Business Teacher Education (BTE); A Panacea for Human Capital Development in Nigeria

ERIC Educational Resources Information Center

Okifo, Joseph; Ayo, Abel O.

2015-01-01

The focus of this paper is on business teacher education, a panacea for human capital development in Nigeria. Human capital suggests that education, and training, health and standard of living raises the productivity of workers and increases their lifetime earning capacity. Therefore, BTE is a panacea for human capital development because the…

Standard development at the Human Variome Project.

PubMed

Smith, Timothy D; Vihinen, Mauno

2015-01-01

The Human Variome Project (HVP) is a world organization working towards facilitating the collection, curation, interpretation and free and open sharing of genetic variation information. A key component of HVP activities is the development of standards and guidelines. HVP Standards are systems, procedures and technologies that the HVP Consortium has determined must be used by HVP-affiliated data sharing infrastructure and should be used by the broader community. HVP guidelines are considered to be beneficial for HVP affiliated data sharing infrastructure and the broader community to adopt. The HVP also maintains a process for assessing systems, processes and tools that implement HVP Standards and Guidelines. Recommended System Status is an accreditation process designed to encourage the adoption of HVP Standards and Guidelines. Here, we describe the HVP standards development process and discuss the accepted standards, guidelines and recommended systems as well as those under acceptance. Certain HVP Standards and Guidelines are already widely adopted by the community and there are committed users for the others. © The Author(s) 2015. Published by Oxford University Press.

Standard development at the Human Variome Project

PubMed Central

Smith, Timothy D.; Vihinen, Mauno

2015-01-01

The Human Variome Project (HVP) is a world organization working towards facilitating the collection, curation, interpretation and free and open sharing of genetic variation information. A key component of HVP activities is the development of standards and guidelines. HVP Standards are systems, procedures and technologies that the HVP Consortium has determined must be used by HVP-affiliated data sharing infrastructure and should be used by the broader community. HVP guidelines are considered to be beneficial for HVP affiliated data sharing infrastructure and the broader community to adopt. The HVP also maintains a process for assessing systems, processes and tools that implement HVP Standards and Guidelines. Recommended System Status is an accreditation process designed to encourage the adoption of HVP Standards and Guidelines. Here, we describe the HVP standards development process and discuss the accepted standards, guidelines and recommended systems as well as those under acceptance. Certain HVP Standards and Guidelines are already widely adopted by the community and there are committed users for the others. PMID:25818894

Human Integration Design Processes (HIDP)

NASA Technical Reports Server (NTRS)

Boyer, Jennifer

2014-01-01

The purpose of the Human Integration Design Processes (HIDP) document is to provide human-systems integration design processes, including methodologies and best practices that NASA has used to meet human systems and human rating requirements for developing crewed spacecraft. HIDP content is framed around human-centered design methodologies and processes in support of human-system integration requirements and human rating. NASA-STD-3001, Space Flight Human-System Standard, is a two-volume set of National Aeronautics and Space Administration (NASA) Agency-level standards established by the Office of the Chief Health and Medical Officer, directed at minimizing health and performance risks for flight crews in human space flight programs. Volume 1 of NASA-STD-3001, Crew Health, sets standards for fitness for duty, space flight permissible exposure limits, permissible outcome limits, levels of medical care, medical diagnosis, intervention, treatment and care, and countermeasures. Volume 2 of NASASTD- 3001, Human Factors, Habitability, and Environmental Health, focuses on human physical and cognitive capabilities and limitations and defines standards for spacecraft (including orbiters, habitats, and suits), internal environments, facilities, payloads, and related equipment, hardware, and software with which the crew interfaces during space operations. The NASA Procedural Requirements (NPR) 8705.2B, Human-Rating Requirements for Space Systems, specifies the Agency's human-rating processes, procedures, and requirements. The HIDP was written to share NASA's knowledge of processes directed toward achieving human certification of a spacecraft through implementation of human-systems integration requirements. Although the HIDP speaks directly to implementation of NASA-STD-3001 and NPR 8705.2B requirements, the human-centered design, evaluation, and design processes described in this document can be applied to any set of human-systems requirements and are independent of reference missions. The HIDP is a reference document that is intended to be used during the development of crewed space systems and operations to guide human-systems development process activities.

Developing Human Resources through Actualizing Human Potential

ERIC Educational Resources Information Center

Clarken, Rodney H.

2012-01-01

The key to human resource development is in actualizing individual and collective thinking, feeling and choosing potentials related to our minds, hearts and wills respectively. These capacities and faculties must be balanced and regulated according to the standards of truth, love and justice for individual, community and institutional development,…

Objective structured clinical interview training using a virtual human patient.

PubMed

Parsons, Thomas D; Kenny, Patrick; Ntuen, Celestine A; Pataki, Caroly S; Pato, Michele T; Rizzo, Albert A; St-George, Cheryl; Sugar, Jeffery

2008-01-01

Effective interview skills are a core competency for psychiatry residents and developing psychotherapists. Although schools commonly make use of standardized patients to teach interview skills, the diversity of the scenarios standardized patients can characterize is limited by availability of human actors. Further, there is the economic concern related to the time and money needed to train standardized patients. Perhaps most damaging is the "standardization" of standardized patients -- will they in fact consistently proffer psychometrically reliable and valid interactions with the training clinicians. Virtual Human Agent (VHA) technology has evolved to a point where researchers may begin developing mental health applications that make use of virtual reality patients. The work presented here is a preliminary attempt at what we believe to be a large application area. Herein we describe an ongoing study of our virtual patients (VP). We present an approach that allows novice mental health clinicians to conduct an interview with a virtual character that emulates an adolescent male with conduct disorder. This study illustrates the ways in which a variety of core research components developed at the University of Southern California facilitates the rapid development of mental health applications.

ISBT 128 Standard for Coding Medical Products of Human Origin

PubMed Central

Ashford, Paul; Delgado, Matthew

2017-01-01

Background ISBT 128 is an international standard for the terminology, coding, labeling, and identification of medical products of human origin (MPHO). Full implementation of ISBT 128 improves traceability, transparency, vigilance and surveillance, and interoperability. Methods ICCBBA maintains the ISBT 128 standard through the activities of a network of expert volunteers, including representatives from professional scientific societies, governments and users, to standardize and maintain MPHO identification. These individuals are organized into Technical Advisory Groups and work within a structured framework as part of a quality-controlled standards development process. Results The extensive involvement of international scientific and professional societies in the development of the standard has ensured that ISBT 128 has gained widespread recognition. The user community has developed confidence in the ability of the standard to adapt to new developments in their fields of interest. The standard is fully compatible with Single European Code requirements for tissues and cells and is utilized by many European tissue establishments. ISBT 128's flexibility and robustness has allowed for expansions into subject areas such as cellular therapy, regenerative medicine, and tissue banking. Conclusion ISBT 128 is the internationally recognized standard for coding MPHO and has gained widespread use globally throughout the past two decades. PMID:29344013

Human Factors Engineering Requirements for the International Space Station - Successes and Challenges

NASA Technical Reports Server (NTRS)

Whitmore, M.; Blume, J.

2003-01-01

Advanced technology coupled with the desire to explore space has resulted in increasingly longer human space missions. Indeed, any exploration mission outside of Earth's neighborhood, in other words, beyond the moon, will necessarily be several months or even years. The International Space Station (ISS) serves as an important advancement toward executing a successful human space mission that is longer than a standard trip around the world or to the moon. The ISS, which is a permanently occupied microgravity research facility orbiting the earth, will support missions four to six months in duration. In planning for the ISS, the NASA developed an agency-wide set of human factors standards for the first time in a space exploration program. The Man-Systems Integration Standard (MSIS), NASA-STD-3000, a multi-volume set of guidelines for human-centered design in microgravity, was developed with the cooperation of human factors experts from various NASA centers, industry, academia, and other government agencies. The ISS program formed a human factors team analogous to any major engineering subsystem. This team develops and maintains the human factors requirements regarding end-to-end architecture design and performance, hardware and software design requirements, and test and verification requirements. It is also responsible for providing program integration across all of the larger scale elements, smaller scale hardware, and international partners.

Legal and ethical standards for protecting women's human rights and the practice of conscientious objection in reproductive healthcare settings.

PubMed

Zampas, Christina

2013-12-01

The practice of conscientious objection by healthcare workers is growing across the globe. It is most common in reproductive healthcare settings because of the religious or moral values placed on beliefs as to when life begins. It is often invoked in the context of abortion and contraceptive services, including the provision of information related to such services. Few states adequately regulate the practice, leading to denial of access to lawful reproductive healthcare services and violations of fundamental human rights. International ethical, health, and human rights standards have recently attempted to address these challenges by harmonizing the practice of conscientious objection with women's right to sexual and reproductive health services. FIGO ethical standards have had an important role in influencing human rights development in this area. They consider regulation of the unfettered use of conscientious objection essential to the realization of sexual and reproductive rights. Under international human rights law, states have a positive obligation to act in this regard. While ethical and human rights standards regarding this issue are growing, they do not yet exhaustively cover all the situations in which women's health and human rights are in jeopardy because of the practice. The present article sets forth existing ethical and human rights standards on the issue and illustrates the need for further development and clarity on balancing these rights and interests. Copyright © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Human System Drivers for Exploration Missions

NASA Technical Reports Server (NTRS)

Kundrot, Craig E.; Steinberg, Susan; Charles, John B.

2010-01-01

Evaluation of DRM4 in terms of the human system includes the ability to meet NASA standards, the inclusion of the human system in the design trade space, preparation for future missions and consideration of a robotic precursor mission. Ensuring both the safety and the performance capability of the human system depends upon satisfying NASA Space Flight Human System Standards.1 These standards in turn drive the development of program-specific requirements for Near-earth Object (NEO) missions. In evaluating DRM4 in terms of these human system standards, the currently existing risk models, technologies and biological countermeasures were used. A summary of this evaluation is provided below in a structure that supports a mission architecture planning activities. 1. Unacceptable Level of Risk The duration of the DRM4 mission leads to an unacceptable level of risk for two aspects of human system health: A. The permissible exposure limit for space flight radiation exposure (a human system standard) would be exceeded by DRM4. B. The risk of visual alterations and abnormally high intracranial pressure would be too high. 1

The Adoption and Diffusion of an NHRD Standard: A Conceptual Framework

ERIC Educational Resources Information Center

Murphy, Aileen; Garavan, Thomas N.

2009-01-01

This article proposes a conceptual framework to explain the adoption and diffusion of a national human resource development (NHRD) standard. NHRD standards are used by governments to promote training and development in organizations and increase the professionalization of practices used by organizations. Institutional theory suggests that adoption…

Estimation of skeletal movement of human locomotion from body surface shapes using dynamic spatial video camera (DSVC) and 4D human model.

PubMed

Saito, Toshikuni; Suzuki, Naoki; Hattori, Asaki; Suzuki, Shigeyuki; Hayashibe, Mitsuhiro; Otake, Yoshito

2006-01-01

We have been developing a DSVC (Dynamic Spatial Video Camera) system to measure and observe human locomotion quantitatively and freely. A 4D (four-dimensional) human model with detailed skeletal structure, joint, muscle, and motor functionality has been built. The purpose of our research was to estimate skeletal movements from body surface shapes using DSVC and the 4D human model. For this purpose, we constructed a body surface model of a subject and resized the standard 4D human model to match with geometrical features of the subject's body surface model. Software that integrates the DSVC system and the 4D human model, and allows dynamic skeletal state analysis from body surface movement data was also developed. We practically applied the developed system in dynamic skeletal state analysis of a lower limb in motion and were able to visualize the motion using geometrically resized standard 4D human model.

National Standard of the Russian Federation for Space Debris Mitigation

NASA Astrophysics Data System (ADS)

Loginov, S.; Yakovlev, M.; Mikhailov, M.; Popkova, L.

2009-03-01

Normative and technical document that define requirements for the mitigation of human-produced near-earth space pollution develops in Russian Federation.NATIONAL STANDARD of the Russian Federation GOST R 52925-2008 «SPACE TECHNOLOGY ITEMS. General Requirements on Space Systems for the Mitigation of Human-Produced near-Earth Space Pollution» was approved in 2008 and entered into force since 1st January of 2009. Requirements of this standard harmonized with requirements of «UN SPACE DEBRIS MITIGATION GUIDELINESÈ»This standard consists of six parts:- Scope;- References to Standards;- Terms & Definitions;- Abbreviations;- General Provisions;- General Requirements on Space Systems for the Mitigation of Human-Produced near-Earth Space Pollution.

ESTABLISH AND STANDARDIZE METHODOLOGY FOR DETECTION OF WATERBORNE VIRUSES FROM HUMAN SOURCES

EPA Science Inventory

Research is conducted to develop and standardize methods to detect and measure occurrence of human enteric viruses that cause waterborne disease. The viruses of concern include the emerging pathogens--hepatitis E virus and group B rotaviruses. Also of concern are the coxsackiev...

Human Health Countermeasures (HHC) Element Management Plan: Human Research Program. Revision B

NASA Technical Reports Server (NTRS)

Norsk, Peter; Baumann, David

2012-01-01

NASA s Human Research Program (HRP) is an applied research and technology program within the Human Exploration and Operations Mission Directorate (HEOMD) that addresses human health and performance risk mitigation strategies in support of exploration missions. The HRP research and technology development is focused on the highest priority risks to crew health and safety with the goal of ensuring mission success and maintaining long-term crew health. Crew health and performance standards, defined by the NASA Chief Health and Medical Officer (CHMO), set the acceptable risk level for exploration missions. The HRP conducts research to inform these standards as well as provide deliverables, such as countermeasures, that ensure standards can be met to maximize human performance and mission success. The Human Health Countermeasures (HHC) Element was formed as part of the HRP to develop a scientifically-based, integrated approach to understanding and mitigating the health risks associated with human spaceflight. These health risks have been organized into four research portfolios that group similar or related risks. A fifth portfolio exists for managing technology developments and infrastructure projects. The HHC Element portfolios consist of: a) Vision and Cardiovascular; b) Exercise and Performance; c) Multisystem; d) Bone; and e) Technology and Infrastructure. The HHC identifies gaps associated with the health risks and plans human physiology research that will result in knowledge required to more fully understand risks and will result in validated countermeasures to mitigate risks.

