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.

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

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

2015-02-01

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

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

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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.

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

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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

A Case for Limiting the Reach of Institutional Review Boards

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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,…

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

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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

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

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

2012-01-01

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

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

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

2013-07-01

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

IRB PERSPECTIVES ON THE RETURN OF INDIVIDUAL RESULTS FROM GENOMIC RESEARCH

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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

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

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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.

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

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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.

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

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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.

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

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

2007-05-01

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

45 CFR 46.109 - IRB review of research.

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2010-10-01

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

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

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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.

Research Ethics: Institutional Review Board Oversight of Art Therapy Research

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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…

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

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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.

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

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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…

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...

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

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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.

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

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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.

21 CFR 56.107 - IRB membership.

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2010-04-01

... professional competence necessary to review the specific research activities, the IRB shall be able to..., applicable law, and standards or professional conduct and practice. The IRB shall therefore include persons... IRB may, in its discretion, invite individuals with competence in special areas to assist in the...

Spotlight on Ethics: Institutional Review Boards as Systemic Bullies

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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…

Victor Frankenstein's Institutional Review Board Proposal, 1790.

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Harrison, Gary; Gannon, William L

2015-10-01

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

Justification and authority in institutional review board decision letters.

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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.

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

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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.

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

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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.

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

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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.

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.

40 CFR 26.109 - IRB review of research.

Science.gov (United States)

2010-07-01

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

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

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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.

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

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.

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.

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.

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...

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.

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.

40 CFR 26.1109 - IRB review of research.

Science.gov (United States)

2010-07-01

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

40 CFR 26.1115 - IRB records.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false IRB records. 26.1115 Section 26.1115 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical...-nursing Adults § 26.1115 IRB records. (a) An IRB shall prepare and maintain adequate documentation of IRB...

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

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.

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

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.

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

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.

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

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

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...

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.

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

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.

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...

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...

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...

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...

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

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...

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 .

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.

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

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...

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.

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

Directory of Open Access Journals (Sweden)

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.

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...

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.

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...

78 FR 16401 - Institutional Review Boards; Correcting Amendments

Science.gov (United States)

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...

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.

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...

Accrual and recruitment practices at Clinical and Translational Science Award (CTSA) institutions: a call for expectations, expertise, and evaluation.

Science.gov (United States)

Kost, Rhonda G; Mervin-Blake, Sabrena; Hallarn, Rose; Rathmann, Charles; Kolb, H Robert; Himmelfarb, Cheryl Dennison; D'Agostino, Toni; Rubinstein, Eric P; Dozier, Ann M; Schuff, Kathryn G

2014-08-01

To respond to increased public and programmatic demand to address underenrollment of clinical translational research studies, the authors examined participant recruitment practices at Clinical and Translational Science Award (CTSA) sites and make recommendations for performance metrics and accountability. The CTSA Recruitment and Retention taskforce in 2010 invited representatives at 46 CTSAs to complete an online 48-question survey querying accrual and recruitment outcomes, practices, evaluation methods, policies, and perceived gaps in related knowledge/practice. Descriptive statistical and thematic analyses were conducted. Forty-six respondents representing 44 CTSAs completed the survey. Recruitment conducted by study teams was the most common practice reported (78%-91%, by study type); 39% reported their institution offered recruitment services to investigators. Respondents valued study feasibility assessment as a successful practice (39%); desired additional resources included feasibility assessments (49%) and participant registries (44%). None reported their institution systematically required justification of feasibility; some indicated relevant information was considered prior to institutional review board (IRB) review (30%) or contract approval (22%). All respondents' IRBs tracked study progress, but only 10% of respondents could report outcome data for timely accrual. Few reported written policies addressing poor accrual or provided data to support recruitment practice effectiveness. Many CTSAs lack the necessary frame work to support study accrual. Recom men dations to enhance accrual include articulating institutional expectations and policy for routine recruitment plan ning; providing recruitment expertise to inform feasibility assessment and recruit ment planning; and developing interdepartmental coordination and integrated informatics infrastructure to drive the conduct, evaluation, and improvement of recruitment practices.

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...

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.

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.

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.

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. ...

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

40 CFR 26.1112 - Review by institution.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Review by institution. 26.1112 Section 26.1112 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN... Exposure of Non-pregnant, Non-nursing Adults § 26.1112 Review by institution. Research covered by this...

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.

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.

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...

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) ...

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...

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.

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.

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

Research Review of the Institute of African Studies

African Journals Online (AJOL)

Please note: As of 2013 the Research Review of the Institute of African Studies is now publishing under the title Contemporary Journal of African Studies. You can view the CJAS pages on AJOL here: http://www.ajol.info/index.php/contjas/index. The Research Review of the Institute of African Studies at the University of ...

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...

Institutional Collaboration on MOOCs in Education—A Literature Review

DEFF Research Database (Denmark)

Nortvig, Anne-Mette; Christiansen, René Boyer

2017-01-01

This literature review seeks to outline the state of the art regarding collaboration between educational institutions on Massive Open Online Courses (MOOCs) launched in Europe and in the US for the past 10 years. The review explores enablers and barriers that influence national institutional MOOC...... collaboration, and looks into how existing knowledge about institutional collaboration on e-learning can be used in MOOC collaboration. The review is based on a literature search in databases and on snowballing techniques. It concludes that collaboration on MOOCs can be advantageous in terms of ensuring quality...... loss of their own national branding and the teachers’ hesitancy or passive resistance to new educational platforms and formats....

Institutional Collaboration on MOOCs in Education--A Literature Review

Science.gov (United States)

Nortvig, Anne-Mette; Christiansen, René B.

2017-01-01

This literature review seeks to outline the state of the art regarding collaboration between educational institutions on Massive Open Online Courses (MOOCs) launched in Europe and in the US for the past 10 years. The review explores enablers and barriers that influence national institutional MOOC collaboration, and looks into how existing…

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

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.

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

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...

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.

"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.

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.

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.

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African Journals Online (AJOL)

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

A rapid evidence review on the effectiveness of institutional health partnerships.

Science.gov (United States)

Kelly, Ema; Doyle, Vicki; Weakliam, David; Schönemann, Yvonne

2015-12-14

Institutional Health Partnerships are long-term, institution to institution partnerships between high income and low and middle income countries which seek to build capacity and strengthen health institutions in order to improve health service delivery and outcomes. Funding for Institutional Health Partnerships has increased in recent years. This paper outlines a rapid evidence review on the effectiveness of this modality. A rapid evidence review of published and grey literature was conducted. Content relating to the effectiveness of working in partnership and methods and frameworks used were extracted and analysed. The results of this analysis were used to structure a discussion regarding the next steps to strengthen the evidence base for the effectiveness of institutional health partnerships. The evidence review, including citation mapping, returned 27 published papers and 17 grey literature documents that met all of the inclusion criteria. Most of the literature did not meet the high standards of formal academic rigour and there was no original research amongst this literature that specifically addressed the effectiveness of institutional health partnerships. This was not surprising given institutional health partnerships do not lend themselves easily to case control studies and randomised control trials due to their high level of diversity and operation in complex social systems. There was, however, a body of practice based knowledge and experience. Evidence for the effectiveness of Institutional Health Partnerships is thin both in terms of quantity and academic rigour. There is a need to better define and differentiate Institutional Health Partnerships in order to measure and compare effectiveness across such a diverse group. Effectiveness needs to be measured at the level of individual partnerships, the bodies that facilitate partnership programmes and the level of health service delivery. There is a need to develop indicators and frameworks that specifically

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

Science.gov (United States)

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

2017-11-01

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

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…

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.

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...

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

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...

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.

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

Eprints Institutional Repository Software: A Review

Directory of Open Access Journals (Sweden)

Mike R. Beazley

2011-01-01

Full Text Available Setting up an institutional repository (IR can be a daunting task. There are many software packages out there, some commercial, some open source, all of which offer different features and functionality. This article will provide some thoughts about one of these software packages: Eprints. Eprints was one of the first IR software packages to appear and has been available for 10 years. It is under continual development by its creators at the University of Southampton and the current version is v3.2.3. Eprints is open-source, meaning that anyone can download and make use of the software for free and the software can be modified however the user likes. This presents clear advantages for institutions will smaller budgets and also for institutions that have programmers on staff. Eprints requires some additional software to run: Linux, Apache, MySQL, and Perl. This software is all open-source and already present on the servers of many institutions. There is now a version of Eprints that will run on Windows servers as well, which will make the adoption of Eprints even easier for some. In brief, Eprints is an excellent choice for any institution looking to get an IR up and running quickly and easily. Installation is straightforward as is the initial configuration. Once the IR is up and running, users may upload documents and provide the necessary metadata for the records by filling out a simple web form. Embargoes on published documents are handled elegantly by the software, and the software links to the SHERPA/RoMEO database so authors can easily verify their rights regarding IR submissions. Eprints has some drawbacks, which will be discussed later in the review, but on the whole it is easy to recommend to anyone looking to start an IR. However, It is less clear that an institution with an existing IR based on another software package should migrate to Eprints.

Institutional ethical review and ethnographic research involving injection drug users: a case study.

Science.gov (United States)

Small, Will; Maher, Lisa; Kerr, Thomas

2014-03-01

Ethnographic research among people who inject drugs (PWID) involves complex ethical issues. While ethical review frameworks have been critiqued by social scientists, there is a lack of social science research examining institutional ethical review processes, particularly in relation to ethnographic work. This case study describes the institutional ethical review of an ethnographic research project using observational fieldwork and in-depth interviews to examine injection drug use. The review process and the salient concerns of the review committee are recounted, and the investigators' responses to the committee's concerns and requests are described to illustrate how key issues were resolved. The review committee expressed concerns regarding researcher safety when conducting fieldwork, and the investigators were asked to liaise with the police regarding the proposed research. An ongoing dialogue with the institutional review committee regarding researcher safety and autonomy from police involvement, as well as formal consultation with a local drug user group and solicitation of opinions from external experts, helped to resolve these issues. This case study suggests that ethical review processes can be particularly challenging for ethnographic projects focused on illegal behaviours, and that while some challenges could be mediated by modifying existing ethical review procedures, there is a need for legislation that provides legal protection of research data and participant confidentiality. Copyright © 2013 Elsevier Ltd. All rights reserved.

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

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…

Enhancing Proof Writing via Cross-Institutional Peer Review

Science.gov (United States)

Ernst, Dana C.; Hodge, Angie; Schultz, Andrew

2015-01-01

In the Spring of 2011, two of the authors of this paper taught number theory courses at their respective institutions. Twice during the semester, students in each class submitted proofs of two to three theorems to be peer reviewed by students in the other class. Each student wrote anonymous and formal referee reports of the submitted theorems,…

KfK, Institute for Reactor Components. Results of research and development activities in 1989

International Nuclear Information System (INIS)

1990-03-01

R and D activities at IRB (Institut fuer Reaktorbauelemente - Institute for Reactor Components) are dedicated to thermodynamics and fluid dynamics. Emphasis is on the design of nuclear reactor and fusion reactor components. Environmental engineering was added recently. Most activities are applications-oriented. Fundamental investigations focus on energy research and energy technology. The activities are carried out in the framework of different projects (PKF/nuclear fusion, PSF/nuclear safety, PSU/pollution control). Points of main effort are the development of basic liquid-metal-cooled blanket solutions, investigations on natural convection in reactor tanks, and the cooling properties of future containments for pressurized water reactors in the case of nuclear fusion accidents. (orig./GL) [de

Cooperative Institute for Research in the Atmosphere (CIRA) Requirements Review

Energy Technology Data Exchange (ETDEWEB)

Zurawski, Jason, W; Mace, Kathryn, P

2016-08-11

In August 2016 The Energy Sciences Network (ESnet) and Colorado State University (CSU) organized a review to characterize the networking requirements of the Cooperative Institute for Research in the Atmosphere (CIRA) located on the campus of Colorado State University. Several key findings highlighting the results from the review were discovered, with benefits to improve the overall scientific process for CIRA and CSU.

The Nuclear Review: the Institution of Nuclear Engineers' response to the Review of Nuclear Power

International Nuclear Information System (INIS)

Anon.

1994-01-01

The United Kingdom Government's Nuclear Review currently underway, addresses whether and in what form nuclear power should continue to be part of the country's power generation capability. This article sets out the response of the Institution of Nuclear Engineers to the Nuclear Review. This pro-nuclear group emphasises the benefits to be gained from diversity of generation in the energy supply industry. The environmentally benign nature of nuclear power is emphasised, in terms of gaseous emissions. The industry's excellent safety record also argues in favour of nuclear power. Finally, as power demand increases globally, a health U.K. nuclear industry could generate British wealth through power exports and via the construction industry. The Institution's view on radioactive waste management is also set out. (UK)

Lapse in Institutional Animal Care and Use Committee Continuing Reviews.

Directory of Open Access Journals (Sweden)

Min-Fu Tsan

Full Text Available The United States federal animal welfare regulations and the Public Health Service Policy on Humane Care and Use of Laboratory Animals require that institutional animal care and use committees (IACUCs conduct continuing reviews of all animal research activities. However, little is known about the lapse rate of IACUC continuing reviews, and how frequently investigators continue research activities during the lapse. It is also not clear what factors may contribute to an institution's lapse in IACUC continuing reviews. As part of the quality assurance program, the Department of Veterans Affairs (VA has collected performance metric data for animal care and use programs since 2011. We analyzed IACUC continuing review performance data at 74-75 VA research facilities from 2011 through 2015. The IACUC continuing review lapse rates improved from 5.6% in 2011 to 2.7% in 2015. The rate of investigators continuing research activities during the lapse also decreased from 47.2% in 2012 to 7.4% in 2015. The type of IACUCs used and the size of animal research programs appeared to have no effect in facility's rates of lapse in IACUC continuing reviews. While approximately 80% of facilities reported no lapse in IACUC continuing reviews, approximately 14% of facilities had lapse rates of >10% each year. Some facilities appeared to be repeat offenders. Four facilities had IACUC lapse rates of >10% in at least 3 out of 5 years, suggesting a system problem in these facilities requiring remedial actions to improve their IACUC continuing review processes.

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.

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...

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...

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.

Institutional review boards' attitudes towards remuneration in paediatric research

DEFF Research Database (Denmark)

Flege, Marius M; Thomsen, Simon F

2017-01-01

Remuneration in paediatric research poses an ethical dilemma. Too large a sum might cause parents to enrol their children in research projects with no benefit for the child, whereas too modest a sum might hamper recruitment. The institutional review boards have the responsibility to only approve ...

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...

Results of 1989/90 research and development activities at KfK Institute for Reactor Components

International Nuclear Information System (INIS)

1991-03-01

R and D activities at IRB (Institut fuer Reaktorbauelemente - Institute for Reactor Components) are dedicated to thermodynamics and fluid dynamics. Emphasis is on the design of nuclear reactor and fusion reactor components. Environmental engineering was added recently. Most activities are applications-oriented. Fundamental investigations focus on energy research and energy technology. The activities are carried out in the framework of different projects (PKF/nuclear fusion, PSF/nuclear safety, PSU/pollution control). Points of main effort are the development of basic liquid-metal-cooled blanket solutions, investigations on natural convection in reactor ranks, and the cooling properties of future containments for pressurized water reactors in the case of nuclear fusion accidents. (orig./GL) [de

Research Review of the Institute of African Studies: Contact

African Journals Online (AJOL)

Principal Contact. Prof. M.E. Kropp Dakubu Editor-in-Chief University of Ghana. Research Review. Institute of African Studies. P.O.Box LG73 Legon, Ghana. Phone: 211-24-4764006. Fax: 233-21-500512. Email: medakubu@ug.edu.gh. Support Contact. Dr Stephen Acheampong Phone: 211-24-4979233

Concordance between local, institutional, and central pathology review in glioblastoma: implications for research and practice: a pilot study.

Science.gov (United States)

Gupta, Tejpal; Nair, Vimoj; Epari, Sridhar; Pietsch, Torsten; Jalali, Rakesh

2012-01-01

There is significant inter-observer variation amongst the neuro-pathologists in the typing, subtyping, and grading of glial neoplasms for diagnosis. Centralized pathology review has been proposed to minimize this inter-observer variation and is now almost mandatory for accrual into multicentric trials. We sought to assess the concordance between neuro-pathologists on histopathological diagnosis of glioblastoma. Comparison of local, institutional, and central neuro-oncopathology reporting in a cohort of 34 patients with newly diagnosed supratentorial glioblastoma accrued consecutively at a tertiary-care institution on a prospective trial testing the addition of a new agent to standard chemo-radiation regimen. Concordance was sub-optimal between local histological diagnosis and central review, fair between local diagnosis and institutional review, and good between institutional and central review, with respect to histological typing/subtyping. Twelve (39%) of 31 patients with local histological diagnosis had identical tumor type, subtype and grade on central review. Overall agreement was modestly better (52%) between local diagnosis and institutional review. In contrast, 28 (83%) of 34 patients had completely concordant histopathologic diagnosis between institutional and central review. The inter-observer reliability test showed poor agreement between local and central review (kappa statistic=0.12, 95% confidence interval (CI): -0.03-0.32, P=0.043), but moderate agreement between institutional and central review (kappa statistic=0.51, 95%CI: 0.17-0.84, P=0.00003). Agreement between local diagnosis and institutional review was fair. There exists significant inter-observer variation regarding histopathological diagnosis of glioblastoma with significant implications for clinical research and practice. There is a need for more objective, quantitative, robust, and reproducible criteria for better subtyping for accurate diagnosis.

Postoperative complications following intraoperative radiotherapy in abdominopelvic malignancy: A single institution analysis of 113 consecutive patients.

Science.gov (United States)

Abdelfatah, Eihab; Page, Andrew; Sacks, Justin; Pierorazio, Phillip; Bivalacqua, Trinity; Efron, Jonathan; Terezakis, Stephanie; Gearhart, Susan; Fang, Sandy; Safar, Bashar; Pawlik, Timothy M; Armour, Elwood; Hacker-Prietz, Amy; Herman, Joseph; Ahuja, Nita

2017-06-01

Intraoperative radiotherapy (IORT) has advantages over external beam radiation therapy (EBRT). Few studies have described side effects associated with its addition. We evaluated our institution's experience with abdominopelvic IORT to assess safety by postoperative complication rates. Prospectively collected IRB-approved database of all patients receiving abdominopelvic IORT (via high dose rate brachytherapy) at Johns Hopkins Hospital between November 2006 and May 2014 was reviewed. Patients were discussed in multidisciplinary conferences. Those selected for IORT were patients for whom curative intent resection was planned for which IORT could improve margin-negative resection and optimize locoregional control. Perioperative complications were classified via Clavien-Dindo scale for postoperative surgical complications. A total of 113 patients were evaluated. Most common diagnosis was sarcoma (50/113, 44%) followed by colorectal cancer (45/113, 40%), most of which were recurrent (84%). There were no perioperative deaths. A total of 57% of patients experienced a complication Grade II or higher: 24% (27/113) Grade II; 27% (30/113) Grade III; 7% (8/113) Grade IV. Wound complications were most common (38%), then gastrointestinal (25%). No radiotherapy variables were significantly associated with complications on uni/multi-variate analysis. Our institution's experience with IORT demonstrated historically expected postoperative complication rates. IORT is safe, with acceptable perioperative morbidity. © 2017 Wiley Periodicals, Inc.

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

Survey of credit risk models in relation to capital adequacy framework for financial institutions

Directory of Open Access Journals (Sweden)

Poomjai Nacaskul

2016-12-01

Full Text Available This article (i iterates what is meant by credit risks and the mathematical-statistical modelling thereof, (ii elaborates the conceptual and technical links between credit risk modelling and capital adequacy framework for financial institutions, particularly as per the New Capital Accord (Basel II’s Internal Ratings-Based (IRB approach, (iii proffer a simple and intuitive taxonomy on contemporary credit risk modelling methodologies, and (iv discuses in some details a number of key models pertinent, in various stages of development, to various application areas in the banking and financial sector.

78 FR 69426 - Submission for OMB Review; 30-Day Comment Request: NIH NCI Central Institutional Review Board...

Science.gov (United States)

2013-11-19

... Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review... response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs... 1 15/60 4 Reviewer Advertisement Checklist Board Members 10 1 20/60 3 Dated: November 7, 2013...

Nature-based interventions in institutional and organisational settings: a scoping review.

Science.gov (United States)

Moeller, Chris; King, Nigel; Burr, Viv; Gibbs, Graham R; Gomersall, Tim

2018-04-26

The objective of this review was to scope the literature on nature-based interventions that could be conducted in institutional settings where people reside full-time for care or rehabilitation purposes. Systematic searches were conducted across CINAHL, Medline, Criminal Justice Abstracts, PsycINFO, Scopus, Social Care Online and Cochrane CENTRAL. A total of 85 studies (reported in 86 articles) were included. Four intervention modalities were identified: Gardening/therapeutic horticulture; animal-assisted therapies; care farming and virtual reality-based simulations of natural environments. The interventions were conducted across a range of settings, including inpatient wards, care homes, prisons and women's shelters. Generally, favourable impacts were seen across intervention types, although the reported effects varied widely. There is a growing body of literature on nature-based interventions that could be applied to a variety of institutional settings. Within most intervention types, there is sufficient research data available to perform full systematic reviews. Recommendations for future systematic reviews are offered.

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…

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.

Review of the Development of Learning Analytics Applied in College-Level Institutes

Directory of Open Access Journals (Sweden)

Ken-Zen Chen

2014-07-01

Full Text Available This article focuses on the recent development of Learning Analytics using higher education institutional big-data. It addresses current state of Learning Analytics, creates a shared understanding, and clarifies misconceptions about the field. This article also reviews prominent examples from peer institutions that are conducting analytics, identifies their data and methodological framework, and comments on market vendors and non-for-profit initiatives. Finally, it suggests an implementation agenda for potential institutions and their stakeholders by drafting necessary preparations and creating iterative implementation flows.

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.

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…

The impacts of institutional child sexual abuse: A rapid review of the evidence.

Science.gov (United States)

Blakemore, Tamara; Herbert, James Leslie; Arney, Fiona; Parkinson, Samantha

2017-12-01

While awareness of institutional child sexual abuse has grown in recent years, there remains limited understanding of its occurrence and outcomes as a distinct form of abuse. Drawing on research commissioned by the Australian Royal Commission into Institutional Responses to Child Sexual Abuse, this article presents a rapid review of available evidence on the impacts of institutional abuse on victim/survivors. Literature searches identified 75 sources spanning international peer reviewed work and reports to Government that document or quantify the impacts of mostly historical child sexual abuse occurring in religious, educational, sporting and residential or out-of-home care settings. Consistent with child sexual abuse in other contexts, institutional child sexual abuse is found to be associated with numerous, pervasive and connected impacts upon the psychological, physical, social, educative and economic wellbeing of victims/survivors. Further, institutional child sexual abuse is associated with vicarious trauma at the individual, family and community level, and with impacts to the spiritual wellbeing of victims/survivors of abuse that occurs in religious settings. The identified literature suggests the trauma of institutional child sexual abuse may be exacerbated by the interplay of abuse dynamics in institutional settings, which may reduce or impede circumstances supporting disclosure, belief, support and protection from future harm. Acknowledging the limitations of the present study and the available evidence, this narrative synthesis provides insights into the complex impacts of institutional child sexual abuse. Copyright © 2017 Elsevier Ltd. All rights reserved.

Literature Review of Enterprise Systems Research Using Institutional Theory: Towards a Conceptual Model

DEFF Research Database (Denmark)

Svejvig, Per

This paper sets out to examine the use of institutional theory as a conceptually rich lens to study social issues of enterprise systems (ES) research. More precisely, the purpose is to categorize current ES research using institutional theory to develop a conceptual model that advances ES research...... model which advocates for multi-level and multi-theory approaches, and applies newer institutional aspects such as institutional logics. The findings show that institutional theory in ES research is in its infancy and adopts mainly traditional institutional aspects like isomorphism....... Key institutional features are presented such as isomorphism, rationalized myths, bridging macro and micro structures, and institutional logics and their implications for ES research are discussed. Through a literature review of 180 articles, of which 18 papers are selected, we build a conceptual...

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).

Reviewing and Revising the Institutional Vision of U.S. Higher Education

Directory of Open Access Journals (Sweden)

Robert Abelman

2014-02-01

Full Text Available This article reviews the literature on the institutional vision of higher education in the United States – that is, the philosophical template through which colleges and universities define and communicate the kinds of human beings they are attempting to cultivate. Key linguistic components found to constitute a well conceived, viable, and easily diffused institutional vision are identified and significant issues, controversies and problems associated with these guiding, governing, and self-promotional mission and vision statements are examined. Particular attention is given to those types of schools recognized in the literature as the most maligned in the academic community or misrepresented in the popular press. A comparative analysis revisits the data of a subset of these investigations with the intention of generating greater insight into the institutional vision of higher education and offering a prescription for how these statements can better serve their institutions.

[Ethic review on clinical experiments of medical devices in medical institutions].

Science.gov (United States)

Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining

2011-07-01

Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.

Quality Assurance Peer Review Chart Rounds in 2011: A Survey of Academic Institutions in the United States

International Nuclear Information System (INIS)

Lawrence, Yaacov Richard; Whiton, Michal A.; Symon, Zvi; Wuthrick, Evan J.; Doyle, Laura; Harrison, Amy S.; Dicker, Adam P.

2012-01-01

Purpose: In light of concerns regarding the quality of radiation treatment delivery, we surveyed the practice of quality assurance peer review chart rounds at American academic institutions. Methods and Materials: An anonymous web-based survey was sent to the chief resident of each institution across the United States. Results: The response rate was 80% (57/71). The median amount of time spent per patient was 2.7 minutes (range, 0.6–14.4). The mean attendance by senior physicians and residents was 73% and 93%, respectively. A physicist was consistently present at peer review rounds in 66% of departments. There was a close association between attendance by senior physicians and departmental organization: in departments with protected time policies, good attendance was 81% vs. 31% without protected time (p = 0.001), and in departments that documented attendance, attending presence was 69% vs. 29% in departments without documentation (p 75% of institutions, whereas dosimetric details (beams, wedges), isodose coverage, intensity-modulated radiation therapy constraints, and dose–volume histograms were always peer reviewed in 63%, 59%, 42%, and 50% of cases, respectively. Chart rounds led to both minor (defined as a small multileaf collimator change/repeated port film) and major (change to dose prescription or replan with dosimetry) treatment changes. Whereas at the majority of institutions changes were rare (<10% of cases), 39% and 11% of institutions reported that minor and major changes, respectively, were made to more than 10% of cases. Conclusion: The implementation of peer review chart rounds seems inconsistent across American academic institutions. Brachytherapy and radiosurgical procedures are rarely reviewed. Attendance by senior physicians is variable, but it improves when scheduling clashes are avoided. The potential effect of a more thorough quality assurance peer review on patient outcomes is not known.

