We found that large academic medical centers have a high electronic IRB adoption rate; however, the capabilities of electronic IRB systems vary greatly. We discuss potential use-cases of a fully exploited electronic IRB system that promise to streamline the clinical research work flow. The key to that approach utilizes a structured and standardized information model for the IRB application. © The Author(s) 2014.

Optimization of Influenza Antiviral Response in Texas

Science.gov (United States)

2015-03-01

or the U.S. Govemment. IRB Protocol number __ N/ A __ . 12a. DISTRIBUTION I AVAILABILITY STATEMENT Approved for public release: distribution is...child care facilities, home isolation, cough etiquette , hand washing, use of personal protective equipment, and vaccinations. They used measures of

32 CFR 219.107 - IRB membership.

Science.gov (United States)

2010-07-01

... counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the... subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons... IRB consists entirely of men or entirely of women, including the institution's consideration of...

10 CFR 745.107 - IRB membership.

Science.gov (United States)

2010-01-01

... advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing... subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons... IRB consists entirely of men or entirely of women, including the institution's consideration of...

22 CFR 225.107 - IRB membership.

Science.gov (United States)

2010-04-01

... Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF HUMAN SUBJECTS § 225.107 IRB membership. (a..., to promote respect for its advice and counsel in safeguarding the rights and welfare of human... individuals who are knowledgeable about and experienced in working with these subjects. (b) Every...

16 CFR 1028.107 - IRB membership.

Science.gov (United States)

2010-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.107 IRB..., to promote respect for its advice and counsel in safeguarding the rights and welfare of human... individuals who are knowledgeable about and experienced in working with these subjects. (b) Every...

28 CFR 46.107 - IRB membership.

Science.gov (United States)

2010-07-01

... Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.107 IRB..., to promote respect for its advice and counsel in safeguarding the rights and welfare of human... individuals who are knowledgeable about and experienced in working with these subjects. (b) Every...

The Effect of Computer Automation on Institutional Review Board (IRB) Office Efficiency

Science.gov (United States)

Oder, Karl; Pittman, Stephanie

2015-01-01

Companies purchase computer systems to make their processes more efficient through automation. Some academic medical centers (AMC) have purchased computer systems for their institutional review boards (IRB) to increase efficiency and compliance with regulations. IRB computer systems are expensive to purchase, deploy, and maintain. An AMC should…

Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.

Directory of Open Access Journals (Sweden)

Anette Blümle

Full Text Available Many clinical studies are ultimately not fully published in peer-reviewed journals. Underreporting of clinical research is wasteful and can result in biased estimates of treatment effect or harm, leading to recommendations that are inappropriate or even dangerous.We assembled a cohort of clinical studies approved 2000-2002 by the Research Ethics Committee of the University of Freiburg, Germany. Published full articles were searched in electronic databases and investigators contacted. Data on study characteristics were extracted from protocols and corresponding publications. We characterized the cohort, quantified its publication outcome and compared protocols and publications for selected aspects.Of 917 approved studies, 807 were started and 110 were not, either locally or as a whole. Of the started studies, 576 (71% were completed according to protocol, 128 (16% discontinued and 42 (5% are still ongoing; for 61 (8% there was no information about their course. We identified 782 full publications corresponding to 419 of the 807 initiated studies; the publication proportion was 52% (95% CI: 0.48-0.55. Study design was not significantly associated with subsequent publication. Multicentre status, international collaboration, large sample size and commercial or non-commercial funding were positively associated with subsequent publication. Commercial funding was mentioned in 203 (48% protocols and in 205 (49% of the publications. In most published studies (339; 81% this information corresponded between protocol and publication. Most studies were published in English (367; 88%; some in German (25; 6% or both languages (27; 6%. The local investigators were listed as (co-authors in the publications corresponding to 259 (62% studies.Half of the clinical research conducted at a large German university medical centre remains unpublished; future research is built on an incomplete database. Research resources are likely wasted as neither health care

40 CFR 26.107 - IRB membership.

Science.gov (United States)

2010-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26.107 IRB membership..., to promote respect for its advice and counsel in safeguarding the rights and welfare of human...

34 CFR 97.107 - IRB membership.

Science.gov (United States)

2010-07-01

... of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.107 IRB..., to promote respect for its advice and counsel in safeguarding the rights and welfare of human...

49 CFR 11.107 - IRB membership.

Science.gov (United States)

2010-10-01

... Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.107 IRB membership. (a..., to promote respect for its advice and counsel in safeguarding the rights and welfare of human... individuals who are knowledgeable about and experienced in working with these subjects. (b) Every...

15 CFR 27.107 - IRB membership.

Science.gov (United States)

2010-01-01

... Commerce and Foreign Trade Office of the Secretary of Commerce PROTECTION OF HUMAN SUBJECTS § 27.107 IRB..., to promote respect for its advice and counsel in safeguarding the rights and welfare of human... individuals who are knowledgeable about and experienced in working with these subjects. (b) Every...

The Ideals of Today’s Modernizing People’s Liberation Army

Science.gov (United States)

2010-06-01

Government. IRB Protocol number ___N/A_____________. 12a. DISTRIBUTION / AVAILABILITY STATEMENT Approved for public release; distribution is unlimited...was a tutor and teacher for the children of the de facto ruler of Lu, Meng Xizi, where he taught ritual etiquette observed at state religious...appropriately to one’s circumstances and role. One must observe the proper rituals, ceremonies, and protocols to promote social cohesion and individual

Treatment of Social Competence in Military Veterans, Service Members, and Civilians with Traumatic Brain Injury

Science.gov (United States)

2012-08-01

study design, measures, and interventions were finalized, IRB approvals were received for all sites, the data dictionary and project protocols were...regulatory applications per site: COMPLETE T3: Prepare data dictionary/syllabus & project protocols : COMPLETE T4: Finalize training agenda and...54 is too informal . . . the subject’s style of communication lacks suitable propriety, or conformity to etiquette , or precision of custom. 55

45 CFR 46.407 - Research not otherwise approvable which presents an opportunity to understand, prevent, or...

Science.gov (United States)

2010-10-01

... an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare... § 46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or...) The IRB finds that the research presents a reasonable opportunity to further the understanding...

45 CFR 46.115 - IRB records.

Science.gov (United States)

2010-10-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy... injuries to subjects. (2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at... findings provided to subjects, as required by § 46.116(b)(5). (b) The records required by this policy shall...

Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research.

Science.gov (United States)

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.

Public service quality improvements: a case for exemption from IRB review of public administration research.

Science.gov (United States)

Jordan, Sara R

2014-01-01

Should the exemption from Institutional Review Board (IRB) evaluations currently in place for quality improvements research be extended to public administration research that addresses questions of improving the quality of public service delivery? As a means to both reduce the level of disdain held by a group of social science researchers for IRBs and to reduce the cost of review for minimal risk studies, I argue here that much of the current public administration research should also be exempted from normal processes of review by IRBs on the basis of their similarity to Quality Improvements (QI) research, a category of studies already granted exemption. This argument dovetails provisions currently in place for studies of public service and public benefit, but reframes these exemptions in the language of "quality improvements," which may be a more comfortable language for IRBs concerned to demonstrate compliance for review of all fields. To expedite this argument into the practices of IRBs, I included a checklist that researchers could use to self-identify their studies as QI, not research as such.

40 CFR 26.1109 - IRB review of research.

Science.gov (United States)

2010-07-01

... 26.1109 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional... meaningfully add to the protection of the rights and welfare of subjects. (c) An IRB shall require...

Acupuncture Antiarrhythmic Effects on Drug Refractory Persistent Atrial Fibrillation: Study Protocol for a Randomized, Controlled Trial

Directory of Open Access Journals (Sweden)

Jimin Park

2015-01-01

Full Text Available Background. Atrial fibrillation (AF is the most common form of arrhythmia. Several trials have suggested that acupuncture may prevent AF. However, the efficacy of acupuncture for AF prevention has not been well investigated. Therefore, we designed a prospective, two-parallel-armed, participant and assessor blinded, randomized, sham-controlled clinical trial to investigate acupuncture in persistent AF (ACU-AF. Methods. A total of 80 participants will be randomly assigned to active acupuncture or sham acupuncture groups in a 1 : 1 ratio. Both groups will take the same antiarrhythmic medication during the study period. Patients will receive 10 sessions of acupuncture treatment once a week for 10 weeks. The primary endpoint is AF recurrence rate. Secondary endpoints are left atrium (LA and left atrial appendage (LAA changes in function and volume, and inflammatory biomarker changes. Ethics. This study protocol was approved by the institutional review boards (IRBs of Kyung Hee University Hospital (number 1335-04. This trial is registered with clinicaltrials.gov NCT02110537.

Study protocol of a pragmatic, randomised controlled pilot trial: clinical effectiveness on smoking cessation of traditional and complementary medicine interventions, including acupuncture and aromatherapy, in combination with nicotine replacement therapy

Science.gov (United States)

Jang, Soobin; Park, Sunju; Jang, Bo-Hyoung; Park, Yu Lee; Lee, Ju Ah; Cho, Chung-Sik; Go, Ho-Yeon; Shin, Yong Cheol; Ko, Seong-Gyu

2017-01-01

Introduction Nicotine dependence is a disease, and tobacco use is related to 6 million deaths annually worldwide. Recently, in many countries, there has been growing interest in the use of traditional and complementary medicine (T&CM) methods, especially acupuncture, as therapeutic interventions for smoking cessation. The aim of this pilot study is to investigate the effectiveness of T&CM interventions on smoking cessation. Methods and analysis The STOP (Stop Tobacco Programme using traditional Korean medicine) study is designed to be a pragmatic, open-label, randomised pilot trial. This trial will evaluate whether adding T&CM methods (ie, ear and body acupuncture, aromatherapy) to conventional cessation methods (ie, nicotine replacement therapy (NRT), counselling) increases smoking cessation rates. Forty participants over 19 years old who are capable of communicating in Korean will be recruited. They will be current smokers who meet one of the following criteria: (1) smoke more than 10 cigarettes a day, (2) smoke less than 10 cigarettes a day and previously failed to cease smoking, or (3) smoke fewer than 10 cigarettes a day and have a nicotine dependence score (Fagerstrom Test for Nicotine Dependence) of 4 points or more. The trial will consist of 4 weeks of treatment and a 20 week follow-up period. A statistician will perform the statistical analyses for both the intention-to-treat (all randomly assigned participants) and per-protocol (participants who completed the trial without any protocol deviations) data using SAS 9.1.3. Ethics and dissemination This study has been approved by the Institutional Review Board (IRB) of the Dunsan Korean Medicine Hospital of Daejeon University (IRB reference no: DJDSKH-15-BM-11–1, Protocol No. version 4.1.).The protocol will be reapproved by IRB if it requires amendment. The trial will be conducted according to the Declaration of Helsinki, 7th version (2013). This study is designed to minimise the risk to participants

Time required for institutional review board review at one Veterans Affairs medical center.

Science.gov (United States)

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

45 CFR 46.109 - IRB review of research.

Science.gov (United States)

2010-10-01

... Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.109 IRB review of research. (a) An... judgment the information would meaningfully add to the protection of the rights and welfare of subjects. (c...

Integración del brazo robot IRB120 en entorno ROS-MATLAB

OpenAIRE

Gómez Cuadrado, José Manuel

2017-01-01

Este proyecto usa el entorno ROS (Robot Operating System) para desarrollar el control del brazo robot IRB 120 y su implementación en el entorno de trabajo MATLAB. Se explicará la creación del modelo del robot, la planificación de trayectorias y la comunicación con dicho robot. This project uses the ROS (Robot Operating System) environment for developing the control of the IRB 120 robotic arm and its implementation in the MATLAB working environment. It will explain the creation of the...

Joint protocol relating to the application of the Vienna Convention and the Paris Convention. Signature, ratification, acceptance, approval or accession. Status as of 31 December 1996

International Nuclear Information System (INIS)

1997-01-01

The document presents the status of signature, ratification, acceptance, approval or accession of the Joint Protocol Relating to the Application of the Vienna Convention and the Paris Convention as of 31 December 1996. The Joint Protocol entered into force on 27 April 1992

Joint protocol relating to the application of the Vienna Convention and the Paris Convention. Signature, ratification, acceptance, approval or accession. Status as of 31 December 1996

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-02-28

The document presents the status of signature, ratification, acceptance, approval or accession of the Joint Protocol Relating to the Application of the Vienna Convention and the Paris Convention as of 31 December 1996. The Joint Protocol entered into force on 27 April 1992.

Adrift in the Gray Zone: IRB Perspectives on Research in the Learning Health System.

Science.gov (United States)

Lee, Sandra Soo-Jin; Kelley, Maureen; Cho, Mildred K; Kraft, Stephanie Alessi; James, Cyan; Constantine, Melissa; Meyer, Adrienne N; Diekema, Douglas; Capron, Alexander M; Wilfond, Benjamin S; Magnus, David

2016-01-01

Human subjects protection in healthcare contexts rests on the premise that a principled boundary distinguishes clinical research and clinical practice. However, growing use of evidence-based clinical practices by health systems makes it increasingly difficult to disentangle research from a wide range of clinical activities that are sometimes called "research on medical practice" (ROMP), including quality improvement activities and comparative effectiveness research. The recent growth of ROMP activities has created an ethical and regulatory gray zone with significant implications for the oversight of human subjects research. We conducted six semi-structured, open-ended focus group discussions with IRB members to understand their experiences and perspectives on ethical oversight of ROMP, including randomization of patients to standard treatments. Our study revealed that IRB members are unclear or divided on the central questions at stake in the current policy debate over ethical oversight of ROMP: IRB members struggle to make a clear distinction between clinical research and medical practice improvement, lack consensus on when ROMP requires IRB review and oversight, and are uncertain about what constitutes incremental risk when patients are randomized to different treatments, any of which may be offered in usual care. They characterized the central challenge as a balancing act, between, on the one hand, making information fully transparent to patients and providing adequate oversight, and on the other hand, avoiding a chilling effect on the research process or harming the physician-patient relationship. Evidence-based guidance that supports IRB members in providing adequate and effective oversight of ROMP without impeding the research process or harming the physician-patient relationship is necessary to realize the full benefits of the learning health system.

Joint protocol relating to the application of the Vienna Convention and the Paris Convention. Status list as of 12 September 2000. Signature, ratification, acceptance, approval or accession

International Nuclear Information System (INIS)

2000-01-01

The document presents the status of signature, ratification, acceptance, approval or accession of the Joint Protocol Relating to the Application of the Vienna Convention and the Paris Convention as of 12 September 2000. The Joint Protocol entered into force on 27 April 1992

Joint Protocol relating to the application of the Vienna Convention and the Paris Convention. Status list as of 30 September 2002. Signature, ratification, acceptance, approval or accession

International Nuclear Information System (INIS)

2002-01-01

The document presents the status of signature, ratification, acceptance, approval or accession of the Joint Protocol Relating to the Application of the Vienna Convention and the Paris Convention as of 30 September 2002. The Joint Protocol entered into force on 27 April 1992

A Brownian Bridge Movement Model to Track Mobile Targets

Science.gov (United States)

2016-09-01

Defense or the U.S. Government . IRB Protocol number ____N/A____. 12a. DISTRIBUTION / AVAILABILITY STATEMENT Approved for public release. Distribution...attributes and the probability of detection is explored through a meta -experiment. The experiment utilizes a three-stage algorithm that generates heat maps...explored through a meta -experiment. The experiment utilizes a three-stage algorithm that generates heat maps, deploys sensors and randomizes intelligence

Study protocol of a pragmatic, randomised controlled pilot trial: clinical effectiveness on smoking cessation of traditional and complementary medicine interventions, including acupuncture and aromatherapy, in combination with nicotine replacement therapy.

Science.gov (United States)

Jang, Soobin; Park, Sunju; Jang, Bo-Hyoung; Park, Yu Lee; Lee, Ju Ah; Cho, Chung-Sik; Go, Ho-Yeon; Shin, Yong Cheol; Ko, Seong-Gyu

2017-06-02

Nicotine dependence is a disease, and tobacco use is related to 6 million deaths annually worldwide. Recently, in many countries, there has been growing interest in the use of traditional and complementary medicine (T&CM) methods, especially acupuncture, as therapeutic interventions for smoking cessation. The aim of this pilot study is to investigate the effectiveness of T&CM interventions on smoking cessation. The STOP (Stop Tobacco Programme using traditional Korean medicine) study is designed to be a pragmatic, open-label, randomised pilot trial. This trial will evaluate whether adding T&CM methods (ie, ear and body acupuncture, aromatherapy) to conventional cessation methods (ie, nicotine replacement therapy (NRT), counselling) increases smoking cessation rates. Forty participants over 19 years old who are capable of communicating in Korean will be recruited. They will be current smokers who meet one of the following criteria: (1) smoke more than 10 cigarettes a day, (2) smoke less than 10 cigarettes a day and previously failed to cease smoking, or (3) smoke fewer than 10 cigarettes a day and have a nicotine dependence score (Fagerstrom Test for Nicotine Dependence) of 4 points or more. The trial will consist of 4 weeks of treatment and a 20 week follow-up period. A statistician will perform the statistical analyses for both the intention-to-treat (all randomly assigned participants) and per-protocol (participants who completed the trial without any protocol deviations) data using SAS 9.1.3. This study has been approved by the Institutional Review Board (IRB) of the Dunsan Korean Medicine Hospital of Daejeon University (IRB reference no: DJDSKH-15-BM-11-1, Protocol No. version 4.1.).The protocol will be reapproved by IRB if it requires amendment. The trial will be conducted according to the Declaration of Helsinki, 7th version (2013). This study is designed to minimise the risk to participants, and the investigators will explain the study to the

Bond deformation paths and electronic instabilities of ultraincompressible transition metal diborides: Case study of OsB2 and IrB2

Science.gov (United States)

Zhang, R. F.; Legut, D.; Wen, X. D.; Veprek, S.; Rajan, K.; Lookman, T.; Mao, H. K.; Zhao, Y. S.

2014-09-01

The energetically most stable orthorhombic structure of OsB2 and IrB2 is dynamically stable for OsB2 but unstable for IrB2. Both diborides have substantially lower shear strength in their easy slip systems than their metal counterparts. This is attributed to an easy sliding facilitated by out-of-plane weakening of metallic Os-Os bonds in OsB2 and by an in-plane bond splitting instability in IrB2. A much higher shear resistance of Os-B and B-B bonds than Os-Os ones is found, suggesting that the strengthened Os-B and B-B bonds are responsible for hardness enhancement in OsB2. In contrast, an in-plane electronic instability in IrB2 limits its strength. The electronic structure of deformed diborides suggests that the electronic instabilities of 5d orbitals are their origin of different bond deformation paths. Neither IrB2 nor OsB2 can be intrinsically superhard.

Validation of Functional Reaching Volume as an Outcome Measure across the Spectrum of Abilities in Muscular Dystrophy

Science.gov (United States)

2017-09-01

refinement of the Soliton software is underway to reassess the utility of Solitons in conjunction with ACTIVE. 15. SUBJECT TERMS 16. SECURITY CLASSIFICATION...Solitons in conjunction with ACTIVE. i. Gain local IRB approval for soliton use with ACTIVE The IRB at Nationwide Children’s Hospital granted...approval to allow the use of Solitons in conjunction with the ACTIVE system on 25 February 2016. ii. Gain local IRB approval for verbal consent after

Geophysical anomalies associated with Imjin River Belt (IRB) in the middle Korean Peninsula revealed by geomagnetic depth sounding and seismological data

Science.gov (United States)

Yang, J.; Choi, H.; Noh, M.; Im, C.

2012-12-01

Imjin River Belt (IRB), located in the middle of the Korean Peninsula, has been one of long-standing geological issues because it is a very important tectonic link to understand a tectonic evolution of north-eastern Asia including China, Korea and Japan. Although the IRB has been considered as an extension of collision belt between the North China Block (NCB) and South China Block (SCB), there is little geophysical observation or study on this issue. In recent, we compiled a new induction arrow map for the Korean Peninsula, on the basis of long-period magneto-telluric (MT) data and the geomagnetic depth sounding data performed since the late 1990's. This newly compiled map has finer spatial resolution expecially in the middle area of the peninsula, which helps us to present the geophysical evidence that the IRB is the continuation or extension of the collision belt to the peninsula. The overall pattern of induction arrows in the peninsula appears to indicate a northwest-southeast direction, which is well-known 'sea effect' by the surrounding seas. However, the results of observations in the middle of the peninsula distinctly show an anomalous pattern around the IRB, which can not be explained only by the surrounding seas. This anomalous pattern may be attributed to enhanced conductivity associated with tectonic events that Imjin River Belt has experienced. The 3-D electromagnetic modeling results, considering both surrounding seas and enhanced conductivity of the IRB, explain well the anomalous observations around the IRB. Furthermore, recent seismological study demonstrates that focal mechanism around the IRB is mainly normal faulting event, which may be interpreted as the reactivation of paleo structures that are related to the post collisional lithospheric delamination. All the geophysical evidences convince us that the IRB is an extension of the collision belt between the NCB and SCB to the peninsula.

Researcher liability for negligence in human subject research: informed consent and researcher malpractice actions.

Science.gov (United States)

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.

Navigating the Process of Ethical Approval: A methodological note

Directory of Open Access Journals (Sweden)

Eileen Carey, RNID, BSc. (hons, MSc.

2010-12-01

Full Text Available Classic grounded theory (CGT methodology is a general methodology whereby the researcher aims to develop an emergent conceptual theory from empirical data collected by the researcher during the research study. Gaining ethical approval from relevant ethics committees to access such data is the starting point for processing a CGT study. The adoption of the Universal Declaration on Bioethics and Human Rights (UNESCO, 2005 is an indication of global consensus on the importance of research ethics. There is, however, a wide variation of health research systems across countries and disciplines (Hearnshaw 2004. Institutional Research Boards (IRB or Research Ethics Committees (REC have been established in many countries to regulate ethical research ensuring that researchers agree to, and adhere to, specific ethical and methodological conditions prior to ethical approval being granted. Interestingly, both the processes and outcomes through which the methodological aspects pertinent to CGT studies are agreed between the researcher and ethics committee remain largely ambiguous and vague. Therefore, meeting the requirements for ethical approval from ethics committees, while enlisting the CGT methodology as a chosen research approach, can be daunting for novice researchers embarking upon their first CGT study.

Transformation impacts of dissolved and solid phase Fe(II) on trichloroethylene (TCE) reduction in an iron-reducing bacteria (IRB) mixed column system: a mathematical model.

Science.gov (United States)

Bae, Yeunook; Kim, Dooil; Cho, Hyun-Hee; Singhal, Naresh; Park, Jae-Woo

2012-12-01

In this research, we conducted trichloroethylene (TCE) reduction in a column filled with iron and iron-reducing bacteria (IRB) and developed a mathematical model to investigate the critical reactions between active species in iron/IRB/contaminant systems. The formation of ferrous iron (Fe(II)) in this system with IRB and zero-valent iron (ZVI, Fe(0)) coated with a ferric iron (Fe(III)) crust significantly affected TCE reduction and IRB respiration in various ways. This study presents a new framework for transformation property and reducing ability of both dissolved (Fe(II)(dissolved)) and solid form ferrous iron (Fe(II)(solid)). Results showed that TCE reduction was strongly depressed by Fe(II)(solid) rather than by other inhibitors (e.g., Fe(III) and lactate), suggesting that Fe(II)(solid) might reduce IRB activation due to attachment to IRB cells. Newly exposed Fe(0) from the released Fe(II)(dissolved) was a strong contributor to TCE reduction compared to Fe(II)(solid). In addition, our research confirmed that less Fe(II)(solid) production strongly supported long-term TCE reduction because it may create an easier TCE approach to Fe(0) or increase IRB growth. Our findings will aid the understanding of the contributions of iron media (e.g., Fe(II)(solid), Fe(II)(dissolved), Fe(III), and Fe(0)) to IRB for decontamination in natural groundwater systems. Copyright © 2012 Elsevier Ltd. All rights reserved.

75 FR 15645 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Revisions to the Emission...

Science.gov (United States)

2010-03-30

... clarify EPA's role in the approval of emission quantification protocols. While the previous SIP- approved... approve severable portions of two revisions to the Texas State Implementation Plan (SIP) submitted by the... to further clarify procedures for using emission protocols and to update the approved list of...

Study Protocol for a Randomized, Double-Blind, Community-Based Efficacy Trial of Various Doses of Zinc in Micronutrient Powders or Tablets in Young Bangladeshi Children

Directory of Open Access Journals (Sweden)

M. Munirul Islam

2018-01-01

Full Text Available Zinc is essential to supporting growth in young children especially for tissues undergoing rapid cellular differentiation and turnover, such as those in the immune system and gastrointestinal tract. Therapeutic zinc supplementation has been initiated in low-income countries as part of diarrhea treatment programs to support these needs for young children, but the effects of preventive supplemental zinc as a tablet or as a multiple micronutrient powder (MNP on child growth and diarrheal disease are mixed and pose programmatic uncertainties. Thus, a randomized, double-blind community-based efficacy trial of five different doses, forms, and frequencies of preventive zinc supplementation vs. a placebo was designed for a study in children aged 9–11 months in an urban community in Dhaka, Bangladesh. The primary outcomes of this 24-week study are incidence of diarrheal disease and linear growth. Study workers will conduct in-home morbidity checks twice weekly; anthropometry will be measured at baseline, 12 weeks and 24 weeks. Serum zinc and other related biomarkers will be measured in a subsample along with an estimate of the exchangeable zinc pool size using stable isotope techniques in a subgroup. Therapeutic zinc will be provided as part of diarrhea treatment, in accordance with Bangladesh’s national policy. Therefore, the proposed study will determine the additional benefit of a preventive zinc supplementation intervention. The protocol has been approved by the Institutional Review Boards (IRBs of icddr,b and Children’s Hospital Oakland Research Institute (CHORI. The IRB review process is underway at the University of Colorado Denver as well.

Comprehensive Reproductive System Care Program - Clinical Breast Care Project (CRSCP-CBCP)

Science.gov (United States)

2013-04-01

tumor heterogeneity. The tumor microenvironment and stromal interactions, metastasis and recurrence, as well as the role of cancer stem cells and tumor...biospecimens (Figure BB-1) donated by 5,977 fully consented subjects to our IRB approved tissue and blood protocols. (Figure BB-2) 10 1/1 c Cll ...E ’(3 Cll c. 1/1 c;; 0 1- CBCP Total Biological Specimens, Cumulative Annual Total thru 3/31/13 60000 50000 40000 30000 20000 10000 0

Electroacupuncture to alleviate postoperative pain after a laparoscopic appendectomy: study protocol for a three-arm, randomised, controlled trial.

Science.gov (United States)

Lee, Seunghoon; Nam, Dongwoo; Kwon, Minsoo; Park, Won Seo; Park, Sun Jin

2017-08-04

The purpose of this study is to evaluate the efficacy and safety of electroacupuncture (EA) for postoperative pain after laparoscopic appendectomy compared with sham electroacupuncture (SEA) and no acupuncture treatment. This study is a protocol for a three-arm, randomised, patient-assessor-blinded (to the type of acupuncture treatment), controlled, parallel trial. 138 participants diagnosed with appendicitis and scheduled for laparoscopic appendectomy will be randomly assigned to the EA group (n=46), SEA group (n=46) or control group (n=46). The EA group will receive acupuncture treatment at both regional and distal acupuncture points with electrostimulation. The SEA group will receive sham acupuncture treatment with mock electrostimulation. Both EA and SEA groups will receive a total of four treatments 1 hour preoperative, 1 hour postoperative and during the morning and afternoon the day after surgery with the same routine postoperative pain control. The control group will receive only routine postoperative pain control. The primary outcome is the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at 24 hours after surgery. The secondary outcomes are the PI-NRS, analgesic consumption, opioid-related side effects, time to first passing flatus, quality of life and adverse events evaluated 6, 12, 24 and 36 hours and 7 days after surgery. The study was planned in accordance with the Helsinki Declaration and the Korean Good Clinical Practice Guidelines to protect the participants and was approved by the institutional review board (IRB) of Kyung Hee University Medical Center (KMC IRB-1427-02). The results will be disseminated in peer-reviewed journals and presented at international conferences. Clinical Research Information Service (KCT0001328). © 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.

Vienna Agreement law 15.986 it approve Vienna Agreement for Protection ozone layer and annex

International Nuclear Information System (INIS)

1988-01-01

The Agreement of Vienna is approved with respect to the protection of the Layer of Ozono, definitions,general duties, research and observations systematics, co-operation in the Spheres Scientific Juridical, and information, Technological Conference, transmission from the protocols, amends, secretariat, adoption to the agreement or the protocols, adoption and amendment of controversy, signing, ratify, approve annexes, solution or vote, relation approving, adhesion, rights between the present agreement and its protocols, entrance in vigor, reserves, retirement, deposition, exchange of information [es

Computerized information management for institutional review boards.

Science.gov (United States)

Hood, Maureen N; Gugerty, Brian; Levine, Richard; Ho, Vincent B

2005-01-01

The use of human subjects for medical research in most industrialized nations requires the scientific and ethical scrutiny of research proposals by a governing institutional review board (IRB) or its equivalent. As part of their primary charge to protect human subjects, IRBs are responsible for the regulatory oversight of not only the research protocol itself but also the research conduct of the investigators and, if applicable, the funding sponsor. This article will discuss the regulatory requirements for an accurate account of IRB protocols and investigators and present an overview of the general flow of information for an IRB protocol. The current and potential uses of information management systems by IRBs will also be reviewed and accompanied by a discussion of the potential advantages and disadvantages of various computerized information systems for management of clinical research.

Regulatory approvals in a large multinational clinical trial: the ESPRIT experience.

Science.gov (United States)

McNay, Laura A; Tavel, Jorge A; Oseekey, Karen; McDermott, Cathy M; Mollerup, David; Bebchuk, Judith D

2002-02-01

While accepted as serving an important function to safeguard human subjects, the process of obtaining regulatory approvals to conduct clinical trials is generally regarded as cumbersome and time-consuming. For large multinational trials, U.S. federally sponsored human subject research abroad involves specific U.S. regulatory requirements, in addition to those of the host country, that act as further hurdles. These requirements may include obtaining an Assurance of Protection for Human Subjects from the Office of Human Research Protection of the U.S. Department of Health and Human Services, maintaining specific Ethics Committee/Institutional Review Board (EC/IRB) composition, and incorporating mandated elements in informed consents, all of which may differ from local policies and guidelines. Specific examples of issues that led to delays in regulatory approvals for sites participating in the multinational clinical trial entitled Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) are presented here. While the goal of these requirements is to protect the rights and welfare of human subjects, they may create substantial delays and engender resentment over the notion of lack of respect for individual country sovereignty. Substudies within ESPRIT have been undertaken to obtain feedback from EC/IRB chairpersons, site personnel responsible for processing the required assurances, ESPRIT investigators, and study participants regarding aspects of current U.S. regulatory requirements related to human subject protection and ethical issues in multinational research. The purpose of these substudies is to compare the attitudes and experiences across countries regarding important ethical issues associated with conducting ESPRIT. One objective of the substudies is to gather additional insight to the impact of U.S. regulatory processes. Another is to help to inform the debate about how to best maximize the rights and welfare of clinical trial

3 July 1985: Convention signed in Brussels on 31 January 1963, supplementary to the Paris Convention of 29 July 1960 on Third Party Liability in the Field of Nuclear Energy and Act approving the Protocols to amend the Paris Convention and the Brussels Supplementary Convention

International Nuclear Information System (INIS)

1985-01-01

This Act refers to the Brussels Supplementary Convention approved by Belgium in 1966 and ratified on 20 August 1985 and approves ratification of the Protocols of 16 November 1982 to amend the Paris Convention and the Brussels Supplementary Convention respectively. The Protocols are reproduced in French, Dutch and German. (NEA) [fr

26 CFR 1.442-1 - Change of annual accounting period.

Science.gov (United States)

2010-04-01

... computing its taxable income and for making its Federal income tax returns. If the taxpayer wants to change.... Proc. 2002-37, 2002-22 I.R.B., automatic approval procedures for certain corporations; Rev. Proc. 2002-38, 2002-22 I.R.B., automatic approval procedures for partnerships, S corporations, electing S...

Research ethics board approval for an international thromboprophylaxis trial.

Science.gov (United States)

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.

45 CFR 46.502 - What information must be provided when registering an IRB?

Science.gov (United States)

2010-10-01

..., facsimile number, and electronic mail address of the senior officer or head official of that institution or..., phone number, facsimile number, and electronic mail address of the contact person providing the... number, and electronic mail address. (d) The name, phone number, and electronic mail address of the IRB...

Analysis of research ethics board approval times in an academic department of medicine.

Science.gov (United States)

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.

Analysis of Regional Timelines To Set Up a Global Phase III Clinical Trial in Breast Cancer: the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Experience

OpenAIRE

Metzger-Filho, Otto; Azambuja, Evandro de; Bradbury, Ian; Saini, Kamal S.; Bines, Jose; Simon, Sergio D. [UNIFESP; Van Dooren, Veerle; Aktan, Gursel; Pritchard, Kathleen I.; Wolff, Antonio C.; Smith, Ian; Jackisch, Christian; Lang, Istvan; Untch, Michael; Boyle, Frances

2013-01-01

Purpose. This study measured the time taken for setting up the different facets of Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization (ALTTO), an international phase III study being conducted in 44 participating countries.Methods. Time to regulatory authority (RA) approval, time to ethics committee/institutional review board (EC/IRB) approval, time from study approval by EC/IRB to first randomized patient, and time from first to last randomized patient were prospectively collected i...

Security analysis of session initiation protocol

OpenAIRE

Dobson, Lucas E.

2010-01-01

Approved for public release; distribution is unlimited The goal of this thesis is to investigate the security of the Session Initiation Protocol (SIP). This was accomplished by researching previously discovered protocol and implementation vulnerabilities, evaluating the current state of security tools and using those tools to discover new vulnerabilities in SIP software. The CVSS v2 system was used to score protocol and implementation vulnerabilities to give them a meaning that was us...

Ethical and regulatory challenges of research using pervasive sensing and other emerging technologies: IRB perspectives.

Science.gov (United States)

Nebeker, Camille; Harlow, John; Espinoza Giacinto, Rebeca; Orozco-Linares, Rubi; Bloss, Cinnamon S; Weibel, Nadir

2017-01-01

Vast quantities of personal health information and private identifiable information are being created through mobile apps, wearable sensors, and social networks. While new strategies and tools for obtaining health data have expanded researchers' abilities to design and test personalized and adaptive health interventions, the deployment of pervasive sensing and computational techniques to gather research data is raising ethical challenges for Institutional Review Boards (IRBs) charged with protecting research participants. To explore experiences with, and perceptions about, technology-enabled research, and identify solutions for promoting responsible conduct of this research we conducted focus groups with human research protection program and IRB affiliates. Our findings outline the need for increased collaboration across stakeholders in terms of: (1) shared and dynamic resources that improve awareness of technologies and decrease potential threats to participant privacy and data confidentiality, and (2) development of appropriate and dynamic standards through collaboration with stakeholders in the research ethics community.

Complete Decomposition of Li ₂ CO ₃ in Li–O ₂ Batteries Using Ir/B ₄ C as Noncarbon-Based Oxygen Electrode

Energy Technology Data Exchange (ETDEWEB)

Song, Shidong; Xu, Wu; Zheng, Jianming; Luo, Langli; Engelhard, Mark H.; Bowden, Mark E.; Liu, Bin; Wang, Chong-Min; Zhang, Ji-Guang

2017-02-10

Incomplete decomposition of Li2CO3 during charge process is a critical barrier for rechargeable Li-O2 batteries. Here we report complete decomposition of Li2CO3 in Li-O2 batteries using ultrafine iridium-decorated boron carbide (Ir/B4C) nanocomposite as oxygen electrode. The systematic investigation on charging the Li2CO3 preloaded Ir/B4C electrode in an ether-based electrolyte demonstrates that Ir/B4C electrode can decompose Li2CO3 with an efficiency close to 100% at below 4.37 V. In contrast, the bare B4C without Ir electrocatalyst can only decompose 4.7% of preloaded Li2CO3. The reaction mechanism of Li2CO3 decomposition in the presence of Ir/B4C electrocatalyst has been further investigated. A Li-O2 battery using Ir/B4C as oxygen electrode material shows highly enhanced cycling stability than that using bare B4C oxygen electrode. These results clearly demonstrate that Ir/B4C is an effecitive oxygen electrode amterial to completely decompose Li2CO3 at relatively low charge voltages and is of significant importance in improving the cycle performanc of aprotic Li-O2 batteries.

77 FR 62449 - Approval and Promulgation of Implementation Plans; Alabama; Disapproval of 110(a)(2)(E)(ii...

Science.gov (United States)

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...

A qualitative study of institutional review board members' experience reviewing research proposals using emergency exception from informed consent.

Science.gov (United States)

McClure, Katie B; Delorio, Nicole M; Schmidt, Terri A; Chiodo, Gary; Gorman, Paul

2007-05-01

Emergency exception to informed consent regulation was introduced to provide a venue to perform research on subjects in emergency situations before obtaining informed consent. For a study to proceed, institutional review boards (IRBs) need to determine if the regulations have been met. To determine IRB members' experience reviewing research protocols using emergency exception to informed consent. This qualitative research used semistructured telephone interviews of 10 selected IRB members from around the US in the fall of 2003. IRB members were chosen as little is known about their views of exception to consent, and part of their mandate is the protection of human subjects in research. Interview questions focused on the length of review process, ethical and legal considerations, training provided to IRB members on the regulations, and experience using community consultation and notification. Content analysis was performed on the transcripts of interviews. To ensure validity, data analysis was performed by individuals with varying backgrounds: three emergency physicians, an IRB member and a layperson. Respondents noted that: (1) emergency exception to informed consent studies require lengthy review; (2) community consultation and notification regulations are vague and hard to implement; (3) current regulations, if applied correctly, protect human subjects; (4) legal counsel is an important aspect of reviewing exception to informed-consent protocols; and (5) IRB members have had little or no formal training in these regulations, but are able to access materials needed to review such protocols. This preliminary study suggests that IRB members find emergency exception to informed consent studies take longer to review than other protocols, and that community consultation and community notification are the most difficult aspect of the regulations with which to comply but that they adequately protect human subjects.