Spaceflight Human System Standards

NASA Technical Reports Server (NTRS)

Holubec, Keith; Tillman, Barry; Connolly, Jan

2009-01-01

NASA created a new approach for human system integration and human performance standards. NASA created two documents a standard and a reference handbook. The standard is titled NASA Space Flight Human-System Standard (SFHSS) and consists of two-volumes: Volume 1- Crew Health This volume covers standards needed to support astronaut health (medical care, nutrition, sleep, exercise, etc.) Volume 2 Human Factors, Habitability and Environmental Health This volume covers the standards for system design that will maintain astronaut performance (ie., environmental factors, design of facilities, layout of workstations, and lighting requirements). It includes classic human factors requirements. The new standards document is written in terms so that it is applicable to a broad range of present and future NASA systems. The document states that all new programs prepare system-specific requirements that will meet the general standards. For example, the new standard does not specify a design should accommodate specific percentiles of a defined population. Rather, NASA-STD-3001, Volume 2 states that all programs shall prepare program-specific requirements that define the user population and their size ranges. The design shall then accommodate the full size range of those users. The companion reference handbook, Human Integration Design Handbook (HIDH), was developed to capture the design consideration information from NASA-STD-3000, and adds spaceflight lessons learned, gaps in knowledge, example solutions, and suggests research to further mature specific disciplines. The HIDH serves two major purposes: HIDH is the reference document for writing human factors requirements for specific systems. HIDH contains design guidance information that helps insure that designers create systems which safely and effectively accommodate the capabilities and limitations of space flight crews.

A Code of Ethics and Integrity for HRD Research and Practice.

ERIC Educational Resources Information Center

Hatcher, Tim; Aragon, Steven R.

2000-01-01

Describes the rationale for a code of ethics and integrity in human resource development (HRD). Outlines the Academy of Human Resource Development's standards. Reviews ethical issues faced by the HRD profession. (SK)

Human Factors, Habitability and Environmental Health and the Human Integration Design Handbook. Volume 2

NASA Technical Reports Server (NTRS)

Houbec, Keith; Tillman, Barry; Connolly, Janis

2010-01-01

For decades, Space Life Sciences and NASA as an Agency have considered NASA-STD-3000, Man-Systems Integration Standards, a significant contribution to human spaceflight programs and to human-systems integration in general. The document has been referenced in numerous design standards both within NASA and by organizations throughout the world. With research program and project results being realized, advances in technology and new information in a variety of topic areas now available, the time arrived to update this extensive suite of requirements and design information. During the past several years, a multi-NASA center effort has been underway to write the update to NASA-STD-3000 with standards and design guidance that would be applicable to all future human spaceflight programs. NASA-STD-3001 - Volumes 1 and 2 - and the Human Integration Design Handbook (HIDH) were created. Volume 1, Crew Health, establishes NASA s spaceflight crew health standards for the pre-flight, in-flight, and post-flight phases of human spaceflight. Volume 2, Human Factors, Habitability and Environmental Health, focuses on the requirements of human-system integration and how the human crew interacts with other systems, and how the human and the system function together to accomplish the tasks for mission success. The HIDH is a compendium of human spaceflight history and knowledge, and provides useful background information and research findings. And as the HIDH is a stand-alone companion to the Standards, the maintenance of the document has been streamlined. This unique and flexible approach ensures that the content is current and addresses the fundamental advances of human performance and human capabilities and constraints research. Current work focuses on the development of new sections of Volume 2 and collecting updates to the HIDH. The new sections in development expand the scope of the standard and address mission operations and support operations. This effort is again collaboration with representatives from the Johnson Space Center Missions Operations and Space Life Sciences Directorates and the Engineering Directorate from Kennedy Space Center as well as discipline experts from across the Agency.

The Development of Human Factor Guidelines for Unmanned Aircraft System Control Stations

NASA Technical Reports Server (NTRS)

Hobbs, Alan

2014-01-01

Despite being referred to as unmanned some of the major challenges confronting unmanned aircraft systems (UAS) relate to human factors. NASA is conducting research to address the human factors relevant to UAS access to non-segregated airspace. This work covers the issues of pilot performance, interaction with ATC, and control station design. A major outcome of this research will be recommendations for human factors design guidelines for UAS control stations to support routine beyond-line-of-sight operations in the US national airspace system (NAS). To be effective, guidelines must be relevant to a wide range of systems, must not be overly prescriptive, and must not impose premature standardization on evolving technologies. In developing guidelines, we recognize that existing regulatory and guidance material may already provide adequate coverage of certain issues. In other cases suitable guidelines may be found in existing military or industry human factors standards. In cases where appropriate existing standards cannot be identified, original guidelines will be proposed.

Standards and Certification. Symposium.

ERIC Educational Resources Information Center

2002

This document contains three papers from a symposium on standards and certification in human resource development (HRD). "Implementing Management Standards in the UK" (Jonathan Winterton, Ruth Winterton) reports on a study that explored the implementation of management standards in 16 organizations and identified 36 key themes and…

How to Develop and Interpret a Credibility Assessment of Numerical Models for Human Research: NASA-STD-7009 Demystified

NASA Technical Reports Server (NTRS)

Nelson, Emily S.; Mulugeta, Lealem; Walton, Marlei; Myers, Jerry G.

2014-01-01

In the wake of the Columbia accident, the NASA-STD-7009 [1] credibility assessment was developed as a unifying platform to describe model credibility and the uncertainties in its modeling predictions. This standard is now being adapted by NASAs Human Research Program to cover a wide range of numerical models for human research. When used properly, the standard can improve the process of code development by encouraging the use of best practices. It can also give management more insight in making informed decisions through a better understanding of the models capabilities and limitations.To a newcomer, the abstractions presented in NASA-STD-7009 and the sheer volume of information that must be absorbed can be overwhelming. This talk is aimed at describing the credibility assessment, which is the heart of the standard, in plain terms. It will outline how to develop a credibility assessment under the standard. It will also show how to quickly interpret the graphs and tables that result from the assessment and how to drill down from the top-level view to the foundation of the assessment. Finally, it will highlight some of the resources that are available for further study.

Self Assessment for Socializing

ERIC Educational Resources Information Center

McDonald, Betty

2011-01-01

Socializing is an integral part of human relations and auger well for the human development. Defined as "the involvement of students in identifying standards and/or criteria to apply to their work and making judgments about the extent to which they have met these criteria and standards", self assessment by its nature teaches students how to…

45 CFR 170.207 - Vocabulary standards for representing electronic health information.

Code of Federal Regulations, 2010 CFR

2010-10-01

... health information. 170.207 Section 170.207 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES HEALTH.... International Health Terminology Standards Development Organization (IHTSDO) Systematized Nomenclature of... States National Library of Medicine. (e) Immunizations. Standard. HL7 Standard Code Set CVX—Vaccines...

Bioanalytical method development and validation for the determination of glycine in human cerebrospinal fluid by ion-pair reversed-phase liquid chromatography-tandem mass spectrometry.

PubMed

Jiang, Jian; James, Christopher A; Wong, Philip

2016-09-05

A LC-MS/MS method has been developed and validated for the determination of glycine in human cerebrospinal fluid (CSF). The validated method used artificial cerebrospinal fluid as a surrogate matrix for calibration standards. The calibration curve range for the assay was 100-10,000ng/mL and (13)C2, (15)N-glycine was used as an internal standard (IS). Pre-validation experiments were performed to demonstrate parallelism with surrogate matrix and standard addition methods. The mean endogenous glycine concentration in a pooled human CSF determined on three days by using artificial CSF as a surrogate matrix and the method of standard addition was found to be 748±30.6 and 768±18.1ng/mL, respectively. A percentage difference of -2.6% indicated that artificial CSF could be used as a surrogate calibration matrix for the determination of glycine in human CSF. Quality control (QC) samples, except the lower limit of quantitation (LLOQ) QC and low QC samples, were prepared by spiking glycine into aliquots of pooled human CSF sample. The low QC sample was prepared from a separate pooled human CSF sample containing low endogenous glycine concentrations, while the LLOQ QC sample was prepared in artificial CSF. Standard addition was used extensively to evaluate matrix effects during validation. The validated method was used to determine the endogenous glycine concentrations in human CSF samples. Incurred sample reanalysis demonstrated reproducibility of the method. Copyright © 2016 Elsevier B.V. All rights reserved.

Revitalization of Space-Related Human Factors, Environmental and Habitability Data

NASA Technical Reports Server (NTRS)

Russo, Dane; Pickett, Lynn K.; Tillman, Barry; Foley, Tico

2007-01-01

The NASA Chief Health and Medical Officer (CHMO) recently directed that the agency establish crew health standards to aid in the development of requirements for future vehicles and habitats. Response to this direction includes development of a new NASA habitability and human factors standard and an accompanying design handbook. The new standard contains high-level, over-arching principles to assure its applicability and usability across all NASA development programs. The handbook will provide detailed design requirements and suggestions that will meet the standards. The information contained in NASA-STD-3000 will be updated and included in the new design handbook. In this approach, each new program will derive detailed program-specific requirements from the new standard using the handbook as a design guide and resource. With the completion of the standard, the focus of this year s effort is the development of the new handbook: Human Integration Design Handbook (HIDH). This is an opportunity for the space flight human factors and habitability community to consolidate up-to-date data for use by NASA programs and designers as well as outside researchers and policy makers looking for the next research focus. The goal of the handbook is to help NASA design and build human space flight systems which accommodate the capabilities and limitations of the crew so as to provide an environment where the crew can live and work effectively, safely, and comfortably. Handbook contents will address that primary goal, addressing unique aspects of space flight and habitation, including reduced gravity conditions, time lags, EVA systems and day/night cycles, not addressed in other standards or handbooks. The handbook will be divided into topics similar to NASA-STD-3000 (anthropometrics, architecture, workstations, etc.) and each topic area will contain elements for designers, human factors practitioners, program managers, operators, and researchers. The handbook will include the following elements: (1) Design considerations include a clear and concise summary of what is important to designers in space vehicle / habitat design, design information to translate Earth-base knowledge to the space environment, space issues and the data necessary to address those issues, and a consistent set of terminology. (2) Updates to Lessons Learned and example solutions from Shuttle and Station program experience will provide historical examples to help prevent repeating mistakes or reinvention of the wheel. (3) Requirements will aid in the translation of standards into program specific requirements. The scope of included requirements will define the pool that each program needs to consider and tailor for their specific program. (4) Requirements rationale will help understanding of the importance of these considerations. The HIDH development team at JSC is finalizing the format of the new handbook, prioritizing topic areas for expansion and update, and contacting subject matter experts within the scientific community to assist with this effort. Plans are also being made to continue handbook expansion and maintenance to assure it remains a valuable resource for human factors and human space flight programs.

Observing Reasonable Consumers.

ERIC Educational Resources Information Center

Silber, Norman I.

1991-01-01

Although courts and legislators usually set legal standards that correspond to empirical knowledge of human behavior, recent developments in behavioral psychology have led courts to appreciate the limits and errors in consumer decision making. "Reasonable consumer" standards that are congruent with cognitive reality should be developed.…

Standardized Curriculum for Business Cooperative Education.

ERIC Educational Resources Information Center

Mississippi State Dept. of Education, Jackson. Office of Vocational, Technical and Adult Education.

Standardized curricula are provided for two courses for the secondary vocational education program in Mississippi: business cooperative education I and II. The 10 units in business cooperative education I are as follows: orientation; keyboarding and skill building; leadership development; personnel development; human relations; business…

Human rights and human dignity in the resolution of certain ethical questions in biomedicine.

PubMed

Wheatley, S

2001-01-01

As medical technology develops, new issues are raised as to how the use of this technology may comply or conflict with existing human rights standards and values. This article considers the application of human rights standards, and in particular the jurisprudence under Article 8 of the European Convention on Human Rights, to the trade in human body organs, the selection of the sex of prospective children, and human reproductive cloning. The current domestic law and regulatory framework is examined, as well as international regulation of this area by the Council of Europe Convention on Human Rights and Biomedicine. The author considers how the balance is to be struck between the ethical objections to many developments in biomedicine, and individual self-determination. It is suggested that, in order to be justified, any limitations on individual self-determination in the use of this new medical technology, should have a basis in the protection of human dignity.

A Human Factors Perspective on Alarm System Research and Development 2000 to 2010

DOE Office of Scientific and Technical Information (OSTI.GOV)

Curt Braun; John Grimes; Eric Shaver

By definition, alarms serve to notify human operators of out-of-parameter conditions that could threaten equipment, the environment, product quality and, of course, human life. Given the complexities of industrial systems, human machine interfaces, and the human operator, the understanding of how alarms and humans can best work together to prevent disaster is continually developing. This review examines advances in alarm research and development from 2000 to 2010 and includes the writings of trade professionals, engineering and human factors researchers, and standards organizations with the goal of documenting advances in alarms system design, research, and implementation.

A Robotics Systems Design Need: A Design Standard to Provide the Systems Focus that is Required for Longterm Exploration Efforts

NASA Technical Reports Server (NTRS)

Dischinger, H. Charles., Jr.; Mullins, Jeffrey B.