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

Pediatric colonic volvulus: A single-institution experience and review.

Science.gov (United States)

Tannouri, Sami; Hendi, Aditi; Gilje, Elizabeth; Grissom, Leslie; Katz, Douglas

2017-06-01

Pediatric colonic volvulus is both rare and underreported. Existing literature consists only of case reports and small series. We present an analysis of cases (n=11) over 15 years at a single institution, focusing on workup and diagnosis. This was an institutional review board approved single-institution retrospective chart review of 11 cases of large bowel volvulus occurring over 15 years (2000-2015). In our series, the most common presenting symptoms were abdominal pain and distention. Afflicted patients often had prior abdominal surgery, a neurodevelopmental disorder or chronic constipation. Of the imaging modalities utilized in the 11 patients studied, colonic volvulus was correctly diagnosed by barium enema in 100% of both cases, CT in 55.6% of cases and by plain radiography of the abdomen in only 22.2%of cases. Colonic volvulus was confirmed by laparotomy in all cases. The cecum (n=5) was the most often affected colonic segment, followed by the sigmoid (n=3). Operative treatment mainly consisted of resection (63.6%) and ostomy creation (36.4%). Colopexy was performed in 18.2% of cases. Plain abdominal radiography may be performed as an initial diagnostic study, however, it should be followed CT or air or contrast enema in children where there is high clinical suspicion and who do not have indications for immediate laparotomy. CT may be the most specific and useful test in diagnosis of colonic volvulus and has the added advantage of detection of complications including bowel ischemia. We demonstrate a range of diagnostic and therapeutic modalities for pediatric colonic volvulus. This underscores the need for further study to draft standard best practices for this life-threatening condition. Prognosis Study: Level IV. Study of a Diagnostic Test: Level III. Copyright © 2017 Elsevier Inc. All rights reserved.

Do chiropractic college faculty understand informed consent: a pilot study

Directory of Open Access Journals (Sweden)

Hondras Maria A

2006-12-01

Full Text Available Abstract Background The purpose of this study was to survey full-time faculty at a single chiropractic college concerning their knowledge of Institutional Review Board (IRB policies in their institution as they pertain to educational research. Methods All full-time faculty were invited to participate in an anonymous survey. Four scenarios involving educational research were described and respondents were asked to select from three possible courses of action for each. In addition, respondents were queried about their knowledge of IRB policies, how they learned of these policies and about their years of service and departmental assignments. Results The response rate was 55%. In no scenario did the level of correct answers by all respondents score higher than 41% and in most, the scores were closer to just under 1 in 3. Sixty-five percent of respondents indicated they were unsure whether Palmer had any policies in place at all, while 4% felt that no such policies were in place. Just over one-quarter (27% were correct in noting that students can decline consent, while more than half (54% did not know whether there were any procedures governing student consent. Conclusion Palmer faculty have only modest understanding about institutional policies regarding the IRB and human subject research, especially pertaining to educational research. The institution needs to develop methods to provide knowledge and training to faculty. The results from this pilot study will be instrumental in developing better protocols for a study designed to survey the entire chiropractic academic community.

Northeast Regional Cancer Institute's Cancer Surveillance and Risk Factor Program

Energy Technology Data Exchange (ETDEWEB)

Lesko, Samuel M.

2007-07-31

. For colorectal cancer, the stage at diagnosis of cases diagnosed in northeast Pennsylvania was compared to data from prior years. A population-based interview study of healthy adults was conducted to document the status of cancer screening and to estimate the prevalence of established cancer risk factors in this community. This study is similar in design to that used by the Centers for Disease Control and Prevention’s (CDC) Behavioral Risk Factor Surveillance System (BRFSS). EXPERIMENTAL METHODS AND PROCEDURES: This program includes two distinct but related projects. The first project uses existing data to conduct cancer surveillance in northeast Pennsylvania, and the second is a population-based study of cancer risk factors and cancer screening behaviors in this same population. HUMAN SUBJECTS CONSIDERATIONS This program includes two projects: cancer surveillance and a population-based study of cancer risk factors and screening behavior. The cancer surveillance project involves only the use of existing aggregate data or de-identified data. As such, the surveillance project is exempt from human subjects considerations. The study of cancer risk factors and screening behaviors includes data from a random sample of adult residents of northeast Pennsylvania who are 18 or more years of age. All races, ethnicities and both sexes are included in proportion to their representation in the population. Subjects are interviewed anonymously by telephone; those who are unable to complete an interview in English are ineligible. This project has been reviewed and approved by the Scranton-Temple Residency Program IRB (IRB00001355), which is the IRB for the Northeast Regional Cancer Institute.

NRC review of Electric Power Research Institute's Advanced Light Reactor Utility Requirements Document - Program summary, Project No. 669

International Nuclear Information System (INIS)

1992-08-01

The staff of the US Nuclear Regulatory Commission has prepared Volume 1 of a safety evaluation report (SER), ''NRC Review of Electric Power Research Institute's Advanced Light Water Reactor Utility Requirements Document -- Program Summary,'' to document the results of its review of the Electric Power Research Institute's ''Advanced Light Water Reactor Utility Requirements Document.'' This SER provides a discussion of the overall purpose and scope of the Requirements Document, the background of the staff's review, the review approach used by the staff, and a summary of the policy and technical issues raised by the staff during its review

Challenges for Smallholder Market Access: a review of literature on institutional arrangements in collective marketing

NARCIS (Netherlands)

Ton, G.

2008-01-01

Purpose of review: This review presents recent research on collective action in agricultural markets, focusing on the institutional settings that increase market access for smallholder farmers. It focuses attention on challenging research areas that try to understand and resolve the inherent

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.

Comprehensive review of the literature on institutional controls to limit land use

International Nuclear Information System (INIS)

1997-08-01

A literature search was conducted to identify case studies that would provide a basis for establishing the effective duration of institutional controls to limit land use and to identify the attributes that contribute to their effectiveness. The literature on a variety of active and passive institutional controls to limit land use on government lands and on private lands adjacent to government lands was reviewed. No case studies and little detailed information were found concerning the periods for which the institutional controls remained effective over the long-term or the aspects of the controls that contributed to their effectiveness in limiting land use. The information available in the literature is discussed and an extensive bibliography and recommendations regarding future work are provided. (author)

Comprehensive review of the literature on institutional controls to limit land use

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-08-01

A literature search was conducted to identify case studies that would provide a basis for establishing the effective duration of institutional controls to limit land use and to identify the attributes that contribute to their effectiveness. The literature on a variety of active and passive institutional controls to limit land use on government lands and on private lands adjacent to government lands was reviewed. No case studies and little detailed information were found concerning the periods for which the institutional controls remained effective over the long-term or the aspects of the controls that contributed to their effectiveness in limiting land use. The information available in the literature is discussed and an extensive bibliography and recommendations regarding future work are provided. (author).

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

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 ...

Postpartum tubal ligation: A retrospective review of anesthetic management at a single institution and a practice survey of academic institutions.

Science.gov (United States)

McKenzie, Christine; Akdagli, Seden; Abir, Gillian; Carvalho, Brendan

2017-12-01

The primary aim was to evaluate institutional anesthetic techniques utilized for postpartum tubal ligation (PPTL). Secondarily, academic institutions were surveyed on their clinical practice for PPTL. An institutional-specific retrospective review of patients with ICD-9 procedure codes for PPTL over a 2-year period was conducted. Obstetric anesthesia fellowship directors were surveyed on anesthetic management of PPTL. Labor and delivery unit. Internet survey. 202 PPTL procedures were reviewed. 47 institutions were surveyed; 26 responses were received. Timing of PPTL, anesthetic management, postoperative pain and length of stay. There was an epidural catheter reactivation failure rate of 26% (18/69 epidural catheter reactivation attempts). Time from epidural catheter insertion to PPTL was a significant factor associated with failure: median [IQR; range] time for successful versus failed epidural catheter reactivation was 17h [10-25; 3-55] and 28h [14-33; 5-42], respectively (P=0.028). Epidural catheter reactivation failure led to significantly longer times to provide surgical anesthesia than successful epidural catheter reactivation or primary spinal technique: median [IQR] 41min [33-54] versus 15min [12-21] and 19min [15-24], respectively (P8h and >24h post-delivery, respectively. Epidural catheter reactivation failure increases with longer intervals between catheter placement and PPTL. Failed epidural catheter reactivation increases anesthetic and operating room times. Our results and the significant variability in practice from our survey suggest recommendations on the timing and anesthetic management are needed to reduce unfulfilled PPTL procedures. Copyright © 2017 Elsevier Inc. All rights reserved.

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

77 FR 58111 - Notice of Submission for OMB Review; Institute of Education Sciences; FAFSA Completion Project...

Science.gov (United States)

2012-09-19

... DEPARTMENT OF EDUCATION Notice of Submission for OMB Review; Institute of Education Sciences; FAFSA Completion Project Evaluation SUMMARY: The Institute of Education Sciences (IES) at the U.S. Department of Education (ED) is conducting a rigorous study of the Free Application for Federal Student Aid...

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.

A Review of Cash Management Policies, Procedures and Practices of Mississippi's Institutions of Higher Learning.

Science.gov (United States)

Mississippi State Legislature, Jackson. Performance Evaluation and Expenditure Review Committee.

This report to the Mississippi Legislature presents the findings of a review of the cash management policies, procedures, and practices of the State Board of Trustees of Institutions of Higher Learning (IHL). The methodology involved review of: applicable Mississippi statutes; standards promulgated by the National Association of College and…

Ethics support in institutional elderly care: a review of the literature.

Science.gov (United States)

van der Dam, Sandra; Molewijk, Bert; Widdershoven, Guy A M; Abma, Tineke A

2014-09-01

Clinical ethics support mechanisms in healthcare are increasing but little is known about the specific developments in elderly care. The aim of this paper is to present a systematic literature review on the characteristics of existing ethics support mechanisms in institutional elderly care. A review was performed in three electronic databases (Pubmed, CINAHL/PsycINFO, Ethxweb). Sixty papers were included in the review. The ethics support mechanisms are classified in four categories: 'institutional bodies' (ethics committee and consultation team); 'frameworks' (analytical tools to assist care professionals); 'educational programmes and moral case deliberation'; and 'written documents and policies'. For each category the goals, methods and ways of organising are described. Ethics support often serves several goals and can be targeted at various levels: case, professional or organisation. Over the past decades a number of changes have taken place in the development of ethics support in elderly care. Considering the goals, ethics support has become more outreaching and proactive, aiming to qualify professionals to integrate ethics in daily care processes. The approaches in clinical ethics support have become more diverse, more focused on everyday ethical issues and better adapted to the concrete learning style of the nursing staff. Ethics support has become less centrally organised and more connected to local contexts and primary process within the organisation. 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.

Some Visual Literacy Initiatives in Academic Institutions: A Literature Review from 1999 to the Present

Science.gov (United States)

Blummer, Barbara

2015-01-01

The ubiquitousness of images in the digital era highlights the importance of individuals' visual communication skills in the 21st Century. We conducted a literature review of visual literacy initiatives in academic institutions to illustrate best practices for imparting these skills in students. The literature review identified five categories of…

Dysphagia in the elderly in long-stay institutions - a systematic literature review

Directory of Open Access Journals (Sweden)

Bianca Paixão Santos

Full Text Available ABSTRACT The objective of this study was to verify in the literature, through a systematic review, the dietary conditions of the elderly in long-stay institutions, seeking to observe the general care and agents that potentiate dysphagia, in order to review aspects of dysphagia and deglutition risk indicators in the elderly. A survey, regarding the articles published from 2009 on, with the descriptors "elderly, long-stay institution and dysphagia", in Portuguese and English, on Scielo, PubMed and Lilacs, was performed, totaling 423 articles in the initial search, from which, 13 that were in agreement with the inclusion criteria adopted were chosen, 2 being repeated in more than one research source. At the end, 11 articles were included for analysis and discussion. It was observed that most the long-stay institutions do not have adequate structure to treat the elderly in a multidisciplinary approach. In all those studies, the negligence with the elderly’s oral hygiene, which potentiates the development of pulmonary infections in cases of aspiration, was evidenced. The association between dementia, food dependency and increase in feeding time was also observed in the literature, as well as the association of medication use with the interference in food dynamics. In addition, many studies have shown that, although the Stomatognathic System structures are altered due to the aging process, the elderly have the functions of speech, chewing and swallowing adapted, without greater damage to their general health. It can be concluded that long-stay institutions do not offer adequate staff to care for the elderly to reduce the risks for dysphagia.

Characterization of the peer review network at the Center for Scientific Review, National Institutes of Health.

Science.gov (United States)

Boyack, Kevin W; Chen, Mei-Ching; Chacko, George

2014-01-01

The National Institutes of Health (NIH) is the largest source of funding for biomedical research in the world. This funding is largely effected through a competitive grants process. Each year the Center for Scientific Review (CSR) at NIH manages the evaluation, by peer review, of more than 55,000 grant applications. A relevant management question is how this scientific evaluation system, supported by finite resources, could be continuously evaluated and improved for maximal benefit to the scientific community and the taxpaying public. Towards this purpose, we have created the first system-level description of peer review at CSR by applying text analysis, bibliometric, and graph visualization techniques to administrative records. We identify otherwise latent relationships across scientific clusters, which in turn suggest opportunities for structural reorganization of the system based on expert evaluation. Such studies support the creation of monitoring tools and provide transparency and knowledge to stakeholders.

Nigeria : Financial Sector Review, Volume 3. Non-Bank Financial Institutions and Markets

OpenAIRE

World Bank

2000-01-01

This report is a comprehensive review of the Nigerian financial system, covering the following areas: i) macro-financial environment; ii) safety and soundness of the banking system; iii) banking supervision; iv) development finance institutions; v) community banks and commercial banks' rural operations; vi) insurance and pensions; vii) housing finance; viii) money and capital markets; and ...

Understanding bureaucracy in health science ethics: toward a better institutional review board.

Science.gov (United States)

Bozeman, Barry; Slade, Catherine; Hirsch, Paul

2009-09-01

Research involving human participants continues to grow dramatically, fueled by advances in medical technology, globalization of research, and financial and professional incentives. This creates increasing opportunities for ethical errors with devastating effects. The typical professional and policy response to calamities involving human participants in research is to layer on more ethical guidelines or strictures. We used a recent case-the Johns Hopkins University/Kennedy Kreiger Institute Lead Paint Study-to examine lessons learned since the Tuskegee Syphilis Study about the role of institutionalized science ethics in the protection of human participants in research. We address the role of the institutional review board as the focal point for policy attention.

Evolutionary institutionalism.

Science.gov (United States)

Fürstenberg, Dr Kai

Institutions are hard to define and hard to study. Long prominent in political science have been two theories: Rational Choice Institutionalism (RCI) and Historical Institutionalism (HI). Arising from the life sciences is now a third: Evolutionary Institutionalism (EI). Comparative strengths and weaknesses of these three theories warrant review, and the value-to-be-added by expanding the third beyond Darwinian evolutionary theory deserves consideration. Should evolutionary institutionalism expand to accommodate new understanding in ecology, such as might apply to the emergence of stability, and in genetics, such as might apply to political behavior? Core arguments are reviewed for each theory with more detailed exposition of the third, EI. Particular attention is paid to EI's gene-institution analogy; to variation, selection, and retention of institutional traits; to endogeneity and exogeneity; to agency and structure; and to ecosystem effects, institutional stability, and empirical limitations in behavioral genetics. RCI, HI, and EI are distinct but complementary. Institutional change, while amenable to rational-choice analysis and, retrospectively, to criticaljuncture and path-dependency analysis, is also, and importantly, ecological. Stability, like change, is an emergent property of institutions, which tend to stabilize after change in a manner analogous to allopatric speciation. EI is more than metaphorically biological in that institutional behaviors are driven by human behaviors whose evolution long preceded the appearance of institutions themselves.

A REVIEW OF BALANCED SCORECARD FRAMEWORK IN HIGHER EDUCATION INSTITUTION (HEIS

Directory of Open Access Journals (Sweden)

Fahmi Fadhl Al-Hosaini

2015-01-01

Full Text Available Many studies have been conducted to investigate the effectives of the BSC in organisations. It is observed that many organisations adopt different perspectives suitable for their functions in line with their vison, mission and strategic themes. Some reseachers have highlighted its relevance to Higher Education institutions. However, previous studies have not defined wich perspectives are most relevant for public HEIs, which are not for profit by nature. Higher Educational Institutions (HEIs are involved in routine processes of providing tertiary education in colleges, universities, and institutes including both undergraduate and postgraduate programmes, vocational and education training. One of the aims of HEIs is to achieve results in terms of products and services for the customers and other stake holders. In this paper, we review recent studies in top journals using the Balanced Scorecard Framework in HEIs. The paper identifies the relenvant perspectives for HEIs and presents its contextual analysis. When implemented, this can be used to monitor their performance and enable them to adjust to emerging challenges that come as a result of implementing key strategies.

MR neurography (MRN) of the long thoracic nerve: retrospective review of clinical findings and imaging results at our institution over 4 years

Energy Technology Data Exchange (ETDEWEB)

Deshmukh, Swati [Northwestern University, Chicago, IL (United States); Fayad, Laura M. [The Johns Hopkins Medical Institutions, The Russell H. Morgan Department of Radiology and Radiological Science, Baltimore, MD (United States); The Johns Hopkins Medical Institutions, Department of Oncology, Baltimore, MD (United States); The Johns Hopkins Medical Institutions, Department of Orthopaedic Surgery, Baltimore, MD (United States); Ahlawat, Shivani [The Johns Hopkins Medical Institutions, The Russell H. Morgan Department of Radiology and Radiological Science, Baltimore, MD (United States)

2017-11-15

Long thoracic nerve (LTN) injury can result in ipsilateral serratus anterior palsy and scapular winging. Traditional means of evaluating patients with suspected LTN injury include physical examination and electrodiagnostic studies. The purpose of our study is to describe high-resolution magnetic resonance (MR) findings in patients with clinical suspicion of LTN neuropathy. In this HIPAA-compliant, IRB-approved, retrospective study, two radiologists reviewed MR imaging performed for long thoracic neuropathy. Clinical presentation, electrodiagnostic studies and MR imaging of 20 subjects [mean age 37 ± 13 years; 25% (5/20) female] were reviewed. Observers reviewed MR imaging for LTN signal intensity, size, course, presence or absence of mass and secondary findings [skeletal muscle denervation (serratus anterior, trapezius, rhomboid) and scapular winging]. Descriptive statistics were reported. Clinical indications included trauma (n = 5), hereditary neuropathy (n = 1), pain (n = 8), winged scapula (n = 6), brachial plexitis (n = 4) and mass (n = 1). Electrodiagnostic testing (n = 7) was positive for serratus anterior denervation in three subjects. Abnormal LTN signal intensity, size, course or mass was present in 0/20. Secondary findings included skeletal muscle denervation in the serratus anterior in 40% (8/20), trapezius in 20% (4/20) and rhomboid in 20% (4/20). In 5% (1/20), an osteochondroma simulated a winged scapula, and in 2/20 (10%) MR showed scapular winging. High-resolution MR imaging is limited in its ability to visualize the long thoracic nerve directly, but does reveal secondary signs that can confirm a clinical suspicion of LTN injury. (orig.)

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

Implementation of Blended Learning in Higher Learning Institutions: A Review of the Literature

Science.gov (United States)

Ma'arop, Amrien Hamila; Embi, Mohamed Amin

2016-01-01

While many educational premises including higher learning institutions favor blended learning over traditional approach and merely online learning, some academicians are still apprehensive about teaching in blended learning. The aim of this review is to synthesize the available evidence in the literature on challenges faced in implementing blended…

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.

Promoting nurse practitioner practice through research: opportunities, challenges, and lessons.

Science.gov (United States)

Hayes, Eileen

2006-04-01

To discuss the opportunities derived, challenges faced, and lessons learned in the research process, including recruiting and retaining nurse practitioner (NP) participants, obtaining institutional approval, and solving research team issues in a National Institutes of Health/National Institute of Nursing Research (NIH/NINR)-funded study of communication between NPs and their older patients in managed care and non-managed care settings. The video-taped interactions between 30 NPs and 150 patients, research team experiences in conducting the research, and a review of relevant literature. Key factors in NP study participation included recognizing the importance of research in demonstrating the effectiveness of the NP role and for advancing the profession, having participated in previous research, enjoying the research process, employer incentives, membership in NP professional organizations, relationships with the university and the school of nursing conducting the research, and knowledge of the coinvestigator's work. NP recruitment was facilitated by word of mouth, professional organization assistance, and articles in a widely distributed, free nursing journal. Data collection was significantly delayed by attrition of NP participants, logistical problems with scheduling and travel, and varied approval procedures by Institutional Review Boards (IRBs) at study sites. The pace of nursing research could be much more efficient if IRB processes involved fewer bureaucratic entanglements. Preliminary study findings, however, show positive outcomes for older patients after NP care. To demonstrate positive patient outcomes and move the NP profession forward, NPs must be willing to commit to participation in research on their effectiveness as providers in today's healthcare environment.

Microfinance institutions' failure to address poverty: A narrative critical literature review

OpenAIRE

Guðjónsson, Sigurður

2017-01-01

This critical literature review begins by giving a short introduction to the microfinance industry. Microfinance institutions (MFIs) are explained and an account is given of their dual performance goals of financial performance (‘financial sustainability’) and social performance (‘outreach’). While MFIs’ social performance is directly aimed at poverty reduction, it is noteworthy that often they fail to address poverty (i.e., they fail to deliver outreach). The aim of the paper is to answer th...

Pediatric Critical Care Telemedicine Program: A Single Institution Review.

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Hernandez, Maria; Hojman, Nayla; Sadorra, Candace; Dharmar, Madan; Nesbitt, Thomas S; Litman, Rebecca; Marcin, James P

2016-01-01

Rural and community emergency departments (EDs) often receive and treat critically ill children despite limited access to pediatric expertise. Increasingly, pediatric critical care programs at children's hospitals are using telemedicine to provide consultations to these EDs with the goal of increasing the quality of care. We conducted a retrospective review of a pediatric critical care telemedicine program at a single university children's hospital. Between the years 2000 and 2014, we reviewed all telemedicine consultations provided to children in rural and community EDs, classified the visits using a comprehensive evidence-based set of chief complaints, and reported the consultations' impact on patient disposition. We also reviewed the total number of pediatric ED visits to calculate the relative frequency with which telemedicine consultations were provided. During the study period, there were 308 consultations provided to acutely ill and/or injured children for a variety of chief complaints, most commonly for respiratory illnesses, acute injury, and neurological conditions. Since inception, the number of consultations has been increasing, as has the number of participating EDs (n = 18). Telemedicine consultations were conducted on 8.6% of seriously ill children, the majority of which resulted in admission to the receiving hospital (n = 150, 49%), with a minority of patients requiring transport to the university children's hospital (n = 103, 33%). This single institutional, university children's hospital-based review demonstrates that a pediatric critical care telemedicine program used to provide consultations to seriously ill children in rural and community EDs is feasible, sustainable, and used relatively infrequently, most typically for the sickest pediatric patients.

76 FR 38694 - Uranium From Russia; Institution of a Five-Year Review Concerning the Suspended Investigation on...

Science.gov (United States)

2011-07-01

... INTERNATIONAL TRADE COMMISSION [Investigation No. 731-TA-539-C (Third Review)] Uranium From Russia; Institution of a Five-Year Review Concerning the Suspended Investigation on Uranium From Russia AGENCY: United...)) (the Act) to determine whether termination of the suspended investigation on uranium from Russia would...

Political and institutional influences on the use of evidence in public health policy. A systematic review.

Science.gov (United States)

Liverani, Marco; Hawkins, Benjamin; Parkhurst, Justin O

2013-01-01

There is increasing recognition that the development of evidence-informed health policy is not only a technical problem of knowledge exchange or translation, but also a political challenge. Yet, while political scientists have long considered the nature of political systems, the role of institutional structures, and the political contestation of policy issues as central to understanding policy decisions, these issues remain largely unexplored by scholars of evidence-informed policy making. We conducted a systematic review of empirical studies that examined the influence of key features of political systems and institutional mechanisms on evidence use, and contextual factors that may contribute to the politicisation of health evidence. Eligible studies were identified through searches of seven health and social sciences databases, websites of relevant organisations, the British Library database, and manual searches of academic journals. Relevant findings were extracted using a uniform data extraction tool and synthesised by narrative review. 56 studies were selected for inclusion. Relevant political and institutional aspects affecting the use of health evidence included the level of state centralisation and democratisation, the influence of external donors and organisations, the organisation and function of bureaucracies, and the framing of evidence in relation to social norms and values. However, our understanding of such influences remains piecemeal given the limited number of empirical analyses on this subject, the paucity of comparative works, and the limited consideration of political and institutional theory in these studies. This review highlights the need for a more explicit engagement with the political and institutional factors affecting the use of health evidence in decision-making. A more nuanced understanding of evidence use in health policy making requires both additional empirical studies of evidence use, and an engagement with theories and approaches

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 ...

Computer Security for Commercial Nuclear Power Plants - Literature Review for Korea Hydro Nuclear Power Central Research Institute

Energy Technology Data Exchange (ETDEWEB)

Duran, Felicia Angelica [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States). Security Systems Analysis Dept.; Waymire, Russell L. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States). Security Systems Analysis Dept.

2013-10-01

Sandia National Laboratories (SNL) is providing training and consultation activities on security planning and design for the Korea Hydro and Nuclear Power Central Research Institute (KHNPCRI). As part of this effort, SNL performed a literature review on computer security requirements, guidance and best practices that are applicable to an advanced nuclear power plant. This report documents the review of reports generated by SNL and other organizations [U.S. Nuclear Regulatory Commission, Nuclear Energy Institute, and International Atomic Energy Agency] related to protection of information technology resources, primarily digital controls and computer resources and their data networks. Copies of the key documents have also been provided to KHNP-CRI.

Computer Security for Commercial Nuclear Power Plants - Literature Review for Korea Hydro Nuclear Power Central Research Institute

International Nuclear Information System (INIS)

Duran, Felicia Angelica; Waymire, Russell L.

