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

"Members of the same club": challenges and decisions faced by US IRBs in identifying and managing conflicts of interest.

Science.gov (United States)

Klitzman, Robert

2011-01-01

Conflicts of interest (COIs) in research have received increasing attention, but many questions arise about how Institutional Review Boards (IRBs) view and approach these. I conducted in-depth interviews of 2 hours each with 46 US IRB chairs, administrators, and members, exploring COI and other issues related to research integrity. I contacted leaders of 60 IRBs (every fourth one among the top 240 institutions by NIH funding), and interviewed IRB leaders from 34 of these institutions (response rate = 55%). Data were analyzed using standard qualitative methods, informed by Grounded Theory. IRBs confront financial and non-financial COIs of PIs, institutions, and IRBs themselves. IRB members may seek to help, or compete with, principal investigators (PIs). Non-financial COI also often appear to be "indirect financial" conflicts based on gain (or loss) not to oneself, but to one's colleagues or larger institution. IRBs faced challenges identifying and managing these COI, and often felt that they could be more effective. IRBs' management of their own potential COI vary, and conflicted members may observe, participate, and/or vote in discussions. Individual IRB members frequently judge for themselves whether to recuse themselves. Challenges arise in addressing these issues, since institutions and PIs need funding, financial information is considered confidential, and COI can be unconscious. This study, the first to explore qualitatively how IRBs confront COIs and probe how IRBs confront non-financial COIs, suggests that IRBs face several types of financial and non-financial COIs, involving themselves, PIs, and institutions, and respond varyingly. These data have critical implications for practice and policy. Disclosure of indirect and non-financial COIs to subjects may not be feasible, partly since IRBs, not PIs, are conflicted. Needs exist to consider guidelines and clarifications concerning when and how, in protocol reviews, IRB members should recuse themselves

“Members of the Same Club”: Challenges and Decisions Faced by US IRBs in Identifying and Managing Conflicts of Interest

Science.gov (United States)

Klitzman, Robert

2011-01-01

Conflicts of interest (COIs) in research have received increasing attention, but many questions arise about how Institutional Review Boards (IRBs) view and approach these. Methods I conducted in-depth interviews of 2 hours each with 46 US IRB chairs, administrators, and members, exploring COI and other issues related to research integrity. I contacted leaders of 60 IRBs (every fourth one among the top 240 institutions by NIH funding), and interviewed IRB leaders from 34 of these institutions (response rate = 55%). Data were analyzed using standard qualitative methods, informed by Grounded Theory. Results IRBs confront financial and non-financial COIs of PIs, institutions, and IRBs themselves. IRB members may seek to help, or compete with, principal investigators (PIs). Non-financial COI also often appear to be “indirect financial” conflicts based on gain (or loss) not to oneself, but to one's colleagues or larger institution. IRBs faced challenges identifying and managing these COI, and often felt that they could be more effective. IRBs' management of their own potential COI vary, and conflicted members may observe, participate, and/or vote in discussions. Individual IRB members frequently judge for themselves whether to recuse themselves. Challenges arise in addressing these issues, since institutions and PIs need funding, financial information is considered confidential, and COI can be unconscious. Conclusions This study, the first to explore qualitatively how IRBs confront COIs and probe how IRBs confront non-financial COIs, suggests that IRBs face several types of financial and non-financial COIs, involving themselves, PIs, and institutions, and respond varyingly. These data have critical implications for practice and policy. Disclosure of indirect and non-financial COIs to subjects may not be feasible, partly since IRBs, not PIs, are conflicted. Needs exist to consider guidelines and clarifications concerning when and how, in protocol reviews, IRB

Customizable orthopaedic oncology implants: one institution's experience with meeting current IRB and FDA requirements.

Science.gov (United States)

Willis, Alexander R; Ippolito, Joseph A; Patterson, Francis R; Benevenia, Joseph; Beebe, Kathleen S

2016-01-01

Customizable orthopaedic implants are often needed for patients with primary malignant bone tumors due to unique anatomy or complex mechanical problems. Currently, obtaining customizable orthopaedic implants for orthopaedic oncology patients can be an arduous task involving submitting approval requests to the Institutional Review Board (IRB) and the Food and Drug Administration (FDA). There is great potential for the delay of a patient's surgery and unnecessary paperwork if the submission pathways are misunderstood or a streamlined protocol is not in place. The objective of this study was to review the existing FDA custom implant approval pathways and to determine whether this process was improved with an institutional protocol. An institutional protocol for obtaining IRB and FDA approval for customizable orthopaedic implants was established with the IRB at our institution in 2013. This protocol was approved by the IRB, such that new patients only require submission of a modification to the existing protocol with individualized patient information. During the two-year period of 2013-2014, eight patients were retrospectively identified as having required customizable implants for various orthopaedic oncology surgeries. The dates of request for IRB approval, request for FDA approval, and total time to surgery were recorded, along with the specific pathway utilized for FDA approval. The average patient age was 12 years old (7-21 years old). The average time to IRB approval of a modification to the pre-approved protocol was 14 days (7-21 days). Average time to FDA approval after submission of the IRB approval to the manufacturer was 12.5 days (7-19 days). FDA approval was obtained for all implants as compassionate use requests in accordance with Section 561 of the Federal Food Drug and Cosmetic Act's expanded access provisions. Establishment of an institutional protocol with pre-approval by the IRB can expedite the otherwise time-consuming and complicated

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.

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.

Telerobotics: through-the-Internet teleoperation of the ABB IRB 2000 industrial robot

Science.gov (United States)

Alvares, Alberto J.; Caribe de Carvalho, Guilherme; Paulinyi, Luis F. d. A.; Alfaro, Sadek C. A.

1999-11-01

Robotic systems can be controlled remotely through the use of telerobotics. This work presents a through-the-internet teleoperation system for remotely operating the IRB2000 industrial robot. The IRB2000 controller allows external access through a RS232 serial communication link, which is based on a 42 function proprietary communication protocol. The proposed teleoperation system uses this communication capability by connecting it to a local area network based on TCP/IP (Transport Control Protocol/Internet Protocol). The system was implemented using a Client/Server architecture, having as server a UNIX (LINUX) platform.

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...

Time to institutional review board approval with local versus central review in a multicenter pragmatic trial.

Science.gov (United States)

Neuman, Mark D; Gaskins, Lakisha J; Ziolek, Tracy

2018-02-01

Central institutional review board (IRB) review will be required for National Institutes of Health-funded multisite human subjects research as of January 2018, with similar requirements extending to most US multisite human research in 2020. Nonetheless, little is known regarding the relative efficiency of central versus local IRB review for multicenter studies. We compared the amount of time required for central versus local IRB review and approval for sites in one ongoing multicenter randomized trial. The REGAIN Trial (Regional versus General Anesthesia for Promoting Independence after Hip Fracture; clinicaltrials.gov number: NCT02507505) is an ongoing randomized trial comparing standard-care spinal anesthesia to standard-care general anesthesia for patients undergoing hip fracture surgery. After approval of the protocol by the sponsor IRB, each participating US site opted either to submit the protocol for local IRB review or to designate the sponsor IRB as the IRB of record (i.e. central IRB) via an authorization agreement after a limited local review. For each US REGAIN site approved through 18 April 2017, we assessed (1) the time in calendar days from protocol receipt to IRB submission, (2) the time in calendar days from IRB submission to IRB approval, and (3) the total time in calendar days from protocol receipt to IRB approval (i.e. time from protocol receipt to IRB submission plus time from IRB submission to IRB approval). The main study protocol was submitted to the sponsor IRB on 25 May 2015 and approved on 8 July 2015 (44 days). Out of 34 sites, 9 received initial approval from the central (sponsor) IRB; 25 sought initial approval via local review. The median time from protocol receipt to IRB submission was 39 days for sites approved by the central IRB (interquartile range: 35-134) versus 58 days for sites approved via local review (interquartile range: 41-105; p = 0.711). The median time from IRB submission to IRB approval for sites approved by

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...

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...

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

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 26.1108 - 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...

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.

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

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.

21 CFR 56.113 - Suspension or termination of IRB approval of research.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Suspension or termination of IRB approval of research. 56.113 Section 56.113 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of...

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.

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…

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...

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...

Why Public Comments Matter: The Case of the National Institutes of Health Policy on Single Institutional Review Board Review of Multicenter Studies.

Science.gov (United States)

Ervin, Ann-Margret; Taylor, Holly A; Ehrhardt, Stephan; Meinert, Curtis L

2018-03-06

In 2014, the National Institutes of Health (NIH) requested public comments on a draft policy requiring NIH-funded, U.S.-based investigators to use a single institutional review board (sIRB) for ethical review of multicenter studies. The authors conducted a directed content analysis and qualitative summary of the comments and discuss how they shaped the final policy. Two reviewers independently assessed support for the policy from a review of comments responding to the draft policy in 2016. A reviewer conducted an open text review to identify prespecified and additional comment themes. A second researcher reviewed 20% of the comments; discrepancies were resolved through discussion. The NIH received 167 comments: 65% (108/167) supportive of the policy, 23% (38/167) not supportive, and 12% (21/167) not indicating support. Clarifications or changes to the policy were suggested in 102/167 comments (61%). Criteria for selecting sIRBs were addressed in 32/102 comments (31%). Also addressed were IRB responsibilities (39/102; 38%), cost (27/102; 26%), the role of local IRBs (14/102; 14%), and allowable policy exceptions (19/102; 19%). The NIH further clarified or provided additional guidance for selection criteria, IRB responsibilities, and cost in the final policy (June 2016). Local IRB reviews and exemptions guidance were unchanged. In this case study, public comments were effective in shaping policy as the NIH modified provisions or planned supplemental guidance in response to comments. Yet critical knowledge gaps remain and empirical data are necessary. The NIH is considering mechanisms to support the establishment of best practices for sIRB implementation.

Justification and authority in institutional review board decision letters.

Science.gov (United States)

Clapp, Justin T; Gleason, Katharine A; Joffe, Steven

2017-12-01

While ethnographic study has described the discussions that occur during human subjects research ethics review, investigators have minimal access to the interactions of ethics oversight committees. They instead receive letters stipulating changes to their proposed studies. Ethics committee letters are central to the practice of research ethics: they change the nature of research, alter the knowledge it produces, and in doing so construct what ethical research is and how it is pursued. However, these letters have rarely been objects of analysis. Accordingly, we conducted a qualitative analysis of letters written by American institutional review boards (IRBs) overseeing biomedical and health behavioral research. We sought to clarify how IRBs exercise their authority by assessing the frequency with which they provided reasons for their stipulations as well as the nature of these reasons. We found that IRBs frequently do not justify their stipulations; rather, they often leave ethical or regulatory concerns implicit or frame their comments as boilerplate language replacements, procedural instructions, or demands for missing information. When they do provide justifications, their rationales exhibit substantial variability in explicitness and clarity. These rhetorical tendencies indicate that the authority of IRBs is grounded primarily in their role as bureaucratic gatekeepers. We conclude by suggesting that greater attention to justification could help shift the basis of the IRB-researcher relationship from compliance to mutual accountability. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

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.

Adherence of non-pharmaceutically sponsored oncology trial protocols to the International Conference on Harmonization (ICH) guidelines in an academic institution outside the ICH jurisdictions and the impact of IRB implementation on this adherence

International Nuclear Information System (INIS)

Zeeneldin, A.A.

2013-01-01

Purpose: To assess adherence of non-pharmaceutically sponsored trials (non-PSTs) to ICH protocol structure guidelines and to estimate the effect of implementing Institutional Review Boards (IRB) review on this adherence. Methods: This is a retrospective exploratory study where 60 non-PST clinical trial protocols (CTPs) were reviewed and halved to IRB-reviewed CTPs (IRCTPs) and non-lRB-reviewed CTPs (non-lRCTPs). Adherence score (AS) was calculated as the number of fulfilled items or sub-items divided by their total number. Results: Three adherence patterns were encountered: (1) items consistently present in both groups e.g. general and background information, objectives, inclusion criteria and intervention details, (2) items consistently absent in both groups and included contact information of investigators and trial sites, product accountability, randomization codes management, interim analyses and many other statistical aspects, and (3) items variably present in both groups where the effect of IRB was verifiable. Trial site details, potential benefits, discontinuation and exclusion criteria, and follow up for adverse events were more encountered in IRCTPs than non-IRCTPs. Withdrawal criteria monitoring of treatment compliance showed a reverse pattern (p < 0.05 for all). The total AS, administrative AS and ethics AS for IRCTPs was 43%, 22% and 70% compared to 38%, 16% and 33% for non-IRCTPs (p < 0.003, <0.001, 0.004), respectively. The scientific AS was 54% for both groups (p = 0.87). Conclusions: IRB-implementation at NCl-Egypt improved ethical and administrative sections of academic protocols. However, this improvement is modest and needs further actions including adoption of protocol templates. Scientific sections were as good after IRB-implementation as they were before that

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...

Ethical review in Pakistan: the credibility gap.

Science.gov (United States)

Jafarey, Aamir Mustafa; Iqbal, Saima Pervaiz; Hassan, Mariam

2012-12-01

The concept of mandatory ethical review of research involving human participants is gradually taking root in Pakistani institutions. Based on the opinions of Institutional Review Board (IRB) members from institutions across the country, the process faces several challenges which threaten its integrity. The lack of registration or accreditation for IRBs has resulted in a wide variation in the calibre and working of such Boards. Despite the recent growth in numbers of people with formal bioethics degrees in the country, a majority of membership remains without any formal training for the work expected from them in ethical review. External pressures to influence deliberations, conflict of interest issues within board leadership and inconsistent application of review requirements all contribute in undermining the reliability of the process. Some of the most significant threats to independent and uninfluenced functioning of such boards arise from institutional leadership itself. In the opinions of IRB members, the review process has to be uniform, consistent and trustworthy if it is to gain the respect of researchers, and IRB need to be given the autonomous space to make independent decisions. Otherwise there is a real danger of IRBs being relegated to being no more than rubber stamping committees.

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.

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...

Institutional review boards: Challenges and opportunities

Directory of Open Access Journals (Sweden)

Ravindra B Ghooi

2014-01-01

Full Text Available Institutional Review Boards (IRBs are an important link in subject protection program, and their function defines ethical credentials of research. Of late there has been a furore in the country over the number of deaths in clinical research, and allegations of unethical research. Clinical trials have been discussed in medical and lay press and even in the parliament, these discussions called for strengthening the subject protection program. The Central Drug Standards and Control Organization (CDSCO, amended the Schedule Y, by issuing three amendments to introduce new compensation rules and registration of IRBs functioning in the country. IRBs in India face a variety of challenges, and need support from the regulators or independent experts. This is also an opportunity to revamp the subject protection program and strengthen the IRB functioning. An independent advisory body comprising of experts who have hands on experience in administering IRBs, is essential to provide support to IRBs in the country. This body should be independent of regulatory influence and work with IRBs to strengthen them.

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.

Resisting the seduction of "ethics creep": using Foucault to surface complexity and contradiction in research ethics review.

Science.gov (United States)

Guta, Adrian; Nixon, Stephanie A; Wilson, Michael G

2013-12-01

In this paper we examine "ethics creep", a concept developed by Haggerty (2004) to account for the increasing bureaucratization of research ethics boards and institutional review boards (REB/IRBs) and the expanding reach of ethics review. We start with an overview of the recent surge of academic interest in ethics creep and similar arguments about the prohibitive effect of ethics review. We then introduce elements of Michel Foucault's theoretical framework which are used to inform our analysis of empirical data drawn from a multi-phase study exploring the accessibility of community-engaged research within existing ethics review structures in Canada. First, we present how ethics creep emerged both explicitly and implicitly in our data. We then present data that demonstrate how REB/IRBs are experiencing their own form of regulation. Finally, we present data that situate ethics review alongside other trends affecting the academy. Our results show that ethics review is growing in some ways while simultaneously being constrained in others. Drawing on Foucauldian theory we reframe ethics creep as a repressive hypothesis which belies the complexity of the phenomenon it purports to explain. Our discussion complicates ethics creep by proposing an understanding of REB/IRBs that locates them at the intersection of various neoliberal discourses about the role of science, ethics, and knowledge production. Copyright © 2012 Elsevier Ltd. All rights reserved.

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.

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.

45 CFR 46.111 - Criteria for IRB approval of research.

Science.gov (United States)

2010-10-01

... Section 46.111 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.111 Criteria for IRB... protect the rights and welfare of these subjects. ...

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.

7 CFR 3405.14 - Proposal review.

Science.gov (United States)

2010-01-01

... Regulations of the Department of Agriculture (Continued) COOPERATIVE STATE RESEARCH, EDUCATION, AND EXTENSION SERVICE, DEPARTMENT OF AGRICULTURE HIGHER EDUCATION CHALLENGE GRANTS PROGRAM Proposal Review and Evaluation § 3405.14 Proposal review. The proposal evaluation process includes both internal staff review and...

Balanced Ethics Review: A Guide for Institutional Review Board Members

Directory of Open Access Journals (Sweden)

Ames Dhai

2016-12-01

Full Text Available The aim of this pocket-book size manual is to assist Institutional Review Board (IRB members and chairs conduct ethics review by balancing the two major morally relevant considerations in health research

Measuring inconsistency in research ethics committee review

OpenAIRE

Trace, Samantha; Kolstoe, Simon Erik

2017-01-01

Background The review of human participant research by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority (HRA) coordinates 67 committees, and has adopted a consistency improvement plan including a process called “Sha...

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.

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.

Understanding the Federal Proposal Review Process.

Science.gov (United States)

Cavin, Janis I.

Information on the peer review process for the evaluation of federal grant proposals is presented to help college grants administrators and faculty develop good proposals. This guidebook provides an overview of the policies and conventions that govern the review and selection of proposals for funding, and details the review procedures of the…

40 CFR 26.1111 - Criteria for IRB approval of research.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Criteria for IRB approval of research. 26.1111 Section 26.1111 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION... subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating...

Approaches to facilitate institutional review board approval of multicenter research studies.

Science.gov (United States)

Marsolo, Keith

2012-07-01

Gaining Institutional Review Board (IRB) approval for a multicenter research study can be a lengthy and time-consuming process. It can increase the complexity of consent forms, decreasing patient understanding and lowering recruitment numbers. It also leads to increased costs through the duplication of effort. This paper examines some of the strategies used to streamline the IRB review process for multicenter studies and provides examples used by 2 existing multicenter comparative effectiveness research networks. A literature search was conducted to identify sources that described the challenges and potential strategies to facilitate multicenter IRB approval. The most promising avenues were identified and included in this review. Phone interviews were conducted with the Principal Investigators and Project Managers of 2 successful multicenter research networks to learn their "keys to success" and their lessons learned. Three strategies were identified that held the most promise: working with IRBs before submission, the use of central and/or federated IRBs, and the establishment of an umbrella protocol. Each of these strategies was used to some degree by the case study projects. Although the approaches documented here can help streamline the IRB approval process, they are not a "silver bullet." Because some of these approaches are still relatively new, empirical data are sparse. However, it is believed that they will significantly reduce the administrative burden of the project as a whole and lead to a decrease in the overall time to protocol approval.

Assessing the quality of VA Human Research Protection Programs: VA vs. affiliated University Institutional Review Board.

Science.gov (United States)

Tsan, Min-Fu; Nguyen, Yen; Brooks, Robert

2013-04-01

We compared the Human Research Protection Program (HRPP) quality indicator data of the Department of Veterans Affairs (VA) facilities using their own VA institutional review boards (IRBs) with those using affiliated university IRBs. From a total of 25 performance metrics, 13 did not demonstrate statistically significant differences, while 12 reached statistically significance differences. Among the 12 with statistically significant differences, facilities using their own VA IRBs performed better on four of the metrics, while facilities using affiliate IRBs performed better on eight. However, the absolute difference was small (0.2-2.7%) in all instances, suggesting that they were of no practical significance. We conclude that it is acceptable for facilities to use their own VA IRBs or affiliated university IRBs as their IRBs of record.

15 CFR 27.111 - Criteria for IRB approval of research.

Science.gov (United States)

2010-01-01

... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Criteria for IRB approval of research. 27.111 Section 27.111 Commerce and Foreign Trade Office of the Secretary of Commerce PROTECTION OF... subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the...

SPRITE: the Spitzer proposal review website

Science.gov (United States)

Crane, Megan K.; Storrie-Lombardi, Lisa J.; Silbermann, Nancy A.; Rebull, Luisa M.

2008-07-01

The Spitzer Science Center (SSC), located on the campus of the California Institute of Technology, supports the science operations of NASA's infrared Spitzer Space Telescope. The SSC issues an annual Call for Proposals inviting investigators worldwide to submit Spitzer Space Telescope proposals. The Spitzer Proposal Review Website (SPRITE) is a MySQL/PHP web database application designed to support the SSC proposal review process. Review panel members use the software to view, grade, and write comments about the proposals, and SSC support team members monitor the grading and ranking process and ultimately generate a ranked list of all the proposals. The software is also used to generate, edit, and email award letters to the proposers. This work was performed at the California Institute of Technology under contract to the National Aeronautics and Space Administration.

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.

A Case for Limiting the Reach of Institutional Review Boards

Science.gov (United States)

Hessler, Richard M.; Donnell-Watson, D. J.; Galliher, John F.

2011-01-01

Institutional review boards (IRBs) governing social and behavioral research seem to systematically exceed the guidelines established by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. We examine a clandestine study of prostitution and another of employment discrimination and conclude that IRBs,…

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.

7 CFR 3406.14 - Proposal review-teaching.

Science.gov (United States)

2010-01-01

... 7 Agriculture 15 2010-01-01 2010-01-01 false Proposal review-teaching. 3406.14 Section 3406.14 Agriculture Regulations of the Department of Agriculture (Continued) COOPERATIVE STATE RESEARCH, EDUCATION... Review and Evaluation of a Teaching Proposal § 3406.14 Proposal review—teaching. The proposal evaluation...

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.

Applying the institutional review board data repository approach to manage ethical considerations in evaluating and studying medical education.

Science.gov (United States)

Thayer, Erin K; Rathkey, Daniel; Miller, Marissa Fuqua; Palmer, Ryan; Mejicano, George C; Pusic, Martin; Kalet, Adina; Gillespie, Colleen; Carney, Patricia A

2016-01-01

Medical educators and educational researchers continue to improve their processes for managing medical student and program evaluation data using sound ethical principles. This is becoming even more important as curricular innovations are occurring across undergraduate and graduate medical education. Dissemination of findings from this work is critical, and peer-reviewed journals often require an institutional review board (IRB) determination. IRB data repositories, originally designed for the longitudinal study of biological specimens, can be applied to medical education research. The benefits of such an approach include obtaining expedited review for multiple related studies within a single IRB application and allowing for more flexibility when conducting complex longitudinal studies involving large datasets from multiple data sources and/or institutions. In this paper, we inform educators and educational researchers on our analysis of the use of the IRB data repository approach to manage ethical considerations as part of best practices for amassing, pooling, and sharing data for educational research, evaluation, and improvement purposes. Fostering multi-institutional studies while following sound ethical principles in the study of medical education is needed, and the IRB data repository approach has many benefits, especially for longitudinal assessment of complex multi-site data.

Review paper on research ethics in Ethiopia: experiences and lessons learnt from Addis Ababa University College of Health Sciences 2007-2012.

Science.gov (United States)

Feleke, Yeweyenhareg; Addissie, Adamu; Wamisho, Biruk L; Davey, Gail

2015-01-01

Health research in Ethiopia is increasing both in volume and type, accompanied with expansion of higher education and research since the past few years. This calls for a proportional competence in the governance of medical research ethics in Ethiopia in the respective research and higher learning institutes. The paper highlights the evolution and progress ofthe ethics review at Addis Ababa University - College of Health Sciences (AAU-CHS) in the given context of health research review system in Ethiopia. Reflections are made on the key lessons to be drawnfrom the formative experiences of the Institutional Review Board (IRB) and their implications to the Ethiopian health research review system. This article is a review paper based on review of published and un published documents on research ethics in Ethiopia and the AAU-CHS (2007-2012). Thematic summaries of review findings are presented in thematic areas - formation of ethics review and key factors in the evolution of ethics review and implications. The IRB at AAU-CHS has been pivotal in providing review and follow-up for important clinical studies in Ethiopia. It has been one of the first IRBs to get WHO/SIDCER recognition from Africa and Ethiopia. Important factors in the successes of the IRB among others included leadership commitment, its placement in institutional structure, and continued capacity building. Financial challenges and sustainability issues need to be addressed for the sustained gains registered so far. Similar factors are considered important for the new and younger IRBs within the emergent Universities and research centers in the country.

40 CFR 26.1113 - Suspension or termination of IRB approval of research.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Suspension or termination of IRB approval of research. 26.1113 Section 26.1113 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Pesticides Involving Intentional Exposure of Non-pregnant, Non-nursing Adults § 26.1113 Suspension or...

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...

Institutional Review Boards at Very High Research Activity Universities: An Opportunity for Social Workers

Science.gov (United States)

Cannon, Clare; Buttell, Frederick

2015-01-01

Objectives: This study investigated to what degree social work was represented in the position of chair of social-behavioral institutional review boards (IRBs) at very high research activity (VHRA) universities in the United States. Method: We collected data on IRB rosters for all 108 schools designated by the Carnegie Foundation as VHRAs in the…

Academic and Institutional Review Board Collaboration to Ensure Ethical Conduct of Doctor of Nursing Practice Projects.

Science.gov (United States)

Foote, Jan M; Conley, Virginia; Williams, Janet K; McCarthy, Ann Marie; Countryman, Michele

2015-07-01

Navigating the regulations to protect human subjects and private health information for Doctor of Nursing Practice (DNP) projects can be a formidable task for students, faculty, and the institutional review board (IRB). Key stakeholders from the University of Iowa College of Nursing and the Human Subjects Office developed a standardized process for DNP students to follow, using a decision algorithm, a student orientation to the human subjects review process conducted by faculty and IRB chairs and staff, and a brief Human Subjects Research Determination form. Over 2 years, 109 students completed the process, and 96.3% of their projects were deemed not to be human subjects research. Every student submitted documentation of adherence to the standardized process. Less time was spent by students, faculty, and the IRB in preparing and processing review requests. The interprofessional collaboration resulted in a streamlined process for the timely review of DNP projects. Copyright 2015, SLACK Incorporated.

Ethical dilemmas in community-based participatory research: recommendations for institutional review boards.

Science.gov (United States)

Flicker, Sarah; Travers, Robb; Guta, Adrian; McDonald, Sean; Meagher, Aileen

2007-07-01

National and international codes of research conduct have been established in most industrialized nations to ensure greater adherence to ethical research practices. Despite these safeguards, however, traditional research approaches often continue to stigmatize marginalized and vulnerable communities. Community-based participatory research (CBPR) has evolved as an effective new research paradigm that attempts to make research a more inclusive and democratic process by fostering the development of partnerships between communities and academics to address community-relevant research priorities. As such, it attempts to redress ethical concerns that have emerged out of more traditional paradigms. Nevertheless, new and emerging ethical dilemmas are commonly associated with CBPR and are rarely addressed in traditional ethical reviews. We conducted a content analysis of forms and guidelines commonly used by institutional review boards (IRBs) in the USA and research ethics boards (REBs) in Canada. Our intent was to see if the forms used by boards reflected common CBPR experience. We drew our sample from affiliated members of the US-based Association of Schools of Public Health and from Canadian universities that offered graduate public health training. This convenience sample (n = 30) was garnered from programs where application forms were available online for download between July and August, 2004. Results show that ethical review forms and guidelines overwhelmingly operate within a biomedical framework that rarely takes into account common CBPR experience. They are primarily focused on the principle of assessing risk to individuals and not to communities and continue to perpetuate the notion that the domain of "knowledge production" is the sole right of academic researchers. Consequently, IRBs and REBs may be unintentionally placing communities at risk by continuing to use procedures inappropriate or unsuitable for CBPR. IRB/REB procedures require a new framework more

Research ethics and Institutional Review Boards. The influence of moral constraints on emotion research.

Science.gov (United States)

Sontag, Michael

2012-01-01

Researchers in the twenty-first century face a set of challenges unknown to researchers a half century ago--the need to justify the moral acceptability of their research methods through formal review processes. However, the role that moral constraints play in the development and demise of scientific theories has largely gone unappreciated. The rise of Institutional Review Boards (IRB) in the 1960s compounded the impact of moral constraints on scientific research and on the theories that develop out of such highly monitored research. To demonstrate the effects of moral constraints on scientific theory and research, this paper offers a history and analysis of the interaction between evolving moral standards and twentieth century emotion theory. Recommendations regarding IRB reform are also reviewed. The paper concludes by arguing that, while appropriate IRB reform is important, it cannot eliminate the need for careful reflection on the broader forces that shape scientific practice and understanding.

An institutional review board-based clinical research quality assurance program.

Science.gov (United States)

Lad, Pramod M; Dahl, Rebecca

2013-01-01

Despite the acknowledged importance of quality assurance in the clinical research process, the problem of how such a program should be implemented at the level of an academic teaching hospital or a similar institution has not been addressed in the literature. Despite the fact that quality assurance is expected in programs which certify and accredit Institutional Review Boards (IRBs), very little is known about the role of the IRB in programs of clinical research quality assurance. In this article we consider the definition of clinical research quality assurance, and describe a program designed to achieve it. The key elements of such a program are education at the site level, which has both mandatory and voluntary components, and an auditing and monitoring program, which reinforces the education on quality assurance. The role of the IRB in achieving the program goals and the organizational placement of the quality assurance program within the IRB structure and function are important items of discussion.

Ethics Review for a Multi-Site Project Involving Tribal Nations in the Northern Plains.

Science.gov (United States)

Angal, Jyoti; Petersen, Julie M; Tobacco, Deborah; Elliott, Amy J

2016-04-01

Increasingly, Tribal Nations are forming ethics review panels, which function separately from institutional review boards (IRBs). The emergence of strong community representation coincides with a widespread effort supported by the U.S. Department of Health & Human Services and other federal agencies to establish a single IRB for all multi-site research. This article underscores the value of a tribal ethics review board and describes the tribal oversight for the Safe Passage Study-a multi-site, community-based project in the Northern Plains. Our experience demonstrates the benefits of tribal ethics review and makes a strong argument for including tribal oversight in future regulatory guidance for multi-site, community-based research. © The Author(s) 2016.

How US institutional review boards decide when researchers need to translate studies.

Science.gov (United States)

Klitzman, Robert

2014-03-01

Informed consent is crucial in research, but potential participants may not all speak the same language, posing questions that have not been examined concerning decisions by institutional review boards (IRBs) and research ethics committees' (RECs) about the need for researchers to translate consent forms and other study materials. Sixty US IRBs (every fourth one in the list of the top 240 institutions by The National Institutes of Health funding) were contacted, and leaders (eg, chairs) from 34 (response rate=57%) and an additional 12 members and administrators were interviewed. IRBs face a range of problems about translation of informed consent documents, questionnaires and manuals-what, when and how to translate (eg, for how many or what proportion of potential subjects), why to do so and how to decide. Difficulties can arise about translation of specific words and of broader cultural concepts regarding processes of informed consent and research, especially in the developing world. In these decisions, IRBs weigh the need for autonomy (through informed consent) and justice (to ensure fair distribution of benefits and burdens of research) against practical concerns about costs to researchers. At times IRBs may have to compromise between these competing goals. These data, the first to examine when and how IRBs/RECs require researchers to translate materials, thus highlight a range of problems with which these committees struggle, suggesting a need for further normative and empirical investigation of these domains, and consideration of guidelines to help IRBs deal with these tensions.

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.

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

Review of heavy ion collider proposals

International Nuclear Information System (INIS)

Ruggiero, A.G.

1985-01-01

In this paper we review proposals for heavy-ion colliders generated during the last few years for several national laboratories. The proposals span over a large range of energy and luminosity to accommodate the experimental needs of both the nuclear and the high-energy physicists. We report also briefly efforts in the same field happening in Europe

Ethical Dilemmas in Community-Based Participatory Research: Recommendations for Institutional Review Boards

Science.gov (United States)

Travers, Robb; Guta, Adrian; McDonald, Sean; Meagher, Aileen

2007-01-01

National and international codes of research conduct have been established in most industrialized nations to ensure greater adherence to ethical research practices. Despite these safeguards, however, traditional research approaches often continue to stigmatize marginalized and vulnerable communities. Community-based participatory research (CBPR) has evolved as an effective new research paradigm that attempts to make research a more inclusive and democratic process by fostering the development of partnerships between communities and academics to address community-relevant research priorities. As such, it attempts to redress ethical concerns that have emerged out of more traditional paradigms. Nevertheless, new and emerging ethical dilemmas are commonly associated with CBPR and are rarely addressed in traditional ethical reviews. We conducted a content analysis of forms and guidelines commonly used by institutional review boards (IRBs) in the USA and research ethics boards (REBs) in Canada. Our intent was to see if the forms used by boards reflected common CBPR experience. We drew our sample from affiliated members of the US-based Association of Schools of Public Health and from Canadian universities that offered graduate public health training. This convenience sample (n = 30) was garnered from programs where application forms were available online for download between July and August, 2004. Results show that ethical review forms and guidelines overwhelmingly operate within a biomedical framework that rarely takes into account common CBPR experience. They are primarily focused on the principle of assessing risk to individuals and not to communities and continue to perpetuate the notion that the domain of “knowledge production” is the sole right of academic researchers. Consequently, IRBs and REBs may be unintentionally placing communities at risk by continuing to use procedures inappropriate or unsuitable for CBPR. IRB/REB procedures require a new framework

Engaging Institutional Review Boards in Developing a Brief, Community-Responsive Human Subjects Training for Community Partners.

Science.gov (United States)

Calzo, Jerel P; Bogart, Laura M; Francis, Evelyn; Kornetsky, Susan Z; Winkler, Sabune J; Kaberry, Julie

2016-01-01

Engaging community partners as co-investigators in community-based participatory research (CBPR) requires certification in the rules, ethics, and principles governing research. Despite developments in making human research protection trainings more convenient and standardized (eg, self-paced Internet modules), time constraints and the structure of the content (which may favor academic audiences) may hinder the training of community partners. This paper is motivated by a case example in which academic and community partners, and stakeholders of a community-based organization actively engaged the leadership of a pediatric hospital-based institutional review board (IRB) in implementing a brief, community-responsive human subjects training session. A 2-hour, discussion-based human subjects training was developed via collaborations between the IRB and the community and academic partners. Interviews with trainees and facilitators after the training were used to evaluate its acceptability and possible future applications. Local IRBs have the potential to assist community partners in building sufficient knowledge of human subjects research protections to engage in specific projects, thereby expediting the progress of vital research to address community needs. We propose the need for developing truncated human subjects education materials to train and certify community partners, and creating formally organized entities within academic and medical institutions that specialize in community-based research to guide the development and implementation of alternative human subjects training certification opportunities for community partners.

Proposals for the writing of peer reviews in lexicography

DEFF Research Database (Denmark)

Bergenholtz, Henning; Gouws, Rufus

2015-01-01

In lexicography a good review is important for the dictionary maker(s), the publishing house and the whole lexicographical community. It is also important for the reviewers because it can expand their research record. Up to a few years ago reviews were still acknowledged in research databases...... regarding ethical aspects. But there are essential differences. These issues are discussed in this paper and some methodological and ethical proposals for peer reviews are made. One of the proposals could create a debate because it argues for an open peer review process and not for the so-called double...

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...

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…

Measuring inconsistency in research ethics committee review.

Science.gov (United States)

Trace, Samantha; Kolstoe, Simon Erik

2017-11-28

The review of human participant research by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority (HRA) coordinates 67 committees, and has adopted a consistency improvement plan including a process called "Shared Ethical Debate" (ShED) where multiple committees review the same project. Committee reviews are compared for consistency by analysing the resulting minutes. We present a description of the ShED process. We report an analysis of minutes created by research ethics committees participating in two ShED exercises, and compare them to minutes produced in a published "mystery shopper" exercise. We propose a consistency score by defining top themes for each exercise, and calculating the ratio between top themes and total themes identified by each committee for each ShED exercise. Our analysis highlights qualitative differences between the ShED 19, ShED 20 and "mystery shopper" exercises. The quantitative measure of consistency showed only one committee across the three exercises with more than half its total themes as top themes (ratio of 0.6). The average consistency scores for the three exercises were 0.23 (ShED19), 0.35 (ShED20) and 0.32 (mystery shopper). There is a statistically significant difference between the ShED 19 exercise, and the ShED 20 and mystery shopper exercises. ShED exercises are effective in identifying inconsistency between ethics committees and we describe a scoring method that could be used to quantify this. However, whilst a level of inconsistency is probably inevitable in research ethics committee reviews, studies must move beyond the ShED methodology to understand why inconsistency occurs, and what an acceptable level of inconsistency might be.

Review of proposed kaon factory facilities

International Nuclear Information System (INIS)

Macek, R.J.

1985-01-01

A number of proton accelerator facilities, popularly called ''Kaon Factories,'' have been proposed to extend the intensity frontier from about 1 GeV to higher energies in the range of 15 to 45 GeV. Seven proposed facilities - LAMPF II, TRIUMF II, SIN II, AGS II, KEK, MUNICH, and KYOTO - are reviewed with emphasis on capabilities of the experimental facilities. Costs and the choice of energy and current are also discussed. 7 refs., 29 figs., 7 tabs

GSBPP CAPSTONE REVIEW

Science.gov (United States)

2016-12-01

Graduate School of Business and Public Policy IRB Institutional Review Board JPME Joint Professional Military Education LSS Lean Six Sigma NASPAA...checking” some of our statistical representations presented throughout this report. We wish to especially thank Terry Rea, Captain, U.S. Navy...relevance of [its] graduate education and research programs” (NPS, 2008, p. 3). Concerning this goal, NPS has instituted several policies and procedures that

7 CFR 3415.14 - Proposal review.

Science.gov (United States)

2010-01-01

... SERVICE, DEPARTMENT OF AGRICULTURE BIOTECHNOLOGY RISK ASSESSMENT RESEARCH GRANTS PROGRAM Scientific Peer... program solicitation (e.g., relationship of application to announced program area). Proposals that do not... and will be returned to the applicant. (b) All applications will be carefully reviewed by the...

Institutional review board and regulatory solutions in the dental PBRN

DEFF Research Database (Denmark)

Gilbert, Gregg H; Qvist, Vibeke; Moore, Sheila D

2010-01-01

Effectively addressing regulatory and human participant protection issues with Institutional Review Boards (IRBs, or ethics committees) and grants administration entities is an important component of conducting research in large collaborative networks. A dental practice-based research network...

76 FR 8381 - Proposal Review for Physics; Notice of Meeting

Science.gov (United States)

2011-02-14

... NATIONAL SCIENCE FOUNDATION Proposal Review for Physics; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L. 92- 463, as amended), the National Science Foundation announces the following meeting: Name: Proposal Review for the Center for Magnetic Self-Organization in...