2005-01-01

The United States is entering a new period of human exploration of the inner Solar System, and robotic human helpers will be partners in that effort. In order to support integration of these new worker robots into existing and new human systems, a new design standard should be developed, to be called the Robot-Systems Integration Standard (RSIS). It will address the requirements for and constraints upon robotic collaborators with humans. These workers are subject to the same functional constraints as humans of work, reach, and visibility/situational awareness envelopes, and they will deal with the same maintenance and communication interfaces. Thus, the RSIS will be created by discipline experts with the same sort of perspective on these and other interface concerns as human engineers.

Building a human rights framework for workers' compensation in the United States: opening the debate on first principles.

PubMed

Hilgert, Jeffrey A

2012-06-01

This article introduces the idea of human rights to the topic of workers' compensation in the United States. It discusses what constitutes a human rights approach and explains how this approach conflicts with those policy ideas that have provided the foundation historically for workers' compensation in the United States. Using legal and historical research, key international labor and human rights standards on employment injury benefits and influential writings in the development of the U.S. workers' compensation system are cited. Workers' injury and illness compensation in the United States does not conform to basic international human rights norms. A comprehensive review of the U.S. workers' compensation system under international human rights standards is needed. Examples of policy changes are highlighted that would begin the process of moving workers' compensation into conformity with human rights standards. Copyright © 2012 Wiley Periodicals, Inc.

NASA Human Integration Design Handbook (HIDH): Revitalization of Space-Related Human Factors, Environmental, and Habitability Data and Design Guidance

NASA Technical Reports Server (NTRS)

Stroud, Kenneth; Pickett, Lynn; Tillman, Barry

2008-01-01

This poster presentation reviews the Human Integration Design Handbook (HIDH). It provides guidance and data to aid vehicle / habitat designers in human-system integration It also aids requirements writers in development of human-system integration requirements from SFHSS Standards

Human Factors Guidelines for UAS in the National Airspace System

NASA Technical Reports Server (NTRS)

Hobbs, Alan; Shively, R. Jay

2013-01-01

The ground control stations (GCS) of some UAS have been characterized by less-than-adequate human-system interfaces. In some cases this may reflect a failure to apply an existing regulation or human factors standard. In other cases, the problem may indicate a lack of suitable guidance material. NASA is leading a community effort to develop recommendations for human factors guidelines for GCS to support routine beyond-line-of-sight UAS operations in the national airspace system (NAS). In contrast to regulations, guidelines are not mandatory requirements. However, by encapsulating solutions to identified problems or areas of risk, guidelines can provide assistance to system developers, users and regulatory agencies. To be effective, guidelines must be relevant to a wide range of systems, must not be overly prescriptive, and must not impose premature standardization on evolving technologies. By assuming that a pilot will be responsible for each UAS operating in the NAS, and that the aircraft will be required to operate in a manner comparable to conventionally piloted aircraft, it is possible to identify a generic set of pilot tasks and the information, control and communication requirements needed to support these tasks. Areas where guidelines will be useful can then be identified, utilizing information from simulations, operational experience and the human factors literature. In developing guidelines, we recognize that existing regulatory and guidance material will, at times, provide adequate coverage of an area. In other cases suitable guidelines may be found in existing military or industry human factors standards. In cases where appropriate existing standards cannot be identified, original guidelines will be proposed.

A Whole New World of Interventions: The Performance Technologist as Integrating Generalist.

ERIC Educational Resources Information Center

Hutchison, Cathleen Smith; Stein, Faith S.

1997-01-01

The authors update an article on intervention, discussing career development, communications, feedback, financial, human development, information, instructional, labor relations, measurement and evaluation, quality improvement, resource, reward and recognition, and selection systems; documentation and standards; ergonomics and human factors;…

The role of socio-communicative rearing environments in the development of social and physical cognition in apes.

PubMed

Russell, Jamie L; Lyn, Heidi; Schaeffer, Jennifer A; Hopkins, William D

2011-11-01

The cultural intelligence hypothesis (CIH) claims that humans' advanced cognition is a direct result of human culture and that children are uniquely specialized to absorb and utilize this cultural experience (Tomasello, 2000). Comparative data demonstrating that 2.5-year-old human children outperform apes on measures of social cognition but not on measures of physical cognition support this claim (Herrmann et al., 2007). However, the previous study failed to control for rearing when comparing these two species. Specifically, the human children were raised in a human culture whereas the apes were raised in standard sanctuary settings. To further explore the CIH, here we compared the performance on multiple measures of social and physical cognition in a group of standard reared apes raised in conditions typical of zoo and biomedical laboratory settings to that of apes reared in an enculturated socio-communicatively rich environment. Overall, the enculturated apes significantly outperformed their standard reared counterparts on the cognitive tasks and this was particularly true for measures of communication. Furthermore, the performance of the enculturated apes was very similar to previously reported data from 2.5-year-old children. We conclude that apes who are reared in a human-like socio-communicatively rich environment develop superior communicative abilities compared to apes reared in standard laboratory settings, which supports some assumptions of the cultural intelligence hypothesis. 2011 Blackwell Publishing Ltd.

The ethics of HIV research in developing nations.

PubMed

Resnik, David B

1998-10-01

This paper discusses a dispute concerning the ethics of research on preventing the perinatal transmission of HIV in developing nations. Critics of this research argue that it is unethical because it denies a proven treatment to placebo-control groups. Since studies conducted in developed nations would not deny this treatment to subjects, the critics maintain that these experiments manifest a double standard for ethical research and that a single standard of ethics should apply to all research on human subjects. Proponents of the research, however, argue that these charges fail to understand the ethical complexities of research in developing nations, and that study designs can vary according to the social, economic, and scientific conditions of research. This essay explores some of the ethical issues raised by this controversial case in order to shed some light on the deeper, meta-ethical questions. The paper argues that standards of ethical research on human subjects are universal but not absolute: there are some general ethical principles that apply to all cases of human subjects research but the application of these principles must take into account factors inherent in particular situations.

Milk and serum standard reference materials for monitoring organic contaminants in human samples.

PubMed

Schantz, Michele M; Eppe, Gauthier; Focant, Jean-François; Hamilton, Coreen; Heckert, N Alan; Heltsley, Rebecca M; Hoover, Dale; Keller, Jennifer M; Leigh, Stefan D; Patterson, Donald G; Pintar, Adam L; Sharpless, Katherine E; Sjödin, Andreas; Turner, Wayman E; Vander Pol, Stacy S; Wise, Stephen A

2013-02-01

Four new Standard Reference Materials (SRMs) have been developed to assist in the quality assurance of chemical contaminant measurements required for human biomonitoring studies, SRM 1953 Organic Contaminants in Non-Fortified Human Milk, SRM 1954 Organic Contaminants in Fortified Human Milk, SRM 1957 Organic Contaminants in Non-Fortified Human Serum, and SRM 1958 Organic Contaminants in Fortified Human Serum. These materials were developed as part of a collaboration between the National Institute of Standards and Technology (NIST) and the Centers for Disease Control and Prevention (CDC) with both agencies contributing data used in the certification of mass fraction values for a wide range of organic contaminants including polychlorinated biphenyl (PCB) congeners, chlorinated pesticides, polybrominated diphenyl ether (PBDE) congeners, and polychlorinated dibenzo-p-dioxin (PCDD) and dibenzofuran (PCDF) congeners. The certified mass fractions of the organic contaminants in unfortified samples, SRM 1953 and SRM 1957, ranged from 12 ng/kg to 2200 ng/kg with the exception of 4,4'-DDE in SRM 1953 at 7400 ng/kg with expanded uncertainties generally <14 %. This agreement suggests that there were no significant biases existing among the multiple methods used for analysis.

Milk and serum standard reference materials for monitoring organic contaminants in human samples

PubMed Central

Eppe, Gauthier; Focant, Jean-François; Hamilton, Coreen; Heckert, N. Alan; Heltsley, Rebecca M.; Hoover, Dale; Keller, Jennifer M.; Leigh, Stefan D.; Patterson, Donald G.; Pintar, Adam L.; Sharpless, Katherine E.; Sjödin, Andreas; Turner, Wayman E.; Vander Pol, Stacy S.; Wise, Stephen A.

2016-01-01

Four new Standard Reference Materials (SRMs) have been developed to assist in the quality assurance of chemical contaminant measurements required for human biomonitoring studies, SRM 1953 Organic Contaminants in Non-Fortified Human Milk, SRM 1954 Organic Contaminants in Fortified Human Milk, SRM 1957 Organic Contaminants in Non-Fortified Human Serum, and SRM 1958 Organic Contaminants in Fortified Human Serum. These materials were developed as part of a collaboration between the National Institute of Standards and Technology (NIST) and the Centers for Disease Control and Prevention (CDC) with both agencies contributing data used in the certification of mass fraction values for a wide range of organic contaminants including polychlorinated biphenyl (PCB) congeners, chlorinated pesticides, polybrominated diphenyl ether (PBDE) congeners, and polychlorinated dibenzo-p-dioxin (PCDD) and dibenzofuran (PCDF) congeners. The certified mass fractions of the organic contaminants in unfortified samples, SRM 1953 and SRM 1957, ranged from 12 ng/kg to 2200 ng/kg with the exception of 4,4′-DDE in SRM 1953 at 7400 ng/kg with expanded uncertainties generally <14 %. This agreement suggests that there were no significant biases existing among the multiple methods used for analysis. PMID:23132544

Use of Case Study Methods in Human Resource Management, Development, and Training Courses: Strategies and Techniques

ERIC Educational Resources Information Center

Maxwell, James R.; Gilberti, Anthony F.; Mupinga, Davison M.

2006-01-01

This paper will study some of the problems associated with case studies and make recommendations using standard and innovative methodologies effectively. Human resource management (HRM) and resource development cases provide context for analysis and decision-making designs in different industries. In most HRM development and training courses…

Contact and perspective taking improve humanness standards and perceptions of humanness of older adults and people with dementia: a cross-sectional survey study.

PubMed

Miron, Anca M; McFadden, Susan H; Hermus, Nathan J; Buelow, Jennifer; Nazario, Amanda S; Seelman, Katarena

2017-10-01

No empirical work has systematically explored perceptions of humanness of people with dementia and of older adults and the variables that could improve these perceptions. We thus investigated the role of contact and perspective taking in improving perceptions of humanness of these social groups. To do so, we developed a new concept, humanness standards, defined as the amount of evidence of ability impairment needed to conclude that elderly people and those with dementia have lost personhood. We used a cross-sectional survey design (n = 619) to assess participants' humanness standards and perceptions of uniquely human characteristics and human nature characteristics of two social groups (people with dementia and older adults). Half the participants (n = 311) completed a survey about people with dementia and half (n = 308) assessed older adults. People with dementia were perceived as possessing humanness characteristics to a lesser extent than were older adults. For both groups, contact predicted enhanced perceptions of humanness characteristics. Participants' degree of contact with individuals with dementia also predicted humanness standards, but only under low perspective-taking conditions. As predicted, for older adults, participants set the highest humanness impairment thresholds in the high contact/high perspective-taking condition. We conclude that while social programs that bring persons with dementia and other individuals in contact could change humanness standards and perceptions of humanness characteristics of people with dementia, in the case of elderly adults, the contact must be supplemented by variables that facilitate taking the perspective of the person.

ASTM lights the way for tissue engineered medical products standards: jump start for combination medical products that restore biological function of human tissues.

PubMed

Picciolo, G L; Stocum, D L

2001-01-01

Everybody hopes for better health and restoration of impaired bodily function, and now that hope is illuminated by the promise of powerful biological tools that make human cells grow and replace human tissue. ASTM Committee F04 on Medical and Surgical Materials and Devices is taking the lead by defining some of those tools as standards that can be used for the development, production, testing, and regulatory approval of medical products.

Image quality metrics for volumetric laser displays

NASA Astrophysics Data System (ADS)

Williams, Rodney D.; Donohoo, Daniel

1991-08-01

This paper addresses the extensions to the image quality metrics and related human factors research that are needed to establish the baseline standards for emerging volume display technologies. The existing and recently developed technologies for multiplanar volume displays are reviewed with an emphasis on basic human visual issues. Human factors image quality metrics and guidelines are needed to firmly establish this technology in the marketplace. The human visual requirements and the display design tradeoffs for these prototype laser-based volume displays are addressed and several critical image quality issues identified for further research. The American National Standard for Human Factors Engineering of Visual Display Terminal Workstations (ANSIHFS-100) and other international standards (ISO, DIN) can serve as a starting point, but this research base must be extended to provide new image quality metrics for this new technology for volume displays.

Towards a Policy Framework for Decent Work.

ERIC Educational Resources Information Center

Egger, Philippe

2002-01-01

International Labour Organization (ILO) standards for decent work promote social justice and humane working conditions. These standards can contribute to sustainable development, macroeconomic security, and fairer distribution of benefits from growth. The ILO is working for policy integration and promotion of international labor standards as a…

78 FR 29135 - HIT Standards Committee Advisory Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES HIT Standards Committee Advisory Meeting AGENCY: Office of...: HIT Standards Committee. General Function of the Committee: To provide recommendations to the National... Federal Health IT Strategic Plan, and in accordance with policies developed by the HIT Policy Committee...

Current Status Of Ergonomic Standards

NASA Astrophysics Data System (ADS)

Lynch, Gene

1984-05-01

The last five years have seen the development and adoption of new kinds of standards for the display industry. This standardization activity deals with the complex human computer interface. Here the concerns involve health, safety, productivity, and operator well-being. The standards attempt to specify the "proper" use of visual display units. There is a wide range of implications for the display industry - as manufacturers of displays, as employers, and as users of visual display units. In this paper we examine the development of these standards, their impact on the display industry and implications for the future.