2013-01-01

Sandia National Laboratories (SNL) is providing training and consultation activities on security planning and design for the Korea Hydro and Nuclear Power Central Research Institute (KHNPCRI). As part of this effort, SNL performed a literature review on computer security requirements, guidance and best practices that are applicable to an advanced nuclear power plant. This report documents the review of reports generated by SNL and other organizations [U.S. Nuclear Regulatory Commission, Nuclear Energy Institute, and International Atomic Energy Agency] related to protection of information technology resources, primarily digital controls and computer resources and their data networks. Copies of the key documents have also been provided to KHNP-CRI.

Institutional entrepreneurship:

DEFF Research Database (Denmark)

Gretzinger, Susanne

2018-01-01

Institutional entrepreneurship pays specific attention to the process and outcomes of agents who are willing and capable of changing institutions. It has some common ground with the political entrepreneur, a concept that proposes change in norms and institutions because of commitment and activities...... of agents or organisations in the policy arena. The present chapter understands institutional entrepreneurship as the process of changing institutionalised practices. Based on a literature review, it describes the triggers, activities and potential effects of institutional entrepreneurs. The chapter...... concludes by tentatively arguing that political entrepreneurs can be institutional entrepreneurs, but institutional entrepreneurship can be considered as the broader concept that incorporates strategies and visions as well as interpretative-discursive power into the conceptual framework....

Research ethics consultation: ethical and professional practice challenges and recommendations.

Science.gov (United States)

Sharp, Richard R; Taylor, Holly A; Brinich, Margaret A; Boyle, Mary M; Cho, Mildred; Coors, Marilyn; Danis, Marion; Havard, Molly; Magnus, David; Wilfond, Benjamin

2015-05-01

The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical and Translational Science Award Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: (1) managing multiple institutional roles and responsibilities, (2) managing sensitive information, and (3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services.

76 FR 70151 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

Science.gov (United States)

2011-11-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

Fostering Child Development by Improving Care Quality: A Systematic Review of the Effectiveness of Structural Interventions and Caregiver Trainings in Institutional Care.

Science.gov (United States)

Hermenau, Katharin; Goessmann, Katharina; Rygaard, Niels Peter; Landolt, Markus A; Hecker, Tobias

2017-12-01

Quality of child care has been shown to have a crucial impact on children's development and psychological adjustment, particularly for orphans with a history of maltreatment and trauma. However, adequate care for orphans is often impacted by unfavorable caregiver-child ratios and poorly trained, overburdened personnel, especially in institutional care in countries with limited resources and large numbers of orphans. This systematic review investigated the effects of structural interventions and caregiver trainings on child development in institutional environments. The 24 intervention studies included in this systematic review reported beneficial effects on the children's emotional, social, and cognitive development. Yet, few studies focused on effects of interventions on the child-caregiver relationship or the general institutional environment. Moreover, our review revealed that interventions aimed at improving institutional care settings have largely neglected violence and abuse prevention. Unfortunately, our findings are partially limited by constraints of study design and methodology. In sum, this systematic review sheds light on obstacles and possibilities for the improvement in institutional care. There must be greater efforts at preventing violence, abuse, and neglect of children living in institutional care. Therefore, we advocate for combining attachment theory-based models with maltreatment prevention approaches and then testing them using rigorous scientific standards. By using approaches grounded in the evidence, it could be possible to enable more children to grow up in supportive and nonviolent environments.

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)

Institutional framework for integrated Pharmaceutical Benefits Management: results from a systematic review

Directory of Open Access Journals (Sweden)

Tomasz Roman Hermanowski

2015-09-01

Full Text Available Objectives: In this paper, we emphasised that effective management of health plans beneficiaries access to reimbursed medicines requires proper institutional set-up. The main objective was to identify and recommend an institutional framework of integrated pharmaceutical care providing effective, safe and equitable access to medicines. Method: The institutional framework of drug policy was derived on the basis of publications obtained by systematic reviews. A comparative analysis concerning adaptation of coordinated pharmaceutical care services in the USA, the UK, Poland, Italy, Denmark and Germany was performed. Results: While most European Union Member States promote the implementation of selected e-Health tools, like e-Prescribing, these efforts do not necessarily implement an integrated package. There is no single agent who would manage an insured patients’ access to medicines and health care in a coordinated manner, thereby increasing the efficiency and safety of drug policy. More attention should be paid by European Union Member States as to how to integrate various e-Health tools to enhance benefits to both individuals and societies. One solution could be to implement an integrated “pharmacy benefit management” model, which is well established in the USA and Canada and provides an integrated package of cost-containment methods, implemented within a transparent institutional framework and powered by strong motivation of the agent.

Role of institutional entrepreneurship in building adaptive capacity in community-based healthcare organisations: realist review protocol.

Science.gov (United States)

Iyengar, Sweatha; Katz, Aaron; Durham, Jo

2016-03-24

Over the past 3 decades, there has been a substantial shift to the marketisation of government-funded health services. For organisations traditionally buffered from the competitive pressures of for-profit enterprises, such as community-based organisations, this means developing the capacity to adapt to competitive tendering processes, shifting client expectations, and increasing demands for greater accountability. Drawing on ideas of institutional entrepreneurship, we believe that attempts to build adaptive capacity require the transformation of existing institutional arrangements. Key in this may be identifying and fostering institutional entrepreneurs--actors who take the lead in being the impetus for, and giving direction to, structural change. This study focuses on the strategies used by institutional entrepreneurs to build adaptive capacity in the community-based healthcare sector. The research will use an adapted rapid realist review. The review will find underlying theories that explain the circumstances surrounding the implementation of capacity-building strategies that shape organisational response and generate outcomes by activating causal mechanisms. An early scoping of the literature, and consultations with key stakeholders, will be undertaken to identify an initial programme theory. We will search for relevant journal articles and grey literature. Data will be extracted based on contextual factors, mechanisms and outcomes, and their configurations. The analysis will seek patterns and regularities in these configurations and will focus on confirming, refuting or refining our programme theory. The study does not involve primary research and, therefore, does not require formal ethical approval. However, ethical standards of utility, usefulness, feasibility, propriety, accuracy and accountability will be followed. The results will be written up according to the Realist and Meta-Review Evidence Synthesis: Evolving Standards guidelines. Once completed

The match between institutional elderly care management research and management challenges - a systematic literature review

Science.gov (United States)

2012-01-01

Background Elderly care practice and its management together with policy and research play a crucial role in responding to increasing challenges in institutional care for elderly people. Successful dialogue between these is necessary. The purpose of this systematic literature review is to compare how institutional elderly care management research meets the care challenges currently emphasized in international long-term care policy documents. Methods This paper was based on a systematic literature review. After screening 1971 abstracts using inclusion/exclusion criteria, 58 refereed articles published between 2000 and 2010 remained for analysis. The articles were analyzed using theory-based content analysis by comparing the results to the framework based on analysis of international long-term care management policy documents. Results The current challenges of long-term care management identified from policy documents were Integrated Care Management, Productivity Management, Quality Management, Workforce Management and ICT Management. The research on institutional elderly care management responded somewhat to the challenges mentioned in policy documents. However, some of the challenges were studied broadly and some were paid only minor attention. Further, only few studies focused on the core items of challenges addressed in policy documents. Conclusions Institutional care management research needs to focus more on challenges in integrated care, productivity, ICT and division of labor. Managers, researchers and policy-makers should assume more active collaborative roles in processes of research, policymaking and policy implementation. In addition managers’ and policymakers’ scientific literacy needs to be enhanced. PMID:23137416

The match between institutional elderly care management research and management challenges - a systematic literature review

Directory of Open Access Journals (Sweden)

Kokkonen Kaija

2012-11-01

Full Text Available Abstract Background Elderly care practice and its management together with policy and research play a crucial role in responding to increasing challenges in institutional care for elderly people. Successful dialogue between these is necessary. The purpose of this systematic literature review is to compare how institutional elderly care management research meets the care challenges currently emphasized in international long-term care policy documents. Methods This paper was based on a systematic literature review. After screening 1971 abstracts using inclusion/exclusion criteria, 58 refereed articles published between 2000 and 2010 remained for analysis. The articles were analyzed using theory-based content analysis by comparing the results to the framework based on analysis of international long-term care management policy documents. Results The current challenges of long-term care management identified from policy documents were Integrated Care Management, Productivity Management, Quality Management, Workforce Management and ICT Management. The research on institutional elderly care management responded somewhat to the challenges mentioned in policy documents. However, some of the challenges were studied broadly and some were paid only minor attention. Further, only few studies focused on the core items of challenges addressed in policy documents. Conclusions Institutional care management research needs to focus more on challenges in integrated care, productivity, ICT and division of labor. Managers, researchers and policy-makers should assume more active collaborative roles in processes of research, policymaking and policy implementation. In addition managers’ and policymakers’ scientific literacy needs to be enhanced.

The match between institutional elderly care management research and management challenges - a systematic literature review.

Science.gov (United States)

Kokkonen, Kaija; Rissanen, Sari; Hujala, Anneli

2012-11-08

Elderly care practice and its management together with policy and research play a crucial role in responding to increasing challenges in institutional care for elderly people. Successful dialogue between these is necessary. The purpose of this systematic literature review is to compare how institutional elderly care management research meets the care challenges currently emphasized in international long-term care policy documents. This paper was based on a systematic literature review. After screening 1971 abstracts using inclusion/exclusion criteria, 58 refereed articles published between 2000 and 2010 remained for analysis. The articles were analyzed using theory-based content analysis by comparing the results to the framework based on analysis of international long-term care management policy documents. The current challenges of long-term care management identified from policy documents were Integrated Care Management, Productivity Management, Quality Management, Workforce Management and ICT Management. The research on institutional elderly care management responded somewhat to the challenges mentioned in policy documents. However, some of the challenges were studied broadly and some were paid only minor attention. Further, only few studies focused on the core items of challenges addressed in policy documents. Institutional care management research needs to focus more on challenges in integrated care, productivity, ICT and division of labor. Managers, researchers and policy-makers should assume more active collaborative roles in processes of research, policymaking and policy implementation. In addition managers' and policymakers' scientific literacy needs to be enhanced.

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

Imaging yield from 133 consecutive patients with prostate cancer and low trigger PSA from a single institution

International Nuclear Information System (INIS)

Shinagare, A.B.; Keraliya, A.; Somarouthu, B.; Tirumani, S.H.; Ramaiya, N.H.; Kantoff, P.W.

2016-01-01

Aim: To investigate the yield of imaging in patients with relapsed prostate cancer (PC) with a low trigger prostate-specific antigen (PSA). Materials and methods: This institutional review board (IRB)-approved, Health Insurance Portability and Accountability Act (HIPAA)-compliant retrospective study included all 133 patients (mean age 68 years; range 45–88; median 69 months since original diagnosis; interquartile range [IQR]: 32–139) with hormone-sensitive PC (HSPC, n=28) or castration-resistant PC (CRPC, n=105) and trigger PSA 0.05 for all). Fifty-seven of the 133 (43%) patients had findings seen only at CT, of which 37 had new extra-osseous findings. Only 2/133 (2%) had findings at bone scintigraphy not seen at CT, both in areas not covered on CT. Conclusion: Imaging frequently demonstrated new metastatic and non-metastatic findings in patients with a low trigger PSA. CT is valuable in these patients because extra-osseous findings not visible at bone scintigraphy are frequently seen. - Highlights: • New and existing metastases common in prostate cancer with low trigger PSA. • Previous reports of threshold PSA levels may not apply in follow-up setting. • No difference in metastatic pattern between hormone sensitive and resistant disease. • CT showed extra-osseous findings not seen on bone scan in 44% patients. • Bone scan rarely showed findings not visible on concurrent CT.

Review of ANSI [American National Standards Institute] N13.11: A status report

International Nuclear Information System (INIS)

Sims, C.S.

1988-01-01

In 1983, the American National Standards Institute (ANSI) issued the dosimetry standard titled ''Personnel Dosimetry Performance -- Criteria for Testing'' as ANSI N13.11. This standard forms the basis for the National Voluntary Laboratory Accreditation Program (NVLAP) which has become familiar to dosimeter processors in recent years. This standard is particularly important because the Nuclear Regulatory Commission (NRC) requires that all licensees have personnel dosimetry devices processed by processors that are NVLAP accredited. This standard is currently undergoing review and modifications are going to be made. This paper contains a brief history of the events leading to the development of ANSI N13.11 - 1983, information concerning the present standard and associated performance test results, and the selection of the review group. Following that, the status of the review is presented and statements regarding the future outlook for the standard are made. 10 refs., 5 tabs

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...

The effect of HCV serological status on Doxorubicin based ...

African Journals Online (AJOL)

Karim Yousri Welaya

2014-09-10

Sep 10, 2014 ... Pretreatment evaluation included serological testing for HCV. FAC Adjuvant ... National Cancer Institute; IRB, Institutional Research Board; LVEF, ..... Mild Skin changes, including skin discoloration and nail changes, not ...

Philanthropic Fundraising of Higher Education Institutions: A Review of the Malaysian and Australian Perspectives

Directory of Open Access Journals (Sweden)

Mohd Isa Rohayati

2016-06-01

Full Text Available Currently, higher education institutions are facing rapidly rising costs and limitations in governmental funding. Accordingly, higher education institutions need sustainable forms of funding to operate effectively and remain competitive. In their attempts to identify causes and initiatives, world universities have paid more attention to philanthropic support. In their effort to raise funds, many institutions have grappled with questions of why donors give and what motivates donors to give. To address these questions, scholars must consider the influence of demographic and socio-economic characteristics, as well as internal and external motivational parameters on successful giving behaviour. However, much more attention has been paid to universities in Western countries and the United States. This study aims to review the factors influencing organizational philanthropic fundraising success and to gain an understanding of factors affecting donors’ giving decisions and perceptions of giving. This work focuses on donors’ giving to Malaysian and Australian public universities.

The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards?

Directory of Open Access Journals (Sweden)

Roger A. Barker

2018-05-01

Full Text Available Stem cell-based clinical interventions are increasingly advancing through preclinical testing and approaching clinical trials. The complexity and diversity of these approaches, and the confusion created by unproven and untested stem cell-based “therapies,” create a growing need for a more comprehensive review of these early-stage human trials to ensure they place the patients at minimal risk of adverse events but are also based on solid evidence of preclinical efficacy with a clear scientific rationale for that effect. To address this issue and supplement the independent review process, especially that of the ethics and institutional review boards who may not be experts in stem cell biology, the International Society for Stem Cell Research (ISSCR has developed a set of practical questions to cover the major issues for which clear evidence-based answers need to be obtained before approving a stem cell-based trial. Keywords: human stem cell-derived interventions, early phase clinical trials, institutional review and ethics boards, review process, guidelines

Relevance of First-Tier, Peer-Reviewed Journals in the Tenure and Promotion Process at Non-Doctoral Granting Engineering Institutions

Directory of Open Access Journals (Sweden)

Amanda S. Florio

2012-02-01

Full Text Available The IEEE (formerly the Institute of Electrical and Electronics Engineers is the world's largest professional society dedicated to the advancement of technology. While it is indeed growing into multiple technology areas, the IEEE is still first an organization of electrical, electronics, and computer engineering professionals. It has over 400,000 members and publishes nearly 100, first-tier, peer-reviewed journals. As such a large purveyor of scholarly works, engineering faculty at almost all academic institutions (doctoral granting and non-doctoral granting are familiar with the IEEE. For this reason, the IEEE makes an excellent case study for the relevance of first-tier, peer-reviewed journals in the tenure and promotion process at non-doctoral granting engineering institutions. In our work, we surveyed editors of the 97 IEEE journals. 93% of respondents indicated that 10% or less of their submissions were from non-academic institutions. None (0% of the respondents believed that the number of non-doctoral granting institution submissions would be increasing over the next three years. In fact, a majority of the respondents (55% see the number of non-doctoral granting institution submissions decreasing in the same time frame. To correlate this data, we examined a sample of 2,099 articles published in the first issue of each IEEE journal in 2009. 357 (17% of these 2,099 articles were authored by individuals from academic institutions in the United States. Of the 357, only 35 were published by individuals from non-doctoral granting institutions (1.7%, with only 8 (0.38% from institutions where a bachelor degree is the highest offered.

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

Science.gov (United States)

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.

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

The Utility of Expert Diagnosis in Surgical Neuropathology: Analysis of Consultations Reviewed at 5 National Comprehensive Cancer Network Institutions.

Science.gov (United States)

Bruner, Janet M; Louis, David N; McLendon, Roger; Rosenblum, Marc K; Archambault, W Tad; Most, Susan; Tihan, Tarik

2017-03-01

The aim of this study was to characterize the type and degree of discrepancies between non-expert and expert diagnoses of CNS tumors to identify the value of consultations in surgical neuropathology. Neuropathology experts from 5 National Comprehensive Cancer Network (NCCN) member institutions participated in the review of 1281 consultations selected based on inclusion criteria. The consultation cases were re-reviewed at the NCCN headquarters to determine concordance with the original diagnoses. Among all consultations, 249 (19.4%) were submitted for expert diagnoses without final diagnoses from the submitting institution. Within the remaining 1032 patients, the serious/major discrepancy rate was 4.8%, and less serious and minor discrepancies were seen in 19.4% of the cases. The discrepancy rate was higher among patients who were referred to NCCN institutions for consultation compared to those who were referred for treatment only. The discrepancy rates, patient demographics, type of consultations and submitting institutions varied among participating NCCN institutions. Expert consultations identified a subset of cases with significant diagnostic discrepancies, and constituted the initial diagnoses in some cases. These data indicate that expert consultations in glial tumors and all types of pediatric CNS tumors can improve accurate diagnosis and enable appropriate management. © 2017 American Association of Neuropathologists, Inc. All rights reserved.

NRC review of Electric Power Research Institute's Advanced Light Water Reactor Utility Requirements Document - Evolutionary plant designs, Chapter 1, Project No. 669

International Nuclear Information System (INIS)

1992-08-01

The staff of the US Nuclear Regulatory Commission has prepared Volume 2 (Parts 1 and 2) of a safety evaluation report (SER), ''NRC Review of Electric Power Research Institute's Advanced Light Water Reactor Utility Requirements Document -- Evolutionary Plant Designs,'' to document the results of its review of the Electric Power Research Institute's ''Advanced Light Water Reactor Utility Requirements Document.'' This SER gives the results of the staff's review of Volume II of the Requirements Document for evolutionary plant designs, which consists of 13 chapters and contains utility design requirements for an evolutionary nuclear power plant (approximately 1300 megawatts-electric)

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.

Informal institutions and radical ideologies under institutional transformation

Directory of Open Access Journals (Sweden)

Irina Starodubrovskaya

2015-06-01

Full Text Available This article questions one of the central postulates of institutional economic theory, i.e., that of the sustainability and purely evolutionary changes of informal institutions. To study the phenomenon of the destruction of informal institutions and its consequences, we use the tools of sociological theory, which acknowledge that a period of intensive urbanization is characterized by anomie, i.e., a lack of norms, in which traditional institutions are destroyed, while new urban institutions have not yet taken shape. We reviewed the possible reactions of communities and individuals to the conditions of anomie, including the compensatory mechanisms of ideologies. In the case of the Dagestan Republic, we show how the proliferation of fundamentalist Islamic ideology is associated with the state of anomie and the consequences to which it could lead from an institutional point of view. The analysis of the situation in Dagestan is based on long-term field research conducted in the region.

Research Ethics Consultation: Ethical and Professional Practice Challenges and Recommendations

Science.gov (United States)

Sharp, Richard R.; Taylor, Holly A.; Brinich, Margaret A.; Boyle, Mary M.; Cho, Mildred; Coors, Marilyn; Danis, Marion; Havard, Molly; Magnus, David; Wilfond, Benjamin

2015-01-01

The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include: assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical Translational Science Award (CTSA) Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: 1) managing multiple institutional roles and responsibilities, 2) managing sensitive information, and 3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services. PMID:25607942

77 FR 53909 - Certain Pasta From Italy and Turkey; Institution of Five-year Reviews Concerning the...

Science.gov (United States)

2012-09-04

...)] Certain Pasta From Italy and Turkey; Institution of Five-year Reviews Concerning the Countervailing and Antidumping Duty Orders on Certain Pasta From Italy and Turkey AGENCY: United States International Trade... revocation of the countervailing and antidumping duty orders on certain pasta from Italy and Turkey would be...

77 FR 48506 - Notice of Submission for OMB Review; Institute of Education Sciences; What Works Clearinghouse

Science.gov (United States)

2012-08-14

... DEPARTMENT OF EDUCATION Notice of Submission for OMB Review; Institute of Education Sciences; What... request to continue a currently approved collection under OMB Control Number 1850-0788 for the What Works... considered public records. Title of Collection: What Works Clearinghouse. OMB Control Number: 1850-0788. Type...

Innovation and Institutional Embeddedness of Multinational Corporations

DEFF Research Database (Denmark)

Pogrebnyakov, Nicolai

2014-01-01

Review of: Innovation and Institutional Embeddedness of Multinational Corporations / edited by Martin Heidenreich. (Cheltenham: Edward Elgar, 2012)......Review of: Innovation and Institutional Embeddedness of Multinational Corporations / edited by Martin Heidenreich. (Cheltenham: Edward Elgar, 2012)...

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.

Low-Dose-Rate Brachytherapy Versus Cryotherapy in Low- and Intermediate-Risk Prostate Cancer

International Nuclear Information System (INIS)

Gestaut, Matthew M.; Cai, Wendi; Vyas, Shilpa; Patel, Belur J.; Hasan, Salman A.; MunozMaldonado, Yolanda; Deb, Niloyjyoti; Swanson, Gregory

2017-01-01

Purpose: Cryotherapy and brachytherapy are definitive local treatment options for low- to intermediate-risk prostate cancer. There are both prospective and retrospective data for brachytherapy, but the use of cryotherapy has been limited primarily to single-institution retrospective studies. Currently, no published evidence has compared low-dose-rate brachytherapy versus cryotherapy. Methods and Materials: Institutional review board approval was obtained to conduct a retrospective chart review of consecutive patients treated at our institution from 1990 to 2012. For inclusion, patients must have received a prostate cancer diagnosis and have been considered to have low- to intermediate-risk disease according to the National Comprehensive Cancer Network criteria. All patients received brachytherapy or cryotherapy treatment. Disease specifics and failure details were collected for all patients. Failure was defined as prostate-specific antigen nadir +2 ng/mL. Results: A total of 359 patients were analyzed. The groups comprised 50 low-risk cryotherapy (LRC), 92 intermediate-risk cryotherapy (IRC), 133 low-risk brachytherapy (LRB), and 84 intermediate-risk brachytherapy (IRB) patients. The median prostate-specific antigen follow-up periods were 85.6 months (LRC), 59.2 months (IRC), 74.9 months (LRB), and 59.8 months (IRB). The 5-year biochemical progression–free survival (bPFS) rate was 57.9% in the cryotherapy group versus 89.6% in the brachytherapy group (P<.0001). The 5-year bPFS rate was 70.0% (LRC), 51.4% (IRC), 89.4% (LRB), and 89.7% (IRB). The bPFS rate was significantly different between brachytherapy and cryotherapy for low- and intermediate-risk groups (P<.05). The mean nadir temperature reached for cryotherapy patients was −35°C (range, −96°C to −6°C). Cryotherapy used a median of 2 freeze-thaw cycles (range, 2-4 freeze-thaw cycles). Conclusions: Results from this study suggest that cryotherapy is inferior to brachytherapy for patients with

Low-Dose-Rate Brachytherapy Versus Cryotherapy in Low- and Intermediate-Risk Prostate Cancer

Energy Technology Data Exchange (ETDEWEB)

Gestaut, Matthew M., E-mail: Matthew.Gestaut@BSWHealth.org [Department of Radiation Oncology, Baylor Scott and White Memorial Hospital, Texas A& M University School of Medicine, Temple, Texas (United States); Cai, Wendi [Department of Biostatistics, Baylor Scott and White Health, Temple, Texas (United States); Vyas, Shilpa [Department of Radiation Oncology, Swedish Cancer Institute, Seattle, Washington (United States); Patel, Belur J. [Department of Urology, Baylor Scott and White Memorial Hospital, Texas A& M University School of Medicine, Temple, Texas (United States); Hasan, Salman A. [Department of Radiation Oncology, Baylor Scott and White Memorial Hospital, Texas A& M University School of Medicine, Temple, Texas (United States); MunozMaldonado, Yolanda [Department of Biostatistics, Baylor Scott and White Health, Temple, Texas (United States); Deb, Niloyjyoti; Swanson, Gregory [Department of Radiation Oncology, Baylor Scott and White Memorial Hospital, Texas A& M University School of Medicine, Temple, Texas (United States)

2017-05-01

Purpose: Cryotherapy and brachytherapy are definitive local treatment options for low- to intermediate-risk prostate cancer. There are both prospective and retrospective data for brachytherapy, but the use of cryotherapy has been limited primarily to single-institution retrospective studies. Currently, no published evidence has compared low-dose-rate brachytherapy versus cryotherapy. Methods and Materials: Institutional review board approval was obtained to conduct a retrospective chart review of consecutive patients treated at our institution from 1990 to 2012. For inclusion, patients must have received a prostate cancer diagnosis and have been considered to have low- to intermediate-risk disease according to the National Comprehensive Cancer Network criteria. All patients received brachytherapy or cryotherapy treatment. Disease specifics and failure details were collected for all patients. Failure was defined as prostate-specific antigen nadir +2 ng/mL. Results: A total of 359 patients were analyzed. The groups comprised 50 low-risk cryotherapy (LRC), 92 intermediate-risk cryotherapy (IRC), 133 low-risk brachytherapy (LRB), and 84 intermediate-risk brachytherapy (IRB) patients. The median prostate-specific antigen follow-up periods were 85.6 months (LRC), 59.2 months (IRC), 74.9 months (LRB), and 59.8 months (IRB). The 5-year biochemical progression–free survival (bPFS) rate was 57.9% in the cryotherapy group versus 89.6% in the brachytherapy group (P<.0001). The 5-year bPFS rate was 70.0% (LRC), 51.4% (IRC), 89.4% (LRB), and 89.7% (IRB). The bPFS rate was significantly different between brachytherapy and cryotherapy for low- and intermediate-risk groups (P<.05). The mean nadir temperature reached for cryotherapy patients was −35°C (range, −96°C to −6°C). Cryotherapy used a median of 2 freeze-thaw cycles (range, 2-4 freeze-thaw cycles). Conclusions: Results from this study suggest that cryotherapy is inferior to brachytherapy for patients with

The Role of Universities and Other Institutions in Successful Entrepreneurship: Some Insights from a Literature Review

Science.gov (United States)

Zarate-Hoyos, German A.; Larios-Meoño, Fernando

2015-01-01

The purpose of this paper is to analyze the role of universities and other institutions in successful entrepreneurship. Insights are obtained following a literature review approach. Case studies from the United States (New York startup), Spain (Mondragon), and Germany provide strong evidence that universities are very instrumental in the creation,…

NRC review of Electric Power Research Institute's Advanced Light Water Reactor Utility Requirements Document - Evolutionary plant designs, Chapters 2--13, Project No. 669

International Nuclear Information System (INIS)

1992-08-01

The staff of the US Nuclear Regulatory Commission has prepared Volume 2 (Parts 1 and 2) of a safety evaluation report (SER), ''NRC Review of Electric Power Research Institute's Advanced Light Water Reactor Utility Requirements Document -- Evolutionary Plant Designs,'' to document the results of its review of the Electric Power Research Institute's ''Advanced Light Water Reactor Utility Requirements Document.'' This SER gives the results of the staff's review of Volume II of the Requirements Document for evolutionary plant designs, which consists of 13 chapters and contains utility design requirements for an evolutionary nuclear power plant (approximately 1300 megawatts-electric)

Measurement of Perceived Service Quality in Higher Education Institutions: A Review of HEdPERF Scale Use

Science.gov (United States)

Silva, Danilo Soares; de Morales, Gustavo Hermínio Salati Marcondes; Makiya, Ieda Kanashiro; Cesar, Francisco Ignácio Giocondo

2017-01-01

Purpose: This study aims to find evidence of the HEdPERF scale use for measuring the perceived service quality from the perspective of students in higher education institutions (HEIs) worldwide. Design/methodology/approach: A systematic review of the literature was conducted to find evidence of the scale use in articles published between January…

77 FR 76057 - National Cancer Institute; Notice of Closed Meeting

Science.gov (United States)

2012-12-26

..., Scientific Review Officer, Resources and Training Review Branch, Division of Extramural Activities, National... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute...--Institutional Training and Education Institutional Training and Education Grant. Date: February 25-26, 2013...