3D T2-weighted imaging to shorten multiparametric prostate MRI protocols.

Science.gov (United States)

Polanec, Stephan H; Lazar, Mathias; Wengert, Georg J; Bickel, Hubert; Spick, Claudio; Susani, Martin; Shariat, Shahrokh; Clauser, Paola; Baltzer, Pascal A T

2018-04-01

To determine whether 3D acquisitions provide equivalent image quality, lesion delineation quality and PI-RADS v2 performance compared to 2D acquisitions in T2-weighted imaging of the prostate at 3 T. This IRB-approved, prospective study included 150 consecutive patients (mean age 63.7 years, 35-84 years; mean PSA 7.2 ng/ml, 0.4-31.1 ng/ml). Two uroradiologists (R1, R2) independently rated image quality and lesion delineation quality using a five-point ordinal scale and assigned a PI-RADS score for 2D and 3D T2-weighted image data sets. Data were compared using visual grading characteristics (VGC) and receiver operating characteristics (ROC)/area under the curve (AUC) analysis. Image quality was similarly good to excellent for 2D T2w (mean score R1, 4.3 ± 0.81; R2, 4.7 ± 0.83) and 3D T2w (mean score R1, 4.3 ± 0.82; R2, 4.7 ± 0.69), p = 0.269. Lesion delineation was rated good to excellent for 2D (mean score R1, 4.16 ± 0.81; R2, 4.19 ± 0.92) and 3D T2w (R1, 4.19 ± 0.94; R2, 4.27 ± 0.94) without significant differences (p = 0.785). ROC analysis showed an equivalent performance for 2D (AUC 0.580-0.623) and 3D (AUC 0.576-0.629) T2w (p > 0.05, respectively). Three-dimensional acquisitions demonstrated equivalent image and lesion delineation quality, and PI-RADS v2 performance, compared to 2D in T2-weighted imaging of the prostate. Three-dimensional T2-weighted imaging could be used to considerably shorten prostate MRI protocols in clinical practice. • 3D shows equivalent image quality and lesion delineation compared to 2D T2w. • 3D T2w and 2D T2w image acquisition demonstrated comparable diagnostic performance. • Using a single 3D T2w acquisition may shorten the protocol by 40%. • Combined with short DCE, multiparametric protocols of 10 min are feasible.

How to do human-subjects research if you do not have an institutional review board.

Science.gov (United States)

Rice, Todd W

2008-10-01

Biomedical research with human subjects has expanded outside of traditional medical centers and hospitals into other health care entities, such as rehabilitation facilities, free-standing out-patient treatment centers, and even home-health agencies. Regardless of the location, federal regulations mandate that all human-subjects research must be overseen by an institutional review board (IRB) or ethics committee to ensure the research abide by the Code of Federal Regulations. Consequently, all human-subjects research must be reviewed and approved by an IRB prior to initiation of any research procedures. Unfortunately, many of these nontraditional research facilities do not have easy access to an IRB. This does not render such research exempt from federal oversight. Clinicians at these facilities have viable options for obtaining IRB approval and legally conducting such research. This paper outlines the available options and their pros and cons.

From the Form to the Face to Face: IRBs, Ethnographic Researchers, and Human Subjects Translate Consent

Science.gov (United States)

Metro, Rosalie

2014-01-01

Based on my fieldwork with Burmese teachers in Thailand, I describe the drawbacks of using IRB-mandated written consent procedures in my cross-cultural collaborative ethnographic research on education. Drawing on theories of intersubjectivity (Mikhail Bakhtin), ethics (Emmanuel Levinas), and translation (Naoki Sakai), I describe face-to-face…

Institutional review board community members: who are they, what do they do, and whom do they represent?

Science.gov (United States)

Klitzman, Robert

2012-07-01

The roles of nonaffiliated and nonscientific institutional review board (IRB) members at academic medical centers have received some attention, but questions remain-Who are they, what do they do, and whom, if anyone, do they represent? The author interviewed 46 IRB chairs, directors, administrators, and members in 2007-2009. He contacted the leadership of 60 IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health funding), interviewed IRB leaders from 34 of these institutions, then recruited 7 additional members from these IRBs to interview. Regular IRB members often called these individuals community members and were confused as to who these members were, or should be, and whether they did, or should, represent anyone and, if so, whom. IRBs encountered challenges in finding, training, and retaining these community members. Tensions emerged because nonscientific members, by definition, have no scientific training, so they have difficulty understanding key aspects of protocols, making them feel unempowered to contribute to reviews. IRBs varied in how much they encouraged these members to participate, in what ways, and with what success. At academic medical centers, IRBs struggled with how to view, choose, employ, and retain nonaffiliated and nonscientific members, and they varied widely in these regards. Some IRBs had these members review entire protocols, others only limited parts (particularly reading consent forms for comprehension), pro forma. Yet, at times, these members' input proved very important. These findings have critical implications for policy, practice, and research.

Subdissociative intranasal ketamine plus standard pain therapy versus standard pain therapy in the treatment of paediatric sickle cell disease vaso-occlusive crises in resource-limited settings: study protocol for a randomised controlled trial.

Science.gov (United States)

Young, James R; Sawe, Hendry Robert; Mfinanga, Juma A; Nshom, Ernest; Helm, Ethan; Moore, Charity G; Runyon, Michael S; Reynolds, Stacy L

2017-07-10

Pediatric sickle cell disease, highly prevalent in sub-Saharan Africa, carries great morbidity and mortality risk. Limited resources and monitoring make management of acute vaso-occlusive crises challenging. This study aims to evaluate the efficacy and safety of subdissociative intranasal ketamine as a cheap, readily available and easily administered adjunct to standard pain therapy. We hypothesise that subdissociative, intranasal ketamine may significantly augment current approaches to pain management in resource-limited settings in a safe and cost-effective manner. This is a multicentred, randomised, double-blind, placebo-controlled trial enrolling children 4-16 years of age with sickle cell disease and painful vaso-occlusive pain crises. Study sites include two sub-Saharan teaching and referral hospitals with acute intake areas. All patients receive standard analgesic therapy during evaluation. Patients randomised to the treatment arm receive 1 mg/kg intranasal ketamine at onset of therapy, while placebo arm participants receive volume-matched intranasal normal saline. All participants and clinical staff are blinded to the treatment allocation. Data will be analysed on an intention-to-treat basis. Primary endpoints are changes in self-report pain scales (Faces Pain Scale-Revised) at 30, 60 and 120 minutes and rates of adverse events. Secondary endpoints include hospital length of stay, total analgesia use and quality of life assessment 2-3 weeks postintervention. The research methods for this study have been approved by the Cameroon Baptist Convention Health Board Institutional Review Board (IRB2015-07), the Tanzanian National Institute for Medical Research (NIMR/HQ/R.8a/Vol. IX/2299), Muhimbili National Hospital IRB (MNH/IRB/I/2015/14) and the Tanzanian Food and Drugs Authority (TFDA0015/CTR/0015/9). Data reports will be provided to the Data and Safety Monitoring Board (DSMB) periodically throughout the study as well as all reports of adverse events. All

Analysis of regional timelines to set up a global phase III clinical trial in breast cancer: the adjuvant lapatinib and/or trastuzumab treatment optimization experience.

Science.gov (United States)

Metzger-Filho, Otto; de Azambuja, Evandro; Bradbury, Ian; Saini, Kamal S; Bines, José; Simon, Sergio D; Dooren, Veerle Van; Aktan, Gursel; Pritchard, Kathleen I; Wolff, Antonio C; Smith, Ian; Jackisch, Christian; Lang, Istvan; Untch, Michael; Boyle, Frances; Xu, Binghe; Baselga, Jose; Perez, Edith A; Piccart-Gebhart, Martine

2013-01-01

This study measured the time taken for setting up the different facets of adjuvant lapatinib and/or trastuzumab treatment optimization (ALTTO), an nternational phase III study being conducted in 44 participating countries. Time to regulatory authority (RA) approval, time to ethics committee/institutional review board (EC/IRB) approval, time from study approval by EC/IRB to first randomized patient, and time from first to last randomized patient were prospectively collected in the ALTTO study. Analyses were conducted by grouping countries into either geographic regions or economic classes as per the World Bank's criteria. South America had a significantly longer time to RA approval (median: 236 days, range: 21-257 days) than Europe (median: 52 days, range: 0-151 days), North America (median: 26 days, range: 22-30 days), and Asia-Pacific (median: 62 days, range: 37-75 days). Upper-middle economies had longer times to RA approval (median: 123 days, range: 21-257 days) than high-income (median: 47 days, range: 0-112 days) and lower-middle income economies (median: 57 days, range: 37-62 days). No significant difference was observed for time to EC/IRB approval across the studied regions (median: 59 days, range 0-174 days). Overall, the median time from EC/IRB approval to first recruited patient was 169 days (range: 26-412 days). This study highlights the long time intervals required to activate a global phase III trial. Collaborative research groups, pharmaceutical industry sponsors, and regulatory authorities should analyze the current system and enter into dialogue for optimizing local policies. This would enable faster access of patients to innovative therapies and enhance the efficiency of clinical research.

Blockchain protocols in clinical trials: Transparency and traceability of consent [version 3; referees: 1 approved, 2 approved with reservations, 1 not approved

OpenAIRE

Mehdi Benchoufi; Raphael Porcher; Philippe Ravaud

2017-01-01

Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing the collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we will built a consent workflow using a rising technology called Blockchain. This is a...

Blockchain protocols in clinical trials: Transparency and traceability of consent [version 5; referees: 1 approved, 2 approved with reservations, 2 not approved

Directory of Open Access Journals (Sweden)

Mehdi Benchoufi

2018-02-01

Full Text Available Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security

Blockchain protocols in clinical trials: Transparency and traceability of consent [version 4; referees: 1 approved, 2 approved with reservations, 2 not approved

Directory of Open Access Journals (Sweden)

Mehdi Benchoufi

2017-12-01

Full Text Available Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security

Comprehensive Study of Acute Effects and Recovery After Concussion

Science.gov (United States)

2015-10-01

MCW IRB regarding personality questionnaire changes and head impact sensor company changes • Amendment under review as of Sept 29, 2015 regarding...a large (3Tb) memory system, and four general purpose graphical processing unit (GPU) systems, each with four Nvidia K40 GPUs. Each of these... company changed prior to study implementation and MCW IRB provided oversight for Banyan Biomarkers’ research activities. Approved by MCW IRB Aug 24

Development of an institutional review board preapproval process for Doctor of Nursing Practice students: process and outcome.

Science.gov (United States)

Szanton, Sarah L; Taylor, Holly A; Terhaar, Mary

2013-01-01

As Doctor of Nursing Practice (DNP) programs proliferate, effective collaboration with institutional review boards (IRBs) is important to protect human subjects. It is particularly important that faculty and students recognize which DNP students' projects should be considered as "human subjects research" or "quality improvement." The former require IRB review, whereas the latter may be eligible for expedited review or may be considered exempt. We report outcomes following implementation of a combination of didactic training, one-to-one consultation, and a decision support protocol to improve preparation for and collaboration with the IRB at a large university. In the first year of using this protocol, 53% of projects were deemed human subjects research and received IRB review. The other 47% were deemed quality improvement projects and did not require IRB review. We offer our experience as an approach for teaching students how to protect the subjects included in their quality improvement activities. Copyright 2012, SLACK Incorporated.

Hybrid protocols plus natural treatments for inflammatory conditions.

Science.gov (United States)

1998-01-01

Hybrid protocols combine one, two, or three pharmaceutical drugs with several nutritional or immune-based therapies. These protocols are not limited solely to FDA-approved drugs or strictly to alternative therapies. The rationale for using a hybrid protocol is to find an effective antiviral regimen that also restores immune function. The goal is to obtain the benefits of protease inhibitors without viral resistance and side effects which include problems with fat metabolism and cholesterol levels. Natural treatments for inflammatory conditions are also described. Options include licorice root, ginger root, and slippery elm.

Blockchain protocols in clinical trials: Transparency and traceability of consent [version 3; referees: 1 approved, 2 approved with reservations, 1 not approved

Directory of Open Access Journals (Sweden)

Mehdi Benchoufi

2017-07-01

Full Text Available Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing the collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we will built a consent workflow using a rising technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain; thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each revision of the protocol, consent was sought again. We obtained a single document, in a standard open format, that accounted for the whole consent collection process: timestamped consent status with regards to each version of the protocol. This document cannot be corrupted, and can be checked on any dedicated public website. It should be considered as a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened in order to remove the need for third parties, here the trial stakeholders, and give participative control to the peer-to-peer users. In the future, we think that the complex data flow of a clinical trial can be tracked using Blockchain, that a blockchain core functionality, named Smart Contract, could help prevent clinical trial events not to happen in the right chronological order: for example including patients before they consented or analysing case report forms data before freezing the database

40 CFR 1043.50 - Approval of methods to meet Tier 1 retrofit NOX standards.

Science.gov (United States)

2010-07-01

... retrofit NOX standards. 1043.50 Section 1043.50 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... SUBJECT TO THE MARPOL PROTOCOL § 1043.50 Approval of methods to meet Tier 1 retrofit NOX standards. Regulation 13 of Annex VI provides for certification of Approved Methods, which are retrofit procedures that...

Ethics of social media research: common concerns and practical considerations.

Science.gov (United States)

Moreno, Megan A; Goniu, Natalie; Moreno, Peter S; Diekema, Douglas

2013-09-01

Social media Websites (SMWs) are increasingly popular research tools. These sites provide new opportunities for researchers, but raise new challenges for Institutional Review Boards (IRBs) that review these research protocols. As of yet, there is little-to-no guidance regarding how an IRB should review the studies involving SMWs. The purpose of this article was to review the common risks inherent in social media research and consider how researchers can consider these risks when writing research protocols. We focused this article on three common research approaches: observational research, interactive research, and survey/interview research. Concomitant with these research approaches, we gave particular attention to the issues pertinent to SMW research, including privacy, consent, and confidentiality. After considering these challenges, we outlined key considerations for both researchers and reviewers when creating or reviewing SMW IRB protocols. Our goal in this article was to provide a detailed examination of relevant ethics and regulatory issues for both researchers and those who review their protocols.

Ethics of Social Media Research: Common Concerns and Practical Considerations

Science.gov (United States)

Goniu, Natalie; Moreno, Peter S.; Diekema, Douglas

2013-01-01

Abstract Social media Websites (SMWs) are increasingly popular research tools. These sites provide new opportunities for researchers, but raise new challenges for Institutional Review Boards (IRBs) that review these research protocols. As of yet, there is little-to-no guidance regarding how an IRB should review the studies involving SMWs. The purpose of this article was to review the common risks inherent in social media research and consider how researchers can consider these risks when writing research protocols. We focused this article on three common research approaches: observational research, interactive research, and survey/interview research. Concomitant with these research approaches, we gave particular attention to the issues pertinent to SMW research, including privacy, consent, and confidentiality. After considering these challenges, we outlined key considerations for both researchers and reviewers when creating or reviewing SMW IRB protocols. Our goal in this article was to provide a detailed examination of relevant ethics and regulatory issues for both researchers and those who review their protocols. PMID:23679571

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

Science.gov (United States)

Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

2016-04-01

A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. 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/

Measurement protocols for performance testing of dosimetry services for external radiations

International Nuclear Information System (INIS)

1993-01-01

In the Health and Safety Executive's ''Requirements for the Approval of Dosimetry Services under the Ionising Radiations Regulations 1985'', it is stipulated that dosimetry services seeking approval must show that they have successfully completed a performance test. The services must arrange for the tests to be carried out on application and thereafter every 18 months, by a laboratory which has received accreditation from the National Measurement Accreditation Service (NAMAS) for the whole performance testing activity. The performance tests must be carried out to published protocols and the purpose here is to provide protocols for external, whole body film and TLD dosimetry services, and for skin and extremity dosimetry services. (Author)

76 FR 32321 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Revision to the...

Science.gov (United States)

2011-06-06

...) Program--Quality Assurance Protocol for the Safety Inspection Program in Non-I/M Counties AGENCY... approve revisions to the Pennsylvania State Implementation Plan (SIP). The revision consists of a change... prior SIP-approved I/M program to change the duration of the timing of quality assurance audits...

Patients come from populations and populations contain patients. A two-stage scientific and ethics review: The next adaptation for single institutional review boards.

Science.gov (United States)

Knopman, David; Alford, Eli; Tate, Kaitlin; Long, Mark; Khachaturian, Ara S

2017-08-01

For nearly 50 years, institutional review boards (IRB) and independent ethics committees have featured local oversight as a core function of research ethics reviews. However growing complexity in Alzheimer's clinical research suggests current approaches to research volunteer safety is hampering development of new therapeutics. As a partial response to this challenge, the NIH has mandated that all NIH-funded multi-site studies will use a single Institutional Review Board. The perspective describes a joint program to provide a single IRB of record (sIRB) for phases of multi-site studies. The approach follows two steps. One, an expert Scientific Review Committee (SRC) of senior researchers in the field will conduct the review principally of scientific merit, significance, feasibility, and the likelihood of meaningful results. The second step will be the IRB's regulatory and ethics review. The IRB will apply appropriate regulatory criteria for approval including minimization of risks to subjects and risks reasonable in relation to anticipated benefits, equitable subject selection, informed consent, protections for vulnerable populations, and application of local context considerations, among others. There is a steady demand for scientific, ethical and regulatory review of planned Alzheimer's studies. As of January 15, 2017, there are nearly 400 open studies, Phase II and III, industry and NIH sponsored trials on disease indications affecting memory, movement and mood in the US. The effort will initially accept protocols for studies of Alzheimer's disease, dementia, and related disorders effecting memory, movement and mood. Future aims will be to provide scientific review and, where applicable, regulatory and ethical review in an international context outside North America with sites possibly in Asia, Europe and Australia. Copyright © 2017 the Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

Desarrollo de una interfaz para el control del robot IRB desde Matlab

OpenAIRE

Gutiérrez Corbacho, Azahara

2014-01-01

El objetivo de este proyecto es realizar la comunicación con el brazo robótico, IRB120 de ABB, a través de la herramienta de software matemático Matlab. Para ello desarrollaremos un socket de comunicación, que se encargará enviar y procesar los datos. Para comprobar que la comunicación funciona y que el envío de datos se realiza correctamente, se implementarán en Matlab, una serie de interfaces de comunicación con el robot y una aplicación final. La primera, será una interfaz gráfica r...

Ethics approval: responsibilities of journal editors, authors and research ethics committees.

Science.gov (United States)

Bain, Luchuo Engelbert

2017-01-01

Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply unaware of its importance. Good research involves risks taken by research participants and uses tax payers' money in the process. These mandates the research endeavor to aim at attaining the highest degree of respect for the sacrifices made by others for science. Most researchers mistake scientific clearance or approval, for ethics approval. For a study to be ethical sound, it must be scientifically sound. This is only one of the activities carried out during protocol review. It is not uncommon for sensitive ethical concerns, especially in the social sciences to be overlooked and considered not to be accompanied by any serious risks for the research participants.The researcher has the responsibility of systematically consulting the competent ethics committee for advice and consequent approvals or ethical waivers. Journal editors and reviewers have the duty to systematically evaluate the ethical soundness of manuscripts submitted for review. Capacity building in research ethics and institutional support for Research Ethics Committees to speed up protocol review could reduce the incentive of carrying out research in human subjects without ethics approvals. It is hypocritical and idle to continue to expect optimal reviews on time and of good quality, from ethics committees functioning purely on altruistic grounds. Capacity building for researchers in research ethics, and institutional reforms and support for Research Ethics Committees appear not to have received the attention they truly deserve.

Control del brazo robot IRB120 mediante el dispositivo háptico PHANTOM

OpenAIRE

Pardo Alía, Samuel

2016-01-01

El proyecto expuesto en el presente libro consiste en el control del brazo robot IRB120 a través de diferentes aplicaciones por medio de una interfaz gráfica creada con el software matemático MATLAB. Todo ello se llevará a cabo gracias a un socket de comunicación desarrollado en lenguaje RAPID que permite el envío simultáneo de varias posiciones al robot. Entre esas aplicaciones destaca el empleo del dispositivo háptico Phantom Omni para la creación de dibujos o textos a man...

Model Additional Protocol

International Nuclear Information System (INIS)

Rockwood, Laura

2001-01-01

Since the end of the cold war a series of events has changed the circumstances and requirements of the safeguards system. The discovery of a clandestine nuclear weapons program in Iraq, the continuing difficulty in verifying the initial report of Democratic People's Republic of Korea upon entry into force of their safeguards agreement, and the decision of the South African Government to give up its nuclear weapons program and join the Treaty on the Non-Proliferation of Nuclear Weapons have all played a role in an ambitious effort by IAEA Member States and the Secretariat to strengthen the safeguards system. A major milestone in this effort was reached in May 1997 when the IAEA Board of Governors approved a Model Protocol Additional to Safeguards Agreements. The Model Additional Protocol was negotiated over a period of less than a year by an open-ended committee of the Board involving some 70 Member States and two regional inspectorates. The IAEA is now in the process of negotiating additional protocols, State by State, and implementing them. These additional protocols will provide the IAEA with rights of access to information about all activities related to the use of nuclear material in States with comprehensive safeguards agreements and greatly expanded physical access for IAEA inspectors to confirm or verify this information. In conjunction with this, the IAEA is working on the integration of these measures with those provided for in comprehensive safeguards agreements, with a view to maximizing the effectiveness and efficiency, within available resources, the implementation of safeguards. Details concerning the Model Additional Protocol are given. (author)

Comparison of Outcomes before and after Ohio's Law Mandating Use of the FDA-Approved Protocol for Medication Abortion: A Retrospective Cohort Study.

Directory of Open Access Journals (Sweden)

Ushma D Upadhyay

2016-08-01

Full Text Available In February 2011, an Ohio law took effect mandating use of the United States Food and Drug Administration (FDA-approved protocol for mifepristone, which is used with misoprostol for medication abortion. Other state legislatures have passed or enacted similar laws requiring use of the FDA-approved protocol for medication abortion. The objective of this study is to examine the association of this legal change with medication abortion outcomes and utilization.We used a retrospective cohort design, comparing outcomes of medication abortion patients in the prelaw period to those in the postlaw period. Sociodemographic and clinical chart data were abstracted from all medication abortion patients from 1 y prior to the law's implementation (January 2010-January 2011 to 3 y post implementation (February 2011-October 2014 at four abortion-providing health care facilities in Ohio. Outcome data were analyzed for all women undergoing abortion at ≤49 d gestation during the study period. The main outcomes were as follows: need for additional intervention following medication abortion (such as aspiration, repeat misoprostol, and blood transfusion, frequency of continuing pregnancy, reports of side effects, and the proportion of abortions that were medication abortions (versus other abortion procedures. Among the 2,783 medication abortions ≤49 d gestation, 4.9% (95% CI: 3.7%-6.2% in the prelaw and 14.3% (95% CI: 12.6%-16.0% in the postlaw period required one or more additional interventions. Women obtaining a medication abortion in the postlaw period had three times the odds of requiring an additional intervention as women in the prelaw period (adjusted odds ratio [AOR] = 3.11, 95% CI: 2.27-4.27. In a mixed effects multivariable model that uses facility-months as the unit of analysis to account for lack of independence by site, we found that the law change was associated with a 9.4% (95% CI: 4.0%-18.4% absolute increase in the rate of requiring an additional

Investigating Long-Term Monitoring Protocols in support of Quivira NWR Habitat Objectives

Data.gov (United States)

Department of the Interior — The project purpose is to investigate long-term monitoring protocols in support of Quivira NWR habitat objectives as described in the Refuge’s recently approved CCP...

Building a protocol expressway: the case of Mayo Clinic Cancer Center.

Science.gov (United States)

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 Lean methodologies is an effective tool to structure the definition, planning, analysis, and implementation of significant process changes.

My Retina Tracker™: An On-line International Registry for People Affected with Inherited Orphan Retinal Degenerative Diseases and their Genetic Relatives - A New Resource.

Science.gov (United States)

Fisher, Joan K; Bromley, Russell L; Mansfield, Brian C

2016-01-01

My Retina Tracker™ is a new on-line registry for people affected with inherited orphan retinal degenerative diseases, and their unaffected, genetic relatives. Created and supported by the Foundation Fighting Blindness, it is an international resource designed to capture the disease from the perspective of the registry participant and their retinal health care providers. The registry operates under an Institutional Review Board (IRB)-approved protocol and allows sharing of de-identified data with participants, researchers and clinicians. All participants sign an informed consent that includes selecting which data they wish to share. There is no minimum age of participation. Guardians must sign on behalf of minors, and children between the ages of 12 to 17 also sign an informed assent. Participants may compare their disease to others in the registry using graphical interpretations of the aggregate registry data. Researchers and clinicians have two levels of access. The first provides an interface to interrogate all data fields registrants have agreed to share based on their answers in the IRB informed consent. The second provides a route to contact people in the registry who may be eligible for studies or trials, through the Foundation.

The Shared Health Research Information Network (SHRINE): a prototype federated query tool for clinical data repositories.

Science.gov (United States)

Weber, Griffin M; Murphy, Shawn N; McMurry, Andrew J; Macfadden, Douglas; Nigrin, Daniel J; Churchill, Susanne; Kohane, Isaac S

2009-01-01

The authors developed a prototype Shared Health Research Information Network (SHRINE) to identify the technical, regulatory, and political challenges of creating a federated query tool for clinical data repositories. Separate Institutional Review Boards (IRBs) at Harvard's three largest affiliated health centers approved use of their data, and the Harvard Medical School IRB approved building a Query Aggregator Interface that can simultaneously send queries to each hospital and display aggregate counts of the number of matching patients. Our experience creating three local repositories using the open source Informatics for Integrating Biology and the Bedside (i2b2) platform can be used as a road map for other institutions. The authors are actively working with the IRBs and regulatory groups to develop procedures that will ultimately allow investigators to obtain identified patient data and biomaterials through SHRINE. This will guide us in creating a future technical architecture that is scalable to a national level, compliant with ethical guidelines, and protective of the interests of the participating hospitals.

A New Ethical Challenge for Institutional Review Boards (IRBs/Ethics Committees (ECs in the Assessment of Pediatric Clinical Trials

Directory of Open Access Journals (Sweden)

Klaus Rose

2015-05-01

Full Text Available Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA’s Pediatric Committee (PDCO may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs/ethics committees (ECs and that clinical trials resulting from negotiations with EMA’s PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients.

Meeting the Challenge: The National Cancer Institute's Central Institutional Review Board for Multi-Site Research.

Science.gov (United States)

Massett, Holly A; Hampp, Sharon L; Goldberg, Jacquelyn L; Mooney, Margaret; Parreco, Linda K; Minasian, Lori; Montello, Mike; Mishkin, Grace E; Davis, Catasha; Abrams, Jeffrey S

2018-03-10

The National Institutes of Health (NIH) issued a new policy that requires a single institutional review board (IRB) of record be used for all protocols funded by the NIH that are carried out at more than one site in the United States, effective January 2018. This policy affects several hundred clinical trials opened annually across the NIH. Limited data exist to compare the use of a single IRB to that of multiple local IRBs, so some institutions are resistant to or distrustful of single IRBs. Since 2001, the National Cancer Institute (NCI) has funded a central IRB (CIRB) that provides human patient reviews for its extensive national cancer clinical trials program. This paper presents data to show the adoption, efficiencies gained, and satisfaction of the CIRB among NCI trial networks and reviews key lessons gleaned from 16 years of experience that may be informative for others charged with implementation of the new NIH single-IRB policy.

Wirelessly programmed deep brain stimulation of the bilateral subthalamic nucleus for the treatment of primary Parkinson′s disease: study protocol for a multicenter, randomized, parallel-controlled optimal-efficiency trial

Directory of Open Access Journals (Sweden)

Chen-cheng Zhang

2016-01-01

Ethics: The study protocol has been approved by the Ethics Committee of Tangdu Hospital of the Fourth Military Medical University of China (approval number: 2012009; Ethics Committee of Changhai Hospital of China (approval number: CHEC2012-044; Clinical Trial Ethics Committee, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine of China (approval number: 2012-67; Clinical Trial and Biomedical Ethics Committee of West China Hospital of Sichuan University of China (approval number: 2012-7; Ethics Committee of First Affiliated Hospital of Guangzhou Medical University of China (approval number: 2013-8. The study protocol will be performed in strict accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Signed informed consent will be obtained from the patients or their relatives.

SU-E-J-124: FDG PET Metrics Analysis in the Context of An Adaptive PET Protocol for Node Positive Gynecologic Cancer Patients

Energy Technology Data Exchange (ETDEWEB)

Nawrocki, J; Chino, J; Light, K; Vergalasova, I; Craciunescu, O [Duke University Medical Center, Durham, NC (United States)

2014-06-01

Purpose: To compare PET extracted metrics and investigate the role of a gradient-based PET segmentation tool, PET Edge (MIM Software Inc., Cleveland, OH), in the context of an adaptive PET protocol for node positive gynecologic cancer patients. Methods: An IRB approved protocol enrolled women with gynecological, PET visible malignancies. A PET-CT was obtained for treatment planning prescribed to 45–50.4Gy with a 55– 70Gy boost to the PET positive nodes. An intra-treatment PET-CT was obtained between 30–36Gy, and all volumes re-contoured. Standard uptake values (SUVmax, SUVmean, SUVmedian) and GTV volumes were extracted from the clinician contoured GTVs on the pre- and intra-treament PET-CT for primaries and nodes and compared with a two tailed Wilcoxon signed-rank test. The differences between primary and node GTV volumes contoured in the treatment planning system and those volumes generated using PET Edge were also investigated. Bland-Altman plots were used to describe significant differences between the two contouring methods. Results: Thirteen women were enrolled in this study. The median baseline/intra-treatment primary (SUVmax, mean, median) were (30.5, 9.09, 7.83)/( 16.6, 4.35, 3.74), and nodes were (20.1, 4.64, 3.93)/( 6.78, 3.13, 3.26). The p values were all < 0.001. The clinical contours were all larger than the PET Edge generated ones, with mean difference of +20.6 ml for primary, and +23.5 ml for nodes. The Bland-Altman revealed changes between clinician/PET Edge contours to be mostly within the margins of the coefficient of variability. However, there was a proportional trend, i.e. the larger the GTV, the larger the clinical contours as compared to PET Edge contours. Conclusion: Primary and node SUV values taken from the intratreament PET-CT can be used to assess the disease response and to design an adaptive plan. The PET Edge tool can streamline the contouring process and lead to smaller, less user-dependent contours.

Project of law authorizing the approval of the protocol at the convention of November 27, 1992 dealing with the creation of an international indemnification fund for the damages due to the pollution by hydrocarbons; Projet de loi autorisant l'approbation du protocole a la convention du 27 novembre 1992 portant creation d'un fonds international d'indemnisation pour les dommages dus a la pollution par les hydrocarbures

Energy Technology Data Exchange (ETDEWEB)

NONE

2004-04-01

A series of recent tanker-ship wrecks has shown the insufficiency of the international indemnification fund (FIPOL 71) created in December 18, 1971 by the international maritime organization for victims of oil spill damages. The total available amount of the fund was raised to about 160 million euros by the protocols adopted in 1992, but despite this improvement, the fund remained far below the real damage costs of the recent maritime catastrophes. For this reason, a new protocol has been created which implements a complementary fund which can mobilize an additional amount of about 662 million euros. This new protocol has also redefined the rules of the financial participation of the contracting states. The present document is a project of law authorizing the approval of this protocol by France. It recalls the historical events that led to its creation, the changes added with respect to the previous protocol and its juridical framework inside the European Community. The text of the new protocol is attached. (J.S.)

Dietary Fat and Vitamin E in Prostate Cancer Risk Among African Americans and West Africans: A Case-Control Study

National Research Council Canada - National Science Library

Ukoli, Flora A; Smith, Ernest; Malin, Alecia; Zhao, Barbara; Osime, Usifo; Stain, Steven

2005-01-01

.... Nashville site: Administrative process including grant transfer, IRB approval, research assistant hire, design of souvenirs, posters and brochures has been completed, and purchase of supplies is in progress...

Dietary Fat and Vitamin E in Prostate Cancer Risk Among African Americans and Africans: A Case-Control Study

National Research Council Canada - National Science Library

Ukoli, Flora A; Smith, Ernest; Malin, Alecia; Zhao, Barbara; Osime, Usifo; Stain, Steven

2006-01-01

.... Nashville site: Administrative process including grant transfer, IRB approval, research assistant hire, design of souvenirs, posters and brochures has been completed, and purchase of supplies is in progress...

Safety of intrathecal transplantation of human umbilical cord mesenchymal stem cells for treating hereditary cerebellar ataxia: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Yi-hua An

2016-01-01

Trial registration: ClinicalTrials.gov identifier: NCT01489267; registered on 30 October 2011. The study protocol has been approved by the ethics committee of the General Hospital of Chinese Armed Police Forces, China (approval No. 201117.

SU-E-J-249: Characterization of Gynecological Tumor Heterogeneity Using Texture Analysis in the Context of An 18F-FDG PET Adaptive Protocol

Energy Technology Data Exchange (ETDEWEB)

Nawrocki, J [Duke University Medical Physics Graduate Program, Durham, NC (United States); Chino, J; Craciunescu, O [Duke University Medical Center Department of Radiation Oncology, Durham, NC (United States); Das, S [University of North Carolina School of Medicine, Chapel Hill, NC (United States)

2015-06-15

Purpose: We propose a method to examine gynecological tumor heterogeneity using texture analysis in the context of an adaptive PET protocol in order to establish if texture metrics from baseline PET-CT predict tumor response better than SUV metrics alone as well as determine texture features correlating with tumor response during radiation therapy. Methods: This IRB approved protocol included 29 women with node positive gynecological cancers visible on FDG-PET treated with EBRT to the PET positive nodes. A baseline and intra-treatment PET-CT was obtained. Tumor outcome was determined based on RECIST on posttreatment PET-CT. Primary GTVs were segmented using 40% threshold and a semi-automatic gradient-based contouring tool, PET Edge (MIM Software Inc., Cleveland, OH). SUV histogram features, Metabolic Volume (MV), and Total Lesion Glycolysis (TLG) were calculated. Four 3D texture matrices describing local and regional relationships between voxel intensities in the GTV were generated: co-occurrence, run length, size zone, and neighborhood difference. From these, 39 texture features were calculated. Prognostic power of baseline features derived from gradientbased and threshold GTVs were determined using the Wilcoxon rank-sum test. Receiver Operating Characteristics and logistic regression was performed using JMP (SAS Institute Inc., Cary, NC) to find probabilities of predicting response. Changes in features during treatment were determined using the Wilcoxon signed-rank test. Results: Of the 29 patients, there were 16 complete responders, 7 partial responders, and 6 non-responders. Comparing CR/PR vs. NR for gradient-based GTVs, 7 texture values, TLG, and SUV kurtosis had a p < 0.05. Threshold GTVs yielded 4 texture features and TLG with p < 0.05. From baseline to intra-treatment, 14 texture features, SUVmean, SUVmax, MV, and TLG changed with p < 0.05. Conclusion: Texture analysis of PET imaged gynecological tumors is an effective method for early prognosis and should

SU-E-J-249: Characterization of Gynecological Tumor Heterogeneity Using Texture Analysis in the Context of An 18F-FDG PET Adaptive Protocol

International Nuclear Information System (INIS)

Nawrocki, J; Chino, J; Craciunescu, O; Das, S

2015-01-01

Purpose: We propose a method to examine gynecological tumor heterogeneity using texture analysis in the context of an adaptive PET protocol in order to establish if texture metrics from baseline PET-CT predict tumor response better than SUV metrics alone as well as determine texture features correlating with tumor response during radiation therapy. Methods: This IRB approved protocol included 29 women with node positive gynecological cancers visible on FDG-PET treated with EBRT to the PET positive nodes. A baseline and intra-treatment PET-CT was obtained. Tumor outcome was determined based on RECIST on posttreatment PET-CT. Primary GTVs were segmented using 40% threshold and a semi-automatic gradient-based contouring tool, PET Edge (MIM Software Inc., Cleveland, OH). SUV histogram features, Metabolic Volume (MV), and Total Lesion Glycolysis (TLG) were calculated. Four 3D texture matrices describing local and regional relationships between voxel intensities in the GTV were generated: co-occurrence, run length, size zone, and neighborhood difference. From these, 39 texture features were calculated. Prognostic power of baseline features derived from gradientbased and threshold GTVs were determined using the Wilcoxon rank-sum test. Receiver Operating Characteristics and logistic regression was performed using JMP (SAS Institute Inc., Cary, NC) to find probabilities of predicting response. Changes in features during treatment were determined using the Wilcoxon signed-rank test. Results: Of the 29 patients, there were 16 complete responders, 7 partial responders, and 6 non-responders. Comparing CR/PR vs. NR for gradient-based GTVs, 7 texture values, TLG, and SUV kurtosis had a p < 0.05. Threshold GTVs yielded 4 texture features and TLG with p < 0.05. From baseline to intra-treatment, 14 texture features, SUVmean, SUVmax, MV, and TLG changed with p < 0.05. Conclusion: Texture analysis of PET imaged gynecological tumors is an effective method for early prognosis and should

Procedure for getting safety classed concrete structures approved by Finnish Radiation and Nuclear Safety Authority

International Nuclear Information System (INIS)

Halme, Ville-Juhani

2015-01-01

Posiva is preparing geological final disposal in the Finnish bedrock in Olkiluoto, Eurajoki. The final disposal facility includes encapsulation plant and underground repository. Most of the main civil structures are concrete structures. STUK is the supervising authority in civil structures. The National Building Code of Finland and STUK's Regulatory Guide on nuclear safety (YVL) are the most important instructions when constructing concrete structures into nuclear installation. Posiva has classified concrete structures in two classes according STUK's YVL-guidance: EYT (non-nuclear) and Safety Class 3 (SC 3, nuclear safety significance). When building SC 3 concrete structures, specific protocol must be followed. Protocol includes planned routines for design, construction, supervision, quality control (QC) and quality assurance (QA) activities. Documents relating concrete structures must be approved by Posiva and STUK before construction work. After structures have been designed and actual building is ongoing, there are two main steps. Before concreting, readiness inspection for concreting must be arranged. Readiness inspection will be arranged according to a specific plan and the date must be informed to STUK. After establishing readiness for concreting, casting work can begin. Once concrete structures are done, inspected and approved, final documentation according to a quality control plan will be reviewed by Posiva. After Posiva's approval, final documentation will be sent for STUK's approval. In the end STUK will give the permission for commissioning of the concrete structures after approved commissioning inspection. The document is made up of an abstract and a poster

A single center analysis of factors influencing study start-up timeline in clinical trials.