The Role of Socio-Communicative Rearing Environments on the Development of Social and Physical Cognition in Apes

PubMed Central

Russell, J. L.; Lyn, H.; Schaeffer, J. A.; Hopkins, W. D.

2011-01-01

The cultural intelligence hypothesis (CIH) claims that humans' advanced cognition is a direct result of human culture and that children are uniquely specialized to absorb and utilize this cultural experience (Tomasello, 2000). Comparative data demonstrating that 2.5 year old human children outperform apes on measures of social cognition but not on measures of physical cognition support this claim (E. Herrmann, J. Call, M. V. Hernandez-Lloreda, B. Hare, & M. Tomasello, 2007). However, the previous study failed to control for rearing when comparing these two species. Specifically, the human children were raised in a human culture whereas the apes were raised in standard sanctuary settings. To further explore the CIH, here we compared the performance on multiple measures of social and physical cognition in a group of standard reared apes raised in conditions typical of zoo and biomedical laboratory settings to that of apes reared in an enculturated socio-communicatively rich environment. Overall, the enculturated apes significantly outperformed their standard reared counterparts on the cognitive tasks and this was particularly true for measures of communication. Furthermore, the performance of the enculturated apes was very similar to previously reported data from 2.5 year old children. We conclude that apes who are reared in a human-like socio-communicatively rich environment develop superior communicative abilities compared to apes reared in standard laboratory settings, which supports some assumptions of the cultural intelligence hypothesis. PMID:22010903

In vitro development of donated frozen-thawed human embryos in a prototype static microfluidic device: a randomized controlled trial.

PubMed

Kieslinger, Dorit C; Hao, Zhenxia; Vergouw, Carlijn G; Kostelijk, Elisabeth H; Lambalk, Cornelis B; Le Gac, Séverine

2015-03-01

To compare the development of human embryos in microfluidic devices with culture in standard microdrop dishes, both under static conditions. Prospective randomized controlled trial. In vitro fertilization laboratory. One hundred eighteen donated frozen-thawed human day-4 embryos. Random allocation of embryos that fulfilled the inclusion criteria to single-embryo culture in a microfluidics device (n = 58) or standard microdrop dish (n = 60). Blastocyst formation rate and quality after 24, 28, 48, and 72 hours of culture. The percentage of frozen-thawed day-4 embryos that developed to the blastocyst stage did not differ significantly in the standard microdrop dishes and microfluidic devices after 28 hours of culture (53.3% vs. 58.6%) or at any of the other time points. The proportion of embryos that would have been suitable for embryo transfer was comparable after 28 hours of culture in the control dishes and microfluidic devices (90.0% vs. 93.1%). Furthermore, blastocyst quality was similar in the two study groups. This study shows that a microfluidic device can successfully support human blastocyst development in vitro under static culture conditions. Future studies need to clarify whether earlier stage embryos will benefit from the culture in microfluidic devices more than the tested day-4 embryos because many important steps in the development of human embryos already take place before day 4. Further improvements of the microfluidic device will include parallel culture of single embryos, application of medium refreshment, and built-in sensors. NTR3867. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Addressing security issues related to virtual institute distributed activities

NASA Astrophysics Data System (ADS)

Stytz, Martin R.; Banks, Sheila B.

2008-03-01

One issue confounding the development and experimentation of distributed modeling and simulation environments is the inability of the project team to identify and collaborate with resources, both human and technical, from outside the United States. This limitation is especially significant within the human behavior representation area where areas such as cultural effects research and joint command team behavior modeling require the participation of various cultural and national representatives. To address this limitation, as well as other human behavior representation research issues, NATO Research and Technology Organization initiated a project to develop a NATO virtual institute that enables more effective and more collaborative research into human behavior representation. However, in building and operating a virtual institute one of the chief concerns must be the cyber security of the institute. Because the institute "exists" in cyberspace, all of its activities are susceptible to cyberattacks, subterfuge, denial of service and all of the vulnerabilities that networked computers must face. In our opinion, for the concept of virtual institutes to be successful and useful, their operations and services must be protected from the threats in the cyber environment. A key to developing the required protection is the development and promulgation of standards for cyber security. In this paper, we discuss the types of cyber standards that are required, how new internet technologies can be exploited and can benefit the promulgation, development, maintenance, and robustness of the standards. This paper is organized as follows. Section One introduces the concept of the virtual institutes, the expected benefits, and the motivation for our research and for research in this area. Section Two presents background material and a discussion of topics related to VIs, uman behavior and cultural modeling, and network-centric warfare. Section Three contains a discussion of the security challenges that face the virtual institute and the characteristics of the standards that must be employed. Section Four contains our proposal for documentation of the cybersecurity standards. Section Five contains the conclusion and suggestions for further work.

78 FR 43889 - Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA), Center for...

77 FR 37408 - HIT Standards Committee Advisory Meeting; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES HIT Standards Committee Advisory Meeting; Notice of... be open to the public. Name of Committee: HIT Standards Committee. General Function of the Committee... with policies developed by the HIT Policy Committee. Date and Time: The meeting will be held on July 19...

77 FR 65691 - HIT Standards Committee Advisory Meeting; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES HIT Standards Committee Advisory Meeting; Notice of... public. Name of Committee: HIT Standards Committee. General Function of the Committee: To provide... developed by the HIT Policy Committee. Date and Time: The meeting will be held on November 13, 2012, from 9...

76 FR 70455 - HIT Standards Committee Advisory Meeting; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES HIT Standards Committee Advisory Meeting; Notice of... public. Name of Committee: HIT Standards Committee. General Function of the Committee: to provide... developed by the HIT Policy Committee. Date and Time: The meeting will be held on December 14, 2011, from 9...

76 FR 79684 - HIT Standards Committee Advisory Meeting; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES HIT Standards Committee Advisory Meeting; Notice of... public. Name of Committee: HIT Standards Committee. General Function of the Committee: to provide... developed by the HIT Policy Committee. Date and Time: The meeting will be held on January 25, 2012, from 9 a...

77 FR 65690 - HIT Standards Committee Advisory Meeting; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES HIT Standards Committee Advisory Meeting; Notice of... public. Name of Committee: HIT Standards Committee. General Function of the Committee: To provide... developed by the HIT Policy Committee. Date and Time: The meeting will be held on December 19, 2012, from 9...

77 FR 45353 - HIT Standards Committee Advisory Meeting; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-31

... DEPARTMENT OF HEALTH AND HUMAN SERVICES HIT Standards Committee Advisory Meeting; Notice of... public. Name of Committee: HIT Standards Committee. General Function of the Committee: To provide... developed by the HIT Policy Committee. Date and Time: The meeting will be held on August 15, 2012, from 9:00...

77 FR 2727 - HIT Standards Committee Advisory Meeting; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES HIT Standards Committee Advisory Meeting; Notice of... public. Name of Committee: HIT Standards Committee. General Function of the Committee: To provide... developed by the HIT Policy Committee. Date and Time: The meeting will be held on February 29, 2012, from 9...

77 FR 73661 - HIT Standards Committee Advisory Meetings; Notice of Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES HIT Standards Committee Advisory Meetings; Notice of... public. Name of Committee: HIT Standards Committee. General Function of the Committee: To provide... developed by the HIT Policy Committee. Date and Time: These meetings will be held on the following dates and...

77 FR 60438 - HIT Standards Committee Advisory Meeting; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES HIT Standards Committee Advisory Meeting; Notice of... public. Name of Committee: HIT Standards Committee. General Function of the Committee: To provide... developed by the HIT Policy Committee. Date and Time: The meeting will be held on October 17, 2012, from 9 a...

77 FR 50690 - HIT Standards Committee Advisory Meeting; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES HIT Standards Committee Advisory Meeting; Notice of... public. Name of Committee: HIT Standards Committee. General Function of the Committee: To provide... developed by the HIT Policy Committee. Date and Time: The meeting will be held on September 19, 2012, from 9...

21 CFR 861.38 - Standards advisory committees.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Standards advisory committees. 861.38 Section 861.38 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Development and Publication § 861.38 Standards advisory committees. (a) The Food and Drug Administration will...

Technology--The Extension of Human Potential

ERIC Educational Resources Information Center

Childress, Vincent W.

2018-01-01

Technology is defined differently depending on one's point of view, but in "Standards for Technological Literacy," technology is defined as "Human innovation…the generation of knowledge and processes…that solve problems and extend human capabilities" (ITEA/ITEEA 2000/2002/2007). The processes associated with the development of…

Quantitative determination of galantamine in human plasma by sensitive liquid chromatography-tandem mass spectrometry using loratadine as an internal standard.

PubMed

Nirogi, Ramakrishna V S; Kandikere, Vishwottam N; Mudigonda, Koteshwara; Maurya, Santosh

2007-02-01

A simple, rapid, sensitive, and selective liquid chromatography-tandem mass spectrometry method is developed and validated for the quantitation of galantamine, an acetylcholinesterase inhibitor in human plasma, using a commercially available compound, loratadine, as the internal standard. Following liquid-liquid extraction, the analytes are separated using an isocratic mobile phase on a reverse-phase C18 column and analyzed by mass spectrometry in the multiple reaction monitoring mode using the respective (M+H)+ ions, m/z 288 to 213 for galantamine and m/z 383 and 337 for the internal standard. The assay exhibit a linear dynamic range of 0.5-100 ng/mL for galantamine in human plasma. The lower limit of quantitation is 0.5 ng/mL, with a relative standard deviation of less than 8%. Acceptable precision and accuracy are obtained for concentrations over the standard curve range. A run time of 2.5 min for each sample makes it possible to analyze more than 400 human plasma samples per day. The validated method is successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability, or bioequivalence studies.

Development and evaluation of a study design typology for human research.

PubMed

Carini, Simona; Pollock, Brad H; Lehmann, Harold P; Bakken, Suzanne; Barbour, Edward M; Gabriel, Davera; Hagler, Herbert K; Harper, Caryn R; Mollah, Shamim A; Nahm, Meredith; Nguyen, Hien H; Scheuermann, Richard H; Sim, Ida

2009-11-14

A systematic classification of study designs would be useful for researchers, systematic reviewers, readers, and research administrators, among others. As part of the Human Studies Database Project, we developed the Study Design Typology to standardize the classification of study designs in human research. We then performed a multiple observer masked evaluation of active research protocols in four institutions according to a standardized protocol. Thirty-five protocols were classified by three reviewers each into one of nine high-level study designs for interventional and observational research (e.g., N-of-1, Parallel Group, Case Crossover). Rater classification agreement was moderately high for the 35 protocols (Fleiss' kappa = 0.442) and higher still for the 23 quantitative studies (Fleiss' kappa = 0.463). We conclude that our typology shows initial promise for reliably distinguishing study design types for quantitative human research.

Water Quality Standards for Coral Reef Protection | Science ...

EPA Pesticide Factsheets

The U.S. Clean Water Act provides a legal framework to protect coastal biological resources such as coral reefs, mangrove forests, and seagrass meadows from the damaging effects of human activities. Even though many resources are protected under this authority, water quality standards have not been effectively applied to coral reefs. The Environmental Protection Agency is promoting biocriteria and other water quality standards through collaborative development of bioassessment procedures, indicators and monitoring strategies. To support regulatory action, bioassessment indicators must be biologically meaningful, relevant to management, responsive to human disturbance, and relatively immune to natural variability. A rapid bioassessment protocol for reef-building stony corals was developed and tested for regulatory applicability. Preliminary testing in the Florida Keys found indicators had sufficient precision and provided information relevant to coral reef management. Sensitivity to human disturbance was demonstrated in the U.S. Virgin Islands for five of eight indicators tested. Once established, monitoring programs using these indicators can provide valuable, long-term records of coral condition and regulatory compliance. Development of a rapid bioassement protocol for reef-building stony corals was tested for regulatory applicability.

Who is in Your Waiting Room? Health Care Professionals as Culturally Responsive and Trauma-Informed First Responders to Human Trafficking.

PubMed

Rollins, Rochelle; Gribble, Anna; Barrett, Sharon E; Powell, Clydette

2017-01-01

Evidence-based practice standards are not yet well defined for assisting potential victims of human trafficking. Nonetheless, health care professionals are learning to be first responders in identifying, treating, and referring potential victims. As more public and private sector resources are used to train health care professionals about human trafficking, more evaluation and research are needed to develop an effective standard of care. Adopting a public health lens and using the "National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care" can guide critical decision making and actions. Through collaboration between researchers and policymakers, lessons learned in health care settings can inform future evidence-based standards of care so that all patients receive the services that they need. © 2017 American Medical Association. All Rights Reserved.

Picture This... Developing Standards for Electronic Images at the National Library of Medicine

PubMed Central

Masys, Daniel R.

1990-01-01

New computer technologies have made it feasible to represent, store, and communicate high resolution biomedical images via electronic means. Traditional two dimensional medical images such as those on printed pages have been supplemented by three dimensional images which can be rendered, rotated, and “dissected” from any point of view. The library of the future will provide electronic access not only to words and numbers, but to pictures, sounds, and other nontextual information. There currently exist few widely-accepted standards for the representation and communication of complex images, yet such standards will be critical to the feasibility and usefulness of digital image collections in the life sciences. The National Library of Medicine is embarked on a project to develop a complete digital volumetric representation of an adult human male and female. This “Visible Human Project” will address the issue of standards for computer representation of biological structure.