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

Science.gov (United States)

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

2017-07-10

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

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

The role of universities and other institutions in successful entrepreneurship:Some insights from a literature review

Directory of Open Access Journals (Sweden)

German A. Zarate - Hoyos

2015-12-01

Full Text Available The purpose of this paper is to analyze the role of universities and other institutions in successful entrepreneurship. Insights are obtained following a literature review approach. Case studies from the United States (New York startup, Spain (Mondragon, and Germany provide strong evidence that universities are very instrumental in the creation, design and implementation of entrepreneurial initiatives by providing new and ongoing entrepreneurs with human capital training, fundamentals, and theoretical and empirical models to contribute to lasting businesses. Results from university research on gender and risk-issues lead to believe that women are more risk averse than men to work and invest in star-up businesses. Other institutions, such as governments, are critical to provide with the necessary incentives to launch start-up businesses, including tax cuts, seed capital funding, investment in human capital, etc. While the evidence supporting the links between education and entrepreneurial outcomes is promisi g it is not yet definitive. In addition to providing a review of existing research, this paper suggests an integrative framework for future research.

Suicide patterns in children and adolescents: a review from a pediatric institution in England.

Science.gov (United States)

Zainum, Khairul; Cohen, Marta C

2017-06-01

Suicide is a catastrophic event to both families and communities yet it is potentially preventable. This study aims to determine incidence and patterns of suicide in children and young adolescents in our region, raise awareness of this entity as a potentially preventable cause of death in this age group, and identify its possible associated risk factors. We retrospectively reviewed suicide cases presenting as sudden unexpected death in children and adolescents that underwent coronial post-mortems at our institution. This is the largest pathological review of completed suicide in children and young adolescents within a single institution in the United Kingdom. We identified 23 suicide cases during a 12 year period from 2003 to 2015, in which 18 cases (78%) were male and 5 cases (22%) were female. The age range was from 8 to 16 years (mean age 12.82 +/- 2.52 SD). With the exception of one case, all of the victims were Caucasian. The majority, 19 cases (81%), were found dead inside their place of residence, 15 of whom were discovered in their own bedrooms. Twenty-one cases (91%) died from neck compression due to hanging; 6 cases (26%) had used the cord of a dressing gown and 5 (22%) opted to use a belt as the ligature. Two cases (9%) that died from multiple-drug toxicity were female. In 7 cases (30.5%) there was evidence of self-harm and in 3 cases (13%) there was a history of previous suicide attempts. Petechial hemorrhages were found at autopsy in more than half of hanging victims and only three cases (14%) displayed dual distribution of post-mortem hypostasis (back and legs). Seven victims (30.5%) left some form of suicide message to family members and friends, 2 of which wrote the message on their arm. Parental separation, conflict with parents, and depression, were common amongst decedents prior to committing suicide. Substance abuse was uncommon in suicide within our cases. Valuable information is available from thorough review of suicide data in children and

Brief review of topmost scientific results obtained in 2016 at the Joint Institute for Nuclear Research

International Nuclear Information System (INIS)

Kravchenko, E.I.; Sabaeva, E.V.

2017-01-01

This brief review presents the topmost scientific results obtained in 2016 at the Joint Institute for Nuclear Research in such fields as theoretical and experimental physics, radiation and radiobiological research, accelerators, information technology and computer physics. It also provides information about the publications by JINR staff members and activities carried out at the JINR University Centre in 2016. [ru

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.

The Impacts of State Performance Funding Systems on Higher Education Institutions: Research Literature Review and Policy Recommendations. CCRC Working Paper No. 37

Science.gov (United States)

Dougherty, Kevin J.; Reddy, Vikash

2011-01-01

Over the past three decades policymakers have been seeking new ways to secure improved performance from higher education institutions. One popular approach has been performance funding, which involves use of a formula to tie funding to institutional performance on specified indicators. This report reviews findings from studies on performance…

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.

Fostering Institutional Creativity at Multiple Levels: Towards Facilitated Institutional Bricolage

Directory of Open Access Journals (Sweden)

Douglas J. Merrey

2012-02-01

Full Text Available Problems occur when institutional arrangements for collective management of food and water systems fail to meet demands. Many of the problems characterising river basins and other collectively managed water resource systems can be ascribed largely to the failure of institutions to enable problems beyond the individual to be managed collectively. The nature of these demands, and the institutional responses to them, vary widely and are not amenable to simple definitions and prescriptions. We begin with a brief review of conventional approaches to analysing institutions and organisations, focused largely, but not exclusively, on river basins. We observe that attempts to reduce the institutional landscape of river basins to over-simplistic formulas introduces more problems than solutions, because the reality is that institutions evolve through complex creative processes that adopt and adapt diverse ingredients – rather like making a stew. Despite such intricacies, institutions are clearly non-random, so we continue a search for a means of describing them. We adopt the concept of bricolage, as proposed by Cleaver and others, and use it to show the value of promoting and facilitating an organic creative approach to building and strengthening river basin and other water management institutions.

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

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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.

[Burden of relatives and their expectations towards psychiatric institutions. A review of the literature and own results].

Science.gov (United States)

Schmid, R; Spiessl, H; Vukovich, A; Cording, C

2003-03-01

This article aimed to provide an overview regarding the burden of relatives of mentally ill patients and their expectations towards psychiatric institutions. The literature was selected from Medline covering the years 1996 - 2002. 342 articles were reviewed, 145 of which were described in this review. The burden of relatives are manifold and can be classified into the following categories: time spent on caring, financial difficulties, occupational restrictions, detrimental effects on relatives own physical and psychological well-being, reduction in leisure activities, negative effects on social relationships, experiences of discrimination and refusal, deficiencies in information about illness, feelings of not being taken seriously, insufficient service support, long distance to mental health service, emotional burdens of caregivers and difficulties with the patients behaviour. The expectations of the relatives mainly refer to the categories "relationship between staff and relatives", "information about illness" and "establishing of institutions required". The various burdens of relatives and their expectations towards psychiatric services point to necessary improvements of mental health services in the sense of a consumer-oriented psychiatric care.

Brief review of topmost scientific results obtained in 2015 at the Joint Institute for Nuclear Research

International Nuclear Information System (INIS)

Sabaeva, E.V.; Krupko, E.I.

2016-01-01

This brief review presents the topmost scientific results obtained in 2015 at the Joint Institute for Nuclear Research in such fields as theoretical and experimental physics, radiation and radiobiological research, accelerators, information technology and computer physics. It also provides information about the publications by JINR staff members, awards given to JINR scientists, and activities carried out at the JINR University Centre in 2015. [ru

Brief review of topmost scientific results obtained in 2013 at the Joint Institute for Nuclear Research

International Nuclear Information System (INIS)

Sabaeva, E.V.; Kravchenko, E.I.

2014-01-01

This brief review presents the topmost scientific results obtained in 2013 at the Joint Institute for Nuclear Research in such areas as theoretical physics, experimental physics, radiation and radiobiological research, accelerators, information technology and computer physics. It also provides information on the number of publications by JINR staff members, awards given to JINR scientists, and activities carried out at the JINR University Centre in 2013.

Brief review of topmost scientific results obtained in 2014 at the Joint Institute for Nuclear Research

International Nuclear Information System (INIS)

Bulatova, V.V.; Sabaeva, E.V.

2015-01-01

This brief review presents the topmost scientific results obtained in 2014 at the Joint Institute for Nuclear Research in such fields as theoretical and experimental physics, radiation and radiobiological research, accelerators, information technology and computer physics. It also provides information about the publications by JINR staff members, patents for inventions, awards given to JINR scientists, and activities carried out at the JINR University Centre in 2014. [ru

78 FR 64222 - National Cancer Institute; Notice of Closed Meetings

Science.gov (United States)

2013-10-28

... Conference Call). Contact Person: Robert Bird, Ph.D., Chief, Resources and Training Review Branch, Division....D., Scientific Review Officer, Resources and Training Review Branch, Division of Extramural... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute...

Evaluation of portfolio credit risk based on survival analysis for progressive censored data

Science.gov (United States)

Jaber, Jamil J.; Ismail, Noriszura; Ramli, Siti Norafidah Mohd

2017-04-01

In credit risk management, the Basel committee provides a choice of three approaches to the financial institutions for calculating the required capital: the standardized approach, the Internal Ratings-Based (IRB) approach, and the Advanced IRB approach. The IRB approach is usually preferred compared to the standard approach due to its higher accuracy and lower capital charges. This paper use several parametric models (Exponential, log-normal, Gamma, Weibull, Log-logistic, Gompertz) to evaluate the credit risk of the corporate portfolio in the Jordanian banks based on the monthly sample collected from January 2010 to December 2015. The best model is selected using several goodness-of-fit criteria (MSE, AIC, BIC). The results indicate that the Gompertz distribution is the best model parametric model for the data.

Factors influencing the effectiveness of research ethics committees.

Science.gov (United States)

Schuppli, C A; Fraser, D

2007-05-01

Research ethics committees - animal ethics committees (AECs) for animal-based research and institutional research boards (IRBs) for human subjects - have a key role in research governance, but there has been little study of the factors influencing their effectiveness. The objectives of this study were to examine how the effectiveness of a research ethics committee is influenced by committee composition and dynamics, recruitment of members, workload, participation level and member turnover. As a model, 28 members of AECs at four universities in western Canada were interviewed. Committees were selected to represent variation in the number and type of protocols reviewed, and participants were selected to include different types of committee members. We found that a bias towards institutional or scientific interests may result from (1) a preponderance of institutional and scientist members, (2) an intimidating atmosphere for community members and other minority members, (3) recruitment of community members who are affiliated with the institution and (4) members joining for reasons other than to fulfil the committee mandate. Thoroughness of protocol review may be influenced by heavy workloads, type of review process and lack of full committee participation. These results, together with results from the literature on research ethics committees, suggested potential ways to improve the effectiveness of research ethics committees.

Institutional shareholder activism in Nigeria

OpenAIRE

Uche, C.; Adegbite, E.; Jones, M.

2016-01-01

The file attached to this record is the author's final peer reviewed version. The Publisher's final version can be found by following the DOI link. Abstract Purpose-The purpose of this paper is to investigate institutional shareholder activism in Nigeria. It addresses the paucity of empirical research on institutional shareholder activism in sub-Saharan Africa. Design/Methodology-This study employs agency theory to understand the institutional shareholder approach to shareholde...

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

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...

Defining and implementing a model for pharmacy resident research projects

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Dick TB

2015-09-01

Full Text Available Objective: To describe a standard approach to provide a support structure for pharmacy resident research that emphasizes self-identification of a residency research project. Methods: A subcommittee of the residency advisory committee was formed at our institution. The committee was initially comprised of 2 clinical pharmacy specialists, 1 drug information pharmacist, and 2 pharmacy administrators. The committee developed research guidelines that are distributed to residents prior to the residency start that detail the research process, important deadlines, and available resources. Instructions for institutional review board (IRB training and deadlines for various assignments and presentations throughout the residency year are clearly defined. Residents conceive their own research project and emphasis is placed on completing assignments early in the residency year. Results: In the 4 years this research process has been in place, 15 of 16 (94% residents successfully identified their own research question. All 15 residents submitted a complete research protocol to the IRB by the August deadline. Four residents have presented the results of their research at multi-disciplinary national professional meetings and 1 has published a manuscript. Feedback from outgoing residents has been positive overall and their perceptions of their research projects and the process are positive. Conclusion: Pharmacy residents selecting their own research projects for their residency year is a feasible alternative to assigning or providing lists of research projects from which to select a project.

Blended Learning as Transformational Institutional Learning

Science.gov (United States)

VanDerLinden, Kim

2014-01-01

This chapter reviews institutional approaches to blended learning and the ways in which institutions support faculty in the intentional redesign of courses to produce optimal learning. The chapter positions blended learning as a strategic opportunity to engage in organizational learning.

A Review of Propulsion Industrial Base Studies and an Introduction to the National Institute of Rocket Propulsion Systems

Science.gov (United States)

Doreswamy, Rajiv; Fry, Emma K.

2012-01-01

Over the past decade there have been over 40 studies that have examined the state of the industrial base and infrastructure that supports propulsion systems development in the United States. This paper offers a comprehensive, systematic review of these studies and develops conclusions and recommendations in the areas of budget, policy, sustainment, infrastructure, workforce retention and development and mission/vision and policy. The National Institute for Rocket Propulsion System (NIRPS) is a coordinated, national organization that is responding to the key issues highlighted in these studies. The paper outlines the case for NIRPS and the specific actions that the Institute is taking to address these issues.

Cost-benefit analysis in the public sector. Kosten-Nutzen-Analyse in der oeffentlichen Versorgung

Energy Technology Data Exchange (ETDEWEB)

Schoeller, A [comp.

1986-01-01

The publications in the 'IRB Literaturauslesen' contain citations of journal articles, scientific books, periodicals, research reports and projects, dissertations, company publications, institutes' reports, construction standards, documentation services, and so-called 'grey' literature (i.e. unpublished literature that is difficult to access) on the title subject. The information is derived from the databases of Informationszentrum Raum und Bau of the Fraunhofer-Gesellschaft (IRB). The issue abstracted deals with energy supply systems, the processing of drinking water, waste water treatment, and alternative technologies. With 43 refs..

77 FR 5032 - National Cancer Institute; Notice of Meeting

Science.gov (United States)

2012-02-01

... Initiatives; RFA and RFP Concept Reviews; and Scientific Presentations. Place: National Institutes of Health... Group(s); and Budget Presentations; Reports of Special Initiatives; RFA and RFP Concept Reviews; and Scientific Presentations. Place: National Institutes of Health, Building 31, 31 Center Drive, 6th Floor, Conf...

INSTITUTE OF SCIENTIFIC REVIEW TO A PLURALITY OF MODERN SCIENCE: NEED OR FICTION?

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Olga Mukha

2013-08-01

Full Text Available The current situation of plurality epistemological provokes distinct lack of clear criteria for scientific criticism humanities texts. This research raises the question of verification procedure for knowledge obtained humanities, its status and importance. Changes relate to the modern paradigm of scientific methodology in general, which involves switching from a focus on results orientation to the process of getting the truth (W.V.O. Quine, Thomas Kuhn, Paul Feyerabend, Imre Lakatos, etc.. To determine the relationships with the text as a carrier of the alleged truth reception is off ered three formats of relations: Text – Author, Text – Reader and Text – Reviewer. The article stresses questions of general and specific objectives for the scientifi c peer review, as well as the problem of plagiarism and its ethical and legal consequences. It is proposed to consider plan algorithm scientific review of the 26 criteria for it, which will help to streamline Institute of scientific criticism. Recent cover content requirements (which include: the incorporation of a scientific context, the definition of methodological systems, structured research, avoiding plagiarism, there is a real «increase of knowledge» and applied significance, etc. and technical design, the variable respectively specifi c edition. Compliance with a number of requirements set out will help improve the effi ciency and profitability of the humanities.

HER2-positive male breast cancer with thyroid cancer: an institutional report and review of literature.

Science.gov (United States)

Bardhan, Pooja; Bui, Marilyn M; Minton, Susan; Loftus, Loretta; Carter, W Bradford; Laronga, Christine; Ismail-Khan, Roohi

2012-01-01

We report a rare finding of two male breast cancer patients with HER2-positive breast cancer who also developed thyroid cancer. We reviewed 45 male breast cancer patients treated in our institution from 2003 to 2008. Only five male breast cancer patients were HER2-positive. In reviewing the published data, we found no cases of thyroid cancer and concurrent breast cancer in men. However, breast cancer and thyroid cancer have shown close association in women. This finding therefore provokes speculation as to whether we should investigate whether women with HER2-positive breast cancer are at a higher risk for thyroid cancer. Although this observation seems to be clinically prevalent, publications are sparse in clinical research areas linking thyroid cancer to breast cancer.

Project risk management: A review of an institutional project life cycle

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Wanjiru Gachie

2017-11-01

Full Text Available This article is a desktop analysis of project risk management involving a project management institutional restructuring. The pragmatic nature of this research allows for the literature review and the document analysis to be integrated and presented as both a descriptive and analytical research. The analysis demonstrates that the project committee did not proactively manage project risk. The restructuring was a change management project, entailing the implementation of many organisational changes, such as restructuring, lay-off of some part of the administrative workforce, adoption of new technology, provision of new approaches to well-established procedures, and implementation of new performance initiative, the process which should have been managed with an effective integrated risk strategy and plan. Analysis of the restructuring project risk management exhibits little evidence of a systematic (computer based or manual record that should have provided policies, procedures, and structures for managing risk. The article concludes that the restructuring risk process was inadequate and it could not have ensured a successful project. An analysis of the restructuring project risk monitoring and control exhibits a reactive rather than proactive application of risk management procedures. The analysis further indicates that the committee failed to make use of the various project risk management processes, standards, and guidelines. Based on the conclusions, the article recommends that project risk planning, strategy, control, and monitoring should be put in place for future institutional projects. The project management team should also put in place procedures for primary stakeholders engagements, identify and address their nature of interest and power in future risk management projects

78 FR 107 - National Human Genome Research Institute; Notice of Closed Meeting

Science.gov (United States)

2013-01-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... evaluate grant applications. Place: National Human Genome Research Institute, 3rd Floor Conference Room....D., Scientific Review Officer, Scientific Review Branch, National Human Genome Research Institute...

75 FR 19984 - National Human Genome Research Institute; Notice of Closed Meetings

Science.gov (United States)

2010-04-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome..., National Human Genome Research Institute, National Institutes of Health, 5635 Fishers Lane, Suite 4075... Nakamura, PhD, Scientific Review Officer, Scientific Review Branch, National Human Genome Research...

76 FR 17930 - National Human Genome Research Institute; Notice of Closed Meeting

Science.gov (United States)

2011-03-31

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special... Review Officer, Scientific Review Branch, National Human Genome Research Institute, 5635 Fishers Lane...

76 FR 58023 - National Human Genome Research Institute; Notice of Closed Meeting

Science.gov (United States)

2011-09-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Initial..., Scientific Review Officer, Office of Scientific Review, National Human Genome Research Institute, National...

Institutional Collaboration on MOOCs in Education

DEFF Research Database (Denmark)

Nortvig, Anne-Mette; Christiansen, René Boyer

2017-01-01

and innovation in the common learning designs, and that—in order to succeed—such projects need strategic and institutional support from all partners involved. Moreover, the review points out barriers concerning the reluctance of individual institutions to engage in national collaboration due to fear of potential...

A review of research activities at the Research Reactor Institute of Kyoto University in view of research publication information

International Nuclear Information System (INIS)

Takeuchi, Takayuki; Mizuma, Mitsuo; Kimura, Itsuro.

1995-01-01

A database of research publication was constructed for the purpose of grasping all of the research activities at the Research Reactor Institute, Kyoto University. The database named KURRIP collects all of the research publications of the Institute by not only its own staff but also visiting scientists. The publications are in the form of original papers, review papers, papers in proceedings, short notes and letters, synopses over 3 pages presented orally at scientific meeting, books and doctoral theses. At present, the KURRIP database contains the information on 6,210 items which have been published for 30 years since the Institute was established as an interuniversity research institute for joint use of a research reactor and other related large facilities in 1963. By utilizing the KURRIP database, the analyses have been done: (1) affiliation of the authors, (2) kind of publications, (3) classification of publishers, (4) research fields, and (5) experimental facilities. The KURRIP database is now stored in the Data Processing Center of Kyoto University and can be utilized through a computer center at one of the main national universities in Japan. (author)

Review of Literature for Inputs to the National Water Savings Model and Spreadsheet Tool-Commercial/Institutional

Energy Technology Data Exchange (ETDEWEB)

Whitehead, Camilla Dunham; Melody, Moya; Lutz, James

2009-05-29

Lawrence Berkeley National Laboratory (LBNL) is developing a computer model and spreadsheet tool for the United States Environmental Protection Agency (EPA) to help estimate the water savings attributable to their WaterSense program. WaterSense has developed a labeling program for three types of plumbing fixtures commonly used in commercial and institutional settings: flushometer valve toilets, urinals, and pre-rinse spray valves. This National Water Savings-Commercial/Institutional (NWS-CI) model is patterned after the National Water Savings-Residential model, which was completed in 2008. Calculating the quantity of water and money saved through the WaterSense labeling program requires three primary inputs: (1) the quantity of a given product in use; (2) the frequency with which units of the product are replaced or are installed in new construction; and (3) the number of times or the duration the product is used in various settings. To obtain the information required for developing the NWS-CI model, LBNL reviewed various resources pertaining to the three WaterSense-labeled commercial/institutional products. The data gathered ranged from the number of commercial buildings in the United States to numbers of employees in various sectors of the economy and plumbing codes for commercial buildings. This document summarizes information obtained about the three products' attributes, quantities, and use in commercial and institutional settings that is needed to estimate how much water EPA's WaterSense program saves.

INFLUENCE OF RELATIONS WITH INTERNATIONAL FINANCIAL INSTITUTIONS ON INSTITUTIONAL TRANSFORMATIONS OF ECONOMY

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Galyna POCHENCHUK

2014-12-01

Full Text Available The article deals with the problem of the impact of transitional countries cooperation with international financial institutions on institutional changes which take place in emerging market economies, on the base of Ukraine. Research is carried out from the standpoint of institutional theory. The main reforms that took place in emerging market economy countries were based on the Washington Consensus strategy recommended by international financial institutions. The results of implementing this strategy are varied in different countries. In Ukraine strict adherence to requirements in the early stages of reforms without internal institutional conditions and characteristics led to a deep and protracted crisis of forming a "transformational stability." The general formal institutions of the market economy have been created according to the neoliberal concept which is provided by IFIs. However, experience of transitive economies including Ukraine, confirms the ineffectiveness of many established formal institutions borrowed from the developed countries. The author reviews the basic theory of institutional changes, argues that the terms of cooperation circulated by international financial institutions not only affect economic development strategy, but also determine the role of the national government in relations with markets. Under present conditions prevailing in Ukraine, it is impossible to manage without assistance of international financial institutions. But we need to pay more attention to technical and advisory cooperation in realization of institutional reforms, and credits – to take as a required time for receiving the results of reforms.

76 FR 58025 - National Heart, Lung and Blood Institute Notice of Closed Meetings

Science.gov (United States)

2011-09-19

... Institute Special Emphasis Panel; Gene Therapy Resource Program LentiVirus Vector Production. Date: October...: Tony L Creazzo, PhD, Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung..., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

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

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

Science.gov (United States)

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

2016-01-01

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

A burn center paradigm to fulfill deferred consent public disclosure and community consultation requirements for emergency care research.

Science.gov (United States)

Blackford, Martha G; Falletta, Lynn; Andrews, David A; Reed, Michael D

2012-09-01

To fulfill Food and Drug Administration and Department of Health and Human Services emergency care research informed consent requirements, our burn center planned and executed a deferred consent strategy gaining Institutional Review Board (IRB) approval to proceed with the clinical study. These federal regulations dictate public disclosure and community consultation unique to acute care research. Our regional burn center developed and implemented a deferred consent public notification and community consultation paradigm appropriate for a burn study. Published accounts of deferred consent strategies focus on acute care resuscitation practices. We adapted those strategies to design and conduct a comprehensive public notification/community consultation plan to satisfy deferred consent requirements for burn center research. To implement a robust media campaign we engaged the hospital's public relations department, distributed media materials, recruited hospital staff for speaking engagements, enlisted community volunteers, and developed initiatives to inform "hard-to-reach" populations. The hospital's IRB determined we fulfilled our obligation to notify the defined community. Our communication strategy should provide a paradigm other burn centers may appropriate and adapt when planning and executing a deferred consent initiative. Copyright © 2012 Elsevier Ltd and ISBI. All rights reserved.

Ethical issues in bipolar disorders pedigree research: privacy concerns, informed consent, and grounds for waiver.