Science.gov (United States)

Krafcik, Brianna M; Doros, Gheorghe; Malikova, Marina A

2017-11-01

Efficient start-up phase in clinical trials is crucial to execution. The goal was to determine factors contributing to delays. The start-up milestones were assessed for 38 studies and analyzed. Total start-up time was shorter for following studies: device trials, no outsourcing, fewer ancillary services used and in interventional versus observational designs. The use of a centralized Institutional Review Board (IRB) versus a local IRB reduced time to approval. Studies that never enrolled took longer on average to finalize their budget/contract, and obtain IRB than ones that did enroll. Different features of clinical trials can affect timeline of start-up process. An understanding of the impact of each feature allows for optimization.

Developing implementation strategies for firearm safety promotion in paediatric primary care for suicide prevention in two large US health systems: a study protocol for a mixed-methods implementation study.

Science.gov (United States)

Wolk, Courtney Benjamin; Jager-Hyman, Shari; Marcus, Steven C; Ahmedani, Brian K; Zeber, John E; Fein, Joel A; Brown, Gregory K; Lieberman, Adina; Beidas, Rinad S

2017-06-24

The promotion of safe firearm practices, or firearms means restriction, is a promising but infrequently used suicide prevention strategy in the USA. Safety Check is an evidence-based practice for improving parental firearm safety behaviour in paediatric primary care. However, providers rarely discuss firearm safety during visits, suggesting the need to better understand barriers and facilitators to promoting this approach. This study, Adolescent Suicide Prevention In Routine clinical Encounters, aims to engender a better understanding of how to implement the three firearm components of Safety Check as a suicide prevention strategy in paediatric primary care. The National Institute of Mental Health-funded Mental Health Research Network (MHRN), a consortium of 13 healthcare systems across the USA, affords a unique opportunity to better understand how to implement a firearm safety intervention in paediatric primary care from a system-level perspective. We will collaboratively develop implementation strategies in partnership with MHRN stakeholders. First, we will survey leadership of 82 primary care practices (ie, practices serving children, adolescents and young adults) within two MHRN systems to understand acceptability and use of the three firearm components of Safety Check (ie, screening, brief counselling around firearm safety and provision of firearm locks). Then, in collaboration with MHRN stakeholders, we will use intervention mapping and the Consolidated Framework for Implementation Research to systematically develop and evaluate a multilevel menu of implementation strategies for promoting firearm safety as a suicide prevention strategy in paediatric primary care. Study procedures have been approved by the University of Pennsylvania. Henry Ford Health System and Baylor Scott & White institutional review boards (IRBs) have ceded IRB review to the University of Pennsylvania IRB. Results will be submitted for publication in peer-reviewed journals. © Article

Perinuclear anti-neutrophil cytoplasmic antibodies (p-anca) in chronic ulcerative colitis: Experience in a Mexican institution

Science.gov (United States)

Yamamoto-Furusho, Jesus K; Takahashi-Monroy, Takeshi; Vergara-Fernandez, Omar; Reyes, Edgardo; Uscanga, Luis

2006-01-01

AIM: To assess the prevalence and clinical value of p-ANCA in a sample of Mexican ulcerative colitis (UC) patients. METHODS: In a prospective, IRB-approved protocol, p-ANCA was determined in 80 patients with UC (mean age, 32 ± 12.9 years). The severity and extension of disease were determined by clinical methods, searching a statistical association with p-ANCA status. RESULTS: p-ANCA were detected in 41 (51%) patients. Severity of disease was the only clinical variable statistically associated with their presence (P < 0.0001; OR = 9; CI 95% = 3.2-24.7). CONCLUSION: The prevalence of p-ANCA was similar to that reported in other countries. Their presence was associated to UC severity, but offered no more information than the obtained by clinical methods. PMID:16733859

Standardised test protocol (Constant Score) for evaluation of functionality in patients with shoulder disorders

DEFF Research Database (Denmark)

Ban, Ilija; Troelsen, Anders; Christiansen, David Høyrup

2013-01-01

INTRODUCTION: The Constant Score (CS), developed as a scoring system to evaluate overall functionality of patients with shoulder disorders, is widely used but has been criticised for relying on an imprecise terminology and for lack of a standardised methodology. A modified guideline was therefore...... differences. One of the authors of the modified CS approved both the English and the Danish test protocol. CONCLUSION: A simple test protocol of the modified CS was developed in both English and Danish. With precise terminology and definitions, the test protocol is the first of its kind. We suggest its use...

Qualitative approach to patient-reported outcomes in oncology: protocol of a French study.

Science.gov (United States)

Orri, Massimiliano; Sibeoni, Jordan; Labey, Mathilde; Bousquet, Guilhem; Verneuil, Laurence; Revah-Levy, Anne

2015-07-10

The past decade has been characterised by movement from a doctor-centred to a patient-centred approach to treatment outcomes, in which doctors try to see the illness through their patients' eyes. Patients, family members and doctors are the three participants in cancer care, but their perspectives about what have been helpful during cancer treatment have never simultaneously and explicitly compared in the same qualitative study. The aim of this study project is to explore patients' perspectives about the care they receive, as well as families' and doctors' perspectives about what have been helpful for the patient. These three points of view will be compared and contrasted in order to analyse the convergences and divergences in these perspectives. This is a national multicentre qualitative study. Participants will be constituted by three different subsamples: (1) patients with cancer (skin, breast, urological and lung cancers), (2) their relatives, and (3) their referring physicians. Recruitment will follow the purposive sample technique, and the final sample size will be determined by data saturation. Data will be collected through open-ended semistructured interviews and independently analysed with NVivo V.10 software by three researchers according to the principles of Interpretative Phenomenological Analysis. The research protocol received approval from the University Paris Descartes review board (IRB number: 20140600001072), and participants will provide written consent. To the best of our knowledge, this is the first study to focus on the simultaneous exploration of the separate points of view of patients, families and doctors about the care received during the cancer care journey. We expect that our findings will help to improve communication and relationships between doctors, patients and families. Comparison of these three points of view will provide information about the convergences and divergences of these perspectives and how to address the needs of all

76 FR 47085 - Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer

Science.gov (United States)

2011-08-04

... manufacturers take action to prevent the further use of devices for which no PMA or PDP has been filed and may... completion of a product development protocol (PDP) for the class III preamendments device pacemaker... injury designed to be eliminated or reduced by requiring this device to meet the statute's approval...

Method-centered digital communities on protocols.io for fast-paced scientific innovation [version 2; referees: 2 approved

Directory of Open Access Journals (Sweden)

Lori Kindler

2017-06-01

Full Text Available The Internet has enabled online social interaction for scientists beyond physical meetings and conferences. Yet despite these innovations in communication, dissemination of methods is often relegated to just academic publishing. Further, these methods remain static, with subsequent advances published elsewhere and unlinked. For communities undergoing fast-paced innovation, researchers need new capabilities to share, obtain feedback, and publish methods at the forefront of scientific development. For example, a renaissance in virology is now underway given the new metagenomic methods to sequence viral DNA directly from an environment. Metagenomics makes it possible to "see" natural viral communities that could not be previously studied through culturing methods. Yet, the knowledge of specialized techniques for the production and analysis of viral metagenomes remains in a subset of labs.  This problem is common to any community using and developing emerging technologies and techniques. We developed new capabilities to create virtual communities in protocols.io, an open access platform, for disseminating protocols and knowledge at the forefront of scientific development. To demonstrate these capabilities, we present a virology community forum called VERVENet. These new features allow virology researchers to share protocols and their annotations and optimizations, connect with the broader virtual community to share knowledge, job postings, conference announcements through a common online forum, and discover the current literature through personalized recommendations to promote discussion of cutting edge research. Virtual communities in protocols.io enhance a researcher's ability to: discuss and share protocols, connect with fellow community members, and learn about new and innovative research in the field.  The web-based software for developing virtual communities is free to use on protocols.io. Data are available through public APIs at protocols.io.

76 FR 32333 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Revision to the...

Science.gov (United States)

2011-06-06

...) Program--Quality Assurance Protocol for the Safety Inspection Program in Non-I/M Counties AGENCY... Implementation Plan (SIP) revision submitted by the Commonwealth of Pennsylvania for the purpose of changing the...). Specifically, the Commonwealth is amending a provision of its prior SIP-approved I/M program to amend the...

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African Journals Online (AJOL)

This study was approved by the Loma Linda University. Institutional Review Board (IRB) ... about exclusive breastfeeding, he encouraged me to follow the instructions. .... Women also cited the benefits of adhering to exclusive breastfeeding for ...

Integrative Cardiac Health Project

Science.gov (United States)

2012-10-01

C - reactive protein, lipoprotein (a), thyroid stimulating hormone, vitamin D, and fibrin D-dimer), blood pressure, heart rate, pulse pressure, EKG ...WRNMMC IRB approval on 23 Feb 12 and begun study enrollment/data collection in March. ICHP personnel involvement (collection of EKG , CIMT, training on... read and approved of the manuscript. Running Title: Abbreviated Mindfulness and Lifestyle Modification KEY WORDS: Mindfulness, Lifestyle

Measurement protocol for performance testing of the determination of tritium in water

International Nuclear Information System (INIS)

1993-01-01

In the Health and Safety Executive's ''Requirements for the Approval of Dosimetry Services under the Ionising Radiations Regulations 1985'', it is stipulated that dosimetry services seeking approval must show that they have successfully completed a performance test. The services must arrange for the tests to be carried out on application and thereafter every 18 months, by a laboratory which has received accreditation from the National Measurement Accreditation Service (NAMAS) for conducting the performance tests. Accreditation by NAMAS ensures that the laboratories carrying out the performance tests are of an appropriate standard. It includes requirements for quality control and audit procedures, to authenticate traceability to national standards, and to provide a reliable record keeping system for the performance tests. A list of laboratories which are accredited by NAMAS for carrying out HSE published performance tests will be maintained by the Secretary of the Dosimetry Services Panel. The performance tests must be carried out to published protocols. The results have to be expressed in terms of bias and random error, as defined in HSE's criteria for performance tests. The purpose here is to provide a protocol for laboratories to conduct performance tests on dosimetry services performing tritium determinations in urine. The test is deliberately not exhaustive, instead it is a simple test allowing the basic performance of a service to be assessed for approval. (author)

Regulatory considerations concerning IND radiopharmaceutical drug products

International Nuclear Information System (INIS)

Nissel, M.

1985-01-01

The Food and Drug Administration is charged by the Food, Drug, and Cosmetic Act, as presently amended, to assure that any drug introduced into interstate commerce is safe and effective for the purposes for which it is labeled. A radiopharmaceutical is, by definition, a new drug unless there is in effect an approved New Drug Application (NDA) for it. Before the data for the NDA are compiled, investigative studies have to be done. Before such studies can be performed in humans, an exemption from the Act is necessary. This exemption, technically the Claimed Exemption for an Investigational New Drug, is termed the IND. Both the scientific and the administrative requirements for an IND are discussed. For radiopharmaceutical drug products (RDP's), the radiation hazards, as well as the pharmacological ones, must be documented. Should the early studies demonstrate a potential for efficacy in a certain condition or disease state, an investigative protocol for an extended clinical trial is presented. The necessary requirements for Institutional Review Board (IRB) approval and consent forms are discussed. For certain research purposes, uniquely for radioactive drugs, an IND is not required for certain specific studies; the requirements for such a research study, conducted under the auspices of an approved radioactive drug research committee, are outlined

Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols

DEFF Research Database (Denmark)

Chan, A.W.; Hrobjartsson, A.; Jorgensen, K.J.

2008-01-01

OBJECTIVE: To evaluate how often sample size calculations and methods of statistical analysis are pre-specified or changed in randomised trials. DESIGN: Retrospective cohort study. Data source Protocols and journal publications of published randomised parallel group trials initially approved...... in 1994-5 by the scientific-ethics committees for Copenhagen and Frederiksberg, Denmark (n=70). MAIN OUTCOME MEASURE: Proportion of protocols and publications that did not provide key information about sample size calculations and statistical methods; proportion of trials with discrepancies between...... of handling missing data was described in 16 protocols and 49 publications. 39/49 protocols and 42/43 publications reported the statistical test used to analyse primary outcome measures. Unacknowledged discrepancies between protocols and publications were found for sample size calculations (18/34 trials...

The programme 'fission product deposition' at the IRB of Juelich nuclear research centre

International Nuclear Information System (INIS)

Gottaut, H.; Iniotakis, N.; Malinowski, J.; Muenchow, K.H.; Sackmann, B.

1976-01-01

The transport and deposition behaviour of the non-gaseous fission and activation products in the primary circuit of HTR-type reactors determines the possibility of inspection and maintenance of single components of the primary circuit as well as the safety of the reactor in normal operation and during accidents. For the investigation of these problems, the programme 'fission product deposition' was started at Juelich nuclear research centre in 1969 in cooperation with a number of industrial firms. The programme covers in-pile and out-of-pile experiments, in which the HTR conditions are simulated as realistically as possible, as well as various laboratory experiments and extensive theoretical studies. It is the objective of this work to establish a realistic physical model and computer programme with which the transport and deposition of nuclides in the primary circuit of HTR reactors can be calculated in advance. A report is given on the experimental and theoretical studies carried out at the IRB of Juelich nuclear research centre. (orig./AK) [de

[Sampling and measurement methods of the protocol design of the China Nine-Province Survey for blindness, visual impairment and cataract surgery].

Science.gov (United States)

Zhao, Jia-liang; Wang, Yu; Gao, Xue-cheng; Ellwein, Leon B; Liu, Hu

2011-09-01

To design the protocol of the China nine-province survey for blindness, visual impairment and cataract surgery to evaluate the prevalence and main causes of blindness and visual impairment, and the prevalence and outcomes of the cataract surgery. The protocol design was began after accepting the task for the national survey for blindness, visual impairment and cataract surgery from the Department of Medicine, Ministry of Health, China, in November, 2005. The protocol in Beijing Shunyi Eye Study in 1996 and Guangdong Doumen County Eye Study in 1997, both supported by World Health Organization, was taken as the basis for the protocol design. The relative experts were invited to discuss and prove the draft protocol. An international advisor committee was established to examine and approve the draft protocol. Finally, the survey protocol was checked and approved by the Department of Medicine, Ministry of Health, China and Prevention Program of Blindness and Deafness, WHO. The survey protocol was designed according to the characteristics and the scale of the survey. The contents of the protocol included determination of target population and survey sites, calculation of the sample size, design of the random sampling, composition and organization of the survey teams, determination of the examinee, the flowchart of the field work, survey items and methods, diagnostic criteria of blindness and moderate and sever visual impairment, the measures of the quality control, the methods of the data management. The designed protocol became the standard and practical protocol for the survey to evaluate the prevalence and main causes of blindness and visual impairment, and the prevalence and outcomes of the cataract surgery.

Fertility Preservation for Children Diagnosed with Cancer

Medline Plus

Full Text Available ... for Children Diagnosed with Cancer Ask Your Doctor Information for Patients Many adult survivors of childhood cancer ... study approved by an IRB . Resources For more information about infertility risk and fertility preservation options for ...

How blockchain-timestamped protocols could improve the trustworthiness of medical science [version 3; referees: 3 approved

OpenAIRE

Greg Irving; John Holden

2017-01-01

Trust in scientific research is diminished by evidence that data are being manipulated. Outcome switching, data dredging and selective publication are some of the problems that undermine the integrity of published research. Methods for using blockchain to provide proof of pre-specified endpoints in clinical trial protocols were first reported by Carlisle.?We wished to empirically test such an approach using a clinical trial protocol where outcome switching has previously been reported. Here w...

75 FR 27647 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Revisions to the Emission...

Science.gov (United States)

2010-05-18

... severable portions of two revisions to the Texas State Implementation Plan (SIP) submitted by the State of... further clarify procedures for using emission protocols and to update the approved list of emission credit... to recently recodified 30 TAC Chapter 117 provisions. EPA has determined that these SIP revisions...

Variation in radiographic protocols in paediatric interventional cardiology

International Nuclear Information System (INIS)

McFadden, S L; Hughes, C M; Winder, R J

2013-01-01

The aim of this work is to determine current radiographic protocols in paediatric interventional cardiology (IC) in the UK and Ireland. To do this we investigated which imaging parameters/protocols are commonly used in IC in different hospitals, to identify if a standard technique is used and illustrate any variation in practice. A questionnaire was sent to all hospitals in the UK and Ireland which perform paediatric IC to obtain information on techniques used in each clinical department and on the range of clinical examinations performed. Ethical and research governance approval was sought from the Office for Research Ethics Committees Northern Ireland and the individual trusts. A response rate of 79% was achieved, and a wide variation in technique was found between hospitals. The main differences in technique involved variations in the use of an anti-scatter grid and the use of additional filtration to the radiation beam, frame rates for digital acquisition and pre-programmed projections/paediatric specific programming in the equipment. We conclude that there is no standard protocol for carrying out paediatric IC in the UK or Ireland. Each hospital carries out the IC procedure according to its own local protocols resulting in a wide variation in radiation dose. (paper)

Variation in radiographic protocols in paediatric interventional cardiology.

Science.gov (United States)

McFadden, S L; Hughes, C M; Winder, R J

2013-06-01

The aim of this work is to determine current radiographic protocols in paediatric interventional cardiology (IC) in the UK and Ireland. To do this we investigated which imaging parameters/protocols are commonly used in IC in different hospitals, to identify if a standard technique is used and illustrate any variation in practice. A questionnaire was sent to all hospitals in the UK and Ireland which perform paediatric IC to obtain information on techniques used in each clinical department and on the range of clinical examinations performed. Ethical and research governance approval was sought from the Office for Research Ethics Committees Northern Ireland and the individual trusts. A response rate of 79% was achieved, and a wide variation in technique was found between hospitals. The main differences in technique involved variations in the use of an anti-scatter grid and the use of additional filtration to the radiation beam, frame rates for digital acquisition and pre-programmed projections/paediatric specific programming in the equipment. We conclude that there is no standard protocol for carrying out paediatric IC in the UK or Ireland. Each hospital carries out the IC procedure according to its own local protocols resulting in a wide variation in radiation dose.

Bill authorizing the approval of the additional protocol to the construction agreement between the French government and the International organization of fusion energy for the joint implementation of the ITER project, and relative to the role of the labour inspection on the ITER international organization site and dealing with occupational health and safety

International Nuclear Information System (INIS)

2009-10-01

The aim of the additional protocol to the construction agreement between the French Government and the ITER Organization is to allow the French labour inspection services to control the good respect of the French occupational health and safety regulation at the project site (Cadarache, Bouches du Rhone) and to play its role of adviser to the persons responsible for the organization. This bill gives permission to the approval of this additional protocol. It allows the labour inspectors to do their job on the ITER site. (J.S.)

The Project Based Mechanisms of the Kyoto Protocol. Credible Instruments or Challenges to the Integrity of the Kyoto Protocol?

Energy Technology Data Exchange (ETDEWEB)

Takeuchi Waldegren, Linn

2006-03-15

The project based mechanisms of the Kyoto Protocol are innovative instruments which allow projects to earn credits for reducing greenhouse gas (GHG) emissions. The credits can in turn be used by countries to reach their emissions targets according to the Kyoto Protocol. The Project based mechanisms are known as the Clean Development Mechanism (CDM) and the Joint Implementation (JI). If the project based mechanisms are to be effective policy instruments they must ensure the integrity of the Kyoto Protocol, and their ability to promote and prove real emission reductions is critical. The environmental credibility of the project based mechanisms will also ensure their ability to promote cost effectiveness. Key concepts in this context are environmental and project additionality, and their role and value for the project based mechanisms are analyzed. Environmental additionality is established by comparing a project's emissions to a baseline. The baseline's credibility is thus vital. The concept of project additionality is somewhat controversial, but is nonetheless of equal importance. The case studies of CDM approved methodologies (AMs) and proposed projects suggest that there are credibility issues that need to be addressed if the project based mechanisms are to promote real emissions reductions.

Redactions in protocols for drug trials: what industry sponsors concealed.

Science.gov (United States)

Marquardsen, Mikkel; Ogden, Michelle; Gøtzsche, Peter C

2018-04-01

Objective To describe the redactions in contemporary protocols for industry-sponsored randomised drug trials with patient relevant outcomes and to evaluate whether there was a legitimate rationale for the redactions. Design Cohort study. Under the Freedom of Information Act, we requested access to trial protocols approved by a research ethics committee in Denmark from October 2012 to March 2013. We received 17 consecutive protocols, which had been redacted before we got them, and nine protocols without redactions. In five additional cases, the companies refused to let the committees give us access, and in three other cases, documents were missing. Participants Not applicable. Setting Not applicable. Main outcome measure Amount and nature of redactions in 22 predefined key protocol variables. Results The redactions were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials: data analysis, handling of missing data, detection and analysis of adverse events, definition of the outcomes, interim analyses and premature termination of the study, sponsor's access to incoming data while the study is running, ownership to the data and investigators' publication rights. The parts of the text that were redacted differed widely, both between companies and within the same company. Conclusions We could not identify any legitimate rationale for the redactions. The current mistrust in industry-sponsored drug trials can only change if the industry offers unconditional access to its trial protocols and other relevant documents and data.

Medical students as human subjects in educational research

Directory of Open Access Journals (Sweden)

Adina L. Kalet

2013-02-01

Full Text Available Introduction: Special concerns often arise when medical students are themselves the subjects of education research. A recently completed large, multi-center randomized controlled trial of computer-assisted learning modules for surgical clerks provided the opportunity to explore the perceived level of risk of studies where medical students serve as human subjects by reporting on: 1 the response of Institutional Review Boards (IRBs at seven institutions to the same study protocol; and 2 the thoughts and feelings of students across study sites about being research subjects. Methods: From July 2009 to August 2010, all third-year medical students at seven collaborating institutions were eligible to participate. Patterns of IRB review of the same protocol were compared. Participation burden was calculated in terms of the time spent interacting with the modules. Focus groups were conducted with medical students at each site. Transcripts were coded by three independent reviewers and analyzed using Atlas.ti. Results: The IRBs at the seven participating institutions granted full (n=1, expedited (n=4, or exempt (n=2 review of the WISE Trial protocol. 995 (73% of those eligible consented to participate, and 207 (20% of these students completed all outcome measures. The average time to complete the computer modules and associated measures was 175 min. Common themes in focus groups with participant students included the desire to contribute to medical education research, the absence of coercion to consent, and the low-risk nature of the research. Discussion: Our findings demonstrate that risk assessment and the extent of review utilized for medical education research vary among IRBs. Despite variability in the perception of risk implied by differing IRB requirements, students themselves felt education research was low risk and did not consider themselves to be vulnerable. The vast majority of eligible medical students were willing to participate as research

Fertility Preservation for Children Diagnosed with Cancer

Medline Plus

Full Text Available ... Online Fertility Preservation Toolkit for Patients and Their Providers Open menu Reprotopia_Main_Menu About SaveMyFertility Provider ... of a clinical study approved by an IRB . Resources For more information about infertility risk and fertility ...

Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair. Final order.

Science.gov (United States)

2016-01-05

The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) for surgical mesh for transvaginal pelvic organ prolapse (POP) repair.

Protocol of specific health monitoring: ionizing radiation, 11 years later

International Nuclear Information System (INIS)

Castillejo Puertas, F. M.

2016-01-01

Since the approval on November 11 t h 2003 of the Protocol of Specific Health Monitoring for Workers Exposed to Ionizing Radiation a study has been carried out to discover its effectiveness. These areas were examined: the daily practice od accupational medicine and, in particular, its specific task in the application of the different clinical/labour criteria for workers exposed to ionizing radiation or at risk of radioactive contamination; the degree of its uses as well as the updates and improvements. For that purpose, a descriptive bibliographic revision has been used for the last 11 years. The results revealed the lack of updates of the Protocol as well as the few usable objective criteria, when the clinical/labour aptitudes are reflected upon. (Author)

Newborn hearing screening protocol in tuscany region.

Science.gov (United States)

Berrettini, Stefano; Ghirri, Paolo; Lazzerini, Francesco; Lenzi, Giovanni; Forli, Francesca

2017-09-20

Newborn hearing screening has to be considered the first step of a program for the identification, diagnosis, treatment and habilitation/rehabilitation of children with hearing impairment. In Tuscany Region of Italy, the universal newborn hearing screening is mandatory since november 2007. The first guidelines for the execution of the screening have been released in June 2008; then many other Italian regions partially or totally adopted these guidelines. On the basis of the experience from 2008 and according to the recent evidences in the scientific literature, a new screening protocol was released in Tuscany region. The new protocol is an evolution of the previous one. Some issues reported in the previous protocol and in the Joint Committee on Infant Hearing statement published in 2007 were revised, such as the risk factors for auditory neuropathy and for late onset, progressive or acquired hearing loss. The new updated guidelines were submitted to the Sanitary Regional Council and then they have been approved in August 2016. The updated screening protocol is mainly aimed to identify newborns with a congenital moderate-to-profound hearing loss, but it also provides indications for the audiological follow-up of children with risk's factor for progressive or late onset hearing loss; further it provides indications for the audiological surveillance of children at risk for acquired hearing impairment. Then, in the new guidelines the role of the family paediatrician in the newborn hearing screening and audiological follow-up and surveillance is underscored. Finally the new guidelines provide indications for the treatment with hearing aids and cochlear implant, in accordance with the recent Italian Health Technology Assessment (HTA) guidelines. In the paper we report the modality of execution of the universal newborn hearing screening in the Tuscany Region, according to the recently updated protocol. The main features of the protocol and the critical issues are

Local administration of enriched mononuclear cells, platelets and zoledronic acid for preventing collapse of the femoral head in the early stage of osteonecrosis: study protocol for a prospective randomized parallel-controlled clinical trial

Directory of Open Access Journals (Sweden)

Ning Ma

2016-01-01

Trial registration: ClinicalTrial.gov identifier: NCT02721940. Written approval for this protocol was obtained from the ethics committee of the Chinese PLA General Hospital in China (approval No. S2015-082-01.

Safety of Therapeutic Fever Induction in Cancer Patients Using Approved PAMP Drugs

Directory of Open Access Journals (Sweden)

Uwe Rudolf Max Reuter

2018-04-01

Full Text Available William Coley, between 1895 and 1936, treated hundreds of cancer patients using infusions of fever inducing bacerial extracts. Similar experiments were done by Klyuyeva and co-workers in the 1940ies in Russia using trypanosoma extracts. Many remissions and cures were reported. We have conjectured that pathogen associated molecular pattern substances (PAMP are the molecular explanation for the beneficial treatments in both groups. We could show that a combination of PAMP can eradicate solid tumours in cancer mice if applied several times. Accordingly, we suggested to combine PAMP containing approved drugs to treat cancer patients using a protocol similar to the old fever induction regimen. In this retrospective phase-1 study we report on the fever induction capacity and safety of applications of bacterial extracts, combinations of bacterial extracts with approved drugs, and combinations of approved drugs in 131 mainly cancer patients. Adverse reactions were those which can be expected during a feverish infection and mild. Over 523 fever inductions, no severe adverse reaction was observed.

Anticipate and communicate: Ethical management of incidental and secondary findings in the clinical, research, and direct-to-consumer contexts (December 2013 report of the Presidential Commission for the Study of Bioethical Issues).

Science.gov (United States)

Weiner, Christine

2014-09-15

Genomic population research increases the possibility of finding genetic coding anomalies that are not the primary object of research but may have significance for the current and future medical care of research participants and progeny. The December 2013 Report of the Presidential Commission for the Study of Bioethical Issues (Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts (http://bioethics.gov/sites/default/files/FINALAnticipateCommunicate_PCSBI_0.pdf)) recommends that a researcher anticipate these findings and make a plan that addresses which findings will be communicated to research participants and how. Following these recommendations will be disruptive for both investigators and institutional review boards (IRBs) until the research community reaches consensus, or a mechanism for evolving consensus, on which results should be returned to research participants. A protocol-by-protocol approach, though laborious, makes sense for both investigators and IRBs as the research community thinks through the implications of genomic research. Epidemiologists will note that discussion of the return of results and the plan for communicating findings should be included in both the participant consent agreement and the research protocol submitted to the IRB. © The Author 2014. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Phase 2 Study of AZD2014, a Dual mTORC1/mTORC1 Inhibitor,for NF2 Patients with Progressive or Symptomatic Meningiomas

Science.gov (United States)

2017-06-01

statistical support for the clinical trial. Funding support N/A Name Nicola Gribbin, RN Project Role Research Nurse Nearest person-month worked 1...the author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other...Obtain institutional approval for proposed clinical trial (months 1-6) In year 1, we obtained IRB approval at MGH and USAMRMC Human Research Protection

Optical Quality, Threshold Target Identification, and Military Target Task Performance After Advanced Keratorefractive Surgery

Science.gov (United States)

2012-05-01

Expiration Date 27 October 2011 2 cornea is approved by the Food and Drug Administration (FDA) and the procedure is not considered...and Drug Administration , the Department of Walter Reed National Military Medical Center, Bethesda IRBNet# 20481 IRB Approval Date: 29 November 2011...farsightedness or astigmatism, the clear front surface of your eye, the “ cornea ”, does not have the proper focusing power. To correct this deficiency you must

34 CFR 97.111 - Criteria for IRB approval of research.

Science.gov (United States)

2010-07-01

... 97.111 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research... protect the rights and welfare of these subjects. (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and...

28 CFR 46.111 - Criteria for IRB approval of research.

Science.gov (United States)

2010-07-01

..., prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons... coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or... protect the rights and welfare of these subjects. ...

22 CFR 225.111 - Criteria for IRB approval of research.

Science.gov (United States)

2010-04-01

..., prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons... coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or... protect the rights and welfare of these subjects. ...

Investigation of the Study Characteristics Affecting Clinical Trial Quality Using the Protocol Deviations Leading to Exclusion of Subjects From the Per Protocol Set Data in Studies for New Drug Application: A Retrospective Analysis.

Science.gov (United States)

Kohara, Norihito; Kaneko, Masayuki; Narukawa, Mamoru

2018-01-01

The concept of the risk-based approach has been introduced as an effort to secure the quality of clinical trials. In the risk-based approach, identification and evaluation of risk in advance are considered important. For recently completed clinical trials, we investigated the relationship between study characteristics and protocol deviations leading to the exclusion of subjects from Per Protocol Set (PPS) efficacy analysis. New drugs approved in Japan in the fiscal year 2014-2015 were targeted in the research. The reasons for excluding subjects from the PPS efficacy analysis were described in 102 trials out of 492 in the summary of new drug application documents, which was publicly disclosed after the drug's regulatory approval. The author extracted these reasons along with the numbers of the cases and the study characteristics of each clinical trial. Then, the direct comparison, univariate regression analysis, and multivariate regression analysis was carried out based on the exclusion rate. The study characteristics for which exclusion of subjects from the PPS efficacy analysis were frequently observed was multiregional clinical trials in study region; inhalant and external use in administration route; Anti-infective for systemic use; Respiratory system, Dermatologicals, and Nervous system in therapeutic drug under the Anatomical Therapeutic Chemical Classification. In the multivariate regression analysis, the clinical trial variables of inhalant, Respiratory system, or Dermatologicals were selected as study characteristics leading to a higher exclusion rate. The characteristics of the clinical trial that is likely to cause protocol deviations that will affect efficacy analysis were suggested. These studies should be considered for specific attention and priority observation in the trial protocol or its monitoring plan and execution, such as a clear description of inclusion/exclusion criteria in the protocol, development of training materials to site staff, and

How blockchain-timestamped protocols could improve the trustworthiness of medical science [version 3; referees: 3 approved

Directory of Open Access Journals (Sweden)

Greg Irving

2017-03-01

Full Text Available Trust in scientific research is diminished by evidence that data are being manipulated. Outcome switching, data dredging and selective publication are some of the problems that undermine the integrity of published research. Methods for using blockchain to provide proof of pre-specified endpoints in clinical trial protocols were first reported by Carlisle. We wished to empirically test such an approach using a clinical trial protocol where outcome switching has previously been reported. Here we confirm the use of blockchain as a low cost, independently verifiable method to audit and confirm the reliability of scientific studies.

How blockchain-timestamped protocols could improve the trustworthiness of medical science [version 2; referees: 2 approved

Directory of Open Access Journals (Sweden)

Greg Irving

2016-05-01

Full Text Available Trust in scientific research is diminished by evidence that data are being manipulated. Outcome switching, data dredging and selective publication are some of the problems that undermine the integrity of published research. Methods for using blockchain to provide proof of pre-specified endpoints in clinical trial protocols were first reported by Carlisle. We wished to empirically test such an approach using a clinical trial protocol where outcome switching has previously been reported. Here we confirm the use of blockchain as a low cost, independently verifiable method to audit and confirm the reliability of scientific studies.

Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory

DEFF Research Database (Denmark)

Hróbjartsson, Asbjørn; Pildal, Julie; Chan, An-Wen

2009-01-01

OBJECTIVE: To compare the reporting on blinding in protocols and articles describing randomized controlled trials. STUDY DESIGN AND SETTING: We studied 73 protocols of trials approved by the scientific/ethical committees for Copenhagen and Frederiksberg, 1994 and 1995, and their corresponding...... publications. RESULTS: Three out of 73 trials (4%) reported blinding in the protocol that contradicted that in the publication (e.g., "open" vs. "double blind"). The proportion of "double-blind" trials with a clear description of the blinding of participants increased from 11 out of 58 (19%) when based...... on publications alone to 39 (67%) when adding the information in the protocol. The similar proportions for the blinding of health care providers were 2 (3%) and 22 (38%); and for the blinding of data collectors, they were 8 (14%) and 14 (24%). In 52 of 58 publications (90%), it was unclear whether all patients...

A Comprehensive Review of US FDA-Approved Immune Checkpoint Inhibitors in Urothelial Carcinoma

Directory of Open Access Journals (Sweden)

Fu-Shun Hsu

2017-01-01

Full Text Available Few effective treatment options are available for patients with advanced or metastatic urothelial carcinoma (UC after unsuccessful first-line platinum-based chemotherapy. To date, immune checkpoint inhibitors are novel therapeutic agents for UC treatment. From May 2016 to May 2017, five anti-PD-1/PD-L1 monoclonal antibodies received accelerated or regular approval from the US Food and Drug Administration (FDA for the treatment of patients with locally advanced or metastatic UC. The present comprehensive review presents the background information of these five US FDA-approved anticancer agents to provide a basic but concise understanding of these agents for advanced studies. We summarize their immune checkpoint mechanisms, clinical efficacy, recommended usage protocols, adverse events, and the limitations of the PD-L1 biomarker assays.

Design and Rationale of a Comparative Effectiveness Study to Evaluate Two Acupuncture Methods for the Treatment of Headaches Associated with Traumatic Brain Injury

Science.gov (United States)

2011-01-01

origins (4) Drug/opioid desensitization (with abuse potential) (5) Somatic (sleep, appetite, sexual, and energy) dys- function. Problems with Current Care...participants who learn about the study through institutional review board (IRB)–approved advertisements or who are referred from the TBI clinic are screened

The compressed breast during mammography and breast tomosynthesis: in vivo shape characterization and modeling

NARCIS (Netherlands)

Rodriguez Ruiz, A.; Agasthya, G.A.; Sechopoulos, I.

2017-01-01

To characterize and develop a patient-based 3D model of the compressed breast undergoing mammography and breast tomosynthesis. During this IRB-approved, HIPAA-compliant study, 50 women were recruited to undergo 3D breast surface imaging with structured light (SL) during breast compression, along

SU-F-SPS-03: Direct Measurement of Organ Doses Resulting From Head and Cervical Spine Trauma CT Protocols

Energy Technology Data Exchange (ETDEWEB)

Carranza, C; Lipnharski, I; Quails, N; Correa, N; Rill, L; Arreola, M [University of Florida, Gainesville, FL (United States)

2016-06-15

Purpose: This retrospective study analyzes the exposure history of emergency department (ED) patients undergoing head and cervical spine trauma computed tomography (CT) studies. This study investigated dose levels received by trauma patients and addressed any potential concerns regarding radiation dose issues. Methods: Under proper IRB approval, a cohort of 300 trauma cases of head and cervical spine trauma CT scans received in the ED was studied. The radiological image viewing software of the hospital was used to view patient images and image data. The following parameters were extracted: the imaging history of patients, the reported dose metrics from the scanner including the volumetric CT Dose Index (CTDIvol) and Dose Length Product (DLP). A postmortem subject was scanned using the same scan techniques utilized in a standard clinical head and cervical spine trauma CT protocol with 120 kVp and 280 mAs. The CTDIvol was recorded for the subject and the organ doses were measured using optically stimulated luminescent (OSL) dosimeters. Typical organ doses to the brain, thyroid, lens, salivary glands, and skin, based on the cadaver studies, were then calculated and reported for the cohort. Results: The CTDIvol reported by the CT scanner was 25.5 mGy for the postmortem subject. The average CTDIvol from the patient cohort was 34.1 mGy. From these metrics, typical average organ doses in mGy were found to be: Brain (44.57), Thyroid (33.40), Lens (82.45), Salivary Glands (61.29), Skin (47.50). The imaging history of the cohort showed that on average trauma patients received 26.1 scans over a lifetime. Conclusion: The average number of scans received on average by trauma ED patients shows that radiation doses in trauma patients may be a concern. Available dose tracking software would be helpful to track doses in trauma ED patients, highlighting the importance of minimizing unnecessary scans and keeping doses ALARA.