Incorporating Research Findings into Standards and Requirements for Space Medicine

NASA Technical Reports Server (NTRS)

Duncan, J. Michael

2006-01-01

The Vision for Exploration has been the catalyst for NASA to refocus its life sciences research. In the future, life sciences research funded by NASA will be focused on answering questions that directly impact setting physiological standards and developing effective countermeasures to the undesirable physiological and psychological effects of spaceflight for maintaining the health of the human system. This, in turn, will contribute to the success of exploration class missions. We will show how research will impact setting physiologic standards, such as exposure limits, outcome limits, and accepted performance ranges. We will give examples of how a physiologic standard can eventually be translated into an operational requirement, then a functional requirement, and eventually spaceflight hardware or procedures. This knowledge will be important to the space medicine community as well as to vehicle contractors who, for the first time, must now consider the human system in developing and constructing a vehicle that can achieve the goal of success.

Designing an Automated Assessment of Public Speaking Skills Using Multimodal Cues

ERIC Educational Resources Information Center

Chen, Lei; Feng, Gary; Leong, Chee Wee; Joe, Jilliam; Kitchen, Christopher; Lee, Chong Min

2016-01-01

Traditional assessments of public speaking skills rely on human scoring. We report an initial study on the development of an automated scoring model for public speaking performances using multimodal technologies. Task design, rubric development, and human rating were conducted according to standards in educational assessment. An initial corpus of…

77 FR 15760 - HIT Standards Committee Advisory Meeting; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES HIT Standards Committee Advisory Meeting; Notice of... public. Name of Committee: HIT Standards Committee. General Function of the Committee: to provide... developed by the HIT Policy Committee. Date and Time: The meeting will be held on April 18, 2012, from 9 a.m...

77 FR 27459 - HIT Standards Committee Advisory Meeting; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES HIT Standards Committee Advisory Meeting; Notice of... public. Name of Committee: HIT Standards Committee. General Function of the Committee: To provide... developed by the HIT Policy Committee. Date and Time: The meeting will be held on June 20, 2012, from 9 a.m...

Behavioural Development in Chimpanzee (Pan troglodytes) and Human Newborns across the First Month of Life.

ERIC Educational Resources Information Center

Hallock, Martha B.; And Others

1989-01-01

Reports comparisons of behaviors of nine chimpanzee and nine human newborns on a standardized human neonatal assessment scale at the ages of three days and one month. Human infants scored higher than chimpanzee infants on the orientation cluster at both ages, but were lower than chimpanzee infants in motoric maturity. (RJC)

Development of 3-Year Roadmap to Transform the Discipline of Systems Engineering

DTIC Science & Technology

2010-03-31

quickly humans could physically construct them. Indeed, magnetic core memory was entirely constructed by human hands until it was superseded by...For their mainframe computers, IBM develops the applications, operating system, computer hardware and microprocessors (off the shelf standard memory ...processor developers work on potential computational and memory pipelines to support the required performance capabilities and use the available transistors

AIDS research in developing countries: do the ends justify the means?

PubMed

Clark, Peter A

2002-09-01

Concrete ethical standards for human research are clearly stipulated in both international and national codes of ethics, and are meant to protect human subjects, especially the most vulnerable. A recent clinical study conducted from 1994 to 1997 by Dr. Thomas C, Quinn, M.D. has fueled the debate raging in the scientific community regarding the ethics of clinical AIDS research in developing countries. Quinn's conducted a community-based, randomized, controlled study of 15,127 rural Ugandans to determine whether intermittent antibiotic treatment to reduce the prevalence of other sexually transmitted diseases would also reduce the rate of HIV transmission. Subsequently, the study identified 415 couples in which one partner was HIV positive and one was initially HIV negative and followed them prospectively for up to 30 months. Researchers were not permitted to inform the seronegative partner of the HIV status of the other partner. As a result, 90 of the initially HIV negative partners (21.7%) seroconverted during a follow-up period of 30 months. To allow for research studies in developing countries that are not permitted in the United States appears to make the Third World equivalent to a 'research sweat shop'. Developing nations offer easy access to patients, reduced costs, and less stringent regulations. This appears to create a double standard for medical research that is both ethically and humanly unacceptable, especially when other viable option exist. To allow relativism to seep into the international and national ethical standards will open the door to an idea that condones the possible abuse of those least able to protect themselves. Researchers have an ethical responsibility to uphold the integrity of these ethical standards. Failure to do so today may have a devastating impact on humanity in the future.

International standards for brucellosis prevention and management.

PubMed

Ragan, V; Vroegindewey, G; Babcock, S

2013-04-01

International standards are a crucial element in brucellosis prevention and management. They allow policy-makers, scientists, epidemiologists, laboratories and trade entities to have a common vocabulary for communication and understanding of the disease. These standards cover the entire spectrum of activities from surveillance, testing, prophylaxis, transport and trade to policy development, research and reporting. Developing, adhering to and monitoring standards increases both the effectiveness and efficiency of prevention and management programmes. Creating standards with the input of all stakeholders ensures that the standards do not adversely affect the requirements of any of the multiple parties involved. The World Organisation for Animal Health (OIE), in conjunction with its Member Countries, and through its standing and ad hoc committees plus expert input, has taken a key leadership role in developing and reviewing brucellosis standards. These standards are used to harmonise testing, prevention processes, vaccines and reporting, to support trade and to protect human and animal health.

Re-Engineering the Business Education Programme in Universities for Enhanced Human Resources Development in Nigeria

ERIC Educational Resources Information Center

Okoli, B. E.; Azih, N.

2015-01-01

The paper reviewed a business education programme in Nigeria vis-a-vis its role in human resource development and highlighted deficiencies in programme curricular and delivery changes needed in remodeling of the programme to enhance learning outcomes, increase skill acquisition, meet world's standards and current labour demands in business…

Development and Evaluation of the Habitat Demonstration Unit Medical Operations Workstation and Opportunities for Future Research

NASA Technical Reports Server (NTRS)

Howard, Robert L., Jr.

2012-01-01

As NASA develops missions to leave Earth orbit and explore distant destinations (Mars, Moon, Asteroids) it is necessary to rethink human spaceflight paradigms in the life sciences. Standards developed for low earth orbit human spaceflight may not be fully applicable and in-space research may be required to develop new standards. Preventative and emergency medical care may require new capabilities never before used in space. Due to spacecraft volume limitations, this work area may also be shared with various animal and plant life science research. This paper explores the prototype Medical Operations Workstation within the NASA Habitat Demonstration Unit and discusses some of the lessons learned from field analogue missions involving the workstation. Keywords: Exploration, medical, health, crew, injury emergency, biology, animal, plant, science, preventative, emergency.

NASA Standards Inform Comfortable Car Seats

NASA Technical Reports Server (NTRS)

2014-01-01

NASA developed standards, which included the neutral body posture (NBP), to specify ways to design flight systems that support human health and safety. Nissan Motor Company, with US offices in Franklin, Tennessee, turned to NASA's NBP research for the development of a new driver's seat. The 2013 Altima now features the new seat, and the company plans to incorporate the seats in upcoming vehicles.

Simultaneous quantification of α-lactalbumin and β-casein in human milk using ultra-performance liquid chromatography with tandem mass spectrometry based on their signature peptides and winged isotope internal standards.

PubMed

Chen, Qi; Zhang, Jingshun; Ke, Xing; Lai, Shiyun; Li, Duo; Yang, Jinchuan; Mo, Weimin; Ren, Yiping

2016-09-01

In recent years, there is an increasing need to measure the concentration of individual proteins in human milk, instead of total human milk proteins. Due to lack of human milk protein standards, there are only few quantification methods established. The objective of the present work was to develop a simple and rapid quantification method for simultaneous determination of α-lactalbumin and β-casein in human milk using signature peptides according to a modified quantitative proteomics strategy. The internal standards containing the signature peptide sequences were synthesized with isotope-labeled amino acids. The purity of synthesized peptides as standards was determined by amino acid analysis method and area normalization method. The contents of α-lactalbumin and β-casein in human milk were measured according to the equimolar relationship between the two proteins and their corresponding signature peptides. The method validation results showed a satisfied linearity (R(2)>0.99) and recoveries (97.2-102.5% for α-lactalbumin and 99.5-100.3% for β-casein). The limit of quantification for α-lactalbumin and β-casein was 8.0mg/100g and 1.2mg/100g, respectively. CVs for α-lactalbumin and β-casein in human milk were 5.2% and 3.0%. The contents of α-lactalbumin and β-casein in 147 human milk samples were successfully determined by the established method and their contents were 205.5-578.2mg/100g and 116.4-467.4mg/100g at different lactation stages. The developed method allows simultaneously determination of α-lactalbumin and β-casein in human milk. The quantitative strategy based on signature peptide should be applicable to other endogenous proteins in breast milk and other body fluids. Copyright © 2016 Elsevier B.V. All rights reserved.

[International regulation of ethics committees on biomedical research as protection mechanisms for people: analysis of the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research of the Council of Europe].

PubMed

de Lecuona, Itziar

2013-01-01

The article explores and analyses the content of the Council of Europe's Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research regarding the standard legal instrument in biomedical research, issued by an international organization with leadership in bioethics. This implies ethics committees are mechanisms of protection of humans in biomedical research and not mere bureaucratic agencies and that a sound inescapable international regulatory framework exists for States to regulate biomedical research. The methodology used focuses on the analysis of the background, the context in which it is made and the nature and scope of the Protocol. It also identifies and analyses the characteristics and functions of ethics committees in biomedical research and, in particular, the information that should be provided to this bodies to develop their functions previously, during and at the end of research projects. This analysis will provide guidelines, suggestions and conclusions for the awareness and training of members of these committees in order to influence the daily practice. This paper may also be of interest to legal practitioners who work in different areas of biomedical research. From this practical perspective, the article examines the legal treatment of the Protocol to meet new challenges and classic issues in research: the treatment of human biological samples, the use of placebos, avoiding double standards, human vulnerability, undue influence and conflicts of interest, among others. Also, from a critical view, this work links the legal responses to develop work procedures that are required for an effective performance of the functions assigned of ethics committees in biomedical research. An existing international legal response that lacks doctrinal standards and provides little support should, however, serve as a guide and standard to develop actions that allow ethics committees -as key bodies for States- to advance in the protection of humans in biomedical research.

Defining the Relationship Between Human Error Classes and Technology Intervention Strategies

NASA Technical Reports Server (NTRS)

Wiegmann, Douglas A.; Rantanen, Eas M.

2003-01-01

The modus operandi in addressing human error in aviation systems is predominantly that of technological interventions or fixes. Such interventions exhibit considerable variability both in terms of sophistication and application. Some technological interventions address human error directly while others do so only indirectly. Some attempt to eliminate the occurrence of errors altogether whereas others look to reduce the negative consequences of these errors. In any case, technological interventions add to the complexity of the systems and may interact with other system components in unforeseeable ways and often create opportunities for novel human errors. Consequently, there is a need to develop standards for evaluating the potential safety benefit of each of these intervention products so that resources can be effectively invested to produce the biggest benefit to flight safety as well as to mitigate any adverse ramifications. The purpose of this project was to help define the relationship between human error and technological interventions, with the ultimate goal of developing a set of standards for evaluating or measuring the potential benefits of new human error fixes.

ACCOUNTABILITY WITHIN NEW OZONE STANDARDS

EPA Science Inventory

Over the past two decades, as part of the effort to develop the National Ambient Air Quality Standards (NAAQS), researchers have been using real human exposure data to help analyze the magnitude and extent of the risks from specific or multiple pollutants. Surrogates for exposur...

Development of the Digital Arthritis Index, a Novel Metric to Measure Disease Parameters in a Rat Model of Rheumatoid Arthritis.

PubMed

Lim, Maria A; Louie, Brenton; Ford, Daniel; Heath, Kyle; Cha, Paulyn; Betts-Lacroix, Joe; Lum, Pek Yee; Robertson, Timothy L; Schaevitz, Laura

2017-01-01

Despite a broad spectrum of anti-arthritic drugs currently on the market, there is a constant demand to develop improved therapeutic agents. Efficient compound screening and rapid evaluation of treatment efficacy in animal models of rheumatoid arthritis (RA) can accelerate the development of clinical candidates. Compound screening by evaluation of disease phenotypes in animal models facilitates preclinical research by enhancing understanding of human pathophysiology; however, there is still a continuous need to improve methods for evaluating disease. Current clinical assessment methods are challenged by the subjective nature of scoring-based methods, time-consuming longitudinal experiments, and the requirement for better functional readouts with relevance to human disease. To address these needs, we developed a low-touch, digital platform for phenotyping preclinical rodent models of disease. As a proof-of-concept, we utilized the rat collagen-induced arthritis (CIA) model of RA and developed the Digital Arthritis Index (DAI), an objective and automated behavioral metric that does not require human-animal interaction during the measurement and calculation of disease parameters. The DAI detected the development of arthritis similar to standard in vivo methods, including ankle joint measurements and arthritis scores, as well as demonstrated a positive correlation to ankle joint histopathology. The DAI also determined responses to multiple standard-of-care (SOC) treatments and nine repurposed compounds predicted by the SMarTR TM Engine to have varying degrees of impact on RA. The disease profiles generated by the DAI complemented those generated by standard methods. The DAI is a highly reproducible and automated approach that can be used in-conjunction with standard methods for detecting RA disease progression and conducting phenotypic drug screens.