Sex-Divergent Clinical Outcomes and Precision Medicine: An Important New Role for Institutional Review Boards and Research Ethics Committees

Directory of Open Access Journals (Sweden)

Ignacio Segarra

2017-07-01

Full Text Available The efforts toward individualized medicine have constantly increased in an attempt to improve treatment options. These efforts have led to the development of small molecules which target specific molecular pathways involved in cancer progression. We have reviewed preclinical studies of sunitinib that incorporate sex as a covariate to explore possible sex-based differences in pharmacokinetics and drug–drug interactions (DDI to attempt a relationship with published clinical outputs. We observed that covariate sex is lacking in most clinical outcome reports and suggest a series of ethic-based proposals to improve research activities and identify relevant different sex outcomes. We propose a deeper integration of preclinical, clinical, and translational research addressing statistical and clinical significance jointly; to embed specific sex-divergent endpoints to evaluate possible gender differences objectively during all stages of research; to pay greater attention to sex-divergent outcomes in polypharmacy scenarios, DDI and bioequivalence studies; the clear reporting of preclinical and clinical findings regarding sex-divergent outcomes; as well as to encourage the active role of scientists and the pharmaceutical industry to foster a new scientific culture through their research programs, practice, and participation in editorial boards and Institutional Ethics Review Boards (IRBs and Research Ethics Committees (RECs. We establish the IRB/REC as the centerpiece for the implementation of these proposals. We suggest the expansion of its competence to follow up clinical trials to ensure that sex differences are addressed and recognized; to engage in data monitoring committees to improve clinical research cooperation and ethically address those potential clinical outcome differences between male and female patients to analyze their social and clinical implications in research and healthcare policies.

Variation in standards of research compensation and child assent practices: a comparison of 69 institutional review board-approved informed permission and assent forms for 3 multicenter pediatric clinical trials.

Science.gov (United States)

Kimberly, Michael B; Hoehn, K Sarah; Feudtner, Chris; Nelson, Robert M; Schreiner, Mark

2006-05-01

To systematically compare standards for compensation and child participant assent in informed permission, assent, and consent forms (IP-A-CFs) approved by 55 local institutional review boards (IRBs) reviewing 3 standardized multicenter research protocols. Sixty-nine principal investigators participating in any of 3 national, multicenter clinical trials submitted standardized research protocols for their trials to their local IRBs for approval. Copies of the subsequently IRB-approved IP-A-CFs were then forwarded to an academic clinical research organization. This collection of IRB-approved forms allowed for a quasiexperimental retrospective evaluation of the variation in informed permission, assent, and consent standards operationalized by the local IRBs. Standards for compensation and child participant assent varied substantially across 69 IRB-approved IP-A-CFs. Among the 48 IP-A-CFs offering compensation, monetary compensation was offered by 33 as reimbursement for travel, parking, or food expenses, whereas monetary or material compensation was offered by 22 for subject inconvenience and by 13 for subject time. Compensation ranged widely within and across studies (study 1, $180-1425; study 2, $0-500; and study 3, $0-100). Regarding child participant assent, among the 57 IP-A-CFs that included a form of assent documentation, 33 included a line for assent on the informed permission or consent form, whereas 35 included a separate form written in simplified language. Of the IP-A-CFs that stipulated the documentation of assent, 31 specified > or =1 age ranges for obtaining assent. Informed permission or consent forms were addressed either to parents or child participants. In response to identical clinical trial protocols, local IRBs generate IP-A-CFs that vary considerably regarding compensation and child participant assent.

Deceased Donor Intervention Research: A Survey of Transplant Surgeons, Organ Procurement Professionals, and Institutional Review Board Members.

Science.gov (United States)

Rodrigue, J R; Feng, S; Johansson, A C; Glazier, A K; Abt, P L

2016-01-01

Innovative deceased donor intervention strategies have the potential to increase the number and quality of transplantable organs. Yet there is confusion over regulatory and legal requirements, as well as ethical considerations. We surveyed transplant surgeons (n = 294), organ procurement organization (OPO) professionals (n = 83), and institutional review board (IRB) members (n = 317) and found wide variations in their perceptions about research classification, risk assessment for donors and organ transplant recipients, regulatory oversight requirements, and informed consent in the context of deceased donor intervention research. For instance, when presented with different research scenarios, IRB members were more likely than transplant surgeons and OPO professionals to feel that study review and oversight were necessary by the IRBs at the investigator, donor, and transplant center hospitals. Survey findings underscore the need to clarify ethical, legal, and regulatory requirements and their application to deceased donor intervention research to accelerate the pace of scientific discovery and facilitate more transplants. © Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.

Curriculum Online Review System: Proposing Curriculum with Collaboration

Science.gov (United States)

Rhinehart, Marilyn; Barlow, Rhonda; Shafer, Stu; Hassur, Debby

2009-01-01

The Curriculum Online Review System (CORS) at Johnson County Community College (JCCC) uses SharePoint as a Web platform for the JCCC Curriculum Proposals Process. The CORS application manages proposals throughout the approval process using collaboration tools and workflows to notify all stakeholders. This innovative new program has changed the way…

75 FR 81315 - Earth Sciences Proposal Review Panel; Notice of Meeting

Science.gov (United States)

2010-12-27

... NATIONAL SCIENCE FOUNDATION Earth Sciences Proposal Review Panel; Notice of Meeting In accordance... announces the following meeting. Name: Proposal Review Panel in Earth Sciences (1569). Date and Time... Kelz, Program Director, Instrumentation & Facilities Program, Division of Earth Sciences, Room 785...

Spotlight on Ethics: Institutional Review Boards as Systemic Bullies

Science.gov (United States)

Carr, Caleb T.

2015-01-01

Bullying, often considered an interpersonal or intergroup behaviour, has not been explored as an unintended artefact of organisational structure. Institutional review boards (IRBs), the 'human research ethics committees' at US universities, help oversee the protection of human research subjects, particularly in the social sciences within…

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...

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.

75 FR 15460 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2010-03-29

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L. 92- 463, as amended), the National Science Foundation announces the following meeting. Name: Proposal Review Panel for Physics, LIGO Site Visit in Louisiana (1208...

77 FR 69505 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2012-11-19

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L. 92- 463, as amended), the National Science Foundation announces the following meeting. Name: LIGO Operations Proposal and Annual Review in Physics (1208). Date...

Defense Contract Audit Agency Reviews of Price Proposals

National Research Council Canada - National Science Library

1998-01-01

.... Auditors perform field pricing reviews of contractor price proposals when procurement office information is insufficient to perform the cost or price analysis needed to negotiate contract prices...

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...

Institutional review board challenges related to community-based participatory research on human exposure to environmental toxins: A case study

Directory of Open Access Journals (Sweden)

Rudel Ruthann A

2010-07-01

Full Text Available Abstract Background We report on the challenges of obtaining Institutional Review Board (IRB coverage for a community-based participatory research (CBPR environmental justice project, which involved reporting biomonitoring and household exposure results to participants, and included lay participation in research. Methods We draw on our experiences guiding a multi-partner CBPR project through university and state Institutional Review Board reviews, and other CBPR colleagues' written accounts and conference presentations and discussions. We also interviewed academics involved in CBPR to learn of their challenges with Institutional Review Boards. Results We found that Institutional Review Boards are generally unfamiliar with CBPR, reluctant to oversee community partners, and resistant to ongoing researcher-participant interaction. Institutional Review Boards sometimes unintentionally violate the very principles of beneficence and justice which they are supposed to uphold. For example, some Institutional Review Boards refuse to allow report-back of individual data to participants, which contradicts the CBPR principles that guide a growing number of projects. This causes significant delays and may divert research and dissemination efforts. Our extensive education of our university Institutional Review Board convinced them to provide human subjects protection coverage for two community-based organizations in our partnership. Conclusions IRBs and funders should develop clear, routine review guidelines that respect the unique qualities of CBPR, while researchers and community partners can educate IRB staff and board members about the objectives, ethical frameworks, and research methods of CBPR. These strategies can better protect research participants from the harm of unnecessary delays and exclusion from the research process, while facilitating the ethical communication of study results to participants and communities.

Review of public comments on proposed seismic design criteria

International Nuclear Information System (INIS)

Philippacopoulos, A.J.; Shaukat, S.K.; Chokshi, N.C.; Bagchi, G.; Nuclear Regulatory Commission, Washington, DC; Nuclear Regulatory Commission, Washington, DC

1989-01-01

During the first quarter of 1988, the Nuclear Regulatory Commission (NRC) prepared a proposed Revision 2 to the NUREG-0800 Standard Review Plan (SRP) Sections 2.5.2 (Vibratory Ground Motion), 3.7.1 (Seismic Design Parameters), 3.7.2 (Seismic Systems Analysis) and 3.7.3 (Seismic Subsystem Analysis). The proposed Revision 2 to the SRP was a result of many years' work carried out by the NRC and the nuclear industry on the Unresolved Safety Issue (USI) A-40: ''Seismic Design Criteria.'' The background material related to NRC's efforts for resolving the A-40 issue is described in NUREG-1233. In June 1988, the proposed Revision 2 of the SRP was issued by NRC for public review and comments. Comments were received from Sargent and Lundy Engineers, Westinghouse Electric Corporation, Stevenson and Associates, Duke Power Company, General Electric Company and Electric Power Research Institute. In September 1988, Brookhaven National Laboratory (BNL) and its consultants (C.J. Costantino, R.P. Kennedy, J. Stevenson, M. Shinozuka and A.S. Veletsos) were requested to carry out a review of the comments received from the above six organizations. The objective of this review was to assist the NRC staff with the evaluation and resolution of the public comments. This review was initiated during October 1988 and it was completed on January 1989. As a result of this review, a set of modifications to the above mentioned sections of the SRP were recommended by BNL and its consultants. This paper summarizes the recommended modifications. 4 refs

Institutional review board perspectives on obligations to disclose genetic incidental findings to research participants.

Science.gov (United States)

Gliwa, Catherine; Yurkiewicz, Ilana R; Lehmann, Lisa Soleymani; Hull, Sara Chandros; Jones, Nathan; Berkman, Benjamin E

2016-07-01

Researchers' obligations to disclose genetic incidental findings (GIFs) have been widely debated, but there has been little empirical study of the engagement of institutional review boards (IRBs) with this issue. This article presents data from the first extensive (n = 796) national survey of IRB professionals' understanding of, experience with, and beliefs surrounding GIFs. Most respondents had dealt with questions about GIFs (74%), but only a minority (47%) felt prepared to address them. Although a majority believed that there is an obligation to disclose GIFs (78%), there is still not consensus about the supporting ethical principles. Respondents generally did not endorse the idea that researchers' additional time and effort (7%), and lack of resources (29%), were valid reasons for diminishing a putative obligation. Most (96%) supported a right not to know, but this view became less pronounced (63%) when framed in terms of specific case studies. IRBs are actively engaged with GIFs but have not yet reached consensus. Respondents were uncomfortable with arguments that could be used to limit an obligation to return GIFs. This could indicate that IRBs are providing some of the impetus for the trend toward returning GIFs, although questions remain about the relative contribution of other stakeholders.Genet Med 18 7, 705-711.

78 FR 65452 - Proposed Information Collection (Veterans, Researchers, and IRB Members Experiences With...

Science.gov (United States)

2013-10-31

... qualitative research methods to understand Veterans' preferences on research recruitment methods. The data... research study subjects and to explore Veterans views on recruitment procedures. DATES: Written comments... Members Experiences with Recruitment Restrictions). Type of Review: New collection. Abstracts: The VHA...

Engaging Institutional Review Boards in Developing a Brief, Community-Responsive Human Subjects Training for Community Partners

Science.gov (United States)

Calzo, Jerel P.; Bogart, Laura M.; Francis, Evelyn; Kornetsky, Susan Z.; Winkler, Sabune J.; Kaberry, Julie M.

2017-01-01

BACKGROUND Engaging community partners as co-investigators in community-based participatory research (CBPR) requires certification in the rules, ethics, and principles governing research. Despite developments in making human research protection trainings more convenient and standardized (e.g., self-paced Internet modules), time constraints and the structure of the content (which may favor academic audiences) may hinder the training of community partners. OBJECTIVES This paper is motivated by a case example in which academic and community partners, and stakeholders of a community-based organization actively engaged the leadership of a pediatric hospital-based Institutional Review Board (IRB) in implementing a brief, community-responsive human subjects training session. METHODS A two hour, discussion-based human subjects training was developed via collaborations between the IRB and the community and academic partners. Interviews with trainees and facilitators after the training were used to evaluate its acceptability and possible future applications. CONCLUSIONS Local Institutional Review Boards have the potential to assist community partners in building sufficient knowledge of human subjects research protections to engage in specific projects, thereby expediting the progress of vital research to address community needs. We propose the need for developing truncated human subjects education materials to train and certify community partners, and creating formally organized entities within academic and medical institutions that specialize in community-based research to guide the development and implementation of alternative human subjects training certification opportunities for community partners. PMID:28230554

Review of a Proposed Quarterly Coal Publication

Energy Technology Data Exchange (ETDEWEB)

1981-01-01

This Review of a Proposed Quartery Coal Publication contains findings and recommendations regarding the content of a new summary Energy Information Administration (EIA) coal and coke publication entitled The Quarterly Coal Review (QCR). It is divided into five sections: results of interviews with selected EIA data users; identification of major functions of the coal and coke industries; analysis of coal and coke data collection activities; evaluation of issues conerning data presentation including recommendations for the content of the proposed QCR; and comparison of the proposed QCR with other EIA publications. Major findings and recommendations are as follows: (1) User interviews indicate a definite need for a compehensive publication that would support analyses and examine economic, supply and demand trends in the coal industry; (2) the organization of the publication should reflect the natural order of activities of the coal and coke industries. Based on an analysis of the industries, these functions are: production, stocks, imports, exports, distribution, and consumption; (3) current EIA coal and coke surveys collect sufficient data to provide a summary of the coal and coke industries on a quarterly basis; (4) coal and coke data should be presented separately. Coke data could be presented as an appendix; (5) three geographic aggregations are recommended in the QCR. These are: US total, coal producing districts, and state; (6) coal consumption data should be consolidated into four major consumer categories: electric utilities, coke plants, other industrial, and residential commercial; (7) several EIA publications could be eliminated by the proposed QCR.

Review of partitioning proposals for spent nuclear fuels

International Nuclear Information System (INIS)

Bowersox, D.F.

1976-07-01

The initial phase of a study about recovery of valuable fission products from spent nuclear fuels has been to review various partitioning proposals. This report briefly describes the aqueous Purex process, the salt transport process, melt refining, fluoride volatility process, and gravimetric separations. All these processes appear to be possible technically, but further research will be necessary to determine which are most feasible. This review includes general recommendations for experimental research and development of several partitioning options

Expanding Group Peer Review: A Proposal for Medical Education Scholarship.

Science.gov (United States)

Dumenco, Luba; Engle, Deborah L; Goodell, Kristen; Nagler, Alisa; Ovitsh, Robin K; Whicker, Shari A

2017-02-01

After participating in a group peer-review exercise at a workshop presented by Academic Medicine and MedEdPORTAL editors at the 2015 Association of American Medical Colleges Medical Education Meeting, the authors realized that the way their work group reviewed a manuscript was very different from the way by which they each would have reviewed the paper as an individual. Further, the group peer-review process yielded more robust feedback for the manuscript's authors than did the traditional individual peer-review process. This realization motivated the authors to reconvene and collaborate to write this Commentary to share their experience and propose the expanded use of group peer review in medical education scholarship.The authors consider the benefits of a peer-review process for reviewers, including learning how to improve their own manuscripts. They suggest that the benefits of a team review model may be similar to those of teamwork and team-based learning in medicine and medical education. They call for research to investigate this, to provide evidence to support group review, and to determine whether specific paper types would benefit most from team review (e.g., particularly complex manuscripts, those receiving widely disparate initial individual reviews). In addition, the authors propose ways in which a team-based approach to peer review could be expanded by journals and institutions. They believe that exploring the use of group peer review potentially could create a new methodology for skill development in research and scholarly writing and could enhance the quality of medical education scholarship.

The Role of Intuition in Risk/Benefit Decision-Making in Human Subjects Research.

Science.gov (United States)

Resnik, David B

2017-01-01

One of the key principles of ethical research involving human subjects is that the risks of research to should be acceptable in relation to expected benefits. Institutional review board (IRB) members often rely on intuition to make risk/benefit decisions concerning proposed human studies. Some have objected to using intuition to make these decisions because intuition is unreliable and biased and lacks transparency. In this article, I examine the role of intuition in IRB risk/benefit decision-making and argue that there are practical and philosophical limits to our ability to reduce our reliance on intuition in this process. The fact that IRB risk/benefit decision-making involves intuition need not imply that it is hopelessly subjective or biased, however, since there are strategies that IRBs can employ to improve their decisions, such as using empirical data to estimate the probability of potential harms and benefits, developing classification systems to guide the evaluation of harms and benefits, and engaging in moral reasoning concerning the acceptability of risks.

PENERAPAN CRITICAL REVIEW ARTIKEL PEMBELAJARAN IPA UNTUK MENINGKATKAN KEMAMPUAN MAHASISWA DALAM MENYUSUN PROPOSAL SKRIPSI

Directory of Open Access Journals (Sweden)

Parmin -

2012-10-01

Full Text Available Penelitian bertujuan untuk meningkatkan kemampuan mahasiswa dalam menyusun proposal skripsi melalui penerapan critical review artikel ilmiah bersumber dari jurnal. Penelitian dirancang dengan metode penelitian tindakan kelas. Hasil penelitian menunjukkan 63% proposal skripsi mahasiswa pada mata kuliah Metodologi Penelitian mendapatkan nilai diatas 80. Berdasarkan hasil yang telah diperoleh dapat disimpulkan penerapan critical review atau kajian kritis terhadap artikel ilmiah dapat meningkatkan kemampuan mahasiswa dalam menyusun proposal penelitian.   The aims of this research is to improve students' ability in developing a proposal thesis by applying critical review of scientific articles come from journals. The research is designed by class action research. The results showed 63% of students thesis proposals on Research Methodology course scored above 80. Based on the results obtained it can be concluded that the application has been critical review or critical study of scientific articles can enhance students' ability in preparing research proposals.

A Phase-1 Clinical Trial of a DNA Vaccine for Venezuelan Equine Encephalitis Delivered by Intramuscular or Intradermal Electroporation

Science.gov (United States)

2016-05-25

by the Aspire Institutional Review Board (IRB) http://aspire-irb.com and the Western IRB institutional biosafety committee was the Western IRB IBC...antibodies at each scheduled time point. Geometric mean titers, standard errors, and 95% CIs were calculated using log-transformed titers, replacing any

76 FR 60934 - Proposal Review Panel for Human Resource Development; Notice of Meeting

Science.gov (United States)

2011-09-30

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Human Resource Development; Notice of...; Proposal Review Panel Human Resource Development ( 1199). Date/Time: November 1, 2011; 5 p.m. to 10 p.m...: Part-Open. Contact Person: Kelly Mack, Division of Human Resource Development, Room 815, National...

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).

76 FR 60933 - Proposal Review Panel for Human Resource Development; Notice of Meeting

Science.gov (United States)

2011-09-30

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Human Resource Development; Notice of..., Proposal Review Panel Human Resource Development ( 1199). Date/Time: October 17, 2011; 5 p.m. to 10 p.m... Meeting: Part-Open. Contact Person: Kelly Mack, Division of Human Resource Development, Room 815, National...

78 FR 16301 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2013-03-14

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance... announces the following meeting. Name: LIGO Annual Review Site Visit at Hanford Observatory for Physics... Physics, National Science Foundation, Arlington, VA (703) 292-4432. [[Page 16302

76 FR 66998 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2011-10-28

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance... announces the following meeting. Name: LIGO Annual Review Site Visit at Hanford Observatory for Physics...: Partially Closed. Contact Person: Thomas Carruthers, Program Director, Division of Physics, National Science...

77 FR 14441 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2012-03-09

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance... announces the following meeting. Name: LIGO Annual Review Site Visit at Hanford Observatory for Physics...: Partially Closed. Contact Person: Thomas Carruthers, Program Director, Division of Physics, National Science...

76 FR 19147 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2011-04-06

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance... announces the following meeting. Name: LIGO Laboratory Annual Review at Livingston Observatory for Physics...: Partially Closed. Contact Person: Thomas Carruthers, Program Director, Division of Physics, National Science...

75 FR 70951 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2010-11-19

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance... announces the following meeting. Name: LIGO Laboratory Annual Review at Hanford Observatory for Physics... Physics, National Science Foundation, (703) 292-7373. Purpose of Meeting: To provide an evaluation of the...

Ethical considerations in malaria research proposal review: empirical evidence from 114 proposals submitted to an Ethics Committee in Thailand.

Science.gov (United States)

Adams, Pornpimon; Prakobtham, Sukanya; Limphattharacharoen, Chanthima; Vutikes, Pitchapa; Khusmith, Srisin; Pengsaa, Krisana; Wilairatana, Polrat; Kaewkungwal, Jaranit

2015-09-14

Malaria research is typically conducted in developing countries in areas of endemic disease. This raises specific ethical issues, including those related to local cultural concepts of health and disease, the educational background of study subjects, and principles of justice at the community and country level. Research Ethics Committees (RECs) are responsible for regulating the ethical conduct of research, but questions have been raised whether RECs facilitate or impede research, and about the quality of REC review itself. This study examines the review process for malaria research proposals submitted to the Ethics Committee of the Faculty of Tropical Medicine at Mahidol University, Thailand. Proposals for all studies submitted for review from January 2010 to December 2014 were included. Individual REC members' reviewing forms were evaluated. Ethical issues (e.g., scientific merit, risk-benefit, sample size, or informed-consent) raised in the forms were counted and analysed according to characteristics, including study classification/design, use of specimens, study site, and study population. All 114 proposals submitted during the study period were analysed, comprising biomedical studies (17 %), drug trials (13 %), laboratory studies (24 %) and epidemiological studies (46 %). They included multi-site (13 %) and international studies (4 %), and those involving minority populations (28 %), children (17 %) and pregnant women (7 %). Drug trials had the highest proportion of questions raised for most ethical issues, while issues concerning privacy and confidentiality tended to be highest for laboratory and epidemiology studies. Clarifications on ethical issues were requested by the ethics committee more for proposals involving new specimen collection. Studies involving stored data and specimens tended to attract more issues around privacy and confidentiality. Proposals involving minority populations were more likely to raise issues than those that did not

Patent portfolio management: literature review and a proposed model.

Science.gov (United States)

Conegundes De Jesus, Camila Kiyomi; Salerno, Mario Sergio

2018-05-09

Patents and patent portfolios are gaining attention in the last decades, from the called 'pro-patent era' to the recent billionaire transactions involving patent portfolios. The field is growing in importance, both theoretically and practically and despite having substantial literature on new product development portfolio management, we have not found an article relating this theory to patent portfolios. Areas covered: The paper develops a systematic literature review on patent portfolio management to organize the evolution and tendencies of patent portfolio management, highlighting distinctive features of patent portfolio management. Interview with IP manager of three life sciences companies, including a leading multinational group provided relevant information about patent portfolio management. Expert opinion: Based on the systematic literature review on portfolio management, more specifically, on new product development portfolio theory, and interview the paper proposes the paper proposes a reference model to manage patent portfolios. The model comprises four stages aligned with the three goals of the NPD portfolio management: 1 - Linking strategy of the Company's NPD Portfolio to Patent Portfolio; 2 - Balancing the portfolio in buckets; 3 - Patent Valuation (maximizing valuation); 4 - Regularly reviewing the patent portfolio.

77 FR 18268 - Proposal Review Panel for Engineering Education and Centers; Notice of Meeting

Science.gov (United States)

2012-03-27

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Engineering Education and Centers; Notice of... Science Foundation announces the following meeting: Name: Proposal Review Panel for Engineering Education...--ERC Research Program 3:30 p.m.--7:30 p.m. Closed--ERC Education Program Thursday, March 29, 2012 8 a.m...

78 FR 15745 - Proposal Review Panel for Social and Economic Sciences; Notice of Meeting

Science.gov (United States)

2013-03-12

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Social and Economic Sciences; Notice of... Science Foundation (NSF) announces the following Site Visit. Name: Proposal Review Panel for Social and Economic Sciences, 10748. Date and Time: March 21, 2013 8:30 a.m. to 5:00 p.m., March 22, 2013 8:00 a.m. to...

PENERAPAN CRITICAL REVIEW ARTIKEL PEMBELAJARAN IPA UNTUK MENINGKATKAN KEMAMPUAN MAHASISWA DALAM MENYUSUN PROPOSAL SKRIPSI

Directory of Open Access Journals (Sweden)

p parmin

2016-02-01

Full Text Available The aims of this research is to improve students’ ability in develop- ing a proposal thesis by applying critical review of scientific articles come from journals. The research is designed by class action research. The results showed 63% of students thesis proposals on Research Methodology course scored above 80. Based on the results obtained it can be concluded that the application has been critical review or critical study of scientific articles can enhance students’ ability in preparing research proposals.

What Do Ethical Guidelines for Epidemiology Say About an Ethics Review? A Qualitative Systematic Review.

Science.gov (United States)

Piasecki, Jan; Waligora, Marcin; Dranseika, Vilius

2017-06-01

Epidemiological research is subject to an ethics review. The aim of this qualitative review is to compare existing ethical guidelines in English for epidemiological research and public health practice in regard to the scope and matter of an ethics review. Authors systematically searched PubMed, Google Scholar and Google Search for ethical guidelines. Qualitative analysis (constant comparative method) was applied to categorize important aspects of the an ethics review process. Eight ethical guidelines in English for epidemiological research were retrieved. Five main categories that are relevant to the review of epidemiological research by Institutional Review Boards/Research Ethics Committees were distinguished. Within the scope of main categories, fifty-nine subcategories were analyzed. There are important differences between the guidelines in terms of the scope and matter of an ethics review. Not all guidelines encompass all identified ethically important issues, and some do not define precisely the scope and matter of an ethics review, leaving much to the ethics of the individual researchers and the discretion of IRBs/RECs.

76 FR 44050 - Information Collection Requests Under OMB Review; Proposed Collection of Information

Science.gov (United States)

2011-07-22

... for Peace Corps Response assignments to provide basic information concerning technical and language... PEACE CORPS Information Collection Requests Under OMB Review; Proposed Collection of Information AGENCY: Peace Corps. ACTION: Submission for Office of Management and Budget (OMB) review; comment request...

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

78 FR 25309 - Proposal Review Panel Physics; Notice of Meeting

Science.gov (United States)

2013-04-30

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel Physics; Notice of Meeting In accordance with..., 2013 8:30 a.m.-6:30 p.m. May 15, 2013 8:30 a.m.-6:00 p.m. Place: University of Maryland, College Park... Physics Frontier Center; National Science Foundation, 4201 Wilson Blvd., Arlington, VA 22230. Telephone...

What scientists want from their research ethics committee.

Science.gov (United States)

Keith-Spiegel, Patricia; Tabachnick, Barbara

2006-03-01

Whereas investigators have directed considerable criticism against Institutional Review Boards (IRBs), the desirable characteristics of IRBs have not previously been empirically determined. A sample of 886 experienced biomedical and social and behavioral scientists rated 45 descriptors of IRB actions and functions as to their importance. Predictions derived from organizational justice research findings in other work settings were generally borne out. Investigators place high value on the fairness and respectful consideration of their IRBs. Expected differences between biomedical and social behavioral researchers and other variables were unfounded. Recommendations are offered for educating IRBs to accord researchers greater respect and fair treatment.

77 FR 27804 - Proposal Review Panel for Chemistry; Notice of Meeting

Science.gov (United States)

2012-05-11

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Chemistry; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L. 92- 463, as amended), the National Science Foundation announces the following meeting: Name: Centers for Chemical Innovation (CCI) Solar Fuels: Powering the...

75 FR 3493 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2010-01-21

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance... announces the following meeting. Name: University of Nebraska Site Visit in Physics (1208). Date and Time... Director for Elementary Particle Physics, National Science Foundation, 4201 Wilson Blvd., Arlington, VA...

75 FR 57298 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2010-09-20

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance... announces the following meeting. Name: University of Notre Dame Site Visit in Physics (1208). Date and Time..., Program Director for Physics Education and Disciplinary Research, National Science Foundation, 4201 Wilson...

75 FR 63865 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2010-10-18

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance... announces the following meeting. Name: Michigan State University Site Visit in Physics (1208). Date and Time... Reidy, Program Director for Elementary Particle Physics, National Science Foundation, 4201 Wilson Blvd...

75 FR 70952 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2010-11-19

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L. 92- 463, as amended), the National Science Foundation... Director for Elementary Particle Physics, National Science Foundation, 4201 Wilson Blvd., Arlington, VA...

76 FR 24921 - Proposal Review Panel for Chemistry; Notice of Meeting

Science.gov (United States)

2011-05-03

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Chemistry; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L. 92- 463, as amended), the National Science Foundation..., Program Director, Chemistry Centers Program, Division of Chemistry, Room 1055, National Science Foundation...

78 FR 4464 - Proposal Review Panel for Chemistry; Notice of Meeting

Science.gov (United States)

2013-01-22

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Chemistry; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L. 92- 463, as amended), the National Science Foundation... Chemistry, Room 1055, National Science Foundation, 4201 Wilson Boulevard, Arlington, VA 22230, (703) 292...

76 FR 12996 - Proposal Review Panel for Chemistry; Notice of Meeting

Science.gov (United States)

2011-03-09

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Chemistry; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L. 92- 463 as amended), the National Science Foundation... Director, Chemistry Centers Program, Division of Chemistry, Room 1055, National Science Foundation, 4201...

76 FR 6499 - Proposal Review Panel for Chemistry; Notice of Meeting

Science.gov (United States)

2011-02-04

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Chemistry; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L. 92- 463 as amended), the National Science Foundation... Director, Chemistry Centers Program, Division of Chemistry, Room 1055, National Science Foundation, 4201...

Peer review of health research funding proposals: A systematic map and systematic review of innovations for effectiveness and efficiency.

Science.gov (United States)

Shepherd, Jonathan; Frampton, Geoff K; Pickett, Karen; Wyatt, Jeremy C

2018-01-01

To investigate methods and processes for timely, efficient and good quality peer review of research funding proposals in health. A two-stage evidence synthesis: (1) a systematic map to describe the key characteristics of the evidence base, followed by (2) a systematic review of the studies stakeholders prioritised as relevant from the map on the effectiveness and efficiency of peer review 'innovations'. Standard processes included literature searching, duplicate inclusion criteria screening, study keyword coding, data extraction, critical appraisal and study synthesis. A total of 83 studies from 15 countries were included in the systematic map. The evidence base is diverse, investigating many aspects of the systems for, and processes of, peer review. The systematic review included eight studies from Australia, Canada, and the USA, evaluating a broad range of peer review innovations. These studies showed that simplifying the process by shortening proposal forms, using smaller reviewer panels, or expediting processes can speed up the review process and reduce costs, but this might come at the expense of peer review quality, a key aspect that has not been assessed. Virtual peer review using videoconferencing or teleconferencing appears promising for reducing costs by avoiding the need for reviewers to travel, but again any consequences for quality have not been adequately assessed. There is increasing international research activity into the peer review of health research funding. The studies reviewed had methodological limitations and variable generalisability to research funders. Given these limitations it is not currently possible to recommend immediate implementation of these innovations. However, many appear promising based on existing evidence, and could be adapted as necessary by funders and evaluated. Where feasible, experimental evaluation, including randomised controlled trials, should be conducted, evaluating impact on effectiveness, efficiency and quality.

Peer review of health research funding proposals: A systematic map and systematic review of innovations for effectiveness and efficiency

Science.gov (United States)

Frampton, Geoff K.; Pickett, Karen; Wyatt, Jeremy C.

2018-01-01

Objective To investigate methods and processes for timely, efficient and good quality peer review of research funding proposals in health. Methods A two-stage evidence synthesis: (1) a systematic map to describe the key characteristics of the evidence base, followed by (2) a systematic review of the studies stakeholders prioritised as relevant from the map on the effectiveness and efficiency of peer review ‘innovations’. Standard processes included literature searching, duplicate inclusion criteria screening, study keyword coding, data extraction, critical appraisal and study synthesis. Results A total of 83 studies from 15 countries were included in the systematic map. The evidence base is diverse, investigating many aspects of the systems for, and processes of, peer review. The systematic review included eight studies from Australia, Canada, and the USA, evaluating a broad range of peer review innovations. These studies showed that simplifying the process by shortening proposal forms, using smaller reviewer panels, or expediting processes can speed up the review process and reduce costs, but this might come at the expense of peer review quality, a key aspect that has not been assessed. Virtual peer review using videoconferencing or teleconferencing appears promising for reducing costs by avoiding the need for reviewers to travel, but again any consequences for quality have not been adequately assessed. Conclusions There is increasing international research activity into the peer review of health research funding. The studies reviewed had methodological limitations and variable generalisability to research funders. Given these limitations it is not currently possible to recommend immediate implementation of these innovations. However, many appear promising based on existing evidence, and could be adapted as necessary by funders and evaluated. Where feasible, experimental evaluation, including randomised controlled trials, should be conducted, evaluating impact

Comitês de Ética em Pesquisa: adequação à Resolução 196/96 Institutional Review Boards: compliance with Resolution 196/96

Directory of Open Access Journals (Sweden)

Ellen Hardy

2004-12-01

Full Text Available OBJETIVO: Este artigo apresenta a avaliação da estrutura, funcionamento e atuação de 17 Comitês de Ética em Pesquisa, na opinião de seus presidentes, considerando as determinações da Resolução 196/96 do Conselho Nacional de Saúde, Ministério da Saúde, Brasil. MÉTODOS: Foram identificados os presidentes de 33 Comitês que avaliavam projetos de pesquisa em regulação da fecundidade. Eles foram indicados pelos responsáveis dos serviços de ginecologia de 46 faculdades de medicina no Brasil e pelos diretores de quatro centros de pesquisa em reprodução humana. Uma carta foi enviada aos presidentes, convidando-os a participar voluntariamente de uma pesquisa, preenchendo um questionário. RESULTADOS: Dezessete presidentes responderam o questionário. Os resultados mostraram uma série de violações à Resolução 196/96. Três Comitês não tinham representantes da comunidade; quatro demoravam mais de um mês para emitir o parecer final dos protocolos e 13 não acompanhavam o desenvolvimento dos projetos. A composição e arquivamento dos protocolos estavam de acordo com a Resolução, porém, o tempo de mandato era diferente do estabelecido em oito dos Comitês avaliados. Quase todos os presidentes (entre 14 e 17 consideraram a composição e atuação de seus CEPs adequados. A grande maioria dos presidentes (11 qualificou a Resolução como sendo apropriada, porém, difícil de ser cumprida. CONCLUSÃO: Os resultados sugerem que um amplo debate sobre a viabilidade operacional da Resolução seria oportuno. Este processo resultaria em sugestões valiosas para o aperfeiçoamento e aplicabilidade das normas. Isto contribuiria para a melhoria da qualidade cientifica e ética dos estudos desenvolvidos no Brasil.PURPOSE: This article intends to evaluate the structure, functioning and performance of 17 Institutional Review Boards (IRB, from the viewpoint of their presidents, in relation to the instructions of Resolution 196/96 of the

Clinical Trials

Medline Plus

Full Text Available ... that the participants' rights are protected. The IRB reviews the trial's protocol before the study begins. An IRB will only approve research that deals with medically important questions ...

77 FR 24228 - Proposal Review Panel for Social and Economic Sciences; Notice of Meeting

Science.gov (United States)

2012-04-23

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Social and Economic Sciences; Notice of...; Division of Social and Economic Sciences, Room 990, National Science Foundation, 4201 Wilson Boulevard... Science Foundation announces the following meeting: Name: Site visit review of the Nanoscale Science and...

75 FR 52995 - Submission for OMB Review, Comment Request, Proposed Collection: State Library Administrative...

Science.gov (United States)

2010-08-30

..., Proposed Collection: State Library Administrative Agencies Survey, FY 2011-2013 AGENCY: Institute of Museum... OMB Review, Comment Request. SUMMARY: The Institute of Museum and Library Services announces the... whether the proposed collection of information is necessary for the proper performance of the functions of...

UNIVERSITY TURBINE SYSTEMS RESEARCH PROGRAM SUMMARY AND DIRECTORY

Energy Technology Data Exchange (ETDEWEB)

Lawrence P. Golan; Richard A. Wenglarz

2004-07-01

The South Carolina Institute for Energy Studies (SCIES), administratively housed at Clemson University, has participated in the advancement of combustion turbine technology for over a decade. The University Turbine Systems Research Program, previously referred to as the Advanced Gas Turbine Systems Research (AGTSR) program, has been administered by SCIES for the U.S. DOE during the 1992-2003 timeframe. The structure of the program is based on a concept presented to the DOE by Clemson University. Under the supervision of the DOE National Energy Technology Laboratory (NETL), the UTSR consortium brings together the engineering departments at leading U.S. universities and U.S. combustion turbine developers to provide a solid base of knowledge for the future generations of land-based gas turbines. In the UTSR program, an Industrial Review Board (IRB) (Appendix C) of gas turbine companies and related organizations defines needed gas turbine research. SCIES prepares yearly requests for university proposals to address the research needs identified by the IRB organizations. IRB technical representatives evaluate the university proposals and review progress reports from the awarded university projects. To accelerate technology transfer technical workshops are held to provide opportunities for university, industry and government officials to share comments and improve quality and relevancy of the research. To provide educational growth at the Universities, in addition to sponsored research, the UTSR provides faculty and student fellowships. The basis for all activities--research, technology transfer, and education--is the DOE Turbine Program Plan and identification, through UTSR consortium group processes, technology needed to meet Program Goals that can be appropriately researched at Performing Member Universities.

Panic disorder: a review of DSM-IV panic disorder and proposals for DSM-V.

Science.gov (United States)

Craske, Michelle G; Kircanski, Katharina; Epstein, Alyssa; Wittchen, Hans-Ulrich; Pine, Danny S; Lewis-Fernández, Roberto; Hinton, Devon

2010-02-01

This review covers the literature since the publication of DSM-IV on the diagnostic criteria for panic attacks (PAs) and panic disorder (PD). Specific recommendations are made based on the evidence available. In particular, slight changes are proposed for the wording of the diagnostic criteria for PAs to ease the differentiation between panic and surrounding anxiety; simplification and clarification of the operationalization of types of PAs (expected vs. unexpected) is proposed; and consideration is given to the value of PAs as a specifier for all DSM diagnoses and to the cultural validity of certain symptom profiles. In addition, slight changes are proposed for the wording of the diagnostic criteria to increase clarity and parsimony of the criteria. Finally, based on the available evidence, no changes are proposed with regard to the developmental expression of PAs or PD. This review presents a number of options and preliminary recommendations to be considered for DSM-V.