Science.gov (United States)

Parker, Lisa S

2002-02-01

Focusing on bipolar disorders research, this article considers ethical issues of informed consent and privacy arising in genetic pedigree research at two stages: the construction of tentative pedigrees to determine family eligibility for study and, subsequently, the enrollment of subjects in and conduct of the family study. Increasing concern to protect the privacy of family members of primary subjects or probands, following ethical controversy over a survey study at Virginia Commonwealth University, has led some researchers and Institutional Review Boards (IRBs) to apply informed consent requirements to those represented on a tentative pedigree at the initial stage of research. This article analyzes the possible benefits, risks, and burdens to prospective subjects of seeking prospective consent for pedigree construction at this initial stage. It argues that the likely risk-benefit ratio favors granting a waiver of consent requirements for this stage of pedigree research and presents grounds for IRBs to grant such a waiver. The article closes by considering particular ethical concerns that should be addressed in the informed consent discussion when enrolling subjects in pedigree studies of bipolar disorder, including concerns about subjects' competence to consent, management of interim and incidental findings, and issues particular to psychiatric research.

Evolving Management of Symptomatic Chronic Subdural Hematoma: Experience of a Single Institution and Review of the Literature

Science.gov (United States)

Balser, David; Rodgers, Shaun D.; Johnson, Blair; Shi, Chen; Tabak, Esteban; Samadani, Uzma

2015-01-01

Objective Chronic subdural hematoma has an increasing incidence and results in high morbidity and mortality. We review here the ten-year experience of a single institution and the literature regarding the treatment and major associations of chronic subdural hematoma (cSDH). Methods We retrospectively reviewed all cSDHs surgically treated from 2000 to 2010 at our institution to evaluate duration from admission to treatment, type of treatment, length of stay in critical care, length of stay in the hospital and recurrence. The literature was reviewed with regards to incidence, associations and treatment of cSDH. Results From 2000–2008, 44 patients were treated with burr holes. From 2008 to 2010, 29 patients were treated with twist drill evacuation (SEPS). 4 patients from each group were readmitted for reoperation (9% vs. 14%; p=.53). The average time to intervention for SEPS (11.2±15.3 hrs) was faster than for burr holes (40.3±69.1 hrs) (p=.02). The total hospital LOS was shorter for SEPS (9.3±6.8 days) versus burr holes (13.4±10.2 days) (p=.04); both were significantly longer than for a brain tumor patient undergoing craniotomy (7.0±0.5 days, n=94, P<.01). Conclusion Despite decreasing lengths of stay over time as treatment for cSDH evolved from burr holes to SEPS, the length of stay for a cSDH is still greater than that of a patient undergoing craniotomy for brain tumor. We noted 11% recurrence in our series of patients, which included individuals who recurred as late as 3 years after initial diagnosis. PMID:23485050

A Review and Analysis of the Ayurvedic Institute's Ayurvedic Studies Program.

Science.gov (United States)

Rogers, Curtis R.

The Ayurvedic Institute, which has been licensed as a private institution of higher education in New Mexico since 1994, offers training in the traditional therapy of East Indian Ayurveda, which includes the use of herbs, nutrition, panchakarma cleansing, and accupressure massage. The institute also offers training in the related disciplines of…

Management of eight labor and delivery patients dependent on buprenorphine (Subutex™: A retrospective chart review [version 2; referees: 2 approved

Directory of Open Access Journals (Sweden)

Solina Tith

2018-02-01

Full Text Available Background: Opioid use during pregnancy is a growing concern in the United States. Buprenorphine has been recommended by “The American College of Obstetrics and Gynecology” as an alternative to methadone to decrease risks associated with the use of illicit opioids during pregnancy. The partial μ-opioid agonists’ unique pharmacology, including its long half time and high affinity to the μ-opioid receptor, complicates patient management in a highly kinetic, and often urgent field like obstetric anesthesia. We reviewed our management and outcomes in this medically complex population. Methods: An Institutional Review Board (IRB approved retrospective chart review was conducted of women admitted to the University of Washington Medical Center Labor and Delivery unit from July 2012 to November 2013 using buprenorphine. All deliveries, including intrauterine fetal demise, were included. Results: Eight women were admitted during this period to our L&D floor on buprenorphine. All required peri-partum anesthetic management either for labor and/or cesarean delivery management. Analgesic management included dilaudid or fentanyl PCA and/or continued epidural infusion, and in one instance ketamine infusion, while the pre-admission buprenorphine regimen was continued. Five babies were viable, two women experienced intrauterine fetal death at 22 and 36 weeks gestational age (GSA, respectively, and one neonate died shortly after delivery due to a congenital diaphragmatic hernia. Conclusions: This case series illuminates the medical complexity of parturients using buprenorphine. Different treatment modalities in the absence of evidence-based guidelines included additional opioid administration and continued epidural analgesia. The management of post-cesarean pain in patients on partial μ-opioid agonists remains complex and variable, and evidence-based guidelines could be useful for clinicians to direct care.

77 FR 11555 - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional...

Science.gov (United States)

2012-02-27

..., Office for Human Research Protections (OHRP) and FDA have been actively working to harmonize the Agencies... criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of... review to assure the protection of the rights and welfare of subjects in clinical investigations. The...

Predicting Discharge to Institutional Long-Term Care After Stroke: A Systematic Review and Metaanalysis.

Science.gov (United States)

Burton, Jennifer K; Ferguson, Eilidh E C; Barugh, Amanda J; Walesby, Katherine E; MacLullich, Alasdair M J; Shenkin, Susan D; Quinn, Terry J

2018-01-01

Stroke is a leading cause of disability worldwide, and a significant proportion of stroke survivors require long-term institutional care. Understanding who cannot be discharged home is important for health and social care planning. Our aim was to establish predictive factors for discharge to institutional care after hospitalization for stroke. We registered and conducted a systematic review and meta-analysis (PROSPERO: CRD42015023497) of observational studies. We searched MEDLINE, EMBASE, and CINAHL Plus to February 2017. Quantitative synthesis was performed where data allowed. Acute and rehabilitation hospitals. Adults hospitalized for stroke who were newly admitted directly to long-term institutional care at the time of hospital discharge. Factors associated with new institutionalization. From 10,420 records, we included 18 studies (n = 32,139 participants). The studies were heterogeneous and conducted in Europe, North America, and East Asia. Eight studies were at high risk of selection bias. The proportion of those surviving to discharge who were newly discharged to long-term care varied from 7% to 39% (median 17%, interquartile range 12%), and the model of care received in the long-term care setting was not defined. Older age and greater stroke severity had a consistently positive association with the need for long-term care admission. Individuals who had a severe stroke were 26 times as likely to be admitted to long-term care than those who had a minor stroke. Individuals aged 65 and older had a risk of stroke that was three times as great as that of younger individuals. Potentially modifiable factors were rarely examined. Age and stroke severity are important predictors of institutional long-term care admission directly from the hospital after an acute stroke. Potentially modifiable factors should be the target of future research. Stroke outcome studies should report discharge destination, defining the model of care provided in the long-term care setting. �

The Economic and Monetary Union's Institutional Framework

DEFF Research Database (Denmark)

Dosenrode, Søren

2002-01-01

The chapters emphasise is on the EMU's institutions. The chapter contains i.a. a short review of the contents, objectives, developments from 1990-2002 of the EMU, the ESCB (structure & tasks) as well as interaction with other institutions incuding the Council of Ministers. An underlying issue...

78 FR 75929 - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings

Science.gov (United States)

2013-12-13

... Craniofacial Research Special Emphasis Panel; Review of NIDCR Institutional Career Development Award K12... review and evaluate grant applications. Place: National Institutes of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20892. Contact Person: Victor Henriquez, Ph.D., Scientific Review Officer...

Clinical Trials

Medline Plus

Full Text Available ... clinical trials. An IRB is an independent committee created by the institution that sponsors a clinical trial. ... have not only shaped medical practice around the world, but have improved the health of millions of ...

Factors associated with institutional delivery service utilization in Ethiopia

Directory of Open Access Journals (Sweden)

Kebede A

2016-09-01

Full Text Available Alemi Kebede,1 Kalkidan Hassen,2 Aderajew Nigussie Teklehaymanot1 1Department of Population and Family Health, 2College of Health Sciences, Jimma University, Ethiopia Background: Most obstetric complications occur unpredictably during the time of delivery, but they can be prevented with proper medical care in the health facilities. Despite the Ethiopian government’s efforts to expand health service facilities and promote health institution-based delivery service in the country, an estimated 85% of births still take place at home.Objective: The review was conducted with the aim of generating the best evidence on the determinants of institutional delivery service utilization in Ethiopia.Methods: The reviewed studies were accessed through electronic web-based search strategy from PubMed, HINARI, Mendeley reference manager, Cochrane Library for Systematic Reviews, and Google Scholar. Review Manager V5.3 software was used for meta-analysis. Mantel–Haenszel odds ratios (ORs and their 95% confidence intervals (CIs were calculated. Heterogeneity of the study was assessed using I2 test.Results: People living in urban areas (OR =13.16, CI =1.24, 3.68, with primary and above educational level of the mother and husband (OR =4.95, CI =2.3, 4. 8, and OR =4.43, CI =1.14, 3.36, respectively, who encountered problems during pregnancy (OR =2.83, CI =4.54, 7.39, and living at a distance <5 km from nearby health facility (OR =2.6, CI =3.33, 6.57 showed significant association with institutional delivery service utilization. Women’s autonomy was not significantly associated with institutional delivery service utilization.Conclusion and recommendation: Distance to health facility and problems during pregnancy were factors positively and significantly associated with institutional delivery service utilization. Promoting couples education beyond primary education regarding the danger signs of pregnancy and benefits of institutional delivery through available

Do democratic institutions and foreign direct investment affect ...

African Journals Online (AJOL)

Do democratic institutions and foreign direct investment affect economic growth? Evidence from ... International Journal of Development and Management Review ... The importance of sound democratic institutional structures and foreign direct investment for enhancing economic growth is well documentedin literature.

Forging stronger partnerships between academic health centers and patient-driven organizations.

Science.gov (United States)

Gallin, Elaine K; Bond, Enriqueta; Califf, Robert M; Crowley, William F; Davis, Pamela; Galbraith, Richard; Reece, E Albert

2013-09-01

In this article, the authors review the unique role that patient-driven organizations, such as patient advocacy groups and voluntary health organizations (PAG/VHOs), play in translational and clinical research. The importance of fostering collaborations between these organizations and U.S. academic health centers (AHCs) is also discussed. Although both the PAG/VHO community and AHCs are heterogeneous, and although not all organizations are well governed or provide independent, well-researched views, there are many outstanding, well-managed, independent PAG/VHOs in the United States whose missions overlap with those of AHCs. The characteristics of effective PAG/VHOs that would serve as excellent partners for AHCs are discussed, and examples are provided regarding their many contributions, which have included advancing research on rare diseases, recruiting patients for clinical trials, and establishing patient registries and biospecimen banks. The authors present feedback obtained from informal discussions with PAG/VHO staff, as well as a survey of a small sample of organizations, that has identified bureaucratic processes, negotiating intellectual property rights, and institutional review board (IRB) delays as the most problematic areas of interactions with AHCs. Actions are suggested for building effective partnerships between the two sectors and the activities that AHCs should undertake to facilitate their interactions with PAG/VHOs including streamlining contract review and IRB processes and finding ways to better align the incentives motivating academic clinical and translational investigators with the goals of PAG/VHOs. This article is one product of the Clinical Research Forum's Partnering with Patient Advocacy Groups Initiative.

Review on Overseas Contracts of a Nuclear Research Institute in Korea

Energy Technology Data Exchange (ETDEWEB)

Lee, Myung Ho; Lee, Eui Jin [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

2010-10-15

Since its establishment, Korea Atomic Energy Research Institute (KAERI) has made various contracts in research, design, engineering and consultation with a lot of foreign counterparts all over the world, including international organizations. As one of the global nuclear energy research leaders, KAERI can make a large scale contract because it has already procured a turnkey EPC (Engineering, Procurement, Construction) contract for a research and training reactor in the spring of 2010 by forming a consortium with a construction and engineering company. A contract in nuclear business industries is to be made under the limited control of regulatory authorities because the contractors must ensure nuclear safety and follow the international nuclear non-proliferation guidelines to secure the peaceful use of nuclear energy at an international level. The export and import of strategic technologies, products or materials (including nuclear materials) must be directly controlled by the authorities in accordance with the applicable law. In 2009, KAERI organized a new team to manage the overseas contracts and to make the limited control reflected in the contract documentation. In large scale project contracts, more attention shall be given to the contracts to prevent claims and also to the consideration of the regulatory requirements. In this context, the nature of the past KAERI contracts was reviewed. The conditions of several recent KAERI contracts were also individually reviewed based on the FIDIC (Federation Internationale des Ingenieurs-Conseils) model service agreement, which is generally accepted by service contractors. Ways to increase the quality of future contracts and to improve the standard model agreement which is used to prepare the draft contract were also considered

Review on Overseas Contracts of a Nuclear Research Institute in Korea

International Nuclear Information System (INIS)

Lee, Myung Ho; Lee, Eui Jin

2010-01-01

Since its establishment, Korea Atomic Energy Research Institute (KAERI) has made various contracts in research, design, engineering and consultation with a lot of foreign counterparts all over the world, including international organizations. As one of the global nuclear energy research leaders, KAERI can make a large scale contract because it has already procured a turnkey EPC (Engineering, Procurement, Construction) contract for a research and training reactor in the spring of 2010 by forming a consortium with a construction and engineering company. A contract in nuclear business industries is to be made under the limited control of regulatory authorities because the contractors must ensure nuclear safety and follow the international nuclear non-proliferation guidelines to secure the peaceful use of nuclear energy at an international level. The export and import of strategic technologies, products or materials (including nuclear materials) must be directly controlled by the authorities in accordance with the applicable law. In 2009, KAERI organized a new team to manage the overseas contracts and to make the limited control reflected in the contract documentation. In large scale project contracts, more attention shall be given to the contracts to prevent claims and also to the consideration of the regulatory requirements. In this context, the nature of the past KAERI contracts was reviewed. The conditions of several recent KAERI contracts were also individually reviewed based on the FIDIC (Federation Internationale des Ingenieurs-Conseils) model service agreement, which is generally accepted by service contractors. Ways to increase the quality of future contracts and to improve the standard model agreement which is used to prepare the draft contract were also considered

Turkish University seniors' knowledge of and opinions on fertility and ...

African Journals Online (AJOL)

A higher percentage of females planned parenthood in the future than males. Males desired more ... creased divorces, desire to focus on career, and economic factors.4,5 ... Board of the researchers' institution (IRB; EOU-15-05-. 28/10).

Using institutional theory in enterprise systems research

DEFF Research Database (Denmark)

Svejvig, Per

2013-01-01

This paper sets out to examine the use of institutional theory as a conceptually rich lens to study social issues of enterprise systems (ES) research. More precisely, the purpose is to categorize current ES research using institutional theory to develop a conceptual model that advances ES research...... model that advocates multi-level and multi-theory approaches and applies newer institutional aspects such as institutional logics. The findings show that institutional theory in ES research is in its infancy and adopts mainly traditional institutional aspects like isomorphism, with the organization....... Key institutional features are presented such as isomorphism, rationalized myths, and bridging macro and micro structures, and institutional logics and their implications for ES research are discussed. Through a literature review of 181 articles, of which 18 papers are selected, we build a conceptual...

78 FR 12767 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed...

Science.gov (United States)

2013-02-25

... National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Initial Review Group; Population Sciences Subcommittee. Date...., Scientific Review Officer, Division of Scientific Review, Eunice Kennedy Shriver National Institute, of Child...

77 FR 59933 - National Human Genome Research Institute; Notice of Closed Meetings

Science.gov (United States)

2012-10-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research....D., Scientific Review Officer, Scientific Review Branch, National Human Genome Research Institute...

Low-Dose-Rate Brachytherapy Versus Cryotherapy in Low- and Intermediate-Risk Prostate Cancer.

Science.gov (United States)

Gestaut, Matthew M; Cai, Wendi; Vyas, Shilpa; Patel, Belur J; Hasan, Salman A; MunozMaldonado, Yolanda; Deb, Niloyjyoti; Swanson, Gregory

2017-05-01

Cryotherapy and brachytherapy are definitive local treatment options for low- to intermediate-risk prostate cancer. There are both prospective and retrospective data for brachytherapy, but the use of cryotherapy has been limited primarily to single-institution retrospective studies. Currently, no published evidence has compared low-dose-rate brachytherapy versus cryotherapy. Institutional review board approval was obtained to conduct a retrospective chart review of consecutive patients treated at our institution from 1990 to 2012. For inclusion, patients must have received a prostate cancer diagnosis and have been considered to have low- to intermediate-risk disease according to the National Comprehensive Cancer Network criteria. All patients received brachytherapy or cryotherapy treatment. Disease specifics and failure details were collected for all patients. Failure was defined as prostate-specific antigen nadir +2 ng/mL. A total of 359 patients were analyzed. The groups comprised 50 low-risk cryotherapy (LRC), 92 intermediate-risk cryotherapy (IRC), 133 low-risk brachytherapy (LRB), and 84 intermediate-risk brachytherapy (IRB) patients. The median prostate-specific antigen follow-up periods were 85.6 months (LRC), 59.2 months (IRC), 74.9 months (LRB), and 59.8 months (IRB). The 5-year biochemical progression-free survival (bPFS) rate was 57.9% in the cryotherapy group versus 89.6% in the brachytherapy group (Pcryotherapy for low- and intermediate-risk groups (Pcryotherapy patients was -35°C (range, -96°C to -6°C). Cryotherapy used a median of 2 freeze-thaw cycles (range, 2-4 freeze-thaw cycles). Results from this study suggest that cryotherapy is inferior to brachytherapy for patients with low- to intermediate-risk prostate cancer. Patient selection criteria for consideration of cryotherapy and brachytherapy are similar in terms of anesthesia candidacy. Therefore, cryotherapy would not be recommended as a first-line local therapy for this particular

77 FR 59200 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

Science.gov (United States)

2012-09-26

... Institute Special Emphasis Panel Mentored Career Transition Scientist Award. Date: October 18-19, 2012. Time: 8 a.m. to 1 p.m. Agenda: To review and evaluate grant applications. Place: The William F. Bolger... Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

77 FR 60706 - National Human Genome Research Institute; Notice of Closed Meeting

Science.gov (United States)

2012-10-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special.... Nakamura, Ph.D., Scientific Review Officer, Scientific Review Branch, National Human Genome Research...

76 FR 65204 - National Human Genome Research Institute; Notice of Closed Meetings

Science.gov (United States)

2011-10-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome... Review Officer, Scientific Review Branch, National Human Genome Research Institute, 5635 Fishers Lane...

76 FR 53685 - National Institutes of Health

Science.gov (United States)

2011-08-29

..., CSR management to enhance the operations, processes, organization of, and services provided by the... data collection projects, the Center for Scientific Review (CSR), National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the...

Operational Risk Management in Financial Institutions: A Literature Review

Directory of Open Access Journals (Sweden)

Suren Pakhchanyan

2016-10-01

Full Text Available Following the three-pillar structure of the Basel II/III framework, the article categorises and surveys 279 academic papers on operational risk in financial institutions, covering the period from 1998 to 2014. In doing so, different lines of both theoretical and empirical directions for research are identified. In addition, this study provides an overview of existing consortia databases and other publicly available sources on operational loss that may be incorporated into empirical research, as well as in risk measurement processes by financial institutions. Finally, this paper highlights the research gaps in operational risk and outlines recommendations for further research.

75 FR 52538 - National Human Genome Research Institute; Notice of Closed Meeting

Science.gov (United States)

2010-08-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special... Person: Ken D. Nakamura, PhD, Scientific Review Officer, Scientific Review Branch, National Human Genome...

76 FR 35223 - National Human Genome Research Institute; Notice of Closed Meeting

Science.gov (United States)

2011-06-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special... Person: Rudy O. Pozzatti, PhD, Scientific Review Officer, Scientific Review Branch, National Human Genome...

76 FR 27068 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

Science.gov (United States)

2011-05-10

... Institute Special Emphasis Panel, SBIR Contract Review. Date: June 2, 2011. Time: 1 p.m. to 4 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 6701 Rockledge Drive...

Readability of patient education materials in ophthalmology: a single-institution study and systematic review.

Science.gov (United States)

Williams, Andrew M; Muir, Kelly W; Rosdahl, Jullia A

2016-08-03

Patient education materials should be written at a level that is understandable for patients with low health literacy. The aims of this study are (1) to review the literature on readability of ophthalmic patient education materials and (2) to evaluate and revise our institution's patient education materials about glaucoma using evidence-based guidelines on writing for patients with low health literacy. A systematic search was conducted on the PubMed/MEDLINE database for studies that have evaluated readability level of ophthalmic patient education materials, and the reported readability scores were assessed. Additionally, we collected evidence-based guidelines for writing easy-to-read patient education materials, and these recommendations were applied to revise 12 patient education handouts on various glaucoma topics at our institution. Readability measures, including Flesch-Kincaid Grade Level (FKGL), and word count were calculated for the original and revised documents. The original and revised versions of the handouts were then scored in random order by two glaucoma specialists using the Suitability Assessment of Materials (SAM) instrument, a grading scale used to evaluate suitability of health information materials for patients. Paired t test was used to analyze changes in readability measures, word count, and SAM score between original and revised handouts. Finally, five glaucoma patients were interviewed to discuss the revised materials, and patient feedback was analyzed qualitatively. Our literature search included 13 studies that evaluated a total of 950 educational materials. Among the mean FKGL readability scores reported in these studies, the median was 11 (representing an eleventh-grade reading level). At our institution, handouts' readability averaged a tenth-grade reading level (FKGL = 10.0 ± 1.6), but revising the handouts improved their readability to a sixth-grade reading level (FKGL = 6.4 ± 1.2) (p readability and suitability of

76 FR 31619 - National Cancer Institute; Notice of Closed Meetings

Science.gov (United States)

2011-06-01

... personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; SBIR Phase IIB...: To review and evaluate contract proposals. Place: National Institutes of Health, 6116 Executive...

75 FR 42451 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

Science.gov (United States)

2010-07-21

... Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory... and Alcoholism, Initial Review Group, Neuroscience Review Subcommittee. Date: November 2-3, 2010. Time..., Scientific Review Officer, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health...

75 FR 69091 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

Science.gov (United States)

2010-11-10

... Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory... Alcoholism Initial Review Group; Clinical Treatment and Health Services Research Review Subcommittee. Date..., Scientific Review Officer, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health...

Research data management in academic institutions: A scoping review.

Directory of Open Access Journals (Sweden)

Laure Perrier

Full Text Available The purpose of this study is to describe the volume, topics, and methodological nature of the existing research literature on research data management in academic institutions.We conducted a scoping review by searching forty literature databases encompassing a broad range of disciplines from inception to April 2016. We included all study types and data extracted on study design, discipline, data collection tools, and phase of the research data lifecycle.We included 301 articles plus 10 companion reports after screening 13,002 titles and abstracts and 654 full-text articles. Most articles (85% were published from 2010 onwards and conducted within the sciences (86%. More than three-quarters of the articles (78% reported methods that included interviews, cross-sectional, or case studies. Most articles (68% included the Giving Access to Data phase of the UK Data Archive Research Data Lifecycle that examines activities such as sharing data. When studies were grouped into five dominant groupings (Stakeholder, Data, Library, Tool/Device, and Publication, data quality emerged as an integral element.Most studies relied on self-reports (interviews, surveys or accounts from an observer (case studies and we found few studies that collected empirical evidence on activities amongst data producers, particularly those examining the impact of research data management interventions. As well, fewer studies examined research data management at the early phases of research projects. The quality of all research outputs needs attention, from the application of best practices in research data management studies, to data producers depositing data in repositories for long-term use.

Orbital exenteration: Institutional review of evolving trends in indications and rehabilitation techniques.

Science.gov (United States)

Kiratli, Hayyam; Koç, İrem

2018-06-01

To determine the changes in indications for orbital exenteration over 20 years and to assess its impact on patient survival. Evolving techniques of rehabilitation of the orbit in our institution were also evaluated. This was a retrospective review of hospital records of patients who underwent orbital exenteration from 1995 to 2015 in a tertiary care center. Data extracted included primary location of the tumor, preoperative treatments, interval between initial diagnosis and exenteration, status of surgical margins, presence of metastatic disease, and postoperative survival. The types of prosthesis utilized over the years were also reviewed. Cox regression analysis was performed for categorical variables. Kaplan-Meier analysis was used to estimate post-exenteration survival. Over a 20-year period, orbital exenteration was performed on 100 orbits of 100 patients. The mean age was 39.4 years (range: 2 months to 90 years). The most common indications among 98 malignant causes were retinoblastoma, squamous cell carcinoma, basal cell carcinoma, extraocular extension of uveal melanoma, and conjunctival melanoma. Postoperative survival was significantly related to age and tumor location but independent from gender, surgical margin, histopathological diagnosis, previous treatment modality, and preoperative interval. In the whole cohort, 1-year and 5-year survival rates were 97% and 84%, respectively. Exenteration appears to be life-saving in children with orbital extension of retinoblastoma. While patients exenterated for malignant eyelid tumors have the best chance of survival, those with orbital extension of uveal melanoma and adenoid cystic carcinoma of the lacrimal gland have the worst prognosis.

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

Science.gov (United States)

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

2009-01-01

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

77 FR 22793 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

Science.gov (United States)

2012-04-17

... Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory... and Alcoholism Initial Review Group Neuroscience Review Subcommittee. Date: June 13, 2012. Time: 8 a.m... Review Officer, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, 5635...

75 FR 10293 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

Science.gov (United States)

2010-03-05

... Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory... and Alcoholism, Initial Review Group Neuroscience Review Subcommittee. Date: June 7-8, 2010. Time: 8 a.... Scientific Review Officer, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health...

Children as subjectos endowed with right: a systematic review of children in situation of institutional care

Directory of Open Access Journals (Sweden)

Thais Pacheco Epifânio

2017-06-01

Full Text Available Introduction: This study addresses the context of children in shelters and their rights after the implementation of the Child and Adolescent Statute (Estatuto da Criança e do Adolescente - ECA in 1990. Objective: To analyze the content of articles approaching children in situation of institutional care in the view of the guidelines proposed by ECA. Method: A systematic review was carried out in the LILACS database using the following descriptors: “institutionalized child” or “shelter” or “social shelter”, in Portuguese language. A total of 111 articles were found, of which 92 were excluded after reading the abstract as they did not meet the selection criteria set in the research. After reading the 19 remaining articles in full length, 5 were eliminated because they did not address the theme under study. Thus, 14 articles were used in the analysis. Results: After selection of relevant articles for research and analysis of content, three categories of analysis, based on the recurrent themes of the texts and their relation to the present research theme, were identified: “Shelters as institutions with complete institutional characteristics”, “Shelters and their stance in relation to ECA recommendations” and “The stigma of sheltered children: subjects with rights or subjugated mass?”. The description of shelters is evidently not in consonance with the law, but clearly resembles the old model of sheltering, with unpreparedness and lack of knowledge of laws from the part of professionals. This leads children to be viewed as objects of custody of the State. Conclusion: There is an evident need for training the professionals involved in the process of institutional shelter and also the need for raising empowerment and awareness of the rights of children in society.