MEDICAL SCIENCE, RESEARCH AND HIGHER EDUCATION IN AZERBAIJAN FROM BIOETHICAL DEVELOPMENTS PERSPECTIVE

PubMed Central

VUGAR, MAMMADOV; KERIM, MUNIR; LALA, JAFAROVA

2017-01-01

Azerbaijan is a modern, rapidly developing democratic country at the crossroads of Europe and Asia. The country is currently harmonizing its national legislation with international norms, and reforming its national scientific and medical. Higher standards of medical research and education will enhance public health and protect human rights to life and health that are specified in Azerbaijan Constitution. In order to raise its medical research and education to international standards, Azerbaijani scientists and authorities are studying the experience of other countries and taking measures to implement international standards and norms in the country’s national legislation. Cooperation with the WHO, UNESCO and other international and foreign organizations, both on regional and global level is creating steps to achieve this goal. These steps include, for example, creation of the Azerbaijan unit of the UNESCO Chair in Bioethics and teaching bioethics based on UNESCO’s Bioethics Core Curriculum. Another step is providing research fellowship for young Azerbaijani professionals to study at leading medical research and educational centers around the world including Harvard Medical School and Boston Children’s Hospital in the USA, and Koc University in Turkey. A complementary step is the development of local bioethical research, including its legal, ethical and scientific foundations. Adherence to ethical principles in different spheres of life is currently one of the most challenging social and professional issues, especially, this is true with the development of new medical technologies in recent decades and the development of new ethical and legal standards, issues involving different areas of health and medicine and their relation to human rights. Bioethics in Azerbaijan is developing as an important field that deals with universal moral principles within the context of both national laws and the UNESCO Universal Declaration on Bioethics and Human Rights. PMID:28409020

21 CFR 812.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES..., to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain...

21 CFR 812.1 - Scope.

Code of Federal Regulations, 2012 CFR

2012-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES..., to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain...

21 CFR 812.1 - Scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES..., to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain...

21 CFR 812.1 - Scope.

Code of Federal Regulations, 2014 CFR

2014-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES..., to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain...

Next Generation Life Support (NGLS): High Performance EVA Glove (HPEG) Technology Development Element

NASA Technical Reports Server (NTRS)

Walsh, Sarah; Barta, Daniel; Stephan, Ryan; Gaddis, Stephen

2015-01-01

The overall objective is to develop advanced gloves for extra vehicular activity (EVA) for future human space exploration missions and generate corresponding standards by which progress may be quantitatively assessed. The glove prototypes that result from the successful completion of this technology development activity will be delivered to NASA's Human Exploration Operations Mission Directorate (HEOMD) and ultimately to be included in an integrated test with the next generation spacesuit currently under development.

A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions

PubMed Central

Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A

2013-01-01

Background If trials of therapeutic interventions are to serve society’s interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world’s nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial’s stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. PMID:21429960

A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions.

PubMed

Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A

2011-06-01

If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as 'core', 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.

NASA Technical Standards Program and Implications for Lessons Learned and Technical Standard Integration

NASA Technical Reports Server (NTRS)

Gill, Paul S.; Garcia, Danny; Vaughan, William W.; Parker, Nelson C. (Technical Monitor)

2002-01-01

The National Aeronautics and Space Agency consists of fourteen Facilities throughout the United States. They are organized to support the Agency's principal Enterprises: (1) Space Science, (2) Earth Science, (3) Aerospace Technology, (4) Human Exploration and Development of Space, and (5) Biological and Physical Research. Technical Standards are important to the activities of each Enterprise and have been an integral part in the development and operation of NASA Programs and Projects since the Agency was established in 1959. However, for years each Center was responsible for its own standards development and selection of non-NASA technical standards that met the needs of Programs and Projects for which they were responsible. There were few Agencywide applicable Technical Standards, mainly those in area of safety. Department of Defense Standards and Specifications were the foundation and main source for Technical Standards used by the Agency. This process existed until about 1997 when NASA embarked on a Program to convert NASA's Center-developed Technical Standards into Agencywide endorsed NASA Preferred Technical Standards. In addition, action was taken regarding the formal adoption of non-NASA Technical Standards (DOD, SAE, ASTM, ASME, IEEE, etc.) as NASA Preferred Technical Standards.

Liquid-liquid extraction of strongly protein bound BMS-299897 from human plasma and cerebrospinal fluid, followed by high-performance liquid chromatography/tandem mass spectrometry.

PubMed

Xue, Y J; Pursley, Janice; Arnold, Mark

2007-04-11

BMS-299897 is a gamma-secretase inhibitor that is being developed for the treatment of Alzheimer's disease. Liquid-liquid extraction (LLE), chromatographic/tandem mass spectrometry (LC/MS/MS) methods have been developed and validated for the quantitation of BMS-299897 in human plasma and cerebrospinal fluid (CSF). Both methods utilized (13)C6-BMS-299897, the stable label isotope analog, as the internal standard. For the human plasma extraction method, two incubation steps were required after the addition of 5 mM ammonium acetate and the internal standard in acetonitrile to release the analyte bound to proteins prior to LLE with toluene. For the human CSF extraction method, after the addition of 0.5 N HCl and the internal standard, CSF samples were extracted with toluene and no incubation was required. The organic layers obtained from both extraction methods were removed and evaporated to dryness. The residues were reconstituted and injected into the LC/MS/MS system. Chromatographic separation was achieved isocratically on a MetaChem C18 Hypersil BDS column (2.0 mm x 50 mm, 3 microm). The mobile phase contained 10 mM ammonium acetate pH 5 and acetonitrile. Detection was by negative ion electrospray tandem mass spectrometry. The standard curves ranged from 1 to 1000 ng/ml for human plasma and 0.25-100 ng/ml for human CSF. Both standard curves were fitted to a 1/x weighted quadratic regression model. For both methods, the intra-assay precision was within 8.2% CV, the inter-assay precision was within 5.4% CV, and assay accuracy was within +/-7.4% of the nominal values. The validation and sample analysis results demonstrated that both methods had acceptable precision and accuracy across the calibration ranges.

Child Rights as a Framework for Advancing Professional Standards for Practice, Ethics, and Professional Development in School Psychology

ERIC Educational Resources Information Center

Nastasi, Bonnie Kaul; Naser, Shereen

2014-01-01

The United Nations (1989) Convention on the Rights of the Child was designed to promote and protect the survival, development, and well-being of children, thus extending human rights to individuals from birth to age 18. This article examines the consistency of the Articles of the Convention with the professional standards for school psychology, as…

Developing Proactive Methods for General Aviation Data Collection

DTIC Science & Technology

2010-11-01

standard weather package that all pilots would review before flying. 17. Key Words 18. Distribution Statement General Aviation...completed page authorized iii ACKNOWLEDGMENTS We are indebted to the many Flight Standards District Office employees that provided assistance beyond...Directive / Level of Effort Agree- ment between the Human Factors Research and Engineering Group (AJP-61), Flight Standards Service – General Aviation

Collaborative studies on the development of national reference standards for potency determination of H7N9 influenza vaccine

PubMed Central

Li, Changgui; Xu, Kangwei; Hashem, Anwar; Shao, Ming; Liu, Shuzhen; Zou, Yong; Gao, Qiang; Zhang, Yongchao; Yuan, Liyong; Xu, Miao; Li, Xuguang; Wang, Junzhi

2015-01-01

The outbreak of human infections of a novel avian influenza virus A (H7N9) prompted the development of the vaccines against this virus. Like all types of influenza vaccines, H7N9 vaccine must be tested for its potency prior to being used in humans. However, the unavailability of international reference reagents for the potency determination of H7N9 vaccines substantially hinders the progress in vaccine development. To facilitate clinical development, we enlisted 5 participants in a collaborative study to develop critical reagents used in Single Radial Immunodiffusion (SRID), the currently acceptable assay for potency determination of influenza vaccine. Specifically, the hemagglutinin (HA) content of one vaccine bulk for influenza A (H7N9), herein designated as Primary Liquid Standard (PLS), was determined by SDS-PAGE. In addition, the freeze-dried antigen references derived from PLS were prepared to enhance the stability for long term storage. The final HA content of lyophilized antigen references were calibrated against PLS by SRID assay in a collaborative study. Importantly, application of these national reference standards to potency analyses greatly facilitated the development of H7N9 vaccines in China. PMID:25970793

Linking rights and standards: the process of developing "rights-based" minimum standards on food security, nutrition and food aid.

PubMed

Young, Helen; Taylor, Anna; Way, Sally-Anne; Leaning, Jennifer

2004-06-01

This article examines the recent revision of the Sphere Minimum Standards in disaster response relating to food security, nutrition and food aid. It describes how the revision attempted to incorporate the principles of the Humanitarian Charter, as well as relevant human rights principles and values into the Sphere Minimum Standards. The initial aim of the revision was to ensure that the Sphere Minimum Standards better reflected the principles embodied in the Humanitarian Charter. This was later broadened to ensure that key legal standards and principles from human rights and humanitarian law were considered and also incorporated, in part to fill the "protection gap" within the existing standards. In relation to the food security, nutrition and food aid standards, it was agreed by participants in the process that the human right to adequate food and freedom from hunger should be incorporated. In relation to more general principles underlying the Humanitarian Charter, itself drawn largely from human rights and humanitarian law, it was agreed that there was a need to strengthen "protection" elements within the standards and a need to incorporate the basic principles of the right to life with dignity, non-discrimination, impartiality and participation, as well as to explore the relevance of the concept of the progressive realisation of the right to food. The questions raised in linking rights to operational standards required thought, on the one hand, about whether the technical standards reflected a deep understanding of the values expressed within the legal instruments, and whether the existing standards were adequate in relation to those legal rights. On the other hand, it also required reflection on how operational standards like Sphere could give concrete content to human rights, such as the right to food and the right to be free from hunger. However, there remain challenges in examining what a rights-based approach will mean in terms of the role of humanitarian agencies as duty-bearers of rights, given that the primary responsibility rests with state governments. It will also require reflection on the modes and mechanisms of accountability that are brought to bear in ensuring the implementation of the Minimum Standards.

Proteomics Standards Initiative: Fifteen Years of Progress and Future Work

PubMed Central

2017-01-01

The Proteomics Standards Initiative (PSI) of the Human Proteome Organization (HUPO) has now been developing and promoting open community standards and software tools in the field of proteomics for 15 years. Under the guidance of the chair, cochairs, and other leadership positions, the PSI working groups are tasked with the development and maintenance of community standards via special workshops and ongoing work. Among the existing ratified standards, the PSI working groups continue to update PSI-MI XML, MITAB, mzML, mzIdentML, mzQuantML, mzTab, and the MIAPE (Minimum Information About a Proteomics Experiment) guidelines with the advance of new technologies and techniques. Furthermore, new standards are currently either in the final stages of completion (proBed and proBAM for proteogenomics results as well as PEFF) or in early stages of design (a spectral library standard format, a universal spectrum identifier, the qcML quality control format, and the Protein Expression Interface (PROXI) web services Application Programming Interface). In this work we review the current status of all of these aspects of the PSI, describe synergies with other efforts such as the ProteomeXchange Consortium, the Human Proteome Project, and the metabolomics community, and provide a look at future directions of the PSI. PMID:28849660

Proteomics Standards Initiative: Fifteen Years of Progress and Future Work.

PubMed

Deutsch, Eric W; Orchard, Sandra; Binz, Pierre-Alain; Bittremieux, Wout; Eisenacher, Martin; Hermjakob, Henning; Kawano, Shin; Lam, Henry; Mayer, Gerhard; Menschaert, Gerben; Perez-Riverol, Yasset; Salek, Reza M; Tabb, David L; Tenzer, Stefan; Vizcaíno, Juan Antonio; Walzer, Mathias; Jones, Andrew R

2017-12-01

The Proteomics Standards Initiative (PSI) of the Human Proteome Organization (HUPO) has now been developing and promoting open community standards and software tools in the field of proteomics for 15 years. Under the guidance of the chair, cochairs, and other leadership positions, the PSI working groups are tasked with the development and maintenance of community standards via special workshops and ongoing work. Among the existing ratified standards, the PSI working groups continue to update PSI-MI XML, MITAB, mzML, mzIdentML, mzQuantML, mzTab, and the MIAPE (Minimum Information About a Proteomics Experiment) guidelines with the advance of new technologies and techniques. Furthermore, new standards are currently either in the final stages of completion (proBed and proBAM for proteogenomics results as well as PEFF) or in early stages of design (a spectral library standard format, a universal spectrum identifier, the qcML quality control format, and the Protein Expression Interface (PROXI) web services Application Programming Interface). In this work we review the current status of all of these aspects of the PSI, describe synergies with other efforts such as the ProteomeXchange Consortium, the Human Proteome Project, and the metabolomics community, and provide a look at future directions of the PSI.

Incidence and Mortality of Testicular Cancer and Relationships with Development in Asia.

PubMed

Sadeghi, Mostafa; Ghoncheh, Mahshid; Mohammadian-Hafshejani, Abdollah; Gandomani, Hamidreza Sadeghi; Rafiemanesh, Hosein; Salehiniya, Hamid

2016-01-01

Testicular cancer is one of the most common cancers among young men between ages 20-34 in countries with high or very high levels of the Human Development Index (HDI). This study investigated the incidence and mortality of prostate cancer and the relationship with the HDI and its dimensions in Asia in 2012. The study was conducted based on data from the world data of cancer and the World Bank (including the HDI and its components). Standardized incidence and mortality rates of testicular cancer were calculated for Asian countries. Correlations between incidence and/ormortality rates, and the HDI and its components were assessed with the use of the correlation test, using SPSS software. There was a total of 14902 incidences and 5832 death were recorded in Asian countries in 2012. Among the Asian countries, the five countries with the highest standardized incidence rates of testicular cancer were Israel, Georgia, Turkey, Lebanon and Kazakhstan and the five countries with the highest standardized mortality rates were Turkey, Georgia, Jordan, Cambodia and the Syrian Arab Republic. A positive correlation of 0.382 was observed between the standardized incidence rates of testicular cancer and the HDI (p=0.009). Also a negative correlation of 0.298 between the standardized mortality rate of testicular cancer and the Human Development Index was noted although this relation was statistically non-significant (p=0.052). There is a positive correlation between HDI and the standardized incidence rate of testicular cancer and negative correlation with standardized mortality rate.