Fosfomycin versus meropenem in bacteraemic urinary tract infections caused by extended-spectrum β-lactamase-producing Escherichia coli (FOREST): study protocol for an investigator-driven randomised controlled trial.

Science.gov (United States)

Rosso-Fernández, Clara; Sojo-Dorado, Jesús; Barriga, Angel; Lavín-Alconero, Lucía; Palacios, Zaira; López-Hernández, Inmaculada; Merino, Vicente; Camean, Manuel; Pascual, Alvaro; Rodríguez-Baño, Jesús

2015-03-31

Finding therapeutic alternatives to carbapenems in infections caused by extended-spectrum β-lactamase-producing Escherichia coli (ESBL-EC) is imperative. Although fosfomycin was discovered more than 40 years ago, it was not investigated in accordance with current standards and so is not used in clinical practice except in desperate situations. It is one of the so-called neglected antibiotics of high potential interest for the future. The main objective of this project is to demonstrate the clinical non-inferiority of intravenous fosfomycin with regard to meropenem for treating bacteraemic urinary tract infections (UTI) caused by ESBL-EC. This is a 'real practice' multicentre, open-label, phase III randomised controlled trial, designed to compare the clinical and microbiological efficacy, and safety of intravenous fosfomycin (4 g/6 h) and meropenem (1 g/8 h) as targeted therapy for this infection; a change to oral therapy is permitted after 5 days in both arms, in accordance with predetermined options. The study design follows the latest recommendations for designing trials investigating new options for multidrug-resistant bacteria. Secondary objectives include the study of fosfomycin concentrations in plasma and the impact of both drugs on intestinal colonisation by multidrug-resistant Gram-negative bacilli. Ethical approval was obtained from the Andalusian Coordinating Institutional Review Board (IRB) for Biomedical Research (Referral Ethics Committee), which obtained approval from the local ethics committees at all participating sites in Spain (22 sites). Data will be presented at international conferences and published in peer-reviewed journals. This project is proposed as an initial step in the investigation of an orphan antimicrobial of low cost with high potential as a therapeutic alternative in common infections such as UTI in selected patients. These results may have a major impact on the use of antibiotics and the development of new projects

Clinical Trials

Medline Plus

Full Text Available ... are ethical and that the participants' rights are protected. The IRB reviews the trial's protocol before the ... may know about studies going on in your area. You can visit the following website to learn ...

Interventions for Sustainable Weight Loss in Military Families

Science.gov (United States)

recruitment of 290 adult family members of Active Duty / Retirees (ADMP). To enhance our marketing efforts, we received IRB approval to create a study...through connections made at the 2017 IPR meeting, we participated in discussions with LTC McKnight ( Principle Advisor and Military Attach Environmental

Effects of UAV Supervisory Control on F-18 Formation Flight Performance in a Simulator Environment

Science.gov (United States)

2013-03-01

of stimuli. The complexity and level of multitasking required by aviators is generally viewed as high, but the field could significantly benefit...Strike Lead). Volunteers for this study were recruited from the base by an Institutional Review Board (IRB) approved email sent to squadrons at NAS

Research Ethics: Institutional Review Board Oversight of Art Therapy Research

Science.gov (United States)

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…

Dr. John H. Hopps Jr. Research Scholars Program

Science.gov (United States)

2014-10-20

Program staff, alumni and existing participants. Over the course of the last five months, SageFox has successfully obtained IRB approval for all...and awards. Progress made in development of the HoppsNet system included design and implementation of a relational database in MySQL , development of

Generación de trayectorias y evitación de obstáculos para el robot IRB120 en entorno Matlab

OpenAIRE

Blanco Fernández, Nicolás

2015-01-01

En este proyecto se abordará el desarrollo de una aplicación que permita una comunicación eficaz y fluida con el brazo robótico IRB120 de ABB desde el entorno Matlab, posibilitando la generación de trayectorias definidas por el usuario a través de unos “puntos de paso” intermedios, así como la detección de nuevos obstáculos presentes en la trayectoria del robot y la planificación de nuevas trayectorias recalculadas para evitarlos. La detección del área de trabajo se efectuará mediante el s...

Ethics and observational studies in medical research: various rules in a common framework

Science.gov (United States)

Claudot, Frédérique; Alla, François; Fresson, Jeanne; Calvez, Thierry; Coudane, Henry; Bonaïti-Pellié, Catherine

2009-01-01

Background Research ethics have become universal in their principles through international agreements. The standardization of regulations facilitates the internationalization of research concerning drugs. However, in so-called observational studies (i.e. from data collected retrospectively or prospectively, obtained without any additional therapy or monitoring procedure), the modalities used for applying the main principles vary from one country to the other. This situation may entail problems for the conduct of multi-centric international studies, as well as for the publication of results if the authors and editors come from countries governed by different regulations. In particular, several French observational studies were rejected or retracted by United States peer reviewed journals, because their protocols have not been submitted to an Institutional Review Board/Independent Ethics Committee (IRB/IEC). Methods national legislation case analysis Results In accordance with European regulation, French observational studies from data obtained without any additional therapy or monitoring procedure, do not need the approval of an IRB/IEC. Nevertheless, these researches are neither exempt from scientific opinion nor from ethical and legal authorization. Conclusion We wish to demonstrate through the study of this example that different bodies of law can provide equivalent levels of protection that respect the same ethical principles. Our purpose in writing this paper was to encourage public bodies, scientific journals, and researchers to gain a better understanding of the various sets of specific national regulations and to speak a common language. PMID:19336436

Reactions to Participating in Dating Violence Research: Are Our Questions Distressing Participants?

Science.gov (United States)

Shorey, Ryan C.; Cornelius, Tara L.; Bell, Kathryn M.

2011-01-01

In recent years, there has been increased research focus on dating violence, producing important information for reducing these violent relationships. Yet Institutional Review Boards (IRBs) are often hesitant to approve research on dating violence, citing emotional distress of participants as a possible risk of participation. However, no known…

A Next Generation Repository for Sharing Sensitive Network and Security Data

Science.gov (United States)

2018-01-01

protocols, trends regarding the Internet -of- Things (e.g., in terms of traffic growth) or malicious trends (e.g., scanning). 3.2 Darknet Data Network...Cyber-risk & Trust IP – Internet Protocol IODA – Internet Outage Detection and Analysis IoT – Internet of Things IRB – Institutional Review Board...09 13. SUPPLEMENTARY NOTES 14. ABSTRACT Defending critical infrastructure from cyber-security threats, understanding macroscopic Internet and

Dehumanization and Irregular Warfare

Science.gov (United States)

2013-06-01

author and do not reflect the official policy or position of the Department of Defense or the U.S. Government. IRB Protocol number ____N/A____...films.122 This reframing of cultural training as a discussion of proper etiquette , rather 120

Validation of the Tensoval Duo Control II blood pressure monitor for clinic use and self-measurement according to the British Hypertension Society protocol and the European Society of Hypertension International Protocol Revision 2010.

Science.gov (United States)

de Greeff, Annemarie; Shennan, Andrew H

2013-06-01

The Tensoval Duo Control II is an automated upper arm device that uses a combination of oscillometric and auscultatory technology to determine blood pressure noninvasively. The accuracy of this device was assessed according to the British Hypertension Society (BHS) protocol and the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) in an adult population. Ethical approval was obtained. Eighty-five and 33 adult individuals, respectively, were recruited to fulfil the requirements of each protocol. Trained observers took nine sequential same-arm measurements alternating between a mercury sphygmomanometer and the device. The device had to achieve at least a B grade for both systolic and diastolic pressures to pass the BHS protocol and had to fulfil the criteria of all three phases of the ESH-IP2 protocol to receive recommendation. The device achieved an A/A grading for the BHS protocol and passed all three phases of the ESH-IP2 protocol. The mean difference±SD for the BHS/ESH protocols, respectively, was -1.8±6.5/-0.7±5.7 mmHg for systolic pressure and 1.9±5.1/2.4±4.5 mmHg for diastolic pressure. The device maintained its A/A grading throughout the low-pressure, medium-pressure and high-pressure ranges. The Tensoval Duo Control II device is recommended for clinical and home use according to both the BHS and the ESH-IP2 standard.

Protocol Additional to the Agreement between the People's Republic of China and the International Atomic Energy Agency for the Application of Safeguards in China

International Nuclear Information System (INIS)

2002-01-01

The text of the Protocol Additional to the Safeguards Agreement concluded between the People's Republic of China and the International Atomic Energy Agency for the application of safeguards in China is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 25 November 1998. It was signed in Vienna on 31 December 1998. Pursuant to Article 10 of the Additional Protocol, the Protocol entered into force on the date on which the Agency received from China written notification that China's statutory and constitutional requirements for entry into force have been met, i.e. on 28 March 2002

Implementing an ultrasound-based protocol for diagnosingappendicitis while maintaining diagnostic accuracy

International Nuclear Information System (INIS)

Van Atta, Angela J.; Baskin, Henry J.; Maves, Connie K.; Dansie, David M.; Rollins, Michael D.; Bolte, Robert G.; Mundorff, Michael B.; Andrews, Seth P.

2015-01-01

The use of ultrasound to diagnose appendicitis in children is well-documented but not universally employed outside of pediatric academic centers, especially in the United States. Various obstacles make it difficult for institutions and radiologists to abandon a successful and accurate CT-based imaging protocol in favor of a US-based protocol. To describe how we overcame barriers to implementing a US-based appendicitis protocol among a large group of nonacademic private-practice pediatric radiologists while maintaining diagnostic accuracy and decreasing medical costs. A multidisciplinary team of physicians (pediatric surgery, pediatric emergency medicine and pediatric radiology) approved an imaging protocol using US as the primary modality to evaluate suspected appendicitis with CT for equivocal cases. The protocol addressed potential bias against US and accommodated for institutional limitations of radiologist and sonographer experience and availability. Radiologists coded US reports according to the probability of appendicitis. Radiology reports were compared with clinical outcomes to assess diagnostic accuracy. During the study period, physicians from each group were apprised of the interim US protocol accuracy results. Problematic cases were discussed openly. A total of 512 children were enrolled and underwent US for evaluation of appendicitis over a 30-month period. Diagnostic accuracy was comparable to published results for combined US/CT protocols. Comparing the first 12 months to the last 12 months of the study period, the proportion of children achieving an unequivocal US result increased from 30% (51/169) to 53% (149/282) and the proportion of children undergoing surgery based solely on US findings increased from 55% (23/42) to 84% (92/109). Overall, 63% (325/512) of patients in the protocol did not require a CT. Total patient costs were reduced by $30,182 annually. We overcame several barriers to implementing a US protocol. During the study period our

Implementing an ultrasound-based protocol for diagnosingappendicitis while maintaining diagnostic accuracy

Energy Technology Data Exchange (ETDEWEB)

Van Atta, Angela J. [University of Utah School of Medicine, Salt Lake City, UT (United States); Baskin, Henry J.; Maves, Connie K.; Dansie, David M. [Primary Children' s Hospital, Department of Radiology, Salt Lake City, UT (United States); Rollins, Michael D. [University of Utah School of Medicine, Department of Surgery, Division of Pediatric Surgery, Salt Lake City, UT (United States); Bolte, Robert G. [University of Utah School of Medicine, Department of Pediatrics, Division of Pediatric Emergency Medicine, Salt Lake City, UT (United States); Mundorff, Michael B.; Andrews, Seth P. [Primary Children' s Hospital, Systems Improvement, Salt Lake City, UT (United States)

2015-05-01

The use of ultrasound to diagnose appendicitis in children is well-documented but not universally employed outside of pediatric academic centers, especially in the United States. Various obstacles make it difficult for institutions and radiologists to abandon a successful and accurate CT-based imaging protocol in favor of a US-based protocol. To describe how we overcame barriers to implementing a US-based appendicitis protocol among a large group of nonacademic private-practice pediatric radiologists while maintaining diagnostic accuracy and decreasing medical costs. A multidisciplinary team of physicians (pediatric surgery, pediatric emergency medicine and pediatric radiology) approved an imaging protocol using US as the primary modality to evaluate suspected appendicitis with CT for equivocal cases. The protocol addressed potential bias against US and accommodated for institutional limitations of radiologist and sonographer experience and availability. Radiologists coded US reports according to the probability of appendicitis. Radiology reports were compared with clinical outcomes to assess diagnostic accuracy. During the study period, physicians from each group were apprised of the interim US protocol accuracy results. Problematic cases were discussed openly. A total of 512 children were enrolled and underwent US for evaluation of appendicitis over a 30-month period. Diagnostic accuracy was comparable to published results for combined US/CT protocols. Comparing the first 12 months to the last 12 months of the study period, the proportion of children achieving an unequivocal US result increased from 30% (51/169) to 53% (149/282) and the proportion of children undergoing surgery based solely on US findings increased from 55% (23/42) to 84% (92/109). Overall, 63% (325/512) of patients in the protocol did not require a CT. Total patient costs were reduced by $30,182 annually. We overcame several barriers to implementing a US protocol. During the study period our

Application of Modbus communication protocol and float-point display in MCS51 system

International Nuclear Information System (INIS)

Kong Xiangcheng; Liu Shaozhen

2010-01-01

As its widely opening and easy performance, Modbus communication protocol has a great advantage in field bus using. Details are given on a method to implement Modbus communication protocol based on MCS51 system, and the advantage of uVision integrated environment. The design realizes Modbus RTU mode communication, meanwhile the problem of synchronization in communication is solved. And float-point operation and display are achieved by format print. All of this are carried out under uVision integrated environment. The result approves that the response ratio of Modbus communication is 100%. The design shows the advantage of uVision integrated environment and MCS51 system. And also gives solution to the occasion where communication interface and low cost are required. (authors)

38 CFR 17.65 - Approvals and provisional approvals of community residential care facilities.

Science.gov (United States)

2010-07-01

... approvals of community residential care facilities. 17.65 Section 17.65 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Community Residential Care § 17.65 Approvals and provisional approvals of community residential care facilities. (a) An approval of a facility meeting all of...

Protocol Additional to the agreement between France, the European Atomic Energy Community and the International Atomic Energy Agency for the application of safeguards in France

International Nuclear Information System (INIS)

2005-01-01

The text of the Protocol Additional to the Agreement between France, the European Atomic Energy Community and the International Atomic Energy Agency for the Application of Safeguards in France is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 11 June 1998. It was signed in Vienna on 22 September 1998. Pursuant to Article 16 of the Additional Protocol, the Protocol entered into force on 30 April 2004, the date on which the Agency received written notification that the European Atomic Energy Community and France had met their respective internal requirements for entry into force

Novel strategies to improve immunomodulation and non invasive clinical monitoring in VCA

Science.gov (United States)

2017-08-01

and motor vehicle accidents, amongst others. People with these types of traumatic injuries have decreased quality of life, and are often disabled ...ability to restore form and function after these injuries. Disability with associated long-term medical care and disability benefit costs is common...entirely new IRB protocol that is specific and inclusive only of the work stated in the Statement of Work for this award. This protocol has been

19 CFR 115.41 - Certificate of approval for containers approved after manufacture.

Science.gov (United States)

2010-04-01

... after manufacture. 115.41 Section 115.41 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT... PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.41 Certificate of approval for containers approved after manufacture. The Certifying Authority shall...

Patient recruitment into a multicenter randomized clinical trial for kidney disease: report of the focal segmental glomerulosclerosis clinical trial (FSGS CT).

Science.gov (United States)

Ferris, Maria; Norwood, Victoria; Radeva, Milena; Gassman, Jennifer J; Al-Uzri, Amira; Askenazi, David; Matoo, Tej; Pinsk, Maury; Sharma, Amita; Smoyer, William; Stults, Jenna; Vyas, Shefali; Weiss, Robert; Gipson, Debbie; Kaskel, Frederick; Friedman, Aaron; Moxey-Mims, Marva; Trachtman, Howard

2013-02-01

We describe the experience of the focal segmental glomerulosclerosis clinical trial (FSGS CT) in the identification and recruitment of participants into the study. This National Institutes of Health funded study, a multicenter, open-label, randomized comparison of cyclosporine versus oral dexamethasone pulses plus mycophenolate mofetil, experienced difficulty and delays meeting enrollment goals. These problems occurred despite the support of patient advocacy groups and aggressive recruitment strategies. Multiple barriers were identified including: (1) inaccurate estimates of the number of potential incident FSGS patients at participating centers; (2) delays in securing one of the test agents; (3) prolonged time between IRB approval and execution of a subcontract (mean 7.5 ± 0.8 months); (4) prolonged time between IRB approval and enrollment of the first patient at participating sites (mean 19.6 ± 1.4 months); and (5) reorganization of clinical coordinating core infrastructure to align resources with enrollment. A Web-based anonymous survey of site investigators revealed site-related barriers to patient recruitment. The value of a variety of recruitment tools was of marginal utility in facilitating patient enrollment. We conclude that improvements in the logistics of study approval and regulatory start-up and testing of promising novel agents are important factors in promoting enrollment into randomized clinical trials in nephrology. © 2013 Wiley Periodicals, Inc.

Organic matter and hydrogen as electron donor for SRB and IRB activities in a clayey medium

International Nuclear Information System (INIS)

Chautard, C.; Mifsud, A.; Libert, M.; Marsal, F.

2012-01-01

Document available in extended abstract form only. According to the French concept for the disposal of High-Level radioactive Waste (HLW), waste will be emplaced in an environment with multiple metallic components into a geological clay formation. The presence of microorganisms has recently been evidenced in deep clayey environment. Therefore, neither the introduction of microbial species during the construction and operational phases nor the survival of bacteria after the disposal closure can be excluded. Indeed, microbial species may be able to tolerate specific environment with few nutrients to sustain life under high temperature, dry and highly radioactive conditions. Moreover, despite the low porosity of clays, cracks in the excavated disturbed zone and remaining void spaces between disposal components may be favorable for bacterial growth. Sulfate-Reducing Bacteria (SRB) and Iron-Reducing Bacteria (IRB) activities are notably expected to influence iron-clay reactivity, including corrosion processes. Their potential development must be investigated in order to better assess their metabolism, which may in turn influence the evolution of metallic and clayey materials involved in a HLW disposal cell. More specifically, deep geological environments containing low amounts of biodegradable Organic Matter (OM) are generally nutrient poor for microbial development. However, the radiolysis of pore water and the corrosion of metallic components of HLW disposal cell in anoxic conditions will lead to the production of hydrogen, which may also be used as an electron donor for microbial activity. Thus, the purpose of the present work is to quantify the potential of bacterial growth stimulation due either to the production of hydrogen or the presence of OM. In a first step, characterization of DOM leached from Tournemire clay powder has been performed in order to identify and estimate the concentration of soluble organic matter available for bacteria activity which will

Release protocol to address DOE moratorium on shipments of waste generated in radiologically controlled areas

International Nuclear Information System (INIS)

Rathbun, L.A.; Boothe, G.F.

1992-10-01

On May 17, 1991 the US DOE Office of Waste Operations issued a moratorium on the shipment of hazardous waste from radiologically contaminated or potentially contaminated areas on DOE sites to offsite facilities not licensed for radiological material. This document describes a release protocol generated by Westinghouse Hanford submitted for US DOE approval. Topics considered include designating Radiological Materials Management Areas (RMMAs), classification of wastes, handling of mixed wastes, detection limits

Victor Frankenstein's Institutional Review Board Proposal, 1790.

Science.gov (United States)

Harrison, Gary; Gannon, William L

2015-10-01

To show how the case of Mary Shelley's Victor Frankenstein brings light to the ethical and moral issues raised in Institutional Review Board (IRB) protocols, we nest an imaginary IRB proposal dated August 1790 by Victor Frankenstein within a discussion of the importance and function of the IRB. Considering the world of science as would have appeared in 1790 when Victor was a student at Ingolstadt, we offer a schematic overview of a fecund moment when advances in comparative anatomy, medical experimentation and theories of life involving animalcules and animal electricity sparked intensive debates about the basic principles of life and the relationship between body and soul. Constructing an IRB application based upon myriad speculations circulating up to 1790, we imagine how Victor would have drawn upon his contemporaries' scientific work to justify the feasibility of his project, as well as how he might have outlined the ethical implications of his plan to animate life from "dead" tissues. In Mary Shelley's Frankenstein, Victor failed to consider his creature's autonomy, vulnerability, and welfare. In this IRB proposal, we show Victor facing those issues of justice and emphasize how the novel can be an important component in courses or workshops on research ethics. Had Victor Frankenstein had to submit an IRB proposal tragedy may have been averted, for he would have been compelled to consider the consequences of his experiment and acknowledge, if not fulfill, his concomitant responsibilities to the creature that he abandoned and left to fend for itself.

Safety of protocol violations in acute stroke tPA administration.

Science.gov (United States)

Lyerly, Michael J; Albright, Karen C; Boehme, Amelia K; Bavarsad Shahripour, Reza; Houston, James T; Rawal, Pawan V; Kapoor, Niren; Alvi, Muhammad; Sisson, April; Alexandrov, Anne W; Alexandrov, Andrei V

2014-01-01

Intravenous (IV) tissue plasminogen activator remains the only approved therapy for acute ischemic stroke (AIS) in the United States; however, less than 10% of patients receive treatment. This is partially because of the large number of contraindications, narrow treatment window, and physician reluctance to deviate from these criteria. We retrospectively analyzed consecutive patients who received IV thrombolysis at our stroke center for National Institute of Neurological Disorders and Stroke (NINDS) protocol violations and rates of symptomatic intracerebral hemorrhage (sICH). Other outcome variables included systemic hemorrhage, modified Rankin Scale at discharge, and discharge disposition. A total of 212 patients were identified in our stroke registry between 2009 and 2011 and included in the analysis. Protocol violations occurred in 76 patients (36%). The most common violations were thrombolysis beyond 3 hours (26%), aggressive blood pressure management (15%), elevated prothrombin time (PT) or partial thromboplastin time (PTT) (6.6%), minor or resolving deficits (4.2%), unclear time of onset (3.9%), and stroke within 3 months (3%). There were no significant differences in any of the safety outcomes or discharge disposition between patients with or without protocol violations. Controlling for age, National Institutes of Health Stroke Scale on admission, and glucose on admission, there was no significant increase in sICH (odds ratio: 3.8; 95% confidence interval: .37-38.72) in the patients who had protocol violations. Despite more than one third of patients receiving thrombolysis with protocol violations, overall rates of hemorrhage remained low and did not differ from those who did not have violations. Our data support the need to expand access to thrombolysis in AIS patients. Published by Elsevier Inc.

Protocol Additional to the Agreement between the United States of America and the International Atomic Energy Agency for the Application of Safeguards in the United States of America

International Nuclear Information System (INIS)

2009-01-01

The text of the Protocol Additional to the Agreement between the United States of America and the International Atomic Energy Agency for the Application of Safeguards in the United States of America is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 11 June 1998. It was signed in Vienna on 12 June 1998

Independent value of image fusion in unenhanced breast MRI using diffusion-weighted and morphological T2-weighted images for lesion characterization in patients with recently detected BI-RADS 4/5 X-ray mammography findings

Energy Technology Data Exchange (ETDEWEB)

Bickelhaupt, Sebastian; Tesdorff, Jana; Delorme, Stefan; Schlemmer, Heinz-Peter [German Cancer Research Center (dkfz), Department of Radiology, Heidelberg (Germany); Laun, Frederik Bernd; Kuder, Tristan Anselm [German Cancer Research Center (dkfz), Medical Physics in Radiology, Heidelberg (Germany); Lederer, Wolfgang; Teiner, Susanne [Radiological Practice at the ATOS Clinic Heidelberg, Heidelberg (Germany); Maier-Hein, Klaus [German Cancer Research Center (dkfz), Junior Group Medical Image Computing, Heidelberg (Germany); Daniel, Heidi [Radiology Center Mannheim (RZM), Mannheim (Germany); Stieber, Anne [University Hospital Heidelberg, Department of Clinical and Interventional Radiology, Heidelberg (Germany)

2017-02-15

The aim of this study was to evaluate the accuracy and applicability of solitarily reading fused image series of T2-weighted and high-b-value diffusion-weighted sequences for lesion characterization as compared to sequential or combined image analysis of these unenhanced sequences and to contrast- enhanced breast MRI. This IRB-approved study included 50 female participants with suspicious breast lesions detected in screening X-ray mammograms, all of which provided written informed consent. Prior to biopsy, all women underwent MRI including diffusion-weighted imaging (DWIBS, b = 1500s/mm{sup 2}). Images were analyzed as follows: prospective image fusion of DWIBS and T2-weighted images (FU), side-by-side analysis of DWIBS and T2-weighted series (CO), combination of the first two methods (CO+FU), and full contrast-enhanced diagnostic protocol (FDP). Diagnostic indices, confidence, and image quality of the protocols were compared by two blinded readers. Reading the CO+FU (accuracy 0.92; NPV 96.1 %; PPV 87.6 %) and the CO series (0.90; 96.1 %; 83.7 %) provided a diagnostic performance similar to the FDP (0.95; 96.1 %; 91.3 %; p > 0.05). FU reading alone significantly reduced the diagnostic accuracy (0.82; 93.3 %; 73.4 %; p = 0.023). MR evaluation of suspicious BI-RADS 4 and 5 lesions detected on mammography by using a non-contrast-enhanced T2-weighted and DWIBS sequence protocol is most accurate if MR images were read using the CO+FU protocol. (orig.)

Developing Recruitment Methods for Vulnerable, Traumatized Adolescents: A Feminist Evaluation Approach

Science.gov (United States)

Campbell, Rebecca; Greeson, Megan R.; Fehler-Cabral, Giannina

2014-01-01

This article describes the process by which we created a recruitment protocol for engaging adolescent sexual assault victims in a qualitative evaluation study. Working in collaboration with forensic nurses, rape victim advocates, adolescent rape survivors, and our institutional review board (IRB), we created a prospective recruitment method…

Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

Science.gov (United States)

Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

2014-07-16

To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

How to design and write a clinical research protocol in Cosmetic Dermatology*

Science.gov (United States)

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

Demonstrating Patterns in the Views Of Stakeholders Regarding Ethically-Salient Issues in Clinical Research: A Novel Use of Graphical Models in Empirical Ethics Inquiry.

Science.gov (United States)

Kim, Jane Paik; Roberts, Laura Weiss

Empirical ethics inquiry works from the notion that stakeholder perspectives are necessary for gauging the ethical acceptability of human studies and assuring that research aligns with societal expectations. Although common, studies involving different populations often entail comparisons of trends that problematize the interpretation of results. Using graphical model selection - a technique aimed at transcending limitations of conventional methods - this report presents data on the ethics of clinical research with two objectives: (1) to display the patterns of views held by ill and healthy individuals in clinical research as a test of the study's original hypothesis and (2) to introduce graphical model selection as a key analytic tool for ethics research. In this IRB-approved, NIH-funded project, data were collected from 60 mentally ill and 43 physically ill clinical research protocol volunteers, 47 healthy protocol-consented participants, and 29 healthy individuals without research protocol experience. Respondents were queried on the ethical acceptability of research involving people with mental and physical illness (i.e., cancer, HIV, depression, schizophrenia, and post-traumatic stress disorder) and non-illness related sources of vulnerability (e.g., age, class, gender, ethnicity). Using a statistical algorithm, we selected graphical models to display interrelationships among responses to questions. Both mentally and physically ill protocol volunteers revealed a high degree of connectivity among ethically-salient perspectives. Healthy participants, irrespective of research protocol experience, revealed patterns of views that were not highly connected. Between ill and healthy protocol participants, the pattern of views is vastly different. Experience with illness was tied to dense connectivity, whereas healthy individuals expressed views with sparse connections. In offering a nuanced perspective on the interrelation of ethically relevant responses, graphical

Redfield Energy Approval

Science.gov (United States)

This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-This October 27, 2016 letter from EPA approves the petition from Redfield Energy, LLC, regarding non-grandfathered ethanol produced

Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.

Science.gov (United States)

DiMasi, Joseph A

2013-06-01

Much of the literature on trends and factors affecting biopharmaceutical innovation has focused overwhelmingly on the development and approval of never-before approved drugs and biologics. Little attention has been paid to new uses for already-approved compounds, which can be an important form of innovation. This paper aimed to determine and analyze recent trends in the number and type of new or modified US indication approvals for drugs and biologics. We also examine regulatory approval-phase times for new-use efficacy supplements and compare them to approval-phase times for original-use approvals over the same period. We developed a data set of efficacy supplements approved by the US Food and Drug Administration (FDA) from 1998 to 2011 that includes information on the type, approval-phase time (time from submission to the FDA of an application for marketing approval to approval of the application), and FDA therapeutic-significance rating for the approved application, which we obtained from an FDA Web site. This data set was merged with a Tufts Center for the Study of Drug Development (CSDD) data set of US new drug and biologics approvals. We developed descriptive statistics on trends in the number and type of new-use efficacy supplements, on US regulatory approval-phase times for the supplements, and on original new drug and biologics approvals over the study period and for the time from original- to new-use approval. The total number of new-use efficacy-supplement approvals did not exhibit a marked trend, but the number of new pediatric-indication approvals increased substantially. Approval-phase times for new-use supplements varied by therapeutic class and FDA therapeutic-significance rating. Mean approval-phase times were highest for central nervous system compounds (13.8 months) and lowest for antineoplastics (8.9 months). The mean time from original to supplement approval was substantially longer for new pediatric indications than for other new uses. Mean

A protocol for a randomized clinical trial of interactive video dance: potential for effects on cognitive function.

Science.gov (United States)

Jovancevic, Jelena; Rosano, Caterina; Perera, Subashan; Erickson, Kirk I; Studenski, Stephanie

2012-06-06

Physical exercise has the potential to affect cognitive function, but most evidence to date focuses on cognitive effects of fitness training. Cognitive exercise also may influence cognitive function, but many cognitive training paradigms have failed to provide carry-over to daily cognitive function. Video games provide a broader, more contextual approach to cognitive training that may induce cognitive gains and have carry over to daily function. Most video games do not involve physical exercise, but some novel forms of interactive video games combine physical activity and cognitive challenge. This paper describes a randomized clinical trial in 168 postmenopausal sedentary overweight women that compares an interactive video dance game with brisk walking and delayed entry controls. The primary endpoint is adherence to activity at six months. Additional endpoints include aspects of physical and mental health. We focus this report primarily on the rationale and plans for assessment of multiple cognitive functions. This randomized clinical trial may provide new information about the cognitive effects of interactive videodance. It is also the first trial to examine physical and cognitive effects in older women. Interactive video games may offer novel strategies to promote physical activity and health across the life span.The study is IRB approved and the number is: PRO08080012ClinicalTrials.gov Identifier: NCT01443455.

Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture

Directory of Open Access Journals (Sweden)

Bate R

2012-07-01

Full Text Available Roger Bate,1 Lorraine Mooney,2 Kimberly Hess,3 Julissa Milligan,1 Amir Attaran41American Enterprise Institute, Washington DC, USA; 2Africa Fighting Malaria, London, UK; 3Africa Fighting Malaria, Washington DC, USA; 4Faculty of Law and Medicine, University of Ottawa, Ottawa, CanadaBackground: Some medicines for sale in developing countries are approved by a stringent regulatory authority (SRA or the World Health Organization (WHO prequalification program; many of these are global brands. This study ascertains whether medicines approved by SRAs or the WHO perform better in simple quality tests than those that have not been approved by either.Methods: Over the past 4 years, 2652 essential drugs (products to treat malaria, tuberculosis, and bacterial infections were procured by covert shoppers from eleven African cities and eight cities in a variety of mid-income nations. All samples were assessed using the Global Pharma Health Fund eV Minilab® protocol to identify whether they were substandard, degraded, or counterfeit.Results: The failure rate among SRA-approved products was 1.01%, among WHO-approved products was 6.80%, and 13.01% among products that were not approved by either. African cities had a greater proportion of SRA- or WHO-approved products (31.50% than Indian cities (26.57%, but they also experienced a higher failure rate (14.21% than Indian cities (7.83%. The remainder of cities tested had both the highest proportion of approved products at 34.46% and the lowest failure rate at 2.70%. Products made in Africa had the highest failure rate at 25.77%, followed by Chinese products at 15.74%, Indian products at 3.70%, and European/US products, which failed least often, at 1.70%. Most worrying is that 17.65% of Chinese products approved by the WHO failed.Conclusion: The results strongly indicate that approval by either an SRA or the WHO is correlated with higher medicine quality at a statistically significant level. The comparatively high

Protocol Additional to the Agreement between Ukraine and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non- Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2006-01-01

The text of the Protocol Additional to the Agreement between Ukraine and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 7 June 2000. It was signed on 15 August 2000 in Vienna [es

Protocol Additional to the Agreement between Mauritius and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2008-01-01

The text of the Protocol Additional to the Agreement between Mauritius and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 14 September 2004. It was signed on 9 December 2004 in Vienna

Biosafety assessment protocols for new organisms in New Zealand: Can they apply internationally to emerging technologies?

International Nuclear Information System (INIS)

Barratt, B.I.P.; Moeed, A.; Malone, L.A.

2006-01-01

An analysis of established biosafety protocols for release into the environment of exotic plants and biological control agents for weeds and arthropod pests has been carried out to determine whether such protocols can be applied to relatively new and emerging technologies intended for the primary production industries, such as transgenic plants. Example case studies are described to indicate the scope of issues considered by regulators who make decisions on new organism releases. No transgenic plants have been released to date in New Zealand, but two field test approvals are described as examples. An analysis of the biosafety protocols has shown that, while many of the risk criteria considered for decision-making by regulators are similar for all new organisms, a case-by-case examination of risks and potential impacts is required in order to fully assess risk. The value of post-release monitoring and validation of decisions made by regulators is emphasised

Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.

Science.gov (United States)

Ghobadi, Comeron W; Hayman, Emily L; Finkle, Joshua H; Walter, Jessica R; Xu, Shuai

2017-01-01

The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool. Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

30 CFR 18.95 - Approval of machines constructed of components approved, accepted or certified under Bureau of...

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval of machines constructed of components... APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.95 Approval of machines constructed of components approved...

Protocol Additional to the agreement between Ukraine and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2006-01-01

The text of the Protocol Additional to the Agreement between Ukraine and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 7 June 2000. It was signed on 15 August 2000 in Vienna. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 24 January 2006, the date on which the Agency received from Ukraine written notification that Ukraine's constitutional requirements for entry into force had been met

The limits of evidence in drug approval and availability: a case study of cilostazol and naftidrofuryl for the treatment of intermittent claudication.

Science.gov (United States)

Hong, Haeyeon; Mackey, William C

2014-08-01

Despite numerous efforts to develop effective medications for the treatment of intermittent claudication (IC) over the past 4 decades, a gold standard medical management option has yet to be defined. Although not life-threatening, IC interferes with mobility and activities of daily living, significantly impairing quality of life and potentially causing depression. Cilostazol, the leading pharmacologic agent for IC in the United States, was approved by the US Food and Drug Administration (FDA) in 1999 based on controversial data. Meanwhile, naftidrofuryl, the first-line pharmacologic agent for IC in the United Kingdom and Europe, has never been approved by the FDA and therefore is not available in the United States. The clinical data for cilostazol and naftidrofuryl are plagued by flaws related to lack of protocol standardization, objective endpoints, and strict eligibility criteria in study subjects, making identification of a true treatment effect impossible. Furthermore, no prospective randomized trial comparing the efficacy of cilostazol and naftidrofuryl has been conducted, because the manufacturers of these agents have much to lose and little to gain from such a study. This article provides an overview of the pharmacology of cilostazol and naftidrofuryl, and the clinical studies leading to their approval and clinical acceptance. It further explores the possible sources of bias in analyzing these clinical trials, some of which have been brought to light by the National Institute for Health and Clinical Excellence (NICE) of the United Kingdom in its technology appraisal guidance. It also speculates the ways in which economic incentives may affect drug-marketing decisions. A literature review of pharmacology and clinical trials for cilostazol and naftidrofuryl was performed in PubMed. The majority of included clinical trials were initially identified through the most recent Cochrane review articles as well as the FDA's approval packet for cilostazol. The

Protocol Additional to the agreement between the Republic of Afghanistan and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2005-01-01

The text of the Protocol Additional to the Agreement between the Republic of Afghanistan and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 1 March 2005. It was signed on 19 July 2005 in Vienna. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 19 July 2005, upon signature by the representatives of Afghanistan and the Agency

Protocol Additional to the agreement between the Republic of Madagascar and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2003-01-01

The text of the Protocol Additional to the Agreement between the Republic of Madagascar and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 18 June 2003. It was signed in Vienna on 18 September 2003. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force upon signature by the representatives of Madagascar and the Agency, i.e., on 18 September 2003

Protocol Additional to the agreement between the Government of Iceland and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2003-01-01

The text of the Protocol Additional to the Agreement between the Government of Iceland and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 9 September 2003. It was signed in Vienna on 12 September 2003. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force upon signature by the representatives of Iceland and the Agency, i.e., on 12 September 2003

Protocol Additional to the agreement between the Republic of Palau and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2005-01-01

The text of the Protocol Additional to the Agreement between the Republic of Palau and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 1 March 2005. It was signed on 10 May 2005 in New York and 13 May 2005 in Vienna. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 13 May 2005, upon signature by the representatives of Palau and the Agency

Protocol Additional to the Agreement Between the Republic of Burundi and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2008-01-01

The text of the Protocol Additional to the Agreement between the Republic of Burundi and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 13 June 2007. It was signed in Vienna on 27 September 2007. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 27 September 2007, upon signature by the representatives of Burundi and the Agency

Protocol Additional to the agreement between the Republic of Madagascar and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

2003-12-23

The text of the Protocol Additional to the Agreement between the Republic of Madagascar and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 18 June 2003. It was signed in Vienna on 18 September 2003. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force upon signature by the representatives of Madagascar and the Agency, i.e., on 18 September 2003.