Reuse of samples: ethical issues encountered by two institutional ethics review committees in Kenya.

Science.gov (United States)

Langat, Simon K

2005-10-01

There is growing concern about the reuse and exploitation of biological materials (human tissues) for use in research worldwide. Most discussions about samples have taken place in developed countries, where genetic manipulation techniques have greatly advanced in recent years. There is very little discussion in developing countries, although collaborative research with institutions from developed countries is on the increase. The study sought to identify and describe ethical issues arising in the storage, reuse and exportation of samples in a developing country. Research protocols presented to two Ethics Review Committees in Kenya during a period of two years were reviewed. A record was made of the protocol title, sample collected, request for storage, reuse or exportation and whether or not subject consent was sought. The findings indicated that about 25% out of the 388 protocols sought permission for reuse and only half of those actually informed subjects of the contemplated re-use. Less than 20% requested storage and again, about half of them sought consent from subjects. There is an indication that investigators do not see the need to seek consent for storage, reuse and exportation of samples. It is proposed that these issues should be addressed through policy interventions at both the national and global levels.

75 FR 8374 - National Human Genome Research Institute; Notice of Closed Meeting

Science.gov (United States)

2010-02-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special... Officer, Scientific Review Branch, National Human Genome Research Institute, National Institutes of Health...

77 FR 71604 - National Human Genome Research Institute; Notice of Closed Meeting

Science.gov (United States)

2012-12-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special..., Scientific Review Branch, National Human Genome Research Institute, National Institutes of Health, 5635...

75 FR 53703 - National Human Genome Research Institute; Notice of Closed Meeting

Science.gov (United States)

2010-09-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome..., Scientific Review Branch, National Human Genome Research Institute, National Institutes of Health, 5635.... (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of...

Ethical Conduct of Research in Children: Pediatricians and Their IRB (Part 1 of 2).

Science.gov (United States)

Rose, Carlos D

2017-05-01

As human experimentation continues to grow into an ever more complex and sophisticated endeavor, the relevant ethical and regulatory structures become more intricate. When pediatricians and general practitioners are invited by pharmaceutical companies to enroll their offices in a clinical trial or a multicenter observational study or when they develop their own research questions, they frequently find themselves at a loss in the human research environment. The legal and regulatory complexity may have an unintended deterring effect at a time when office-based high quality pediatric research is urgently needed to support evidence-based medicine. Unfortunately, in many instances, unaware practitioners become involved in low-risk research activities without knowing it and become entangled in legal, auditing, and compliance procedures. This paper, written in 2 parts, aims at providing a general guidance on the principles that regulate human research with a focus on pediatrics. Part 1 discusses the history, the legal framework, and the consent process and highlights some practical aspects of initial protocol submission, continued review, and institutional review board determinations with the main focus on multicenter clinical trials (industry-sponsored research). Part 2 focuses on pediatric research regulation, also known as subpart-D, and minimal risk research, which encompasses many research activities aimed at addressing questions that may emerge in pediatricians' practices (investigator-initiated research). Copyright © 2017 by the American Academy of Pediatrics.

76 FR 16798 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

Science.gov (United States)

2011-03-25

... Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory... Alcoholism Initial Review Group; Neuroscience Review Subcommittee. Date: June 9-10, 2011. Time: 8:30 a.m. to..., Scientific Review Officer, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health...

Surgical management of esophageal achalasia: Evolution of an institutional approach to minimally invasive repair.

Science.gov (United States)

Petrosyan, Mikael; Khalafallah, Adham M; Guzzetta, Phillip C; Sandler, Anthony D; Darbari, Anil; Kane, Timothy D

2016-10-01

Surgical management of esophageal achalasia (EA) in children has transitioned over the past 2 decades to predominantly involve laparoscopic Heller myotomy (LHM) or minimally invasive surgery (MIS). More recently, peroral endoscopic myotomy (POEM) has been utilized to treat achalasia in children. Since the overall experience with surgical management of EA is contingent upon disease incidence and surgeon experience, the aim of this study is to report a single institutional contemporary experience for outcomes of surgical treatment of EA by LHM and POEM, with regards to other comparable series in children. An IRB approved retrospective review of all patients with EA who underwent treatment by a surgical approach at a tertiary US children's hospital from 2006 to 2015. Data including demographics, operative approach, Eckardt scores pre- and postoperatively, complications, outcomes, and follow-up were analyzed. A total of 33 patients underwent 35 operative procedures to treat achalasia. Of these operations; 25 patients underwent laparoscopic Heller myotomy (LHM) with Dor fundoplication; 4 patients underwent LHM alone; 2 patients underwent LHM with Thal fundoplication; 2 patients underwent primary POEM; 2 patients who had had LHM with Dor fundoplication underwent redo LHM with takedown of Dor fundoplication. Intraoperative complications included 2 mucosal perforations (6%), 1 aspiration, 1 pneumothorax (1 POEM patient). Follow ranged from 8months to 7years (8-84months). There were no deaths and no conversions to open operations. Five patients required intervention after surgical treatment of achalasia for recurrent dysphagia including 3 who underwent between 1 and 3 pneumatic dilations; and 2 who had redo LHM with takedown of Dor fundoplication with all patients achieving complete resolution of symptoms. Esophageal achalasia in children occurs at a much lower incidence than in adults as documented by published series describing the surgical treatment in children. We

75 FR 67380 - National Human Genome Research Institute; Notice of Closed Meeting

Science.gov (United States)

2010-11-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... Review Branch, National Human Genome Research Institute, National Institutes of Health, 5635 Fishers Lane.... (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of...

Factors associated with the utilization of institutional and home birth services among women in Ethiopia: A scoping review

Directory of Open Access Journals (Sweden)

Bronwyn Lapp

2016-12-01

Full Text Available Objective: To examine the factors associated with the use of institutional delivery and home birth services among women in Ethiopia. Methods: Fifteen peer-reviewed, primary research articles published between 2011 and 2015 were selected for this scoping review. The articles included case-control, cross-sectional, and retrospective follow-up studies conducted in Ethiopia. Results: Findings were categorized with use of content and factorial analysis. The data in this scoping review revealed a significant inequality in skilled care use among Ethiopian women with differences in economic status, education, residence, autonomy in decision making, parity, and antenatal care attendance. Conclusion: Sociodemographic, accessibility, and obstetric factors are key determinants of skilled care utilization. Strategies and policy changes to address maternal health service use should aim to improve economic status, facilitate higher education, increase access to care, promote the empowerment of women, and enhance antenatal care initiatives. Additional research should be conducted to evaluate the influence of the media and culture on skilled care utilization, since few studies have examined these factors.

Private Institutions and Business Power in Global Governance

DEFF Research Database (Denmark)

Ougaard, Morten

2008-01-01

Review essay. This article reviews the books "Transnational Private Governance and its Limits" edited by Jean-Christophe Graz and Andreas Nölke, "Business Power in Global Governance" by Doris Fuchs, and Private Institutions and Global Governance. The New Politics of Environmental Sustainability...

Characteristics and determinants of knowledge transfer policies at universities and public institutions in medical research--protocol for a systematic review of the qualitative research literature.

Science.gov (United States)

Jahn, Rosa; Müller, Olaf; Bozorgmehr, Kayvan

2015-08-19

Universities, public institutions, and the transfer of knowledge to the private sector play a major role in the development of medical technologies. The decisions of universities and public institutions regarding the transfer of knowledge impact the accessibility of the final product, making it easier or more difficult for consumers to access these products. In the case of medical research, these products are pharmaceuticals, diagnostics, or medical procedures. The ethical dimension of access to these potentially lifesaving products is apparent and distinguishes the transfer of medical knowledge from the transfer of knowledge in other areas. While the general field of technology transfer from academic and public to private actors is attracting an increasing amount of scholarly attention, the specifications of knowledge transfer in the medical field are not as well explored. This review seeks to provide a systematic overview and analysis of the qualitative literature on the characteristics and determinants of knowledge transfer in medical research and development. The review systematically searches the literature for qualitative studies that focus on knowledge transfer characteristics and determinants at medical academic and public research institutions. It aims at identifying and analyzing the literature on the content and context of knowledge transfer policies, decision-making processes, and actors at academic and public institutions. The search strategy includes the databases PubMed, Web of Science, ProQuest, and DiVa. These databases will be searched based on pre-specified search terms. The studies selected for inclusion in the review will be critically assessed for their quality utilizing the Qualitative Research Checklist developed by the Clinical Appraisal Skills Programme. Data extraction and synthesis will be based on the meta-ethnographic approach. This review seeks to further the understanding of the kinds of transfer pathways that exist in medical

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

Science.gov (United States)

Gilbert, Amy Lewis; Knopf, Amelia S; Fortenberry, J Dennis; Hosek, Sybil G; Kapogiannis, Bill G; Zimet, Gregory D

2015-07-01

The Adolescent Medicine Trials Network Protocol 113 (ATN113) is an open-label, multisite demonstration project and Phase II safety study of human immunodeficiency virus (HIV) preexposure prophylaxis with 15- to 17-year-old young men who have sex with men that requires adolescent consent for participation. The purpose of this study was to examine factors related to the process by which Institutional Review Boards (IRBs) and researchers made decisions regarding whether to approve and implement ATN113 so as to inform future biomedical HIV prevention research with high-risk adolescent populations. Participants included 17 researchers at 13 sites in 12 states considering ATN113 implementation. Qualitative descriptive methods were used. Data sources included interviews and documents generated during the initiation process. A common process for initiating ATN113 emerged, and informants described how they identified and addressed practical, ethical, and legal challenges that arose. Informants described the process as responding to the protocol, preparing for IRB submission, abstaining from or proceeding with submission, responding to IRB concerns, and reacting to the outcomes. A complex array of factors impacting approval and implementation were identified, and ATN113 was ultimately implemented in seven of 13 sites. Informants also reflected on lessons learned that may help inform future biomedical HIV prevention research with high-risk adolescent populations. The results illustrate factors for consideration in determining whether to implement such trials, demonstrate that such protocols have the potential to be approved, and highlight a need for clearer standards regarding biomedical HIV prevention research with high-risk adolescent populations. Copyright © 2015 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Annual index & ranking for institutional Open Access performance

DEFF Research Database (Denmark)

Grigorov, Ivo

A simple institutional index based on % of peer-review publications that are accessible through (gold and/or green) OA via the internet, can be a very powerful tool for both administrators and funders to see where their efforts and institutions rank in the global OA effort. Credible answers...... to questions like: "Who are the leaders?", "Who are the latest performers?", "What publicly-funded institutes researching into topical themes with socio-economic consequences, could do better at making their research accessible to stakeholders?" can also stimulate non-commited institutes to invest more in OA...

Institutions, Entrepreneurship, and Economic Growth

DEFF Research Database (Denmark)

Bjørnskov, Christian; Foss, Nicolai Juul

2016-01-01

sample limitations, omitted variable biases, causality issues, and response heterogeneity. We argue that theories in management research, such as the resource-based view, transaction cost economics, and strategic entrepreneurship theory, can fill some of the conceptual and theoretical gaps.......We review the literature that links institutions, entrepreneurship, and economic growth outcomes, focusing in particular on empirical research. Most of the literature has an economics orientation, but we also review relevant literature from other social sciences, including management research...

W. Richard Scott, Institutions and Organizations: Ideas, Interests, and Identities

DEFF Research Database (Denmark)

Jakobsen, Michael

2014-01-01

Book review of: W. Richard Scott: Institutions and Organizations: Ideas, Interests, and Identities. 4th edition. Thousand Oaks, CA: SAGE Publications, 2014. xiii, 345 pp.......Book review of: W. Richard Scott: Institutions and Organizations: Ideas, Interests, and Identities. 4th edition. Thousand Oaks, CA: SAGE Publications, 2014. xiii, 345 pp....

77 FR 12859 - National Institute of Neurological Disorders and Stroke Notice of Meeting

Science.gov (United States)

2012-03-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of...: A Blueprint for Transforming Prevention, Care, Education, and Research and a review of information... Blueprint for Transforming Prevention, Care, Education, and Research and a review of information gathered on...

75 FR 48699 - National Cancer Institute; Notice of Closed Meeting

Science.gov (United States)

2010-08-11

... personal privacy. Name of Committee: National Cancer Institute Initial Review Group, Subcommittee I--Career Development, NCI-I Career Development. Date: September 21, 2010. Time: 8 a.m. to 6 p.m. Agenda: To review and.... Contact Person: Sergei Radaev, PhD, Scientific Review Officer, Resources and Training Review Branch...

The impact of Cochrane Reviews: a mixed-methods evaluation of outputs from Cochrane Review Groups supported by the National Institute for Health Research.

Science.gov (United States)

Bunn, Frances; Trivedi, Daksha; Alderson, Phil; Hamilton, Laura; Martin, Alice; Pinkney, Emma; Iliffe, Steve

2015-04-01

The last few decades have seen a growing emphasis on evidence-informed decision-making in health care. Systematic reviews, such as those produced by Cochrane, have been a key component of this movement. The National Institute for Health Research (NIHR) Systematic Review Programme currently supports 20 Cochrane Review Groups (CRGs) in the UK and it is important that this funding represents value for money. The overall aim was to identify the impacts and likely impacts on health care, patient outcomes and value for money of Cochrane Reviews published by 20 NIHR-funded CRGs during the years 2007-11. We sent questionnaires to CRGs and review authors, undertook interviews with guideline developers (GDs) and used bibliometrics and documentary review to get an overview of CRG impact and to evaluate the impact of a sample of 60 Cochrane Reviews. The evaluation was guided by a framework with four categories (knowledge production, research targeting, informing policy development and impact on practice/services). A total of 3187 new and updated reviews were published on the Cochrane Database of Systematic Reviews between 2007 and 2011, 1502 (47%) of which were produced by the 20 CRGs funded by the NIHR. We found 40 examples where reviews appeared to have influenced primary research and reviews had contributed to the creation of new knowledge and stimulated debate. Twenty-seven of the 60 reviews had 100 or more citations in Google Scholar™ (Google, CA, USA). Overall, 483 systematic reviews had been cited in 247 sets of guidance. This included 62 sets of international guidance, 175 sets of national guidance (87 from the UK) and 10 examples of local guidance. Evidence from the interviews suggested that Cochrane Reviews often play an instrumental role in informing guidance, although reviews being a poor fit with guideline scope or methods, reviews being out of date and a lack of communication between CRGs and GDs were barriers to their use. Cochrane Reviews appeared to have led

Primary intracranial soft tissue sarcomas in children, adolescents, and young adults: single institution experience and review of the literature.

Science.gov (United States)

Maher, Ossama M; Khatua, Soumen; Mukherjee, Devashis; Olar, Adriana; Lazar, Alexander; Luthra, Raja; Liu, Diane; Wu, Jimin; Ketonen, Leena; Zaky, Wafik

2016-03-01

There is a paucity of literature reporting the outcome of intracranial sarcomas (IS) in children, adolescents, and young adults (CAYA). A multimodal therapeutic approach is commonly used, with no well-established treatment consensus. We conducted a retrospective review of CAYA with IS, treated at our institution, to determine their clinical findings, treatments, and outcomes. Immunohistochemistry (PDGFRA and EGFR) and DNA sequencing were performed on 5 tumor samples. A literature review of IS was also conducted. We reviewed 13 patients (median age, 7 years) with a primary diagnosis of IS between 1990 and 2015. Diagnoses included unclassified sarcoma (n = 9), chondrosarcoma (n = 2), and rhabdomyosarcoma (n = 2). Five patients underwent upfront gross total resection (GTR) of the tumor. The 5-drug regimen (vincristine, doxorubicin, cyclophosphamide, etoposide, and ifosfamide) was the most common treatment used. Nine patients died due to progression or recurrence (n = 8) or secondary malignancy (n = 1). The median follow-up period of the 4 surviving patients was 1.69 years (range 1.44-5.17 years). The 5-year progression-free survival and overall survival rates were 21 and 44 %, respectively. BRAF, TP53, KRAS, KIT, ERBB2, MET, RET, ATM, and EGFR mutations were detected in 4 of the 5 tissue samples. All 5 samples were immunopositive for PDGFRA, and only 2 were positive for EGFR. IS remain a therapeutic challenge due to high progression and recurrence rates. Collaborative multi-institutional studies are warranted to delineate a treatment consensus and investigate tumor biology to improve the disease outcome.

Recruitment Practices And Institutional Change

DEFF Research Database (Denmark)

Holm, Anna; Ulhøi, John Parm

Up to now, there has been little research on recruitment practices from an organizational perspective, and in part it lags behind practice. This paper attempts to rectify this by studying recent changes in the recruitment practices of Danish organizations. We employ new institutional theory......, and individuals’ social cognition. Among other things, this is reflected in the use of online recruitment and employer branding. The study concludes that the recruitment field has transformed and reviewed its practices due to institutional changes in how individuals search for employment and expect to be hired....

Doing more good than harm? The effects of participation in sex research on young people in the Netherlands.

Science.gov (United States)

Kuyper, Lisette; de Wit, John; Adam, Philippe; Woertman, Liesbeth

2012-04-01

Ethical guidelines for research with human participants stress the importance of minimizing risks and maximizing benefits. In order to assist Institutional Review Boards (IRBs) and researchers to make more informed risk/benefit analyses with regard to sex research among adolescents, the current study examined the effects of participation in sex research among 899 young people (15-25 years old). Participants completed three questionnaires on a wide range of sexuality-related measures. They also completed scales measuring their levels of distress, need for help, and positive feelings due to their research participation. In general, negative effects of research participation seemed limited, while benefits of participation appeared substantial. Several differences with regard to sociodemographic characteristics were found (e.g., females experienced more distress then males and younger or lower educated participants experienced more positive feelings). In addition, victims of sexual coercion reported more distress and need for help due to their participation, but also experienced more positive feelings. No significant differences were found in relation to experience with sexual risk behaviors (e.g., experience with one-night-stands). Several limitations of the study were discussed, as were implications for future research. Overall, the findings caution IRBs and researchers against being overly protective regarding the inclusion of young people in sex research.

The quality of reports of medical and public health research from Palestinian institutions: a systematic review.

Science.gov (United States)

Albarqouni, Loai; Abu-Rmeileh, Niveen Me; Elessi, Khamis; Obeidallah, Mohammad; Bjertness, Espen; Chalmers, Iain

2017-06-09

Over the past decade, there has been an increase in reports of health research from Palestine, but no assessment of their quality. We have assessed the quality of reports of Palestinian health research and factors associated with it. This is a systematic review. We searched Medline and Scopus for reports of original research relevant to human health or healthcare authored by researchers affiliated with Palestinian institutions and published between January 2000 and August 2015 inclusive. We used international guidelines to assess report quality, classifying as adequate those with ≥50% of items completely addressed. Of 2383 reports identified, 497 met our inclusion criteria. Just over half (264; 55%) of these were published after 2010. 354 (71%) of first authors were affiliated with Palestinian institutions; 261 (53%) reports had coauthors from outside Palestine. The majority of the reports in our study were inadequately reported (342; 69%), and none had adequately reported all items. Of 439 observational studies, 11 (2.5%) reports provided adequate descriptions of eligibility criteria and selection procedures; 35 (8%) reported efforts to address potential sources of bias; 50 (11.4%) reported the basis for the study sample size; and funding sources were mentioned in 74 reports (17%). Higher reporting quality was associated with international affiliation of the first author (prevalence ratio (PR) 1.6 (95% CI 1.2 to 2.1)), international collaboration (PR 2.9 (95% CI 1.7 to 5.0)), international funding (PR 1.9 (95% CI1.5 to 2.5)), publication after 2005 (PR 3.9 (95% CI 1.8 to 8.5)) and four or more coauthors (PR 1.5 (95% CI 1.1 to 2.1)). Although the quality of reports of Palestinian research has improved in recent years, it remains well below an acceptable standard. International reporting guidelines should be used to guide research design and improve the quality of reports of research. The systematic review protocol was registered in the International Prospective

76 FR 5594 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed...

Science.gov (United States)

2011-02-01

... National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Initial Review Group, Developmental Biology Subcommittee... Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6100...

78 FR 55266 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

Science.gov (United States)

2013-09-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of...., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes Of Health, Room 759, 6707 Democracy... grant applications. Place: Hotel Kabuki, 1625 Post Street, San Francisco, CA 94115. Contact Person...

Sexual and Gender Minority Adolescents' Views On HIV Research Participation and Parental Permission: A Mixed-Methods Study.

Science.gov (United States)

Mustanski, Brian; Coventry, Ryan; Macapagal, Kathryn; Arbeit, Miriam R; Fisher, Celia B

2017-06-01

Sexual and gender minority adolescents are underrepresented in HIV research, partly because institutional review boards (IRBs) are reluctant to waive parental permission requirements for these studies. Understanding teenagers' perspectives on parental permission and the risks and benefits of participating in HIV research is critical to informing evidence-based IRB decisions. Data from 74 sexual and gender minority adolescents aged 14-17 who participated in an online focus group in 2015 were used to examine perspectives on the risks and benefits of participation in a hypothetical HIV surveillance study and the need for parental permission and adequate protections. Data were analyzed thematically; mixed methods analyses examined whether concerns about parental permission differed by whether teenagers were out to their parents. Most adolescents, especially those who were not out to their parents, would be unwilling to participate in an HIV study if parental permission were required. Perceived benefits of participation included overcoming barriers to HIV testing and contributing to the health of sexual and gender minority youth. Few risks of participation were identified. Adolescents suggested steps that researchers could take to facilitate informed decision making about research participation and ensure minors' safety in the absence of parental permission; these included incorporating multimedia presentations into the consent process and explaining researchers' motivations for conducting the study. Respondents believed that the benefits of HIV surveillance research outweighed the risks. Requiring parental permission may exclude many sexual and gender minority teenagers from taking part in HIV research, especially if they are not out. Copyright © 2017 by the Guttmacher Institute.

Academic Libraries’ Role in Improving Institutions Research Impact

KAUST Repository

Tamarkin, Molly

2015-11-11

In the changing landscape of scientific research and scholarly communication, importance of “quality in research”, “reviewed research” and “reviewed publications” in qualifying for the ratings and rankings are widely discussed. While publishing the research pieces in peer-reviewed and highly ranked journals are increasingly important, there are different methods and tools to be in place at Institutional level to increase researchers’ profile and the ranking of the institutions. As a young research based university created in 2009, King Abdullah University of Science and Technology (KAUST) focuses on the bibliometrics and altemetrics tools, author affiliations, author naming and plug-ins to different search engines, research evaluation systems as well as to research repositories. The University has launched an institutional repository in September 2012 as a home for the intellectual outputs of KAUST researchers, and then adopted the first institutional open access mandate in the Arab region effective June 31, 2014. Integration with ORCID became a key element in this process and the best way to ensure data quality for researcher’s scientific contributions systematically. We will present the inclusion and creation of ORCID identifiers in the existing systems as an institutional member to ORCID, and the creation of dedicated integration tools with Current Research Information System (CRIS) as a standardized common resource to monitor KAUST research outputs. We will also present our experiences in awareness programs, trainings, outreach, implementation of systems and tools like PlumX, as well as our approach in improving the research impact and profiling our Institution’s research to the world.

Academic Libraries’ Role in Improving Institutions Research Impact

KAUST Repository

Tamarkin, Molly; Vijayakumar, J.K.; Baessa, Mohamed A.; Grenz, Daryl M.

2015-01-01

In the changing landscape of scientific research and scholarly communication, importance of “quality in research”, “reviewed research” and “reviewed publications” in qualifying for the ratings and rankings are widely discussed. While publishing the research pieces in peer-reviewed and highly ranked journals are increasingly important, there are different methods and tools to be in place at Institutional level to increase researchers’ profile and the ranking of the institutions. As a young research based university created in 2009, King Abdullah University of Science and Technology (KAUST) focuses on the bibliometrics and altemetrics tools, author affiliations, author naming and plug-ins to different search engines, research evaluation systems as well as to research repositories. The University has launched an institutional repository in September 2012 as a home for the intellectual outputs of KAUST researchers, and then adopted the first institutional open access mandate in the Arab region effective June 31, 2014. Integration with ORCID became a key element in this process and the best way to ensure data quality for researcher’s scientific contributions systematically. We will present the inclusion and creation of ORCID identifiers in the existing systems as an institutional member to ORCID, and the creation of dedicated integration tools with Current Research Information System (CRIS) as a standardized common resource to monitor KAUST research outputs. We will also present our experiences in awareness programs, trainings, outreach, implementation of systems and tools like PlumX, as well as our approach in improving the research impact and profiling our Institution’s research to the world.

77 FR 34394 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed...

Science.gov (United States)

2012-06-11

... National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Initial Review Group, Obstetrics and Maternal-Fetal Biology... of Scientific Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development...

76 FR 12125 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed...

Science.gov (United States)

2011-03-04

... National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Special Emphasis Panel; Corpus Luteal Contribution to...., Scientific Review Officer, Division of Scientific Review, Eunice Kennedy Shriver National Institute of Child...

75 FR 36100 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed...

Science.gov (United States)

2010-06-24

... National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Special Emphasis Panel National Childrens Study. Date: July..., Scientific Review Administrator, Division of Scientific Review, National Institute of Child Health and Human...

75 FR 26761 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed...

Science.gov (United States)

2010-05-12

... National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Special Emphasis Panel; Asymmetric Robotic Gait Training and... Review Administrator, Division of Scientific Review, National Institute of Child Health and Human...

77 FR 34393 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed...

Science.gov (United States)

2012-06-11

... National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d...: National Institute of Child Health and Human Development Initial Review Group; Biobehavioral and Behavioral... Review, Eunice Kennedy Shriver National Institute o Child Health and Human Development, NIH, 6100...