Human milk and infant formula can induce in vitro adipocyte differentiation in murine 3T3-L1 preadipocytes.

PubMed

Lyle, R E; Corley, J D; McGehee, R E

1998-11-01

The potential of infant diet to influence fat cell development has largely been examined in clinical studies with conflicting results. In this study, the direct effects of two standard infant formulas, Enfamil and Similac, as well as human milk were examined using a well characterized model of adipocyte differentiation, the 3T3-L1 murine preadipocyte cell line. After exposure to a hormonal regimen of insulin, dexamethasone, and 1-methyl-3-isobutylmethylxanthine, these cells undergo a mitotic expansion phase followed by terminal differentiation. On d 4 of hormonal exposure, greater than 95% of 3T3-L1 cells exhibit the morphologic and biochemical characteristics of mature adipocytes. In this study, cells were exposed to control medium, or control medium supplemented with either 10% Enfamil, 10% Similac, 10% human milk (skim or whole), or the standard hormonal regimen. Oil Red O-detectable lipid accumulation, immunocytochemical cell proliferation assays, and activated expression of adipocyte differentiation-specific mRNAs by Northern blot analysis were used to assess the effects of treatment on adipocyte differentiation. Results from each level of assessment revealed that both Enfamil and human milk were as effective as the standard hormonal regimen at stimulating adipocyte differentiation. In contrast, results from treatment with Similac or human skim milk were indistinguishable from control unstimulated cells. This study, demonstrating that Enfamil and human milk are capable of independently inducing in vitro adipocyte differentiation, suggests that diet during infancy could influence body fat development.

Biobanking human endometrial tissue and blood specimens: standard operating procedure and importance to reproductive biology research and diagnostic development.

PubMed

Sheldon, Elizabeth; Vo, Kim Chi; McIntire, Ramsey A; Aghajanova, Lusine; Zelenko, Zara; Irwin, Juan C; Giudice, Linda C

2011-05-01

To develop a standard operating procedure (SOP) for collection, transport, storage of human endometrial tissue and blood samples, subject and specimen annotation, and establishing sample priorities. The SOP synthesizes sound scientific procedures, the literature on ischemia research, sample collection and gene expression profiling, good laboratory practices, and the authors' experience of workflow and sample quality. The National Institutes of Health, University of California, San Francisco, Human Endometrial Tissue and DNA Bank. Women undergoing endometrial biopsy or hysterectomy for nonmalignant indications. Collecting, processing, storing, distributing endometrial tissue and blood samples under approved institutional review board protocols and written informed consent from participating subjects. Standard operating procedure. The SOP addresses rigorous and consistent subject annotation, specimen processing and characterization, strict regulatory compliance, and a reference for researchers to track collection and storage times that may influence their research. The comprehensive and systematic approach to the procurement of human blood and endometrial tissue in this SOP ensures the high quality, reliability, and scientific usefulness of biospecimens made available to investigators by the National Institutes of Health, University of California, San Francisco, Human Endometrial Tissue and DNA Bank. The detail and perspective in this SOP also provides a blueprint for implementation of similar collection programs at other institutions. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

DEVELOPMENT OF A MODEL FOR REAL TIME CO CONCENTRATIONS NEAR ROADWAYS

EPA Science Inventory

Although emission standards for mobile sources continue to be tightened, tailpipe emissions in urban areas continue to be a major source of human exposure to air toxics. Current human exposure models using simplified assumptions based on fixed air monitoring stations and region...

A tool kit for evaluating electronic flight bags

DOT National Transportation Integrated Search

2006-09-01

Over the past few years, the Volpe Center has developed a set of five tools that can be used to evaluate Electronic Flight Bags (EFBs) from a human factors perspective. The goal of these tools is to help streamline and standardize EFB human factors a...

Screening Vaccine Formulations in Fresh Human Whole Blood.

PubMed

Hakimi, Jalil; Aboutorabian, Sepideh; To, Frederick; Ausar, Salvador F; Rahman, Nausheen; Brookes, Roger H

2017-01-01

Monitoring the immunological functionality of vaccine formulations is critical for vaccine development. While the traditional approach using established animal models has been relatively effective, the use of animals is costly and cumbersome, and animal models are not always reflective of a human response. The development of a human-based approach would be a major step forward in understanding how vaccine formulations might behave in humans. Here, we describe a platform methodology using fresh human whole blood (hWB) to monitor adjuvant-modulated, antigen-specific responses to vaccine formulations, which is amenable to analysis by standard immunoassays as well as a variety of other analytical techniques.

NASA Occupant Protection Standards Development

NASA Technical Reports Server (NTRS)

Somers, Jeffrey; Gernhardt, Michael; Lawrence, Charles

2012-01-01

Historically, spacecraft landing systems have been tested with human volunteers, because analytical methods for estimating injury risk were insufficient. These tests were conducted with flight-like suits and seats to verify the safety of the landing systems. Currently, NASA uses the Brinkley Dynamic Response Index to estimate injury risk, although applying it to the NASA environment has drawbacks: (1) Does not indicate severity or anatomical location of injury (2) Unclear if model applies to NASA applications. Because of these limitations, a new validated, analytical approach was desired. Leveraging off of the current state of the art in automotive safety and racing, a new approach was developed. The approach has several aspects: (1) Define the acceptable level of injury risk by injury severity (2) Determine the appropriate human surrogate for testing and modeling (3) Mine existing human injury data to determine appropriate Injury Assessment Reference Values (IARV). (4) Rigorously Validate the IARVs with sub-injurious human testing (5) Use validated IARVs to update standards and vehicle requirement

Rules and Regulations That Impact Children's Health

EPA Pesticide Factsheets

EPA is committed to considering risks to children in developing standards to protect human health and the environment through rulemaking guidance, transparency in regulatory development, and rules and actions for air, water, and chemical safety.

Validation of an optimized method for the determination of iodine in human breast milk by inductively coupled plasma mass spectrometry (ICPMS) after tetramethylammonium hydroxide extraction.

PubMed

Huynh, Dao; Zhou, Shao Jia; Gibson, Robert; Palmer, Lyndon; Muhlhausler, Beverly

2015-01-01

In this study a novel method to determine iodine concentrations in human breast milk was developed and validated. The iodine was analyzed by inductively coupled plasma mass spectrometry (ICPMS) following tetramethylammonium hydroxide (TMAH) extraction at 90°C in disposable polypropylene tubes. While similar approaches have been used previously, this method adopted a shorter extraction time (1h vs. 3h) and used antimony (Sb) as the internal standard, which exhibited greater stability in breast milk and milk powder matrices compared to tellurium (Te). Method validation included: defining iodine linearity up to 200μgL(-1); confirming recovery of iodine from NIST 1549 milk powder. A recovery of 94-98% was also achieved for the NIST 1549 milk powder and human breast milk samples spiked with sodium iodide and thyroxine (T4) solutions. The method quantitation limit (MQL) for human breast milk was 1.6μgL(-1). The intra-assay and inter-assay coefficient of variation for the breast milk samples and NIST powder were <1% and <3.5%, respectively. NIST 1549 milk powder, human breast milk samples and calibration standards spiked with the internal standard were all stable for at least 2.5 months after extraction. The results of the validation process confirmed that this newly developed method provides greater accuracy and precision in the assessment of iodine concentrations in human breast milk than previous methods and therefore offers a more reliable approach for assessing iodine concentrations in human breast milk. Copyright © 2014 Elsevier GmbH. All rights reserved.

Development of a standardized battery of performance tests for the assessment of noise stress effects

NASA Technical Reports Server (NTRS)

Theologus, G. C.; Wheaton, G. R.; Mirabella, A.; Brahlek, R. E.

1973-01-01

A set of 36 relatively independent categories of human performance were identified. These categories encompass human performance in the cognitive, perceptual, and psychomotor areas, and include diagnostic measures and sensitive performance metrics. Then a prototype standardized test battery was constructed, and research was conducted to obtain information on the sensitivity of the tests to stress, the sensitivity of selected categories of performance degradation, the time course of stress effects on each of the selected tests, and the learning curves associated with each test. A research project utilizing a three factor partially repeated analysis of covariance design was conducted in which 60 male subjects were exposed to variations in noise level and quality during performance testing. Effects of randomly intermittent noise on performance of the reaction time tests were observed, but most of the other performance tests showed consistent stability. The results of 14 analyses of covariance of the data taken from the performance of the 60 subjects on the prototype standardized test battery provided information which will enable the final development and test of a standardized test battery and the associated development of differential sensitivity metrics and diagnostic classificatory system.

Materials and Process Specifications and Standards

DTIC Science & Technology

1977-11-01

Integrity Requirements; Fracture Control 65 5.9.3 Some Special Problems in Electronic 66 Materials Specifications 5.9.3.1 Thermal Stresses 66...fatigue and fracture and by defining human engineering concepts. Conform to OSHA regulations such as toxicity, noise levels etc. Develop...Standardization Society of the Valves and Fittings Industry. 41 4.6.2.4 OTHER ORGANIZATIONS There are a number of standards-making organizations that cannot

Development and application of Human Genome Epidemiology

NASA Astrophysics Data System (ADS)

Xu, Jingwen

2017-12-01

Epidemiology is a science that studies distribution of diseases and health in population and its influencing factors, it also studies how to prevent and cure disease and promote health strategies and measures. Epidemiology has developed rapidly in recent years and it is an intercross subject with various other disciplines to form a series of branch disciplines such as Genetic epidemiology, molecular epidemiology, drug epidemiology and tumor epidemiology. With the implementation and completion of Human Genome Project (HGP), Human Genome Epidemiology (HuGE) has emerged at this historic moment. In this review, the development of Human Genome Epidemiology, research content, the construction and structure of relevant network, research standards, as well as the existing results and problems are briefly outlined.

Prevalidation of a human cornea construct as an alternative to animal corneas for in vitro drug absorption studies.

PubMed

Hahne, Matthias; Zorn-Kruppa, Michaela; Guzman, Gustavo; Brandner, Johanna M; Haltner-Ukomado, Eleonore; Wätzig, Hermann; Reichl, Stephan

2012-08-01

The use of ophthalmic drugs has increased consistently over the past few decades. Currently, most research is conducted using in vivo and ex vivo animal experiments; however, they have many disadvantages, including ethical concerns, high costs, the questionable extension of animal results to humans, and poor standardization. Although several cell culture-based cornea models have been developed, none have been validated and accepted for general use. In this study, a standardized, three-dimensional model of the human cornea (Hemicornea, HC) based on immortalized human corneal cells and cultivated in serum-free conditions was developed for drug absorption studies and prevalidated using compounds with a wide range of molecular characteristics (sodium fluorescein, rhodamine B, fluorescein isothiocyanate-labeled dextran, aciclovir, bimatoprost, dexamethasone, and timolol maleate). The HC model was independently cultured in three different laboratories, and the intralaboratory and interlaboratory reproducibility was analyzed and compared with the rabbit cornea. This analysis showed that the HC has a barrier in the same range as excised animal corneas, although with a higher reproducibility and lower variability. Because of the demonstrated transferability, the HC represents a promising in vitro alternative to the use of ex vivo tissue and offers a well-defined and standardized system for drug absorption studies. Copyright © 2012 Wiley Periodicals, Inc.

50 CFR 600.355 - National Standard 10-Safety of Life at Sea.

Code of Federal Regulations, 2011 CFR

2011-10-01

... measures shall, to the extent practicable, promote the safety of human life at sea. (b) General. (1... considered the same as “safety of human life at sea. The safety of a vessel and the people aboard is... their development to ensure they recognize any impact on the safety of human life at sea and minimize or...

Human factors considerations in the design and evaluation of moving map displays of ownership on the airport surface

DOT National Transportation Integrated Search

2004-09-01

The Federal Aviation Administration (FAA) has requested human factors guidance to support the new moving map Technical Standard Order (TSO)-C165, Electronic Map Display Equipment for Graphical Depiction of Aircraft Position. This document was develop...

75 FR 79328 - Technical Corrections to the Standards Applicable to Generators of Hazardous Waste; Alternative...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

..., 541710 Research and Development in the Physical, Engineering, and Life Sciences. 54172, 541720 Research and Development in the Social Sciences and Humanities. III. Statutory and Executive Order Reviews For...

Developing human rights based indicators to support country monitoring of rehabilitation services and programmes for people with disabilities: a study protocol.

PubMed

Skempes, Dimitrios; Bickenbach, Jerome

2015-09-24

Rehabilitation care is fundamental to health and human dignity and a human right enshrined in the United Nations Convention on the Rights of Persons with Disabilities. The provision of rehabilitation is important for reducing the need for formal support and enabling persons with disabilities to lead an independent life. Increasingly scholars and advocacy groups voice concerns over the significant barriers facing people with disabilities in accessing appropriate and quality rehabilitation. A growing body of research highlights a "respond-need" gap in the provision of rehabilitation and assistive technologies and underscore the lack of indicators for assessing performance of rehabilitation systems and monitoring States compliance with human rights standards in rehabilitation service planning and programming. While research on human rights and health monitoring has increased exponentially over the last decade far too little attention has been paid to rehabilitation services. The proposed research aims to reduce this knowledge gap by developing a human rights based monitoring framework with indicators to support human rights accountability and performance assessment in rehabilitation. Concept mapping, a stakeholder-driven approach will be used as the core method to identify rights based indicators and develop the rehabilitation services monitoring framework. Concept mapping requires participants from various stakeholders groups to generate a list of the potential indicators through on line brainstorming, sort the indicators for conceptual similarity into clusters and rate them against predefined criteria. Multidimensional scaling and hierarchical cluster data analysis will be performed to develop the monitoring framework while bridging analysis will provide useful insights about patterns of agreement or disagreement among participants views on indicators. This study has the potential to influence future practices on data collection and measurement of compliance with human rights standards in rehabilitation service delivery and organization. The development of a valid and universally applicable set of indicators will have a profound impact on the design and implementation of evidence informed disability policies and programs as it can support countries in strengthening performance measurement through documentation of comparative information on rehabilitation care systems. Most importantly, the resulting indicators can be used by disabled people's organizations as well as national and international institutions to define a minimal standard for monitoring and reporting progress on the implementation of the Convention on the Rights of Persons with Disabilities in the area of rehabilitation.