Protocol Additional to the agreement between the Government of Iceland and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

2003-12-23

The text of the Protocol Additional to the Agreement between the Government of Iceland and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 9 September 2003. It was signed in Vienna on 12 September 2003. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force upon signature by the representatives of Iceland and the Agency, i.e., on 12 September 2003.

Approach to integrate current safeguards measures with additional protocol requirements at national level

International Nuclear Information System (INIS)

Ramirez, R.

2001-01-01

Peru adhered to the Additional Protocol in March 2000 which was also approved by the Congress in May 2001. After approval by law the obligations derived from this Additional Protocol will be in force after 180 days. After the signing of the Protocol an approach was designed to help better fulfill these requirements in an integrated way with the previous measures. As first stage, a review of the current state of safeguards was undertaken. Under the current agreement (an INFCIRC/153 type agreement) the reporting is less complicated and inexpensive to be carried out because these reports include only the declared nuclear material and the features of declared facilities where the nuclear material is used. No other related facility or material or activity needs to be declared. In Peru there are only two MBAs where low enriched uranium (LEU) is used and the record system includes general ledgers, inventory records and operational books. The results of national inspections and copies of reports and communications sent to the IAEA are also kept in this system. Under the agreement and subsidiary arrangements material balance reports (MBR), physical inventory listings (PIL) and inventory change reports (ICR) are prepared and submitted to the IAEA at scheduled periods. The MBR and PIL reports are sent after yearly regular inspections carried out by the IAEA. The ICR is sent just every time when an import or export of nuclear material is made. The time devoted to carry out all of these activities is not so extensive for both the State System for Accountability and Control (SSAC) and the users because of the limited nuclear activities in the country. Because of the characteristics and limited quantities of nuclear material the efforts for inspection and reporting activities are few. Another subject under review was the procedure for controlling the imports of nuclear material. Under the current agreement this subject was not a problem, as all of the radioactive and nuclear

Protocol Additional to the Agreement between Mongolia and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-proliferation of Nuclear weapons

International Nuclear Information System (INIS)

2003-01-01

The text of the Protocol Additional to the Agreement between Mongolia and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 11 September 2001. It was signed in Vienna on 5 December 2001

Protocol Additional to the Agreement between Uruguay and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2004-01-01

The text of the Protocol Additional to the Agreement between Uruguay and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 23 September 1997. It was signed in Vienna on 29 September 1997

Drugs Approved for Breast Cancer

Science.gov (United States)

... Ask about Your Treatment Research Drugs Approved for Breast Cancer This page lists cancer drugs approved by the ... are not listed here. Drugs Approved to Prevent Breast Cancer Evista (Raloxifene Hydrochloride) Raloxifene Hydrochloride Tamoxifen Citrate Drugs ...

Considerations When Writing and Reviewing a Higher Education Teaching Protocol Involving Animals.

Science.gov (United States)

Vemulapalli, Tracy H; Donkin, Shawn S; Lescun, Timothy B; O'Neil, Peggy A; Zollner, Patrick A

2017-09-01

The targeted use of animals in teaching at institutions of higher learning is fundamental to educating the next generation of professionals in the biologic and animal sciences. As with animal research, universities and colleges that use animals in teaching are subject to regulatory oversight. Instructors must receive approval from their IACUC before using animals in their teaching. However, the questions asked on many institutions' animal care and use protocol (ACUP) are often geared more toward the use of animals for research. These questions may not be wholly appropriate in evaluating a teaching protocol; some questions are not applicable (for example, power analysis to justify animal numbers) whereas other important questions may be missing. This article discusses the issues surrounding the rationale for animal use in teaching; it also proposes a framework that instructors and IACUC members alike can use when writing and reviewing teaching ACUP. We hope this framework will help to ensure the most appropriate IACUC review of the ethical use of animals in higher education.

NATO or Neutrality : Decisions by Denmark, Finland, Norway, and Sweden

Science.gov (United States)

2017-09-01

collection of information is estimated to average 1 hour per response, including the time for reviewing instruction, searching existing data sources...gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate...Department of Defense or the U.S. Government . IRB number ____N/A____. 12a. DISTRIBUTION / AVAILABILITY STATEMENT Approved for public release

Genetic and Epigenetic Determinants of Lung Cancer Subtype: Adenocarcinoma to Small Cell Conversion

Science.gov (United States)

2015-08-01

have obtained full IRB approval for this study at both the primary sites, Memorial Sloan Kettering Cancer Center (MSKCC) and Dana Farber Cancer...California, The University of Copenhagen, Fox Chase Cancer Center, Johns Hopkins University, and Memorial Sloan Kettering. (NEW...sequencer to generate paired-end colour space reads (50 nucleotides forward and 35 nucleotides reverse) by a multiplexed operation. The colour -space

Impact of maternal antibodies and infant gut microbiota on the immunogenicity of rotavirus vaccines in African, Indian and European infants: protocol for a prospective cohort study.

Science.gov (United States)

Sindhu, Kuladaipalayam Natarajan C; Cunliffe, Nigel; Peak, Matthew; Turner, Mark; Darby, Alistair; Grassly, Nicholas; Gordon, Melita; Dube, Queen; Babji, Sudhir; Praharaj, Ira; Verghese, Valsan; Iturriza-Gómara, Miren; Kang, Gagandeep

2017-03-29

Gastroenteritis is the leading cause of morbidity and mortality among young children living in resource-poor settings, majority of which is attributed to rotavirus. Rotavirus vaccination can therefore have a significant impact on infant mortality. However, rotavirus vaccine efficacy in Sub-Saharan Africa and Southeast Asia is significantly lower than in high-income countries. Maternally derived antibodies, infant gut microbiota and concomitant oral polio vaccination have been proposed as potential reasons for poor vaccine performance in low-income settings. The overall aim of this study is to compare the role of maternally derived antibodies and infant gut microbiota in determining immune response to rotavirus vaccine in high-income and low-income settings, using the same vaccine and a similar study protocol. The study is an observational cohort in three countries-Malawi, India and UK. Mothers will be enrolled in third trimester of pregnancy and followed up, along with infants after delivery, until the infant completes two doses of oral rotavirus vaccine (along with routine immunisation). The levels of prevaccination maternally derived rotavirus-specific antibodies (IgG) will be correlated with infant seroconversion and antibody titres, 4 weeks after the second dose of rotavirus vaccine. Both within-country and between-country comparisons of gut microbiome will be carried out between children who seroconvert and those who do not. The impact of oral polio vaccine coadministration on rotavirus vaccine response will be studied in Indian infants. Ethical approvals have been obtained from Integrated Research Application System (IRAS, NHS ethics) in UK, College of Medicine Research and Ethics Committee (COMREC) in Malawi and Institutional Review Board (IRB), Christian Medical College, Vellore in India. Participant recruitment and follow-up is ongoing at all three sites. Analysis of data, followed by publication of the results, is expected in 2018. Published by the BMJ

Drugs Approved for Thyroid Cancer

Science.gov (United States)

... Ask about Your Treatment Research Drugs Approved for Thyroid Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Thyroid Cancer Cabozantinib-S-Malate Caprelsa (Vandetanib) Cometriq (Cabozantinib-S-Malate) Doxorubicin ...

Stimulated echo diffusion tensor imaging and SPAIR T2 -weighted imaging in chronic exertional compartment syndrome of the lower leg muscles.

Science.gov (United States)

Sigmund, Eric E; Sui, Dabang; Ukpebor, Obehi; Baete, Steven; Fieremans, Els; Babb, James S; Mechlin, Michael; Liu, Kecheng; Kwon, Jane; McGorty, KellyAnne; Hodnett, Philip A; Bencardino, Jenny

2013-11-01

To evaluate the performance of diffusion tensor imaging (DTI) in the evaluation of chronic exertional compartment syndrome (CECS) as compared to T2 -weighted (T2w) imaging. Using an Institutional Review Board (IRB)-approved, Health Insurance Portability and Accountability Act (HIPAA)-compliant protocol, spectral adiabatic inversion recovery (SPAIR) T2w imaging and stimulated echo DTI were applied to eight healthy volunteers and 14 suspected CECS patients before and after exertion. Longitudinal and transverse diffusion eigenvalues, mean diffusivity (MD), and fractional anisotropy (FA) were measured in seven calf muscle compartments, which in patients were classified by their response on T2w: normal (20% change). Mixed model analysis of variance compared subject groups and compartments in terms of response factors (post/pre-exercise ratios) of DTI parameters. All diffusivities significantly increased (P DTI shows promise as an ancillary imaging method in the diagnosis and understanding of the pathophysiology in CECS. Future studies may explore its utility in predicting response to treatment. Copyright © 2013 Wiley Periodicals, Inc.

Atypical autonomic dysreflexia during robotic-assisted body weight supported treadmill training in an individual with motor incomplete spinal cord injury.

Science.gov (United States)

Geigle, Paula R; Frye, Sara Kate; Perreault, John; Scott, William H; Gorman, Peter H

2013-03-01

A 41-year-old man with a history of C6 American Spinal Injury Association (ASIA) Impairment Scale (AIS) C spinal cord injury (SCI), enrolled in an Institutional Review Board (IRB)-approved, robotic-assisted body weight-supported treadmill training (BWSTT), and aquatic exercise research protocol developed asymptomatic autonomic dysreflexia (AD) during training. Little information is available regarding the relationship of robotic-assisted BWSTT and AD. After successfully completing 36 sessions of aquatic exercise, he reported exertional fatigue during his 10th Lokomat intervention and exhibited asymptomatic or silent AD during this and the three subsequent BWSTT sessions. Standard facilitators of AD were assessed and no obvious irritant identified other than the actual physical exertion and positioning required during robotic-assisted BWSTT. Increased awareness of potential silent AD presenting during robotic assisted BWSTT training for individuals with motor incomplete SCI is required as in this case AD clinical signs were not concurrent with occurrence. Frequent vital sign assessment before, during, and at conclusion of each BWSTT session is strongly recommended.

Protocol Additional to the agreement between New Zealand and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

1998-01-01

The document reproduces the text of the Protocol Additional to the Safeguards Agreement (INFCIRC/185) concluded between New Zealand and the IAEA for the application of safeguards in connection with the Treaty for the Non-Proliferation of Nuclear Weapons (NPT). The Additional Protocol was approved by the Board of Governors on 14 September 1998, signed in Vienna on 24 September 1998, and it entered into force on the same date

Protocol Additional to the agreement between New Zealand and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

1998-11-25

The document reproduces the text of the Protocol Additional to the Safeguards Agreement (INFCIRC/185) concluded between New Zealand and the IAEA for the application of safeguards in connection with the Treaty for the Non-Proliferation of Nuclear Weapons (NPT). The Additional Protocol was approved by the Board of Governors on 14 September 1998, signed in Vienna on 24 September 1998, and it entered into force on the same date

Review by a local medical research ethics committee of the conduct of approved research projects, by examination of patients' case notes, consent forms, and research records and by interview.

Science.gov (United States)

Smith, T; Moore, E J; Tunstall-Pedoe, H

1997-05-31

To monitor the conduct of medical research projects that have already been approved by the local medical research ethics committee. Follow up study of ethically approved studies (randomly selected from all the studies approved in the previous year) by examination of patients' case notes, consent forms, and research records and by interview of the researchers at their workplace. Tayside, Scotland (mixed rural and urban population). 30 research projects approved by Tayside local medical research ethics committee. Adherence to the agreed protocol, particularly for recruitment (obtaining and recording informed consent) and for specific requirements of the ethics committee, including notification of changes to the protocol and of adverse events. In one project only oral consent had been obtained, and in a quarter of the studies one or more consent forms were incorrectly completed. Inadequate filing of case notes in five studies and of consent forms in six made them unavailable for scrutiny. Adverse events were reported, but there was a general failure to report the abandoning or non-starting of projects in two studies the investigators failed to notify a change in the responsible researcher. Monitoring of medical research by local medical research ethics committees promotes and preserves ethical standards, protects subjects and researchers, discourages fraud, and has the support of investigators. We recommend that 10% of projects should undergo on-site review, with all others monitored by questionnaire. This would require about six person hours of time and a salary bill of 120 pounds per study monitored.

Abbreviated protocol for breast MRI: Are multiple sequences needed for cancer detection?

International Nuclear Information System (INIS)

Mango, Victoria L.; Morris, Elizabeth A.; David Dershaw, D.; Abramson, Andrea; Fry, Charles; Moskowitz, Chaya S.; Hughes, Mary; Kaplan, Jennifer; Jochelson, Maxine S.

2015-01-01

Highlights: • Abbreviated breast MR demonstrates high sensitivity for breast carcinoma detection. • Time to perform/interpret the abbreviated exam is shorter than a standard MRI exam. • An abbreviated breast MRI could reduce costs and make MRI screening more available. - Abstract: Objective: To evaluate the ability of an abbreviated breast magnetic resonance imaging (MRI) protocol, consisting of a precontrast T1 weighted (T1W) image and single early post-contrast T1W image, to detect breast carcinoma. Materials and methods: A HIPAA compliant Institutional Review Board approved review of 100 consecutive breast MRI examinations in patients with biopsy proven unicentric breast carcinoma. 79% were invasive carcinomas and 21% were ductal carcinoma in situ. Four experienced breast radiologists, blinded to carcinoma location, history and prior examinations, assessed the abbreviated protocol evaluating only the first post-contrast T1W image, post-processed subtracted first post-contrast and subtraction maximum intensity projection images. Detection and localization of tumor were compared to the standard full diagnostic examination consisting of 13 pre-contrast, post-contrast and post-processed sequences. Results: All 100 cancers were visualized on initial reading of the abbreviated protocol by at least one reader. The mean sensitivity for each sequence was 96% for the first post-contrast sequence, 96% for the first post-contrast subtraction sequence and 93% for the subtraction MIP sequence. Within each sequence, there was no significant difference between the sensitivities among the 4 readers (p = 0.471, p = 0.656, p = 0.139). Mean interpretation time was 44 s (range 11–167 s). The abbreviated imaging protocol could be performed in approximately 10–15 min, compared to 30–40 min for the standard protocol. Conclusion: An abbreviated breast MRI protocol allows detection of breast carcinoma. One pre and post-contrast T1W sequence may be adequate for detecting

Abbreviated protocol for breast MRI: Are multiple sequences needed for cancer detection?

Energy Technology Data Exchange (ETDEWEB)

Mango, Victoria L., E-mail: vlm2125@columbia.edu [Columbia University Medical Center, Herbert Irving Pavilion, 161 Fort Washington Avenue, 10th Floor, New York, NY 10032 (United States); Memorial Sloan-Kettering Cancer Center, Breast and Imaging Center, 300 East 66th Street, New York, NY 10065 (United States); Morris, Elizabeth A., E-mail: morrise@mskcc.org [Memorial Sloan-Kettering Cancer Center, Breast and Imaging Center, 300 East 66th Street, New York, NY 10065 (United States); David Dershaw, D., E-mail: dershawd@mskcc.org [Memorial Sloan-Kettering Cancer Center, Breast and Imaging Center, 300 East 66th Street, New York, NY 10065 (United States); Abramson, Andrea, E-mail: abramsoa@mskcc.org [Memorial Sloan-Kettering Cancer Center, Breast and Imaging Center, 300 East 66th Street, New York, NY 10065 (United States); Fry, Charles, E-mail: charles_fry@nymc.edu [Memorial Sloan-Kettering Cancer Center, Breast and Imaging Center, 300 East 66th Street, New York, NY 10065 (United States); New York Medical College, 40 Sunshine Cottage Rd, Valhalla, NY 10595 (United States); Moskowitz, Chaya S. [Memorial Sloan-Kettering Cancer Center, Breast and Imaging Center, 300 East 66th Street, New York, NY 10065 (United States); Hughes, Mary, E-mail: hughesm@mskcc.org [Memorial Sloan-Kettering Cancer Center, Breast and Imaging Center, 300 East 66th Street, New York, NY 10065 (United States); Kaplan, Jennifer, E-mail: kaplanj@mskcc.org [Memorial Sloan-Kettering Cancer Center, Breast and Imaging Center, 300 East 66th Street, New York, NY 10065 (United States); Jochelson, Maxine S., E-mail: jochelsm@mskcc.org [Memorial Sloan-Kettering Cancer Center, Breast and Imaging Center, 300 East 66th Street, New York, NY 10065 (United States)

2015-01-15

Highlights: • Abbreviated breast MR demonstrates high sensitivity for breast carcinoma detection. • Time to perform/interpret the abbreviated exam is shorter than a standard MRI exam. • An abbreviated breast MRI could reduce costs and make MRI screening more available. - Abstract: Objective: To evaluate the ability of an abbreviated breast magnetic resonance imaging (MRI) protocol, consisting of a precontrast T1 weighted (T1W) image and single early post-contrast T1W image, to detect breast carcinoma. Materials and methods: A HIPAA compliant Institutional Review Board approved review of 100 consecutive breast MRI examinations in patients with biopsy proven unicentric breast carcinoma. 79% were invasive carcinomas and 21% were ductal carcinoma in situ. Four experienced breast radiologists, blinded to carcinoma location, history and prior examinations, assessed the abbreviated protocol evaluating only the first post-contrast T1W image, post-processed subtracted first post-contrast and subtraction maximum intensity projection images. Detection and localization of tumor were compared to the standard full diagnostic examination consisting of 13 pre-contrast, post-contrast and post-processed sequences. Results: All 100 cancers were visualized on initial reading of the abbreviated protocol by at least one reader. The mean sensitivity for each sequence was 96% for the first post-contrast sequence, 96% for the first post-contrast subtraction sequence and 93% for the subtraction MIP sequence. Within each sequence, there was no significant difference between the sensitivities among the 4 readers (p = 0.471, p = 0.656, p = 0.139). Mean interpretation time was 44 s (range 11–167 s). The abbreviated imaging protocol could be performed in approximately 10–15 min, compared to 30–40 min for the standard protocol. Conclusion: An abbreviated breast MRI protocol allows detection of breast carcinoma. One pre and post-contrast T1W sequence may be adequate for detecting

[Informed Consent and the Approval by Ethics Committees of Studies Involving the Use of Atypical Antipsychotics in the Management of Delirium].

Science.gov (United States)

Millán-González, Ricardo

2012-03-01

Delirium is an acute alteration of consciousness and cognition. Atypical antipsychotics (AA) have recently become a main part of its treatment. Studies in this population generate a series of ethical dilemmas concerning the voluntary participation of patients and their state of vulnerability since their mental faculties are, by definition, compromised. To assess whether studies with AA for the treatment of delirium obtained an approval by an ethics committee on human research (ECHR), if an informed consent (IC) was obtained, whether the IC was verbal or written, and who gave the approval to participate. Systematic review of Medline for studies of delirium where quetiapine and olanzapine were the main treatment, assessing the existence of an ECHR approval and implementation of an IC. 11 studies were identified (6 of quetiapine and 5 of olanzapine). 5 had an ECHR approval. Most studies examining the treatment of delirium with quetiapine or olanzapine were not subject to approval by an ECHR and most of them did not obtain an IC from the patient's legal guardian. It is essential that future studies of antipsychotics and other drugs for the treatment of delirium have the protocol approved by an ECHR and a written IC signed by the patient's legal representative, since by definition delirium is a condition that compromises superior mental processes. Copyright © 2012 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

Protocol Additional to the agreement between Canada and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2000-01-01

The text of the Protocol Additional to the Safeguards Agreement concluded between Canada and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty for the Non-Proliferation of Nuclear Weapons (NPT) is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 11 June 1998. It was signed in Vienna on 24 September 1998. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on the date on which the Agency received from Canada written notification that Canada's statutory and/or constitutional requirements for entry into force have been met, i.e. on 8 September 2000

Protocol Additional to the Agreement between Canada and the International Atomic Energy Agency for the Application of Safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2000-01-01

The text of the Protocol Additional to the Safeguards Agreement concluded between Canada and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty for the Non-Proliferation of Nuclear Weapons (NPT) is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 11 June 1998. It was signed in Vienna on 24 September 1998 [fr

Protocol additional to the agreement between the Holy See and the International Atomic Energy Agency for the application of safeguards in connection with the treaty on the non-proliferation of nuclear weapons

International Nuclear Information System (INIS)

1998-01-01

The document reproduces the text of the Protocol Additional to the Safeguards Agreement (INFCIRC/187) concluded between the Holy See and the IAEA for the application of safeguards in connection with the Treaty for the Non-Proliferation of Nuclear Weapons (NPT). The Additional Protocol was approved by the Board of Governors on 14 September 1998, and signed in Vienna on 24 September 1998, when it entered into force

Protocol Additional to the Agreement between the Republic of Indonesia and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

1999-01-01

The document reproduces the text of the Protocol Additional to the Agreement between the Republic of Indonesia and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on Non-Proliferation of Nuclear Weapons (NPT), which was approved by the Board of Governors on 20 September 1999 and signed in Vienna on 29 September 1999. The Protocol entered into force on 29 September 1999

Protocol Additional to the Agreement between the Republic of Indonesia and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on Non-Proliferation of Nuclear Weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

1999-10-29

The document reproduces the text of the Protocol Additional to the Agreement between the Republic of Indonesia and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on Non-Proliferation of Nuclear Weapons (NPT), which was approved by the Board of Governors on 20 September 1999 and signed in Vienna on 29 September 1999. The Protocol entered into force on 29 September 1999.

Protocol additional to the agreement between the Holy See and the International Atomic Energy Agency for the application of safeguards in connection with the treaty on the non-proliferation of nuclear weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

1998-11-25

The document reproduces the text of the Protocol Additional to the Safeguards Agreement (INFCIRC/187) concluded between the Holy See and the IAEA for the application of safeguards in connection with the Treaty for the Non-Proliferation of Nuclear Weapons (NPT). The Additional Protocol was approved by the Board of Governors on 14 September 1998, and signed in Vienna on 24 September 1998, when it entered into force

Protocol Additional to the Agreement between the Republic of Kazakhstan and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2007-01-01

The text of the Protocol Additional to the Agreement between the Republic of Kazakhstan and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 18 June 2003. It was signed on 6 February 2004 in Vienna. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 9 May 2007, the date on which the Agency received from Kazakhstan written notification that Kazakhstan's statutory and constitutional requirements for entry into force had been met

Protocol Additional to the Agreement between the Republic of Botswana and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2007-01-01

The text of the Protocol Additional to the Agreement between the Republic of Botswana and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Board of Governors approved the Additional Protocol on 20 September 2005. It was signed on 21 July 2006 in Gaborone, Botswana, and on 24 August 2006 in Vienna, Austria. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 24 August 2006, upon signature by the representatives of Botswana and the Agency

Protocol Additional to the Agreement between the Republic of Kazakhstan and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2007-01-01

The text of the Protocol Additional to the Agreement between the Republic of Kazakhstan and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 18 June 2003. It was signed on 6 February 2004 in Vienna. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 9 May 2007, the date on which the Agency received from Kazakhstan written notification that Kazakhstan's statutory and constitutional requirements for entry into force had been met [es

Protocol Additional to the agreement between the Republic of Malta and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2006-01-01

The text of the Protocol Additional to the Agreement between the Republic of Malta and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 28 November 2002. It was signed on 24 April 2003 in Vienna. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 12 July 2005, the date on which the Agency received from Malta written notification that Malta's statutory and constitutional requirements for entry into force had been met

Protocol Additional to the Agreement between the Republic of Kazakhstan and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2007-01-01

The text of the Protocol Additional to the Agreement between the Republic of Kazakhstan and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 18 June 2003. It was signed on 6 February 2004 in Vienna. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 9 May 2007, the date on which the Agency received from Kazakhstan written notification that Kazakhstan's statutory and constitutional requirements for entry into force had been met [fr

Protocol Additional to the Agreement between Saint Kitts and Nevis and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non‑Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2014-01-01

The text of the Protocol Additional to the Agreement between Saint Kitts and Nevis and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 10 September 2013. It was signed on 16 April 2014 in Basseterre, Saint Kitts and Nevis, and on 19 May 2014 in Vienna, Austria. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 19 May 2014, upon signature by the representatives of Saint Kitts and Nevis and the Agency

Protocol additional to the agreement between the Republic of Mali and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2002-01-01

The text of the Protocol Additional to the Safeguards Agreement 1 concluded between the Republic of Mali and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 10 September 2002. It was signed in Vienna on 12 September 2002. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force upon signature by the representatives of Mali and the Agency, i.e. on 12 September 2002

Protocol additional to the agreement between the Hashemite Kingdom of Jordan and the International Atomic Energy Agency for the application of safeguards in connection with the treaty on the non-proliferation of nuclear weapons

International Nuclear Information System (INIS)

1998-08-01

The document reproduces the text of the Protocol Additional to the Safeguards Agreement (INFCIRC/258) concluded between the Hashemite Kingdom of Jordan and the IAEA for the application of safeguards in connection with the Treaty for the Non-proliferation of Nuclear Weapons (NPT). The Additional Protocol was approved by the Board of Governors on 18 March 1998 and it entered into force on 28 july 1998

Protocol Additional to the Agreement between the Government of the Kingdom of Denmark and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2013-01-01

The text of the Protocol Additional to the Agreement between the Government of the Kingdom of Denmark and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 5 March 2013. It was signed on 22 March 2013 in Vienna, Austria. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 22 March 2013, upon signature by the representatives of the Denmark and the Agency.

A novel region-growing based semi-automatic segmentation protocol for three-dimensional condylar reconstruction using cone beam computed tomography (CBCT.

Directory of Open Access Journals (Sweden)

Tong Xi

Full Text Available OBJECTIVE: To present and validate a semi-automatic segmentation protocol to enable an accurate 3D reconstruction of the mandibular condyles using cone beam computed tomography (CBCT. MATERIALS AND METHODS: Approval from the regional medical ethics review board was obtained for this study. Bilateral mandibular condyles in ten CBCT datasets of patients were segmented using the currently proposed semi-automatic segmentation protocol. This segmentation protocol combined 3D region-growing and local thresholding algorithms. The segmentation of a total of twenty condyles was performed by two observers. The Dice-coefficient and distance map calculations were used to evaluate the accuracy and reproducibility of the segmented and 3D rendered condyles. RESULTS: The mean inter-observer Dice-coefficient was 0.98 (range [0.95-0.99]. An average 90th percentile distance of 0.32 mm was found, indicating an excellent inter-observer similarity of the segmented and 3D rendered condyles. No systematic errors were observed in the currently proposed segmentation protocol. CONCLUSION: The novel semi-automated segmentation protocol is an accurate and reproducible tool to segment and render condyles in 3D. The implementation of this protocol in the clinical practice allows the CBCT to be used as an imaging modality for the quantitative analysis of condylar morphology.

Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials.

Directory of Open Access Journals (Sweden)

Benjamin Kasenda

2016-06-01

Full Text Available Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i the existence and types of publication agreements in trial protocols, (ii the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii the frequency of co-authorship by industry employees.We used a retrospective cohort of randomized clinical trials (RCTs based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5% mentioned an agreement regarding publication of results. Of these 456, 393 (86.2% documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6% agreements were without constraints of publication. The remaining 24 (5.3% protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0% trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]. Of 71 agreements reported in publications, 52 (73.2% were concordant with those documented in the protocol. In 14 of 37 (37.8% publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements.Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do

Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials

Science.gov (United States)

Kasenda, Benjamin; von Elm, Erik; You, John J.; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J.; Stegert, Mihaela; Olu, Kelechi K.; Tikkinen, Kari A. O.; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M.; Mertz, Dominik; Akl, Elie A.; Bassler, Dirk; Busse, Jason W.; Nordmann, Alain; Gloy, Viktoria; Ebrahim, Shanil; Schandelmaier, Stefan; Sun, Xin; Vandvik, Per O.; Johnston, Bradley C.; Walter, Martin A.; Burnand, Bernard; Hemkens, Lars G.; Bucher, Heiner C.; Guyatt, Gordon H.; Briel, Matthias

2016-01-01

Background Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner’s right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions Publication agreements constraining academic authors’ independence are common. Journal articles seldom report on

Exploiting social influence to magnify population-level behaviour change in maternal and child health: study protocol for a randomised controlled trial of network targeting algorithms in rural Honduras.

Science.gov (United States)

Shakya, Holly B; Stafford, Derek; Hughes, D Alex; Keegan, Thomas; Negron, Rennie; Broome, Jai; McKnight, Mark; Nicoll, Liza; Nelson, Jennifer; Iriarte, Emma; Ordonez, Maria; Airoldi, Edo; Fowler, James H; Christakis, Nicholas A

2017-03-13

Despite global progress on many measures of child health, rates of neonatal mortality remain high in the developing world. Evidence suggests that substantial improvements can be achieved with simple, low-cost interventions within family and community settings, particularly those designed to change knowledge and behaviour at the community level. Using social network analysis to identify structurally influential community members and then targeting them for intervention shows promise for the implementation of sustainable community-wide behaviour change. We will use a detailed understanding of social network structure and function to identify novel ways of targeting influential individuals to foster cascades of behavioural change at a population level. Our work will involve experimental and observational analyses. We will map face-to-face social networks of 30 000 people in 176 villages in Western Honduras, and then conduct a randomised controlled trial of a friendship-based network-targeting algorithm with a set of well-established care interventions. We will also test whether the proportion of the population targeted affects the degree to which the intervention spreads throughout the network. We will test scalable methods of network targeting that would not, in the future, require the actual mapping of social networks but would still offer the prospect of rapidly identifying influential targets for public health interventions. The Yale IRB and the Honduran Ministry of Health approved all data collection procedures (Protocol number 1506016012) and all participants will provide informed consent before enrolment. We will publish our findings in peer-reviewed journals as well as engage non-governmental organisations and other actors through venues for exchanging practical methods for behavioural health interventions, such as global health conferences. We will also develop a 'toolkit' for practitioners to use in network-based intervention efforts, including public

Development and Validation of a Simplified Renal Replacement Therapy Suitable for Prolonged Field Care in a Porcine (Sus scrofa) Model of Acute Kidney Injury

Science.gov (United States)

2018-03-01

7. PROTOCOL PERSONNEL CHANGES: Have there been any personnel/staffing changes (PI/CI/ AI /TC/Instructor) since the last IACUC approval of protocol, or...approved this addition. ADDITIONS: (Include Name, Protocol function - PI/CI/ AI /TC/Instructor, IACUC approval - Yes/No) NAME PROTOCOL FUNCTION...IACUC APPROVAL Mrs. Lauren Walker AI Yes Maj Robert Faulconer AI Yes DELETIONS: (Include Name, Protocol function - PI/CI/ AI /TC/Instructor

Protocol Implementation Generator

DEFF Research Database (Denmark)

Carvalho Quaresma, Jose Nuno; Probst, Christian W.

2010-01-01

Users expect communication systems to guarantee, amongst others, privacy and integrity of their data. These can be ensured by using well-established protocols; the best protocol, however, is useless if not all parties involved in a communication have a correct implementation of the protocol and a...... Generator framework based on the LySatool and a translator from the LySa language into C or Java....... necessary tools. In this paper, we present the Protocol Implementation Generator (PiG), a framework that can be used to add protocol generation to protocol negotiation, or to easily share and implement new protocols throughout a network. PiG enables the sharing, verification, and translation...

Protocol Additional to the Agreement between the Republic of Slovenia and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2000-01-01

The document reproduces the text of the Protocol Additional to the Safeguards Agreement concluded between the Republic of Slovenia and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons (NPT). The Protocol was approved by the Board of Governors on 25 November 1998, signed in Vienna on 26 November 1998, and entered into force on 22 August 2000

Protocol Additional to the Agreement between the Republic of Iraq and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2010-01-01

The text of the Protocol Additional to the Agreement between the Republic of Iraq and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 24 September 2008. It was signed on 9 October 2008 in Vienna [es

Protocol Additional to the Agreement between the Kingdom of Swaziland and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2010-01-01

The text of the Protocol Additional to the Agreement between the Kingdom of Swaziland and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 4 March 2008. It was signed in Vienna on 23 July 2010 [es

Protocol Additional to the Agreement between the Republic of Slovenia and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

2000-09-14

The document reproduces the text of the Protocol Additional to the Safeguards Agreement concluded between the Republic of Slovenia and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons (NPT). The Protocol was approved by the Board of Governors on 25 November 1998, signed in Vienna on 26 November 1998, and entered into force on 22 August 2000.

Protocol Additional to the Agreement between the Republic of Iraq and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2010-01-01

The text of the Protocol Additional to the Agreement between the Republic of Iraq and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 24 September 2008. It was signed on 9 October 2008 in Vienna

Protocol Additional to the Agreement between the Kingdom of Swaziland and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2010-01-01

The text of the Protocol Additional to the Agreement between the Kingdom of Swaziland and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 4 March 2008. It was signed in Vienna on 23 July 2010

Protocol Additional to the Agreement between the Republic of Singapore and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2008-01-01

The text of the Protocol Additional to the Agreement between the Republic of Singapore and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 20 September 2005. It was signed in Vienna on 22 September 2005

Protocol Additional to the Agreement between the Kingdom of Swaziland and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2010-09-01

The text of the Protocol Additional to the Agreement between the Kingdom of Swaziland and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 4 March 2008. It was signed in Vienna on 23 July 2010

A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans

Science.gov (United States)

2016-10-01

nurses and health- care providers at the VASDHS for referrals. An Internet website for recruitment was also developed and approved by our IRB bodies. We...conducted at 0 and 3 months for PTSD symptoms, psychological distress, depression , quality of life, behavioral factors, and physiological/ biochemical...PE and EC on PTSD symptoms, depression , anger, quality of life, and physiological/biochemical stress markers. Prior evidence supports TM as a

Prevention of Stimulant-Induced Euphoria with an Opioid Receptor Antagonist

Science.gov (United States)

2014-10-01

that could lead to low self esteem , substance abuse, criminality and accidents [1]. ADHD also affects veterans. Upon returning to civilian life...Broadcast emails, images and text for Facebook advertising , and a Facebook Ad Landing Page (the internet webpage that will open if potential subject...clicks on the Facebook advertisement ). AME 15 IRB Approval: 9/19/13 Added: Olivia Bogucki, Stephannie Furtak, Brittany Hughes, Tara

Optical Quality and Threshold Target Identification and Military Target Task Performance after Advanced Keratorefractive Surgery

Science.gov (United States)

2013-05-01

to make the flap and reshape the cornea is approved by the Food and Drug Administration (FDA) and the procedure is not considered Walter Reed...Investigation Regulatory Office, the Food and Drug Administration , the Department of Health and Human Services (DHHS) Office for Human Research...Research Administrative Updates: the following personnel and study changes at both WRSRC and WRNMMC were submitted to the WRNMMC IRB

Protocol additional to the agreement between the People's Republic of Bangladesh and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2001-01-01

The text of the Protocol Additional to the Safeguards Agreement' concluded between the People's Republic of Bangladesh and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty for the Non-Proliferation of Nuclear Weapons (NPT) is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 25 September 2000. It was signed in Vienna on 30 March 2001. 2. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force upon signature by the representatives of Bangladesh and the Agency, i.e. on 30 March 2001

Protocol additional to the agreement between the People's Republic of Bangladesh and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

2001-05-04

The text of the Protocol Additional to the Safeguards Agreement' concluded between the People's Republic of Bangladesh and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty for the Non-Proliferation of Nuclear Weapons (NPT) is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 25 September 2000. It was signed in Vienna on 30 March 2001. 2. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force upon signature by the representatives of Bangladesh and the Agency, i.e. on 30 March 2001.