78 FR 18998 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting

Science.gov (United States)

2013-03-28

... National Institute of Child Health & Human Development; Notice of Meeting Pursuant to section 10(d) of the... Committee: National Institute of Child Health and Human Development Special Emphasis Panel, Diet, Obesity.... Kandasamy, Ph.D., Scientific Review Officer, Division of Scientific Review, National Institute of Child...

77 FR 73036 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed...

Science.gov (United States)

2012-12-07

... National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Special Emphasis Panel. NICHD T32 Teleconference Review... of Scientific Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development...

75 FR 36101 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed...

Science.gov (United States)

2010-06-24

... National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Special Emphasis Panel Slack and Slick Channels. Date: July..., PhD, Scientific Review Administrator, Division of Scientific Review, National Institute of Child...

7th International Summer Institute in Surface Science

CERN Document Server

Howe, Russell

1986-01-01

This volume contains review articles which were written by the invited speak­ ers of the seventh International Summer Institute in Surface Science (ISISS), held at the University of Wisconsin - Milwaukee in July 1985. The form of ISISS is a set of tutorial review lectures presented over a one-week period by internationally recognized experts on various aspects of surface science. Each speaker is asked, in addition, to write a review article on his lecture topic. No single volume in the series Chemistry and Physics of Solid Surfaces can possibly cover the entire field of modern surface science. However, the series as a whole is intended to provide experts and students alike with a comprehensive set of reviews and literature references, particularly empha­ sizing the gas-solid interface. The collected articles from previous Summer Institutes have been published under the following titles: Surface Science: Recent Progress and Perspectives, Crit. Rev. Solid State Sci. 4, 125-559 (1974) Chemistry and Physics of ...

77 FR 28613 - National Cancer Institute; Notice of Closed Meetings

Science.gov (United States)

2012-05-15

... Nanotechnology. Date: July 11-12, 2012. Time: 8:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant.... to 3:30 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health... Call). Contact Person: Adriana Stoica, Ph.D., Scientific Review Officer, Special Review and Logistics...

Assessing the scientific research productivity of a Brazilian healthcare institution: a case study at the heart institute of São Paulo, Brazil

Directory of Open Access Journals (Sweden)

Beatriz Helena Tess

2009-06-01

Full Text Available INTRODUCTION: The present study was motivated by the need to systematically assess the research productivity of the Heart Institute (InCor, Medical School of the University of São Paulo, Brazil. OBJECTIVE: To explore methodology for the assessment of institutional scientific research productivity. MATERIALS AND METHODS: Bibliometric indicators based on searches for author affiliation of original scientific articles or reviews published in journals indexed in the databases Web of Science, MEDLINE, EMBASE, LILACS and SciELO from January 2000 to December 2003 were used in this study. The retrieved records were analyzed according to the index parameters of the journals and modes of access. The number of citations was used to calculate the institutional impact factor. RESULTS: Out of 1253 records retrieved from the five databases, 604 original articles and reviews were analyzed; of these, 246 (41% articles were published in national journals and 221 (90% of those were in journals with free online access through SciELO or their own websites. Of the 358 articles published in international journals, 333 (93% had controlled online access and 223 (67% were available through the Capes Portal of Journals. The average impact of each article for InCor was 2.224 in the period studied. CONCLUSION: A simple and practical methodology to evaluate the scientific production of health research institutions includes searches in the LILACS database for national journals and in MEDLINE and the Web of Science for international journals. The institutional impact factor of articles indexed in the Web of Science may serve as a measure by which to assess and review the scientific productivity of a research institution.

Towards a Foundation of Material Approaches in Neo-institutional Theory

DEFF Research Database (Denmark)

Cartel, Melodie; Boxenbaum, Eva

Socio-material approaches of innovation are currently developing fast in neo-institutional theory yet they lack global coherence. As a result, their contribution to the understanding of institutional innovation is fragile. This paper develops a coherent view on socio-material approaches...... of innovation in neo-institutional theory. Drawing on a literature review, we propose that material approaches of institutional innovation focus on the design of institutions. We build on the concept of bricolage to unveil the three activities involved in the design of institutions: crafting, testing...... and evaluating. Eventually, we articulate these findings with existing insights on institutional innovation and develop a multilevel model of institutional innovation....

76 FR 29772 - National Human Genome Research Institute; Notice of Closed Meetings

Science.gov (United States)

2011-05-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research... of Scientific Review, National Human Genome Research Institute, National Institutes of Health...

NRC review of Electric Power Research Institute's advanced light water reactor utility requirements document. Passive plant designs, chapter 1, project number 669

International Nuclear Information System (INIS)

1994-08-01

The Electric Power Research Institute (EPRI) is preparing a compendium of technical requirements, referred to as the open-quotes Advanced Light Water Reactor [ALWR] Utility Requirements Documentclose quotes, that is acceptable to the design of an ALWR power plant. When completed, this document is intended to be a comprehensive statement of utility requirements for the design, construction, and performance of an ALWR power plant for the 1990s and beyond. The Requirements Document consists of three volumes. Volume 1, open-quotes ALWR Policy and Summary of Top-Tier Requirementsclose quotes, is a management-level synopsis of the Requirements Document, including the design objectives and philosophy, the overall physical configuration and features of a future nuclear plant design, and the steps necessary to take the proposed ALWR design criteria beyond the conceptual design state to a completed, functioning power plant. Volume II consists of 13 chapters and contains utility design requirements for an evolutionary nuclear power plant [approximately 1350 megawatts-electric (MWe)]. Volume III contains utility design requirements for nuclear plants for which passive features will be used in their designs (approximately 600 MWe). In April 1992, the staff of the Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, issued Volume 1 and Volume 2 (Parts 1 and 2) of its safety evaluation report (SER) to document the results of its review of Volumes 1 and 2 of the Requirements Document. Volume 1, open-quotes NRC Review of Electric Power Research Institute's Advanced Light Water Reactor Utility Requirements Document - Program Summaryclose quotes, provided a discussion of the overall purpose and scope of the Requirements Document, the background of the staff's review, the review approach used by the staff, and a summary of the policy and technical issues raised by the staff during its review

77 FR 5035 - National Human Genome Research Institute; Notice of Closed Meetings

Science.gov (United States)

2012-02-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research... Officer, Scientific Review Branch, National Human Genome Research Institute, National Institutes of Health...

Anaesthesia-related haemodynamic complications in Williams syndrome patients: a review of one institution's experience.

Science.gov (United States)

Olsen, M; Fahy, C J; Costi, D A; Kelly, A J; Burgoyne, L L

2014-09-01

Williams syndrome is a genetic disorder associated with cardiac pathology, including supravalvular aortic stenosis and coronary artery stenosis. Sudden cardiac death has been reported in the perioperative period and attributed to cardiovascular pathology. In this retrospective audit, case note and anaesthetic records were reviewed for all confirmed Williams syndrome patients who had received an anaesthetic in our institution between July 1974 and November 2009. There were a total of 108 anaesthetics administered in 29 patients. Twelve of the anaesthetics (11.1%) were associated with cardiac complications including cardiac arrest in two cases (1.85%). Of the two cardiac arrests, one patient died within the first 24 hours postanaesthetic and the other patient survived, giving an overall mortality of 0.9% (3.4%). We conclude that Williams syndrome confers a significant anaesthetic risk, which should be recognised and considered by clinicians planning procedures requiring general anaesthesia.

75 FR 5798 - National Institute on Drug Abuse; Notice of Closed Meetings

Science.gov (United States)

2010-02-04

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse, Special..., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, National..., [email protected] . Name of Committee: National Institute on Drug Abuse, Special Emphasis Panel...

78 FR 64222 - National Human Genome Research Institute; Notice of Closed Meetings

Science.gov (United States)

2013-10-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research... Review, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD 20892, 301...

78 FR 20933 - National Human Genome Research Institute; Notice of Closed Meeting

Science.gov (United States)

2013-04-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special... review and evaluate grant applications. Place: National Human Genome Research Institute, Room 3055, 5635...

78 FR 31953 - National Human Genome Research Institute; Notice of Closed Meeting

Science.gov (United States)

2013-05-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special... review and evaluate grant applications. Place: National Human Genome Research Institute, 3rd Floor...

77 FR 22332 - National Human Genome Research Institute; Notice of Closed Meeting

Science.gov (United States)

2012-04-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special.... Agenda: To review and evaluate grant applications. Place: National Human Genome Research Institute, 5635...

77 FR 28888 - National Human Genome Research Institute Notice of Closed Meeting

Science.gov (United States)

2012-05-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Initial...: To review and evaluate grant applications. Place: National Human Genome Research Institute, 3635...

76 FR 5390 - National Human Genome Research Institute; Notice of Closed Meeting

Science.gov (United States)

2011-01-31

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Place: National Human Genome Research Institute Special Emphasis... Officer, Scientific Review Branch, National Human Genome Research Institute, 5635 Fishers Lane, Suite 4076...

Why Do Institutions Offer MOOCs?

Science.gov (United States)

Hollands, Fiona M.; Tirthali, Devayani

2014-01-01

By reviewing the literature and interviewing 83 individuals knowledgeable about massive open online courses (MOOCs), we investigate the goals of institutions of higher education that are currently developing and delivering such courses. We identify six major goals for MOOC initiatives: extending reach and access, building and maintaining brand,…

76 FR 26308 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

Science.gov (United States)

2011-05-06

... Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory... and Alcoholism Initial Review Group, Epidemiology, Prevention and Behavior Research Review... Institutes On Alcohol Abuse & Alcoholism National, Institutes Of Health, 5635 Fishers Lane, Rm. 3037...

75 FR 7489 - National Cancer Institute; Notice of Closed Meetings

Science.gov (United States)

2010-02-19

... review and evaluate grant applications. Place: Legacy Hotel and Meeting Center, 1775 Rockville Pike, Rockville, MD 20852. Contact Person: Lalita D. Palekar, PhD, Scientific Review Officer, Special Review and... Institute Special Emphasis Panel; NCI Cancer Nanotechnology Training (R25) and Career Development Award (K99...

Human subjects concerns in ground based ECLSS testing - Managing uncertainty in closely recycled systems

Science.gov (United States)

Crump, William J.; Janik, Daniel S.; Thomas, L. Dale

1990-01-01

U.S. space missions have to this point used water either made on board or carried from earth and discarded after use. For Space Station Freedom, long duration life support will include air and water recycling using a series of physical-chemical subsystems. The Environmental Control and Life Support System (ECLSS) designed for this application must be tested extensively at all stages of hardware maturity. Human test subjects are required to conduct some of these tests, and the risks associated with the use of development hardware must be addressed. Federal guidelines for protection of human subjects require careful consideration of risks and potential benefits by an Institutional Review Board (IRB) before and during testing. This paper reviews the ethical principles guiding this consideration, details the problems and uncertainties inherent in current hardware testing, and presents an incremental approach to risk assessment for ECLSS testing.

Guiding and Modelling Quality Improvement in Higher Education Institutions

Science.gov (United States)

Little, Daniel

2015-01-01

The article considers the process of creating quality improvement in higher education institutions from the point of view of current organisational theory and social-science modelling techniques. The author considers the higher education institution as a functioning complex of rules, norms and other organisational features and reviews the social…

Disciplining governance in Africa : a comparison of the World Bank’s Country Policy and Institutional Assessment and the African Union’s African Peer Review Mechanism

NARCIS (Netherlands)

S. Kassa (Saba)

2017-01-01

markdownabstractThis study examines the promotion of governance in the African Continent. It compares the Country Policy and Institutional Assessment (CPIA) of the World Bank to the African Peer Review Mechanism (APRM) of the African Union. These governance assessments represent differing

The Value of a Resident Aesthetic Clinic: A 7-Year Institutional Review and Survey of the Chief Resident Experience.

Science.gov (United States)

Weissler, Jason M; Carney, Martin J; Yan, Chen; Percec, Ivona

2017-10-16

With the evolving plastic surgery training paradigm, there is an increasing emphasis on aesthetic surgery education during residency. In an effort to improve aesthetic education and to encourage preparation for independent practice, our institution has supported a resident-run aesthetic clinic for over two decades. To provide insight into the educational benefits of a resident-run cosmetic clinic through longitudinal resident follow up and institutional experiential review. A retrospective review was conducted to identify all clinic-based aesthetic operations performed between 2009 and 2016. To capture residents' perspectives on the cosmetic resident clinic, questionnaires were distributed to the cohort. Primary outcome measures included: volume and types of cases performed, impact of clinic experience on training, confidence level performing cosmetic procedures, and satisfaction with chief clinic. Unpaired t tests were calculated to compare case volume/type with level of confidence and degree of preparedness to perform cosmetic procedures independently. Overall, 264 operations performed by 18 graduated chief residents were reviewed. Surveys were distributed to 28 chief residents (71.4% completion rate). Performing twenty or more clinic-based procedures was associated with higher levels of preparedness to perform cosmetic procedures independently (P = 0.037). Residents reported the highest confidence when performing cosmetic breast procedures when compared to face/neck (P = 0.005), body/trunk procedures (P = 0.39), and noninvasive facial procedures (P = 0.85). The continued growth of aesthetic surgery highlights the need for comprehensive training and preparation for the new generation of plastic surgeons. Performing cosmetic procedures in clinic is a valuable adjunct to the traditional educational curriculum and increases preparedness and confidence for independent practice. © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission

The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards?

Science.gov (United States)

Barker, Roger A; Carpenter, Melissa K; Forbes, Stuart; Goldman, Steven A; Jamieson, Catriona; Murry, Charles E; Takahashi, Jun; Weir, Gordon

2018-05-08

Stem cell-based clinical interventions are increasingly advancing through preclinical testing and approaching clinical trials. The complexity and diversity of these approaches, and the confusion created by unproven and untested stem cell-based "therapies," create a growing need for a more comprehensive review of these early-stage human trials to ensure they place the patients at minimal risk of adverse events but are also based on solid evidence of preclinical efficacy with a clear scientific rationale for that effect. To address this issue and supplement the independent review process, especially that of the ethics and institutional review boards who may not be experts in stem cell biology, the International Society for Stem Cell Research (ISSCR) has developed a set of practical questions to cover the major issues for which clear evidence-based answers need to be obtained before approving a stem cell-based trial. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

76 FR 19780 - National Human Genome Research Institute; Notice of Closed Meeting

Science.gov (United States)

2011-04-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... E. Day, PhD, Scientific Review Officer, CIDR, National Human Genome Research Institute, National... . (Catalogue of Federal Domestic Assistance Program No. 93.172, Human Genome Research, National Institutes of...

78 FR 24223 - National Human Genome Research Institute; Notice of Closed Meeting

Science.gov (United States)

2013-04-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Initial...: To review and evaluate grant applications. Place: National Human Genome Research Institute, 3rd floor...

1995-1996 annual report of the Petroleum Recovery Institute

International Nuclear Information System (INIS)

1996-01-01

Financial performance and technical achievements were highlighted in the Petroleum Recovery Institute's 1995-96 annual review, with a special review of PRI's involvement with microgravity science. A list of PRI research and technology contracts and research reports from 1995-1996 was also included

78 FR 41940 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

Science.gov (United States)

2013-07-12

... Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory... and Alcoholism Initial Review Group; Biomedical Research Review Subcommittee. Date: October 22, 2013... Officer, National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, 5635 Fishers...

76 FR 1625 - National Cancer Institute; Notice of Closed Meeting

Science.gov (United States)

2011-01-11

... personal privacy. Name of Committee: National Cancer Institute Initial Review Group; Subcommittee I--Career Development, Career Development. Date: February 22-23, 2011. Time: February 22, 2011, 8 a.m. to 6 p.m. Agenda: To review and evaluate to review and evaluate grant applications. Place: Hilton Alexandria Old Town...

75 FR 26761 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed...

Science.gov (United States)

2010-05-12

... National Institute of Child Health and Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Special Emphasis Panel; Asymmetric Robotic Gait Training and... Review Administrator, Division of Scientific Review, National Institute of Child Health and Human...

78 FR 56240 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting

Science.gov (United States)

2013-09-12

... National Institute of Child Health and Human Development; Notice of Meeting Pursuant to section 10(d) of... Committee: National Institute of Child Health and Human Development Special Emphasis Panel; Further...., Scientific Review Officer, Division of Scientific Review, National Institute of Child Health and Human...

A system architecture for sharing de-identified, research-ready brain scans and health information across clinical imaging centers.

Science.gov (United States)

Chervenak, Ann L; van Erp, Theo G M; Kesselman, Carl; D'Arcy, Mike; Sobell, Janet; Keator, David; Dahm, Lisa; Murry, Jim; Law, Meng; Hasso, Anton; Ames, Joseph; Macciardi, Fabio; Potkin, Steven G

2012-01-01

Progress in our understanding of brain disorders increasingly relies on the costly collection of large standardized brain magnetic resonance imaging (MRI) data sets. Moreover, the clinical interpretation of brain scans benefits from compare and contrast analyses of scans from patients with similar, and sometimes rare, demographic, diagnostic, and treatment status. A solution to both needs is to acquire standardized, research-ready clinical brain scans and to build the information technology infrastructure to share such scans, along with other pertinent information, across hospitals. This paper describes the design, deployment, and operation of a federated imaging system that captures and shares standardized, de-identified clinical brain images in a federation across multiple institutions. In addition to describing innovative aspects of the system architecture and our initial testing of the deployed infrastructure, we also describe the Standardized Imaging Protocol (SIP) developed for the project and our interactions with the Institutional Review Board (IRB) regarding handling patient data in the federated environment.

76 FR 23826 - National Institute on Drug Abuse; Notice of Closed Meetings

Science.gov (United States)

2011-04-28

... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse..., PhD, Scientific Review Administrator, Office of Extramural Affairs, National Institute on Drug Abuse[email protected] . Name of Committee: National Institute on Drug Abuse Special Emphasis Panel, New Molecular...

75 FR 63491 - National Institute on Drug Abuse; Notice of Closed Meetings

Science.gov (United States)

2010-10-15

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis... Review Administrator, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 220... Committee: National Institute on Drug Abuse Special Emphasis Panel, Treatment and Services Use. Date...

75 FR 11552 - National Institute on Drug Abuse; Notice of Closed Meetings

Science.gov (United States)

2010-03-11

... unwarranted invasion of person al privacy. Name of Committee: National Institute on Drug Abuse Special..., Contract Review Specialist, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room... . Name of Committee: National Institute on Drug Abuse Special Emphasis Panel Clinical Worlds: Enhancing...

76 FR 3916 - National Institute on Drug Abuse; Notice of Closed Meetings

Science.gov (United States)

2011-01-21

... invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel..., Scientific Review Administrator, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, [email protected] . Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Seek, Test...

78 FR 64960 - National Institute on Drug Abuse; Notice of Closed Meetings

Science.gov (United States)

2013-10-30

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis..., Ph.D., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH... . Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; CEBRA: Cutting-Edge Basic...

78 FR 23772 - National Institute on Drug Abuse; Notice of Closed Meetings

Science.gov (United States)

2013-04-22

... invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel... Furr, Contract Review Specialist, Office of Extramural Affairs, National Institute on Drug Abuse, [email protected] . Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; National Drugged...

78 FR 58320 - National Institute on Drug Abuse; Notice of Closed Meetings

Science.gov (United States)

2013-09-23

... invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis [email protected] . Name of Committee: National Institute on Drug Abuse Special Emphasis Panel Strategic..., Ph.D., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH...

78 FR 13362 - National Institute on Drug Abuse; Notice of Closed Meeting

Science.gov (United States)

2013-02-27

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; NIH Pathway..., Ph.D., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH..., Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: February 20...

77 FR 27075 - National Institute on Drug Abuse; Notice of Closed Meetings

Science.gov (United States)

2012-05-08

... invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel....D., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH... . Name of Committee: National Institute on Drug Abuse Special Emphasis Panel NIDA B/START Small Grant...

76 FR 22715 - National Institute on Drug Abuse; Notice of Closed Meeting

Science.gov (United States)

2011-04-22

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; NIDA Blending..., Training and Special Projects Review Branch, Office of Extramural Affairs, National Institute on Drug Abuse... Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health...

77 FR 70171 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

Science.gov (United States)

2012-11-23

... Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory... and Alcoholism Initial Review Group Neuroscience Review Subcommittee. Date: March 6, 2013. Time: 8:00... Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, 5635 Fishers Lane, RM 2081...

78 FR 41938 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

Science.gov (United States)

2013-07-12

... Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory... and Alcoholism Initial Review Group, Neuroscience Review Subcommittee. Date: November 5, 2013. Time: 8..., National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, 5635 Fishers Lane, RM...

77 FR 5029 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed...

Science.gov (United States)

2012-02-01

... National Institute of Child Health and Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Special Emphasis Panel; Perinatal HIV-Infected Youth. Date...., Scientific Review Officer Division of Scientific Review, Eunice Kennedy Shriver National Institute of Child...

75 FR 36431 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed...

Science.gov (United States)

2010-06-25

... National Institute of Child Health and Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Special Emphasis Panel--Assays of Biological Specimens in..., Scientific Review Officer, Division of Scientific Review, Eunice Kennedy Shriver National Institute of Child...

Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective

Directory of Open Access Journals (Sweden)

von Dadelszen Peter

2010-07-01

Full Text Available Abstract Background For ethical approval of a multicentre study in Canada, investigators must apply separately to individual Research Ethics Boards (REBs. In principle, the protection of human research subjects is of utmost importance. However, in practice, the process of multicentre ethics review can be time consuming and costly, requiring duplication of effort for researchers and REBs. We used our experience with ethical review of The Canadian Perinatal Network (CPN, to gain insight into the Canadian system. Methods The applications forms of 16 different REBs were abstracted for a list of standardized items. The application process across sites was compared. Correspondence between the REB and the investigators was documented in order to construct a timeline to approval, identify the specific issues raised by each board, and describe how they were resolved. Results Each REB had a different application form. Most (n = 9 had a two or three step application process. Overall, it took a median of 31 days (range 2-174 days to receive an initial response from the REB. Approval took a median of 42 days (range 4-443 days. Privacy and consent were the two major issues raised. Several additional minor or administrative issues were raised which delayed approval. Conclusions For CPN, the Canadian REB process of ethical review proved challenging. REBs acted independently and without unified application forms or submission procedures. We call for a critical examination of the ethical, privacy and institutional review processes in Canada, to determine the best way to undertake multicentre review.

Analisis Konten dan Kebijakan Akses Institutional Repository

Directory of Open Access Journals (Sweden)

Amirul Ulum

2016-07-01

Abstract; Institutional repository has become a major concern of higher education in Indonesia. The number of institutional respository was increased, one of the reason is the ranking web of repositories has been conducted by the Cybermetrics Lab in 2008. At that time, many institutions started to build institutional repository in order to manage the scientific work and also trying to reach the better ranks. Meanwhile, it is an achievement of institution performance which can be promote and increase visibility for the institution. University of Surabaya has also developed the institutional repository and managed by the library. The aims of this study is to analyze the content availability and access policies defined by the University of Surabaya repository  providing services to the academic community and external users. The method used in this study by using observations of the institutional repository University of Surabaya with a literature review to clarify the analysis of the content and access policies. The results of this study indicate that the library's role is has the authority to manage the scientific work of academic community can be done through the institutional repository. However there is still need for library to be proactive to communicate regulations on mandatory deposit of scientific work and create intensive promotion of the institutional repository.

An exploratory study on awareness towards institutional social responsibility in Indian higher education institutions

Directory of Open Access Journals (Sweden)

Richa Mishra

2016-06-01

Full Text Available Institutional Social responsibility (ISR in context to a Higher Educational Institution has been defined as the ethical practice in transference of knowledge, and the active participation in betterment of quality of life in the society. It is an offshoot of the concept of Corporate Social responsibility (CSR, but unlike CSR, it is neither mandatory nor actively monitored or researched in Indian context. However, awareness towards aspects of ISR has been increasing, especially in Indian Universities. Indian Universities adopt practices related to Adoption of Villages, Awareness Drives, Environmental Care and rural Education initiatives. Critics often see ISR as an unnecessary burden; review of literature from around the world suggests that ISR practices contribute to increased accountability towards exploitation of resources by Educational Institutes as well as better reputation of Educational Institutes in the society. The purpose of this paper is to examine the perception towards the concept of ISR in Educational Institutes in India. The paper opted for a questionnaire-based exploratory survey of 50 faculty members, across Private Universities in Rajasthan. The findings suggest lacking awareness but a significant acceptance of need of ISR practices. The paper includes implications for the Universities to include ISR practices in their strategy to address its obligations to the society and simultaneously gain a competitive advantage.

General principles of institutional risks influence on pension systems

Science.gov (United States)

Nepp, A. N.; Shilkov, A. A.; Sheveleva, A. Y.; Mamedbakov, M. R.

2016-12-01

This paper examines the tools used to study the influence of institutional factors on investment returns. The research object are the tools used in the evaluation of institutional risks in the pension system, in particular, the correlation model of factors impacting on the `anti-director' index, econometric estimates combining the different determinants of savings, the model of endogenous institutional change, etc. Research work focusing on issues of institutional factors affecting pension systems (authored by La Porta, Guiso, Gianetti, El-Mekkaouide Freitas, Neyapti B., and others) is reviewed. The model is examined in terms of the impact of institutional risks on pension systems, especially with regard to the funded part. The study identified the following factors that affect financial institutions, including pension institutions: management quality, regulation quality, rule of law, political stability, and corruption control.

78 FR 25460 - National Institute on Drug Abuse; Notice of Closed Meetings

Science.gov (United States)

2013-05-01

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis...., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, 6001... Committee: National Institute on Drug Abuse Special Emphasis Panel; Cohort Studies of HIV/AIDS and Substance...

78 FR 27410 - National Institute on Drug Abuse; Notice of Closed Meeting

Science.gov (United States)

2013-05-10

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; R13..., Grants Review Branch, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, 6001... Committee: National Institute on Drug Abuse Special Emphasis Panel; PA-11-197 NIH Pathway to Independence...

78 FR 56238 - National Institute on Drug Abuse; Notice of Closed Meetings

Science.gov (United States)

2013-09-12

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel Multisite... Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4234, MSC 9550... review and funding cycle. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; I...

75 FR 42104 - National Institute on Drug Abuse; Notice of Closed Meeting

Science.gov (United States)

2010-07-20

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel Systems... Administrator, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 220, MSC 8401... review and funding cycle. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel 2010...

The Institute of Automotive Engineering at the Technical University of Dresden; Das Institut fuer Verbrennungsmotoren und Kraftfahrzeuge (IVK) an der TU Dresden

Energy Technology Data Exchange (ETDEWEB)

Bergmann, M.