78 FR 25101 - Proposal Review Panel for Physics, Notice of Meeting

Science.gov (United States)

2013-04-29

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics, Notice of Meeting In accordance... Physics, 1208 Date and Time: Tuesday, April 30, 2013; 8:00 a.m.-6:00 p.m., Wednesday, May 1, 2013, 8:00 a... Meeting: Partially Closed. Contact Person: Mark Coles, Director of Large Facilities, Division of Physics...

75 FR 67142 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2010-11-01

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance... announces the following meeting: Name: Site Visit to the Center for the Physics of Living Cells 1208. Dates... Physics of Living Cells (CPLC). Agenda Monday, November 8, 2010 9 a.m.-11:55 a.m.--Open--Directors...

Proposed Guidance for Preparing and Reviewing Molten Salt Nonpower Reactor Licence Applications (NUREG-1537)

Energy Technology Data Exchange (ETDEWEB)

Belles, Randy [ORNL; Flanagan, George F. [ORNL; Voth, Marcus [Boston Government Services, LLC

2018-05-01

Development of non-power molten salt reactor (MSR) test facilities is under consideration to support the analyses needed for development of a full-scale MSR. These non-power MSR test facilities will require review by the US Nuclear Regulatory Commission (NRC) staff. This report proposes chapter adaptations for NUREG-1537 in the form of interim staff guidance to address preparation and review of molten salt non-power reactor license applications. The proposed adaptations are based on a previous regulatory gap analysis of select chapters from NUREG-1537 for their applicability to non-power MSRs operating with a homogeneous fuel salt mixture.

Institutional Barriers to Research on Sensitive Topics: Case of Sex Communication Research Among University Students

Directory of Open Access Journals (Sweden)

Carey M. Noland

2012-11-01

Full Text Available When conducting research on sensitive topics, it is challenging to use new methods of data collection given the apprehensions of Institutional Review Boards (IRBs. This is especially worrying because sensitive topics of research often require novel approaches. In this article a brief personal history of navigating the IRB process for conducting sex communication research is presented, along with data from a survey that tested the assumptions long held by many IRBs. Results support some of the assumptions IRBs hold about sex communication research, but do not support some other assumptions.

Review of the research proposal for the steam generator retired from Kori unit 1

Energy Technology Data Exchange (ETDEWEB)

Kim, Joung Soo; Han, Joung Ho; Kim, Hong Pyo; Lim, Yun Soo; Lee, Deok Hyun; Hwang, Seong Sik; Hur, Do Haeng [Korea Atomic Energy Research Institute, Taejeon (Korea)

2002-03-01

The tubes of the steam generator retired form Kori unit 1 have many different kinds of failures, such as denting pitting, wastage, ODSCC, PWSCC.Korea Electric Power Research Institute (KEPRI) submitted a research proposal for the steam generator to the Korea Institute S and T Evaluation and Planning (KSITEP). The KISTEP requested Korea Atomic Energy Research Institute to review the proposal by organizing a committee which should be composed of the specialists of the related domestic research institutes. Opinions of the committee on the objectives, research fields, economic benefit and validity in the research proposal were reviewed and suggested optimal research fields to be fulfilled successfully for the retired steam generator. Also, the rolls for the participants in the research works were allocated, which is critical in order to do the project effectively. 6 figs., 5 tabs. (Author)

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

76 FR 54474 - Submission for OMB Review; Comment Request New proposed collection, Biospecimen and Physical...

Science.gov (United States)

2011-09-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request New proposed collection, Biospecimen and Physical Measures Formative Research Methodology... and Budget (OMB) a request to review and approve the information collection listed below. This...

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

State environmental review of a proposed utility independent spent fuel storage installation

International Nuclear Information System (INIS)

Sabel, G.; Halstead, R.

1991-01-01

This paper describes the environmental review process which was applied by the State of Minnesota to a proposed dry cask storage facility. An environmental analysis of the proposed project is summarized, as are alternatives including other dry storage technologies, increased in-pool storage, transhipment, reprocessing, use of higher burnup fuel and conservation. Public comments and concerns included potential cask failures, health impacts, and the possibility of the site becoming a open-quotes permanentclose quotes storage facility. State intervention in the federal license process is also described

BioPower and economic theology. Critical review of the Giorgio Agamben’s proposals

Directory of Open Access Journals (Sweden)

Adán Salinas Araya

2015-02-01

Full Text Available The article make a critical review of the Giorgio Agamben’s proposals, showing the tensions between Homo sacer I and The Kingdom and the Glory. In this review is taken in particular consideration how a possible economic theology would constitute a projection of the Foucault’s biopolitical analysis; or rather, continuity of schmittians political theology. For this, the main arguments of the Agamben’s proposal and some of the Schmitt debates with Benjamin and Peterson are reconstructed. In the first case, regarding messianism, and the second, regarding the impossibility of political theology. The economic theology of Agamben and the political theology of Schmitt would share a same status, both necessarily express the conviction that theology is able to justify a speech and a political order.

Health effects of water-borne radon: review of a proposed study. Final report

International Nuclear Information System (INIS)

1986-01-01

The Science Advisory Board's Radiation Advisory Committee was requested to review the scientific merit of a proposal to conduct an epidemiological study of radon in indoor air. The Board accepted the request and formed a Radioepidemiology Subcommittee which responded to two overriding scientific issues: Can further epidemiological study contribute to an understanding of the risks of lung cancer associated with household exposures. The Subcommittee concludes that scientific uncertainties in current epidemiological studies (chiefly studies of uranium miners) could be further reduced through direct investigations of the domestic population. Is the proposed study under review by the Office of Research and Development, entitled Health Effects of Waterborne Radon, appropriately designed to address the risk. For reasons cited in the attached report, the Subcommittee concludes that it is not appropriately designed

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...

Detailed oil and gas proposals in UK energy review

International Nuclear Information System (INIS)

2006-01-01

The UK government is proposing a four-pronged attack to try and sustain future oil and gas production from the UK with measures designed to coerce and encourage maximum exploitation of reserves under the Energy Review proposals. Tax is to be looked at again. There will also be a move towards web-based licence awards to speed up the licensing process for oil and gas exploration blocks; an infrastructure task force in the West of Shetlands region is planned, and the Stewardship initiative will be refocused. The 218-page Energy Review policy document says: 'Using regulatory powers if necessary, Government must press for full investment in fields that are already producing. We will immediately refocus the DTI's Stewardship initiative - on maintaining reliability and encouraging nearby exploration and should see results in these areas by the middle of next year.' Turning to the plans for a taskforce, the Energy Review announces: 'We are establishing a Taskforce with Industry to get the right infrastructure (for example pipelines) in place to the west of Shetland so that, with minimal impact to the environment, we can speed up development and exploration in the area. The Taskforce will report by the end of the year.' Also the Department of Trade and Industry will re-examine the UK's licensing regime, as part of a policy for 'Ensuring the development of a dynamic market fit for the future.' On this point, the government says: 'The commercial framework needs to change so that it encourages the industry to be dynamic in the future by facilitating a strong market in assets and rapid access to infrastructure. For example, the DTI is moving to a web-based system of licence assignments that will substantially speed up deal making and reduce costs, especially for smaller firms. We will also continue to build on the work of PILOT to secure the long-term future of the industry in the UK.' And on tax: 'It is vital to ensure that we have the right fiscal approach,' the government

Reforming EIA systems: A critical review of proposals in Brazil

Energy Technology Data Exchange (ETDEWEB)

Fonseca, Alberto, E-mail: albertof@em.ufop.br [Federal University of Ouro Preto, Minas Gerais (Brazil); Sánchez, Luis Enrique [University of São Paulo, São Paulo (Brazil); Ribeiro, José Claudio Junqueira [Escola Superior Dom Helder Câmara, Belo Horizonte, Minas Gerais (Brazil)

2017-01-15

Environmental Impact Assessment (EIA) systems are under pressure in many countries, driven by a call for efficiency and streamlining. Such a phenomenon is particularly clear in Brazil, where, in the past few years, a number of influential associations put forward documents proposing significant changes to environmental licensing and impact assessment regulations. So far, there is no publicly available information about any initiative towards scrutinizing those proposals. The objective of this study was to critically review the merits and drawbacks of the changes proposed in those documents. The analysis triangulated content analysis, focus group and online survey data. The focus group included ten seasoned Brazilian EIA specialists; the survey, based on Likert-scale and open-ended questions, resulted in 322 valid responses from EIA professionals. Results show that the proposals generally agree that the current EIA system, while playing a key role in mitigating impacts and enhancing project design, needs many changes. Nonetheless, the proposals neither offered solutions to overcome political, technical and budget barriers, nor established a sense of priority of the most urgent issues. Findings from the focus group and the survey signaled that a number of proposed actions might face public outcry, and that those changes that do not depend on legislative action are more likely to be implementable. Previous studies about EIA reform focused mostly on the context of developed countries after changes had taken place. This study, while addressing the perspective of a large developing country in a “before-reform” stage, shows that capacity-building is a key requirement in EIA reform. - Highlights: • Brazil's EIA system is under strong pressure for change. • Findings corroborate ineffectiveness in current system. • There are tensions as to the best approaches to overcome problems. • Exact effects of proposals are uncertain. • Low institutional capacity can

75 FR 1790 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB...

Science.gov (United States)

2010-01-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0605... clinical investigators and sponsors better understand their responsibilities related to continuing review...-463-6332 or 301-796-3400); or the Office of Communication, Outreach and Development (HFM-40), Center...

Dysfunctional breathing: a review of the literature and proposal for classification

Directory of Open Access Journals (Sweden)

Richard Boulding

2016-09-01

Full Text Available Dysfunctional breathing is a term describing breathing disorders where chronic changes in breathing pattern result in dyspnoea and other symptoms in the absence or in excess of the magnitude of physiological respiratory or cardiac disease. We reviewed the literature and propose a classification system for the common dysfunctional breathing patterns described. The literature was searched using the terms: dysfunctional breathing, hyperventilation, Nijmegen questionnaire and thoraco-abdominal asynchrony. We have summarised the presentation, assessment and treatment of dysfunctional breathing, and propose that the following system be used for classification. 1 Hyperventilation syndrome: associated with symptoms both related to respiratory alkalosis and independent of hypocapnia. 2 Periodic deep sighing: frequent sighing with an irregular breathing pattern. 3 Thoracic dominant breathing: can often manifest in somatic disease, if occurring without disease it may be considered dysfunctional and results in dyspnoea. 4 Forced abdominal expiration: these patients utilise inappropriate and excessive abdominal muscle contraction to aid expiration. 5 Thoraco-abdominal asynchrony: where there is delay between rib cage and abdominal contraction resulting in ineffective breathing mechanics. This review highlights the common abnormalities, current diagnostic methods and therapeutic implications in dysfunctional breathing. Future work should aim to further investigate the prevalence, clinical associations and treatment of these presentations.

Diagnostic Principles of Peri-Implantitis: a Systematic Review and Guidelines for Peri-Implantitis Diagnosis Proposal

Directory of Open Access Journals (Sweden)

Ausra Ramanauskaite

2016-09-01

Full Text Available Objectives: To review and summarize the literature concerning peri-implantitis diagnostic parameters and to propose guidelines for peri-implantitis diagnosis. Material and Methods: An electronic literature search was conducted of the MEDLINE (Ovid and EMBASE databases for articles published between 2011 and 2016. Sequential screening at the title/abstract and full-text levels was performed. Systematic reviews/guidelines of consensus conferences proposing classification or suggesting diagnostic parameters for peri-implantitis in the English language were included. The review was recorded on PROSPERO system with the code CRD42016033287. Results: The search resulted in 10 articles that met the inclusion criteria. Four were papers from consensus conferences, two recommended diagnostic guidelines, three proposed classification of peri-implantitis, and one suggested an index for implant success. The following parameters were suggested to be used for peri-implantitis diagnosis: pain, mobility, bleeding on probing, probing depth, suppuration/exudate, and radiographic bone loss. In all of the papers, different definitions of peri-implantitis or implant success, as well as different thresholds for the above mentioned clinical and radiographical parameters, were used. Current evidence rationale for the diagnosis of peri-implantitis and classification based on consecutive evaluation of soft-tissue conditions and the amount of bone loss were suggested. Conclusions: Currently there is no single uniform definition of peri-implantitis or the parameters that should be used. Rationale for diagnosis and prognosis of peri-implantitis as well as classification of the disease is proposed.

Review of the proposed materials of construction for the SBWR and AP600 advanced reactors

International Nuclear Information System (INIS)

Diercks, D.R.; Shack, W.J.; Chung, H.M.; Kassner, T.F.

1994-06-01

Two advanced light water reactor (LWR) concepts, namely the General Electric Simplified Boiling Water Reactor (SBWR) and the Westinghouse Advanced Passive 600 MWe Reactor (AP600), were reviewed in detail by Argonne National Laboratory. The objectives of these reviews were to (a) evaluate proposed advanced-reactor designs and the materials of construction for the safety systems, (b) identify all aging and environmentally related degradation mechanisms for the materials of construction, and (c) evaluate from the safety viewpoint the suitability of the proposed materials for the design application. Safety-related systems selected for review for these two LWRs included (a) reactor pressure vessel, (b) control rod drive system and reactor internals, (c) coolant pressure boundary, (d) engineered safety systems, (e) steam generators (AP600 only), (f) turbines, and (g) fuel storage and handling system. In addition, the use of cobalt-based alloys in these plants was reviewed. The selected materials for both reactors were generally sound, and no major selection errors were found. It was apparent that considerable thought had been given to the materials selection process, making use of lessons learned from previous LWR experience. The review resulted in the suggestion of alternate an possibly better materials choices in a number of cases, and several potential problem areas have been cited

40 CFR 26.1125 - Prior submission of proposed human research for EPA review.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Prior submission of proposed human research for EPA review. 26.1125 Section 26.1125 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Pesticides Involving Intentional Exposure of Non-pregnant, Non-nursing Adults § 26.1125 Prior submission of...

Nutritional supplements as radioprotectors -- A review and proposal

Energy Technology Data Exchange (ETDEWEB)

Muscatello, A.C.

1998-12-31

The scientific literature contains several reports that show nutritional substances, such as vitamins, minerals, and phytochemicals (plant chemicals), provide substantial radioprotective effects in animal studies. Incorporating these substances to the human diet, already voluntarily practiced by a large segment of the population, in addition to providing other favorable health effects, may also provide a radioprotective effect. This potential radioprotective effect would be very useful in mitigating the effects of occupational radiation exposure to astronauts (especially future Mars explorers), airline crews, nuclear workers, both commercial and government, and populations exposed to nuclear accidents, e.g. Chernobyl. This paper reviews the existing evidence of radioprotective effects by nutritional supplements and proposes that their efficacy be evaluated, first with animal studies, followed by human tests with astronauts and cosmonauts on long-term missions, such as to the Mir space station and the International Space Station (ISS).

Nutritional supplements as radioprotectors -- A review and proposal

International Nuclear Information System (INIS)

Muscatello, A.C.

1998-01-01

The scientific literature contains several reports that show nutritional substances, such as vitamins, minerals, and phytochemicals (plant chemicals), provide substantial radioprotective effects in animal studies. Incorporating these substances to the human diet, already voluntarily practiced by a large segment of the population, in addition to providing other favorable health effects, may also provide a radioprotective effect. This potential radioprotective effect would be very useful in mitigating the effects of occupational radiation exposure to astronauts (especially future Mars explorers), airline crews, nuclear workers, both commercial and government, and populations exposed to nuclear accidents, e.g. Chernobyl. This paper reviews the existing evidence of radioprotective effects by nutritional supplements and proposes that their efficacy be evaluated, first with animal studies, followed by human tests with astronauts and cosmonauts on long-term missions, such as to the Mir space station and the International Space Station (ISS)

77 FR 3844 - Agency Information Collection (Architect-Engineer Fee Proposal) Activity Under OMB Review

Science.gov (United States)

2012-01-25

... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0208] Agency Information Collection (Architect--Engineer Fee Proposal) Activity Under OMB Review AGENCY: Veterans Health Administration... . Please refer to ``OMB Control No. 2900-0208.'' SUPPLEMENTARY INFORMATION: Titles: a. Architect--Engineer...

Blending genetics and sociocultural historical inquiry: ethics, culture, and human subjects protection in international cross cultural research.

Science.gov (United States)

Sampson, Deborah A; Caldwell, Dennis; Taylor, Andre D; Taylor, Jacquelyn Y

2013-03-01

In this paper, we examine the implementation and difficulties when conducting genetics research in a rural, traditional West African culture within the frame of the United States' grounded research ethics. Research challenges are highlighted by Western researchers following U.S. Institutional Review Board (IRB) guidelines and practices in a non-Western country. IRB concepts are culture bound in Western ideals that may not have synchronicity and compatibility with non-Western cultures. Differences in sociocultural norms, traditions, language, and geography were influencing factors that can affect application of IRB principles. Suggestions for change are offered, which will potentially aid researchers considering application of IRB requirements when conducting research in non-Westernized, non-industrialized countries.

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

77 FR 24227 - Proposal Review Panel for Social and Economic Sciences; Notice of Meeting

Science.gov (United States)

2012-04-23

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Social and Economic Sciences; Notice of... Engineering Center (NSEC) at Arizona State University by the Division Social and Economic Sciences ( 10748... Kronz, Program Director; Science, Technology and Society Program; Division of Social and Economic...

75 FR 6413 - Office of New Reactors; Proposed Revision to Standard Review Plan, Section 14.3.12 on Physical...

Science.gov (United States)

2010-02-09

... Standard Review Plan, Section 14.3.12 on Physical Security Hardware Inspections, Tests, Analyses, and.... SUMMARY: The NRC is soliciting public comment on NUREG-0800, ``Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants,'' on a proposed Revision 1 to Standard Review Plan (SRP...

43 CFR 404.51 - Are proposed projects under the Rural Water Supply Program reviewed by the Administration?

Science.gov (United States)

2010-10-01

... Water Supply Program reviewed by the Administration? 404.51 Section 404.51 Public Lands: Interior... SUPPLY PROGRAM Feasibility Studies § 404.51 Are proposed projects under the Rural Water Supply Program... the Reclamation's Rural Water Supply Program. This includes review under Executive Order 12322 to...

Current issues on a standard for surrogate pregnancy procedures

OpenAIRE

Ha, Jung-Ok

2012-01-01

While Korea does not have any legal statement on surrogacy, treatments are carried out in practice. As a result, every Institutional Review Board (IRB) of each fertility clinic faces an ethical predicament in reviewing each case. There is a need to arrange the institutions' own standards of surrogate pregnancy procedures before the establishment of national or professional regulation. This article examines the legal, social, and medical issues of surrogacy to help IRBs to judge their cases.

Current issues on a standard for surrogate pregnancy procedures.

Science.gov (United States)

Ha, Jung-Ok

2012-12-01

While Korea does not have any legal statement on surrogacy, treatments are carried out in practice. As a result, every Institutional Review Board (IRB) of each fertility clinic faces an ethical predicament in reviewing each case. There is a need to arrange the institutions' own standards of surrogate pregnancy procedures before the establishment of national or professional regulation. This article examines the legal, social, and medical issues of surrogacy to help IRBs to judge their cases.

"There Are No Known Benefits . . .": Considering the Risk/Benefit Ratio of Qualitative Research.

Science.gov (United States)

Opsal, Tara; Wolgemuth, Jennifer; Cross, Jennifer; Kaanta, Tanya; Dickmann, Ellyn; Colomer, Soria; Erdil-Moody, Zeynep

2016-07-01

Institutional review boards (IRBs) are responsible for weighing the risks and benefits of research participation. Qualitative researchers note numerous instances where IRB ethical frameworks fail to align with the ethics of their research projects and point out that IRB understandings of the benefits and risks of research often differ from those of the participants they seek to protect. This qualitative cross-case research investigates participants' interview experiences in six qualitative studies that differed in their methods, subject of focus, and populations. Our findings indicate that contemporary IRBs' use of population "vulnerability" and topic "sensitivity" to assess project risk does not adequately determine the benefits, risks, or ethicality of research. We recommend that IRBs treat as real the evidence for benefits in qualitative research, recognize that sensitivity and vulnerability do not predict risk, and encourage researchers to attend to relationships in their projects. © The Author(s) 2015.

78 FR 52569 - Submission for OMB Review, Comment Request, Proposed Collection: State Library Administrative...

Science.gov (United States)

2013-08-23

..., Proposed Collection: State Library Administrative Agencies Survey, FY 2014-2016 AGENCY: Institute of Museum... Review, Comment Request. SUMMARY: The Institute of Museum and Library Services (IMLS), as part of its... the proper performance of the functions of the agency, including whether the information will have...

A systematic literature review of resilience engineering: Research areas and a research agenda proposal

International Nuclear Information System (INIS)

Righi, Angela Weber; Saurin, Tarcisio Abreu; Wachs, Priscila

2015-01-01

Resilience engineering (RE) has been advocated as a new safety management paradigm, compatible with the nature of complex socio-technical systems. This study aims to identify the research areas and to propose a research agenda for RE, based on a systematic literature review that encompasses 237 studies from 2006 to 2014. Six research areas are identified: theory of RE; identification and classification of resilience; safety management tools; analysis of accidents; risk assessment; and training. The area “theory of RE” accounted for 52% of the studies, and it indicates that research has emphasized the description of how resilient performance occurs. The proposal for a research agenda is focused on: refining key constructs; positioning RE in relation to other theories; exploring other research strategies in addition to case-based studies; investigating barriers for implementing RE; and balancing the importance on describing and understanding resilience with the emphasis on the design of resilient systems, and the evaluation of these designs. - Highlights: • Six research areas on RE are identified. • A research agenda for RE is proposed. • RE research is mostly descriptive and based on case studies. • Design science is suggested as a research strategy for RE. • Five domains account for 75% of the reviewed studies

76 FR 54216 - Pacific Fishery Management Council (Council); Work Session To Review Proposed Salmon Methodology...

Science.gov (United States)

2011-08-31

... Fishery Management Council (Council); Work Session To Review Proposed Salmon Methodology Changes AGENCY.... ACTION: Notice of a public meeting. SUMMARY: The Pacific Fishery Management Council's Salmon Technical Team (STT), Scientific and Statistical Committee (SSC) Salmon Subcommittee, and Model Evaluation...

77 FR 58526 - Pacific Fishery Management Council; Public Meeting; Work Session To Review Proposed Salmon...

Science.gov (United States)

2012-09-21

... Fishery Management Council; Public Meeting; Work Session To Review Proposed Salmon Methodology Changes...), Commerce. ACTION: Notice of a public meeting. SUMMARY: The Pacific Fishery Management Council's Salmon Technical Team (STT), Scientific and Statistical Committee (SSC) Salmon Subcommittee, and Model Evaluation...

PACMan to Help Sort Hubble Proposals

Science.gov (United States)

Kohler, Susanna

2017-04-01

Every year, astronomers submit over a thousand proposals requesting time on the Hubble Space Telescope (HST). Currently, humans must sort through each of these proposals by hand before sending them off for review. Could this burden be shifted to computers?A Problem of VolumeAstronomer Molly Peeples gathered stats on the HST submissions sent in last week for the upcoming HST Cycle 25 (the deadline was Friday night), relative to previous years. This years proposal round broke the record, with over 1200 proposals submitted in total for Cycle 25. [Molly Peeples]Each proposal cycle for HST time attracts on the order of 1100 proposals accounting for far more HST time than is available. The proposals are therefore carefully reviewed by around 150 international members of the astronomy community during a six-month process to select those with the highest scientific merit.Ideally, each proposal will be read by reviewers that have scientific expertise relevant to the proposal topic: if a proposal requests HST time to study star formation, for instance, then the reviewers assigned to it should have research expertise in star formation.How does this matching of proposals to reviewers occur? The current method relies on self-reported categorization of the submitted proposals. This is unreliable, however; proposals are often mis-categorized by submitters due to misunderstanding or ambiguous cases.As a result, the Science Policies Group at the Space Telescope Science Institute (STScI) which oversees the review of HST proposals must go through each of the proposals by hand and re-categorize them. The proposals are then matched to reviewers with self-declared expertise in the same category.With the number of HST proposals on the rise and the expectation that the upcoming James Webb Space Telescope (JWST) will elicit even more proposals for time than Hubble scientists at STScI and NASA are now asking: could the human hours necessary for this task be spared? Could a computer program

What Is Everyday Ethics? A Review and a Proposal for an Integrative Concept.

Science.gov (United States)

Zizzo, Natalie; Bell, Emily; Racine, Eric

2016-01-01

"Everyday ethics" is a term that has been used in the clinical and ethics literature for decades to designate normatively important and pervasive issues in healthcare. In spite of its importance, the term has not been reviewed and analyzed carefully. We undertook a literature review to understand how the term has been employed and defined, finding that it is often contrasted to "dramatic ethics." We identified the core attributes most commonly associated with everyday ethics. We then propose an integrative model of everyday ethics that builds on the contribution of different ethical theories. This model proposes that the function of everyday ethics is to serve as an integrative concept that (1) helps to detect current blind spots in bioethics (that is, shifts the focus from dramatic ethics) and (2) mobilizes moral agents to address these shortcomings of ethical insight. This novel integrative model has theoretical, methodological, practical, and pedagogical implications, which we explore. Because of the pivotal role that moral experience plays in this integrative model, the model could help to bridge empirical ethics research with more conceptual and normative work. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.

Engaging patients and stakeholders in research proposal review: the patient-centered outcomes research institute.

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Fleurence, Rachael L; Forsythe, Laura P; Lauer, Michael; Rotter, Jason; Ioannidis, John P A; Beal, Anne; Frank, Lori; Selby, Joseph V

2014-07-15

The inaugural round of merit review for the Patient-Centered Outcomes Research Institute (PCORI) in November 2012 included patients and other stakeholders, as well as scientists. This article examines relationships among scores of the 3 reviewer types, changes in scoring after in-person discussion, and the effect of inclusion of patient and stakeholder reviewers on the review process. In the first phase, 363 scientists scored 480 applications. In the second phase, 59 scientists, 21 patients, and 31 stakeholders provided a "prediscussion" score and a final "postdiscussion" score after an in-person meeting for applications. Bland-Altman plots were used to characterize levels of agreement among and within reviewer types before and after discussion. Before discussion, there was little agreement among average scores given by the 4 lead scientific reviewers and patient and stakeholder reviewers. After discussion, the 4 primary reviewers showed mild convergence in their scores, and the 21-member panel came to a much stronger agreement. Of the 25 awards with the best (and lowest) scores after phase 2, only 13 had ranked in the top 25 after the phase 1 review by scientists. Five percent of the 480 proposals submitted were funded. The authors conclude that patient and stakeholder reviewers brought different perspectives to the review process but that in-person discussion led to closer agreement among reviewer types. It is not yet known whether these conclusions are generalizable to future rounds of peer review. Future work would benefit from additional data collection for evaluation purposes and from long-term evaluation of the effect on the funded research.

76 FR 30700 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Proposed...

Science.gov (United States)

2011-05-26

... agencies, and others to promote reductions in toxic chemical releases. Industrial facilities use the TRI... Activities; Submission to OMB for Review and Approval; Proposed Collections; Toxic Chemical Release Reporting... that manufacture, process, or otherwise use specified toxic chemicals in amounts above reporting...

THE MANAGEMENT OF CREDIT RISK ACCORDING TO INTERNAL RATINGS- BASED APPROACH

Directory of Open Access Journals (Sweden)

BOLOCAN DRAGOS-MIHAIL

2010-12-01

Full Text Available The internal ratings based approach (IRB Approach was created as part of Basel II replacing the original Basle Accord of 1988 (Basle I in an effort to create a better framework for regulating bank capital. This paper covers the methodology and components of the IRB Approach used to determine capital requirements for credit risk. Such an approach, which relies heavily upon a banks internal assessment of its counterparties and exposures, can secure two key objectives consistent with those which support the wider review of The New Basel Capital Accord.. IRB approach should promote safety and soundness in the financial system and, consistent with providing incentive compatibility, that the structure and requirements of the IRB approach do not impinge upon or undermine banks well-established lending and credit risk management practices

40 CFR 142.310 - How can a person served by the public water system obtain EPA review of a State proposed small...

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2010-07-01

... water system obtain EPA review of a State proposed small system variance? 142.310 Section 142.310... PRIMARY DRINKING WATER REGULATIONS IMPLEMENTATION Variances for Small System Public Participation § 142.310 How can a person served by the public water system obtain EPA review of a State proposed small...

Dynamic Response of Dam-Reservoir Systems: Review and a Semi-Analytical Proposal

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Paulo Marcelo Vieira Ribeiro

Full Text Available Abstract This paper presents a review of current techniques employed for dynamic analysis of concrete gravity dams under seismic action. Traditional procedures applied in design bureaus, such as the Pseudo-Static method, often neglect structural dynamic properties, as well as ground amplification effects. A practical alternative arises with the Pseudo-Dynamic method, which considers a simplified spectrum response in the fundamental mode. The authors propose a self-contained development and detailed examples of this latter method, including a comparison with finite element models using transient response of fluid-structure systems. It is verified that application of the traditional procedure should be done carefully and limited to extremely rigid dams. On the other hand, the proposed development is straightforward and in agreement with finite element results for general cases where dam flexibility plays an important role.

77 FR 41453 - Submission for OMB Review, Comment Request, Proposed Collection: General Clearance for Guidelines...

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2012-07-13

... of Museum and Library Services, National Foundation for the Arts and Humanities. ACTION: Submission for OMB Review, Comment Request. SUMMARY: The Institute of Museum and Library Services announces the... whether the proposed collection of information is necessary for the proper performance of the functions of...

77 FR 69631 - Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing...

Science.gov (United States)

2012-11-20

...) is needed in order to assure the protection of the rights and welfare of human subjects in clinical... responsibilities. To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and FDA have been actively working to...

Cigarette smoking and depression comorbidity: systematic review and proposed theoretical model.

Science.gov (United States)

Mathew, Amanda R; Hogarth, Lee; Leventhal, Adam M; Cook, Jessica W; Hitsman, Brian

2017-03-01

Despite decades of research on co-occurring smoking and depression, cessation rates remain consistently lower for depressed smokers than for smokers in the general population, highlighting the need for theory-driven models of smoking and depression. This paper provides a systematic review with a particular focus upon psychological states that disproportionately motivate smoking in depression, and frame an incentive learning theory account of smoking-depression co-occurrence. We searched PubMed, Scopus, PsychINFO and CINAHL to December 2014, which yielded 852 papers. Using pre-established eligibility criteria, we identified papers focused on clinical issues and motivational mechanisms underlying smoking in established, adult smokers (i.e. maintenance, quit attempts and cessation/relapse) with elevated symptoms of depression. Two reviewers determined independently whether papers met review criteria. We included 297 papers in qualitative synthesis. Our review identified three primary mechanisms that underlie persistent smoking among depressed smokers: low positive affect, high negative affect and cognitive impairment. We propose a novel application of incentive learning theory which posits that depressed smokers experience greater increases in the expected value of smoking in the face of these three motivational states, which promotes goal-directed choice of smoking behavior over alternative actions. The incentive learning theory accounts for current evidence on how depression primes smoking behavior and provides a unique framework for conceptualizing psychological mechanisms of smoking maintenance among depressed smokers. Treatment should focus upon correcting adverse internal states and beliefs about the high value of smoking in those states to improve cessation outcomes for depressed smokers. © 2016 Society for the Study of Addiction.

78 FR 16401 - Institutional Review Boards; Correcting Amendments

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2013-03-15

.... 56.107 IRB membership. (a) * * * In addition to possessing the professional competence necessary to... professional conduct and practice. * * * * * * * * Dated: March 12, 2013. Leslie Kux, Assistant Commissioner...

Atmospheric pollution problems and control proposals associated with solid waste management in China: A review

International Nuclear Information System (INIS)

Tian, Hezhong; Gao, Jiajia; Hao, Jiming; Lu, Long; Zhu, Chuanyong; Qiu, Peipei

2013-01-01

Highlights: ► Air pollution problems generated in MSW management processes in China are presented. ► Both quantity and composition of MSW generation in China are identified. ► The status of different methods for MSW treatment and disposal are reviewed. ► Some comprehensive control proposals for improving MSW management are proposed. -- Abstract: Along with population growth, rapid urbanization and industrialization process, the volume of municipal solid waste (MSW) generation in China has been increasing sharply in the past 30 years and the total amount of MSW yields will continue to increase. Nowadays, due to global warming warrants particular attention throughout the world, a series of air pollutants (including greenhouse gases, odorous gases, PCDD/Fs, heavy metals, PM, etc.) discharged from waste disposal and treatment processes have become one of the new significant emerging air pollution sources, which arousing great concerns about their adverse effects on surrounding ambient air quality and public health. At present, the overall safely disposed ratio of the collected MSW in China is reported at approximately 78% in 2010, and there are mainly three types of MSW disposal methods practiced in China, including landfill, composting and incineration. The characteristics of air pollutants and greenhouse gases discharge vary substantially among different MSW disposal methods. By presenting a thorough review of MSW generation in China and providing a summarization of the current status of MSW disposal methods practices, this review article makes an integrated overview analysis of existing air pollution problems associated with MSW collection, separation, and disposal processes. Furthermore, some comprehensive control proposals to prevent air pollution for improving MSW management of China in the future are put forward

Atmospheric pollution problems and control proposals associated with solid waste management in China: A review

Energy Technology Data Exchange (ETDEWEB)

Tian, Hezhong, E-mail: hztian@bnu.edu.cn [State Key Joint Laboratory of Environmental Simulation and Pollution Control, School of Environment, Beijing Normal University, Beijing 100875 (China); Gao, Jiajia [State Key Joint Laboratory of Environmental Simulation and Pollution Control, School of Environment, Beijing Normal University, Beijing 100875 (China); Hao, Jiming [School of Environment, Tsinghua University, Beijing 100084 (China); Lu, Long; Zhu, Chuanyong; Qiu, Peipei [State Key Joint Laboratory of Environmental Simulation and Pollution Control, School of Environment, Beijing Normal University, Beijing 100875 (China)

2013-05-15

Highlights: ► Air pollution problems generated in MSW management processes in China are presented. ► Both quantity and composition of MSW generation in China are identified. ► The status of different methods for MSW treatment and disposal are reviewed. ► Some comprehensive control proposals for improving MSW management are proposed. -- Abstract: Along with population growth, rapid urbanization and industrialization process, the volume of municipal solid waste (MSW) generation in China has been increasing sharply in the past 30 years and the total amount of MSW yields will continue to increase. Nowadays, due to global warming warrants particular attention throughout the world, a series of air pollutants (including greenhouse gases, odorous gases, PCDD/Fs, heavy metals, PM, etc.) discharged from waste disposal and treatment processes have become one of the new significant emerging air pollution sources, which arousing great concerns about their adverse effects on surrounding ambient air quality and public health. At present, the overall safely disposed ratio of the collected MSW in China is reported at approximately 78% in 2010, and there are mainly three types of MSW disposal methods practiced in China, including landfill, composting and incineration. The characteristics of air pollutants and greenhouse gases discharge vary substantially among different MSW disposal methods. By presenting a thorough review of MSW generation in China and providing a summarization of the current status of MSW disposal methods practices, this review article makes an integrated overview analysis of existing air pollution problems associated with MSW collection, separation, and disposal processes. Furthermore, some comprehensive control proposals to prevent air pollution for improving MSW management of China in the future are put forward.

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

Deaths during apprehensions of agitated persons. A review of proposed pathophysiological theories

Directory of Open Access Journals (Sweden)

Tamsen Fredrik

2014-06-01

Full Text Available The pathophysiology of sudden death during apprehension remains largely unclear. The most frequently discussed mechanisms are excited delirium, positional asphyxia, metabolic acidosis, acute and chronic drug abuse, and autonomic instability. As in most areas of forensic medicine, much of the knowledge comes from case reports, which are of little use in understanding causality. Experimental studies of some aspects have been performed, and they show somewhat divergent results and interpretations. The aim of this review is to summarize the different proposed theories, and to point out important issues for further research.

76 FR 31381 - Office Of New Reactors; Proposed Revision 4 to Standard Review Plan; Section 8.1 on Electric...

Science.gov (United States)

2011-05-31

... Standard Review Plan; Section 8.1 on Electric Power--Introduction AGENCY: U.S. Nuclear Regulatory...,'' on a proposed Revision 4 to Standard Review Plan (SRP), Section 8.1 on ``Electric Power--Introduction,'' (Agencywide Documents Access and Management System (ADAMS) Accession No. ML111180542). The previous version of...

Systematic review of proposed definitions of nocturnal polyuria and population-based evidence of their diagnostic accuracy.

Science.gov (United States)

Olesen, Tine Kold; Denys, Marie-Astrid; Vande Walle, Johan; Everaert, Karel

2018-02-06

Background Evidence of diagnostic accuracy for proposed definitions of nocturnal polyuria is currently unclear. Purpose Systematic review to determine population-based evidence of the diagnostic accuracy of proposed definitions of nocturnal polyuria based on data from frequency-volume charts. Methods Seventeen pre-specified search terms identified 351 unique investigations published from 1990 to 2016 in BIOSIS, Embase, Embase Alerts, International Pharmaceutical Abstract, Medline, and Cochrane. Thirteen original communications were included in this review based on pre-specified exclusion criteria. Data were extracted from each paper regarding subject age, sex, ethnicity, health status, sample size, data collection methods, and diagnostic discrimination of proposed definitions including sensitivity, specificity, positive and negative predictive value. Results The sample size of study cohorts, participant age, sex, ethnicity, and health status varied considerably in 13 studies reporting on the diagnostic performance of seven different definitions of nocturnal polyuria using frequency-volume chart data from 4968 participants. Most study cohorts were small, mono-ethnic, including only Caucasian males aged 50 or higher with primary or secondary polyuria that were compared to a control group of healthy men without nocturia in prospective or retrospective settings. Proposed definitions had poor discriminatory accuracy in evaluations based on data from subjects independent from the original study cohorts with findings being similar regarding the most widely evaluated definition endorsed by ICS. Conclusions Diagnostic performance characteristics for proposed definitions of nocturnal polyuria show poor to modest discrimination and are not based on sufficient level of evidence from representative, multi-ethnic population-based data from both females and males of all adult ages.

76 FR 71037 - Proposed National Toxicology Program (NTP) Review Process for the Report on Carcinogens: Request...

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2011-11-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Proposed National Toxicology Program (NTP) Review Process...: Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences.... Bucher, Associate Director, National Toxicology Program. [FR Doc. 2011-29615 Filed 11-15-11; 8:45 am...

75 FR 14150 - Proposed Rate Adjustment, Public Forum, and Opportunities for Public Review and Comment for...

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2010-03-24

... DEPARTMENT OF ENERGY Southeastern Power Administration Proposed Rate Adjustment, Public Forum, and Opportunities for Public Review and Comment for Georgia-Alabama-South Carolina System of Projects AGENCY: Southeastern Power Administration, DOE. ACTION: Notice to change date and location of the Public Information...