Surface and subsurface cleanup protocol for radionuclides, Gunnison, Colorado, UMTRA project processing site

International Nuclear Information System (INIS)

1993-09-01

Surface and subsurface soil cleanup protocols for the Gunnison, Colorado, processing sits are summarized as follows: In accordance with EPA-promulgated land cleanup standards (40 CFR 192), in situ Ra-226 is to be cleaned up based on bulk concentrations not exceeding 5 and 15 pCi/g in 15-cm surface and subsurface depth increments, averaged over 100-m 2 grid blocks, where the parent Ra-226 concentrations are greater than, or in secular equilibrium with, the Th-230 parent. A bulk interpretation of these EPA standards has been accepted by the Nuclear Regulatory Commission (NRC), and while the concentration of the finer-sized soil fraction less than a No. 4 mesh sieve contains the higher concentration of radioactivity, the bulk approach in effect integrates the total sample radioactivity over the entire sample mass. In locations where Th-230 has differentially migrated in subsoil relative to Ra-226, a Th-230 cleanup protocol has been developed in accordance with Supplemental Standard provisions of 40 CFR 192 for NRC/Colorado Department of Health (CDH) approval for timely implementation. Detailed elements of the protocol are contained in Appendix A, Generic Protocol from Thorium-230 Cleanup/Verification at UMTRA Project Processing Sites. The cleanup of other radionuclides or nonradiological hazards that pose a significant threat to the public and the environment will be determined and implemented in accordance with pathway analysis to assess impacts and the implications of ALARA specified in 40 CFR 192 relative to supplemental standards

A protocol for a randomized clinical trial of interactive video dance: potential for effects on cognitive function

Directory of Open Access Journals (Sweden)

Jovancevic Jelena

2012-06-01

Full Text Available Abstract Background Physical exercise has the potential to affect cognitive function, but most evidence to date focuses on cognitive effects of fitness training. Cognitive exercise also may influence cognitive function, but many cognitive training paradigms have failed to provide carry-over to daily cognitive function. Video games provide a broader, more contextual approach to cognitive training that may induce cognitive gains and have carry over to daily function. Most video games do not involve physical exercise, but some novel forms of interactive video games combine physical activity and cognitive challenge. Methods/Design This paper describes a randomized clinical trial in 168 postmenopausal sedentary overweight women that compares an interactive video dance game with brisk walking and delayed entry controls. The primary endpoint is adherence to activity at six months. Additional endpoints include aspects of physical and mental health. We focus this report primarily on the rationale and plans for assessment of multiple cognitive functions. Discussion This randomized clinical trial may provide new information about the cognitive effects of interactive videodance. It is also the first trial to examine physical and cognitive effects in older women. Interactive video games may offer novel strategies to promote physical activity and health across the life span. The study is IRB approved and the number is: PRO08080012 ClinicalTrials.gov Identifier: NCT01443455

Vertical Protocol Composition

DEFF Research Database (Denmark)

Groß, Thomas; Mödersheim, Sebastian Alexander

2011-01-01

The security of key exchange and secure channel protocols, such as TLS, has been studied intensively. However, only few works have considered what happens when the established keys are actually used—to run some protocol securely over the established “channel”. We call this a vertical protocol.......e., that the combination cannot introduce attacks that the individual protocols in isolation do not have. In this work, we prove a composability result in the symbolic model that allows for arbitrary vertical composition (including self-composition). It holds for protocols from any suite of channel and application...

Protocol Additional to the agreement between the Swiss Confederation and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2005-01-01

The text of the Protocol Additional to the Agreement between the Swiss Confederation and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Board of Governors approved the Additional Protocol on 7 June 2000. It was signed on 16 June 2000 in Vienna. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 1 February 2005, the date upon which the Agency received from the Swiss Confederation written notification that the Swiss Confederation's statutory and/or constitutional requirements for entry into force had been met

Protocol Additional to the agreement between the Swiss Confederation and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

2005-03-11

The text of the Protocol Additional to the Agreement between the Swiss Confederation and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Board of Governors approved the Additional Protocol on 7 June 2000. It was signed on 16 June 2000 in Vienna. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 1 February 2005, the date upon which the Agency received from the Swiss Confederation written notification that the Swiss Confederation's statutory and/or constitutional requirements for entry into force had been met.

Common Occupational Disability Tests and Case Law References: An Ontario MVA perspective on interpretation and best practice methodology supporting a holistic model, Part I of III (Pre-104 IRB).

Science.gov (United States)

Salmon, J Douglas; Gouws, Jacques J; Bachmann, Corina Anghel

2016-05-01

This three-part paper presents practical holistic models of determining impairment and occupational disability with respect to common "own occupation" and "any occupation" definitions. The models consider physical, emotional and cognitive impairments in unison, and draw upon case law support for empirically based functional assessment of secondary cognitive symptoms arising from psychological conditions, including chronic pain disorders. Case law is presented, primarily in the context of Ontario motor vehicle accident legislation, to demonstrate how triers of fact have addressed occupational disability in the context of chronic pain; and interpreted the "own occupation" and "any occupation" definitions. In interpreting the definitions of "own occupation" and "any occupation", courts have considered various concepts, such as: work as an integrated whole, competitive productivity, demonstrated job performance vs. employment, work adaptation relative to impairment stability, suitable work, retraining considerations, self-employment, and remuneration/socio-economic status. The first segment of the paper reviews the above concepts largely in the context of pre-104 Income Replacement Benefit (IRB) entitlement, while the second segment focuses on post-104 IRB entitlement. In the final segment, the paper presents a critical evaluation of computerized transferable skills analysis (TSAs) in the occupational disability context. By contrast, support is offered for the notion that (neuro) psychovocational assessments and situational work assessments should play a key role in "own occupation" disability determination, even where specific vocational rehabilitation/retraining recommendations are not requested by the referral source (e.g., insurer disability examination).

Ethical and regulatory issues with conducting sexuality research with LGBT adolescents: a call to action for a scientifically informed approach.

Science.gov (United States)

Mustanski, Brian

2011-08-01

Lesbian, gay, bisexual, and transgender (LGBT) adolescents experience disparities in mental and sexual health. There is also a lack of research on this population relative to other adolescents, which limits our ability to effectively address these health disparities. Researchers may unfortunately avoid conducting research with this population because of anticipated or actual experiences with difficulties in obtaining IRB approval. A case example is provided to illustrate the ethical and regulatory issues related to research with LGBT adolescents. Relevant U.S. federal and local regulations related to research on sexual and mental health with adolescents is then reviewed. Data are presented demonstrating that requiring parental consent for LGBT youth under age 18 would likely alter study result. Data are also presented on participants' appraisals of the risks and discomforts associated with research participation. The provision of such empirical data on the risks of research participation is consistent with the goal of moving the IRB process of risk/benefit assessment from being entirely subjective to being evidence-based. Finally, recommendations are provided on how to approach these issues in IRB applications and investigators are called to help to build a corpus of scholarship that can advance empirical knowledge in this area.

Protocol Additional to the Agreement between the Republic of the Philippines and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2010-01-01

The text of the Protocol Additional to the Agreement between the Republic of the Philippines and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 23 September 1997. It was signed in Vienna on 30 September 1997 [es

Protocol Additional to the Agreement between the Government of Japan and the International Atomic Energy Agency in implementation of Article III.1 and 4 of the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2000-01-01

The document reproduces the text of the Protocol Additional to the Agreement between the Government of Japan and the International Atomic Energy Agency in implementation of Article III.1 and 4 of the Treaty on the Non-Proliferation of Nuclear Weapons (NPT), which was approved by the Board of Governors on 25 November 1998 and signed in Vienna on 4 December 1998. The Protocol entered into force on 16 December 1998

Protocol Additional to the Agreement between the Government of Japan and the International Atomic Energy Agency in implementation of Article III.1 and 4 of the Treaty on the Non-Proliferation of Nuclear Weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

2000-02-16

The document reproduces the text of the Protocol Additional to the Agreement between the Government of Japan and the International Atomic Energy Agency in implementation of Article III.1 and 4 of the Treaty on the Non-Proliferation of Nuclear Weapons (NPT), which was approved by the Board of Governors on 25 November 1998 and signed in Vienna on 4 December 1998. The Protocol entered into force on 16 December 1998.

Protocol Additional to the Agreement between the Republic of the Philippines and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2010-01-01

The text of the Protocol Additional to the Agreement between the Republic of the Philippines and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 23 September 1997. It was signed in Vienna on 30 September 1997

Protocol Additional to the Agreement between the Republic of the Philippines and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2010-01-01

The text of the Protocol Additional to the Agreement between the Republic of the Philippines and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 23 September 1997. It was signed in Vienna on 30 September 1997 [fr

Abbreviated MRI protocols for detecting breast cancer in women with dense breasts

Energy Technology Data Exchange (ETDEWEB)

Chen, Shung Qing; Huang, Min; Shen, Yu Ying; Liu, Chen Lu; Xu, Chuan Xiao [The Affiliated Suzhou Hospital, Nanjing Medical University, Suzhou (China)

2017-06-15

To evaluate the validity of two abbreviated protocols (AP) of MRI in breast cancer screening of dense breast tissue. This was a retrospective study in 356 participants with dense breast tissue and negative mammography results. The study was approved by the Nanjing Medical University Ethics Committee. Patients were imaged with a full diagnostic protocol (FDP) of MRI. Two APs (AP-1 consisting of the first post-contrast subtracted [FAST] and maximum-intensity projection [MIP] images, and AP-2 consisting of AP-1 combined with diffusion-weighted imaging [DWI]) and FDP images were analyzed separately, and the sensitivities and specificities of breast cancer detection were calculated. Of the 356 women, 67 lesions were detected in 67 women (18.8%) by standard MR protocol, and histological examination revealed 14 malignant lesions and 53 benign lesions. The average interpretation time of AP-1 and AP-2 were 37 seconds and 54 seconds, respectively, while the average interpretation time of the FDP was 3 minutes and 25 seconds. The sensitivities of the AP-1, AP-2, and FDP were 92.9, 100, and 100%, respectively, and the specificities of the three MR protocols were 86.5, 95.0, and 96.8%, respectively. There was no significant difference among the three MR protocols in the diagnosis of breast cancer (p > 0.05). However, the specificity of AP-1 was significantly lower than that of AP-2 (p = 0.031) and FDP (p = 0.035), while there was no difference between AP-2 and FDP (p > 0.05). The AP may be efficient in the breast cancer screening of dense breast tissue. FAST and MIP images combined with DWI of MRI are helpful to improve the specificity of breast cancer detection.

Protocol Additional to the Agreement of 30 January 1973 between Morocco and the Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2011-01-01

The text of the Protocol Additional to the Agreement of 30 January 1973 between the Government of the Kingdom of Morocco and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 16 June 2004. It was signed on 22 September 2004 in Vienna, Austria [fr

Protocol Additional to the Agreement of 30 January 1973 between Morocco and the Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2011-01-01

The text of the Protocol Additional to the Agreement of 30 January 1973 between the Government of the Kingdom of Morocco and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 16 June 2004. It was signed on 22 September 2004 in Vienna, Austria [es

Protocol Additional to the Agreement of 30 January 1973 between Morocco and the Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2011-01-01

The text of the Protocol Additional to the Agreement of 30 January 1973 between the Government of the Kingdom of Morocco and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 16 June 2004. It was signed on 22 September 2004 in Vienna, Austria

Protocol Additional to the Agreement between the Republic of Montenegro and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2011-01-01

The text of the Protocol Additional to the Agreement between the Republic of Montenegro and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 13 June 2007. It was signed on 26 May 2008 in Vienna, Austria. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 4 March 2011, the date on which the Agency received from the Republic of Montenegro written notification that Montenegro's statutory and constitutional requirements for entry into force had been met

Protocol Additional to the agreement between the Republic of Cyprus and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

2003-03-12

The text of the Protocol Additional to the Agreement between the Republic of Cyprus and the International Atomic Energy Agency for the Application of Safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 25 November 1998. It was signed in Vienna on 29 July 1999. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 19 February 2003, the date on which the Agency received from the Republic of Cyprus written notification that Cyprus' statutory and constitutional requirements for entry into force had been met.

Protocol Additional to the Agreement Between the United Arab Emirates and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2011-01-01

The text of the Protocol Additional to the Agreement between the United Arab Emirates and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 3 March 2009. It was signed in Vienna on 8 April 2009. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 20 December 2010, the date on which the Agency received from the United Arab Emirates written notification that the United Arab Emirates' statutory and constitutional requirements for entry into force had been met [es

Protocol Additional to the Agreement Between the United Arab Emirates and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2011-01-01

The text of the Protocol Additional to the Agreement between the United Arab Emirates and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 3 March 2009. It was signed in Vienna on 8 April 2009. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 20 December 2010, the date on which the Agency received from the United Arab Emirates written notification that the United Arab Emirates' statutory and constitutional requirements for entry into force had been met

Protocol Additional to the Agreement between the Principality of Andorra and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2012-01-01

The text of the Protocol Additional to the Agreement between the Principality of Andorra and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 7 December 2000. It was signed in Vienna, Austria on 9 January 2001. 2. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 19 December 2011, the date on which the Agency received from the Principality of Andorra written notification that its statutory and constitutional requirements for entry into force had been met.

Protocol Additional to the agreement between the Republic of Cyprus and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2003-01-01

The text of the Protocol Additional to the Agreement between the Republic of Cyprus and the International Atomic Energy Agency for the Application of Safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 25 November 1998. It was signed in Vienna on 29 July 1999. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 19 February 2003, the date on which the Agency received from the Republic of Cyprus written notification that Cyprus' statutory and constitutional requirements for entry into force had been met

Protocol Additional to the agreement between the Republic of Azerbaijan and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2000-01-01

The text of the Protocol Additional to the Safeguards Agreement concluded between the Republic of Azerbaijan and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty for the Non-Proliferation of Nuclear Weapons (NPT) is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 7 June 2000. It was signed in Vienna on 5 July 2000. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on the date on which the Agency received from Azerbaijan written notification that Azerbaijan's statutory and/or constitutional requirements for entry into force have been met, i.e. on 29 November 2000

Protocol Additional to the Agreement between the Republic of Uzbekistan and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

1998-01-01

The document reproduces the text of the Protocol Additional to the Safeguards Agreement (INFCIRC/508) concluded between the Republic of Uzbekistan and the IAEA for the application of safeguards in connection with the Treaty for the Non-Proliferation of Nuclear Weapons (NPT). The Additional Protocol was approved by the Board of Governors on 14 September 1998, signed in Vienna on 22 September 1998, and applied provisionally as from the date of signature

Protocol Additional to the Agreement between the Republic of Madagascar and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2004-01-01

The text of the Protocol Additional to the Agreement between the Republic of Madagascar and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 18 June 2003. It was signed in Vienna on 18 September 2003 [es

Protocol Additional to the Agreement between the Republic of Madagascar and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2004-01-01

The text of the Protocol Additional to the Agreement between the Republic of Madagascar and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 18 June 2003. It was signed in Vienna on 18 September 2003 [fr

Protocol Additional to the Agreement between the Principality of Monaco and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

1999-01-01

The document reproduces the text of the Protocol Additional to the Safeguards Agreement (INFCIRC/524) concluded between the Principality of Monaco and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons (NPT). The Additional Protocol was approved by the Board of Governors on 25 November 1998, signed in Vienna on 30 September 1999, and entered into force on the same date

Protocol Additional to the Agreement between the Principality of Monaco and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

1999-10-29

The document reproduces the text of the Protocol Additional to the Safeguards Agreement (INFCIRC/524) concluded between the Principality of Monaco and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons (NPT). The Additional Protocol was approved by the Board of Governors on 25 November 1998, signed in Vienna on 30 September 1999, and entered into force on the same date.

Protocol Additional to the Agreement between the Republic of Uzbekistan and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

1998-11-25

The document reproduces the text of the Protocol Additional to the Safeguards Agreement (INFCIRC/508) concluded between the Republic of Uzbekistan and the IAEA for the application of safeguards in connection with the Treaty for the Non-Proliferation of Nuclear Weapons (NPT). The Additional Protocol was approved by the Board of Governors on 14 September 1998, signed in Vienna on 22 September 1998, and applied provisionally as from the date of signature

Protocol Additional to the Agreement between the Republic of Madagascar and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2004-01-01

The text of the Protocol Additional to the Agreement between the Republic of Madagascar and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 18 June 2003. It was signed in Vienna on 18 September 2003

Protocol between the government of the Republic of Latvia and the International Atomic Energy Agency additional to the agreement for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

2002-03-28

The text of the Protocol Additional to the Safeguards Agreement concluded between the Republic of Latvia and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 7 December 2000. It was signed in Vienna on 12 July 2001. 2. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force upon signature by the representatives of Latvia and the Agency, i.e. on 12 July 2001.

Protocol between the government of the Republic of Latvia and the International Atomic Energy Agency additional to the agreement for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2002-01-01

The text of the Protocol Additional to the Safeguards Agreement concluded between the Republic of Latvia and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 7 December 2000. It was signed in Vienna on 12 July 2001. 2. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force upon signature by the representatives of Latvia and the Agency, i.e. on 12 July 2001

Protocol additional to the agreement between the Government of the Republic of Ghana and the International Atomic Energy Agency for the application of safeguards in connection with the treaty on the non-proliferation of nuclear weapons

International Nuclear Information System (INIS)

1998-01-01

The document reproduces the text of the Protocol Additional to the Safeguards Agreement (INFCIRC/226) concluded between the Government of the Republic of Ghana and the IAEA for the application of safeguards in connection with the Treaty for the Non-Proliferation of Nuclear Weapons (NPT). The Additional Protocol was approved by the Board of Governors on 11 June 1998, and signed in Vienna on 12 June 1998. Pending entry into force, the Protocol is being applied provisionally as from the date of signature, i.e. 12 June 1998

Protocol additional to the agreement between the Government of the Republic of Ghana and the International Atomic Energy Agency for the application of safeguards in connection with the treaty on the non-proliferation of nuclear weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

1998-11-25

The document reproduces the text of the Protocol Additional to the Safeguards Agreement (INFCIRC/226) concluded between the Government of the Republic of Ghana and the IAEA for the application of safeguards in connection with the Treaty for the Non-Proliferation of Nuclear Weapons (NPT). The Additional Protocol was approved by the Board of Governors on 11 June 1998, and signed in Vienna on 12 June 1998. Pending entry into force, the Protocol is being applied provisionally as from the date of signature, i.e. 12 June 1998

Protocol Additional to the Agreement of 30 January 1973 between Morocco and the Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2011-01-01

The text of the Protocol Additional to the Agreement of 30 January 1973 between the Government of the Kingdom of Morocco and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 16 June 2004. It was signed on 22 September 2004 in Vienna, Austria. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 21 April 2011, the date on which the Agency received from the Kingdom of Morocco written notification that Morocco's statutory and constitutional requirements for entry into force had been met

Electronic Approval of Invoices (AEF)

CERN Document Server

2004-01-01

With a view to the simplification of administrative procedures, AS and FI Departments have completed the second phase of the new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. Phase II includes handling the electronic approval process of invoices whose amounts do not correspond exactly to those of the associated orders. In such cases, budgetary approval is required for the entire invoiced amount. Further information can be obtained at : http://ais.cern.ch/projs/AEF/help/F_help.htm Phase II of the procedure will be introduced gradually with effect from April 2004. Finance Department, Accounts Payable Section Tel: 72295 Organisation and Procedures Tel: 75885 Information Technologies Department,...

Marketing Approval of Ethical Kampo Medicines.

Science.gov (United States)

Hakamatsuka, Takashi

2017-01-01

Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.

Protocol Additional to the agreement between the Union of the Comoros and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2009-01-01

The text of the Protocol Additional to the Agreement between the Union of the Comoros and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 16 June 2005. It was signed in Vienna on 13 December 2005. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 20 January 2009, the date on which the Agency received from the Union of the Comoros written notification that Comoros' statutory and constitutional requirements for entry into force had been met

40 CFR 145.31 - Approval process.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Approval process. 145.31 Section 145.31 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) STATE UIC PROGRAM REQUIREMENTS Program Approval, Revision and Withdrawal § 145.31 Approval process. (a...

40 CFR 52.2122 - Approval status.

Science.gov (United States)

2010-07-01

... sources covered by CTGs issued by the previous January. (b) EPA disapproved South Carolina's generic...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) South Carolina § 52.2122 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves South Carolina's plans for...

Protocol Additional to the Agreement between the People's Republic of Bulgaria and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2000-01-01

The document reproduces the text of the Protocol Additional to the Safeguards Agreement concluded between the People's Republic of Bulgaria and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons (NPT). The Protocol was approved by the Board of Governors on 14 September 1998, signed in Vienna on 24 September 1998, and entered into force on 10 October 2000

Protocol Additional to the Agreement between the People's Republic of Bulgaria and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

2000-10-25

The document reproduces the text of the Protocol Additional to the Safeguards Agreement concluded between the People's Republic of Bulgaria and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons (NPT). The Protocol was approved by the Board of Governors on 14 September 1998, signed in Vienna on 24 September 1998, and entered into force on 10 October 2000.

Protocol Additional to the agreement between the Government of the Republic of South Africa and the International Atomic Energy Agency for the application of safeguards in connection With the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2002-01-01

The text of the Protocol Additional to the Safeguards Agreement 1 concluded between the Government of the Republic of South Africa and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 12 June 2002. It was signed in Vienna on 13 September 2002. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force upon signature by the representatives of South Africa and the Agency, i.e. on 13 September 2002

75 FR 48302 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

Science.gov (United States)

2010-08-10

....gov ). FOR FURTHER INFORMATION CONTACT: For information on credit account approval for reimbursable..., at (301) 851-2908. SUPPLEMENTARY INFORMATION: Title: Credit Account Approval for Reimbursable... Inspection Service [Docket No. APHIS-2010-0071] Notice of Request for Extension of Approval of an Information...

78 FR 54617 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

Science.gov (United States)

2013-09-05

...] Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval for... (202) 799-7039 before coming. FOR FURTHER INFORMATION CONTACT: For information on credit account... Coordinator, at (301) 851-2908. SUPPLEMENTARY INFORMATION: Title: Credit Account Approval for Reimbursable...

Targeting Discoidin Domain Receptors in Prostate Cancer

Science.gov (United States)

2016-08-01

showed an apparent reduced tumor burden in the treated mice using bioluminescence. However, several mice suffered bone fractures , which compromised...metastases remains a challenge due to the limited arsenal of effective therapeutic drugs that reduce disease progression. Therefore, a major goal in PCa...blinded in relation to patient identification, as required. An IRB (exempt) was approved by Wayne State University for the use of this TMA as requested

Perceptions of gender-based discrimination during surgical training and practice

OpenAIRE

Bruce, Adrienne N.; Battista, Alexis; Plankey, Michael W.; Johnson, Lynt B.; Marshall, M. Blair

2015-01-01

Background: Women represent 15% of practicing general surgeons. Gender-based discrimination has been implicated as discouraging women from surgery. We sought to determine women’s perceptions of gender-based discrimination in the surgical training and working environment.Methods: Following IRB approval, we fielded a pilot survey measuring perceptions and impact of gender-based discrimination in medical school, residency training, and surgical practice. It was sent electronically to 1,065 indiv...

Nursing Student Perceptions of Reflective Journaling: A Conjoint Value Analysis

OpenAIRE

Hendrix, Thomas J.; O'Malley, Maureen; Sullivan, Catherine; Carmon, Bernice

2012-01-01

This study used a statistical technique, conjoint value analysis, to determine student perceptions related to the importance of predetermined reflective journaling attributes. An expert Delphi panel determined these attributes and integrated them into a survey which presented students with multiple journaling experiences from which they had to choose. After obtaining IRB approval, a convenience sample of 66 baccalaureate nursing students completed the survey. The relative importance of the at...

Comparing Web, Group and Telehealth Formats of a Military Parenting Program

Science.gov (United States)

2017-06-01

spots, social media , community events and military partners. A ‘refer a friend’ campaign is currently being reviewed by our IRB. Once approved, a...postcard asking current study families to ‘refer a friend’ as one method to assist with our overall recruitment. We know that word of mouth , especially...as the individualized ADAPT web-facilitated condition 2 2. KEY WORDS Parenting, military, comparative effectiveness, children, randomized trial

40 CFR 52.1772 - Approval status.

Science.gov (United States)

2010-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) North Carolina § 52.1772 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves North Carolina's plans for... CTGs issued by the previous January. (b) New Source review permits issued pursuant to section 173 of...

Protocol Additional to the agreement between the Czech Republic and the International Atomic Energy Agency for the application of safeguards in connection With the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2002-01-01

The text of the Protocol Additional to the Safeguards Agreement concluded between the Czech Republic and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 20 September 1999. It was signed in Vienna on 28 September 1999. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on the date on which the Agency received from the Czech Republic written notification that the Czech Republic's statutory and/or constitutional requirements for entry into force have been met, i.e. on 1 July 2002

9 CFR 147.52 - Approved tests.

Science.gov (United States)

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approved tests. 147.52 Section 147.52 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry...

30 CFR 14.10 - Post-approval product audit.

Science.gov (United States)

2010-07-01

..., AND APPROVAL OF MINING PRODUCTS REQUIREMENTS FOR THE APPROVAL OF FLAME-RESISTANT CONVEYOR BELTS General Provisions § 14.10 Post-approval product audit. (a) Approved conveyor belts will be subject to... based. MSHA will select an approved conveyor belt to be audited; the selected belt will be...

Protocol Additional to the Agreement between the Kingdom of Lesotho and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2010-01-01

The text of the Protocol Additional to the Agreement between the Kingdom of Lesotho and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 24 September 2008. It was signed on 22 April 2010 in Berlin, Germany, and on 26 April 2010 in Vienna, Austria [es

Protocol Additional to the Agreement between the Kingdom of Lesotho and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2010-01-01

The text of the Protocol Additional to the Agreement between the Kingdom of Lesotho and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 24 September 2008. It was signed on 22 April 2010 in Berlin, Germany, and on 26 April 2010 in Vienna, Austria

Protocol Additional to the Agreement between the Socialist Republic of Viet Nam and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2012-01-01

The text of the Protocol Additional to the Agreement between the Socialist Republic of Viet Nam and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 6 March 2007. It was signed on 10 August 2007 in Vienna, Austria. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 17 September 2012, the date on which the Agency received from the Socialist Republic of Viet Nam written notification that Vietnam's statutory and constitutional requirements for entry into force had been met [fr

Protocol Additional to the Agreement between the Principality of Andorra and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons (Spanish Edition)

International Nuclear Information System (INIS)

2012-01-01

The text of the Protocol Additional to the Agreement between the Principality of Andorra and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 7 December 2000. It was signed in Vienna, Austria on 9 January 2001. 2. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 19 December 2011, the date on which the Agency received from the Principality of Andorra written notification that its statutory and constitutional requirements for entry into force had been met. [es

Protocol Additional to the Agreement between the Socialist Republic of Viet Nam and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2012-01-01

The text of the Protocol Additional to the Agreement between the Socialist Republic of Viet Nam and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 6 March 2007. It was signed on 10 August 2007 in Vienna, Austria. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 17 September 2012, the date on which the Agency received from the Socialist Republic of Viet Nam written notification that Vietnam's statutory and constitutional requirements for entry into force had been met [es

Protocol Additional to the Agreement between the Socialist Republic of Viet Nam and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2012-01-01

The text of the Protocol Additional to the Agreement between the Socialist Republic of Viet Nam and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 6 March 2007. It was signed on 10 August 2007 in Vienna, Austria. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 17 September 2012, the date on which the Agency received from the Socialist Republic of Viet Nam written notification that Vietnam's statutory and constitutional requirements for entry into force had been met

Protocol Additional to the Agreement between the Principality of Andorra and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons (Chinese Edition)

International Nuclear Information System (INIS)

2012-01-01

The text of the Protocol Additional to the Agreement between the Principality of Andorra and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 7 December 2000. It was signed in Vienna, Austria on 9 January 2001. 2. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 19 December 2011, the date on which the Agency received from the Principality of Andorra written notification that its statutory and constitutional requirements for entry into force had been met.

Protocol Additional to the agreement between the Republic of Colombia and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America

International Nuclear Information System (INIS)

2009-01-01

The text of the Protocol Additional to the Agreement between the Republic of Colombia and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 25 November 2004. It was signed in Vienna on 11 May 2005. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 5 March 2009, the date on which the Agency received from Colombia written notification that Colombia's statutory and constitutional requirements for entry into force had been met

Protocol of specific health monitoring: ionizing radiation, 11 years later; Protocolo de vigilancia sanitaria especifica: radiaciones ionizantes, 11 anos despues

Energy Technology Data Exchange (ETDEWEB)

Castillejo Puertas, F. M.

2016-08-01

Since the approval on November 11{sup t}h 2003 of the Protocol of Specific Health Monitoring for Workers Exposed to Ionizing Radiation a study has been carried out to discover its effectiveness. These areas were examined: the daily practice od accupational medicine and, in particular, its specific task in the application of the different clinical/labour criteria for workers exposed to ionizing radiation or at risk of radioactive contamination; the degree of its uses as well as the updates and improvements. For that purpose, a descriptive bibliographic revision has been used for the last 11 years. The results revealed the lack of updates of the Protocol as well as the few usable objective criteria, when the clinical/labour aptitudes are reflected upon. (Author)

Protocol Additional to the Agreement between the Socialist People's Libyan Arab Jamahiriya and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2007-01-01

The text of the Protocol Additional to the Agreement between the Socialist People's Libyan Arab Jamahiriya and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Board of Governors approved the Additional Protocol on 9 March 2004. It was signed on 10 March 2004 in Vienna [es

Protocol Additional to the Agreement between the Socialist People's Libyan Arab Jamahiriya and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2007-01-01

The text of the Protocol Additional to the Agreement between the Socialist People's Libyan Arab Jamahiriya and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Board of Governors approved the Additional Protocol on 9 March 2004. It was signed on 10 March 2004 in Vienna

7 CFR 1710.406 - Loan approval.

Science.gov (United States)

2010-01-01

... 7 Agriculture 11 2010-01-01 2010-01-01 false Loan approval. 1710.406 Section 1710.406 Agriculture... GENERAL AND PRE-LOAN POLICIES AND PROCEDURES COMMON TO ELECTRIC LOANS AND GUARANTEES Application Requirements and Procedures for Loans § 1710.406 Loan approval. (a) A loan is approved when the Administrator...

40 CFR 123.61 - Approval process.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 21 2010-07-01 2010-07-01 false Approval process. 123.61 Section 123... REQUIREMENTS Program Approval, Revision, and Withdrawal § 123.61 Approval process. (a) After determining that a...; and (6) Briefly outline the fundamental aspects of the State's proposed program, and the process for...

Protocol Additional to the agreement between the Republic of Seychelles and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2004-01-01

The text of the Protocol Additional to the Agreement between the Republic of Seychelles and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Board of Governors approved the Protocol Additional on 18 March 2003. It was signed on 29 March 2004 in Windhoek and on 7 April 2004 in Vienna. Pursuant to Article 17 of the Protocol Additional, the Protocol entered into force on 13 October 2004, the date on which the Agency received from the Republic of Seychelles written notification that the Republic of Seychelles's statutory and/or constitutional requirements for entry into force had been met

Protocol Additional to the Agreement between the Republic of Mozambique and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2011-01-01

The text of the Protocol Additional to the Agreement between the Republic of Mozambique and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 22 November 2007. It was signed on 23 June 2010 in Lisbon, Portugal, and on 8 July 2010 in Vienna, Austria. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 1 March 2011, the date on which the Agency received from the Republic of Mozambique written notification that Mozambique's statutory and constitutional requirements for entry into force had been met

Protocol between the Democratic Republic of Congo and the International Atomic Energy Agency Additional to the Agreement for the Application of Safeguards in Connection with the Treaty on the Non-proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2003-01-01

The text of the Protocol Additional to the Agreement between the Republic of Zaire and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons (NPT)1 is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 28 November 2002. It was signed in Vienna on 9 April 2003

Protocol Additional to the Agreement between the Government of the Kingdom of Denmark and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2013-01-01

The text of the Protocol Additional to the Agreement between the Government of the Kingdom of Denmark and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 5 March 2013. It was signed on 22 March 2013 in Vienna, Austria [es

Protocol Additional to the Agreement between the Government of the Republic of Lithuania and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2000-01-01

The document reproduces the text of the Protocol Additional to the Safeguards Agreement concluded between the Government of the Republic of Lithuania and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons (NPT). The Protocol was approved by the Board of Governors on 8 December 1997, signed in Vienna on 11 March 1998, and entered into force on 5 July 2000

Protocol Additional to the Agreement between the Government of the Republic of Lithuania and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

2000-10-25

The document reproduces the text of the Protocol Additional to the Safeguards Agreement concluded between the Government of the Republic of Lithuania and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons (NPT). The Protocol was approved by the Board of Governors on 8 December 1997, signed in Vienna on 11 March 1998, and entered into force on 5 July 2000.

Protocol Additional to the Agreement between the Government of the Kingdom of Denmark and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2013-01-01

The text of the Protocol Additional to the Agreement between the Government of the Kingdom of Denmark and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 5 March 2013. It was signed on 22 March 2013 in Vienna, Austria

Protocol Additional to the Agreement between the Government of the Republic of Turkey and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2002-01-01

The text of the Protocol Additional to the Safeguards Agreement concluded between the Republic of Turkey and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 7 June 2000. It was signed in Vienna on 6 July 2000

Editor's note: notice of retraction.

Science.gov (United States)

Shafer, Steven L

2014-11-01

In 2009, Joachim Boldt published an article in Anesthesia & Analgesia comparing albumin and hydroxyethyl starch priming cardiopulmonary bypass. The study was retracted in December 2010 for lack of IRB approval. A subsequent investigation by Klinikum Ludwigshafen determined that the study was fabricated. Based on the finding by Landesärztekammer Rheinland-Pfalz, the State Medical Association of Rheinland-Pfalz, that the studies were conducted without IRB approval, Anesthesia & Analgesia retracted 22 papers by Dr. Boldt in 2011 for unethical conduct of research. A subsequent investigation by Klinikum Ludwigshafen found that Boldt’s studies "failed to meet required standards," included "false data" in at least 10 studies, and found "clear evidence of procedural irregularities and research misconduct on the part of Dr. Joachim Boldt." In light of these concerns, Justus-Liebig Universität Giessen undertook an investigation of Dr. Boldt’s work from that institution. This investigation cast doubt on the veracity of Boldt J, Heesen M, Müller M, Pabsdorf M, Hempelmann G. The effects of albumin versus hydroxyethyl starch solution on cardiorespiratory and circulatory variables in critically ill patient. Anesth Analg 1996;83: 254–61. Based on evidence of data manipulation reported by Justus-Liebig Universität Giessen to the journal, this paper is hereby retracted.

40 CFR 52.1323 - Approval status.

Science.gov (United States)

2010-07-01

... on January 16, 1979 (44 FR 3274) are met. (b) The Administrator approves Rule 10 CSR 10-2.290 as.... (c) The Administrator approves Rule 10 CSR 10-2.230 as identified under § 52.1320, paragraph (c)(70... SIP would be the emission limits stated in the rule. (d) The Administrator approves Rule 10 CSR 10-5...

Surface and subsurface cleanup protocol for radionuclides, Gunnison, Colorado, UMTRA project processing site. Final [report

Energy Technology Data Exchange (ETDEWEB)

1993-09-01

Surface and subsurface soil cleanup protocols for the Gunnison, Colorado, processing sits are summarized as follows: In accordance with EPA-promulgated land cleanup standards (40 CFR 192), in situ Ra-226 is to be cleaned up based on bulk concentrations not exceeding 5 and 15 pCi/g in 15-cm surface and subsurface depth increments, averaged over 100-m{sup 2} grid blocks, where the parent Ra-226 concentrations are greater than, or in secular equilibrium with, the Th-230 parent. A bulk interpretation of these EPA standards has been accepted by the Nuclear Regulatory Commission (NRC), and while the concentration of the finer-sized soil fraction less than a No. 4 mesh sieve contains the higher concentration of radioactivity, the bulk approach in effect integrates the total sample radioactivity over the entire sample mass. In locations where Th-230 has differentially migrated in subsoil relative to Ra-226, a Th-230 cleanup protocol has been developed in accordance with Supplemental Standard provisions of 40 CFR 192 for NRC/Colorado Department of Health (CDH) approval for timely implementation. Detailed elements of the protocol are contained in Appendix A, Generic Protocol from Thorium-230 Cleanup/Verification at UMTRA Project Processing Sites. The cleanup of other radionuclides or nonradiological hazards that pose a significant threat to the public and the environment will be determined and implemented in accordance with pathway analysis to assess impacts and the implications of ALARA specified in 40 CFR 192 relative to supplemental standards.

30 CFR 14.7 - Approval marking and distribution records.

Science.gov (United States)

2010-07-01

..., EVALUATION, AND APPROVAL OF MINING PRODUCTS REQUIREMENTS FOR THE APPROVAL OF FLAME-RESISTANT CONVEYOR BELTS General Provisions § 14.7 Approval marking and distribution records. (a) An approved conveyor belt must be marketed only under the name specified in the approval. (b) Approved conveyor belt must be legibly and...

Protocol additional to the agreement between the United Republic of Tanzania and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2005-01-01

The text of the Protocol Additional to the Agreement between the United Republic of Tanzania and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Board of Governors approved the Additional Protocol on 16 June 2004. It was signed on 23 September 2004 in Vienna. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 7 February 2005, the date on which the Agency received from the United Republic of Tanzania written notification that the United Republic of Tanzania's statutory and/or constitutional requirements for entry into force had been met

Protocol additional to the agreement between the United Republic of Tanzania and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

2005-03-07

The text of the Protocol Additional to the Agreement between the United Republic of Tanzania and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Board of Governors approved the Additional Protocol on 16 June 2004. It was signed on 23 September 2004 in Vienna. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 7 February 2005, the date on which the Agency received from the United Republic of Tanzania written notification that the United Republic of Tanzania's statutory and/or constitutional requirements for entry into force had been met.

Drugs Approved for Kidney (Renal Cell) Cancer

Science.gov (United States)

... Your Treatment Research Drugs Approved for Kidney (Renal Cell) Cancer This page lists cancer drugs approved by the ... not listed here. Drugs Approved for Kidney (Renal Cell) Cancer Afinitor (Everolimus) Aldesleukin Avastin (Bevacizumab) Axitinib Bevacizumab Cabometyx ( ...

Assessment tools for the measurement of the self-efficacy of drug users: protocol for a systematic review.