1995-05-01

The Institute of Automotive Engineering belongs to the oldest German Institutes of this kind at all. Founded in 1918, the Institute reviews a history of over 75 years. Students training at the Institute takes aim at a future emloyment in fields of research and development and design and computing. Both car manufactures and suppliers appreciate the practice-oriented education given at the Institute. Corresponding to the internal structure the Institute provides a training at following teaching and research fields: Internal Combustion Engines, Automotive Drive Engineering and Automotive Electrics/Electronics. For that the Institute is equipped with modern test bench facilities and CAD/CAE workstations. (orig.) [Deutsch] Das IVK blickt auf eine lange Tradition zurueck und zaehlt noch heute zu den fuehrenden Ausbildungs- und Forschungsstaetten fuer Kraftfahrzeug- und Motoreningenieure. Derzeit bestehen drei Professuren: Verbrennungsmotoren, Kraftfahrzeug- und Antriebstechnik sowie Kraftfahrzeug-Elektronik/-Elektrik. (orig.)

NRC review of Electric Power Research Institute's advanced light water reactor utility requirements document. Passive plant designs, chapters 2-13, project number 669

International Nuclear Information System (INIS)

1994-08-01

The Electric Power Research Institute (EPRI) is preparing a compendium of technical requirements, referred to as the open-quotes Advanced Light Water Reactor [ALWR] Utility Requirements Documentclose quotes, that is acceptable to the design of an ALWR power plant. When completed, this document is intended to be a comprehensive statement of utility requirements for the design, construction, and performance of an ALWR power plant for the 1990s and beyond. The Requirements Document consists of three volumes. Volume I, open-quotes ALWR Policy and Summary of Top-Tier Requirementsclose quotes, is a management-level synopsis of the Requirements Document, including the design objectives and philosophy, the overall physical configuration and features of a future nuclear plant design, and the steps necessary to take the proposed ALWR design criteria beyond the conceptual design state to a completed, functioning power plant. Volume II consists of 13 chapters and contains utility design requirements for an evolutionary nuclear power plant [approximately 1350 megawatts-electric (MWe)]. Volume III contains utility design requirements for nuclear plants for which passive features will be used in their designs (approximately 600 MWe). In April 1992, the staff of the Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, issued Volume 1 and Volume 2 (Parts 1 and 2) of its safety evaluation report (SER) to document the results of its review of Volumes 1 and 2 of the Requirements Document. Volume 1, open-quotes NRC Review of Electric Power Research Institute's Advanced Light Water Reactor Utility Requirements Document - Program Summaryclose quotes, provided a discussion of the overall purpose and scope of the Requirements Document, the background of the staff's review, the review approach used by the staff, and a summary of the policy and technical issues raised by the staff during its review

Review of Public Forestry Administrations and Related Institutions in ...

African Journals Online (AJOL)

The main findings of a study on forest administration and related institutional arrangements (PFA) are highlighted. The relevance and changing roles of PFA in Sub-Saharan African (SSA) countries are covered in the context of new paradigm for sustainable forest management (SFM). The current weak capacities and low ...

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

Science.gov (United States)

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

2018-07-01

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

77 FR 69640 - National Institute on Drug Abuse; Notice of Closed Meetings

Science.gov (United States)

2012-11-20

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis..., Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4234, MSC 9550, 6001... Institute on Drug Abuse Special Emphasis Panel CEBRA Conflict Review. Date: November 29, 2012. Time: 4:00 p...

76 FR 59414 - National Institute on Drug Abuse; Notice of Closed Meetings

Science.gov (United States)

2011-09-26

... invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel, I... Branch, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4235, MSC 9550...: National Institute on Drug Abuse Special Emphasis Panel, B/START Review Committee. Date: October 14, 2011...

76 FR 31967 - National Institute on Drug Abuse; Notice of Closed Meeting

Science.gov (United States)

2011-06-02

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; N01DA-11-7777.... Ruiz, PhD, Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse....: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: May 26...

A Review of Criteria for Outdoor Classroom in Selected Tertiary Educational Institutions in Kuala Lumpur

Science.gov (United States)

Maheran, Y.; Fadzidah, A.; Nur Fadhilah, R.; Farha, S.

2017-12-01

A proper design outdoor environment in higher institutions contributes to the students’ learning performances and produce better learning outcomes. Campus surrounding has the potential to provide an informal outdoor learning environment, especially when it has the existing physical element, like open spaces and natural features, that may support the learning process. However, scholarly discourses on environmental aspects in tertiary education have minimal environmental inputs to fulfill students’ needs for outdoor exposure. Universities have always emphasized on traditional instructional methods in classroom settings, without concerning the importance of outdoor classroom towards students’ learning needs. Moreover, the inconvenience and discomfort outdoor surrounding in campus environment offers a minimal opportunity for students to study outside the classroom, and students eventually do not favor to utilize the spaces because no learning facility is provided. Hence, the objective of this study is to identify the appropriate criteria of outdoor areas that could be converted to be outdoor classrooms in tertiary institutions. This paper presents a review of scholars’ work in regards to the characteristics of the outdoor classrooms that could be designed as part of contemporary effective learning space, for the development of students’ learning performances. The information gathered from this study will become useful knowledge in promoting effective outdoor classroom and create successful outdoor learning space in landscape campus design. It I hoped that the finding of this study could provide guidelines on how outdoor classrooms should be designed to improve students’ academic achievement.

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.

76 FR 57748 - National Cancer Institute Notice of Closed Meetings

Science.gov (United States)

2011-09-16

... Logistics Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Boulevard... Crystal City, 2799 Jefferson Davis Highway, Arlington, VA 22202. Contact Person: Sergei Radaev, PhD..., Scientific Review Officer, Special Review Logistics Branch, Division of Extramural Activities, National...

A review of formal institutions affecting water supply and access in Botswana

Science.gov (United States)

Mogomotsi, Patricia K.; Mogomotsi, Goemeone E. J.; Matlhola, Dimpho M.

2018-06-01

Over the years, many countries across the world have increasingly experienced the collapse of their ecosystems, leading to an elevated increase on the demand for freshwater resources. Botswana is not an exception. The problem of disrupted potable water supply is widespread across the country. However, the physical shortage of water in the country is arguably coupled by lack of effective and efficient water supply and management institutions and water infrastructure. Most of the research on water scarcity in Botswana is mostly inclined towards physical water scarcity, while little is investigated on how the design of institutions for water management in developing countries leads to water scarcity. Furthermore, the premises of most research is neoclassical economics ideas, thereby offering solutions as developing and/or reforming water markets and water pricing mechanisms, among other findings. This paper analyses potable water supply and access in Botswana within a new institutional economics paradigm. The study examines key features of water institutions in Botswana on how they affect water supply and access, applying new institutional economics fundamentals. The study extensively uses various secondary data sources including weather and climate reports, policy documents, maps and charts and survey data, among others. The paper argues that to achieve effective water allocation in Botswana, there is a need to balance social and environmental water resource needs through water policies and other statutory enactments, as well as the crafting of practical management strategies. The country, therefore, requires not only a swift institutional transformation in the water sector, but also needs practical governance structure necessary for implementing integrated water resources management and driving water resources towards sustainability.

INL Sitewide Institutional Controls Annual Report FY2006

Energy Technology Data Exchange (ETDEWEB)

W. L. Jolley

2006-08-01

This document reports the results of the fiscal year 2006 institutional controls assessment at Comprehensive Environmental Response, Compensation, and Liability Act sites at the Idaho National Laboratory. These activities are described in the INEEL Sitewide Institutional Control Plan. Inspections were performed by Long-term Stewardship Program personnel with representatives of the various facilities. The assessments showed that the various institutional control measures in place across the Idaho National Laboratory Site are functioning as intended. Information in the Idaho National Engineering and Environmental Laboratory Comprehensive Facilities and Land Use Plan was reviewed as part of the annual assessment and was revised as needed to reflect the current status of the institutional control sites.

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.

75 FR 16815 - National Institute on Drug Abuse; Notice of Closed Meeting

Science.gov (United States)

2010-04-02

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Mechanism for Time-Sensitive Drug Abuse Research. Date: April 8, 2010. Time: 12 p.m. to 3 p.m. Agenda: To review and..., Office of Extramural Affairs, National Institute on Drug Abuse, National Institutes of Health, DHHS, 6101...

76 FR 31620 - National Institute of Environmental Health Sciences; Notice of Closed Meetings

Science.gov (United States)

2011-06-01

... Health Sciences Special Emphasis Panel, Research on Ethics and Integrity of Human and or Animal Subjects... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of..., DVM, Chief, Scientific Review Branch, Division of Extramural Research and Training, National Institute...

Total hip arthroplasty at the rothman institute.

Science.gov (United States)

Austin, Matthew S; Higuera, Carlos A; Rothman, Richard H

2012-07-01

Total hip arthroplasty (THA) is one of the most successful surgical interventions devised in modern times. Attempts to change the current THA procedure with unproven innovations bring the risk of increased failure rates while trying to improve the benefit of the surgery. This manuscript examines the evolution of THA at the Rothman Institute illustrating the key elements that lead the success of this procedure at this institution. These key elements include femoral stem design, use of highly crossed-linked polyethylene and use of pain and rehabilitation protocols. We attempted to describe the long-term results regarding safety, effectiveness, and durability of specific THA implant designs used at this institution drawing on reported evidence in the literature. The authors performed a review of peer-reviewed articles related to the Rothman Institute's experience with THA. Total hip arthroplasty is an efficient, safe, and durable procedure. It is a highly successful operation to restore function and improve pain. The survivorship of THA procedures at the Rothman Institute is higher than 99% at 10 years based on mechanical failure. The use of collarless, tapered wedge femoral stem, highly crossed-linked polyethylene, and improved pain rehabilitation protocols have contributed to this success. There is a well-documented long-term survivorship after THA. Future innovation in THA should address new challenges with younger and more demanding patients, rather than change current methods that have a proven good survivorship. This innovation depends mainly upon improvements in the bearing surfaces and advances in pain control and rehabilitation.

Review of the Confucius Institutes' Strategy for the Dissemination of Chinese Culture

Science.gov (United States)

Ying, Wu

2016-01-01

Following four years of continuous expansion in scale, the Confucius Institutes have begun entering the stage of implicit development: the most pressing question that needs answering is whether the Confucius Institutes, which are devoted to the dissemination of Chinese culture, can achieve the spread of Chinese culture overseas through day-to-day…

8th International Summer Institute in Surface Science

CERN Document Server

Howe, Russell

1988-01-01

This volume contains review articles written by the invited speakers at the eighth International Summer Institute in Surface Science (ISISS 1987), held at the University of Wisconsin-Milwaukee in August of 1987. During the course of ISISS, invited speakers, all internationally recognized experts in the various fields of surface science, present tutorial review lectures. In addition, these experts are asked to write review articles on their lecture topic. Former ISISS speakers serve as advisors concerning the selection of speakers and lecture topics. Em­ phasis is given to those areas which have not been covered in depth by recent Summer Institutes, as well as to areas which have recently gained in significance and in which important progress has been made. Because of space limitations, no individual volume of Chemistry and Physics of Solid Surfaces can possibly cover the whole area of modem surface science, or even give a complete survey of recent pro­ gress in the field. However, an attempt is made to pres...

[Architecture and design of mental health institutions].

Science.gov (United States)

Richter, Dirk; Hoffmann, Holger

2014-04-01

The physical environment of mental health institutions is regarded as a therapeutic agent within the treatment. There is only little scientific evidence on the consequences of architecture and design on psychiatric patients available. A systematic review was conducted on studies from adult mental health institutions. 25 studies were included into the review. Pre-post-studies and control group conditions were predominant study designs. Randomized controlled trials were not available. Interventions reached from art installations up to entire ward renovations. Outcome indicators were rather heterogeneous, including psychopathology, behavioural observations and aggression incidents. Overwhelmingly, the studies revealed positive results of interventions into the physical environment. We found positive outcomes independent from the intervention in detail. This result should be interpreted in the light of the generally low study quality and further methodological problems. © Georg Thieme Verlag KG Stuttgart · New York.

Research at the Paul Scherrer Institut

International Nuclear Information System (INIS)

Walter, H.K.

1996-01-01

The Paul Scherrer Institut (PSI) is a multidisciplinary research institute for natural sciences and technology. In national and international collaboration with universities, other research institutes and industry, PSI is active in elementary particle physics, life sciences, solid-state physics, material sciences, nuclear and non-nuclear energy research, and energy-related ecology. PSI's priorities lie in research fields which are relevant to sustainable development, serve educational needs and are beyond the possibilities of a single university department. PSI develops and operates complex research installations open of the world's most powerful cyclotron, allowing to operate high intensity secondary pion and muon beams, a neutron spallation source and various applications in medicine and materials research. A short review on research at PSI is presented, with special concentration on particle physics experiments. (author)

78 FR 28235 - National Cancer Institute; Notice of Closed Meetings

Science.gov (United States)

2013-05-14

... Basal- like Breast Cancer. Date: June 13, 2013. Time: 12:00 p.m. to 1:00 p.m. Agenda: To review and... Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute...

A short review of critical experiments performed at the Kurchatov Institute

International Nuclear Information System (INIS)

Gagarinski, A.Yu.; Glushkov, Y.S.; Ponomarev-Stepnoi, N.N.

1997-01-01

Since the 1950s, the Institute of Atomic Energy (now the Russian Research Center Kurchatov Institute) has investigated nuclear reactors intended for various purposes. A summary of the present state of these assemblies is given in an attachment to the paper. A second attachment provides a brief description of critical experiments for small nuclear power systems intended for decentralized power generation. The critical assemblies for these experiments were moderated by water and zirconium hydride, and fuel elements ranged in enrichment from 5% to 95% uranium 235. 7 refs

A short review of critical experiments performed at the Kurchatov Institute

Energy Technology Data Exchange (ETDEWEB)

Gagarinski, A.Yu.; Glushkov, Y.S.; Ponomarev-Stepnoi, N.N. [Kurchatov Institute (Russian Federation)

1997-06-01

Since the 1950s, the Institute of Atomic Energy (now the Russian Research Center Kurchatov Institute) has investigated nuclear reactors intended for various purposes. A summary of the present state of these assemblies is given in an attachment to the paper. A second attachment provides a brief description of critical experiments for small nuclear power systems intended for decentralized power generation. The critical assemblies for these experiments were moderated by water and zirconium hydride, and fuel elements ranged in enrichment from 5% to 95% uranium 235. 7 refs.

The OpenAIRE Guide for Research Institutions

Directory of Open Access Journals (Sweden)

Gültekin Gürdal

2013-11-01

Full Text Available This text is transcript of OpenAIRE Guide which is prepared in order to help research institutions was released on 13.04.2011and translated with the cooperation of ANKOS Open Access and Institutional Repositories Grup members and OpenAIREplus project team of Turkey which is coordinated from Izmir Institute of Technology Library. OpenAIRE Project aims to support researchers in complying with the European Commission Seventh Framework Programme Open Access Pilot through a European Helpdesk System; support researchers in depositing their research publications in an institutional or disciplinary repository; build up an OpenAIRE portal and e-infrastructure for repository networks. The project will work in tadem with OpeanAIREplus Project which has the principal goal of creating a robust, participatory service for the cross-linking of peer-reviewed scientific publications and associated datasets.

Protecting human research subjects: the past defines the future.

Science.gov (United States)

Breault, Joseph L

2006-01-01

The creation of Institutional Review Boards to assure the protection of research subjects came out of terrible research abuses that resulted in the Belmont Report and federal regulations establishing rules for federally funded research and its independent review. The Common Rule became widely accepted as the way to oversee human research that is funded by federal agencies, or used in FDA submissions. The Office of Human Research Protections, now under the Secretary of DHHS, created Federalwide Assurances with groups that receive federal funding and others, the vast majority of which have agreed to apply the same ethical rules to all research regardless of funding source. There are controversies over the best methods to protect human research subjects, confusion about how to handle some of the gray areas, increased regulatory burdens, and debates about the adequacy of the IRB system. New exciting directions have evolved and overall, research subjects appear better protected than ever.

76 FR 58285 - National Institute of Mental Health Notice of Closed Meetings

Science.gov (United States)

2011-09-20

... Pennsylvania Ave., NW., Washington, DC 20037. Contact Person: Rebecca C. Steiner, PhD, Scientific Review...: Rebecca C. Steiner, PhD, Scientific Review Officer, Division of Extramural Activities, National Institute...

Diversity and Senior Leadership at Elite Institutions of Higher Education

Science.gov (United States)

Gasman, Marybeth; Abiola, Ufuoma; Travers, Christopher

2015-01-01

This article explores the lack of diversity at the 8 Ivy League institutions using a Critical Race Theory lens. It includes a comprehensive literature review of the scholarship related to diversity in academe, but especially within the areas of elite institutions and administration. The article also provides data pertaining to the senior…

78 FR 68856 - National Human Genome Research Institute; Notice of Closed Meeting

Science.gov (United States)

2013-11-15

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... Nakamura, Ph.D., Scientific Review Officer, Scientific Review Branch, National Human Genome Research...-402-0838. [[Page 68857

Review: Current Approaches to Business and Institutional Translation. Proceedings of the International Conference on Economic, Business, Financial and Institutional Translation

Directory of Open Access Journals (Sweden)

Miguel Tolosa Igualada

2016-08-01

Full Text Available Daniel Gallego-Hernández (ed.. Current Approaches to Business and Institutional Translation. Proceedings of the International Conference on Economic, Business, Financial and Institutional Translation / Enfoques actuales en traducción económica e institucional. Actas del Congreso Internacional de Traducción Económica, Comercial, Financiera e Institucional. Suíça: Peter Lang, 2015, 254 páginas. ISBN 978-3-0343-1656-9.

Single-Institution Experience With Component Separation for Ventral Hernia Repair: A Retrospective Review.

Science.gov (United States)

Hill, Brian; Kambeyanda, Rohan; Fewell, Donna; Bryant, Stewart; Delaney, Kevin O; Herrera, Fernando A

2018-06-01

In this study, we reviewed our institution's experience using component separation for repair of ventral hernias. This was a retrospective review of all component separations for ventral hernia between July 2009 and December 2015. Recorded data included body mass index (BMI), preoperative albumin, smoking history, comorbidities, additional procedures, length of surgery, hospitalization, recurrence, and postoperative complications. One hundred ninety-six component separations were performed in the study period. The average patient age was 56 years, and 65.3% of patients were female. The average BMI was 32.6 kg/m; preoperative albumin was 3.59; 18.4% were current smokers; 28.1% were diabetic; and 14.3% had heart disease. Postoperative complications developed in 16.8% of patients. Recurrence developed in 8.7% of patients. Patients who developed a postoperative complication had a higher BMI (P = 0.025) and lower albumin (P = 0.047) compared with patients who did not develop complications. Current smokers were more likely to develop complications (P = 0.008). More than one third of patients had additional procedures at the time of the ventral hernia repair. The addition of a plastic surgery procedure was not associated with an increased risk of developing a complication (P = 0.25). Patients who developed complications had a significantly longer hospital course (P < 0.001) but no difference in total operative time (P = 0.975). Increased number of comorbidities did not statistically correlate with an increased complication rate (P = 0.65) or length of hospital stay (P = 0.43). We identified risk factors that increase the likelihood of postoperative complications and length of hospital stay. In addition, this study suggests that more comorbidities and additional procedures at the time of the hernia repair may not have as large of impact on complication risk as previously thought.

Prudence in public institutions management: the strategic financial ...

African Journals Online (AJOL)

Prudence in public institutions management: the strategic financial efficiency challenge in Nigeria. ... African Research Review ... the constructive optimization of risks with a view to attracting returns in relation to variability, volatility, and vitality.

75 FR 44274 - National Cancer Institute; Notice of Closed Meetings

Science.gov (United States)

2010-07-28

... Cancer Institute Special Emphasis Panel, Nanotechnology Imaging and Sensing Platforms for Improved Diagnosis of Cancer. Date: August 31, 2010. Time: 12 p.m. to 1:30 p.m. Agenda: To review and evaluate... 20852 (Telephone Conference Call). Contact Person: Kenneth L. Bielat, PhD, Scientific Review Officer...

75 FR 50771 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

Science.gov (United States)

2010-08-17

... Institute Special Emphasis Panel; NHLBI Nanotechnology Administrative Centers Contract Review. Date: August 20, 2010. Time: 1 p.m. to 2 p.m. Agenda: To review and evaluate contract proposals. Place: National...: Shelley S Sehnert, PhD, Scientific Review Officer, Review Branch/DERA, National Heart, Lung, and Blood...

OPTIMIZATION OF FINANCING PUBLIC HIGHER EDUCATION INSTITUTIONS IN UKRAINE

Directory of Open Access Journals (Sweden)

Z. Varnaliy

2017-09-01

Full Text Available The paper considers the ways to optimize financing public higher education institutions of Ukraine. Public higher education institutions acutely feel the lack of financial resources. The study describes that it is necessary to reform the models, methods and forms of financing higher education institutions. The paper explains the impact of autonomy of higher education institutions on their development. The autonomy level of university determines the possibilities for diversification from additional sources. The results found that more autonomy of higher education institutions will allow them effectively generate and use financial resources. The review outlines the diversification of financial resources public universities. One of the key factors of the university success is to implement the diversification strategy into the overall academic strategy and mission of the higher education institution. The analysis recommends the performance-based funding system and public higher education institutions achieve certain performance indicators. The performance-based funding system will promote higher competitiveness of education institutions and improve the quality of higher education in general. The conclusions suggest the development trends of financing public higher education institutions of Ukraine.

Community Partnered Research Ethics Training in Practice: A Collaborative Approach to Certification.

Science.gov (United States)

Yonas, Michael A; Jaime, Maria Catrina; Barone, Jean; Valenti, Shannon; Documét, Patricia; Ryan, Christopher M; Miller, Elizabeth

2016-04-01

This report describes the development and implementation of a tailored research ethics training for academic investigators and community research partners (CRP). The Community Partnered Research Ethics Training (CPRET) and Certification is a free and publicly available model and resource created by a university and community partnership to ensure that traditional and non-traditional research partners may study, define, and apply principles of human subjects' research. To date, seven academic and 34 CRP teams have used this highly interactive, engaging, educational, and relationship building process to learn human subjects' research and be certified by the University of Pittsburgh Institutional Review Board (IRB). This accessible, flexible, and engaging research ethics training process serves as a vehicle to strengthen community and academic partnerships to conduct ethical and culturally sensitive research. © The Author(s) 2016.

Institutional Strength in Depth

International Nuclear Information System (INIS)

Weightman, M.

2016-01-01

Much work has been undertaken in order to identify, learn and implement the lessons from the TEPCO Fukushima Daiichi nuclear accident. These have mainly targeted on engineering or operational lessons. Less attention has been paid to the institutional lessons, although there have been some measures to improve individual peer reviews, particularly by the World Association of Nuclear Operators, and the authoritative IAEA report published in 2015 brought forward several important lessons for regulators and advocated a system approach. The report noted that one of the contributing factors the accident was the tendency of stakeholders not to challenge. Additionally, it reported deficiencies in the regulatory authority and system. Earlier, the root cause of the accident was identified by a Japanese independent parliamentary report as being cultural and institutional. The sum total of the institutions, the safety system, was ineffective. While it is important to address the many technical and operational lessons these may not necessary address this more fundamental lesson, and may not serve to provide robust defences against human or institutional failings over a wide variety of possible events and combinations. The overall lesson is that we can have rigorous and comprehensive safety standards and other tools in place to deliver high levels of safety, but ultimately what is important is the ability of the nuclear safety system to ensure that the relevant institutions diligently and effectively apply those standards and tools — to be robust and resilient. This has led to the consideration of applying the principles of the strength in depth philosophy to a nuclear safety system as a way of providing a framework for developing, assessing, reviewing and improving the system. At an IAEA conference in October 2013, a model was presented for a robust national nuclear safety system based on strength in depth philosophy. The model highlighted three main layers: industry, the

77 FR 58402 - National Human Genome Research Institute; Notice of Closed Meetings

Science.gov (United States)

2012-09-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research...: To review and evaluate grant applications. Place: National Human Genome Research Institute, 5635...

Counselling for Sustainable Peace in Tertiary Institutions in Nigeria

Science.gov (United States)

Nduka-Ozo, Stella Ngozi

2016-01-01

This study reviewed the nature of peace in Tertiary Institutions in Nigeria using Ebonyi State University as a case study. The purpose of the study was to review the various factors responsible for lack of peace. The sample was drawn from the three hundred level students of the Faculty of Education. Thirty students were selected from each of the…

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 ...

Medicine utilization review at a university teaching hospital in New Delhi

Directory of Open Access Journals (Sweden)

M Aqil

2012-01-01

Full Text Available Objective: A prospective medicine usage evaluation based on prescription monitoring was conducted in the medicine OPD of our university teaching hospital to know prescribing trends of different categories of medicines. Materials and Methods: A total of 600 patients were included in the study comprising of 339 (56.5% males and 261 (43.5% females. The data were recorded within the OPD by a registered pharmacist on a medicine usage evaluation form, approved by The University Institutional Review Board (IRB. Results: A total of 2365 medicines were prescribed to 600 patients during the 3 months study period. The mean number of medicines per prescription were found to be 3.94. Medicines were most frequently prescribed as solid dosage forms (85.62%, especially tablets (70.82%, and liquid formulations (14.12%. Oral route (96.17% was the most preferred mode of administration, followed by topical (2.11% and parenteral (1.60% routes. Combination therapy (94.33% was more prevalent than monotherapy (5.66%. An overwhelming tendency for prescribing medicines by brand names (99% was observed by the physicians. The most frequently prescribed class of medicines were antimicrobials > analgesics > cardiovascular > gastrointestinal agents. The most prescribed individual medicines among various therapeutic classes included isoniazid (antimicrobial, amlodipine (cardiovascular, metformin (hypoglycemic, cetirizine (antiallergic, rabeprazole (GI medicine, atorvastatin (hypolipidemic, dextromethorphan (respiratory medicine, alprazolam (sedative-hypnotic, paracetamol (analgesic. Conclusions: There is a considerable scope of improvement in the existing prescribing practice, especially prescribing by generic names, needs to be encouraged and a hospital formulary has to be developed for the purpose. The number of medicines to be included per prescription should be judged rationally and polypharmacy ought to be curbed. Use of antimicrobial also needs to be rationalized as over