75 FR 29588 - Office of New Reactors: Proposed NUREG-0800; Standard Review Plan Section 13.6.6, Draft Revision...

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2010-05-26

...; Standard Review Plan Section 13.6.6, Draft Revision 0 on Cyber Security Plan AGENCY: Nuclear Regulatory... Plants,'' on a proposed Standard Review Plan (SRP) Section 13.6.6 on ``Cyber Security Plan'' (Agencywide Documents Access and Management System (ADAMS) Accession No. ML093560837). The Office of Nuclear Security...

What is health systems responsiveness? Review of existing knowledge and proposed conceptual framework

Science.gov (United States)

Mirzoev, Tolib; Kane, Sumit

2017-01-01

Responsiveness is a key objective of national health systems. Responsive health systems anticipate and adapt to existing and future health needs, thus contributing to better health outcomes. Of all the health systems objectives, responsiveness is the least studied, which perhaps reflects lack of comprehensive frameworks that go beyond the normative characteristics of responsive services. This paper contributes to a growing, yet limited, knowledge on this topic. Herewith, we review the current frameworks for understanding health systems responsiveness and drawing on these, as well as key frameworks from the wider public services literature, propose a comprehensive conceptual framework for health systems responsiveness. This paper should be of interest to different stakeholders who are engaged in analysing and improving health systems responsiveness. Our review shows that existing knowledge on health systems responsiveness can be extended along the three areas. First, responsiveness entails an actual experience of people’s interaction with their health system, which confirms or disconfirms their initial expectations of the system. Second, the experience of interaction is shaped by both the people and the health systems sides of this interaction. Third, different influences shape people’s interaction with their health system, ultimately affecting their resultant experiences. Therefore, recognition of both people and health systems sides of interaction and their key determinants would enhance the conceptualisations of responsiveness. Our proposed framework builds on, and advances, the core frameworks in the health systems literature. It positions the experience of interaction between people and health system as the centrepiece and recognises the determinants of responsiveness experience both from the health systems (eg, actors, processes) and the people (eg, initial expectations) sides. While we hope to trigger further thinking on the conceptualisation of health

What is health systems responsiveness? Review of existing knowledge and proposed conceptual framework.

Science.gov (United States)

Mirzoev, Tolib; Kane, Sumit

2017-01-01

Responsiveness is a key objective of national health systems. Responsive health systems anticipate and adapt to existing and future health needs, thus contributing to better health outcomes. Of all the health systems objectives, responsiveness is the least studied, which perhaps reflects lack of comprehensive frameworks that go beyond the normative characteristics of responsive services. This paper contributes to a growing, yet limited, knowledge on this topic. Herewith, we review the current frameworks for understanding health systems responsiveness and drawing on these, as well as key frameworks from the wider public services literature, propose a comprehensive conceptual framework for health systems responsiveness. This paper should be of interest to different stakeholders who are engaged in analysing and improving health systems responsiveness. Our review shows that existing knowledge on health systems responsiveness can be extended along the three areas. First, responsiveness entails an actual experience of people's interaction with their health system, which confirms or disconfirms their initial expectations of the system. Second, the experience of interaction is shaped by both the people and the health systems sides of this interaction. Third, different influences shape people's interaction with their health system, ultimately affecting their resultant experiences. Therefore, recognition of both people and health systems sides of interaction and their key determinants would enhance the conceptualisations of responsiveness. Our proposed framework builds on, and advances, the core frameworks in the health systems literature. It positions the experience of interaction between people and health system as the centrepiece and recognises the determinants of responsiveness experience both from the health systems (eg, actors, processes) and the people (eg, initial expectations) sides. While we hope to trigger further thinking on the conceptualisation of health system

Review of kaon factory proposals

International Nuclear Information System (INIS)

Thiessen, H.A.

1985-01-01

Nuclear physics issues and particle physics issues for a kaon factory are discussed. Kaon factory accelerator proposals are then considered. Secondary beam considerations are covered and hardware development for a kaon factory is discussed. The prospects for construction are presented. 9 refs., 12 figs., 2 tabs

Review of a Proposal for a New Community College Center in Vallejo. Report 10-15

Science.gov (United States)

Wilson, Stacy; Fuller, Ryan

2010-01-01

This report provides a staff review of a proposal by the Solano Community College District to convert its existing facility in Vallejo to a state-approved off-campus educational center of Solano Community College. Educational centers can be a cost-effective means for meeting educational needs of a region through agreements with local high schools,…

Episodic Laryngeal Breathing Disorders: Literature Review and Proposal of Preliminary Theoretical Framework.

Science.gov (United States)

Shembel, Adrianna C; Sandage, Mary J; Verdolini Abbott, Katherine

2017-01-01

The purposes of this literature review were (1) to identify and assess frameworks for clinical characterization of episodic laryngeal breathing disorders (ELBD) and their subtypes, (2) to integrate concepts from these frameworks into a novel theoretical paradigm, and (3) to provide a preliminary algorithm to classify clinical features of ELBD for future study of its clinical manifestations and underlying pathophysiological mechanisms. This is a literature review. Peer-reviewed literature from 1983 to 2015 pertaining to models for ELBD was searched using Pubmed, Ovid, Proquest, Cochrane Database of Systematic Reviews, and Google Scholar. Theoretical models for ELBD were identified, evaluated, and integrated into a novel comprehensive framework. Consensus across three salient models provided a working definition and inclusionary criteria for ELBD within the new framework. Inconsistencies and discrepancies within the models provided an analytic platform for future research. Comparison among three conceptual models-(1) Irritable larynx syndrome, (2) Dichotomous triggers, and (3) Periodic occurrence of laryngeal obstruction-showed that the models uniformly consider ELBD to involve episodic laryngeal obstruction causing dyspnea. The models differed in their description of source of dyspnea, in their inclusion of corollary behaviors, in their inclusion of other laryngeal-based behaviors (eg, cough), and types of triggers. The proposed integrated theoretical framework for ELBD provides a preliminary systematic platform for the identification of key clinical feature patterns indicative of ELBD and associated clinical subgroups. This algorithmic paradigm should evolve with better understanding of this spectrum of disorders and its underlying pathophysiological mechanisms. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Temperature in non-equilibrium states: a review of open problems and current proposals

International Nuclear Information System (INIS)

Casas-Vazquez, J; Jou, D

2003-01-01

The conceptual problems arising in the definition and measurement of temperature in non-equilibrium states are discussed in this paper in situations where the local-equilibrium hypothesis is no longer satisfactory. This is a necessary and urgent discussion because of the increasing interest in thermodynamic theories beyond local equilibrium, in computer simulations, in non-linear statistical mechanics, in new experiments, and in technological applications of nanoscale systems and material sciences. First, we briefly review the concept of temperature from the perspectives of equilibrium thermodynamics and statistical mechanics. Afterwards, we explore which of the equilibrium concepts may be extrapolated beyond local equilibrium and which of them should be modified, then we review several attempts to define temperature in non-equilibrium situations from macroscopic and microscopic bases. A wide review of proposals is offered on effective non-equilibrium temperatures and their application to ideal and real gases, electromagnetic radiation, nuclear collisions, granular systems, glasses, sheared fluids, amorphous semiconductors and turbulent fluids. The consistency between the different relativistic transformation laws for temperature is discussed in the new light gained from this perspective. A wide bibliography is provided in order to foster further research in this field

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

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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.

On orthorexia nervosa: A review of the literature and proposed diagnostic criteria.

Science.gov (United States)

Dunn, Thomas M; Bratman, Steven

2016-04-01

There has been a growing interest among clinicians and researchers about a condition where people restrict their diet based not on quantity of food they consume, but based on its quality. Bratman (1997) coined the term "orthorexia nervosa" to describe people whose extreme diets - intended for health reasons - are in fact leading to malnutrition and/or impairment of daily functioning. There has also recently been intense media interest in people whose highly restrictive "healthy" diet leads to disordered eating. Despite this condition being first described in the U.S., and receiving recent media interest here, orthorexia has largely gone unnoticed in the North American literature. This review article details the literature of orthorexia nervosa, describing its emergence as a condition first described by a physician in a yoga magazine, to its being discussed in the scientific literature. It also reviews prevalence studies and discusses marked shortcomings in the literature. Finally, diagnostic criteria are proposed, as are future directions for research. Copyright © 2015 Elsevier Ltd. All rights reserved.

A Survey Study of Institutional Review Board Thought Processes in the United States and South Korea

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Si-Kyung Jung

2012-09-01

Full Text Available Introduction: In the last several decades, South Korea has rapidly adopted Western customs and practices. Yet, cultural differences between South Korea and the United States exist. The purpose ofthis study was to identify and characterize potential cultural differences in the Korean and US institutional review board (IRB approach to certain topics.Methods: A qualitative analysis of a 9-item survey, describing 4 research study case scenarios, sent to IRB members from the United States and South Korea. The case scenarios involved the followingissues: (1 the need for consent for retrospective chart review when research subjects receive their care after the study is conceived; (2 child assent; (3 individual versus population benefit; and (4 exception from informed consent in emergency resuscitation research. The free-text responses were analyzed and abstracted for recurrent themes.Results: Twenty-three of the 45 survey recipients completed the survey, for an overall response rate of 51%. The themes that emerged were as follows: (1 the importance of parental authority among Korean participants versus the importance of child autonomy and child assent among US participants; (2 the recognition of the rights of a proxy or surrogate who can represent an individual’s values by all participants; and (3 the importance of the community, expressed by the Korean respondents, versus individualism, expressed by US respondents.Conclusion: Whereas US participants appear to emphasize the importance of the individual and the autonomy of a child, the Korean respondents stressed the importance of parental authority andbenefiting the community, above and beyond that of the individual person. However, there was substantial overlap in the themes expressed by respondents from both countries.

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...

Research funding. Big names or big ideas: do peer-review panels select the best science proposals?

Science.gov (United States)

Li, Danielle; Agha, Leila

2015-04-24

This paper examines the success of peer-review panels in predicting the future quality of proposed research. We construct new data to track publication, citation, and patenting outcomes associated with more than 130,000 research project (R01) grants funded by the U.S. National Institutes of Health from 1980 to 2008. We find that better peer-review scores are consistently associated with better research outcomes and that this relationship persists even when we include detailed controls for an investigator's publication history, grant history, institutional affiliations, career stage, and degree types. A one-standard deviation worse peer-review score among awarded grants is associated with 15% fewer citations, 7% fewer publications, 19% fewer high-impact publications, and 14% fewer follow-on patents. Copyright © 2015, American Association for the Advancement of Science.

Feature engineering and a proposed decision-support system for systematic reviewers of medical evidence.

Directory of Open Access Journals (Sweden)

Tanja Bekhuis

Full Text Available Evidence-based medicine depends on the timely synthesis of research findings. An important source of synthesized evidence resides in systematic reviews. However, a bottleneck in review production involves dual screening of citations with titles and abstracts to find eligible studies. For this research, we tested the effect of various kinds of textual information (features on performance of a machine learning classifier. Based on our findings, we propose an automated system to reduce screeing burden, as well as offer quality assurance.We built a database of citations from 5 systematic reviews that varied with respect to domain, topic, and sponsor. Consensus judgments regarding eligibility were inferred from published reports. We extracted 5 feature sets from citations: alphabetic, alphanumeric(+, indexing, features mapped to concepts in systematic reviews, and topic models. To simulate a two-person team, we divided the data into random halves. We optimized the parameters of a Bayesian classifier, then trained and tested models on alternate data halves. Overall, we conducted 50 independent tests.All tests of summary performance (mean F3 surpassed the corresponding baseline, P<0.0001. The ranks for mean F3, precision, and classification error were statistically different across feature sets averaged over reviews; P-values for Friedman's test were .045, .002, and .002, respectively. Differences in ranks for mean recall were not statistically significant. Alphanumeric(+ features were associated with best performance; mean reduction in screening burden for this feature type ranged from 88% to 98% for the second pass through citations and from 38% to 48% overall.A computer-assisted, decision support system based on our methods could substantially reduce the burden of screening citations for systematic review teams and solo reviewers. Additionally, such a system could deliver quality assurance both by confirming concordant decisions and by naming

A proposal for an 'equal peer-review' statement.

Science.gov (United States)

Moustafa, Khaled

2015-08-01

To make the peer-review process as objective as possible, I suggest the introduction of an 'equal peer-review' statement that preserves author anonymity across the board, thus removing any potential bias related to nominal or institutional 'prestige'; this would guarantee an equal peer-review process for all authors and grant applicants. Copyright © 2015 Elsevier Ltd. All rights reserved.

Treatment of peri-implant diseases: a review of the literature and protocol proposal.

Science.gov (United States)

Armas, Joshé; Culshaw, Shauna; Savarrio, Lee

2013-01-01

Over 100,000 implants were placed in the UK in 2010. As the numbers of patients with implant-retained prostheses increases, operators are encountering an increasing number of biological implant complications, most commonly peri-implant mucositis and peri-implantitis. The effective management of these complications is crucial to maintain patients' oral health. In particular, in contrast to common periodontal infections, some peri-implant infections may benefit from surgical intervention as a first line approach. This article reviews the literature on the treatment options for peri-implant mucositis and peri-implantitis and proposes a protocol for their treatment.

Clinical Trials

Medline Plus

Full Text Available ... Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often ... rights that help protect them. Scientific Oversight Institutional Review Board Institutional review boards (IRBs) help provide scientific ...

Clinical Trials

Medline Plus

Full Text Available ... comparison groups by chance, rather than choice. This method helps ensure that any differences observed during a ... patients also have rights that help protect them. Scientific Oversight Institutional Review Board Institutional review boards (IRBs) ...

Ecosystem Vulnerability Review: Proposal of an Interdisciplinary Ecosystem Assessment Approach

Science.gov (United States)

Weißhuhn, Peter; Müller, Felix; Wiggering, Hubert

2018-06-01

To safeguard the sustainable use of ecosystems and their services, early detection of potentially damaging changes in functional capabilities is needed. To support a proper ecosystem management, the analysis of an ecosystem's vulnerability provide information on its weaknesses as well as on its capacity to recover after suffering an impact. However, the application of the vulnerability concept to ecosystems is still an emerging topic. After providing background on the vulnerability concept, we summarize existing ecosystem vulnerability research on the basis of a systematic literature review with a special focus on ecosystem type, disciplinary background, and more detailed definition of the ecosystem vulnerability components. Using the Web of ScienceTM Core Collection, we overviewed the literature from 1991 onwards but used the 5 years from 2011 to 2015 for an in-depth analysis, including 129 articles. We found that ecosystem vulnerability analysis has been applied most notably in conservation biology, climate change research, and ecological risk assessments, pinpointing a limited spreading across the environmental sciences. It occurred primarily within marine and freshwater ecosystems. To avoid confusion, we recommend using the unambiguous term ecosystem vulnerability rather than ecological, environmental, population, or community vulnerability. Further, common ground has been identified, on which to define the ecosystem vulnerability components exposure, sensitivity, and adaptive capacity. We propose a framework for ecosystem assessments that coherently connects the concepts of vulnerability, resilience, and adaptability as different ecosystem responses. A short outlook on the possible operationalization of the concept by ecosystem vulnerabilty indices, and a conclusion section complete the review.

Annual Research Review: The Nature and Classification of Reading Disorders--A Commentary on Proposals for DSM-5

Science.gov (United States)

Snowling, Margaret J.; Hulme, Charles

2012-01-01

This article reviews our understanding of reading disorders in children and relates it to current proposals for their classification in DSM-5. There are two different, commonly occurring, forms of reading disorder in children which arise from different underlying language difficulties. Dyslexia (as defined in DSM-5), or decoding difficulty, refers…

Natural regeneration in Iberian pines: A review of dynamic processes and proposals for management

Energy Technology Data Exchange (ETDEWEB)

Calama, R.; Manso, R.; Lucas-Borja, M.E.; Espelta, J.M.; Piqué, M.; Bravo, F.; Peso, C. del; Pardos, M.

2017-11-01

Aim of study: Designing adequate silvicultural systems for natural regeneration of a forest species requires sound knowledge of the underlying ecological subprocesses: flowering and fruiting, seed dispersal and predation, seed germination, seedling emergence and seedling survival. The main objective of the present work is to carry out a review on the current knowledge about the different subprocesses governing the regeneration process for the main Iberian Pinus species, in order to propose scientifically based management schedules. Area of study: The review focuses on the five main native Pinus species within their most representative areas in the Iberian Peninsula: Pinus nigra in Cuenca mountains, Pinus sylvestris in Sierra de Guadarrama, Pinus pinaster and Pinus pinea in the Northern Plateau and Pinus halepensis in Catalonia Material and methods: Firstly, currently available information on spatiotemporal dynamics and influential factors is introduced for each subprocess and species. Secondly, current regeneration strategies are characterized and the main bottlenecks are identified. Finally, alternative silvicultural practices proposed on the light of the previous information are presented. Main results: Different climate-mediated bottlenecks have been identified to limit natural regeneration of the Iberian pine species, with seed predation and initial seedling survival among the most influential. New approaches focusing on more gradual regeneration fellings, extended rotation periods, prevent big gaps and program fellings on mast years are presented. Research highlights: Natural regeneration of the studied species exhibit an intermittent temporal pattern, which should be aggravated under drier scenarios. More flexible management schedules should fulfil these limitations.

Natural regeneration in Iberian pines: A review of dynamic processes and proposals for management

International Nuclear Information System (INIS)

Calama, R.; Manso, R.; Lucas-Borja, M.E.; Espelta, J.M.; Piqué, M.; Bravo, F.; Peso, C. del; Pardos, M.

2017-01-01

Aim of study: Designing adequate silvicultural systems for natural regeneration of a forest species requires sound knowledge of the underlying ecological subprocesses: flowering and fruiting, seed dispersal and predation, seed germination, seedling emergence and seedling survival. The main objective of the present work is to carry out a review on the current knowledge about the different subprocesses governing the regeneration process for the main Iberian Pinus species, in order to propose scientifically based management schedules. Area of study: The review focuses on the five main native Pinus species within their most representative areas in the Iberian Peninsula: Pinus nigra in Cuenca mountains, Pinus sylvestris in Sierra de Guadarrama, Pinus pinaster and Pinus pinea in the Northern Plateau and Pinus halepensis in Catalonia Material and methods: Firstly, currently available information on spatiotemporal dynamics and influential factors is introduced for each subprocess and species. Secondly, current regeneration strategies are characterized and the main bottlenecks are identified. Finally, alternative silvicultural practices proposed on the light of the previous information are presented. Main results: Different climate-mediated bottlenecks have been identified to limit natural regeneration of the Iberian pine species, with seed predation and initial seedling survival among the most influential. New approaches focusing on more gradual regeneration fellings, extended rotation periods, prevent big gaps and program fellings on mast years are presented. Research highlights: Natural regeneration of the studied species exhibit an intermittent temporal pattern, which should be aggravated under drier scenarios. More flexible management schedules should fulfil these limitations.

Proposal of success criteria for strabismus surgery in patients with Graves' orbitopathy based on a systematic literature review

NARCIS (Netherlands)

Jellema, Hinke Marijke; Braaksma-Besselink, Yvette; Limpens, Jacqueline; von Arx, Georg; Wiersinga, Wilmar M.; Mourits, Maarten P.

2015-01-01

Proposal of success criteria for strabismus surgery for patients with Graves' orbitopathy (GO) based on a systematic review of the literature. We performed a systematic search of OVID MEDLINE, OVID Embase, the Cochrane Central Register of Controlled Trials (CENTRAL) and the publisher subset of

Report of the International Review Committee of the joint proposal of the Japan Hadron Facility (KEK) and the Neutron Science Project (JAERI)

International Nuclear Information System (INIS)

1999-08-01

The International Review Committee composed of twelve Japanese and foreign experts was set up under the Research Evaluation Committee of JAERI, and has reviewed the proposed joint project combining JAERI's Neutron Science Project and KEK's Japan Hadron Facility into one major facility. The review meeting took place on April 26-27, 1999, at JAERI Head quarters, Tokyo. According to the points of review given in advance, the review was implemented based on the joint project report submitted and presentations of both institutions. The Research Evaluation Committee received the review report and its explanations from the Review Committee on July 5. The Research Evaluation Committee has acknowledged appropriateness of the review results. This report describes the review results. (author)

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

32 CFR 206.4 - Proposal development and review.

Science.gov (United States)

2010-07-01

... representatives from the research, business, and government communities. Every effort will be made to ensure balance (geographical, ethnic, gender, institutional type, subject matter) across the entire competition... following issues in the preliminary proposal: (1) How the proposal addresses issues of national capacity in...

What should an ideal spinal injury classification system consist of? A methodological review and conceptual proposal for future classifications.

NARCIS (Netherlands)

Middendorp, J.J. van; Audige, L.; Hanson, B.; Chapman, J.R.; Hosman, A.J.F.

2010-01-01

Since Bohler published the first categorization of spinal injuries based on plain radiographic examinations in 1929, numerous classifications have been proposed. Despite all these efforts, however, only a few have been tested for reliability and validity. This methodological, conceptual review

Systematic review and proposal of a field-based physical fitness-test battery in preschool children: the PREFIT battery.

Science.gov (United States)

Ortega, Francisco B; Cadenas-Sánchez, Cristina; Sánchez-Delgado, Guillermo; Mora-González, José; Martínez-Téllez, Borja; Artero, Enrique G; Castro-Piñero, Jose; Labayen, Idoia; Chillón, Palma; Löf, Marie; Ruiz, Jonatan R

2015-04-01

Physical fitness is a powerful health marker in childhood and adolescence, and it is reasonable to think that it might be just as important in younger children, i.e. preschoolers. At the moment, researchers, clinicians and sport practitioners do not have enough information about which fitness tests are more reliable, valid and informative from the health point of view to be implemented in preschool children. Our aim was to systematically review the studies conducted in preschool children using field-based fitness tests, and examine their (1) reliability, (2) validity, and (3) relationship with health outcomes. Our ultimate goal was to propose a field-based physical fitness-test battery to be used in preschool children. PubMed and Web of Science. Studies conducted in healthy preschool children that included field-based fitness tests. When using PubMed, we included Medical Subject Heading (MeSH) terms to enhance the power of the search. A set of fitness-related terms were combined with 'child, preschool' [MeSH]. The same strategy and terms were used for Web of Science (except for the MeSH option). Since no previous reviews with a similar aim were identified, we searched for all articles published up to 1 April 2014 (no starting date). A total of 2,109 articles were identified, of which 22 articles were finally selected for this review. Most studies focused on reliability of the fitness tests (n = 21, 96%), while very few focused on validity (0 criterion-related validity and 4 (18%) convergent validity) or relationship with health outcomes (0 longitudinal and 1 (5%) cross-sectional study). Motor fitness, particularly balance, was the most studied fitness component, while cardiorespiratory fitness was the least studied. After analyzing the information retrieved in the current systematic review about fitness testing in preschool children, we propose the PREFIT battery, field-based FITness testing in PREschool children. The PREFIT battery is composed of the following

Natural regeneration in Iberian pines: A review of dynamic processes and proposals for management

Directory of Open Access Journals (Sweden)

Rafael Calama

2017-10-01

Full Text Available Aim of study: Designing adequate silvicultural systems for natural regeneration of a forest species requires sound knowledge of the underlying ecological subprocesses: flowering and fruiting, seed dispersal and predation, seed germination, seedling emergence and seedling survival. The main objective of the present work is to carry out a review on the current knowledge about the different subprocesses governing the regeneration process for the main Iberian Pinus species, in order to propose scientifically based management schedules. Area of study: The review focuses on the five main native Pinus species within their most representative areas in the Iberian Peninsula: Pinus nigra in Cuenca mountains, Pinus sylvestris in Sierra de Guadarrama, Pinus pinaster and Pinus pinea in the Northern Plateau and Pinus halepensis in Catalonia Material and methods: Firstly, currently available information on spatiotemporal dynamics and influential factors is introduced for each subprocess and species. Secondly, current regeneration strategies are characterized and the main bottlenecks are identified. Finally, alternative silvicultural practices proposed on the light of the previous information are presented. Main results: Different climate-mediated bottlenecks have been identified to limit natural regeneration of the Iberian pine species, with seed predation and initial seedling survival among the most influential. New approaches focusing on more gradual regeneration fellings, extended rotation periods, prevent big gaps and program fellings on mast years are presented. Research highlights: Natural regeneration of the studied species exhibit an intermittent temporal pattern, which should be aggravated under drier scenarios. More flexible management schedules should fulfil these limitations.

Environmental Sustainability and Energy-Efficient Supply Chain Management: A Review of Research Trends and Proposed Guidelines

Directory of Open Access Journals (Sweden)

Piera Centobelli

2018-01-01

Full Text Available This paper conducts a structured review on the topic of energy efficiency and environmental sustainability in the supply chain management context to define research trends on the topic and identify research gaps. The review is carried out using the largest databases of peer-reviewed literature (Scopus and Web of Science. A sample of 122 papers focusing on the topic of energy-efficient and sustainable supply chain management was selected and analyzed through descriptive and content analysis. The review highlights that despite there is a growing research trend on the topic, different research gaps remain to be covered. These gaps concern the factors influencing energy efficiency and environmental sustainability initiatives, the classification of energy efficiency and environmental sustainability initiatives, the impact of energy efficiency and environmental sustainability on supply chain performance, the customer perspective in sustainable and energy-efficient supply chain, and the different technologies supporting the energy efficiency and environmental sustainability initiatives. The research gaps and the research questions identified offer the opportunity to identify areas of investigation to design future research directions and propose guidelines in the field of supply chain management.

School effectiveness research: a review of criticisms and some proposals to address them.

Directory of Open Access Journals (Sweden)

Andres Sandoval-Hernandez

2008-03-01

Full Text Available Based on Lakato’s notion of research programmes, the paper analyses the structure of the School Effectiveness Research (SER programme and reviews the main criticisms that have arisen, stressing those regarding its objectivity and theoretical limitations. Then, some proposals are made to address these criticisms, namely: to adopt a critical realist approach to the study of SE and an Abductive Theory of Scientific Method that lead to the development of sound theory in the field. Based on this analysis the paper concludes that, in terms of Lakatos, a movement towards a new research programme is needed in order to ensure that the main objectives originally set for SER can be eventually reached.

Preconceptional nutrition and pregnancy outcomes: review and Dietitian-Nutritionist intervention proposal

Directory of Open Access Journals (Sweden)

Lucia Fernández Molina

2016-02-01

Full Text Available The nutritional status of the mother before and during pregnancy has been observed in recent years as one of the most influential environmental factors on fetal development. This study focuses on the early stages of gestation or periconception period: preconception, conception, implantation, embryogenesis and placentation; since they represent a critical step in pregnancy outcomes. After an extensive literature review of 66 studies published between 1990 and 2015, iron, iodine, omega 3 fatty acids, folic acid and other B vitamins, minerals and micronutrients for which more evidence of a positive relationship with the development of the offspring were found. The approach of a dietary intervention by the dietitian, both individually and collectively, in the preconception period in women of childbearing age and/or pregnancy intentions is proposed in this study, being able to continue the intervention in periods of gestation, breastfeeding, postpartum and even offspring, causing long-term benefits, which are likely to remain and manifest throughout an individual’s life.

[Social determinants of odontalgia in epidemiological studies: theoretical review and proposed conceptual model].

Science.gov (United States)

Bastos, João Luiz Dornelles; Gigante, Denise Petrucci; Peres, Karen Glazer; Nedel, Fúlvio Borges

2007-01-01

The epidemiological literature has been limited by the absence of a theoretical framework reflecting the complexity of causal mechanisms for the occurrence of health phenomena / disease conditions. In the field of oral epidemiology, such lack of theory also prevails, since dental caries the leading topic in oral research has been often studied through a biological and reductionist viewpoint. One of the most important consequences of dental caries is dental pain (odontalgia), which has received little attention in studies with sophisticated theoretical models and powerful designs to establish causal relationships. The purpose of this study is to review the scientific literature on the determinants of odontalgia and to discuss theories proposed for the explanation of the phenomenon. Conceptual models and emerging theories on the social determinants of oral health are revised, in an attempt to build up links with the bio-psychosocial pain model, proposing a more elaborate causal model for odontalgia. The framework suggests causal pathways between social structure and oral health through material, psychosocial and behavioral pathways. Aspects of the social structure are highlighted in order to relate them to odontalgia, stressing their importance in discussions of causal relationships in oral health research.

Medicare program; acquisition, protection and disclosure of utilization and quality control peer review organization (PRO) information--HCFA. Proposed rule.

Science.gov (United States)

1984-04-16

This proposal would govern the acquisition, protection and disclosure of information obtained or generated by Utilization and Quality Control Peer Review Organizations (PROs). The Peer Review Improvement Act of 1982 authorizes PROs to acquire information necessary to fulfill their duties and functions, places limits on the disclosure of PRO information, and establishes penalties for unauthorized disclosure. These regulations would implement the PROs' statutory right of access to necessary information and set forth their responsibilities to assure that information once acquired is adequately safeguarded, and used only for proper purposes.

Magnetic resonance imaging: hazard, risk and safety

International Nuclear Information System (INIS)

Narayan, Pradeep; Suri, S.; Singh, P.

2001-01-01

The hazard and risk associated with magnetic resonance imaging is a matter of concern. In 1982, the Food and Drug Administration (FDA), USA issued guidelines to Hospital's Investigational Review Board (IRBs) in 'Guidelines for Evaluating Electromagnetic Exposure Risks for Trials of Clinical Nuclear Magnetic Resonance (NMR)'. In 1997, the Berufsgenossenschaft (BG), professional association for precision engineering and electronics of Germany, in their preliminary proposal for safety limits extended their concerns on static magnetic field. Owing to both time varying and static magnetic fields applied in Magnetic Resonance Imaging (MRI) this became of immediate concern to user community to assess the potential hazard and risk associated with the NMR system

Viewpoint on proposed radiation-protection standards

International Nuclear Information System (INIS)

Auxier, J.A.

1982-01-01

The proposed revision of 10CFR20 is discussed from a personal perspective. A brief historical review of the development of radiation standards is presented, and arguments against the proposed de minimis level elaborated upon

An Open-Book Modular Watershed Modeling Framework for Rapid Prototyping of GPM- based Flood Forecasting in International River Basins

Science.gov (United States)

Katiyar, N.; Hossain, F.

2006-05-01

Floods have always been disastrous for human life. It accounts for about 15 % of the total death related to natural disasters. There are around 263 transboundary river basins listed by UNESCO, wherein at least 30 countries have more than 95% of their territory locked in one or more such transboundary basins. For flood forecasting in the lower riparian nations of these International River Basins (IRBs), real-time rainfall data from upstream nations is naturally the most critical factor governing the forecasting effectiveness. However, many upstream nations fail to provide data to the lower riparian nations due to a lack of in-situ rainfall measurement infrastructure or a lack of a treaty for real-time sharing of rainfall data. A potential solution is therefore to use satellites that inherently measure rainfall across political boundaries. NASA's proposed Global Precipitation Measurement (GPM) mission appears very promising in providing this vital rainfall information under the data- limited scenario that will continue to prevail in most IRBs. However, satellite rainfall is associated with uncertainty and hence, proper characterization of the satellite rainfall error propagation in hydrologic models for flood forecasting is a critical priority that should be resolved in the coming years in anticipation of GPM. In this study, we assess an open book modular watershed modeling approach for estimating the expected error in flood forecasting related to GPM rainfall data. Our motivation stems from the critical challenge in identifying the specific IRBs that would benefit from a pre-programmed satellite-based forecasting system in anticipation of GPM. As the number of flood-prone IRBs is large, conventional data-intensive implementation of existing physically-based distributed hydrologic models on case-by-case IRBs is considered time-consuming for completing such a global assessment. A more parsimonious approach is justified at the expense of a tolerable loss of detail and

Challenges Addressing Unmet Need for Contraception: Voices of ...

African Journals Online (AJOL)

AJRH Managing Editor

Family Planning Service Providers in Rural Tanzania. Jitihada Baraka. 1 ... Keywords: Contraception, Unmet need for family planning, Provider perspectives, Tanzania, Quality of care. Résumé .... the Internal Review Board (IRB) of Columbia.

FACTORS AFFECTING FINANCIAL CONSUMERS’ PRIVATE PENSION PLAN DECISIONS: A LITERATURE REVIEW AND A CONCEPTUAL FRAMEWORK PROPOSAL

Directory of Open Access Journals (Sweden)

Aslı Elif Aydın

2016-08-01

Full Text Available The objective of this study is to propose a framework related to financial consumers’ private pension plan decisions. Specifically, we review the factors affecting consumers’ participation, contribution and asset allocation decisions regarding private pensions. The factors discussed include situational and dispositional factors, personality, motivation, financial literacy, and external influences. Based on this survey of literature, we develop a number of propositions, which are expected to benefit individual retirement planners and pension institutions in gaining a better understanding of retirement saving decisions.

Anticipated Ethics and Regulatory Challenges in PCORnet: The National Patient-Centered Clinical Research Network.

Science.gov (United States)

Ali, Joseph; Califf, Robert; Sugarman, Jeremy

2016-01-01

PCORnet, the National Patient-Centered Clinical Research Network, seeks to establish a robust national health data network for patient-centered comparative effectiveness research. This article reports the results of a PCORnet survey designed to identify the ethics and regulatory challenges anticipated in network implementation. A 12-item online survey was developed by leadership of the PCORnet Ethics and Regulatory Task Force; responses were collected from the 29 PCORnet networks. The most pressing ethics issues identified related to informed consent, patient engagement, privacy and confidentiality, and data sharing. High priority regulatory issues included IRB coordination, privacy and confidentiality, informed consent, and data sharing. Over 150 IRBs and five different approaches to managing multisite IRB review were identified within PCORnet. Further empirical and scholarly work, as well as practical and policy guidance, is essential if important initiatives that rely on comparative effectiveness research are to move forward.

A proposal for a process of selection, bibliometrics and sistemic review of articles on the supply chain performance evaluation

Directory of Open Access Journals (Sweden)

Emílio Della Bruna Junior

2012-11-01

Full Text Available Supply Chain Management has been widely studied through scientific researches and publications, presenting well grounded concepts in both academic and business areas. Meanwhile, the topic of Performance Evaluation is newer and its concepts are still under consolidation. In this context, the paper aims to propose a process for selection and analysis of a portfolio of scientific articles on Supply Chain Performance Evaluation. To do this, it illustrates a process for searching and selecting articles from scientific databases and analyzes them through Bibliometrics and Systemic Review. As a result, a portfolio of 18 papers aligned to the research subject was obtained and the journals, authors and articles with higher academic relevance were identified. The Systemic Review, in turn, has highlighted the knowledge gaps of the evaluated papers and, from these, developed a research question and objective aiming to answer them. These latter will guide the continuity of this research. Finally, it is expected that the proposed process can be useful for researchers wishing to apply it to their research topics.

42 CFR 67.103 - Peer review of contract proposals.

Science.gov (United States)

2010-10-01

... specific health care issues; and (5) Appropriate representation based on gender, racial/ethnic origin, and... the contract(s) awarded as a result of the peer review. (e) Conflict of interest. (1) Members of peer review groups will be screened for potential conflicts of interest prior to appointment and will be...

issue 2 2008.indb

African Journals Online (AJOL)

situations, the roles of Institutional Review Boards (IRBs) may have to be ..... Research should be responsive to the needs of the victims of the emergency. 9. ... feeding in complex humanitarian emergencies: priorities and policy considerations.

Download this PDF file

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 ...

Proposed biopsy performance benchmarks for MRI based on an audit of a large academic center.

Science.gov (United States)

Sedora Román, Neda I; Mehta, Tejas S; Sharpe, Richard E; Slanetz, Priscilla J; Venkataraman, Shambhavi; Fein-Zachary, Valerie; Dialani, Vandana

2018-05-01

Performance benchmarks exist for mammography (MG); however, performance benchmarks for magnetic resonance imaging (MRI) are not yet fully developed. The purpose of our study was to perform an MRI audit based on established MG and screening MRI benchmarks and to review whether these benchmarks can be applied to an MRI practice. An IRB approved retrospective review of breast MRIs was performed at our center from 1/1/2011 through 12/31/13. For patients with biopsy recommendation, core biopsy and surgical pathology results were reviewed. The data were used to derive mean performance parameter values, including abnormal interpretation rate (AIR), positive predictive value (PPV), cancer detection rate (CDR), percentage of minimal cancers and axillary node negative cancers and compared with MG and screening MRI benchmarks. MRIs were also divided by screening and diagnostic indications to assess for differences in performance benchmarks amongst these two groups. Of the 2455 MRIs performed over 3-years, 1563 were performed for screening indications and 892 for diagnostic indications. With the exception of PPV2 for screening breast MRIs from 2011 to 2013, PPVs were met for our screening and diagnostic populations when compared to the MRI screening benchmarks established by the Breast Imaging Reporting and Data System (BI-RADS) 5 Atlas ® . AIR and CDR were lower for screening indications as compared to diagnostic indications. New MRI screening benchmarks can be used for screening MRI audits while the American College of Radiology (ACR) desirable goals for diagnostic MG can be used for diagnostic MRI audits. Our study corroborates established findings regarding differences in AIR and CDR amongst screening versus diagnostic indications. © 2017 Wiley Periodicals, Inc.

Review of Interactive Video--Romanian Project Proposal

Science.gov (United States)

Onita, Mihai; Petan, Sorin; Vasiu, Radu

2016-01-01

In the recent years, the globalization and massification of video education offer involved more and more eLearning scenarios within universities. This article refers to interactive video and proposes an overview of it. We analyze the background information, regarding the eLearning campus used in virtual universities around the world, the MOOC…

Peer review CALMET/CALPUFF dispersion modelling analysis : Proposed Duke Point generation facility Georgia Strait Crossing pipeline

International Nuclear Information System (INIS)

2002-01-01

A peer review of the air quality dispersion modeling analysis for the proposed gas-fired plant at Duke Point in the vicinity of Nanaimo, British Columbia was required, and SENES Consultants Limited (SENES) was commissioned to perform it. British Columbia Hydro had requested that Levelton Engineering Ltd. prepare an air quality impact assessment, and it was submitted to be included in Vancouver Island Generation Project (VIGP) permit application. This permit application was for the Joint Panel Review of the Georgia Strait Crossing Pipeline (GSX) Project and the British Columbia Environmental Assessment Office. The CALMET/CALPUFF Modelling System had been used by Levelton to conduct the air quality dispersion modelling analysis. Copies of the input and output files that had been used for the conduct of the modelling analysis were provided to SENES. The ability for SENES to reproduce the modelling results that had been published in the GSX application represented the first step in the peer review. This was accomplished by running the files received from Levelton into the CALMET/CALPUFF models. A detailed review of the methodology selected by Levelton during the conduct of the dispersion modelling analysis was then initiated by SENES. Some deficiencies were identified by SENES, despite concurrence with the overall conceptual approach adopted by Levelton. The deficiencies concerned meteorological data; startup, partial load and upset conditions; pollutant emissions; health risk assessment; cumulative impact on ambient particulate matter 10 concentrations; and collateral environmental impacts. refs., 2 tabs., 21 figs

Combining Review Text Content and Reviewer-Item Rating Matrix to Predict Review Rating

Science.gov (United States)

Wang, Bingkun; Huang, Yongfeng; Li, Xing

2016-01-01

E-commerce develops rapidly. Learning and taking good advantage of the myriad reviews from online customers has become crucial to the success in this game, which calls for increasingly more accuracy in sentiment classification of these reviews. Therefore the finer-grained review rating prediction is preferred over the rough binary sentiment classification. There are mainly two types of method in current review rating prediction. One includes methods based on review text content which focus almost exclusively on textual content and seldom relate to those reviewers and items remarked in other relevant reviews. The other one contains methods based on collaborative filtering which extract information from previous records in the reviewer-item rating matrix, however, ignoring review textual content. Here we proposed a framework for review rating prediction which shows the effective combination of the two. Then we further proposed three specific methods under this framework. Experiments on two movie review datasets demonstrate that our review rating prediction framework has better performance than those previous methods. PMID:26880879

Combining Review Text Content and Reviewer-Item Rating Matrix to Predict Review Rating.