Science.gov (United States)

Vasconcelos, Selene Cordeiro; Frazão, Iracema da Silva; Sougey, Everton Botelho; Souza, Sandra Lopes de; Silva, Tatiana de Paula Santana da; Lima, Murilo Duarte da Costa

2018-03-14

The abuse of alcohol and other drugs is a worldwide problem, the treatment of which poses a challenge to healthcare workers. This study presents a proposal for a systematic review to analyse the psychometric properties of assessment tools developed to measure the self-efficacy of drug users with regard to resisting the urge to take drugs in high-risk situations. The guiding question was based on PICOS (Population Intervention Comparator Outcome Setting), and the report of the methods of review protocol was written in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Searches will be performed in the PsycINFO, Cochrane, Pubmed, Web of Science, SCOPUS and CINAHL databases, followed by the use of the 'snowball' strategy. The inclusion criteria for the articles will be (1) assessment tool validation studies; (2) assessment tools developed to measure self-efficacy; (3) quantitative measures; (4) measures designed for use on adults; (5) data from self-reports of the participants; (6) studies involving a description of psychometric properties of the measures; and (7) studies that explain how the level of self-efficacy is scored. The search, selection and analysis will be performed by two independent reviewers. In cases of a divergence of opinion, a third reviewer will be consulted. The COSMIN checklist will be used for the appraisal of the methodological quality of the assessment tools and the certainty of the evidence in the articles (risk of bias) will be analysed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. This protocol does not require ethical approval. However, this protocol is part of the thesis entitled Drug-Taking Confidence Questionnaire for use in Brazil, presented for obtaining a doctorate in neuropsychiatry and behavioural sciences from the Federal University of Pernambuco, and has received approval from the human research ethics committee of the Federal

Analyzing the effect of routing protocols on media access control protocols in radio networks

Energy Technology Data Exchange (ETDEWEB)

Barrett, C. L. (Christopher L.); Drozda, M. (Martin); Marathe, A. (Achla); Marathe, M. V. (Madhav V.)

2002-01-01

We study the effect of routing protocols on the performance of media access control (MAC) protocols in wireless radio networks. Three well known MAC protocols: 802.11, CSMA, and MACA are considered. Similarly three recently proposed routing protocols: AODV, DSR and LAR scheme 1 are considered. The experimental analysis was carried out using GloMoSim: a tool for simulating wireless networks. The main focus of our experiments was to study how the routing protocols affect the performance of the MAC protocols when the underlying network and traffic parameters are varied. The performance of the protocols was measured w.r.t. five important parameters: (i) number of received packets, (ii) average latency of each packet, (iii) throughput (iv) long term fairness and (v) number of control packets at the MAC layer level. Our results show that combinations of routing and MAC protocols yield varying performance under varying network topology and traffic situations. The result has an important implication; no combination of routing protocol and MAC protocol is the best over all situations. Also, the performance analysis of protocols at a given level in the protocol stack needs to be studied not locally in isolation but as a part of the complete protocol stack. A novel aspect of our work is the use of statistical technique, ANOVA (Analysis of Variance) to characterize the effect of routing protocols on MAC protocols. This technique is of independent interest and can be utilized in several other simulation and empirical studies.

A protocol proposition of cell therapy for the treatment of chronic obstructive pulmonary disease.

Science.gov (United States)

Ribeiro-Paes, J T; Stessuk, T; Marcelino, M; Faria, C; Marinelli, T; Ribeiro-Paes, M J

2014-01-01

The main feature of pulmonary emphysema is airflow obstruction resulting from the destruction of the alveolar walls distal to the terminal bronchioles. Existing clinical approaches have improved and extended the quality of life of emphysema patients. However, no treatment currently exists that can change the disease course and cure the patient. The different therapeutic approaches that are available aim to increase survival and/or enhance the quality of life of emphysema patients. In this context, cell therapy is a promising therapeutic approach with great potential for degenerative pulmonary diseases. In this protocol proposition, all patients will be submitted to laboratory tests, such as evaluation of heart and lung function and routine examinations. Stem cells will be harvested by means of 10 punctures on each anterior iliac crest, collecting a total volume of 200mL bone marrow. After preparation, separation, counting and labeling (optional) of the mononuclear cells, the patients will receive an intravenous infusion from the pool of Bone Marrow Mononuclear Cells (BMMC). This article proposes a rational and safe clinical cellular therapy protocol which has the potential for developing new projects and can serve as a methodological reference for formulating clinical application protocols related to the use of cellular therapy in COPD. This study protocol was submitted and approved by the Brazilian National Committee of Ethics in Research (CONEP - Brazil) registration number 14764. It is also registered in ClinicalTrials.gov (NCT01110252). Copyright © 2013 Sociedade Portuguesa de Pneumologia. Published by Elsevier España. All rights reserved.

Trial endpoints for drug approval in oncology: Chemoprevention.

Science.gov (United States)

Beitz, J

2001-04-01

As with other drugs, new drug applications for marketing approval of chemopreventive drugs must include data from adequate and well-controlled clinical trials that demonstrate effectiveness and safety for the intended use. This article summarizes the regulatory requirements for traditional marketing approval, as well as for approval under the accelerated approval regulations. Unlike traditional approval, accelerated approval is based on a surrogate endpoint that is reasonably likely to predict clinical benefit. Discussions with the Food and Drug Administration (FDA) regarding the validity of trial endpoints that may serve as surrogates for clinical benefit for accelerated approval should take place as early as possible in drug development. Meetings with the FDA to discuss these issues may be requested throughout the clinical development of a new drug.

Quality of randomized controlled trials published in the International Urogynecology Journal 2007-2016.

Science.gov (United States)

Kim, Kyu Shik; Chung, Jae Hoon; Jo, Jung Ki; Kim, Jae Heon; Kim, Seungjun; Cho, Jeoung Man; Cho, Hee Ju; Choi, Hong Yong; Lee, Seung Wook

2018-07-01

Randomized controlled trials (RCTs) provide the best quality clinical evidence. The aim of this study was to assess the quality of RCTs published by the International Urogynecology Journal (IUJ) in 2007-2016. RCTs in original articles were extracted from PubMed and IUJ homepage. Change in RCT quality over time was assessed with Jadad and van Tulder scales and Cochrane Collaboration's risk of bias tool (CCRBT). Jadad scores of 3-5 or van Tulder scores of >5 indicated high-quality RCTs. The effect on RCT quality of including funding source and institutional review board (IRB) approval statements and describing the intervention was assessed. In addition, changes in RCT topics over time were assessed. Annual RCT frequencies did not change significantly (6.7-15.7%): 36.1% and 25.7% described blinding and allocation concealment, respectively. Both tended to increase between 2013 and 2016, particularly 2013 and 2014. Funding statement inclusion (39.1% overall) and intervention description (78.2% overall) tended to increase steadily. IRB statement inclusion (60.4% overall) increased significantly (p < 0.01). Jadad scores and van Tulder rose significantly until 2014 (p < 0.01). Frequencies of high-quality RCTs tended to rise. CCRBT indicated that RCTs with a low risk of bias tended to increase until 2014. However, from 2015, Jadad scores, van Tulder, and CCRBT the low risk tended to decreased. RCTs with funding and IRB approval statements had higher Jadad and van Tulder scores than unfunded RCTs (p < 0.01 and p < 0.01, respectively). Intervention description did not associate with better quality. RCT quality improved over time, but a dip in quality was observed in 2015-2016 because of decreased blinding and allocation concealment.

Protocol Additional to the Agreement between the Republic of The Gambia and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2011-01-01

The text of the Protocol Additional to the Agreement between the Republic of The Gambia and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 3 March 2010. It was signed on 7 October 2011 in Banjul, The Gambia, and on 18 October 2011 in Vienna, Austria

Protocol Additional to the agreement between the Republic of Chile and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Caribbean

International Nuclear Information System (INIS)

2003-01-01

The text of the Protocol Additional to the Agreement between the Republic of Chile and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Caribbean is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 10 September 2002. It was signed in Vienna on 19 September 2002. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 3 November 2003, the date on which the Agency received from Chile written notification that Chile's statutory and/or constitutional requirements for entry into force had been met

Protocol Additional to the agreement between the Republic of Chile and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Caribbean

Energy Technology Data Exchange (ETDEWEB)

NONE

2003-12-23

The text of the Protocol Additional to the Agreement between the Republic of Chile and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Caribbean is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 10 September 2002. It was signed in Vienna on 19 September 2002. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 3 November 2003, the date on which the Agency received from Chile written notification that Chile's statutory and/or constitutional requirements for entry into force had been met.

A round-robin gamma stereotactic radiosurgery dosimetry interinstitution comparison of calibration protocols

Energy Technology Data Exchange (ETDEWEB)

Drzymala, R. E., E-mail: drzymala@wustl.edu [Department of Radiation Oncology, Washington University, St. Louis, Missouri 63110 (United States); Alvarez, P. E. [Imaging and Radiation Oncology Core Houston, UT MD Anderson Cancer Center, Houston, Texas 77030 (United States); Bednarz, G. [Radiation Oncology Department, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15232 (United States); Bourland, J. D. [Department of Radiation Oncology, Wake Forest University, Winston-Salem, North Carolina 27157 (United States); DeWerd, L. A. [Department of Medical Physics, University of Wisconsin-Madison, Madison, Wisconsin 53705 (United States); Ma, L. [Department of Radiation Oncology, University California San Francisco, San Francisco, California 94143 (United States); Meltsner, S. G. [Department of Radiation Oncology, Duke University Medical Center, Durham, North Carolina 27710 (United States); Neyman, G. [Department of Radiation Oncology, The Cleveland Clinic Foundation, Cleveland, Ohio 44195 (United States); Novotny, J. [Medical Physics Department, Hospital Na Homolce, Prague 15030 (Czech Republic); Petti, P. L. [Gamma Knife Center, Washington Hospital Healthcare System, Fremont, California 94538 (United States); Rivard, M. J. [Department of Radiation Oncology, Tufts University School of Medicine, Boston, Massachusetts 02111 (United States); Shiu, A. S. [Department of Radiation Oncology, University of Southern California, Los Angeles, California 90033 (United States); Goetsch, S. J. [San Diego Medical Physics, Inc., La Jolla, California 92037 (United States)

2015-11-15

Purpose: Absorbed dose calibration for gamma stereotactic radiosurgery is challenging due to the unique geometric conditions, dosimetry characteristics, and nonstandard field size of these devices. Members of the American Association of Physicists in Medicine (AAPM) Task Group 178 on Gamma Stereotactic Radiosurgery Dosimetry and Quality Assurance have participated in a round-robin exchange of calibrated measurement instrumentation and phantoms exploring two approved and two proposed calibration protocols or formalisms on ten gamma radiosurgery units. The objectives of this study were to benchmark and compare new formalisms to existing calibration methods, while maintaining traceability to U.S. primary dosimetry calibration laboratory standards. Methods: Nine institutions made measurements using ten gamma stereotactic radiosurgery units in three different 160 mm diameter spherical phantoms [acrylonitrile butadiene styrene (ABS) plastic, Solid Water, and liquid water] and in air using a positioning jig. Two calibrated miniature ionization chambers and one calibrated electrometer were circulated for all measurements. Reference dose-rates at the phantom center were determined using the well-established AAPM TG-21 or TG-51 dose calibration protocols and using two proposed dose calibration protocols/formalisms: an in-air protocol and a formalism proposed by the International Atomic Energy Agency (IAEA) working group for small and nonstandard radiation fields. Each institution’s results were normalized to the dose-rate determined at that institution using the TG-21 protocol in the ABS phantom. Results: Percentages of dose-rates within 1.5% of the reference dose-rate (TG-21 + ABS phantom) for the eight chamber-protocol-phantom combinations were the following: 88% for TG-21, 70% for TG-51, 93% for the new IAEA nonstandard-field formalism, and 65% for the new in-air protocol. Averages and standard deviations for dose-rates over all measurements relative to the TG-21 + ABS

Protocol Additional to the Agreement between the Government of the Republic of Ghana and the International Atomic Energy Agency for the Application of Safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

1998-01-01

The text of the Protocol Additional to the Safeguards Agreement concluded between the Government of the Republic of Ghana and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty for the Non-Proliferation of Nuclear Weapons (NPT) is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 11 June 1998. It was signed in Vienna on 12 June 1998 [es

Protocol Additional to the Agreement between the Government of the Republic of Ghana and the International Atomic Energy Agency for the Application of Safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

1998-01-01

The text of the Protocol Additional to the Safeguards Agreement concluded between the Government of the Republic of Ghana and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty for the Non-Proliferation of Nuclear Weapons (NPT) is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 11 June 1998. It was signed in Vienna on 12 June 1998 [fr

Protocol Additional to the Agreement between the Government of the Republic of Ghana and the International Atomic Energy Agency for the Application of Safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

1998-01-01

The text of the Protocol Additional to the Safeguards Agreement concluded between the Government of the Republic of Ghana and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty for the Non-Proliferation of Nuclear Weapons (NPT) is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 11 June 1998. It was signed in Vienna on 12 June 1998

Interprofessional primary care protocols: a strategy to promote an evidence-based approach to teamwork and the delivery of care.

Science.gov (United States)

Goldman, Joanne; Meuser, Jamie; Lawrie, Lynne; Rogers, Jess; Reeves, Scott

2010-11-01

Primary care reform involving interprofessional team-based care is a global phenomenon. In Ontario, Canada, 150 Family Health Teams (FHTs) have been approved in the past few years. The transition to a FHT is complex involving many changes and the processes for collaborative teamwork are not clearly delineated. To support the transition to team-based care in FHTs, a project was undertaken to develop and implement a series of interprofessional protocols in four clinical areas. These interprofessional protocols would contain relevant and evidence-based resources to support both a team and evidence-based approach to care. This paper reports on a qualitative study to examine the process of interprofessional protocol development and pilot implementation. Adopting an exploratory case study approach (Robson, 2002 ), 36 interviews were conducted with health professionals and community group members who participated in the creation and piloting of the protocols, and with project managers. In addition, observational and documentary data were gathered on the protocol development and implementation processes. The findings from the protocol development stage demonstrate the value of the focus on evidence and team, the process of assessing and targeting FHT needs, inter-organizational and interprofessional sharing, the importance of facilitation and support, and expectations for implementation. The findings from the pilot implementation stage report on the importance of champions and leaders, the implementation strategies used, FHT and organizational factors affecting implementation, and outcomes achieved. Findings are discussed in relation to the knowledge translation and interprofessional literature. Research is ongoing to examine the effectiveness of dissemination of the protocols to FHTs across the province of Ontario and its impact on health care outcomes.

Trends in global approvals of biotech crops (1992-2014).

Science.gov (United States)

Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

2015-01-01

With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992-2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits.

40 CFR 52.2352 - Change to approved plan.

Science.gov (United States)

2010-07-01

... Utah's approved State Implementation Plan (SIP). This rule language pertains to State Sales Tax... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Change to approved plan. 52.2352... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Utah § 52.2352 Change to approved...

The Evolution of Approval Services.

Science.gov (United States)

Warzala, Martin

1994-01-01

Describes major developments in book approval plans used by academic libraries for acquisition and for information dissemination and document distribution services based on approval-like concepts. Topics addressed include publishers; marketing; the impact of library automation; value-added services; the economic climate; the influence of…

Protocol additional to the agreement between the Republic of Tajikistan and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2005-01-01

The text of the Protocol Additional to the Agreement concluded between the Republic of Tajikistan and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Board of Governors approved the Protocol Additional on 12 June 2002. It was signed on 2 July 2003 in Vienna and on 7 July 2003 in Tashkent. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 14 December 2004, the date on which the Agency received from the Republic of Tajikistan written notification that the Republic of Tajikistan's statutory and/or constitutional requirements for entry into force had been met

Protocol additional to the agreement between the Republic of Tajikistan and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

2005-02-23

The text of the Protocol Additional to the Agreement concluded between the Republic of Tajikistan and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Board of Governors approved the Protocol Additional on 12 June 2002. It was signed on 2 July 2003 in Vienna and on 7 July 2003 in Tashkent. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 14 December 2004, the date on which the Agency received from the Republic of Tajikistan written notification that the Republic of Tajikistan's statutory and/or constitutional requirements for entry into force had been met.

Approval plans issues and innovations

CERN Document Server

Katz, Linda S

2013-01-01

How can you, as an acquisition librarians, keep current on the output of hundreds of publishers? The answer, of course, is that you cannot. For over 30 years, approval plans have been used by librarians to acquire current titles, save staff time, and build core collections. Even today, these reasons seem appropriate, as libraries try to maintain up-to-date collections and control personnel and operating budgets. However, as shown in Approval Plans: Issues and Innovations, the use of approval plans is not so simple and straightforward; their use is subject to complex procedures and policies--an

Evaluation of a Brief Marriage Intervention for Internal Behavioral Health Consultants in Primary Care

Science.gov (United States)

2017-09-01

PRINCIPAL INVESTIGATOR: Dr. Jeffrey A. Cigrang CONTRACTING ORGANIZATION: Wright State University Dayton, OH 45435 REPORT DATE: September 2017...NUMBER WRIGHT STATE UNIVERSITY 3640 COLONEL GLENN HWY DAYTON OH 45435-0001 9. SPONSORING / MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSOR...Coordinate with Sites for flow chart for all study steps, web data collection and database requirements 3-6 100% Coordinate with Sites for IRB protocol

48 CFR 750.7105 - Approving authorities.

Science.gov (United States)

2010-10-01

... CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS Extraordinary Contractual Actions To Protect Foreign Policy Interests of the United States 750.7105 Approving authorities. All authority to approve actions...

Protocol Additional to the Agreement between the Republic of Panama and the International Atomic Energy Agency for the Application of Safeguards in connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America

International Nuclear Information System (INIS)

2002-01-01

The text of the Protocol Additional to the Safeguards Agreement 1 concluded between the Republic of Panama and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America (TLATELOLCO) is reproduced in this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 29 November 2001. It was signed in the City of Panama on 11 December 2001

The effectiveness of Korean medicine treatment in male patients with infertility: a study protocol for a prospective observational pilot study.

Science.gov (United States)

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.

Vedolizumab: first global approval.

Science.gov (United States)

Poole, Raewyn M

2014-07-01

Vedolizumab [Entyvio(®) (US, Europe)], a humanized monoclonal antibody α4β7 integrin receptor antagonist, has been developed by Millennium Pharmaceuticals (d/b/a Takeda Pharmaceuticals International) for the treatment of ulcerative colitis and Crohn's disease. Vedolizumab has received its first global approval for the treatment of ulcerative colitis and Crohn's disease in the US, for use in adult patients with moderate-to-severe disease who have had an inadequate response, loss of response or intolerance to one or more standard therapies (corticosteroids, immunomodulators or tumour necrosis factor-α inhibitor) or demonstrated dependence on corticosteroids. Vedolizumab has since been approved for ulcerative colitis and Crohn's disease in the EU, Norway, Iceland and Liechtenstein. This article summarizes the milestones in the development of vedolizumab leading to its first approval for the treatment of ulcerative colitis and Crohn's disease.

19 CFR 115.55 - Termination of approval.

Science.gov (United States)

2010-04-01

... vehicle by a major repair or alteration of any of the essential features required in § 115.51. Repairs by... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Individual Road Vehicles § 115.55 Termination of approval. Approval of a road...

20 CFR 617.22 - Approval of training.

Science.gov (United States)

2010-04-01

.... Perkins Vocational and Applied Technology Education Act, and employers). (i) This means that training is...) Conditions for approval. Training shall be approved for an adversely affected worker if the State agency...) available for an adversely affected worker. (i) This means that for the worker for whom approval of training...

A Comparison Between Inter-Asterisk eXchange Protocol and Jingle Protocol: Session Time

Directory of Open Access Journals (Sweden)

H. S. Haj Aliwi

2016-08-01

Full Text Available Over the last few years, many multimedia conferencing and Voice over Internet Protocol (VoIP applications have been developed due to the use of signaling protocols in providing video, audio and text chatting services between at least two participants. This paper compares between two widely common signaling protocols: InterAsterisk eXchange Protocol (IAX and the extension of the eXtensible Messaging and Presence Protocol (Jingle in terms of delay time during call setup, call teardown, and media sessions.

30 CFR 75.1108 - Approved conveyor belts.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved conveyor belts. 75.1108 Section 75... Fire-Resistant Hydraulic Fluids on Underground Equipment § 75.1108 Approved conveyor belts. (a) Until December 31, 2009 conveyor belts placed in service in underground coal mines shall be: (1) Approved under...

45 CFR 1340.13 - Approval of applications.

Science.gov (United States)

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false Approval of applications. 1340.13 Section 1340.13... NEGLECT PREVENTION AND TREATMENT PROGRAM CHILD ABUSE AND NEGLECT PREVENTION AND TREATMENT Grants to States § 1340.13 Approval of applications. (a) The Commissioner shall approve an application for an award for...

Understanding barriers to the introduction of precision medicines in non-small cell lung cancer: A qualitative interview protocol [version 1; referees: 2 approved

Directory of Open Access Journals (Sweden)

Stuart Wright

2018-03-01

Full Text Available Background: While precision medicines targeting genetic mutations and alterations in non-small cell lung cancer (NSCLC have been available since 2010, their adoption into clinical practice has been slow. Evidence suggests that a number of barriers, such as insufficient clinician knowledge, a need for training of test providers, or a lack of specific clinical guidelines, may slow the implementation of precision in general. However, little attention has been given to the barriers to providing precision medicines in NSCLC. The purpose of this protocol is to outline the design for a qualitative interview study to identify the barriers and facilitators to the provision of precision medicines for NSCLC.   Methods: This study will use semi-structured interviews with clinicians (n=10, test providers (n=10, and service commissioners (n=10 to identify the perceived barriers and facilitators to providing historical, current, and future precision medicines in NSCLC. Participants will be identified through mailing list advertisements and snowball sampling. Recruitment will continue until data saturation, indicated by no new themes arising from the data. Interviews will be conducted by telephone to facilitate geographical diversity. The qualitative data will be analysed using a framework analysis with themes anticipated to relate to; relevant barriers to providing precision medicines, the impact of different barriers on medicine provision, changes in the ability to provide precision medicines over time, and strategies to facilitate the provision of precision medicines.   Ethics: This study has been approved by the University of Manchester Proportionate Review Research Ethics Committee (Reference number: 2017-1885-3619. Written consent will be obtained from all participants.   Conclusion: This study is the first to explore the barriers and facilitators to providing precision medicines for NSCLC in the English NHS. The findings will inform strategies to

Protocol Additional to the Agreement between the Government of the Republic of Malawi and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2007-01-01

The text of the Protocol Additional to the Agreement between the Government of the Republic of Malawi and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 23 November 2006. It was signed on 5 May 2007 in Lilongwe, Malawi, and on 26 July 2007 in Vienna, Austria [es

Protocol Additional to the Agreement between the Government of the Republic of Malawi and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2007-01-01

The text of the Protocol Additional to the Agreement between the Government of the Republic of Malawi and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 23 November 2006. It was signed on 5 May 2007 in Lilongwe, Malawi, and on 26 July 2007 in Vienna, Austria

27 CFR 5.55 - Certificates of label approval.

Science.gov (United States)

2010-04-01

..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF DISTILLED SPIRITS Requirements for Approval of... certificates of label approval and certificates of exemption from label approval, as well as appeal procedures...

46 CFR 188.10-3 - Approved container.

Science.gov (United States)

2010-10-01

... 46 Shipping 7 2010-10-01 2010-10-01 false Approved container. 188.10-3 Section 188.10-3 Shipping... PROVISIONS Definition of Terms Used in This Subchapter § 188.10-3 Approved container. This term means a container which is properly labeled, marked and approved by DOT for the commodity which it contains. [CGFR...

Safety and efficacy of a novel diffractive lens array using a picosecond 755?nm alexandrite laser for treatment of wrinkles

OpenAIRE

Weiss, Robert A.; McDaniel, David H.; Weiss, Margaret A.; Mahoney, Anne Marie; Beasley, Karen L.; Halvorson, Christian R.

2016-01-01

Introduction Picosecond lasers have been reported to be effective for removal of tattoo pigment. This prospective study evaluated the efficacy and safety of the treatment of peri?oral and ?ocular wrinkles using a novel diffractive lens array coupled with a picosecond 755?nm alexandrite laser. Methods Forty female subjects presenting with wrinkles from photodamage were enrolled in an IRB approved study. Subjects received four picosecond diffractive lens array treatments to the full face at 1 m...

The French dosimetry protocol

International Nuclear Information System (INIS)

Dutreix, A.

1985-01-01

After a general introduction the protocol is divided in five sections dealing with: determination of the quality of X-ray, γ-ray and electron beams; the measuring instrument; calibration of the reference instrument; determination of the reference absorbed dose in the user's beams; determination of the absorbed dose in water at other points, in other conditions. The French protocol is not essentially different from the Nordic protocol and it is based on the experience gained in using both the American and the Nordic protocols. Therefore, only the main difference with the published protocols are discussed. (Auth.)

Electronic Approval of Invoices (AEF)

CERN Multimedia

2003-01-01

With a view to the simplification of administrative procedures, AS and FI Divisions have drawn up a new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. This new procedure, in its current phase, will be gradually implemented from 1 November 2003 onwards. For clarification and further information, please see: http://ais.cern.ch/projs/AEF/help/help.htm . Finance Division, Accounts Payable Tel.: 7.22.95

Protocol Additional to the Agreement between Jamaica and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Treaty on the Non-proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2003-01-01

The text of the Protocol Additional to the Agreement between Jamaica and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 12 June 2002. It was signed in Vienna on 19 March 2003. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force upon signature by the representatives of Jamaica and the Agency, i.e. on 19 March 2003

Protocol Additional to the Agreement between Jamaica and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Treaty on the Non-proliferation of Nuclear Weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

2003-03-28

The text of the Protocol Additional to the Agreement between Jamaica and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 12 June 2002. It was signed in Vienna on 19 March 2003. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force upon signature by the representatives of Jamaica and the Agency, i.e. on 19 March 2003.

The HPA photon protocol and proposed electron protocol

International Nuclear Information System (INIS)

Pitchford, W.G.

1985-01-01

The Hospital Physicists Association (HPA) photon dosimetry protocol has been produced and was published in 1983. Revised values of some components of Csub(lambda) and refinements introduced into the theory in the last few years have enabled new Csub(lambda) values to be produced. The proposed HPA electron protocol is at present in draft form and will be published shortly. Both protocels are discussed. (Auth.)

Trends in global approvals of biotech crops (1992–2014)

Science.gov (United States)

Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

2015-01-01

ABSTRACT With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992–2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits. PMID:26039675

Satellite Communications Using Commercial Protocols

Science.gov (United States)

Ivancic, William D.; Griner, James H.; Dimond, Robert; Frantz, Brian D.; Kachmar, Brian; Shell, Dan

2000-01-01

NASA Glenn Research Center has been working with industry, academia, and other government agencies in assessing commercial communications protocols for satellite and space-based applications. In addition, NASA Glenn has been developing and advocating new satellite-friendly modifications to existing communications protocol standards. This paper summarizes recent research into the applicability of various commercial standard protocols for use over satellite and space- based communications networks as well as expectations for future protocol development. It serves as a reference point from which the detailed work can be readily accessed. Areas that will be addressed include asynchronous-transfer-mode quality of service; completed and ongoing work of the Internet Engineering Task Force; data-link-layer protocol development for unidirectional link routing; and protocols for aeronautical applications, including mobile Internet protocol routing for wireless/mobile hosts and the aeronautical telecommunications network protocol.

MDCT of acute pancreatitis: Intraindividual comparison of single-phase versus dual-phase MDCT for initial assessment of acute pancreatitis using different CT scoring systems

Energy Technology Data Exchange (ETDEWEB)

Avanesov, Maxim, E-mail: m.avanesov@uke.de [Department of Diagnostic and Interventional Radiology and Nuclear Medicine, University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Weinrich, Julius M.; Kraus, Thomas [Department of Diagnostic and Interventional Radiology and Nuclear Medicine, University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Derlin, Thorsten [Department of Nuclear Medicine, Hannover Medical School (Germany); Adam, Gerhard; Yamamura, Jin [Department of Diagnostic and Interventional Radiology and Nuclear Medicine, University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Karul, Murat [Department of Diagnostic and Interventional Radiology, Marienkrankenhaus Hamburg (Germany)

2016-11-15

Objectives: The purpose of the retrospective study was to evaluate the additional value of dual-phase multidetector computed tomography (MDCT) protocols over a single-phase protocol on initial MDCT in patients with acute pancreatitis using three CT-based pancreatitis severity scores with regard to radiation dose. Methods: In this retrospective, IRB approved study MDCT was performed in 102 consecutive patients (73 males; 55years, IQR48–64) with acute pancreatitis. Inclusion criteria were CT findings of interstitial edematous pancreatitis (IP) or necrotizing pancreatitis (NP) and a contrast-enhanced dual-phase (arterial phase and portal-venous phase) abdominal CT performed at ≥72 h after onset of symptoms. The severity of pancreatic and extrapancreatic changes was independently assessed by 2 observers using 3 validated CT-based scoring systems (CTSI, mCTSI, EPIC). All scores were applied to arterial phase and portal venous phase scans and compared to score results of portal venous phase scans, assessed ≥14 days after initial evaluation. For effective dose estimation, volume CT dose index (CTDIvol) and dose length product (DLP) were recorded in all examinations. Results: In neither of the CT severity scores a significant difference was observed after application of a dual-phase protocol compared with a single-phase protocol (IP: CTSI: 2.7 vs. 2.5, p = 0.25; mCTSI: 4.0 vs. 4.0, p = 0.10; EPIC: 2.0 vs. 2.0, p = 0.41; NP: CTSI: 8.0 vs. 7.0, p = 0.64; mCTSI: 8.0 vs. 8.0, p = 0.10; EPIC: 3.0 vs. 3.0, p = 0.06). The application of a single-phase CT protocol was associated with a median effective dose reduction of 36% (mean dose reduction 31%) compared to a dual-phase CT scan. Conclusions: An initial dual-phase abdominal CT after ≥72 h after onset of symptoms of acute pancreatitis was not superior to a single-phase protocol for evaluation of the severity of pancreatic and extrapancreatic changes. However, the effective radiation dose may be reduced by 36% using a

How the negotiators tackled the 'hot air' issue for the second commitment period of the Kyoto Protocol

International Nuclear Information System (INIS)

2013-02-01

In 1997, when the Kyoto Protocol was approved, developed countries set their greenhouse gas (GHG) reduction commitments in relation to a 'base year' level. For the Kyoto Protocol, the year 1990 was chosen in most cases. However, irrespective of GHG mitigation action, the countries of the former Soviet Union have seen their emissions of greenhouse gases significantly decreasing after the collapse of the USSR. Given that their emissions were and still are today far below the commitments they established in 1997, these countries have a significant surplus of allowances referred to as 'hot air'. Before the COP 18 that took place in Doha (Qatar) late 2012, many countries and observers raised concern about this 'hot air'. Typically, there were two separate questions: What should we do with the accumulated surplus from the first commitment period of the Kyoto Protocol (CP1)? And will a new 'hot air' be created during the second commitment period (CP2)? This analysis explores the implications of the decisions made in Doha, using the case of Ukraine to illustrate responses to the questions raised. Indeed, as the European Union regulation forbids European countries to use CP1 units to achieve CP2 targets, Ukraine is the principal country committing to CP2 with a substantial reserve of CP1 units

Security Protocols in a Nutshell

OpenAIRE

Toorani, Mohsen

2016-01-01

Security protocols are building blocks in secure communications. They deploy some security mechanisms to provide certain security services. Security protocols are considered abstract when analyzed, but they can have extra vulnerabilities when implemented. This manuscript provides a holistic study on security protocols. It reviews foundations of security protocols, taxonomy of attacks on security protocols and their implementations, and different methods and models for security analysis of pro...

HyApproval - Handbook for the approval of hydrogen refuelling stations - First preliminary achievements

Energy Technology Data Exchange (ETDEWEB)

Wurster, R.; Vandendungen, G.; Guichard, J.; Molag, M.; Barron, J.; Reijalt, M.; Hill, H.J.; Landinger, H.

2007-05-15

The EU-funded project HyApproval [www.hyapproval.org] aims at developing a universal Handbook to facilitate the approval process of Hydrogen Refuelling Stations (HRS) in Europe. The main goal of the HyApproval partnership with 22 partners from Europe and one each from China, Japan and the USA is to provide a Handbook of technical and regulatory requirements to assist authorisation officials, companies and organisations in the safe implementation and operation of HRS. Achievements during the first 15 months: analyses of HRS technology concepts and of equipment and safety distances/ Intermediate Design Paper/ Regulations, Codes and Standards (RCS) review and comparison/ first Handbook draft and first review sessions with HySafe experts/ safety matrix/ identification of accident scenarios/ agreement on safety documentation/ critical review of reliability data from collections and risk studies/ risk assessment (RA) criteria definition and RA/ matrix of acceptability and awareness levels/ database of Fire Associations and First Responders/ calendar of hydrogen events/ general description of CGH{sub 2} interfaces. (au)

Protocol between the Russian Federation and the International Atomic Energy Agency Additional to the Agreement between the Union of Soviet Socialist Republics and the International Atomic Energy Agency for the Application of Safeguards in the Union of Soviet Socialist Republics

International Nuclear Information System (INIS)

2008-01-01

The text of the Protocol between the Russian Federation and the International Atomic Energy Agency Additional to the Agreement between the Union of Soviet Socialist Republics and the International Atomic Energy Agency for the Application of Safeguards in the Union of Soviet Socialist Republics is reproduced in this document for the information of all Members. The Board of Governors approved the Protocol on 21 March 2000. It was signed on 22 March 2000 in Vienna. Pursuant to Article 11 of the Additional Protocol, the Protocol entered into force on 16 October 2007, the date on which the Agency received from the Russian Federation written notification that the procedures of the Russian Federation required for entry into force had been met

Protocol between the Russian Federation and the International Atomic Energy Agency Additional to the Agreement between the Union of Soviet Socialist Republics and the International Atomic Energy Agency for the Application of Safeguards in the Union of Soviet Socialist Republics

International Nuclear Information System (INIS)

2008-01-01

The text of the Protocol between the Russian Federation and the International Atomic Energy Agency Additional to the Agreement between the Union of Soviet Socialist Republics and the International Atomic Energy Agency for the Application of Safeguards in the Union of Soviet Socialist Republics is reproduced in this document for the information of all Members. The Board of Governors approved the Protocol on 21 March 2000. It was signed on 22 March 2000 in Vienna. Pursuant to Article 11 of the Additional Protocol, the Protocol entered into force on 16 October 2007, the date on which the Agency received from the Russian Federation written notification that the procedures of the Russian Federation required for entry into force had been met [es

Quality Assessment of Process Measures in Antimicrobial Stewardship: Concordance of Valacyclovir Indication and Automatic Prospective Approval in Computerized Provider Order Entry

Science.gov (United States)

Lee, Tiffany; McCoy, Christopher; Mahoney, Monica V

2017-01-01

Abstract Background The Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) recommend computerized decision support at the time of prescribing as an antimicrobial stewardship (AST) tool. Providing antimicrobial indications during prescribing can optimize infection-specific therapy through appropriate antimicrobial selection, dosing, and frequency. The Leapfrog group identifies this as a quality measure for their report card system. At Beth Israel Deaconess Medical Center (BIDMC), indication-based dosing has been incorporated in the computerized provider order entry (CPOE) system since 2006. At BIDMC, valacyclovir is only approved for the treatment of varicella zoster (VZV) infection or prophylaxis of solid organ transplant (SOT) patients at low risk for cytomegalovirus. These indications bypass the need for AST approval. Accuracy validation of the selected indications has not been formally performed. Methods A retrospective chart review was performed in patients prescribed valacyclovir during an 8-month period in 2016. Electronic medical records, laboratory reports, and pharmacy records were reviewed to identify the suspected/confirmed infection. The primary outcome was the concordance rate of selected CPOE valacyclovir indication compared with suspected/confirmed infection at the time of ordering. The secondary outcome was the proportion of valacyclovir use per institutional protocol. Results Overall, 117 patients were included, with a median age of 57.9 years, 51 (43.6%) were male, and 4 (3.4%) were located in an intensive care unit. Fifty-nine orders (50.4%) selected VZV as the indication, followed by 21 orders (17.9%) for SOT prophylaxis. Of orders with any CPOE indication, only 59/101 (58.4%) were concordant with suspected/confirmed infection. Of the valacyclovir orders with a VZV indication, 37 (62.7%) were concordant. Of the orders with SOT prophylaxis indications, 5 (23.8%) were concordant

Analysis of the Education Program Approval Process: A Program Evaluation.

Science.gov (United States)

Fountaine, Charles A.; And Others

A study of the education program approval process involving the Veterans Administration (VA) and the State Approving Agencies (SAAs) had the following objectives: to describe the present education program approval process; to determine time and costs associated with the education program approval process; to describe the approval process at…

Protocol Additional to the agreement between the Republic of Paraguay and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2005-01-01

The text of the Protocol Additional to the Agreement between the Republic of Paraguay and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Board of Governors approved the Additional Protocol on 12 June 2002. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 15 September 2004, the date on which the Agency received from Paraguay written notification that Paraguay's statutory and/or constitutional requirements for entry into force had been met

Protocol Additional to the agreement between the Republic of Nicaragua and the International Atomic Energy Agency for the application of safeguards in connection with the treaty for the prohibition of nuclear weapons in Latin America and the treaty on the non-proliferation of nuclear weapons

International Nuclear Information System (INIS)

2002-01-01

The text of the Protocol Additional to the Agreement between the Republic of Nicaragua and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 12 June 2002. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 18 February 2005, the date on which the Agency received from Nicaragua written notification that Nicaragua's statutory and/or constitutional requirements for entry into force had been met

Protocol Additional to the agreement between the Republic of Nicaragua and the International Atomic Energy Agency for the application of safeguards in connection with the treaty for the prohibition of nuclear weapons in Latin America and the treaty on the non-proliferation of nuclear weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

2002-03-11

The text of the Protocol Additional to the Agreement between the Republic of Nicaragua and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 12 June 2002. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 18 February 2005, the date on which the Agency received from Nicaragua written notification that Nicaragua's statutory and/or constitutional requirements for entry into force had been met.

Characteristics and Causes for Non-Accrued Clinical Research (NACR) at an Academic Medical Institution.