Science.gov (United States)

Wang, Bingkun; Huang, Yongfeng; Li, Xing

2016-01-01

E-commerce develops rapidly. Learning and taking good advantage of the myriad reviews from online customers has become crucial to the success in this game, which calls for increasingly more accuracy in sentiment classification of these reviews. Therefore the finer-grained review rating prediction is preferred over the rough binary sentiment classification. There are mainly two types of method in current review rating prediction. One includes methods based on review text content which focus almost exclusively on textual content and seldom relate to those reviewers and items remarked in other relevant reviews. The other one contains methods based on collaborative filtering which extract information from previous records in the reviewer-item rating matrix, however, ignoring review textual content. Here we proposed a framework for review rating prediction which shows the effective combination of the two. Then we further proposed three specific methods under this framework. Experiments on two movie review datasets demonstrate that our review rating prediction framework has better performance than those previous methods.

Review of 40-year MD theses in Medical Oncology

International Nuclear Information System (INIS)

Zeeneldin, A.; Diyaa, A.; Elgammal, M.; Buhoush, W.; Manar Moneer, M.

2014-01-01

Background and objective: It is almost 40 years since the foundation of the Medical Oncology (MO) Department. We aimed to appraise the clinical research to fulfill the Medical Doctorate (MD) degree in MO at the National Cancer Institute, Cairo University (NCI, CU). Methods: This review included 62 MD theses containing 66 studies. They were reviewed regarding aims, type of study, clinical trial phase, design and methodology, statistical tests, results, limitations, consent and IRB approval. Theses were grouped into 3 periods: 1970-1989, 1990-1999 and 2000- 2008. Results: Almost 76% of the studies were interventional and 24% were observational. Informed consent and Institutional Review Board approval were mentioned in 18 and 2 studies, respectively. While all studies mentioned the aims, none, clearly mentioned the research question. Outcomes were mainly efficacy followed by safety. Study design was inadequately considered, especially in 70’s–80’s period (p = 0.038). Median sample size and study duration were almost stable through the three periods (p = 0.441, 0.354, respectively). Most of the studies used both descriptive and analytical statistical methods. In a descending order, researched cancers were lymphoma, breast, leukemia, liver, urinary bladder, lung and colorectal. The commonest stages researched were IV and III. The number of studies focused on assessing biomarkers, biomarkers plus drugs/procedures, drugs and procedures are 20, 20, 16 and 6, respectively. Conclusion: With time, research within MD theses in MO increased quantitatively and qualitatively. Improvements were noticeable in documentation of study design.

Private animal health and welfare standards in quality assurance programmes: a review and proposed framework for critical evaluation.

Science.gov (United States)

More, S J; Hanlon, A; Marchewka, J; Boyle, L

2017-06-24

In recent years, 'private standards' in animal health and welfare have become increasingly common, and are often incorporated into quality assurance (QA) programmes. Here, we present an overview of the use of private animal health and welfare standards in QA programmes, and propose a generic framework to facilitate critical programme review. Private standards are being developed in direct response to consumer demand for QA, and offer an opportunity for product differentiation and a means to drive consumer choice. Nonetheless, a range of concerns have been raised, relating to the credibility of these standards, their potential as a discriminatory barrier to trade, the multiplicity of private standards that have been developed, the lack of consumer input and compliance costs. There is a need for greater scrutiny of private standards and of associated QA programmes. We propose a framework to clarify the primary programme goal(s) and measureable outputs relevant to animal health and welfare, the primary programme beneficiaries and to determine whether the programme is effective, efficient and transparent. This paper provides a theoretical overview, noting that this framework could be used as a tool directly for programme evaluation, or as a tool to assist with programme development and review. British Veterinary Association.

Muscle dysmorphia: a critical review of the proposed criteria.

Science.gov (United States)

Chung, B

2001-01-01

While body-image related disorders such as anorexia nervosa have focused on thinness, only recently have clinical criteria for a disorder that centers around muscularity--muscle dysmorphia--been proposed. An individual affected by muscle dysmorphia is overly concerned with his or her degree of muscularity. This preoccupation is manifested in the individual's behavior (excessive weight lifting, excessive attention to diet, social impairment). This article examines the historical aspects and proposed criteria for muscle dysmorphia and contrasts them with those of anorexia nervosa. While the authors of the proposed criteria have suggested that muscle dysmorphia be classified as a subcategory of body dysmorphic disorder, both the historical and clinical aspects of this syndrome are more consistent with its classification as an obsessive-compulsive disorder.

Proposed integrated hazardous waste disposal facility. Public environmental review

International Nuclear Information System (INIS)

1998-05-01

This Public Environmental Report describes a proposal by the Health Department of Western Australia to establish a disposal facility for certain hazardous wastes and seeks comments from governments agencies and the public that will assist the EPA to make its recommendations to. The facility would only be used for wastes generated in Western Australia.The proposal specifically includes: a high temperature incinerator for the disposal of organo-chlorines (including agricultural chemicals and PCBs), and other intractable wastes for which this is the optimum disposal method; an area for the burial (after any appropriate conditioning) of low level radioactive intractable wastes arising from the processing of mineral sands (including monazite, ilmenite and zircon) and phosphate rock. Detailed information is presented on those wastes which are currently identified as requiring disposal at the facility.The proposed facility will also be suitable for the disposal of other intractable wastes including radioactive wastes (from industry, medicine and research) and other solid intractable wastes of a chemical nature including spent catalysts etc. Proposals to dispose of these other wastes at this facility in the future will be referred to the Environmental Protection Authority for separate assessment

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.

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 ...

A Review of Long-Term Pain Relief after Genicular Nerve Radiofrequency Ablation in Chronic Knee Osteoarthritis.

Science.gov (United States)

Iannaccone, Ferdinand; Dixon, Samuel; Kaufman, Andrew

2017-03-01

Studies of radiofrequency ablation (RFA) of genicular nerves have reportedly significantly decreased pain up to 3 months post ablation, but no longer term effects have been reported. We performed an analysis of long-term pain relief of 31 RFA procedures of the genicular nerves to analyze the degree of pain relief past 3 months, culminating at 6 months. Chart review and study design was approved by Newark Health Sciences Institutional Review Board (IRB). Chart review and follow-up was performed on all patients who underwent genicular nerve RFA during the period of February 2014 through August of 2015. During this inclusion period 41 genicular nerve RFAs were performed on 31 patients, 5 patients received RFA procedure in both knees. Patient follow-up was performed via telephone interview or in-office visit at least 3 months and 6 months post RFA. Procedures were performed in Medical Special Procedures at University Hospital in Newark, NJ, and the Pain Management Center at Overlook Medical Arts Center in Summit, NJ. Chart review and study design was approved by Newark Health Sciences IRB. Chart review was performed from February 2014 and continued through August 2015. Patient follow-up was conducted at 3 and at least 6 months post treatment to gauge degree of pain relief (0 - none, 100% - complete), their current day's pain score, other treatment modalities tried before RFA, and the medications used. Patients were asked to quantify their satisfaction with procedure length, pre-procedure anxiety, complications, and if they would recommend this procedure to others. Primary and secondary goals were the duration of pain relief after RFA, the quality of pain relief, and the efficacy of our approach for RFA of genicular nerves versus prior published techniques. At 3 month follow-up, the average pain relief was 67% improvement from baseline knee pain, 0% being no relief and 100% being complete relief, and average 0 - 10 pain score was 2.9. At 6 month follow-up, of those who

Review Existing and Proposed Emissions Trading Systems

Energy Technology Data Exchange (ETDEWEB)

NONE

2010-07-01

This paper reviews key design features of mandatory emissions trading systems that had been established or were under consideration in 2010, with a particular focus on implications for the energy sector. Putting a price on greenhouse gas emissions is a cornerstone policy in climate change mitigation. To this end, many countries have implemented or are developing domestic emissions trading systems.

Proposed Advanced Reactor Adaptation of the Standard Review Plan NUREG-0800 Chapter 4 (Reactor) for Sodium-Cooled Fast Reactors and Modular High-Temperature Gas-Cooled Reactors

Energy Technology Data Exchange (ETDEWEB)

Belles, Randy [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Poore, III, Willis P. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Brown, Nicholas R. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Flanagan, George F. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Holbrook, Mark [Idaho National Lab. (INL), Idaho Falls, ID (United States); Moe, Wayne [Idaho National Lab. (INL), Idaho Falls, ID (United States); Sofu, Tanju [Argonne National Lab. (ANL), Argonne, IL (United States)

2017-03-01

This report proposes adaptation of the previous regulatory gap analysis in Chapter 4 (Reactor) of NUREG 0800, Standard Review Plan (SRP) for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR [Light Water Reactor] Edition. The proposed adaptation would result in a Chapter 4 review plan applicable to certain advanced reactors. This report addresses two technologies: the sodium-cooled fast reactor (SFR) and the modular high temperature gas-cooled reactor (mHTGR). SRP Chapter 4, which addresses reactor components, was selected for adaptation because of the possible significant differences in advanced non-light water reactor (non-LWR) technologies compared with the current LWR-based description in Chapter 4. SFR and mHTGR technologies were chosen for this gap analysis because of their diverse designs and the availability of significant historical design detail.

Inorganic Arsenic Determination in Food: A Review of Analytical Proposals and Quality Assessment Over the Last Six Years.

Science.gov (United States)

Llorente-Mirandes, Toni; Rubio, Roser; López-Sánchez, José Fermín

2017-01-01

Here we review recent developments in analytical proposals for the assessment of inorganic arsenic (iAs) content in food products. Interest in the determination of iAs in products for human consumption such as food commodities, wine, and seaweed among others is fueled by the wide recognition of its toxic effects on humans, even at low concentrations. Currently, the need for robust and reliable analytical methods is recognized by various international safety and health agencies, and by organizations in charge of establishing acceptable tolerance levels of iAs in food. This review summarizes the state of the art of analytical methods while highlighting tools for the assessment of quality assessment of the results, such as the production and evaluation of certified reference materials (CRMs) and the availability of specific proficiency testing (PT) programmes. Because the number of studies dedicated to the subject of this review has increased considerably over recent years, the sources consulted and cited here are limited to those from 2010 to the end of 2015.

Combining Review Text Content and Reviewer-Item Rating Matrix to Predict Review Rating

Directory of Open Access Journals (Sweden)

Bingkun Wang

2016-01-01

Full Text Available E-commerce develops rapidly. Learning and taking good advantage of the myriad reviews from online customers has become crucial to the success in this game, which calls for increasingly more accuracy in sentiment classification of these reviews. Therefore the finer-grained review rating prediction is preferred over the rough binary sentiment classification. There are mainly two types of method in current review rating prediction. One includes methods based on review text content which focus almost exclusively on textual content and seldom relate to those reviewers and items remarked in other relevant reviews. The other one contains methods based on collaborative filtering which extract information from previous records in the reviewer-item rating matrix, however, ignoring review textual content. Here we proposed a framework for review rating prediction which shows the effective combination of the two. Then we further proposed three specific methods under this framework. Experiments on two movie review datasets demonstrate that our review rating prediction framework has better performance than those previous methods.

Environmental assessment report on proposed Yeelirrie uranium project

International Nuclear Information System (INIS)

1979-01-01

In accordance with Government requirements, Western Mining Corporation Ltd. has prepared a Draft Environmental Impact Statement/Environmental Review and Management Programme for its proposed uranium mine development at Yeelirrie, Western Australia. This report includes an outline of the proposal, an enviromental assessment, recommendations by the Environmental Protection Authority made after consideration of the Company's draft statement and a review of public and State Government Departmental Submissions received on the Yeelirrie EIS/ERMP

FIFRA Peer Review: Proposed Risk Assessment Methods Process

Science.gov (United States)

From September 11-14, 2012, EPA participated in a Federal Insecticide, Fungicide and Rodenticide Act Scientific Advisory Panel (SAP) meeting on a proposed pollinator risk assessment framework for determining the potential risks of pesticides to honey bees.

34 CFR 350.4 - What regulations apply?

Science.gov (United States)

2010-07-01

... (IRB) reviews research that purposefully requires inclusion of children with disabilities or... REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION DISABILITY AND REHABILITATION RESEARCH PROJECTS AND CENTERS PROGRAM General § 350.4 What regulations apply? The following regulations apply to the Disability and...

48 CFR 370.302 - Types of assurances.

Science.gov (United States)

2010-10-01

....302 Section 370.302 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES HHS SUPPLEMENTATIONS SPECIAL PROGRAMS AFFECTING ACQUISITION Acquisitions Involving Human Subjects 370.302 Types of...'s current “List of Registered Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs...

Perceptual organization in computer vision - A review and a proposal for a classificatory structure

Science.gov (United States)

Sarkar, Sudeep; Boyer, Kim L.

1993-01-01

The evolution of perceptual organization in biological vision, and its necessity in advanced computer vision systems, arises from the characteristic that perception, the extraction of meaning from sensory input, is an intelligent process. This is particularly so for high order organisms and, analogically, for more sophisticated computational models. The role of perceptual organization in computer vision systems is explored. This is done from four vantage points. First, a brief history of perceptual organization research in both humans and computer vision is offered. Next, a classificatory structure in which to cast perceptual organization research to clarify both the nomenclature and the relationships among the many contributions is proposed. Thirdly, the perceptual organization work in computer vision in the context of this classificatory structure is reviewed. Finally, the array of computational techniques applied to perceptual organization problems in computer vision is surveyed.

How to improve the teaching of clinical reasoning: a narrative review and a proposal.

Science.gov (United States)

Schmidt, Henk G; Mamede, Sílvia

2015-10-01

The development of clinical reasoning (CR) in students has traditionally been left to clinical rotations, which, however, often offer limited practice and suboptimal supervision. Medical schools begin to address these limitations by organising pre-clinical CR courses. The purpose of this paper is to review the variety of approaches employed in the teaching of CR and to present a proposal to improve these practices. We conducted a narrative review of the literature on teaching CR. To that end, we searched PubMed and Web of Science for papers published until June 2014. Additional publications were identified in the references cited in the initial papers. We used theoretical considerations to characterise approaches and noted empirical findings, when available. Of the 48 reviewed papers, only 24 reported empirical findings. The approaches to teaching CR were shown to vary on two dimensions. The first pertains to the way the case information is presented. The case is either unfolded to students gradually - the 'serial-cue' approach - or is presented in a 'whole-case' format. The second dimension concerns the purpose of the exercise: is its aim to help students acquire or apply knowledge, or is its purpose to teach students a way of thinking? The most prevalent approach is the serial-cue approach, perhaps because it tries to directly simulate the diagnostic activities of doctors. Evidence supporting its effectiveness is, however, lacking. There is some empirical evidence that whole-case, knowledge-oriented approaches contribute to the improvement of students' CR. However, thinking process-oriented approaches were shown to be largely ineffective. Based on research on how expertise develops in medicine, we argue that students in different phases of their training may benefit from different approaches to the teaching of CR. © 2015 John Wiley & Sons Ltd.

40 CFR 791.60 - Review.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Review. 791.60 Section 791.60...) DATA REIMBURSEMENT Review § 791.60 Review. (a) The hearing officer's proposed order shall become the... Agency review or the Administrator of his own initiative decides to review the proposed order. (b) The...

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.

36 CFR 1010.14 - Review of proposals by project applicants.

Science.gov (United States)

2010-07-01

...) With respect to each project proposed for consideration for which the NEPA Compliance Coordinator... the scope and content of the final EA. (e) With respect to each project proposed for consideration for... Trust and who certify that they have no financial or other interest in the outcome of the project, and...

Empirical Analysis of Exploiting Review Helpfulness for Extractive Summarization of Online Reviews

Science.gov (United States)

Xiong, Wenting; Litman, Diane

2014-01-01

We propose a novel unsupervised extractive approach for summarizing online reviews by exploiting review helpfulness ratings. In addition to using the helpfulness ratings for review-level filtering, we suggest using them as the supervision of a topic model for sentence-level content scoring. The proposed method is metadata-driven, requiring no…

Review of 40-year MD theses in medical oncology.

Science.gov (United States)

Zeeneldin, Ahmed; Diyaa, Amira; Moneer, Manar; Elgammal, Mosaad; Buhoush, Wafa

2014-09-01

It is almost 40 years since the foundation of the Medical Oncology (MO) Department. We aimed to appraise the clinical research to fulfill the Medical Doctorate (MD) degree in MO at the National Cancer Institute, Cairo University (NCI, CU). This review included 62 MD theses containing 66 studies. They were reviewed regarding aims, type of study, clinical trial phase, design and methodology, statistical tests, results, limitations, consent and IRB approval. Theses were grouped into 3 periods: 1970-1989, 1990-1999 and 2000-2008. Almost 76% of the studies were interventional and 24% were observational. Informed consent and Institutional Review Board approval were mentioned in 18 and 2 studies, respectively. While all studies mentioned the aims, none, clearly mentioned the research question. Outcomes were mainly efficacy followed by safety. Study design was inadequately considered, especially in 70's-80's period (p=0.038). Median sample size and study duration were almost stable through the three periods (p=0.441, 0.354, respectively). Most of the studies used both descriptive and analytical statistical methods. In a descending order, researched cancers were lymphoma, breast, leukemia, liver, urinary bladder, lung and colorectal. The commonest stages researched were IV and III. The number of studies focused on assessing biomarkers, biomarkers plus drugs/procedures, drugs and procedures are 20, 20, 16 and 6, respectively. With time, research within MD theses in MO increased quantitatively and qualitatively. Improvements were noticeable in documentation of study design. Copyright © 2014. Production and hosting by Elsevier B.V.

Osteotome-Mediated Sinus Lift without Grafting Material: A Review of Literature and a Technique Proposal

Science.gov (United States)

Taschieri, Silvio; Corbella, Stefano; Saita, Massimo; Tsesis, Igor; Del Fabbro, Massimo

2012-01-01

Implant rehabilitation of the edentulous posterior maxilla may be a challenging procedure in the presence of insufficient bone volume for implant placement. Maxillary sinus augmentation with or without using grafting materials aims to provide adequate bone volume. The aim of the present study was to systematically review the existing literature on transalveolar maxillary sinus augmentation without grafting materials and to propose and describe an osteotome-mediated approach in postextraction sites in combination with platelet derivative. The systematic review showed that high implant survival rate (more than 96% after 5 years) can be achieved even without grafting the site, with a low rate of complications. Available alveolar bone height before surgery was not correlated to survival rate. In the described case report, three implants were placed in posterior maxilla after extraction of two teeth. An osteotome-mediated sinus lifting technique was performed with the use of platelet derivative (PRGF); a synthetic bone substitute was used to fill the gaps between implant and socket walls. No complications occurred, and implants were successfully in site after 1 year from prosthetic loading. The presented technique might represent a viable alternative for the treatment of edentulous posterior maxilla with atrophy of the alveolar bone though it needs to be validated by studies with a large sample size. PMID:22792108

Osteotome-Mediated Sinus Lift without Grafting Material: A Review of Literature and a Technique Proposal

Directory of Open Access Journals (Sweden)

Silvio Taschieri

2012-01-01

Full Text Available Implant rehabilitation of the edentulous posterior maxilla may be a challenging procedure in the presence of insufficient bone volume for implant placement. Maxillary sinus augmentation with or without using grafting materials aims to provide adequate bone volume. The aim of the present study was to systematically review the existing literature on transalveolar maxillary sinus augmentation without grafting materials and to propose and describe an osteotome-mediated approach in postextraction sites in combination with platelet derivative. The systematic review showed that high implant survival rate (more than 96% after 5 years can be achieved even without grafting the site, with a low rate of complications. Available alveolar bone height before surgery was not correlated to survival rate. In the described case report, three implants were placed in posterior maxilla after extraction of two teeth. An osteotome-mediated sinus lifting technique was performed with the use of platelet derivative (PRGF; a synthetic bone substitute was used to fill the gaps between implant and socket walls. No complications occurred, and implants were successfully in site after 1 year from prosthetic loading. The presented technique might represent a viable alternative for the treatment of edentulous posterior maxilla with atrophy of the alveolar bone though it needs to be validated by studies with a large sample size.

75 FR 54351 - Cell and Gene Therapy Clinical Trials in Pediatric Populations; Public Workshop

Science.gov (United States)

2010-09-07

...] Cell and Gene Therapy Clinical Trials in Pediatric Populations; Public Workshop AGENCY: Food and Drug... Biologics Evaluation and Research (CBER) is announcing a public workshop entitled ``Cell and Gene Therapy... Institutional Review Boards (IRBs), gene and cellular therapy clinical researchers, and other stakeholders...

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

Investigating the empirical support for therapeutic targets proposed by the temporal experience of pleasure model in schizophrenia: A systematic review.

Science.gov (United States)

Edwards, Clementine J; Cella, Matteo; Tarrier, Nicholas; Wykes, Til

2015-10-01

Anhedonia and amotivation are substantial predictors of poor functional outcomes in people with schizophrenia and often present a formidable barrier to returning to work or building relationships. The Temporal Experience of Pleasure Model proposes constructs which should be considered therapeutic targets for these symptoms in schizophrenia e.g. anticipatory pleasure, memory, executive functions, motivation and behaviours related to the activity. Recent reviews have highlighted the need for a clear evidence base to drive the development of targeted interventions. To review systematically the empirical evidence for each TEP model component and propose evidence-based therapeutic targets for anhedonia and amotivation in schizophrenia. Following PRISMA guidelines, PubMed and PsycInfo were searched using the terms "schizophrenia" and "anhedonia". Studies were included if they measured anhedonia and participants had a diagnosis of schizophrenia. The methodology, measures and main findings from each study were extracted and critically summarised for each TEP model construct. 80 independent studies were reviewed and executive functions, emotional memory and the translation of motivation into actions are highlighted as key deficits with a strong evidence base in people with schizophrenia. However, there are many relationships that are unclear because the empirical work is limited by over-general tasks and measures. Promising methods for research which have more ecological validity include experience sampling and behavioural tasks assessing motivation. Specific adaptations to Cognitive Remediation Therapy, Cognitive Behavioural Therapy and the utilisation of mobile technology to enhance representations and emotional memory are recommended for future development. Copyright © 2015. Published by Elsevier B.V.

Futility Disputes: A Review of the Literature and Proposed Model for Dispute Navigation Through Trust Building.

Science.gov (United States)

Leland, Brian D; Torke, Alexia M; Wocial, Lucia D; Helft, Paul R

2017-10-01

Futility disputes in the intensive care unit setting have received significant attention in the literature over the past several years. Although the idea of improving communication in an attempt to resolve these challenging situations has been regularly discussed, the concept and role of trust building as the means by which communication improves and disputes are best navigated is largely absent. We take this opportunity to review the current literature on futility disputes and argue the important role of broken trust in these encounters, highlighting current evidence establishing the necessity and utility of trust in both medical decision-making and effective communication. Finally, we propose a futility dispute navigation model built upon improved communication through trust building.

The New Era of Virtual Reality Locomotion: A Systematic Literature Review of Techniques and a Proposed Typology

Directory of Open Access Journals (Sweden)

Costas Boletsis

2017-09-01

Full Text Available The latest technical and interaction advancements that took place in the Virtual Reality (VR field have marked a new era, not only for VR, but also for VR locomotion. Although the latest advancements in VR locomotion have raised the interest of both researchers and users in analyzing and experiencing current VR locomotion techniques, the field of research on VR locomotion, in its new era, is still uncharted. In this work, VR locomotion is explored through a systematic literature review investigating empirical studies of VR locomotion techniques from 2014–2017. The review analyzes the VR locomotion techniques that have been studied, their interaction-related characteristics and the research topics that were addressed in these studies. Thirty-six articles were identified as relevant to the literature review, and the analysis of the articles resulted in 73 instances of 11 VR locomotion techniques, such as real-walking, walking-in-place, point and teleport, joystick-based locomotion, and more. Results showed that since the VR revival, the focus of VR locomotion research has been on VR technology and various technological aspects, overshadowing the investigation of user experience. From an interaction perspective, the majority of the utilized and studied VR locomotion techniques were found to be based on physical interaction, exploiting physical motion cues for navigation in VR environments. A significant contribution of the literature review lies in the proposed typology for VR locomotion, introducing four distinct VR locomotion types: motion-based, room scale-based, controller-based and teleportation-based locomotion.

Lessons learned obtaining informed consent in research with vulnerable populations in community health center settings

Directory of Open Access Journals (Sweden)

Riden Heather E

2012-11-01

Full Text Available Abstract Background To improve equity in access to medical research, successful strategies are needed to recruit diverse populations. Here, we examine experiences of community health center (CHC staff who guided an informed consent process to overcome recruitment barriers in a medical record review study. Methods We conducted ten semi-structured interviews with CHC staff members. Interviews were audiotaped, transcribed, and structurally and thematically coded. We used NVivo, an ethnographic data management software program, to analyze themes related to recruitment challenges. Results CHC interviewees reported that a key challenge to recruitment included the difficult balance between institutional review board (IRB requirements for informed consent, and conveying an appropriate level of risk to patients. CHC staff perceived that the requirements of IRB certification itself posed a barrier to allowing diverse staff to participate in recruitment efforts. A key barrier to recruitment also included the lack of updated contact information on CHC patients. CHC interviewees reported that the successes they experienced reflected an alignment between study aims and CHC goals, and trusted relationships between CHCs and staff and the patients they recruited. Conclusions Making IRB training more accessible to CHC-based staff, improving consent form clarity for participants, and developing processes for routinely updating patient information would greatly lower recruitment barriers for diverse populations in health services research.

Reactive Granulomatous Dermatitis: A Review of Palisaded Neutrophilic and Granulomatous Dermatitis, Interstitial Granulomatous Dermatitis, Interstitial Granulomatous Drug Reaction, and a Proposed Reclassification.

Science.gov (United States)

Rosenbach, Misha; English, Joseph C

2015-07-01

The terms "palisaded neutrophilic and granulomatous dermatitis," "interstitial granulomatous dermatitis," and the subset "interstitial granulomatous drug reaction" are a source of confusion. There exists substantial overlap among the entities with few strict distinguishing features. We review the literature and highlight areas of distinction and overlap, and propose a streamlined diagnostic workup for patients presenting with this cutaneous reaction pattern. Because the systemic disease associations and requisite workup are similar, and the etiopathogenesis is poorly understood but likely similar among these entities, we propose the simplified unifying term "reactive granulomatous dermatitis" to encompass these entities. Copyright © 2015 Elsevier Inc. All rights reserved.

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

Retrievability - a matter of public acceptance? Reflections on the public review of the proposed nuclear fuel waste disposal concept in Canada

International Nuclear Information System (INIS)

Riverin, G.

2000-01-01

Environmental assessment has been used as a planning tool in Canada for almost three decades. Public participation, one of its fundamental principles, is at the heart of environmental assessment in our country. To date, approximately 12 large projects related to nuclear energy have been the subject of public reviews by independent panels of experts appointed by the Government of Canada. These include: the development of uranium mines in Northern Saskatchewan; the construction and operation of two CANDU reactors in New-Brunswick, the second of which was never constructed; proposed uranium hexafluoride refineries in Ontario and Saskatchewan; expansion of a dry storage facility for nuclear spent fuel in Quebec; and decommissioning of uranium mine tailings areas in Ontario. All of the assessments mentioned above were conducted under the environmental assessment regimes of 1975 and 1984 that preceded the Canadian Environmental Assessment Act (1995). One of the public reviews of particular interest to this workshop is that of the proposed concept for deep geological disposal of nuclear fuel waste in Canada. This paper focuses exclusively on the public review of the Nuclear Fuel Waste Disposal Concept developed by Atomic Energy of Canada Limited (AECL), particularly as it relates to public acceptance of retrievability. The paper first describes the historical context in which AECL's concept was developed prior to the public review. It then briefly outlines the changes in the societal context that occurred between the time when decisions were made to proceed with the development of the concept in 1978 and the time when public hearings were held in 1996-1997 and the panel report was presented to the government in 1998. It also provides a short description of the concept itself. The paper then presents a discussion of the arguments used by the public in the panel review, arguments, which demonstrate a decrease in confidence in a concept lacking effective postclosure

Proposed Diagnostic Criteria, Classification Schema, and Review of Literature of Notochord-Derived Ecchordosis Physaliphora

Science.gov (United States)

Lagman, Carlito; Sarmiento, J. Manuel; Turtz, Alan R; Chitale, Rohan V

2016-01-01

Ecchordosis physaliphora (EP) is a benign notochordal remnant derived from ectopic nests found along the craniospinal axis. It typically presents asymptomatically and is diagnosed using classic radiologic features, particularly location, T1-hypointensity, T2-hyperintensity, and lack of enhancement following gadolinium (Gd) contrast administration. Distinguishing EP from its malignant counterpart, chordoma, is of paramount importance, given the aggressive nature of the latter. Advances in imaging and immunohistochemistry have aided in diagnosis to an extent but, to our knowledge, identification of the genetic fingerprint of EP has yet to take place. Further cytological analysis of these lesions in search of a genetic link is warranted. We propose here a set of diagnostic criteria based on features consistently cited in the literature. In this literature review, 23 case reports were identified and collated into a summary of symptomatic cases of ecchordosis physaliphora. An illustrative case report of two patients was also included.  PMID:27158576

Atmospheric pollution problems and control proposals associated with solid waste management in China: a review.

Science.gov (United States)

Tian, Hezhong; Gao, Jiajia; Hao, Jiming; Lu, Long; Zhu, Chuanyong; Qiu, Peipei

2013-05-15

Along with population growth, rapid urbanization and industrialization process, the volume of municipal solid waste (MSW) generation in China has been increasing sharply in the past 30 years and the total amount of MSW yields will continue to increase. Nowadays, due to global warming warrants particular attention throughout the world, a series of air pollutants (including greenhouse gases, odorous gases, PCDD/Fs, heavy metals, PM, etc.) discharged from waste disposal and treatment processes have become one of the new significant emerging air pollution sources, which arousing great concerns about their adverse effects on surrounding ambient air quality and public health. At present, the overall safely disposed ratio of the collected MSW in China is reported at approximately 78% in 2010, and there are mainly three types of MSW disposal methods practiced in China, including landfill, composting and incineration. The characteristics of air pollutants and greenhouse gases discharge vary substantially among different MSW disposal methods. By presenting a thorough review of MSW generation in China and providing a summarization of the current status of MSW disposal methods practices, this review article makes an integrated overview analysis of existing air pollution problems associated with MSW collection, separation, and disposal processes. Furthermore, some comprehensive control proposals to prevent air pollution for improving MSW management of China in the future are put forward. Copyright © 2013 Elsevier B.V. All rights reserved.

A Proposed Solution to the Scholarly Communications Crisis

Science.gov (United States)

Schatzle, Chad

2005-01-01

After reviewing the history and parameters of the scholarly communications crisis, particularly in regard to skyrocketing prices for journals in the natural sciences, the author reviews and rejects previously attempted solutions. He then employs the principles of game theory in proposing a new solution to the crisis.

The qualitative research proposal

Directory of Open Access Journals (Sweden)

H Klopper

2008-09-01

Full Text Available Qualitative research in the health sciences has had to overcome many prejudices and a number of misunderstandings, but today qualitative research is as acceptable as quantitative research designs and is widely funded and published. Writing the proposal of a qualitative study, however, can be a challenging feat, due to the emergent nature of the qualitative research design and the description of the methodology as a process. Even today, many sub-standard proposals at post-graduate evaluation committees and application proposals to be considered for funding are still seen. This problem has led the researcher to develop a framework to guide the qualitative researcher in writing the proposal of a qualitative study based on the following research questions: (i What is the process of writing a qualitative research proposal? and (ii What does the structure and layout of a qualitative proposal look like? The purpose of this article is to discuss the process of writing the qualitative research proposal, as well as describe the structure and layout of a qualitative research proposal. The process of writing a qualitative research proposal is discussed with regards to the most important questions that need to be answered in your research proposal with consideration of the guidelines of being practical, being persuasive, making broader links, aiming for crystal clarity and planning before you write. While the structure of the qualitative research proposal is discussed with regards to the key sections of the proposal, namely the cover page, abstract, introduction, review of the literature, research problem and research questions, research purpose and objectives, research paradigm, research design, research method, ethical considerations, dissemination plan, budget and appendices.

Recommendations on the proposed Monitored Retrievable Storage Facility

Energy Technology Data Exchange (ETDEWEB)

1985-10-01

Following the Department of Energy's announcement in April 1985 that three Tennessee sites were to be considered for the Monitored Retrievable Storage facility, Governor Lamar Alexander initiated a review of the proposal to be coordinated by his Safe Growth Team. Roane County and the City of Oak Ridge, the local governments sharing jurisdiction over DOE's primary and secondary sites, were invited to participate in the state's review of the MRS proposal. Many issues related to the proposed MRS are being considered by the Governor's Safe Growth Team. The primary objective of the Clinch River MRS Task Force has been to determine whether the proposed Monitored Retrievable Storage facility should be accepted by the local governments, and if so, under what conditions. The Clinch River MRS Task Force is organized into an Executive Committee cochaired by the Roane County Executive and Mayor of Oak Ridge and three Study Groups focusing on environmental (including health and safety), socioeconomic, and transportation issues.

Recommendations on the proposed Monitored Retrievable Storage Facility

Energy Technology Data Exchange (ETDEWEB)

1985-10-01

Following the Department of Energy`s announcement in April 1985 that three Tennessee sites were to be considered for the Monitored Retrievable Storage facility, Governor Lamar Alexander initiated a review of the proposal to be coordinated by his Safe Growth Team. Roane County and the City of Oak Ridge, the local governments sharing jurisdiction over DOE`s primary and secondary sites, were invited to participate in the state`s review of the MRS proposal. Many issues related to the proposed MRS are being considered by the Governor`s Safe Growth Team. The primary objective of the Clinch River MRS Task Force has been to determine whether the proposed Monitored Retrievable Storage facility should be accepted by the local governments, and if so, under what conditions. The Clinch River MRS Task Force is organized into an Executive Committee cochaired by the Roane County Executive and Mayor of Oak Ridge and three Study Groups focusing on environmental (including health and safety), socioeconomic, and transportation issues.

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

Comparing Ethical and Epistemic Standards for Investigative Journalists and Equity-Oriented Collaborative Community-Based Researchers: Why Working for a University Matters

Science.gov (United States)

Newman, Anne; Glass, Ronald David

2014-01-01

Criticisms of IRBs are proliferating. In response, we compare the ethical and epistemic standards of two closely related forms of inquiry, investigative journalism and equity-oriented collaborative community-based research (EOCCBR). We argue that a university affiliation justifies formal ethical review of research and suggest how institutionalized…

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…

Nurse Bullying: A Review And A Proposed Solution.

Science.gov (United States)

Castronovo, Marie A; Pullizzi, Amy; Evans, ShaKhira

2016-01-01

Nurse bullying is an extremely common phenomenon which has detrimental consequences to nurses, patients, health care institutions, and to the nursing profession itself. It has even been linked to increased patient mortality. This article demonstrates the critical need to resolve the issue of nurse bullying. It also shows that previous attempts of resolution have not been successful, which may be partly due to the fact that the problem is relatively unacknowledged outside the nursing profession. To resolve the problem of nurse bullying, we believe that the solution must include an incentive for institutions to implement the necessary interventions and to ensure that they are effective. We propose that a measurement pertaining to the level of nurse bullying be factored into the calculation of the value-based incentive payment in the Hospital Value-Based Purchasing program. To facilitate this, we propose that a survey be developed and implemented which is similar to the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. However, whereas the HCAHPS survey measures patients' perspectives of hospital care, this survey would measure nurses' perspectives of workplace bullying. Copyright © 2015 Elsevier Inc. All rights reserved.

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.

Riverland expedited response action proposal

International Nuclear Information System (INIS)

1993-04-01

The US Environmental Protection Agency (EPA) and Washington Department of Ecology (Ecology) recommended that the US Department of Energy (DOE) prepare an expedited response action (ERA) for the Riverland Railroad Car Wash Pit and the 600 Area Army Munitions Burial Site. A non-time-critical ERA proposal includes preparation of an engineering evaluation/cost analysis (EE/CA) section. The EE/CA is a rapid, focused evaluation of available technologies using specific screening factors to assess feasibility, appropriateness, and cost. The ERA proposal will undergo reviews by Westinghouse Hanford Company (WHC), DOE, EPA, Ecology, and the public. Ecology and EPA will issue an Action Agreement Memorandum after resolution of all review comments. The, memorandum will authorize remediation activities. The ERA goal is to reduce the potential for any contaminant migration to the soil column, groundwater, and Columbia River. The ERA may be the final remediation of the 100-IU-1 Operable Unit. A No Action Record of Decision may be issued after cleanup completion

Hydroxypropyl-β-cyclodextrin functionalized calcium carbonate microparticles as a potential carrier for enhancing oral delivery of water-insoluble drugs.

Science.gov (United States)

Zhang, Lihua; Zhu, Wufu; Lin, Qisi; Han, Jin; Jiang, Liqun; Zhang, Yanzhuo

2015-01-01

The objective of the present study was to demonstrate that a novel hydroxypropyl-β-cyclodextrin functionalized calcium carbonate (HP-β-CD/CC) based amorphous solid dispersion (ASD) can be used to increase the solubility and oral bioavailability of water-insoluble drugs. Irbesartan (IRB) was selected as a model compound and loaded into the nanoporous HP-β-CD/CC matrix using an immersion method. The IRB-loaded HP-β-CD/CC formulation was characterized by various analytical techniques, such as specific surface area analysis, scanning electron microscopy (SEM), dynamic light scattering (DLS), powder X-ray diffraction (PXRD), and differential scanning calorimetry (DSC). Analyses with PXRD and DSC confirmed that IRB was fully converted into the amorphous form in the nanopores of HP-β-CD/CC. From the solubility and dissolution tests, it was observed that the aqueous solubility and dissolution rate of IRB-loaded HP-β-CD/CC were increased significantly compared with those of pure IRB and IRB-loaded mesoporous silica. Likewise, the IRB-loaded HP-β-CD/CC formulation exhibited better absorption compared with that of the commercially available IRB capsules in beagle dogs. The mean peak plasma concentration (C max) and the area under the mean plasma concentration-time curve (AUC[0→48]) of IRB-loaded HP-β-CD/CC were 1.56- and 1.52-fold higher than that of the commercial product, respectively. Furthermore, the IRB-loaded HP-β-CD/CC formulation exhibited excellent stability against re-crystallization. These results clearly demonstrate that HP-β-CD/CC based porous ASD is a promising formulation approach to improve the aqueous solubility and the in vivo absorption performance of a water-insoluble compound like IRB.

Expert opinion and review article: The timing of comedone extraction in the treatment of premenstrual acne--a proposed therapeutic approach.

Science.gov (United States)

Steventon, K

2011-04-01

The face is the most exposed part of our body, and deterioration of facial appearance, through disease or ageing, causes psychological distress. Acne lesions and subsequent pigmentation changes contribute to the unevenness of skin colour that is detrimental to facial attractiveness and leads to rejection and stigmatization in our society. The purpose of this review is to look at the root causes of premenstrual acne and, for the first time ever, propose that the specific timing of treatment can, at least in part, resolve the acne lesions. We postulate that it is the timing of the manual extraction that matters in resolving premenstrual acne and that the effectiveness of this therapy could be improved. Based on the reviewed evidence, we propose that it is important to remove the comedones at the time of ovulation, prior to the reduction of the size of the sebaceous orifice and epidermal barrier function, to counteract the onset of increased sebum production, prevent blockage of the pores and subsequent bacterial colonization and inflammation. If performed successfully, the extraction may contribute to a reduction in inflamed acne lesions and thus benefit women by increasing their facial attractiveness, well-being, social function and thereby decrease psychological stress. © 2010 The Author. ICS © 2010 Society of Cosmetic Scientists and the Société Française de Cosmétologie.

21 CFR 56.114 - Cooperative research.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Cooperative research. 56.114 Section 56.114 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL INSTITUTIONAL REVIEW BOARDS IRB Functions and Operations § 56.114 Cooperative research. In complying with these...

77 FR 4819 - Agency Information Collection Request; 60-Day Public Comment Request

Science.gov (United States)

2012-01-31

... board (IRB) to review the research in order to ensure protection of the rights and welfare of the human... part 46, subpart A, the basic HHS Policy for the Protection of Human Subjects. Total Estimated... DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier OS-0990-0260] Agency Information...

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…

Ethical challenges in conducting research in humanitarian crisis ...

African Journals Online (AJOL)

... culturally sensitive to the needs of the victims of the humanitarian crisis. In emergency situations, the roles of Institutional Review Boards (IRBs) may have to be modified without compromising the ethical standards that health researchers have globally attempted to achieve. Malawi Medical Journal Vol. 20 (2) 2008: pp.

Technical Notes: Notes and Proposed Guidelines on Updated ...

African Journals Online (AJOL)

In light of recent expansion in the planning and construction of major building structures as well as other infrastructures such as railways, masshousing, dams, bridges, etc, this paper reviews the extent of seismic hazard in Ethiopia and proposes a review and update of the current out-dated and - in most cases ...

Estimating travel reduction associated with the use of telemedicine by patients and healthcare professionals: proposal for quantitative synthesis in a systematic review

Directory of Open Access Journals (Sweden)

Bahaadinbeigy Kambiz

2011-08-01

Full Text Available Abstract Background A major benefit offered by telemedicine is the avoidance of travel, by patients, their carers and health care professionals. Unfortunately, there is very little published information about the extent of avoided travel. We propose to undertake a systematic review of literature which reports credible data on the reductions in travel associated with the use of telemedicine. Method The conventional approach to quantitative synthesis of the results from multiple studies is to conduct a meta analysis. However, too much heterogeneity exists between available studies to allow a meaningful meta analysis of the avoided travel when telemedicine is used across all possible settings. We propose instead to consider all credible evidence on avoided travel through telemedicine by fitting a linear model which takes into account the relevant factors in the circumstances of the studies performed. We propose the use of stepwise multiple regression to identify which factors are significant. Discussion Our proposed approach is illustrated by the example of teledermatology. In a preliminary review of the literature we found 20 studies in which the percentage of avoided travel through telemedicine could be inferred (a total of 5199 patients. The mean percentage avoided travel reported in the 12 store-and-forward studies was 43%. In the 7 real-time studies and in a single study with a hybrid technique, 70% of the patients avoided travel. A simplified model based on the modality of telemedicine employed (i.e. real-time or store and forward explained 29% of the variance. The use of store and forward teledermatology alone was associated with 43% of avoided travel. The increase in the proportion of patients who avoided travel (25% when real-time telemedicine was employed was significant (P = 0.014. Service planners can use this information to weigh up the costs and benefits of the two approaches.

Estimating travel reduction associated with the use of telemedicine by patients and healthcare professionals: proposal for quantitative synthesis in a systematic review.

Science.gov (United States)

Wootton, Richard; Bahaadinbeigy, Kambiz; Hailey, David

2011-08-08

A major benefit offered by telemedicine is the avoidance of travel, by patients, their carers and health care professionals. Unfortunately, there is very little published information about the extent of avoided travel. We propose to undertake a systematic review of literature which reports credible data on the reductions in travel associated with the use of telemedicine. The conventional approach to quantitative synthesis of the results from multiple studies is to conduct a meta analysis. However, too much heterogeneity exists between available studies to allow a meaningful meta analysis of the avoided travel when telemedicine is used across all possible settings. We propose instead to consider all credible evidence on avoided travel through telemedicine by fitting a linear model which takes into account the relevant factors in the circumstances of the studies performed. We propose the use of stepwise multiple regression to identify which factors are significant. Our proposed approach is illustrated by the example of teledermatology. In a preliminary review of the literature we found 20 studies in which the percentage of avoided travel through telemedicine could be inferred (a total of 5199 patients). The mean percentage avoided travel reported in the 12 store-and-forward studies was 43%. In the 7 real-time studies and in a single study with a hybrid technique, 70% of the patients avoided travel. A simplified model based on the modality of telemedicine employed (i.e. real-time or store and forward) explained 29% of the variance. The use of store and forward teledermatology alone was associated with 43% of avoided travel. The increase in the proportion of patients who avoided travel (25%) when real-time telemedicine was employed was significant (P = 0.014). Service planners can use this information to weigh up the costs and benefits of the two approaches.

76 FR 1619 - Proposed Information Collection Activity; Comment Request

Science.gov (United States)

2011-01-11

... SACWIS Assessment Reviews, at any time in the system life cycle. Submission of the SACWIS SARG and other...-0159] Proposed Information Collection Activity; Comment Request Proposed Projects Title: Statewide... the project, as described in the approved Advance Planning Document, have been adequately completed...

Problem solving in physics: research review, analysis, and a methodological proposal

Directory of Open Access Journals (Sweden)

Maria Helena Fávero

2001-05-01

Full Text Available This article presents a literature review on problem solving in Physics based on the scientific articles published in periodicals of the related field of study. The articles considered for this study were published in the period between the end of the 70`s until 1999. A categorization of the publications , according to the issue investigated, the theoretical background used, the research method adopted, the results and conclusions are considered as a starting point in order to present a research profile of the field of study. Next, this profile is discussed and analyzed , pointing out the convergent aspects that characterize the field. Taking this analysis into account, the following thesis (based on Fávero`s proposal, 2000 is defended: in order to generate tools for the teaching practice of Physics through the study of problem solving, a method that substitutes the idea of knowledge transmission in the communication processes that takes place in the classroom should be developed. This method should comprise the idea of interlocution (Vion, 2000 which focuses on social interaction as a means to reveal metacognitive regulations of the subjects, pariticipants in the process, and their development of awareness in relation to a conceptual field (Vergnaud, 1990 – Physics, in this case. The analysis of these processes considers the verbal exchanges among the subjects (Bromberg & Chabrol, 1999 developed in the situation of interaction. This thesis is supported by the articulation of concepts in Psychology, including its interface with linguistics, such as conceptual field, development of awareness and acts of speech, which are reconsidered in this study.

Is Safety in the Eye of the Beholder? Safeguards in Research With Adults With Intellectual Disability.

Science.gov (United States)

McDonald, Katherine E; Conroy, Nicole E; Kim, Carolyn I; LoBraico, Emily J; Prather, Ellis M; Olick, Robert S

2016-12-01

Human subjects research has a core commitment to participant well-being. This obligation is accentuated for once exploited populations such as adults with intellectual disability. Yet we know little about the public's views on appropriate safeguards for this population. We surveyed adults with intellectual disability, family members and friends, disability service providers, researchers, and Institutional Review Board (IRB) members to compare views on safeguards. We found many points of convergence of views, particularly for decision-making and participation. One trend is that adults with intellectual disability perceive greater safety in being engaged directly in recruitment, and recruitment by specific individuals. Researchers and IRB members need to consider community views to facilitate the safe and respectful inclusion of adults with intellectual disability.

Experience and Meaning in Qualitative Research: A Conceptual Review and a Methodological Device Proposal

Directory of Open Access Journals (Sweden)

Marianne Daher

2017-07-01

Full Text Available The relevance of experience and meaning in qualitative research is mostly accepted and is common ground for qualitative studies. However, there is an increasing trend towards trivializing the use of these notions. As a consequence, a mechanistic use of these terms has emerged within qualitative analysis, which has resulted in the loss of the original richness derived from the theoretical roots of these concepts. In this article, we aim to recover these origins by reviewing theoretical postulates from phenomenological and hermeneutic traditions and to propose their convergence in a holistic perspective. The challenge is to find the local source of meanings that will enlighten on how to understand people's experiences. This discussion is the basis for the encounter context themes (ECT methodological device, which emphasizes the importance of studying experience and meaning as part of a larger whole: the participants' life-world. Hence, ECT seeks to complement the available methodological tools for qualitatively-oriented studies, recovering—rather than re-creating—a theoretical discussion useful for current qualitative research practices.

Dynamics of Phenol Degrading—Iron Reducing Bacteria in Intensive Rice Croopping System

Institute of Scientific and Technical Information of China (English)

LUWENJING; W.REICHARDT; 等

2001-01-01

Field and greenhouse experiments were conducted to investigate the effects of cropping season,nitrogen fertilizer input and aerated fallow o the dynamics of phenol degrading-iron reducing bacteria(PD-IRB)in tropical irrigated rice(Oryza sativa L.)systems,The PD-IRB population density was monitored at different stages of rice growth in two cropping seasons (dry and early wet) in a continuous annual triple rice cropping system under irrigated condition,In this system,the high nitrogen input (195 and 135 kg N ha-1 in dry and ewt seasons ,respectively)plots and control plots receiving no N fertilizer were compared to investigate the effect of nitrogen rate on population size.The phenol degrading-iron reducing bacteria (PD-IRB)were abundant in soils under croppin systems of tropical irrigated rice.However,density of the bacterial populations varied with rice growth stages.Cropping seasons,rhizosphere,and aerated fallow could affect the dynamics of PD-IRB,In the field trial,viable counts of PD-IRB in the topsoil layer(15 cm)ranged between 102 and 108 cells per gram of dry soil.A steep increase in viable counts during the second half of the cropping season suggested that the population density of PD-IRB increased ant advanced crop-growth stages.Population growth of PD-IRB was accelerated during the dry season compared to the wet season,In the greenhouse experiment,the adjacent aerated fallow revealed 1-2 orders of magnitude higher in most probable number(MPN)of PD-IRB than the wet fallow treated plots.As a prominent group of Fe reducing bacteria,PD-IRB predominated in the rhizosphere of rice,since maximum MPN of PD-IRB (2.62×108 g-1 soil) was found in rhizosphere soil.Mineral N fertilizer rates showed no significant effect on PD-IRB population density.

75 FR 60013 - Proposed Flood Elevation Determinations

Science.gov (United States)

2010-09-29

... Planning and Review. This proposed rule is not a significant regulatory action under the criteria of.... Approximately 4.14 None +4953 miles downstream of Tom Miner Creek Road. Yellowstone River East Branch...

The grant writer's handbook how to write a research proposal and succeed

CERN Document Server

Crawley, Gerard M

2016-01-01

The Grant Writer's Handbook: How to Write a Research Proposal and Succeed provides useful and practical advice on all aspects of proposal writing, including developing proposal ideas, drafting the proposal, dealing with referees, and budgeting. The authors base their advice on many years of experience writing and reviewing proposals in many different countries at various levels of scientific maturity. The book describes the numerous kinds of awards available from funding agencies, in particular large collaborative grants involving a number of investigators, and addresses the practical impact of a grant, which is often required of proposals. In addition, information is provided about selection of reviewers and the mechanics of organizing a research grant competition to give the proposal writer the necessary background information. The book includes key comments from a number of experts and is essential reading for anyone writing a research grant proposal.The Grant Writer's Handbook's companion website, featuri...

Mobile Diabetes Management for USAF Active and Retired Military Spouses: Lessons Learned in the Integration of Mobile Integrated Therapies (MIT) into Electronic Medical Records (EMR)

Science.gov (United States)

2013-09-24

submitted CP to IRB  Documented UAT and EFT results  Completed Clinical Review (CR) and sign off for Patient and Provider Use  Note: The project...management, the “high- attention” call-center based services, are tapping into every avenue available to determine how to raise engagement rates from

BrainPort(Registered trademark) Technology Tongue Interface Characterization

Science.gov (United States)

2010-03-01

22 boards in house. … … … … … Experiment Control Workstation HDA with 2000 to 20,000 electrodes ●●● TCP/IP 10/100 Linux-based Control...Defense Advanced Research Projects Agency HD High Density HDA High Density Array IOD Intra-Oral Device IRB Institutional Review Board Electrode

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.

Selection of mutants resistant to black spot disease by chronic irradiation of gamma-rays in Japanese pear 'Osanijisseiki'

International Nuclear Information System (INIS)

Masuda, Tetsuo; Yoshioka, Toji; Kotobuki, Kazuo; Sanada, Tetsuro; Inoue, Kosuke; Murata, Kenji; Kitagawa, Kenichi; Tabira, Hiroki; Yoshida, Akira

1997-01-01

'Osanijisseiki', a self-compatible, spontaneous bud sport of the Japanese pear 'Nijisseiki' is an excellent cultivar with a smooth skin. However, this cultivar is susceptible to Japanese pear black spot disease caused by Alternaria alternata Japanese pear pathotype. To obtain resistant mutants from 'Osanijisseiki', nursery plants of 'Osanijisseiki' have been irradiated chronically with gamma-rays in the Gamma Field of the Institute of Radiation Breeding, NAR, MAFF, since 1986. Screening tests using AK toxin, a host-specific toxin produced by A. alternata Japanese pear pathotype, were performed form 1988 to 1993. Four branches of young trees planted at a distance of 40 m from the 60 Co source were selected as being resistant mutants in 1991 (IRB 502-13T and IRB 502-14T) and 1993 (IRB 502-17T and IRB 502-18T). Sensitivity of the four resistant mutants to AK-toxin and susceptibility to the pathogen were compared with other of susceptible and resistant cultivars. The results showed that these four mutants possessed intermediate resistance. Furthermore, a mutant, IRB 502-13T, had the same characteristics as the original 'Osanijisseiki', except for the difference in toxin sensitivity. The characteristics of the other mutants, IRB 502 14-T, IRB 502-17T, and IRB 502-18T, care being examined. (author)

Social impact assessment: A review and proposed approach: Final report

International Nuclear Information System (INIS)

Bradbury, J.A.

1986-12-01

The objective of the report is to identify the essential components of a comprehensive plan to assess the potential social impacts of the proposed construction and operation of a high level radioactive waste repository by the Nevada Nuclear Waste Storage Investigations (NNWSI) Project. The tasks taken to achieve this objective are: examination of the literature on Social Impact Assessment (SIA); identification of different conceptual frameworks that have been proposed or used in SIA; examination of specific aspects of the frameworks; assessment of strengths and weaknesses of the frameworks; synthesis of common elements in these frameworks; and examination and evaluation of methods of data collection and analysis. 150 refs., 6 figs., 7 tabs

Social impact assessment: A review and proposed approach: Final report

Energy Technology Data Exchange (ETDEWEB)

Bradbury, J A

1986-12-01

The objective of the report is to identify the essential components of a comprehensive plan to assess the potential social impacts of the proposed construction and operation of a high level radioactive waste repository by the Nevada Nuclear Waste Storage Investigations (NNWSI) Project. The tasks taken to achieve this objective are: examination of the literature on Social Impact Assessment (SIA); identification of different conceptual frameworks that have been proposed or used in SIA; examination of specific aspects of the frameworks; assessment of strengths and weaknesses of the frameworks; synthesis of common elements in these frameworks; and examination and evaluation of methods of data collection and analysis. 150 refs., 6 figs., 7 tabs.

Can Virtue Be Learned? An Exploration of Student Learning Experiences in Ethics Courses and Their Implications for Influencing Moral Character

Science.gov (United States)

Agnew Cochran, Elizabeth; Fozard Weaver, Darlene

2017-01-01

What does it mean to teach virtue, or to learn it? We consider this question through an institutional review board (IRB) supported research study attending to student learning experiences in undergraduate ethics courses at a Catholic university with an explicit commitment to social justice. This essay draws on and interprets qualitative data…

Proposed Dunvegan hydroelectric project

International Nuclear Information System (INIS)

Houston, M.

2001-01-01

A new hydroelectric project is being proposed on the Peace River in the vicinity of Dunvegan, Alberta, by Glacier Power. The proposal calls for a low head, run-of-the-river hydroelectric power plant which would comprise a powerhouse containing 40 Kaplan turbines, a weir section, two fishways and a boat lock. The capacity of the generating plant would be 80 MW. As per established guidelines, the review process was initiated in July 1999 and is ongoing. Stakeholders, government agencies, both at the federal and provincial levels, are involved in the review process. The potential effects on the ice regime, fish passage and fish mortality and bank stability are the issues that have warranted the most attention to date. Scheduled to begin on October 2, 2001, a public hearing on the project has been arranged by the Alberta Energy and Utilities Board. The objective sought by Glacier Power is to have the project certified as being a green-power plant. Green power is defined as power produced from renewable sources with low environmental impact. The production of power with minimal environmental impacts is being encouraged in Alberta by Glacier Power, which sells power for a premium. 6 refs., 4 figs

E-commerce Review System to Detect False Reviews.

Science.gov (United States)

Kolhar, Manjur

2017-08-15

E-commerce sites have been doing profitable business since their induction in high-speed and secured networks. Moreover, they continue to influence consumers through various methods. One of the most effective methods is the e-commerce review rating system, in which consumers provide review ratings for the products used. However, almost all e-commerce review rating systems are unable to provide cumulative review ratings. Furthermore, review ratings are influenced by positive and negative malicious feedback ratings, collectively called false reviews. In this paper, we proposed an e-commerce review system framework developed using the cumulative sum method to detect and remove malicious review ratings.

Review of Differences of Steel related Properties between Proposals of European Structural Codes

DEFF Research Database (Denmark)

Hertz, Kristian Dahl

Differences of Steel related Properties between fire chapters of the Proposals of European Structural Codes are indicated for the same physical properties, the right properties are found and it is proposed to use these properties in all codes.......Differences of Steel related Properties between fire chapters of the Proposals of European Structural Codes are indicated for the same physical properties, the right properties are found and it is proposed to use these properties in all codes....

Writing a Research Proposal to The Research Council of Oman.

Science.gov (United States)

Al-Shukaili, Ahmed; Al-Maniri, Abdullah

2017-05-01

Writing a research proposal can be a challenging task for young researchers. This article explains how to write a strong research proposal to apply for funding, specifically, a proposal for The Research Council (TRC) of Oman. Three different research proposal application forms are currently used in TRC, including Open Research Grant (ORG), Graduate Research Support Program (GRSP), and Faculty-mentored Undergraduate Research Award Program (FURAP). The application forms are filled and submitted electronically on TRC website. Each of the proposals submitted to TRC is selected through a rigorous reviewing and screening process. Novelty and originality of the research idea is the most crucial element in writing a research proposal. Performing an in-depth review of the literature will assist you to compose a good researchable question and generate a strong hypothesis. The development of a good hypothesis will offer insight into the specific objectives of a study. Research objectives should be focused, measurable, and achievable by a specific time using the most appropriate methodology. Moreover, it is essential to select a proper study design in-line with the purpose of the study and the hypothesis. Furthermore, social/economic impact and reasonable budget of proposed research are important criteria in research proposal evaluation by TRC. Finally, ethical principles should be observed before writing a research proposal involving human or animal subjects.

Writing a Research Proposal to The Research Council of Oman

Directory of Open Access Journals (Sweden)

Ahmed Al-Shukaili

2017-05-01

Full Text Available Writing a research proposal can be a challenging task for young researchers. This article explains how to write a strong research proposal to apply for funding, specifically, a proposal for The Research Council (TRC of Oman. Three different research proposal application forms are currently used in TRC, including Open Research Grant (ORG, Graduate Research Support Program (GRSP, and Faculty-mentored Undergraduate Research Award Program (FURAP. The application forms are filled and submitted electronically on TRC website. Each of the proposals submitted to TRC is selected through a rigorous reviewing and screening process. Novelty and originality of the research idea is the most crucial element in writing a research proposal. Performing an in-depth review of the literature will assist you to compose a good researchable question and generate a strong hypothesis. The development of a good hypothesis will offer insight into the specific objectives of a study. Research objectives should be focused, measurable, and achievable by a specific time using the most appropriate methodology. Moreover, it is essential to select a proper study design in-line with the purpose of the study and the hypothesis. Furthermore, social/economic impact and reasonable budget of proposed research are important criteria in research proposal evaluation by TRC. Finally, ethical principles should be observed before writing a research proposal involving human or animal subjects.

The Disciplines and Their Structure: A Review of the Proposal.

Science.gov (United States)

Thompson, John C., III

1978-01-01

Jerome Bruner's theory that the structure of the discipline should be the starting point for reorganizing school curricula is reviewed and recent commentaries, representing supporting and opposing viewpoints, are summarized. (MP)

The role of near infrared radiation in photoaging of the skin.

Science.gov (United States)

Schroeder, Peter; Haendeler, Judith; Krutmann, Jean

2008-07-01

Infrared (IR) radiation is non-ionizing, electromagnetic radiation with wavelengths between 760 nm and 1 mm, which is further divided into IRA, IRB and IRC. IR accounts for more than half of the solar energy that reaches the human skin. While IRB and IRC do not penetrate deeply into the skin, more than 65% of IRA reaches the dermis. Human skin is increasingly exposed to IRA-radiation; most relevant sources are (i) natural solar radiation consisting of over 30% IRA, (ii) artificial IRA sources used for therapeutic or wellness purposes and (iii) artificial UV sources contaminated with IRA. As part of natural sunlight, IRA significantly contributes to extrinsic skin aging. This article reviews the cutaneous effects of IRA-radiation, the underlying molecular mechanisms and the available protective strategies.

Dynamics of Phenol Degrading-Iron ReducingBacteria{1mm in Intensive Rice Cropping System

Institute of Scientific and Technical Information of China (English)

无

2001-01-01

Field and greenhouse experiments were conducted to investigate theeffects of cropping season, nitrogen fertilizer input and aeratedfallow on the dynamics of phenol degrading-iron reducingbacteria (PD-IRB) in tropical irrigated rice ({ Oryza sativa L.)systems. The PD-IRB population density was monitored at different stagesof rice growth in two cropping seasons (dry and early wet) in acontinuous annual triple rice cropping system under irrigated condition.In this system, the high nitrogen input (195 and 135 kg N ha-1 indry and wet seasons, respectively) plots and control plots receiving noN fertilizer were compared to investigate the effect of nitrogen rate onpopulation size. The phenol degrading-iron reducing bacteria (PD-IRB)were abundant in soils under cropping systems of tropical irrigatedrice. However, density of the bacterial populations varied with ricegrowth stages. Cropping seasons, rhizosphere, and aerated fallow couldaffect the dynamics of PD-IRB. In the field trial, viable counts ofPD-IRB in the topsoil layer (15 cm) ranged between 102 and 108cells per gram of dry soil. A steep increase in viable counts during thesecond half of the cropping season suggested that the population densityof PD-IRB increased at advanced crop-growth stages. Population growth ofPD-IRB was accelerated during the dry season compared to the wet season.In the greenhouse experiment, the adjacent aerated fallow revealed 1-2orders of magnitude higher in most probable number (MPN) of PD-IRB thanthe wet fallow treated plots. As a prominent group of Fe reducingbacteria, PD-IRB predominated in the rhizosphere of rice, since maximumMPN of PD-IRB (2.62108 g-1 soil) was found in rhizospheresoil. Mineral N fertilizer rates showed no significant effect on PD-IRBpopulation density.

Monju: Current status and proposed improvements

International Nuclear Information System (INIS)

Nagata, Takashi

2001-01-01

Activities since the Monju reactor accident are described. They include investigation of sodium leak, namely cause of thermocouple well failure and damage caused by sodium combustion. This accident did not affect the safety of the reactor or the integrity of the buildings and structures. Improvements have been proposed to overcome the problems highlighted by the comprehensive safety review of Monju. Improvements of communication are discussed, including incident reporting, public information, corporate culture. The proposed countermeasures against sodium leakage are described in detail. They are as follows: prevention of sodium leakage, early detection of sodium leakage, reduction of sodium spilling and prevention of re-ignition, suppression of moisture release from concrete structures. Replacement of thermocouple wells is proposed, as well as methods of preventing flow induced vibration

A performance assessment review tool for the proposed radioactive waste repository at Yucca Mountain, Nevada, USA

International Nuclear Information System (INIS)

Mohanty, Sitakanta; Codell, Richard

2000-01-01

The U.S. Nuclear Regulatory Commission (NRC), with the assistance of the Center for Nuclear Waste Regulatory Analyses, has developed a Total-system Performance Assessment (TPA) Code to assist in evaluating the performance of the Yucca Mountain (YM) High-Level Waste Repository in Nevada, proposed by the U.S. Department of Energy (DOE). The proposed YM repository would be built in a thick sequence of partially saturated volcanic tuff above the water table. Among the unique challenges of this environment are (1) the transport of radionuclides would take place partially through highly heterogeneous unsaturated rock; (2) the waste packages (WPs) would be generally exposed to oxidizing conditions, and (3) water either infiltrating from the surface or recirculating because of decay heat may drip onto the WPs. Tools such as the TPA code and embedded techniques for evaluating YM performance are aimed at (1) determining the parameters and key parts of the repository system that have the most influence on repository performance; (2) performing alternative conceptual models studies, especially with bounding models; (3) estimating the relative importance of the physical phenomena that lead to human exposure to radionuclides; and (4) improving NRC staff capabilities in performance assessment and associated license application reviews. This paper presents an overview of the NRC conceptual framework, approach to conducting system-level sensitivity analyses for determining influential parameters, and alternative conceptual model studies to investigate the effect of model uncertainties. (author)

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

Family Caregiver Research and the HIPAA Factor

Science.gov (United States)

Albert, Steven M.; Levine, Carol

2005-01-01

Research in family caregiving recently has become more challenging because of the strict protection of privacy mandated in the Health Insurance Portability and Accountability Act (HIPAA) of 1996. We ask when should Institutional Review Boards (IRBs) follow HIPAA rules to the letter and when might they use the waiver option? What is the appropriate…

Summary and synthesis: How to present a research proposal

Directory of Open Access Journals (Sweden)

Maninder Singh Setia

2017-01-01

Full Text Available This concluding module attempts to synthesize the key learning points discussed during the course of the previous ten sets of modules on methodology and biostatistics. The objective of this module is to discuss how to present a model research proposal, based on whatever was discussed in the preceding modules. The lynchpin of a research proposal is the protocol, and the key component of a protocol is the study design. However, one must not neglect the other areas, be it the project summary through which one catches the eyes of the reviewer of the proposal, or the background and the literature review, or the aims and objectives of the study. Two critical areas in the “methods” section that cannot be emphasized more are the sampling strategy and a formal estimation of sample size. Without a legitimate sample size, none of the conclusions based on the statistical analysis would be valid. Finally, the ethical parameters of the study should be well understood by the researchers, and that should get reflected in the proposal.

Summary and Synthesis: How to Present a Research Proposal.

Science.gov (United States)

Setia, Maninder Singh; Panda, Saumya

2017-01-01

This concluding module attempts to synthesize the key learning points discussed during the course of the previous ten sets of modules on methodology and biostatistics. The objective of this module is to discuss how to present a model research proposal, based on whatever was discussed in the preceding modules. The lynchpin of a research proposal is the protocol, and the key component of a protocol is the study design. However, one must not neglect the other areas, be it the project summary through which one catches the eyes of the reviewer of the proposal, or the background and the literature review, or the aims and objectives of the study. Two critical areas in the "methods" section that cannot be emphasized more are the sampling strategy and a formal estimation of sample size. Without a legitimate sample size, none of the conclusions based on the statistical analysis would be valid. Finally, the ethical parameters of the study should be well understood by the researchers, and that should get reflected in the proposal.

[Experimental physics at Yale University: Research proposal and budget Proposal, 1 January 1992--31 December 1996

Energy Technology Data Exchange (ETDEWEB)

1992-07-01

This report reviews the following topics: nuclear and quark matter; correlated pairs from heavy ion collisions-search for new low mass resonances coupled to electron-positron collisions; proposed light ion research program; experimental nuclear astrophysics (explosive nucleosynthesis); search for rare decay modes and rare processes in nuclei; and nuclear spectroscopy at the extremes of spin, isospin, and temperature. (LSP).

(Experimental physics at Yale University: Research proposal and budget Proposal, 1 January 1992--31 December 1996)

Energy Technology Data Exchange (ETDEWEB)

1992-01-01

This report reviews the following topics: nuclear and quark matter; correlated pairs from heavy ion collisions-search for new low mass resonances coupled to electron-positron collisions; proposed light ion research program; experimental nuclear astrophysics (explosive nucleosynthesis); search for rare decay modes and rare processes in nuclei; and nuclear spectroscopy at the extremes of spin, isospin, and temperature. (LSP).

[Experimental physics at Yale University: Research proposal and budget Proposal, 1 January 1992--31 December 1996

International Nuclear Information System (INIS)

1992-01-01

This report reviews the following topics: nuclear and quark matter; correlated pairs from heavy ion collisions-search for new low mass resonances coupled to electron-positron collisions; proposed light ion research program; experimental nuclear astrophysics (explosive nucleosynthesis); search for rare decay modes and rare processes in nuclei; and nuclear spectroscopy at the extremes of spin, isospin, and temperature. (LSP)

77 FR 8841 - Proposed Collection; Comment Request

Science.gov (United States)

2012-02-15

... Force Academy announces a proposed public information collection and seeks public comment on the...://www.regulations.gov . Follow the instructions for submitting comments. Mail: Federal Docket Management... Air Force Academy. Each student's background and aptitude is reviewed to determine eligibility. If the...

Self-management interventions : Proposal and validation of a new operational definition

NARCIS (Netherlands)

Jonkman, Nini H; Schuurmans, Marieke J; Jaarsma, Tiny; Shortridge-Baggett, Lillie M; Hoes, Arno W; Trappenburg, Jaap C A

2016-01-01

OBJECTIVES: Systematic reviews on complex interventions like self-management interventions often do not explicitly state an operational definition of the intervention studied, which may impact the review's conclusions. This study aimed to propose an operational definition of self-management

Self-management interventions: Proposal and validation of a new operational definition

NARCIS (Netherlands)

Jonkman, N.H.; Schuurmans, Marieke J.; Jaarsma, Tiny; Shortbridge-Baggett, Lillie M.; Hoes, Arno W.; Trappenburg, Jaap C A

2016-01-01

Objectives: Systematic reviews on complex interventions like self-management interventions often do not explicitly state an operational definition of the intervention studied, which may impact the review's conclusions. This study aimed to propose an operational definition of self-management

Review process for license renewal applications

International Nuclear Information System (INIS)

Craig, John W.; Kuo, P.T.

1991-01-01

In preparation for license renewal reviews, the Nuclear Regulatory Commission has recently published for public review and comment a proposed rule for license renewal and a draft Standard Review Plan as well as a draft Regulatory Guide relating to the implementation of the proposed rule. In support of future license renewal applications, the nuclear industry has also submitted 11 industry reports for NRC review and approval. This paper briefly describe how these parallel regulatory and industry activities will be factored into the NRC review process for license renewal. (author)

On the Track of C/overt Research: Lessons From Taking Ethnographic Ethics to the Extreme

Czech Academy of Sciences Publication Activity Database

Virtová, Tereza; Stöckelová, Tereza; Krásná, H.

(2018) ISSN 1077-8004 R&D Projects: GA ČR GA15-16452S; GA ČR(CZ) GJ16-18371Y Institutional support: RVO:68378025 ; RVO:67985955 Keywords : collaborative ethnography * informed consent * institutional review board (IRB) Subject RIV: AO - Sociology, Demography; AO - Sociology, Demography (FLU-F) OBOR OECD: Sociology; Sociology (FLU-F) Impact factor: 1.159, year: 2016

Dark sides of the proposed Framework Convention on Global Health's many virtues: A systematic review and critical analysis.

Science.gov (United States)

Hoffman, Steven J; Røttingen, John-Arne

2013-06-14

The costs of any proposal for new international law must be fully evaluated and compared with benefits and competing alternatives to ensure adoption will not create more problems than solutions. A systematic review of the research literature was conducted to categorize and assess limitations and unintended negative consequences associated with the proposed Framework Convention on Global Health (FCGH). A critical analysis then interpreted these findings using economic, ethical, legal, and political science perspectives. Of the 442 documents retrieved, nine met the inclusion criteria. Collectively, these documents highlighted that an FCGH could duplicate other efforts, lack feasibility, and have questionable impact. The critical analysis reveals that negative consequences can result from the FCGH's proposed form of international law and proposed functions of influencing national budgets, realizing health rights and resetting global governance for health. These include the direct costs of international law, opportunity costs, reducing political dialogue by legalizing political interactions, petrifying principles that may have only contemporary relevance, imposing foreign values on less powerful countries, forcing externally defined goals on countries, prioritizing individual rights over population-wide well-being, further complicating global governance for health, weakening the World Health Organization (WHO), reducing participation opportunities for non-state actors, and offering sub-optimal solutions for global health challenges. Four options for revising the FCGH proposal are developed to address its weaknesses and strengthen its potential for impact. These include: 1) abandoning international law as the primary commitment mechanism and instead pursuing agreement towards a less formal "framework for global health"; 2) seeking fundamental constitutional reform of WHO to address gaps in global governance for health; 3) mobilizing for a separate political platform

The Ontario Energy Board's proposed new mandate

International Nuclear Information System (INIS)

Laughren, F.

1998-01-01

The Ontario Energy Board's proposed new mandate was reviewed. The role of the Board will be to regulate the monopoly delivery components of the electricity and natural gas industry and to smooth the transition to competition. The Board will monitor market performance and will encourage electricity and natural gas monopoly services to be compatible where possible. The Board will also assist local restructuring efforts when called upon do so and ensure that the marketplace operates efficiently and effectively. Gas marketers' licensing is scheduled to begin in early 1999. Licenses will also apply to the electric industry. The objectives of the proposed licensing, the regulatory requirements and the proposed regulatory approach are described

Coronary artery aneurysms in acute coronary syndrome: case series, review, and proposed management strategy.

Science.gov (United States)

Boyer, Nathan; Gupta, Rajesh; Schevchuck, Alex; Hindnavis, Vindhya; Maliske, Seth; Sheldon, Mark; Drachman, Douglas; Yeghiazarians, Yerem

2014-06-01

Coronary artery aneurysm (CAA) is an uncommon clinical finding, with an incidence varying from 1.5%-4.9% in adults, and is usually considered a variant of coronary artery disease (CAD). CAA identified in the context of acute coronary syndrome (ACS) represents a unique management challenge, particularly if the morphology of the CAA is suspected to have provoked the acute clinical syndrome. CAA is associated with thrombus formation due to abnormal laminar flow, as well as abnormal platelet and endothelial-derived pathophysiologic factors within the CAA. Once formed, mural thrombus may potentiate the deposition of additional thrombus within aneurysmal segments. Percutaneous revascularization of CAA has been associated with complications including distal embolization of thrombus, no-reflow phenomenon, stent malapposition, dissection, and rupture. Presently, there are no formal guidelines to direct the management of CAA in patients presenting with ACS; controversies exist whether conservative, surgical, or catheter-based management should be pursued. In this manuscript, we present an extensive review of the existing literature and associated clinical guidelines, and propose a management algorithm for patients with this complex clinical scenario. Armed with this perspective, therapeutic decisions may be tailored to synthesize patient factors and preferences, individualized clinical assessment, and existing American Heart Association/American College of Cardiology guidelines for management of ACS.

Hydroxypropyl-β-cyclodextrin functionalized calcium carbonate microparticles as a potential carrier for enhancing oral delivery of water-insoluble drugs

Directory of Open Access Journals (Sweden)

Zhang L

2015-04-01

Full Text Available Lihua Zhang,1 Wufu Zhu,2 Qisi Lin,1 Jin Han,1 Liqun Jiang,1 Yanzhuo Zhang1,3 1Jiangsu Key Laboratory of New Drug Research and Clinical Pharmacy, Xuzhou Medical College, Xuzhou, People’s Republic of China; 2School of Pharmacy, Jiangxi Science and Technology Normal University, Nanchang, People’s Republic of China; 3Department of Pharmaceutics, School of Pharmacy, Xuzhou Medical College, Xuzhou, People’s Republic of China Abstract: The objective of the present study was to demonstrate that a novel hydroxypropyl-β-cyclodextrin functionalized calcium carbonate (HP-β-CD/CC based amorphous solid dispersion (ASD can be used to increase the solubility and oral bioavailability of water-insoluble drugs. Irbesartan (IRB was selected as a model compound and loaded into the nanoporous HP-β-CD/CC matrix using an immersion method. The IRB-loaded HP-β-CD/CC formulation was characterized by various analytical techniques, such as specific surface area analysis, scanning electron microscopy (SEM, dynamic light scattering (DLS, powder X-ray diffraction (PXRD, and differential scanning calorimetry (DSC. Analyses with PXRD and DSC confirmed that IRB was fully converted into the amorphous form in the nanopores of HP-β-CD/CC. From the solubility and dissolution tests, it was observed that the aqueous solubility and dissolution rate of IRB-loaded HP-β-CD/CC were increased significantly compared with those of pure IRB and IRB-loaded mesoporous silica. Likewise, the IRB-loaded HP-β-CD/CC formulation exhibited better absorption compared with that of the commercially available IRB capsules in beagle dogs. The mean peak plasma concentration (Cmax and the area under the mean plasma concentration–time curve (AUC[0→48] of IRB-loaded HP-β-CD/CC were 1.56- and 1.52-fold higher than that of the commercial product, respectively. Furthermore, the IRB-loaded HP-β-CD/CC formulation exhibited excellent stability against re-crystallization. These results clearly

Effective Solar Indices for Ionospheric Modeling: A Review and a Proposal for a Real-Time Regional IRI

Science.gov (United States)

Pignalberi, A.; Pezzopane, M.; Rizzi, R.; Galkin, I.