Science.gov (United States)

Tice, Debra G; Carroll, Kelly A; Bhatt, Karishma H; Belknap, Steven M; Mai, David; Gipson, Heather J; West, Dennis P

2013-06-01

The impact of non-accrued clinical research (NACR) represents an important economic burden that is under consideration as the U.S. Department of Health and Human Services looks into reforming the regulations governing IRB review. NACR refers to clinical research projects that fail to enroll subjects. A delineation of the issues surrounding NACR is expected to enhance subject accrual and to minimize occurrence of NACR. The authors assessed demographics, characteristics, and reasons for NACR at an academic medical center, including time trends, funding source, research team (principal investigator, department), IRB resource utilization (IRB level of review, number of required IRB reviews, initial IRB turn-around time, and duration of NACR). The authors analyzed data from 848 clinical research study closures during 2010 and 2011 to determine proportion, incidence, and characteristics of NACR. Studies with subject enrollment during the same time period were used as a comparative measure. Data from 704 (83.0%) study closures reported enrollment of 1 or more subjects while 144 (17.0 %) reported NACR (zero enrollment). PI-reported reasons for NACR included: 32 (22.2%) contract or funding issues; 43 (30.0%) insufficient study-dedicated resources; 41 (28.4%) recruitment issues; 17 (11.8%) sponsor-initiated study closure and 11 (7.6%) were "other/reason unreported". NACR is not uncommon, affecting about one in six clinical research projects in the study population and reported to be more common in some other institutions. The complex and fluid nature of research conduct, non-realistic enrollment goals, and delays in both the approval and/or accrual processes contribute to NACR. Results suggest some simple strategies that investigators and institutions may use to reduce NACR, including careful feasibility assessment, reduction of institutional delays, and prompt initiation of subject accrual for multi-center studies using competitive enrollment. Institutional action to

Business protocol in integrated Europe

OpenAIRE

Pavelová, Nina

2009-01-01

The first chapter devotes to definitions of basic terms such as protocol or business protocol, to differences between protocol and etiquette, and between social etiquette and business etiquette. The second chapter focuses on the factors influencing the European business protocol. The third chapter is devoted to the etiquette of business protocol in the European countries. It touches the topics such as punctuality and planning of business appointment, greeting, business cards, dress and appear...

What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016.

Science.gov (United States)

Kondo, Hideyuki; Saint-Raymond, Agnès; Yasuda, Naoyuki

2018-03-01

The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the European Medicines Agency (EMA) have a long-standing experience of reviews of new medicines, and they meet their target pre-market review periods. In FY 2016 / 2016, 112 and 83 new medicines were approved in Japan and EU, respectively. Out of these medicines, 41 and 27 medicines containing new active ingredients were approved with total pre-market review periods of 209 days and 428 days in Japan and EU, respectively. Approximately one-third of these medicines were reviewed by the Agencies in close timing, within 1 year between pre-market review applications in Japan and in EU. Taking into account the increasing number of global clinical trials and constant number of consultations or scientific advice related to global clinical trials in Japan, it is clear that the importance of the continuous, collaborative relationship between EMA and PMDA is more and more crucial, as it does facilitate close and timely exchange of information and opinions on products and technologies under development. There already are effective collaborative frameworks between PMDA and EMA in addition to daily communication, and our findings support the development and best use of regulatory tools such as consultation services and scientific advice/protocol assistance for the benefit of the pharmaceutical industry but mostly of patients.

Infrared radiation increases skin damage induced by other wavelengths in solar urticaria.

Science.gov (United States)

de Gálvez, María Victoria; Aguilera, José; Sánchez-Roldán, Cristina; Herrera-Ceballos, Enrique

2016-09-01

Photodermatoses are typically investigated by analyzing the individual or combined effects of ultraviolet A (UVA), ultraviolet B (UVB), and visible light using light sources that simulate portions of the solar spectrum. Infrared radiation (IRR), however, accounts for 53% of incident solar radiation, but its effects are not taken into account in standard phototest protocols. The aim was to analyze the effects of IRR, alone and combined with UVA and visible light on solar urticaria lesions, with a distinction between infrared A (IRA) and infrared B (IRB). We performed standard phototests with UVA and visible light in four patients with solar urticaria and also tested the effects after blocking IRB with a water filter. To analyze the direct effect of IRR, we performed phototests with IRA and IRB. Initial standard phototests that were all positive found the induction of erythema and whealing, while when IRR was blocked from the UVA and visible light sources, three of the patients developed no lesions, while the fourth developed a very small wheal. These results suggest that IRR has the potential to produce and exacerbate lesions caused by other types of radiation. Consideration of these effects during phototesting could help prevent diagnostic errors. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A robust ECC based mutual authentication protocol with anonymity for session initiation protocol.

Science.gov (United States)

Mehmood, Zahid; Chen, Gongliang; Li, Jianhua; Li, Linsen; Alzahrani, Bander

2017-01-01

Over the past few years, Session Initiation Protocol (SIP) is found as a substantial application-layer protocol for the multimedia services. It is extensively used for managing, altering, terminating and distributing the multimedia sessions. Authentication plays a pivotal role in SIP environment. Currently, Lu et al. presented an authentication protocol for SIP and profess that newly proposed protocol is protected against all the familiar attacks. However, the detailed analysis describes that the Lu et al.'s protocol is exposed against server masquerading attack and user's masquerading attack. Moreover, it also fails to protect the user's identity as well as it possesses incorrect login and authentication phase. In order to establish a suitable and efficient protocol, having ability to overcome all these discrepancies, a robust ECC-based novel mutual authentication mechanism with anonymity for SIP is presented in this manuscript. The improved protocol contains an explicit parameter for user to cope the issues of security and correctness and is found to be more secure and relatively effective to protect the user's privacy, user's masquerading and server masquerading as it is verified through the comprehensive formal and informal security analysis.

A robust ECC based mutual authentication protocol with anonymity for session initiation protocol.

Directory of Open Access Journals (Sweden)

Zahid Mehmood

Full Text Available Over the past few years, Session Initiation Protocol (SIP is found as a substantial application-layer protocol for the multimedia services. It is extensively used for managing, altering, terminating and distributing the multimedia sessions. Authentication plays a pivotal role in SIP environment. Currently, Lu et al. presented an authentication protocol for SIP and profess that newly proposed protocol is protected against all the familiar attacks. However, the detailed analysis describes that the Lu et al.'s protocol is exposed against server masquerading attack and user's masquerading attack. Moreover, it also fails to protect the user's identity as well as it possesses incorrect login and authentication phase. In order to establish a suitable and efficient protocol, having ability to overcome all these discrepancies, a robust ECC-based novel mutual authentication mechanism with anonymity for SIP is presented in this manuscript. The improved protocol contains an explicit parameter for user to cope the issues of security and correctness and is found to be more secure and relatively effective to protect the user's privacy, user's masquerading and server masquerading as it is verified through the comprehensive formal and informal security analysis.

A Comparison between Gadofosveset Trisodium and Gadobenate Dimeglumine for Steady State MRA of the Thoracic Vasculature

OpenAIRE

Camren, G. Paul; Wilson, Gregory J.; Bamra, Vikram R.; Nguyen, Khahn Q.; Hippe, Daniel S.; Maki, Jeffrey H.

2014-01-01

Purpose. Retrospective comparison between gadofosveset trisodium and gadobenate dimeglumine steady state magnetic resonance angiography (SS-MRA) of the thoracic vasculature at 1.5T using signal-to-noise ratio (SNR) and vessel edge sharpness (ES) as markers of image quality. Materials and Methods. IRB approval was obtained. Twenty separate patients each underwent SS-MRA using high-resolution 3D ECG-triggered coronal IR-TFE at 1.5T approximately 3-4 minutes following 10 or 15 mL gadofosveset or...

Reliability of Iris Recognition as a Means of Identity Verification and Future Impact on Transportation Worker Identification Credential

Science.gov (United States)

2008-03-01

workers, family, friends and acquaintances. 36 We sought approval from the NPS Internal Review Board (IRB) to give away a single Apple iPod Nano as an...over 73,000 individuals seeking entry to the UAE that are on the watch list. All matches have been confirmed via other records. The UAE system is the...American as apple pie, after all baseball is the proverbial “America’s pastime.” Conducting “monitoring” at such an event might be seen as an

Development and Production of a Leishmania Skin Test

Science.gov (United States)

2009-03-01

homologous species than to L.tropica. Phase II Study Report: USTA-06 Page 8 of 53 3. LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS: 21 AE CL CPM CRF...be recruited from the patient data base of the clinical site. If other recruiting measures are needed, such as placing an advertisement in the local...newspaper or by posting or distributing flyers in public areas, such advertisement or flyers will be sent to the IRB for review and approval. Refer to

Patient-Centered Drug Approval: The Role of Patient Advocacy in the Drug Approval Process.

Science.gov (United States)

Mattingly, T Joseph; Simoni-Wastila, Linda

2017-10-01

Recent approval of eteplirsen for Duchenne muscular dystrophy (DMD), a rare disease with few treatment alternatives, has reignited the debate over the U.S. drug approval process. The evolution of legal and regulatory restrictions to the marketing and sale of pharmaceuticals has spanned more than a century, and throughout this history, patient advocacy has played a significant role. Scientific evidence from clinical trials serves as the foundation for drug approval, but the patient voice has become increasingly influential. Although the gold standard for establishing safety and efficacy through randomized controlled trials has been in place for more than 50 years, it poses several limitations for rare disorders where patient recruitment for traditional clinical trials is a major barrier. Organized efforts by patient advocacy groups to help patients with rare diseases access investigational therapy have had a legislative and regulatory effect. After approval by the FDA, patient access to therapy may still be limited by cost. A managed care organization (MCO) with the fiduciary responsibility of managing the health of a population must weigh coverage decisions for costly therapies with questionable effectiveness against alternatives within the constraint of a finite budget. Even when the FDA deems a drug safe and effective, an MCO may determine that the drug should only be made available at a tier level where out-of-pocket costs are still too high for many patients. This limitation of availability may be due to cost, other treatment alternatives, or outcomes from existing clinical evidence. However, if the MCO makes a costly new treatment for a rare disease readily available, it may temporarily satisfy a small contingency at the cost of all of its members. This article examines the risks and benefits of patient-centered drug approval and the potential economic effect of patient-centered drug approval on population health. There is no funding to disclose. Mattingly

Power Saving MAC Protocols for WSNs and Optimization of S-MAC Protocol

Directory of Open Access Journals (Sweden)

Simarpreet Kaur

2012-11-01

Full Text Available Low power MAC protocols have received a lot of consideration in the last few years because of their influence on the lifetime of wireless sensor networks. Since, sensors typically operate on batteries, replacement of which is often difficult. A lot of work has been done to minimize the energy expenditure and prolong the sensor lifetime through energy efficient designs, across layers. Meanwhile, the sensor network should be able to maintain a certain throughput in order to fulfill the QoS requirements of the end user, and to ensure the constancy of the network. This paper introduces different types of MAC protocols used for WSNs and proposes S‐MAC, a Medium‐Access Control protocol designed for Wireless Sensor Networks. S‐MAC uses a few innovative techniques to reduce energy consumption and support selfconfiguration. A new protocol is suggested to improve the energy efficiency, latency and throughput of existing MAC protocol for WSNs. A modification of the protocol is then proposed to eliminate the need for some nodes to stay awake longer than the other nodes which improves the energy efficiency, latency and throughput and hence increases the life span of a wireless sensor network.

49 CFR 1522.109 - TSA review and approval.

Science.gov (United States)

2010-10-01

... 49 Transportation 9 2010-10-01 2010-10-01 false TSA review and approval. 1522.109 Section 1522.109..., DEPARTMENT OF HOMELAND SECURITY SECURITY RULES FOR ALL MODES OF TRANSPORTATION TSA-APPROVED VALIDATION FIRMS AND VALIDATORS TSA-Approved Validation Firms and Validators for the Certified Cargo Screening Program...

49 CFR 1522.115 - Renewal of TSA approval.

Science.gov (United States)

2010-10-01

... 49 Transportation 9 2010-10-01 2010-10-01 false Renewal of TSA approval. 1522.115 Section 1522.115..., DEPARTMENT OF HOMELAND SECURITY SECURITY RULES FOR ALL MODES OF TRANSPORTATION TSA-APPROVED VALIDATION FIRMS AND VALIDATORS TSA-Approved Validation Firms and Validators for the Certified Cargo Screening Program...

29 CFR 1952.157 - Changes to approved plan.

Science.gov (United States)

2010-07-01

... (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS North Carolina § 1952.157 Changes to approved plan. (a) Legislation. (1) On March 29, 1994, the Assistant Secretary approved North Carolina's... section 17 of the Act as amended on November 5, 1990. (2) [Reserved] (b) The Voluntary Protection Program...

48 CFR 2922.103-4 - Approvals.

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Approvals. 2922.103-4 Section 2922.103-4 Federal Acquisition Regulations System DEPARTMENT OF LABOR SOCIOECONOMIC PROGRAMS APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS Basic Labor Policies 2922.103-4 Approvals. The “agency...

38 CFR 21.7220 - Course approval.

Science.gov (United States)

2010-07-01

...) VOCATIONAL REHABILITATION AND EDUCATION All Volunteer Force Educational Assistance Program (Montgomery GI...; Pub. L. 98-525) (b) Course approval criteria. In administering benefits payable under 38 U.S.C...) Section 21.4265—Practical training approved as institutional training or on-job training; (10) Section 21...

Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico

Science.gov (United States)

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

Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico.

Science.gov (United States)

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

33 CFR 115.70 - Advance approval of bridges.

Science.gov (United States)

2010-07-01

... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Advance approval of bridges. 115... BRIDGES BRIDGE LOCATIONS AND CLEARANCES; ADMINISTRATIVE PROCEDURES § 115.70 Advance approval of bridges. (a) The General Bridge Act of 1946 requires the approval of the location and plans of bridges prior...

Cross-Layer Protocol as a Better Option in Wireless Mesh Network with Respect to Layered-Protocol

OpenAIRE

Ahmed Abdulwahab Al-Ahdal; Dr. V. P. Pawar; G. N. Shinde

2014-01-01

The Optimal way to improve Wireless Mesh Networks (WMNs) performance is to use a better network protocol, but whether layered-protocol design or cross-layer design is a better option to optimize protocol performance in WMNs is still an on-going research topic. In this paper, we focus on cross-layer protocol as a better option with respect to layered-protocol. The layered protocol architecture (OSI) model divides networking tasks into layers and defines a pocket of services for each layer to b...

Association between organisational and workplace cultures, and patient outcomes: systematic review protocol.

Science.gov (United States)

Braithwaite, J; Herkes, J; Ludlow, K; Lamprell, G; Testa, L

2016-12-01

Despite widespread interest in the topic, no current synthesis of research is available analysing the linkages between organisational or workplace cultures on the one hand, and patient outcomes on the other. This protocol proposes a systematic review to analyse and synthesise the literature to date on this topic. The resulting review will discuss characteristics of included studies in terms of the type of healthcare settings researched, the measurements of organisational and workplace culture, patient outcomes measured and the influence of these cultures on patient outcomes. A systematic review will be conducted aiming to examine the associations between organisational and workplace cultures, and patient outcomes, guided by the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) statement. An English language search of abstracts will be executed using the following academic databases: CINAHL, EMBASE, Ovid MEDLINE, Web of Science and PsycINFO. The review will include relevant peer-reviewed articles from randomised controlled trials (RCTs), non-RCTs, controlled before and after studies, interrupted time series studies, cross-sectional analyses, qualitative studies and mixed-method studies. Multiple researchers will be involved in assessing the quality of articles for inclusion in the review. This protocol documents a detailed search strategy, including terms and inclusion criteria, which will form the basis of the subsequent systematic review. Ethics approval is not required as no primary data will be collected. Results will be disseminated through a peer-reviewed publication and conference presentations. 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/.

Protocols to Amend the Paris, Vienna and Brussels Supplementary Conventions and the Convention on Supplementary Compensation for Nuclear Damage: Status of their Implementation into National Legislation

International Nuclear Information System (INIS)

Schwartz, J.

2006-01-01

amend the Paris and Brussels Supplementary Compensation Conventions, it is too early to make predictions regarding their entry into force, but one can say, based upon the latest available information that their Contracting Parties are progressing rapidly towards ratification, acceptance or approval of those instruments and their implementation into national law. Nevertheless, there is little encouraging information with respect to the adherence to those Protocols of the many important nuclear power generating countries which have not yet joined the Paris/Brussels any international nuclear liability regime. The need for international co-operation to attract a larger number of adherents to these various instruments, to facilitate their ratification, acceptance or approval and to assist in the adoption of appropriate implementing legislation therefore remains a high priority amongst the international nuclear community. (author)

A Phase II Trial on the Effect of Low Dose versus High Dose Vitamin D Supplementation on Bone Mass in Adults with Neurofibromatosis 1 (NF1)

Science.gov (United States)

2016-10-01

Hamburg. We are working with EurodratCT to finalize our protocol, especially as it relates to the manufacture and transportation of study drug ...custodianship of study drug , cholecalciferol, from the manufacturer in Canada directly to Germany. Reviews from the IRBs and EurodratCT have led to revision of...a quality of life questionnaire (SF-36), fracture history survey, and activity survey. 2. KEYWORDS: 25(OH)D = 25-hydroxy vitamin D BMD = bone

E-Approval Plans in Research Libraries

Science.gov (United States)

Pickett, Carmelita; Tabacaru, Simona; Harrell, Jeanne

2014-01-01

Research libraries have long invested in approval plan services, which offer an economical way to acquire scholarly and scientific publications. Traditional approval plans have evolved and now enable libraries to expand their e-book offerings to better serve researchers. Publishers offer a myriad of e-book purchasing options. These range from…

Premarket Approvals (PMA)

Data.gov (United States)

U.S. Department of Health & Human Services — Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An...

75 FR 28814 - FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports From FHA Approved Lenders

Science.gov (United States)

2010-05-24

... proposal. This information is required for: (1) FHA lender approval, (2) Annual renewal of each FHA lender... following information: Title of Proposal: FHA Lender Approval, Annual Renewal, Periodic Updates and Required... and HUD-92001-C. Description of the Need for the Information and Its Proposed Use: This information is...

[Multidisciplinary protocol for computed tomography imaging and angiographic embolization of splenic injury due to trauma: assessment of pre-protocol and post-protocol outcomes].

Science.gov (United States)

Koo, M; Sabaté, A; Magalló, P; García, M A; Domínguez, J; de Lama, M E; López, S

2011-11-01

To assess conservative treatment of splenic injury due to trauma, following a protocol for computed tomography (CT) and angiographic embolization. To quantify the predictive value of CT for detecting bleeding and need for embolization. The care protocol developed by the multidisciplinary team consisted of angiography with embolization of lesions revealed by contrast extravasation under CT as well as embolization of grade III-V injuries observed, or grade I-II injuries causing hemodynamic instability and/or need for blood transfusion. We collected data on demographic variables, injury severity score (ISS), angiographic findings, and injuries revealed by CT. Pre-protocol and post-protocol outcomes were compared. The sensitivity and specificity of CT findings were calculated for all patients who required angiographic embolization. Forty-four and 30 angiographies were performed in the pre- and post-protocol periods, respectively. The mean (SD) ISSs in the two periods were 25 (11) and 26 (12), respectively. A total of 24 (54%) embolizations were performed in the pre-protocol period and 28 (98%) after implementation of the protocol. Two and 7 embolizations involved the spleen in the 2 periods, respectively; abdominal laparotomies numbered 32 and 25, respectively, and 10 (31%) vs 4 (16%) splenectomies were performed. The specificity and sensitivity values for contrast extravasation found on CT and followed by embolization were 77.7% and 79.5%. The implementation of this multidisciplinary protocol using CT imaging and angiographic embolization led to a decrease in the number of splenectomies. The protocol allows us to take a more conservative treatment approach.

Protocol Additional to the Agreement between the Republic of Nicaragua and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2005-01-01

The text of the Protocol Additional to the Agreement between the Republic of Nicaragua and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for teh Prohibition of Nuclear Weapons in Latin America and the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 12 June 2002 [es

Protocol Additional to the Agreement between the Republic of Nicaragua and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2005-01-01

The text of the Protocol Additional to the Agreement between the Republic of Nicaragua and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for teh Prohibition of Nuclear Weapons in Latin America and the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 12 June 2002 [fr

Protocol Additional to the Agreement between the Republic of Nicaragua and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2005-01-01

The text of the Protocol Additional to the Agreement between the Republic of Nicaragua and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for teh Prohibition of Nuclear Weapons in Latin America and the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 12 June 2002

7 CFR 1710.105 - State regulatory approvals.

Science.gov (United States)

2010-01-01

... and Basic Policies § 1710.105 State regulatory approvals. (a) In States where a borrower is required... loans are approved by RUS: (1) Loans requiring an Environmental Impact Statement; (2) Loans to finance...

Evaluating Data Abstraction Assistant, a novel software application for data abstraction during systematic reviews: protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Ian J. Saldanha

2016-11-01

abstraction approaches. Trial registration The trial is registered at National Information Center on Health Services Research and Health Care Technology (NICHSR under Registration # HSRP20152269: https://wwwcf.nlm.nih.gov/hsr_project/view_hsrproj_record.cfm?NLMUNIQUE_ID=20152269&SEARCH_FOR=Tianjing%20Li . All items from the World Health Organization Trial Registration Data Set are covered at various locations in this protocol. Protocol version and date: This is version 2.0 of the protocol, dated September 6, 2016. As needed, we will communicate any protocol amendments to the Institutional Review Boards (IRBs of Johns Hopkins Bloomberg School of Public Health (JHBSPH and Brown University. We also will make appropriate as-needed modifications to the NICHSR website in a timely fashion.

Protocol Additional to the Agreement of 31 October 1975 between the Government of the Republic of Korea and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2004-01-01

The text of the Protocol Additional to the Agreement of 31 October 1975 between the Government of the Republic of Korea and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 24 March 1999 and signed in Vienna on 21 June 1999. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 19 February 2004, the date on which the Agency received from the Republic of Korea written notification that the Republic of Korea's statutory and/or constitutional requirements for entry into force had been met

Protocol Additional to the Agreement of 31 October 1975 between the Government of the Republic of Korea and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

Energy Technology Data Exchange (ETDEWEB)

NONE

2004-06-10

The text of the Protocol Additional to the Agreement of 31 October 1975 between the Government of the Republic of Korea and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 24 March 1999 and signed in Vienna on 21 June 1999. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 19 February 2004, the date on which the Agency received from the Republic of Korea written notification that the Republic of Korea's statutory and/or constitutional requirements for entry into force had been met.

Inclusion of non-English-speaking patients in research: A single institution experience.

Science.gov (United States)

Bernier, Rachel; Halpin, Erin; Staffa, Steven J; Benson, Lindsey; DiNardo, James A; Nasr, Viviane G

2018-05-01

Considering the recent increase in medical care provided to patients from foreign countries and the diversity of languages spoken by families living within the United States, it is important to determine whether non-English-speaking patients have access to participate in clinical research from which they may benefit. We aimed to determine the number of non-English-speaking patients presenting to Boston Children's Hospital for medical care between 2011 and 2016, the number of clinical research protocols active within the Department of Anesthesiology, Critical Care and Pain Medicine approved to enroll non-English-speaking patients, as well as the number of both non-English- and English-speaking patients approached and enrolled in these studies. Furthermore, we attempted to determine barriers that may have prevented non-English-speaking patients from inclusion in clinical research. We conducted a retrospective review of various data sources during a 5-year period. Data included the number of non-English-speaking patients presenting to Boston Children's Hospital for care as well as the number of English- and non-English-speaking patients approached for studies at the Department of Anesthesiology each year. Additionally, we reviewed data from the IRB which included the justification that research teams provided when opting to exclude non-English-speaking participants. In addition, we attempted to determine the barriers that may have prevented these patients from inclusion in research protocols. We found that the number of non-English-speaking patients presenting to Boston Children's Hospital increased over time. However, the number of studies approved to enroll non-English-speaking patients within the Department of Anesthesiology and the rate of enrollment of these patients did not increase at the same rate. In order to increase the number of non-English-speaking patients approached to participate in research, we must improve cultural awareness and provide investigators

Perspectives used for gaining approval of budgets.

Science.gov (United States)

Franks-Joiner, G L

1990-01-01

Nurse executives think about problems using a certain perspective which may influence decisions on budgetary matters. The nurse executives' perspective used in decision-making may influence which budget proposals are developed and approved. A study was performed to determine the perspective used by nurse executives in decision-making on supplementary budget item proposals and whether perspective use influenced approval. Findings showed that use of the system view or dual-domain perspective in a proposal may enhance nurse executives' changes of gaining approval.

78 FR 2315 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-01-10

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

78 FR 15402 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-03-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

78 FR 11947 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-02-20

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

78 FR 17281 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-03-20

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 16317 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-03-20

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 66909 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-11-07

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule... below, receiving approval for the consumptive use of water pursuant to the Commission's approval by rule...

77 FR 21143 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-04-09

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 25010 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-04-26

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule... below, receiving approval for the consumptive use of water pursuant to the Commission's approval by rule...

77 FR 34455 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-06-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 55891 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-09-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 55892 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-09-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 59239 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-09-26

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

Effects of chlorophyll and chlorophyllin on low-dose aflatoxin B1 pharmacokinetics in human volunteers: A pilot study

Energy Technology Data Exchange (ETDEWEB)

Jubert, C; Mata, J; Bench, G; Dashwood, R; Pereira, C; Tracewell, W; Turteltaub, K; Williams, D; Bailey, G

2009-04-20

Chlorophyll (Chla) and chlorophyllin (CHL) were shown previously to reduce carcinogen bioavailability, biomarker damage, and tumorigenicity in trout and rats. These findings were partially extended to humans (Proc Natl Acad Sci USA 98, 14601-14606 (2001)), where CHL reduced excretion of aflatoxin B{sub 1} (AFB{sub 1})-DNA repair products in Chinese unavoidably exposed to dietary AFB{sub 1}. However, neither AFB{sub 1} pharmacokinetics nor Chla effects were examined. We conducted a small unblinded crossover study to establish AFB{sub 1} pharmacokinetic parameters in human volunteers, and to explore possible effects of CHL or Chla co-treatment on those parameters. For protocol 1, fasted subjects received an IRB-approved dose of 14C-AFB{sub 1} (30 ng, 5 nCi) by capsule with 100 ml water, followed by normal eating and drinking after hr 2. Blood and cumulative urine samples were collected over 72 hr, and {sup 14}C-AFB{sub 1} equivalents were determined by Accelerator Mass Spectrometry. Protocols 2 and 3 were similar except capsules also contained 150 mg of purified Chla, or CHL, respectively. All protocols were repeated 3 times for each of three volunteers. The study revealed rapid human AFB{sub 1} uptake (plasma ka 5.05 {+-} 1.10 hr-1, Tmax 1.0 hr) and urinary elimination (95% complete by 24 hr) kinetics. Chla and CHL treatment each significantly impeded AFB{sub 1} absorption and reduced Cmax and AUC's (plasma and urine) in one or more subjects. These initial results provide AFB{sub 1} pharmacokinetic parameters previously unavailable for humans, and suggest that Chla or CHL co-consumption may limit the bioavailability of ingested aflatoxin in humans, as they do in animal models.

Clinical Experience With Image-Guided Radiotherapy in an Accelerated Partial Breast Intensity-Modulated Radiotherapy Protocol

International Nuclear Information System (INIS)

Leonard, Charles E.; Tallhamer, Michael M.S.; Johnson, Tim; Hunter, Kari C.M.D.; Howell, Kathryn; Kercher, Jane; Widener, Jodi; Kaske, Terese; Paul, Devchand; Sedlacek, Scot; Carter, Dennis L.

2010-01-01

Purpose: To explore the feasibility of fiducial markers for the use of image-guided radiotherapy (IGRT) in an accelerated partial breast intensity modulated radiotherapy protocol. Methods and Materials: 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. Results: 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). Conclusions: 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.

Cryptographic Protocols:

DEFF Research Database (Denmark)

Geisler, Martin Joakim Bittel

cryptography was thus concerned with message confidentiality and integrity. Modern cryptography cover a much wider range of subjects including the area of secure multiparty computation, which will be the main topic of this dissertation. Our first contribution is a new protocol for secure comparison, presented...... implemented the comparison protocol in Java and benchmarks show that is it highly competitive and practical. The biggest contribution of this dissertation is a general framework for secure multiparty computation. Instead of making new ad hoc implementations for each protocol, we want a single and extensible...... in Chapter 2. Comparisons play a key role in many systems such as online auctions and benchmarks — it is not unreasonable to say that when parties come together for a multiparty computation, it is because they want to make decisions that depend on private information. Decisions depend on comparisons. We have...

Quantification protocol for energy efficiency in commercial and institutional buildings

Energy Technology Data Exchange (ETDEWEB)

NONE

2010-10-15

Alberta Environment has developed an approved methodology that can be used to quantify the reduction of direct and indirect greenhouse gas emission observed after the implementation of energy efficiency measures in commercial and institutional buildings. This methodology concerns energy conservation measures that target the heating system, the ventilation, the air conditioning and lightning systems, but also includes building envelope, tap water heating, elevators, occupant small electrical equipment, outdoor lighting, swimming pool pumping or heating. Calculation methodologies for energy conservation proposed by the Efficiency Valuation Organization were adapted by Alberta Environment. The protocol detailed in this document is based on the fact that emissions reductions are represented by the difference between the energy use in the project condition and a baseline. This approach proposes simple and advanced calculation methodologies that allow project developers to use one or the other, depending on the availability of data and on the limitations of the project, to maximize the greenhouse gas emissions reductions quantified. 14 refs., 11 tabs., 5 figs.

Protocol Additional to the Agreement between the United Mexican States and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

2011-01-01

The text of the Protocol Additional to the Agreement between the United Mexican States and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members. The Board of Governors approved the Additional Protocol on 9 March 2004. It was signed on 29 March 2004 in Vienna, Austria. Pursuant to Article 17 of the Additional Protocol, the Protocol entered into force on 4 March 2011, the date on which the Agency received from the United Mexican States written notification that Mexico's statutory and constitutional requirements for entry into force had been met

Applying for ethical approval for research: the main issues.

Science.gov (United States)

Gelling, Leslie

2016-01-13

The need to obtain research ethical approval is common to all research involving human participants. This approval must be obtained before research participants can be approached and before data collection can begin. The process of ethical review is one way that research participants can be confident that possible risks have been considered, minimised and deemed acceptable. This article outlines some of the main issues researchers should consider when planning an application for research ethical approval by answering the following six questions: 'Do I need research ethical approval?', 'How many applications will I need to make?', 'Where should I apply for research ethical approval?', 'What do I need to include in my application?', 'What do research ethics committees look for?' and 'What other approvals might I need?' Answering these questions will enable researchers to navigate the ethical review process.

Poet Marion Approval

Science.gov (United States)

This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable

Poet Portland Approval

Science.gov (United States)

This update August 9, 2016 letter from EPA approves the petition, with modifications, from Poet Biorefining-Portland, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

Poet Alexandria Approval

Science.gov (United States)

This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Alexandria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

Poet Laddonia Approval

Science.gov (United States)

This update Auugust 9, 2016 letter from EPA approves with modifications, the petition from Poet Biorefining Laddonia, Poet Laddonia Facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act f

Protocols for the analytical characterization of therapeutic monoclonal antibodies. II - Enzymatic and chemical sample preparation.

Science.gov (United States)

Bobaly, Balazs; D'Atri, Valentina; Goyon, Alexandre; Colas, Olivier; Beck, Alain; Fekete, Szabolcs; Guillarme, Davy

2017-08-15

The analytical characterization of therapeutic monoclonal antibodies and related proteins usually incorporates various sample preparation methodologies. Indeed, quantitative and qualitative information can be enhanced by simplifying the sample, thanks to the removal of sources of heterogeneity (e.g. N-glycans) and/or by decreasing the molecular size of the tested protein by enzymatic or chemical fragmentation. These approaches make the sample more suitable for chromatographic and mass spectrometric analysis. Structural elucidation and quality control (QC) analysis of biopharmaceutics are usually performed at intact, subunit and peptide levels. In this paper, general sample preparation approaches used to attain peptide, subunit and glycan level analysis are overviewed. Protocols are described to perform tryptic proteolysis, IdeS and papain digestion, reduction as well as deglycosylation by PNGase F and EndoS2 enzymes. Both historical and modern sample preparation methods were compared and evaluated using rituximab and trastuzumab, two reference therapeutic mAb products approved by Food and Drug Administration (FDA) and European Medicines Agency (EMA). The described protocols may help analysts to develop sample preparation methods in the field of therapeutic protein analysis. Copyright © 2017 Elsevier B.V. All rights reserved.

Development of a data entry auditing protocol and quality assurance for a tissue bank database.

Science.gov (United States)

Khushi, Matloob; Carpenter, Jane E; Balleine, Rosemary L; Clarke, Christine L

2012-03-01

Human transcription error is an acknowledged risk when extracting information from paper records for entry into a database. For a tissue bank, it is critical that accurate data are provided to researchers with approved access to tissue bank material. The challenges of tissue bank data collection include manual extraction of data from complex medical reports that are accessed from a number of sources and that differ in style and layout. As a quality assurance measure, the Breast Cancer Tissue Bank (http:\\\\www.abctb.org.au) has implemented an auditing protocol and in order to efficiently execute the process, has developed an open source database plug-in tool (eAuditor) to assist in auditing of data held in our tissue bank database. Using eAuditor, we have identified that human entry errors range from 0.01% when entering donor's clinical follow-up details, to 0.53% when entering pathological details, highlighting the importance of an audit protocol tool such as eAuditor in a tissue bank database. eAuditor was developed and tested on the Caisis open source clinical-research database; however, it can be integrated in other databases where similar functionality is required.

Multimode Communication Protocols Enabling Reconfigurable Radios

Directory of Open Access Journals (Sweden)

Berlemann Lars

2005-01-01

Full Text Available This paper focuses on the realization and application of a generic protocol stack for reconfigurable wireless communication systems. This focus extends the field of software-defined radios which usually concentrates on the physical layer. The generic protocol stack comprises common protocol functionality and behavior which are extended through specific parts of the targeted radio access technology. This paper considers parameterizable modules of basic protocol functions residing in the data link layer of the ISO/OSI model. System-specific functionality of the protocol software is realized through adequate parameterization and composition of the generic modules. The generic protocol stack allows an efficient realization of reconfigurable protocol software and enables a completely reconfigurable wireless communication system. It is a first step from side-by-side realized, preinstalled modes in a terminal towards a dynamic reconfigurable anymode terminal. The presented modules of the generic protocol stack can also be regarded as a toolbox for the accelerated and cost-efficient development of future communication protocols.

Ancestors protocol for scalable key management

Directory of Open Access Journals (Sweden)

Dieter Gollmann

2010-06-01

Full Text Available Group key management is an important functional building block for secure multicast architecture. Thereby, it has been extensively studied in the literature. The main proposed protocol is Adaptive Clustering for Scalable Group Key Management (ASGK. According to ASGK protocol, the multicast group is divided into clusters, where each cluster consists of areas of members. Each cluster uses its own Traffic Encryption Key (TEK. These clusters are updated periodically depending on the dynamism of the members during the secure session. The modified protocol has been proposed based on ASGK with some modifications to balance the number of affected members and the encryption/decryption overhead with any number of the areas when a member joins or leaves the group. This modified protocol is called Ancestors protocol. According to Ancestors protocol, every area receives the dynamism of the members from its parents. The main objective of the modified protocol is to reduce the number of affected members during the leaving and joining members, then 1 affects n overhead would be reduced. A comparative study has been done between ASGK protocol and the modified protocol. According to the comparative results, it found that the modified protocol is always outperforming the ASGK protocol.

Poet Fostoria Approval

Science.gov (United States)

This August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Fostoria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6)

Epistemic Protocols for Distributed Gossiping

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Krzysztof R. Apt

2016-06-01

Full Text Available Gossip protocols aim at arriving, by means of point-to-point or group communications, at a situation in which all the agents know each other's secrets. We consider distributed gossip protocols which are expressed by means of epistemic logic. We provide an operational semantics of such protocols and set up an appropriate framework to argue about their correctness. Then we analyze specific protocols for complete graphs and for directed rings.

Determining the Cardiovascular Effect of Partial versus Complete REBOA in a Porcine (Sus scrofa) Model of Hemorrhagic Shock.

Science.gov (United States)

2018-03-09

0 7. PROTOCOL PERSONNEL CHANGES: Have there been any personnel/staffing changes (PI/CI/ AI /TC/Instructor) since the last IACUC approval of...IACUC has approved this addition. ADDITIONS: (Include Name, Protocol function - PI/CI/ AI /TC/Instructor, IACUC approval - Yes/No) Col Jeremy Cannon... AI – Yes, Mr. Steven Chu ( AI ) – Yes DELETIONS: (Include Name, Protocol function - PI/CI/ AI /TC/Instructor, Effective date of deletion) None 8

Development and Validation of a Porcine (Sus scrofa) Sepsis Model

Science.gov (United States)

2018-03-01

remaining: $ 0.00 2 FDG20170019A 7. PROTOCOL PERSONNEL CHANGES: Have there been any personnel/staffing changes (PI/CI/ AI /TC/Instructor) since...indicate whether or not the IACUC has approved this addition. ADDITIONS: (Include Name, Protocol function - PI/CI/ AI /TC/Instructor, IACUC approval...Yes/No) NAME PROTOCOL FUNCTION IACUC APPROVAL Capt Carl Beyer AI Yes Capt Harris Kashtan AI Yes Capt Andrew Wishy AI Yes DELETIONS: (Include

Immunotherapy Combination Approved for Advanced Kidney Cancer