2018-01-01

The first part of this paper reviews methods using effective solar indices to update a background ionospheric model focusing on those employing the Kriging method to perform the spatial interpolation. Then, it proposes a method to update the International Reference Ionosphere (IRI) model through the assimilation of data collected by a European ionosonde network. The method, called International Reference Ionosphere UPdate (IRI UP), that can potentially operate in real time, is mathematically described and validated for the period 9-25 March 2015 (a time window including the well-known St. Patrick storm occurred on 17 March), using IRI and IRI Real Time Assimilative Model (IRTAM) models as the reference. It relies on foF2 and M(3000)F2 ionospheric characteristics, recorded routinely by a network of 12 European ionosonde stations, which are used to calculate for each station effective values of IRI indices IG_{12} and R_{12} (identified as IG_{{12{eff}}} and R_{{12{eff}}}); then, starting from this discrete dataset of values, two-dimensional (2D) maps of IG_{{12{eff}}} and R_{{12{eff}}} are generated through the universal Kriging method. Five variogram models are proposed and tested statistically to select the best performer for each effective index. Then, computed maps of IG_{{12{eff}}} and R_{{12{eff}}} are used in the IRI model to synthesize updated values of foF2 and hmF2. To evaluate the ability of the proposed method to reproduce rapid local changes that are common under disturbed conditions, quality metrics are calculated for two test stations whose measurements were not assimilated in IRI UP, Fairford (51.7°N, 1.5°W) and San Vito (40.6°N, 17.8°E), for IRI, IRI UP, and IRTAM models. The proposed method turns out to be very effective under highly disturbed conditions, with significant improvements of the foF2 representation and noticeable improvements of the hmF2 one. Important improvements have been verified also for quiet and moderately disturbed

Physics at the proposed National Underground Science Facility

International Nuclear Information System (INIS)

Nieto, M.M.

1983-01-01

The scientific, technical, and financial reasons for building a National Underground Science Facility are discussed. After reviewing examples of other underground facilities, we focus on the Los Alamos proposal and the national for its choice of site

The mantle cells lymphoma: a proposed treatment

International Nuclear Information System (INIS)

Chavez Martinez, Marlene Elizabeth

2012-01-01

A literature review was performed on mantle cells lymphoma in the therapeutic schemes. The literature that has been used is published in journals of medicine specializing in hematology, oncology, radiation therapy, molecular biology and internal medicine. The literature review was performed to propose a scheme of treatment according to Costa Rica. Epigenetic alterations have been revealed in patients with mantle lymphoma on current researches. The mantle lymphoma pathology has been described in various forms of clinical and histological presentation, stressing the importance of detailing the different methods and diagnostic reports. Working groups have proposed and developed various chemotherapy regimens and concluded that CHOP alone is without effect in mantle cell lymphoma unlike R-hyper-CVAD, CHOP / DHAP, high-dose Ara-C. Researchers have tried to develop new treatments based vaccines, use of modified viruses, specific monoclonal antibodies. The classic treatment has been triple intrathecal therapy. The central nervous system has been one of the most momentous sites of mantle cell lymphoma infiltration because poorer patient prognosis [es

[Review of meta-analysis research on exercise in South Korea].

Science.gov (United States)

Song, Youngshin; Gang, Moonhee; Kim, Sun Ae; Shin, In Soo

2014-10-01

The purpose of this study was to evaluate the quality of meta-analysis regarding exercise using Assessment of Multiple Systematic Reviews (AMSTAR) as well as to compare effect size according to outcomes. Electronic databases including the Korean Studies Information Service System (KISS), the National Assembly Library and the DBpia, HAKJISA and RISS4U for the dates 1990 to January 2014 were searched for 'meta-analysis' and 'exercise' in the fields of medical, nursing, physical therapy and physical exercise in Korea. AMSTAR was scored for quality assessment of the 33 articles included in the study. Data were analyzed using descriptive statistics, t-test, ANOVA and χ²-test. The mean score for AMSTAR evaluations was 4.18 (SD=1.78) and about 67% were classified at the low-quality level and 30% at the moderate-quality level. The scores of quality were statistically different by field of research, number of participants, number of databases, financial support and approval by IRB. The effect size that presented in individual studies were different by type of exercise in the applied intervention. This critical appraisal of meta-analysis published in various field that focused on exercise indicates that a guideline such as the PRISMA checklist should be strongly recommended for optimum reporting of meta-analysis across research fields.

Formulation and development of a self-nanoemulsifying drug delivery system of irbesartan

Directory of Open Access Journals (Sweden)

Jaydeep Patel

2011-01-01

Full Text Available Irbesartan (IRB is an angiotensin II receptor blocker antihypertensive agent. The aim of the present investigation was to develop a self-nanoemulsifying drug delivery system (SNEDDS to enhance the oral bioavailability of poorly water-soluble IRB. The solubility of IRB in various oils was determined to identify the oil phase of SNEDDS. Various surfactants and co-surfactants were screened for their ability to emulsify the selected oil. Pseudoternary phase diagrams were constructed to identify the efficient self-emulsifying region. The optimized SNEDDS formulation contained IRB (75 mg, Cremophor® EL (43.33%, Carbitol® (21.67% and Capryol® 90 (32%. SNEDDS was further evaluated for its percentage transmittance, emulsification time, drug content, phase separation, dilution, droplet size and zeta potential. The optimized formulation of IRB-loaded SNEDDS exhibited complete in vitro drug release in 15 min as compared with the plain drug, which had a limited dissolution rate. It was also compared with the pure drug solution by oral administration in male Wister rats. The in vivo study exhibited a 7.5-fold increase in the oral bioavailability of IRB from SNEDDS compared with the pure drug solution. These results suggest the potential use of SNEDDS to improve dissolution and oral bioavailability of poorly water-soluble IRB.

77 FR 25198 - Agency Information Collection Activities: Proposed Collection; Comments Requested: Immigration...

Science.gov (United States)

2012-04-27

... DEPARTMENT OF JUSTICE Executive Office for Immigration Review [OMB Number 1125-0007] Agency Information Collection Activities: Proposed Collection; Comments Requested: Immigration Practitioner Complaint...), Executive Office for Immigration Review (EOIR) will be submitting the following information collection...

Proposed method for regulating major materials licensees

International Nuclear Information System (INIS)

1992-02-01

The Director, Office of Nuclear Material Safety and Safeguards, US Nuclear Regulatory Commission, appointed a Materials Regulatory Review Task Force to conduct a broad-based review of the Commission's current licensing and oversight programs for fuel cycle and large materials plants. The task force, as requested, defined the components and subcomponents of an ideal regulatory evaluation system for these types of licensed plants and compared they to the components and subcomponents of the existing regulatory evaluation system. This report discusses findings from this comparison and proposed recommendations on the basis of these findings

A literature review of coupled thermal-hydrologic-mechanical-chemical processes pertinent to the proposed high-level nuclear waste repository at Yucca Mountain

International Nuclear Information System (INIS)

Manteufel, R.D.; Ahola, M.P.; Turner, D.R.; Chowdhury, A.H.

1993-07-01

A literature review has been conducted to determine the state of knowledge available in the modeling of coupled thermal (T), hydrologic (H), mechanical (M), and chemical (C) processes relevant to the design and/or performance of the proposed high-level waste (HLW) repository at Yucca Mountain, Nevada. The review focuses on identifying coupling mechanisms between individual processes and assessing their importance (i.e., if the coupling is either important, potentially important, or negligible). The significance of considering THMC-coupled processes lies in whether or not the processes impact the design and/or performance objectives of the repository. A review, such as reported here, is useful in identifying which coupled effects will be important, hence which coupled effects will need to be investigated by the US Nuclear Regulatory Commission in order to assess the assumptions, data, analyses, and conclusions in the design and performance assessment of a geologic reposit''. Although this work stems from regulatory interest in the design of the geologic repository, it should be emphasized that the repository design implicitly considers all of the repository performance objectives, including those associated with the time after permanent closure. The scope of this review is considered beyond previous assessments in that it attempts with the current state-of-knowledge) to determine which couplings are important, and identify which computer codes are currently available to model coupled processes

A literature review of coupled thermal-hydrologic-mechanical-chemical processes pertinent to the proposed high-level nuclear waste repository at Yucca Mountain

Energy Technology Data Exchange (ETDEWEB)

Manteufel, R.D.; Ahola, M.P.; Turner, D.R.; Chowdhury, A.H. [Southwest Research Inst., San Antonio, TX (United States). Center for Nuclear Waste Regulatory Analyses

1993-07-01

A literature review has been conducted to determine the state of knowledge available in the modeling of coupled thermal (T), hydrologic (H), mechanical (M), and chemical (C) processes relevant to the design and/or performance of the proposed high-level waste (HLW) repository at Yucca Mountain, Nevada. The review focuses on identifying coupling mechanisms between individual processes and assessing their importance (i.e., if the coupling is either important, potentially important, or negligible). The significance of considering THMC-coupled processes lies in whether or not the processes impact the design and/or performance objectives of the repository. A review, such as reported here, is useful in identifying which coupled effects will be important, hence which coupled effects will need to be investigated by the US Nuclear Regulatory Commission in order to assess the assumptions, data, analyses, and conclusions in the design and performance assessment of a geologic reposit``. Although this work stems from regulatory interest in the design of the geologic repository, it should be emphasized that the repository design implicitly considers all of the repository performance objectives, including those associated with the time after permanent closure. The scope of this review is considered beyond previous assessments in that it attempts with the current state-of-knowledge) to determine which couplings are important, and identify which computer codes are currently available to model coupled processes.

Making sense of resilience: a review from the field of paediatric psycho-oncology and a proposal of a model for its study

Directory of Open Access Journals (Sweden)

Carmina Castellano-Tejedor

2014-10-01

Full Text Available This article is intended to review the concept of resilience from the scope of paediatric psycho-oncology. The origin, its different definitions and its suitability of application in the field of serious physical illness - such as cancer - will be analyzed. Furthermore, the differences between resilience and other concepts commonly associated or confused with it, such as post-traumatic growth or benefit finding, will be discussed. Finally, a proposal for a comprehensive model of resilience in paediatric cancer will be put forward.

Autism Spectrum Disorder: Does Neuroimaging Support the DSM-5 Proposal for a Symptom Dyad? A Systematic Review of Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging Studies

Science.gov (United States)

Pina-Camacho, Laura; Villero, Sonia; Fraguas, David; Boada, Leticia; Janssen, Joost; Navas-Sanchez, Francisco J.; Mayoral, Maria; Llorente, Cloe; Arango, Celso; Parellada, Mara

2012-01-01

A systematic review of 208 studies comprising functional magnetic resonance imaging and diffusion tensor imaging data in patients with "autism spectrum disorder" (ASD) was conducted, in order to determine whether these data support the forthcoming DSM-5 proposal of a social communication and behavioral symptom dyad. Studies consistently reported…

Design reviews from a regulatory perspective

International Nuclear Information System (INIS)

Foster, B.D.

1991-01-01

This paper presents views on the role of the licensing engineer in the design process with specific emphasis on design reviews and the automated information management tools that support design reviews. The licensing engineer is seen as an important member of a design review team. The initial focus of the licensing engineer during design reviews is shown to be on ensuring that applicable regulatory requirements are addressed by the design. The utility of an automated tool, such as a commitments management system, to support regulatory requirements identification is discussed. The next responsibility of the licensing engineer is seen as verifying that regulatory requirements are transformed into measurable performance requirements. Performance requirements are shown to provide the basis for developing detailed design review criteria. Licensing engineer input during design reviews is discussed. This input is shown to be especially critical in cases where review findings may impact application of regulatory requirements. The use of automated tools in supporting design reviews is discussed. An information structure is proposed to support design reviews in a regulated environment. This information structure is shown to be useful to activities beyond design reviews. Incorporation of the proposed information structure into the Licensing Support System is proposed

76 FR 39800 - Proposed Flood Elevation Determinations

Science.gov (United States)

2011-07-07

... Planning and Review. This proposed rule is not a significant regulatory action under the criteria of... Idaho Springs Maps are available for inspection at City Hall, 1711 Miner Street, Idaho Springs, CO 80452.... Town of Macclesfield Maps are available for inspection at the Edgecombe County Planning Department, 201...

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.

New ultra-performance liquid chromatography-tandem mass spectrometry method for the determination of irbesartan in human plasma

Directory of Open Access Journals (Sweden)

Tanveer A. Wani

2015-09-01

Full Text Available With the objective of reducing analysis time and maintaining good efficiency, there has been substantial focus on high-speed chromatographic separations and ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS is a preeminent analytical tool for rapid biomedical analysis. In this study a simple, rapid, sensitive, and specific ultra-performance liquid chromatography-MS/MS method was developed and validated for quantification of the angiotensin II receptor antagonist, irbesartan (IRB, in human plasma. After a simple protein precipitation using methanol and acetonitrile, IRB and internal standard (IS telmisartan were separated on Acquity UPLC BEH C18 column (50 mm × 2.1 mm, i.d. 1.7 μm, Waters, Milford, MA, USA using a mobile phase consisted of acetonitrile: methanol: 10 mM ammonium acetate (70: 15: 15 v/v/v with a flow rate of 0.4 mL/min and detected MS/MS in negative ion mode. The ion transitions recorded in multiple reaction monitoring mode were m/z 427.2→193.08 for IRB and m/z 513.2→469.3 for IS. The assay exhibited a linear dynamic range of 2–500 ng/mL for IRB in human plasma with good correlation coefficient of (0.995 and with a lower limit of quantitation of 2 ng/mL. The intra- and interassay precisions were satisfactory; the relative standard deviations did not exceed 9.91%. The proposed UPLC-MS/MS method is simple, rapid, and highly sensitive, and hence it could be reliable for pharmacokinetic and toxicokinetic study in both animals and humans.

Outsourcing ethical obligations: should the revised common rule address the responsibilities of investigators and sponsors?

Science.gov (United States)

Shah, Seema K

2013-01-01

The Common Rule creates a division of moral labor in research. It implies that investigators and sponsors can outsource their ethical obligations to IRBs and participants, thereby fostering a culture of compliance, rather than one of responsibility. The proposed revisions to the Common Rule are likely to exacerbate this problem. To harness the expressive power of the law, I propose the Common Rule be revised to include the ethical responsibilities of investigators and sponsors. © 2013 American Society of Law, Medicine & Ethics, Inc.

Phonosurgery of the vocal folds : a classification proposal

NARCIS (Netherlands)

Remacle, M; Friedrich, G; Dikkers, FG; de Jong, F

The Phonosurgery Committee of the European Laryngological Society (ELS) has examined the definition and technical description of phonosurgical procedures. Based on this review, the committee has proposed a working classification. The current presentation is restricted to vocal fold surgery (VFS)

Assessment of the proposed decontamination and waste treatment facility at LLNL

International Nuclear Information System (INIS)

Cohen, J.J.

1987-01-01

To provide a centralized decontamination and waste treatment facility (DWTF) at LLNL, the construction of a new installation has been planned. Objectives for this new facility were to replace obsolete, structurally and environmentally sub-marginal liquid and solid waste process facilities and decontamination facility and to bring these facilities into compliance with existing federal, state and local regulations as well as DOE orders. In a previous study, SAIC conducted a preliminary review and evaluation of existing facilities at LLNL and cost effectiveness of the proposed DWTF. This document reports on a detailed review of specific aspects of the proposed DWTF

[Evaluation of new and emerging health technologies. Proposal for classification].

Science.gov (United States)

Prados-Torres, J D; Vidal-España, F; Barnestein-Fonseca, P; Gallo-García, C; Irastorza-Aldasoro, A; Leiva-Fernández, F

2011-01-01

Review and develop a proposal for the classification of health technologies (HT) evaluated by the Health Technology Assessment Agencies (HTAA). Peer review of AETS of the previous proposed classification of HT. Analysis of their input and suggestions for amendments. Construction of a new classification. Pilot study with physicians. Andalusian Public Health System. Spanish HTAA. Experts from HTAA. Tutors of family medicine residents. HT Update classification previously made by the research team. Peer review by Spanish HTAA. Qualitative and quantitative analysis of responses. Construction of a new and pilot study based on 12 evaluation reports of the HTAA. We obtained 11 thematic categories that are classified into 6 major head groups: 1, prevention technology; 2, diagnostic technology; 3, therapeutic technologies; 4, diagnostic and therapeutic technologies; 5, organizational technology, and 6, knowledge management and quality of care. In the pilot there was a good concordance in the classification of 8 of the 12 reports reviewed by physicians. Experts agree on 11 thematic categories of HT. A new classification of HT with double entry (Nature and purpose of HT) is proposed. APPLICABILITY: According to experts, the classification of the work of the HTAA may represent a useful tool to transfer and manage knowledge. Moreover, an adequate classification of the HTAA reports would help clinicians and other potential users to locate them and this can facilitate their dissemination. Copyright © 2010 SECA. Published by Elsevier Espana. All rights reserved.

Neurological Effects of Exposure to Non-Hypoxic Hypobaria

Science.gov (United States)

2014-04-16

be at risk for subclinical brain injury, raising concern about the long-term impact in aircrew. Altitude chamber personnel are a second...flight surgeon FSL BET brain extraction tool FSL FLIRT FMRIB’s linear image registration tool IQ intelligence quotient IRB Institutional Review...population would potentially have similar risks and findings. Chronic brain injury in other neurological diseases is associated with lower

Industrial relations and site management proposals for Sizewell 'B'

International Nuclear Information System (INIS)

Burbridge, R.N.

1986-01-01

The vendor assessment and general contract strategy for the proposed Sizewell 'B' PWR are reviewed with particular reference to a 'Key Date' procedure. The family of programmes used in constructing CEGB projects is indicated and the intended site labour strategy for the project is outlined. To exemplify the current success of these policies, the paper concludes with a brief review of their application to the CEGB's Drax Completion Project. (author)

[Guideline for the assessment of clinical research proposals. Comisión Nacional de Investigación Científica del Instituto Mexicano del Seguro Social].

Science.gov (United States)

Mejía-Aranguré, Juan Manuel; Grijalva-Otero, Israel; Majluf-Cruz, Abraham; Cruz-López, Miguel; Núñez-Enríquez, Juan Carlos; Salamanca-Gómez, Fabio Abdiel

2013-01-01

Medical research is a fundamental tool to achieve the advancement of science, through the improvement of strategies aimed to protect, promote and restore an individual's and society's health. Three characteristics are required to obtain approval of the research proposal: scientific relevance, technical quality and the accomplishment of ethical issues. The present review aimed at the determination of the specific criteria to perform a critical review of research proposals. A research was carried out in the PubMed, Medline, Ovid and Google Scholar databases, using the terms: peer review, research proposals, review and protocols, and reviewers. A total of 3546 related articles were reviewed, without finding a guide to critically assess research proposals. The guides to assess research articles consider that the quality criteria of the study should have been present since the study's conception; many of the issues described to review articles are incorporated in the review of the research proposals. The specific criteria were integrated to allow the reviewer to critically assess research proposals of different areas with scientific basis. The reviewer of research proposals should be considered as a professional that contributes to the promotion of knowledge advancement through his/her comments, which allow researchers to improve the quality of research proposals.

The Ethics of Sharing Plastic Surgery Videos on Social Media: Systematic Literature Review, Ethical Analysis, and Proposed Guidelines.

Science.gov (United States)

Dorfman, Robert G; Vaca, Elbert E; Fine, Neil A; Schierle, Clark F

2017-10-01

Recent videos shared by plastic surgeons on social media applications such as Snapchat, Instagram, and YouTube, among others, have blurred the line between entertainment and patient care. This has left many in the plastic surgery community calling for the development of more structured oversight and guidance regarding video sharing on social media. To date, no official guidelines exist for plastic surgeons to follow. Little is known about the ethical implications of social media use by plastic surgeons, especially with regard to video sharing. A systematic review of the literature on social media use in plastic surgery was performed on October 31, 2016, with an emphasis on ethics and professionalism. An ethical analysis was conducted using the four principles of medical ethics. The initial search yielded 87 articles. Thirty-four articles were included for analyses that were found to be relevant to the use of social media in plastic surgery. No peer-reviewed articles were found that mentioned Snapchat or addressed the ethical implications of sharing live videos of plastic surgery on social media. Using the four principles of medical ethics, it was determined that significant ethical concerns exist with broadcasting these videos. This analysis fills an important gap in the plastic surgery literature by addressing the ethical issues concerning live surgery broadcasts on social media. Plastic surgeons may use the guidelines proposed here to avoid potential pitfalls.

75 FR 70952 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2010-11-19

... for Elementary Particle Physics, National Science Foundation, 4201 Wilson Blvd., Arlington, VA 22230... information concerning individuals associated with the proposals. These matters are exempt under 5 U.S.C. 552b...

75 FR 63865 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2010-10-18

..., Program Director for Elementary Particle Physics, National Science Foundation, 4201 Wilson Blvd... concerning individuals associated with the proposals. These matters are exempt under 5 U.S.C. 552b (c) and (6...

Benefit analysis of proposed information systems

OpenAIRE

Besore, Mark H.

1991-01-01

Approved for public release; distribution is unlimited This thesis reviewed two different approaches to benefit analysis, benefit comparison and user satisfaction, that could be applied to the evaluation of proposed information systems which are under consideration for acquisition by the federal government. Currently the General Services Administration only recommends that present value analysis methods be used in the analysis of alternatives even though the GSA specifies...

Basic Science Research and the Protection of Human Research Participants

Science.gov (United States)

Eiseman, Elisa

2001-03-01

Technological advances in basic biological research have been instrumental in recent biomedical discoveries, such as in the understanding and treatment of cancer, HIV/AIDS, and heart disease. However, many of these advances also raise several new ethical challenges. For example, genetic research may pose no physical risk beyond that of obtaining the initial blood sample, yet it can pose significant psychological and economic risks to research participants, such as stigmatization, discrimination in insurance and employment, invasion of privacy, or breach of confidentiality. These harms may occur even when investigators do not directly interact with the person whose DNA they are studying. Moreover, this type of basic research also raises broader questions, such as what is the definition of a human subject, and what kinds of expertise do Institutional Review Boards (IRBs) need to review the increasingly diverse types of research made possible by these advances in technology. The National Bioethics Advisory Commission (NBAC), a presidentially appointed federal advisory committee, has addressed these and other ethical, scientific and policy issues that arise in basic science research involving human participants. Two of its six reports, in particular, have proposed recommendations in this regard. "Research Involving Human Biological Materials: Ethical and Policy Guidance" addresses the basic research use of human tissues, cells and DNA and the protection of human participants in this type of research. In "Ethical and Policy Issues in the Oversight of Human Research" NBAC proposes a definition of research involving human participants that would apply to all scientific disciplines, including physical, biological, and social sciences, as well as the humanities and related professions, such as business and law. Both of these reports make it clear that the protection of research participants is key to conducting ethically sound research. By ensuring that all participants in

Proposal for a source of polarized protons; Projet de source de protons polarises

Energy Technology Data Exchange (ETDEWEB)

Abragam, A.; Winter, J. M. [Commissariat a l' energie atomique et aux energies alternatives - CEA, Centre d' Etudes Nucleaires de Saclay, BP2, Gif-sur-Yvette (France)

1959-07-01

Proposal for a source of polarized protons based on the theory of adiabatic fast passage due to F. Bloch. Reprint of a paper published in 'Physical review letters', vol 1, n. 10, 15 Nov 1958, p. 374-375 [French] On propose une methode nouvelle pour la realisation d'une source de protons polarises basee sur la theorie du passage adiabatique de F. Bloch. Reproduction d'un article publie dans 'Physical review letters', vol 1, n. 10, 15 nov 1958, p. 374-375.

76 FR 47177 - Notice of Proposed Information Collection Requests

Science.gov (United States)

2011-08-04

... Information Management Services, Office of Management, publishes this notice containing proposed information... Collection Clearance Division, Regulatory Information Management Services, Office of Management, invites..., Regulatory Information Management Services, Office of Management. Federal Student Aid Type of Review...

A proposal for a code of ethics for nurse practitioners.

Science.gov (United States)

Peterson, Moya; Potter, Robert Lyman

2004-03-01

To review established codes for health care professionals and standards of practice for the nurse practitioner (NP) and to utilize these codes and standards, general ethical themes, and a new ethical triangle to propose an ethical code for NPs. Reviews of three generally accepted ethical themes (deontological, teleological, and areteological), the ethical triangle by Potter, the American Academy of Nurse Practitioners (AANP) standards of practice for NPs, and codes of ethics from the American Nurses Association (ANA) and the American Medical Association (AMA). A proposal for a code of ethics for NPs is presented. This code was determined by basic ethical themes and established codes for nursing, formulated by the ANA, and for physicians, formulated by the AMA. The proposal was also developed in consideration of the AANP standards of practice for NPs. The role of the NP is unique in its ethical demands. The authors believe that the expanded practice of NPs presents ethical concerns that are not addressed by the ANA code and yet are relevant to nursing and therefore different than the ethical concerns of physicians. This proposal attempts to broaden NPs' perspective of the role that ethics should hold in their professional lives.

Budget Analysis: Review of the Governor's Proposed Budget, 1999-00.

Science.gov (United States)

New York State Office of the Comptroller, Albany.

This report provides an overview of the 1999-2000 executive budget for New York State. The budget calls for $72.7 billion in all funds spending and proposes that a $1.8 billion surplus from the 1998-99 fiscal year be used to fill budget gaps in fiscal years 2000-01 and 2001-02. The report focuses on spending for education, health and social…

Intermittent losartan administration triggers cardiac post-conditioning in isolated rat hearts: role of BK2 receptors.

Directory of Open Access Journals (Sweden)

Luca Sgarra

Full Text Available The angiotensin (Ang and bradykinin (BK tissue-system plays a pivotal role in post-conditioning, but the efficacy of angiotensin type 1 receptor (AT1R blockers (ARBs in post-ischemic strategies is still under investigation. We evaluated functional and morphological outcomes, together with activation of cytosolic RISK pathway kinases, in rat hearts subjected to losartan (LOS or irbesartan (IRB post-ischemic administration.Isolated rat hearts underwent 30 min ischemia and 120 min reperfusion. Post-conditioning was obtained by intermittent (10 s/each or continuous drug infusion during the first 3 min of reperfusion. Left ventricular end-diastolic pressure (LVEDP, left ventricular developed pressure (dLVP, coronary flow (CF, and left ventricular infarct mass (IM were measured together with the activation status of RISK kinases Akt, p42/44 MAPK and GSK3β.When compared to hearts subjected to ischemia/reperfusion (iI/R alone, continuous IRB or LOS administration did not significantly reduce total infarct mass (cIRB or cLOS vs. iI/R, p = 0.2. Similarly, intermittent IRB (iIRB was not able to enhance cardioprotection. Conversely, intermittent LOS administration (iLOS significantly ameliorated cardiac recovery (iLOS vs iI/R, p<0.01. Differences between iLOS and iIRB persisted under continuous blockade of AT2R (iLOS+cPD vs. iIRB+cPD, p<0.05. Interestingly, iLOS cardioprotection was lost when BK2R was simultaneously blocked (iLOS+cHOE vs. iI/R, p = 0.6, whereas concurrent administration of iBK and iIRB replicated iLOS effects (iIRB+iBK vs. iLOS, p = 0.7. At the molecular level, iIRB treatment did not significantly activate RISK kinases, whereas both iLOS and iBK treatments were associated with activation of the Akt/GSK3β branch of the RISK pathways (p<0.05 vs. iI/R, for both.Our results suggest that intermittent losartan is effective in mediating post-conditioning cardioprotection, whereas irbesartan is not. The infarct mass reduction by intermittent

76 FR 7175 - Notice of Proposed Information Collection Requests

Science.gov (United States)

2011-02-09

... Information Management Services, Office of Management, publishes this notice containing proposed information... Collection Clearance Division, Regulatory Information Management Services, Office of Management, invites..., Regulatory Information Management Services, Office of Management. Office of the Secretary Type of Review...

Yet Another Modest Proposal on the Ph.D/D.A. Question

Science.gov (United States)

Allen, Louise H.

1975-01-01

The paper reviews the advantages and disadvantages of Doctor of Arts programs and their relations to Ph.D programs, particularly in terms of teaching, scholarship and job opportunities. Proposals by Benseler to revive the D.A., and by Brod to reform the Ph.D along the lines of the D.A. are reviewed. (CLK)

Northeast Asia regional energy infrastructure proposals

International Nuclear Information System (INIS)

Hippel, David von; Gulidov, Ruslan; Kalashnikov, Victor; Hayes, Peter

2011-01-01

Economic growth in the countries of Northeast Asia has spurred a massive increase in the need for energy, especially oil, gas, coal, and electricity. Although the region, taken as a whole, possesses financial, technical, labor, and natural resources sufficient to address much of the region's needs now and into the future, no one country has all of those attributes. As a result, over the past two decades, there has been significant interest in regional proposals that would allow sharing of resources, including infrastructure to develop and transport energy resources from the Russian Far East to South Korea, China, and Japan, and cooperation on energy-efficiency, renewable energy, and the nuclear fuel cycle as well. In this article we review some of these proposals, identify some of the factors that could contribute to the success or failure of infrastructure proposals, and explore some of the implications and ramifications of energy cooperation activities for energy security in the region.

Using simplified peer review processes to fund research: a prospective study

Science.gov (United States)

Herbert, Danielle L; Graves, Nicholas; Clarke, Philip; Barnett, Adrian G

2015-01-01

Objective To prospectively test two simplified peer review processes, estimate the agreement between the simplified and official processes, and compare the costs of peer review. Design, participants and setting A prospective parallel study of Project Grant proposals submitted in 2013 to the National Health and Medical Research Council (NHMRC) of Australia. The official funding outcomes were compared with two simplified processes using proposals in Public Health and Basic Science. The two simplified processes were: panels of 7 reviewers who met face-to-face and reviewed only the nine-page research proposal and track record (simplified panel); and 2 reviewers who independently reviewed only the nine-page research proposal (journal panel). The official process used panels of 12 reviewers who met face-to-face and reviewed longer proposals of around 100 pages. We compared the funding outcomes of 72 proposals that were peer reviewed by the simplified and official processes. Main outcome measures Agreement in funding outcomes; costs of peer review based on reviewers’ time and travel costs. Results The agreement between the simplified and official panels (72%, 95% CI 61% to 82%), and the journal and official panels (74%, 62% to 83%), was just below the acceptable threshold of 75%. Using the simplified processes would save $A2.1–$A4.9 million per year in peer review costs. Conclusions Using shorter applications and simpler peer review processes gave reasonable agreement with the more complex official process. Simplified processes save time and money that could be reallocated to actual research. Funding agencies should consider streamlining their application processes. PMID:26137884

The ethics of peer review in bioethics

Science.gov (United States)

Wendler, David; Miller, Franklin

2014-01-01

A good deal has been written on the ethics of peer review, especially in the scientific and medical literatures. In contrast, we are unaware of any articles on the ethics of peer review in bioethics. Recognising this gap, we evaluate the extant proposals regarding ethical standards for peer review in general and consider how they apply to bioethics. We argue that scholars have an obligation to perform peer review based on the extent to which they personally benefit from the peer review process. We also argue, contrary to existing proposals and guidelines, that it can be appropriate for peer reviewers to benefit in their own scholarship from the manuscripts they review. With respect to bioethics in particular, we endorse double-blind review and suggest several ways in which the peer review process might be improved. PMID:24131903

Reviews in innovative software development

DEFF Research Database (Denmark)

Aaen, Ivan; Boelsmand, Jeppe Vestergaard; Jensen, Rasmus

2009-01-01

This paper proposes a new review approach for innovative software development. Innovative software development implies that requirements are rarely available as a basis for reviewing and that the purpose of a review is as much to forward additional ideas, as to validate what has been accomplished...

Concordant, non-atypical breast papillomas do not require surgical excision: A 10-year multi-institution study and review of the literature.

Science.gov (United States)

Grimm, Lars J; Bookhout, Christine E; Bentley, Rex C; Jordan, Sheryl G; Lawton, Thomas J

2018-05-01

Non-atypical papillomas (NAPs) diagnosed on core needle biopsy (CNB) frequently undergo surgical excision due to highly variable upstaging rates. The purpose of this study is to document our dual-institution upgrade rates of NAPs diagnosed on core needle biopsy and review the upgrade rates reported in the literature. Following IRB approval, CNB results from Duke University (7/1/2004-6/30/2014) and the University of North Carolina Chapel Hill (1/1/04-6/30/2013) were reviewed to identify non-atypical papillomas. All cases with surgical excision or 2 years of imaging follow up were included. In addition, a literature review identified 60 published studies on upgrades of NAPs diagnosed at CNB. Cases in our cohort and the published literature were reviewed for confounding factors: [1] missing radiologic-pathologic concordance and/or discordance, [2] papillomas included with high-risk lesions, [3] high risk lesions counted as upgrades, [4] review by a nonspecialized breast pathologist, and [5] cancer incidentally detected. Of the 388 CNBs in our dual-institution cohort, 136 (35%) patients underwent surgical excision and 252 (65%) patients had imaging follow up. After controlling for confounders, no cancers (0/388) were found at surgical excision or during follow up imaging. The literature review upstaging rate was 4.0% (166/4157) but 1.8% (4/227) after excluding studies with confounders. The combined upstaging rate from the literature and this study was 0.6% (4/615). The upstaging rate for CNB diagnosed NAPs was 0% in our cohort and 0.6% overall after adjusting for confounders. This low rate does not warrant reflexive surgical excision and diagnostic imaging follow up should be discretionary. Copyright © 2018 Elsevier Inc. All rights reserved.

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

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

Scoping reviews: time for clarity in definition, methods, and reporting.

Science.gov (United States)

Colquhoun, Heather L; Levac, Danielle; O'Brien, Kelly K; Straus, Sharon; Tricco, Andrea C; Perrier, Laure; Kastner, Monika; Moher, David

2014-12-01

The scoping review has become increasingly popular as a form of knowledge synthesis. However, a lack of consensus on scoping review terminology, definition, methodology, and reporting limits the potential of this form of synthesis. In this article, we propose recommendations to further advance the field of scoping review methodology. We summarize current understanding of scoping review publication rates, terms, definitions, and methods. We propose three recommendations for clarity in term, definition and methodology. We recommend adopting the terms "scoping review" or "scoping study" and the use of a proposed definition. Until such time as further guidance is developed, we recommend the use of the methodological steps outlined in the Arksey and O'Malley framework and further enhanced by Levac et al. The development of reporting guidance for the conduct and reporting of scoping reviews is underway. Consistency in the proposed domains and methodologies of scoping reviews, along with the development of reporting guidance, will facilitate methodological advancement, reduce confusion, facilitate collaboration and improve knowledge translation of scoping review findings. Copyright © 2014 Elsevier Inc. All rights reserved.

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.

A quantitative study of attitudes toward the research participation of adults with intellectual disability: Do stakeholders agree?

Science.gov (United States)

McDonald, Katherine E; Conroy, Nicole E; Olick, Robert S

2017-12-13

Attitudes toward the research participation of adults with intellectual disability inform research policy and practice, impact interest in and support for research participation, and promote or discourage the generation of new knowledge to promote health among adults with intellectual disability. Yet we know little about these beliefs among the public and the scientific community. We quantitatively studied attitudes among adults with intellectual disability, family and friends, disability service providers, researchers, and Institutional Review Board (IRB) members. We predicted that adults with intellectual disability, and researchers would espouse views most consistent with disability rights, whereas IRB members, and to a lesser degree family, friends, and service providers, would espouse more protective views. We surveyed five hundred and twelve members of the five participant stakeholder groups on their attitudes toward the research participation of adults with intellectual disability. We found broad support for research about people with intellectual disability, though slightly more tempered support for their direct participation therein. In general, IRB members and to some extent adults with intellectual disability endorsed direct participation less than others. We also found that adults with intellectual disability strongly believed in their consent capacity. Resources should be directed toward health-related research with adults with intellectual disability, and interventions should be pursued to address ethical challenges and promote beliefs consistent with human rights. Copyright © 2017 Elsevier Inc. All rights reserved.

Exchange Rate as a Determinant of Foreign Direct Investment: Does it Really Matter? Theoretical Aspects, Literature Review and Applied Proposal

Directory of Open Access Journals (Sweden)

Isabel Cristina Ruiz

2005-10-01

Full Text Available This paper re-examines the role of exchange rates as determinant of FDI. It extends the analysis to include the issue of how exchange rates determine the decision of invest in one country depending on whether the firm is deciding to invest on the country to service the local market or to invest on the country in order to re-export. This paper offers a broad literature review of the state of the empirical research in order to draw conclusions of the real importance of the exchange rate as a determinant of FDI. Details of FDI current behavior in Latin American are described and I propose a model of FDI to be applied for these countries. Data sources are given.

39 CFR 3020.75 - Review.

Science.gov (United States)

2010-07-01

... 39 Postal Service 1 2010-07-01 2010-07-01 false Review. 3020.75 Section 3020.75 Postal Service POSTAL REGULATORY COMMISSION PERSONNEL PRODUCT LISTS Proposal of the Commission To Modify the Product Lists Described Within the Mail Classification Schedule § 3020.75 Review. The Commission shall review...

Review of Research: Neuroscience and Reading--A Review for Reading Education Researchers

Science.gov (United States)

Hruby, George G.; Goswami, Usha

2011-01-01

In this review, we lay the groundwork for an interdisciplinary conversation between literacy education research and relevant neuroscience research. We review recent neuroscience research on correlates of proposed cognitive subprocesses in text decoding and reading comprehension and analyze some of the methodological and conceptual challenges of…

78 FR 19509 - Notice of Proposed Information Collection: Comment Request; Comprehensive Needs Assessment (CNA)

Science.gov (United States)

2013-04-01

...The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. HUD is soliciting public comments on the subject proposal.

Systematic review of environmental risk factors for Obsessive-Compulsive Disorder: A proposed roadmap from association to causation.

Science.gov (United States)

Brander, Gustaf; Pérez-Vigil, Ana; Larsson, Henrik; Mataix-Cols, David

2016-06-01

To synthesize the current knowledge on possible environmental risk factors for Obsessive-Compulsive Disorder (OCD). We conducted a systematic review following PRISMA guidelines. The Embase, PubMed and Scopus databases were searched up until October 6, 2015, employing relevant keywords and MeSH terms. 128 studies met inclusion criteria. Potential environmental risk factors for OCD have been identified in the broad areas of perinatal complications, reproductive cycle, and stressful life events. There is limited evidence regarding other potential risk factors, such as parental age, season of birth, socioeconomic status, parental rearing practices, infections, traumatic brain injury, substance use or vitamin deficiency. In general, studies were of limited methodological quality. At present, no environmental risk factors have convincingly been associated with OCD. We propose a roadmap for future studies, consisting of longitudinal, population-based research, employing quasi-experimental family and twin designs to identify risk factors that are not only associated with the disorder but also contribute to its causation either directly or moderating the effect of genes. Copyright © 2016 Elsevier Ltd. All rights reserved.

Variation of Community Consultation and Public Disclosure for a Pediatric Multi-centered “Exception from Informed Consent” Trial

Science.gov (United States)

Holsti, Maija; Zemek, Roger; Baren, Jill; Stanley, Rachel M.; Prashant, Mahajan; Vance, Cheryl; Brown, Kathleen M.; Gonzalez, Victor; King, Denise; Jacobsen, Kammy; Shreve, Kate; van de Bruinhorst, Katrina; Jones, Anne Marie; Chamberlain, James M.

2014-01-01

Background The U.S. federal regulation “Exception from Informed Consent (EFIC) for Emergency Research,” 21 Code of Federal Regulations 50.24, permits emergency research without informed consent under limited conditions. Additional safeguards to protect human subjects include requirements for community consultation and public disclosure prior to starting the research. Because the regulations are vague about these requirements, Institutional Review Boards (IRBs) determine the adequacy of these activities at a local level. Thus there is potential for broad interpretation and practice variation. Aim To describe the variation of community consultation and public disclosure activities approved by IRBs, and the effectiveness of this process for a multi-center, EFIC, pediatric status epilepticus clinical research trial. Methods: Community consultation and public disclosure activities were analyzed for each of 15 participating sites. Surveys were conducted with participants enrolled in the status epilepticus trial to assess the effectiveness of public disclosure dissemination prior to study enrollment. Results Every IRB, among the 15 participating sites, had a varied interpretation of EFIC regulations for community consultation and public disclosure activities. IRBs required various combinations of focus groups, interviews, surveys, and meetings for community consultation; news releases, mailings, and public service announcements for public disclosure. At least 4,335 patients received information about the study from these efforts. 158 chose to be included in the “Opt Out” list. Of the 304 participants who were enrolled under EFIC, 12 (5%) had heard about the study through community consultation or public disclosure activities. The activities reaching the highest number of participants were surveys and focus groups associated with existing meetings. Public disclosure activities were more efficient and cost-effective if they were part of an in-hospital resource for

77 FR 75915 - Review and Approval of Projects

Science.gov (United States)

2012-12-26

... SUSQUEHANNA RIVER BASIN COMMISSION 18 CFR Part 806 Review and Approval of Projects AGENCY... document contains proposed rules that would amend the project review regulations of the Susquehanna River... set forth in this proposed rulemaking is to make further modifications to the Commission's project...

Review comments on Environmental Analysis Cost Reduction Proposals (WIPP-DOE-136), July 1982

International Nuclear Information System (INIS)

Channell, J.K.

1982-11-01

The cost reduction proposals have the laudable goal of significantly reducing the total capital And operating cost connected with WIPP. Furthermore, since the proposed changes would reduce the size and operating rate of the project, they would be expected to have decreased environmental And socioeconomic impacts. However, some of these cost reduction proposals do decrease factors of safety in various components of the project or trade off one type of environmental detriment for another. The report does not contain sufficient detail to justify all of the conclusions reached; more discussion and quantitative information (including costs) is necessary in some cases. Also, there are places where the report is unclear or contradictory. Without a more detailed evaluation, EEG is unable to conclude that each of these cost reduction proposals either has a net environmental/health and safety benefit or a cost savings that justifies a net detriment. A revised Environmental Analysis (EA) should either include additional information or specifically reference backup documents where these conclusions have been justified. In addition, the EA needs to be revised to include the effect of the recently announced (11/18/82) decision by DOE to relocate the underground waste storage areas of the repository to the south

Review of current Southern California edison load management programs and proposal for a new market-driven, mass-market, demand-response program

Energy Technology Data Exchange (ETDEWEB)

Weller, G.H.

2002-01-01

Utility load management programs, including direct load control and interruptible load programs, constitute a large installed base of controllable loads that are employed by utilities as system reliability resources. In response to energy supply shortfalls expected during the summer of 2001, the California Public Utilities Commission in spring 2001 authorized new utility load management programs as well as revisions to existing programs. This report provides an independent review of the designs of these new programs for a large utility (Southern California Edison) and suggests possible improvements to enhance the price responsiveness of the customer actions influenced by these programs. The report also proposes a new program to elicit a mass-market demand response to utility price signals.

Resolving ethical issues in stem cell clinical trials: the example of Parkinson disease.

Science.gov (United States)

Lo, Bernard; Parham, Lindsay

2010-01-01

Clinical trials of stem cell transplantation raise ethical issues that are intertwined with scientific and design issues, including choice of control group and intervention, background interventions, endpoints, and selection of subjects. We recommend that the review and IRB oversight of stem cell clinical trials should be strengthened. Scientific and ethics review should be integrated in order to better assess risks and potential benefits. Informed consent should be enhanced by assuring that participants comprehend key aspects of the trial. For the trial to yield generalizable knowledge, negative findings and serious adverse events must be reported.

A proposed framework for computational fluid dynamics code calibration/validation

International Nuclear Information System (INIS)

Oberkampf, W.L.

1993-01-01

The paper reviews the terminology and methodology that have been introduced during the last several years for building confidence n the predictions from Computational Fluid Dynamics (CID) codes. Code validation terminology developed for nuclear reactor analyses and aerospace applications is reviewed and evaluated. Currently used terminology such as ''calibrated code,'' ''validated code,'' and a ''validation experiment'' is discussed along with the shortcomings and criticisms of these terms. A new framework is proposed for building confidence in CFD code predictions that overcomes some of the difficulties of past procedures and delineates the causes of uncertainty in CFD predictions. Building on previous work, new definitions of code verification and calibration are proposed. These definitions provide more specific requirements for the knowledge level of the flow physics involved and the solution accuracy of the given partial differential equations. As part of the proposed framework, categories are also proposed for flow physics research, flow modeling research, and the application of numerical predictions. The contributions of physical experiments, analytical solutions, and other numerical solutions are discussed, showing that each should be designed to achieve a distinctively separate purpose in building confidence in accuracy of CFD predictions. A number of examples are given for each approach to suggest methods for obtaining the highest value for CFD code quality assurance

76 FR 61111 - Notice of Proposed Information Collection: Comment Request Self-Help Homeownership Opportunity...

Science.gov (United States)

2011-10-03

...The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.

75 FR 6682 - Notice of Proposed Information Collection: Comment Request; Comprehensive Needs Assessment (CNA)

Science.gov (United States)

2010-02-10

...The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.

Pharmacological interventions to treat phlebitis: systematic review.

Science.gov (United States)

dos Reis, Paula Elaine Diniz; Silveira, Renata Cristina de Campos Pereira; Vasques, Christiane Inocêncio; de Carvalho, Emilia Campos

2009-01-01

This study presents a systematic review for evaluating effective pharmacological actions for the treatment of phlebitis stemming from infusion therapy. The studies reviewed were categorized according to the type of therapeutic approach proposed by the author and by the level of evidence presented. The review found that topical nitroglycerin and notoginseny were more effective in the reduction of the inflammatory process when compared with other proposed alternatives. Nevertheless, the development of research related to possible alternatives for the treatment of phlebitis is important.

Alzheimer's Disease and Related Dementias. Hearing before the Subcommittee on Aging of the Committee on Labor and Human Resources. United States Senate, Ninety-Ninth Congress, Second Session on Review of Health Care Services Available for People with Alzheimer's Disease and Related Dementia and To Review Proposals Related to the Treatment of Alzheimer's Disease.

Science.gov (United States)

Congress of the U.S., Washington, DC. Senate Committee on Labor and Human Resources.

A Senate hearing reviewing health care services available for people with Alzheimer's disease and related dementia and reviewing proposals related to the treatment of Alzheimer's disease is presented in this document. Statements are given by Senators Charles E. Grassley, Albert Gore, Paula Hawkins, Howard M. Metzenbaum, Larry Pressler, and Paul…

The Proposed Tobacco Settlement: Issues from a Federal Perspective.

Science.gov (United States)

1998-04-01

of other people at CBO provided helpful comments and suggestions as part of the agency’s internal review process. In addition, Robert Cook- Deegan ...10. Federal Trade Commission, Competition and the Financial Impact of the Proposed Tobacco Industry Settlement (September 1997). 11. Craig Howell

75 FR 61709 - Notice of Proposed Information Collection Requests

Science.gov (United States)

2010-10-06

... Secondary Education Type of Review: Extension. Title of Collection: Improving Literacy through School..., section 1251(j)(1) of the ESEA requires an independent evaluation of the activities supported by funds and... for the congressional mandated program evaluation. Requests for copies of the proposed information...

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

The ethics of peer review in bioethics.

Science.gov (United States)

Wendler, David; Miller, Franklin

2014-10-01

A good deal has been written on the ethics of peer review, especially in the scientific and medical literatures. In contrast, we are unaware of any articles on the ethics of peer review in bioethics. Recognising this gap, we evaluate the extant proposals regarding ethical standards for peer review in general and consider how they apply to bioethics. We argue that scholars have an obligation to perform peer review based on the extent to which they personally benefit from the peer review process. We also argue, contrary to existing proposals and guidelines, that it can be appropriate for peer reviewers to benefit in their own scholarship from the manuscripts they review. With respect to bioethics in particular, we endorse double-blind review and suggest several ways in which the peer review process might be improved. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Deceased Organ Donors With a History of Increased Risk Behavior for the Transmission of Blood-Borne Viral Infection: The UK Experience.

Science.gov (United States)

Trotter, Patrick B; Summers, Dominic M; Robb, Matthew; Hulme, William; Ushiro-Lumb, Ines; Watson, Christopher J E; Neuberger, James; Bradley, J Andrew

2017-07-01

Deceased organ donors are routinely screened for behaviors that increase the risk of transmissible blood-borne viral (BBV) infection, but the impact of this information on organ donation and transplant outcome is not well documented. Our aim was to establish the impact of such behavior on organ donation and utilization, as well transplant recipient outcomes. We identified all UK deceased organ donors from 2003 to 2015 with a disclosed history of increased risk behavior (IRB) including intravenous drug use (IVDU), imprisonment and increased risk sexual behavior. Of 17 262 potential donors, 659 (3.8%) had IRB for BBV and 285 (1.7%) were seropositive for BBV, of whom half had a history of IRB (mostly IVDU [78.5%]). Of actual donors with IRB, 393 were seronegative for viral markers at time of donation. A history of recent IVDU was associated with fewer potential donors proceeding to become actual organ donors (64% vs 75%, P = 0.007). Donors with IRB provided 1091 organs for transplantation (624 kidneys and 467 other organs). Transplant outcome was similar in recipients of organs from donors with and without IRB. There were 3 cases of unexpected hepatitis C virus transmission, all from an active IVDU donor who was hepatitis C virus seronegative at time of donation, but was found to be viremic on retrospective testing. Donors with a history of IRB provide a valuable source of organs for transplantation with good transplant outcomes and there is scope for increasing the use of organs from such donors.

An Accurate and Impartial Expert Assignment Method for Scientific Project Review

Directory of Open Access Journals (Sweden)

Mingliang Yue

2017-12-01

Full Text Available Purpose: This paper proposes an expert assignment method for scientific project review that considers both accuracy and impartiality. As impartial and accurate peer review is extremely important to ensure the quality and feasibility of scientific projects, enhanced methods for managing the process are needed. Design/methodology/approach: To ensure both accuracy and impartiality, we design four criteria, the reviewers’ fitness degree, research intensity, academic association, and potential conflict of interest, to express the characteristics of an appropriate peer review expert. We first formalize the expert assignment problem as an optimization problem based on the designed criteria, and then propose a randomized algorithm to solve the expert assignment problem of identifying reviewer adequacy. Findings: Simulation results show that the proposed method is quite accurate and impartial during expert assignment. Research limitations: Although the criteria used in this paper can properly show the characteristics of a good and appropriate peer review expert, more criteria/conditions can be included in the proposed scheme to further enhance accuracy and impartiality of the expert assignment. Practical implications: The proposed method can help project funding agencies (e.g. the National Natural Science Foundation of China find better experts for project peer review. Originality/value: To the authors’ knowledge, this is the first publication that proposes an algorithm that applies an impartial approach to the project review expert assignment process. The simulation results show the effectiveness of the proposed method.

CMS proposes to OK one-midnight inpatient stays.

Science.gov (United States)

2015-09-01

The Centers for Medicare & Medicaid Services (CMS) has proposed that stays shorter than two midnights be reimbursed as inpatient stays if the documentation in the medical record supports it. CMS made the proposal in the Outpatient Prospective Payment System proposed rule for 2016 and left the policy unchanged for stays of two midnights or longer. CMS also announced that the two Beneficiary and Family Centered Care Quality Improvement Organizations (QIOs), Livanta and KEPRO, will take over the responsibility of Probe and Educate and will review cases for medical necessity when patient stays are one midnight or less, referring hospitals with high denial rates to the Recovery Auditors. Case managers should continue to assist physicians in determining patient status and to make sure that the documentation is complete, accurate, and specifies the severity of illness.

Toward a new model of scientific publishing: Discussion and a proposal

Directory of Open Access Journals (Sweden)

Dwight eKravitz

2011-12-01

Full Text Available The current system of publishing in the neurosciences, is notable for its redundancy, inconsistency, sluggishness, and opacity. These problems persist, and grow worse, because of a continuing failure to fully leverage new technology. Online access has eliminated space limits within peer-reviewed journals, yet we continue to deny publication. Each submission of a rejected manuscript requires the entire machinery of peer review to creak to life. This redundancy causes delays, inconsistency, and increases the burden on authors, reviewers, and editors. Further, reviewers serve a key role in the process but their performance is not tracked; yet alone rewarded. This misalignment of incentives contributes to the inconsistency and sluggishness that pervades peer review. The current system also interferes with the primary purpose of modern journals, providing a quick way of prioritizing the literature. Reviews are written to gauge publication rather than scientific merit and there is no guarantee that the journal’s criteria agree with those of an individual researcher, making any prioritization opaque and noisy at best.The focus of this special issue is the future form of post-publication reception, and the development of a marketplace where a paper rises and falls based on its reception from the field. However, the information that accompanies a paper into the marketplace is as important as the marketplace’s mechanics. Beyond suggestions as to the mechanisms of reception, we propose an update to the system of publishing in which publication is guaranteed, but pre-publication peer review still occurs, giving the authors the opportunity to revise their work following a mini pre-reception from the field. This step also provides a consistent set of rankings and reviews to the marketplace, allowing for early prioritization and stabilizing its early dynamics. We further propose to improve the general quality of reviewing by providing tangible rewards to

Review of Proposed Congressional Budget Exhibits for the Navy's Mission-Funded Shipyards

National Research Council Canada - National Science Library

Frisk, Daniel; Trunkey, R. D

2006-01-01

To improve shipyard reporting and address concerns about the decreased visibility of the operations and costs of mission-funded shipyards, the Congress asked the Navy to submit a report with proposed...

Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations.

Science.gov (United States)

Gelinas, Luke; Pierce, Robin; Winkler, Sabune; Cohen, I Glenn; Lynch, Holly Fernandez; Bierer, Barbara E

2017-03-01

The use of social media as a recruitment tool for research with humans is increasing, and likely to continue to grow. Despite this, to date there has been no specific regulatory guidance and there has been little in the bioethics literature to guide investigators and institutional review boards (IRBs) faced with navigating the ethical issues such use raises. We begin to fill this gap by first defending a nonexceptionalist methodology for assessing social media recruitment; second, examining respect for privacy and investigator transparency as key norms governing social media recruitment; and, finally, analyzing three relatively novel aspects of social media recruitment: (i) the ethical significance of compliance with website "terms of use"; (ii) the ethics of recruiting from the online networks of research participants; and (iii) the ethical implications of online communication from and between participants. Two checklists aimed at guiding investigators and IRBs through the ethical issues are included as appendices.

Reviewing printed and electronic dictionaries

DEFF Research Database (Denmark)

Nielsen, Sandro

2009-01-01

Dictionary reviewing is an integral part of the lexicographic universe. However, lexicographers have called for generally applicable principles embracing both printed and electronic dictionaries. I propose that scholarly reviews contain information that is useful to their intended audiences...

40 CFR 1502.14 - Alternatives including the proposed action.

Science.gov (United States)

2010-07-01

... impacts of the proposal and the alternatives in comparative form, thus sharply defining the issues and... action so that reviewers may evaluate their comparative merits. (c) Include reasonable alternatives not... identify such alternative in the final statement unless another law prohibits the expression of such a...

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

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

Overcoming structural constraints to patient utilization of electronic medical records: a critical review and proposal for an evaluation framework.

Science.gov (United States)

Winkelman, Warren J; Leonard, Kevin J

2004-01-01

There are constraints embedded in medical record structure that limit use by patients in self-directed disease management. Through systematic review of the literature from a critical perspective, four characteristics that either enhance or mitigate the influence of medical record structure on patient utilization of an electronic patient record (EPR) system have been identified: environmental pressures, physician centeredness, collaborative organizational culture, and patient centeredness. An evaluation framework is proposed for use when considering adaptation of existing EPR systems for online patient access. Exemplars of patient-accessible EPR systems from the literature are evaluated utilizing the framework. From this study, it appears that traditional information system research and development methods may not wholly capture many pertinent social issues that arise when expanding access of EPR systems to patients. Critically rooted methods such as action research can directly inform development strategies so that these systems may positively influence health outcomes.

78 FR 38877 - Kraft Pulp Mills NSPS Review

Science.gov (United States)

2013-06-28

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 60 [EPA-HQ-OAR-2012-0640] FRL-9829-3 RIN 2060-AR64 Kraft Pulp Mills NSPS Review AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule... comments on the May 23, 2013, proposed rule titled, ``Kraft Pulp Mills NSPS Review'' is being extended by...

MySQL/PHP web database applications for IPAC proposal submission

Science.gov (United States)

Crane, Megan K.; Storrie-Lombardi, Lisa J.; Silbermann, Nancy A.; Rebull, Luisa M.

2008-07-01

The Infrared Processing and Analysis Center (IPAC) is NASA's multi-mission center of expertise for long-wavelength astrophysics. Proposals for various IPAC missions and programs are ingested via MySQL/PHP web database applications. Proposers use web forms to enter coversheet information and upload PDF files related to the proposal. Upon proposal submission, a unique directory is created on the webserver into which all of the uploaded files are placed. The coversheet information is converted into a PDF file using a PHP extension called FPDF. The files are concatenated into one PDF file using the command-line tool pdftk and then forwarded to the review committee. This work was performed at the California Institute of Technology under contract to the National Aeronautics and Space Administration.

The "peer" in "peer review"

Science.gov (United States)

Perry, Gad; Bertoluci, Jaime; Bury, R. Bruce; Hansen, Robert W.; Jehle, Robert; Measey, John; Moon, Brad R.; Muths, Erin L.; Zuffi, Marco A.L.

2011-01-01

Peer review is the best available mechanism for assessing and improving the quality of scientific work. As herpetology broadens its disciplinary and geographic boundaries, high-quality external review is ever more essential. We are writing this editorial jointly because the review process has become increasingly difficult. The resulting delays slow publication times, negatively affect performance reviews, tenure, promotions, and grant proposal success. It harms authors, agencies, and institutions (Ware 2011).

Proposals for the Reform of Constitutional Regulations on Public Finances

OpenAIRE

Tibor András Hetei

2011-01-01

The main purpose of this paper is to make specific proposals in the areas of public finance and the budget process in the context of the reform of the Hungarian Constitution. In preparing the proposals the author has reviewed the prevailing constitutional regulations as well as the relevant practice of the Constitutional Court, and examined and compared the constitutional schemes of European countries. The paper finds that a number of aspects of the constitutional regulation of public finance...

75 FR 49938 - Proposed Collection; Comment Request; NIH NCI Central Institutional Review Board (CIRB...

Science.gov (United States)

2010-08-16

.... Frequency of Response: Once, except for the SAE Reviewer Worksheet. Affected Public: Includes the Federal...). Board Members CIRB SAE Reviewer Worksheet 10 15 30/60 (.5 hour) 75 (Attachment 6K). Total 2221 Request..., National Institutes of Health. [FR Doc. 2010-20167 Filed 8-13-10; 8:45 am] BILLING CODE 4140-01-P ...

When should we biopsy a solitary central cartilaginous tumor of long bones? Literature review and management proposal

Energy Technology Data Exchange (ETDEWEB)

Parlier-Cuau, Caroline, E-mail: Caroline.parlier@lrb.aphp.fr [Department of Radiologie Osteo-Articulaire, Hopital Lariboisiere, Assistance Publique-Hopitaux de Paris (AP-HP), Faculte de Medecine Denis Diderot, Universite Paris 7, Paris (France); Bousson, Valerie [Department of Radiologie Osteo-Articulaire, Hopital Lariboisiere, Assistance Publique-Hopitaux de Paris (AP-HP), Faculte de Medecine Denis Diderot, Universite Paris 7, Paris (France); Ogilvie, Christian M.; Lackman, Richard D. [Department of Orthopedic Surgery, Pennsylvania Hospital, 800 Spruce Street, Philadelphia, PA 19107 (United States); Laredo, Jean-Denis [Department of Radiologie Osteo-Articulaire, Hopital Lariboisiere, Assistance Publique-Hopitaux de Paris (AP-HP), Faculte de Medecine Denis Diderot, Universite Paris 7, Paris (France); Department of Musculoskeletal Radiology, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104 (United States)

2011-01-15

Differentiation between benign and low-grade malignant cartilaginous tumors is a radiological and pathological challenge. Based on a literature review, we propose the following guidelines for the management of a solitary central cartilaginous tumor of long bones distinguishing three situations: 1.The tumor is considered to be aggressive and requires surgery if one of the following criteria is present: cortical destruction, Moth-eaten or permeative osteolysis, spontaneous pathologic fracture, periosteal reaction, edema surrounding the tumor on MR images, and soft tissue mass. Tumor biopsy followed by complete intralesional treatment is indicated. 2.The tumor is classified as active if two of the following active criteria are present: pain related to the tumor, endosteal scalloping superior to two-thirds of the cortical thickness, extent of endosteal scalloping superior to two-thirds of the lesion length, cortical thickening and enlargement of the medullary cavity. Tumor biopsy or excision is indicated. 3.The tumor is classified as possibly active if one of the previous active criteria is present. In such cases, bone scintigraphy and dynamic-enhanced MR imaging should be obtained. Radionuclide uptake superior to the anterior iliac crest at bone scintigraphy and early and exponential enhancement at dynamic-enhanced MR are considered as two additional active criteria. After these two examinations, if only one criterion is still present, the lesion can be regarded as possibly quiescent, and the following monitoring is suggested: first follow-up at three to six months and then once a year. Otherwise, if two or more active criteria are present, biopsy is recommended. 4.The tumor is considered quiescent and does not require surgery if no active or aggressive criterion is present. A radiological follow-up can be proposed.

75 FR 36150 - Notice of Final Federal Agency Action on Proposed Transportation Project in Illinois

Science.gov (United States)

2010-06-24

.... ACTION: Notice of limitation on claims for judicial review of actions by FHWA and other Federal agencies... result of a tiered environmental review process under the National Environmental Policy Act, 42 U.S.C... judicial review of the Tier 1 Federal agency actions of the proposed highway and transit project will be...

Review: UK medicines likely to be affected by the proposed European Medicines Agency's guidelines on phthalates.

Science.gov (United States)

Jamieson, Lisa; McCully, William

2015-06-13

Phthalates are excipients in drug formulations. However, concerns have been raised about the effects of particular phthalates on reproduction and development. As a result the EMA has introduced guidelines for permitted daily exposure (PDE) limits for certain phthalates. Therefore, the objective of this study was to identify UK licensed medicines that contain the relevant phthalates and determine if they fall within the recommended PDE. The eMC was used to identify which UK licensed medicines contain the phthalates in question. Companies were then contacted for information on the phthalate levels in their products, which was compared with the PDE recommended by the EMA. The eMC search revealed that 54 medicines contained at least one of the phthalates in question. However, only six medicines, namely Asacol 800 mg MR (Warner Chilcott UK), Epilim 200 Gastro-resistant tablets (Sanofi), Prednisolone 2.5 mg and 5 mg Gastro-resistant tablets (Actavis UK), Vivotif (Crucell Italy S.r.l), and Zentiva 200 mg Gastro-resistant tablets (Winthrop Pharmaceuticals UK), were identified as containing levels that exceeded the recommended PDE. These findings indicate that very few UK licensed medicines will be affected by the proposed EMA guidelines. For those medicines identified as exceeding recommendations, these findings highlight the need to instigate a risk-benefit review.

ALARA - the contribution of the proposed new ionising radiations regulations

International Nuclear Information System (INIS)

Young, T.O.

1982-01-01

This paper describes the proposed regulatory requirements and appropriate guidance contained in the approved code of practice on ionising radiations which are designed to support and help reach the objective of keeping radiation doses as low as reasonably achievable. This is discussed against the background of factory legislation, and the way in which the form of the proposed legislation handles this topic is illustrated. The measures required by the proposed legislation are reviewed, both as direct measures designed to create a climate of dose reduction, and as general measures designed to achieve the same end by means of a wide range of requirements. (author)

Are Technology Interruptions Impacting Your Bottom Line? An Innovative Proposal for Change.

Science.gov (United States)

Ledbetter, Tamera; Shultz, Sarah; Beckham, Roxanne

2017-10-01

Nursing interruptions are a costly and dangerous variable in acute care hospitals. Malfunctioning technology equipment interrupts nursing care and prevents full utilization of computer safety systems to prevent patient care errors. This paper identifies an innovative approach to nursing interruptions related to computer and computer cart malfunctions. The impact on human resources is defined and outcome measures were proposed. A multifaceted proposal, based on a literature review, aimed at reducing nursing interruptions is presented. This proposal is expected to increase patient safety, as well as patient and nurse satisfaction. Acute care hospitals utilizing electronic medical records and bar-coded medication administration technology. Nurses, information technology staff, nursing informatics staff, and all leadership teams affected by technology problems and their proposed solutions. Literature from multiple fields was reviewed to evaluate research related to computer/computer cart failures, and the approaches used to resolve these issues. Outcome measured strategic goals related to patient safety, and nurse and patient satisfaction. Specific help desk metrics will demonstrate the effect of interventions. This paper addresses a gap in the literature and proposes practical and innovative solutions. A comprehensive computer and computer cart repair program is essential for patient safety, financial stewardship, and utilization of resources. © 2015 Wiley Periodicals, Inc.

Peer Review of Grant Applications: Criteria Used and Qualitative Study of Reviewer Practices

Science.gov (United States)

Abdoul, Hendy; Perrey, Christophe; Amiel, Philippe; Tubach, Florence; Gottot, Serge; Durand-Zaleski, Isabelle; Alberti, Corinne

2012-01-01

Background Peer review of grant applications has been criticized as lacking reliability. Studies showing poor agreement among reviewers supported this possibility but usually focused on reviewers’ scores and failed to investigate reasons for disagreement. Here, our goal was to determine how reviewers rate applications, by investigating reviewer practices and grant assessment criteria. Methods and Findings We first collected and analyzed a convenience sample of French and international calls for proposals and assessment guidelines, from which we created an overall typology of assessment criteria comprising nine domains relevance to the call for proposals, usefulness, originality, innovativeness, methodology, feasibility, funding, ethical aspects, and writing of the grant application. We then performed a qualitative study of reviewer practices, particularly regarding the use of assessment criteria, among reviewers of the French Academic Hospital Research Grant Agencies (Programmes Hospitaliers de Recherche Clinique, PHRCs). Semi-structured interviews and observation sessions were conducted. Both the time spent assessing each grant application and the assessment methods varied across reviewers. The assessment criteria recommended by the PHRCs were listed by all reviewers as frequently evaluated and useful. However, use of the PHRC criteria was subjective and varied across reviewers. Some reviewers gave the same weight to each assessment criterion, whereas others considered originality to be the most important criterion (12/34), followed by methodology (10/34) and feasibility (4/34). Conceivably, this variability might adversely affect the reliability of the review process, and studies evaluating this hypothesis would be of interest. Conclusions Variability across reviewers may result in mistrust among grant applicants about the review process. Consequently, ensuring transparency is of the utmost importance. Consistency in the review process could also be improved by

Reviewing Printed Subject Bibliographies: A Worksheet.

Science.gov (United States)

Tabachnick, Sharon

1989-01-01

Discusses the importance of reviews of bibliographies to librarians, identifies common problems with the review process, and proposes a worksheet that will enable reviewers of printed subject bibliographies to address the needs of librarians. The theoretical foundation for the concepts used in the worksheet are discussed. (14 references) (CLB)

24 CFR 594.28 - Environmental reviews.

Science.gov (United States)

2010-04-01

... 24 Housing and Urban Development 3 2010-04-01 2010-04-01 false Environmental reviews. 594.28... Grant Amounts § 594.28 Environmental reviews. (a) For all proposed actions or activities that are not considered categorically excluded under 24 CFR 50.20, HUD will perform the appropriate environmental reviews...

Health and safety impacts of nuclear, geothermal, and fossil-fuel electric generation in California. Volume 9. Methodologies for review of the health and safety aspects of proposed nuclear, geothermal, and fossil-fuel sites and facilities

International Nuclear Information System (INIS)

Nero, A.V.; Quinby-Hunt, M.S.

1977-01-01

This report sets forth methodologies for review of the health and safety aspects of proposed nuclear, geothermal, and fossil-fuel sites and facilities for electric power generation. The review is divided into a Notice of Intention process and an Application for Certification process, in accordance with the structure to be used by the California Energy Resources Conservation and Development Commission, the first emphasizing site-specific considerations, the second examining the detailed facility design as well. The Notice of Intention review is divided into three possible stages: an examination of emissions and site characteristics, a basic impact analysis, and an assessment of public impacts. The Application for Certification review is divided into five possible stages: a review of the Notice of Intention treatment, review of the emission control equipment, review of the safety design, review of the general facility design, and an overall assessment of site and facility acceptability

42 CFR 8.25 - Informal review and the reviewing official's response.

Science.gov (United States)

2010-10-01

... GENERAL PROVISIONS CERTIFICATION OF OPIOID TREATMENT PROGRAMS Procedures for Review of Suspension or Proposed Revocation of OTP Certification, and of Adverse Action Regarding Withdrawal of Approval of an...

77 FR 13131 - Proposed Collection: Comment Request Post-Award Reporting Requirements Including New Research...

Science.gov (United States)

2012-03-05

... submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title... Administration, Centers for Disease Control and Prevention, and Agency for Healthcare Research and Quality (AHRQ... information technology. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project...

Rebelling against the (Insulin Resistance: A Review of the Proposed Insulin-Sensitizing Actions of Soybeans, Chickpeas, and Their Bioactive Compounds

Directory of Open Access Journals (Sweden)

Jaime L. Clark

2018-03-01

Full Text Available Insulin resistance is a major risk factor for diseases such as type 2 diabetes and metabolic syndrome. Current methods for management of insulin resistance include pharmacological therapies and lifestyle modifications. Several clinical studies have shown that leguminous plants such as soybeans and pulses (dried beans, dried peas, chickpeas, lentils are able to reduce insulin resistance and related type 2 diabetes parameters. However, to date, no one has summarized the evidence supporting a mechanism of action for soybeans and pulses that explains their ability to lower insulin resistance. While it is commonly assumed that the biological activities of soybeans and pulses are due to their antioxidant activities, these bioactive compounds may operate independent of their antioxidant properties and, thus, their ability to potentially improve insulin sensitivity via alternative mechanisms needs to be acknowledged. Based on published studies using in vivo and in vitro models representing insulin resistant states, the proposed mechanisms of action for insulin-sensitizing actions of soybeans, chickpeas, and their bioactive compounds include increasing glucose transporter-4 levels, inhibiting adipogenesis by down-regulating peroxisome proliferator-activated receptor-γ, reducing adiposity, positively affecting adipokines, and increasing short-chain fatty acid-producing bacteria in the gut. Therefore, this review will discuss the current evidence surrounding the proposed mechanisms of action for soybeans and certain pulses, and their bioactive compounds, to effectively reduce insulin resistance.

78 FR 78998 - 60-Day Notice of Proposed Information Collection: HUD Environmental Review Online System (HEROS)

Science.gov (United States)

2013-12-27

... Information Collection: HUD Environmental Review Online System (HEROS) AGENCY: Office of Community Planning... Information Collection Title of Information Collection: HUD Environmental Review Online System (HEROS). OMB... online tool called the HUD Environmental Review Online System (HEROS), which will allow users to complete...

Grant Writing Skill Building: A Business Administration Curriculum Proposal

Science.gov (United States)

Blankenship, Dianna; Jones, Irma; Lovett, Marvin

2010-01-01

This paper reviews the need for grant writing skills within various types of organizations and the resulting proposal for including grant writing within business administration curriculum at the undergraduate and/or graduate levels. An introduction precedes the results of a survey regarding current grant writing courses within AACSB schools of…

24 CFR 598.405 - Environmental review.

Science.gov (United States)

2010-04-01

... 24 Housing and Urban Development 3 2010-04-01 2010-04-01 false Environmental review. 598.405...-Designation Requirements § 598.405 Environmental review. Where any EZ's strategic plan or any revision thereof proposes the use of HUD EZ Grant Funds for activities that are not excluded from environmental review under...

An Assessment of the Internal Rating Based Approach in Basel II

OpenAIRE

Simone Varotto

2008-01-01

The new bank capital regulation commonly known as Basel II includes a internal rating based approach (IRB) to measuring credit risk in bank portfolios. The IRB relies on the assumptions that the portfolio is fully diversified and that systematic risk is driven by one common factor. In this work we empirically investigate the impact of these assumptions by comparing the risk measures produced by the IRB with those of a more general credit risk model that allows for multiple systematic risk fac...

76 FR 64368 - Notice of Submission of Proposed Information Collection to OMB Homelessness Prevention Study

Science.gov (United States)

2011-10-18

... Proposed Information Collection to OMB Homelessness Prevention Study AGENCY: Office of Policy Development... Homelessness Prevention Study. The proposed information collection was approved under emergency review (OMB...) has submitted to OMB a request to extend approval for information collection for the Homelessness...

7 CFR 1942.105 - Environmental review.

Science.gov (United States)

2010-01-01

... 7 Agriculture 13 2010-01-01 2009-01-01 true Environmental review. 1942.105 Section 1942.105... § 1942.105 Environmental review. FmHA or its successor agency under Public Law 103-354 must conduct and document an environmental review for each proposed project in accordance with subpart G of part 1940 of...

75 FR 4062 - Peer Review Best Practices Workshop

Science.gov (United States)

2010-01-26

... DEPARTMENT OF ENERGY Peer Review Best Practices Workshop AGENCY: Department of Energy, Office of..., demonstration and deployment programs and has used a variety of peer review approaches to select the best...'' for reviewing and selecting project proposals. The workshop will explore classic peer review processes...

Internet Safety and Security Surveys - A Review

DEFF Research Database (Denmark)

Sharp, Robin

This report gives a review of investigations into Internet safety and security over the last 10 years. The review covers a number of surveys of Internet usage, of Internet security in general, and of Internet users' awareness of issues related to safety and security. The focus and approach...... of the various surveys is considered, and is related to more general proposals for investigating the issues involved. A variety of proposals for how to improve levels of Internet safety and security are also described, and they are reviewed in the light of studies of motivational factors which affect the degree...

75 FR 52351 - Proposed Collection; Comment Request; Request; OMB No. 0925-0177 “Special Volunteer and Guest...

Science.gov (United States)

2010-08-25

... Resources, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed... proposed collection of information, including the validity of the methodology and assumptions used; (3...

Peer review quality and transparency of the peer-review process in open access and subscription journals

NARCIS (Netherlands)

Wicherts, J.M.

2016-01-01

Background Recent controversies highlighting substandard peer review in Open Access (OA) and traditional (subscription) journals have increased the need for authors, funders, publishers, and institutions to assure quality of peer-review in academic journals. I propose that transparency of the

A Randomized Clinical Trial of Allopregnanolone for the Treatment of Severe Traumatic Brain Injury

Science.gov (United States)

2010-10-01

by four outside reviewers: Kia Shahlaie, M.D., Ph.D. (University of California, San Francisco ), Anne-Marie Guerguerian, M.D. (University of Toronto...of the Pre-IND Package described below and the UC Davis IRB filing. Pre-IND Meeting Information Package and IND. Medkura Pharmaceutical and Camargo ... Camargo a Pre-IND meeting information document was developed which will serve as the basis for the IND filing that will be made after the Pre-IND meeting

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

Human subjects research handbook: Protecting human research subjects. Second edition

Energy Technology Data Exchange (ETDEWEB)

NONE

1996-01-30

This handbook serves as a guide to understanding and implementing the Federal regulations and US DOE Orders established to protect human research subjects. Material in this handbook is directed towards new and continuing institutional review board (IRB) members, researchers, institutional administrators, DOE officials, and others who may be involved or interested in human subjects research. It offers comprehensive overview of the various requirements, procedures, and issues relating to human subject research today.

Scientific writing and communication papers, proposals, and presentations

CERN Document Server

Hofmann, Angelika H

2014-01-01

Scientific Writing and Communication: Papers, Proposals, and Presentations, Second Edition, serves as a comprehensive " reference guide to scientific writing and communication. The second edition of Angelika Hofmann's successful text covers all the areas of scientific communication that a scientist needs to know and master in order to successfully promote his or her research and career. This unique "all-in-one" handbook begins with a discussion of the basic principles of scientific writing style and composition and then applies these principles to writing research papers, review articles, grant proposals, research statements, and resumes, as well as to preparing academic presentations and posters. Scientific Writing and Communication: Papers, Proposals, and Presentations has been used successfully for a number of years in courses on scientific writing at various universities and institutes worldwide. Readers of the second edition will find numerous new examples and exercises, many with an expanded interdiscip...

77 FR 62518 - Proposed Collection; Comment Request: Recipient Epidemiology and Donor Evaluation Study-III (REDS...

Science.gov (United States)

2012-10-15

... of proposed projects to the Office of Management and Budget (OMB) for review and approval. Proposed... learned, including how donor genetic or environmental factors may affect the quality of collected blood components and influence non-infectious transfusion complications in recipients. Additionally, there is...

76 FR 69743 - Proposed Collection; Comment Request; Application for Collaboration With the NIH Center for...

Science.gov (United States)

2011-11-09

..., for opportunity for public comment on proposed data collection projects, the (insert name of NIH... projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed... chemistry, lead optimization, chemical biology studies, drug development capabilities, expertise, and...

25 CFR 900.33 - Are all proposals to renew term contracts subject to the declination criteria?

Science.gov (United States)

2010-04-01

... 25 Indians 2 2010-04-01 2010-04-01 false Are all proposals to renew term contracts subject to the... Indian Affairs will not review the renewal of a term contract for declination issues where no material... been proposed by the Indian tribe or tribal organization. Proposals to renew term contracts with DOI...

75 FR 26283 - Proposed Collection, Submission for OMB Review, Museums for America Grant Program Evaluation

Science.gov (United States)