Human System Risk Management for Space Flight

NASA Technical Reports Server (NTRS)

Davis, Jeffrey

2015-01-01

This brief abstract reviews the development of the current day approach to human system risk management for space flight and the development of the critical components of this process over the past few years. The human system risk management process now provides a comprehensive assessment of each human system risk by design reference mission (DRM) and is evaluated not only for mission success but also for long-term health impacts for the astronauts. The discipline of bioastronautics is the study of the biological and medical effects of space flight on humans. In 1997, the Space Life Sciences Directorate (SLSD) initiated the Bioastronautics Roadmap (Roadmap) as the "Critical Path Roadmap", and in 1998 participation in the roadmap was expanded to include the National Space Biomedical Research Institute (NSBRI) and the external community. A total of 55 risks and 250 questions were identified and prioritized and in 2000, the Roadmap was base-lined and put under configuration control. The Roadmap took into account several major advisory committee reviews including the Institute of Medicine (IOM) "Safe Passage: Astronaut care for Exploration Missions", 2001. Subsequently, three collaborating organizations at NASA HQ (Chief Health and Medical Officer, Office of Space Flight and Office of Biological & Physical Research), published the Bioastronautics Strategy in 2003, that identified the human as a "critical subsystem of space flight" and noted that "tolerance limits and safe operating bands must be established" to enable human space flight. These offices also requested a review by the IOM of the Roadmap and that review was published in October 2005 as "A Risk Reduction Strategy for Human Exploration of Space: A Review of NASA's Bioastronautics Roadmap", that noted several strengths and weaknesses of the Roadmap and made several recommendations. In parallel with the development of the Roadmap, the Office of the Chief Health and Medical Officer (OCHMO) began a process in 2004 of evaluating the tolerance limits and safe operating bands called for in the Bioastronautics Strategy. Over the next several years, the concept of the "operating bands" were turned into Space Flight Human System Standards (SFHSS), developed by the technical resources of the SLSD at the NASA Johnson Space Center (JSC). These standards were developed and reviewed at the SLSD and then presented to the OCHMO for acceptance. The first set of standards was published in 2007 as the NASA-STD-3001, Volume 1, Crew Health that elaborated standards for several physiological areas such as cardiovascular, musculoskeletal, radiation exposure and nutrition. Volume 2, Human Factors, Habitability and Human Health was published in 2011, along with development guidance in the Human Integration Design Handbook (HIDH). Taken together, the SFHSS Volumes 1 and 2, and the HIDH replaced the NASA-STD-3000 with new standards and revisions of the older document. Three other changes were also taking place that facilitated the development of the human system risk management approach. In 2005, the life sciences research and development portfolio underwent a comprehensive review through the Exploration Systems Architecture Study (ESAS) that resulted in the reformulation of the Bioastronautics Program into Human Research Program (HRP) that was focused on appropriate mitigation results for high priority human health risks. The baseline HRP budget was established in August 2005. In addition, the OCHMO formulated the Health and Medical Technical Authority (HMTA) in 2006 that established the position of the Chief Medical Officer (CMO) at the NASA JSC along with other key technical disciplines, and the OCHMO became the responsible office for the SFHSS as noted above. The final change was the establishment in 2008 of the Human System Risk Board (HSRB), chaired by the CMO with representation from the HRP, SLSD management and technical experts. The HSRB then began to review all human system risks, established a comprehensive risk management and configuration management plan and data sharing policy. These major developments of standards, the HRP, the HMTA and a forum for review of human system risks (HSRB) facilitated the integration of human research, medical operations, systems engineering and many other disciplines in the comprehensive review of human system risks. The HSRB began a comprehensive review of all potential inflight medical conditions and events and over the course of several reviews consolidated the number of human system risks to 30 where the greatest emphasis is placed for investing program dollars for risk mitigation. The HSRB considers all available evidence from human research, medical operations and occupational surveillance in assessing the risks for appropriate mitigation and future work. All applicable DRMs (low earth orbit 6 and 12 months, deep space sortie for 30 days and 1 year, a one year lunar mission, and a planetary mission for 3 years) are considered as human system risks are modified by the hazards associated with space flight such as microgravity, exposure to radiation, distance from the earth, isolation and a closed environment. Each risk has a summary assessment representing the state of knowledge/evidence base for that risk, the available risk mitigations, traceability to the SFHSS and program requirements, and future work required. These data then can drive coordinated budgets across the HRP, the International Space Station, Crew Health and Safety and Advanced Exploration System budgets. These risk assessments were completed for 6 DRMs in December of 2014 and serve as the baseline for which subsequent research and technology development and crew health care portfolios can be assessed. The HSRB will review each risk at least annually and especially when new information is available that must be considered for effective risk mitigation. The current status of each risk can be reported to program management for operations, budget reviews and general oversight of the human system risk management program.

Enhancing Leadership and Governance Competencies to Strengthen Health Systems in Nigeria: Assessment of Organizational Human Resources Development

PubMed Central

Uneke, Chigozie J.; Ezeoha, Abel E.; Ndukwe, Chinwendu D.; Oyibo, Patrick G.; Onwe, Fri Day

2012-01-01

The lack of effective leadership and governance in the health sector has remained a major challenge in Nigeria and contributes to the failure of health systems and poor development of human resources. In this cross-sectional intervention study, leadership and governance competencies of policy makers were enhanced through a training workshop, and an assessment was conducted of organizational activities designed to promote evidence-informed leadership and governance to improve human resources for health (HRH). The training workshop increased the understanding of policy makers with regard to leadership and governance factors that ensure the functionality of health systems and improve human resources development, including policy guidance, intelligence and oversight, collaboration and coalition building, regulation, system design and accountability. Findings indicated that systems for human resources development exist in all participants' organizations, but the functionality of these systems was suboptimal. More systematic and standardized processes are required to improve competencies of leadership and governance for better human resources development in low-income settings. PMID:23372582

American lifelines alliance efforts to improve electric power transmission reliability

USGS Publications Warehouse

Nishenko, S.P.; Savage, W.U.; Honegger, D.G.; McLane, T.R.; ,

2002-01-01

A study was performed on American Lifelines Alliance (ALA) efforts to improve electric power transmission reliability. ALA is a public-private partnership project, with the goal of reducing risks to lifelines from natural hazards and human threat events. The mechanism used by ALA for developing national guidelines for lifeline systems is dependent upon using existing Standards Developing Organizations (SDO) accredited by the American National Standards Institute (ANSI) as means to achieve national consensus.

Ebola Virus Genome Plasticity as a Marker of Its Passaging History: A Comparison of In Vitro Passaging to Non-Human Primate Infection

DTIC Science & Technology

2012-11-28

Simulation Sciences Branch, United States Army Research Laboratory , Aberdeen Proving Ground, Maryland, United States of America Abstract To identify...culture and may support filovirus stock standardization for medical countermeasure development. Citation: Kugelman JR, Lee MS, Rossi CA, McCarthy SE...support filovirus stock standardization for medical countermeasure development. 15. SUBJECT TERMS 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF

DEVELOPMENT OF A MICROSCALE EMISSION FACTOR MODEL FOR PARTICULATE MATTER (MICROFACPM) FOR PREDICTING REAL TIME MOTOR VEHICLE EMISSIONS

EPA Science Inventory

Health risk evaluation needs precise measurement and modeling of human exposures in microenvironments to support review of current air quality standards. The particulate matter emissions from motor vehicles are a major component of human exposures in urban microenvironments. Cu...

The Impact of Conditional Cash Transfer Programs on Human Capital Accumulation

ERIC Educational Resources Information Center

Latham, James David Michael

2013-01-01

Conditional cash transfer (CCT) programs are increasingly being used through the developing world to reduce inequality, break the intergenerational poverty cycle, and build human capital. These programs vary by country but typically make cash transfers conditional upon children meeting certain healthcare and educational standards. While previous…

Dawn of Aurora kinase inhibitors as anticancer drugs.

PubMed

Doggrell, Sheila A

2004-09-01

With the current standard chemotherapy regimens only approximately 25% of acute myelogenous leukaemia (AML) patients survive > 5 years. Aurora kinases are overexpressed in many human cancers. VX-680 inhibited Aurora-A, -B, -C and the FMS-like tyrosine kinase-3 with apparent inhibitory constants of 0.6, 18, 4.6 and 30 nM, respectively. In primary leukaemia cells from patients with AML, which were refractory to standard therapies, VX-680 inhibited colony formation. In nude mice, VX-680 markedly reduced human AML tumours. The development of VX-680 for use in AML should continue.

Genomic Sequence Variation Markup Language (GSVML).

PubMed

Nakaya, Jun; Kimura, Michio; Hiroi, Kaei; Ido, Keisuke; Yang, Woosung; Tanaka, Hiroshi

2010-02-01

With the aim of making good use of internationally accumulated genomic sequence variation data, which is increasing rapidly due to the explosive amount of genomic research at present, the development of an interoperable data exchange format and its international standardization are necessary. Genomic Sequence Variation Markup Language (GSVML) will focus on genomic sequence variation data and human health applications, such as gene based medicine or pharmacogenomics. We developed GSVML through eight steps, based on case analysis and domain investigations. By focusing on the design scope to human health applications and genomic sequence variation, we attempted to eliminate ambiguity and to ensure practicability. We intended to satisfy the requirements derived from the use case analysis of human-based clinical genomic applications. Based on database investigations, we attempted to minimize the redundancy of the data format, while maximizing the data covering range. We also attempted to ensure communication and interface ability with other Markup Languages, for exchange of omics data among various omics researchers or facilities. The interface ability with developing clinical standards, such as the Health Level Seven Genotype Information model, was analyzed. We developed the human health-oriented GSVML comprising variation data, direct annotation, and indirect annotation categories; the variation data category is required, while the direct and indirect annotation categories are optional. The annotation categories contain omics and clinical information, and have internal relationships. For designing, we examined 6 cases for three criteria as human health application and 15 data elements for three criteria as data formats for genomic sequence variation data exchange. The data format of five international SNP databases and six Markup Languages and the interface ability to the Health Level Seven Genotype Model in terms of 317 items were investigated. GSVML was developed as a potential data exchanging format for genomic sequence variation data exchange focusing on human health applications. The international standardization of GSVML is necessary, and is currently underway. GSVML can be applied to enhance the utilization of genomic sequence variation data worldwide by providing a communicable platform between clinical and research applications. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

Assessment of a human computer interface prototyping environment

NASA Technical Reports Server (NTRS)

Moore, Loretta A.

1993-01-01

A Human Computer Interface (HCI) prototyping environment with embedded evaluation capability has been successfully assessed which will be valuable in developing and refining HCI standards and evaluating program/project interface development, especially Space Station Freedom on-board displays for payload operations. The HCI prototyping environment is designed to include four components: (1) a HCI format development tool, (2) a test and evaluation simulator development tool, (3) a dynamic, interactive interface between the HCI prototype and simulator, and (4) an embedded evaluation capability to evaluate the adequacy of an HCI based on a user's performance.

Development of KRISS standard reference photometer (SRP) for ambient ozone measurement

NASA Astrophysics Data System (ADS)

Lee, S.; Lee, J.

2014-12-01

Surface ozone has adverse impacts on human health and ecosystem. Accurate measurement of ambient ozone concentration is essential for developing effective mitigation strategies and understanding atmospheric chemistry. Korea Research Institute of Standards and Science (KRISS) has developed new ozone standard reference photometers (SRPs) for the calibration of ambient ozone instruments. The basic principle of the KRISS ozone SRPs is to determine the absorption of ultraviolet radiation at a specific wavelength, 253.7 nm, by ozone in the atmosphere. Ozone concentration is calculated by converting UV transmittance through the Beer-Lambert Law. This study introduces the newly developed ozone SRPs and characterizes their performance through uncertainty analysis and comparison with BIPM (International Bureau of Weights and Measures) SRP.

Operational forecasting of human-biometeorological conditions

NASA Astrophysics Data System (ADS)

Giannaros, T. M.; Lagouvardos, K.; Kotroni, V.; Matzarakis, A.

2018-03-01

This paper presents the development of an operational forecasting service focusing on human-biometeorological conditions. The service is based on the coupling of numerical weather prediction models with an advanced human-biometeorological model. Human thermal perception and stress forecasts are issued on a daily basis for Greece, in both point and gridded format. A user-friendly presentation approach is adopted for communicating the forecasts to the public via the worldwide web. The development of the presented service highlights the feasibility of replacing standard meteorological parameters and/or indices used in operational weather forecasting activities for assessing the thermal environment. This is of particular significance for providing effective, human-biometeorology-oriented, warnings for both heat waves and cold outbreaks.

Improving sexuality education: the development of teacher-preparation standards.

PubMed

Barr, Elissa M; Goldfarb, Eva S; Russell, Susan; Seabert, Denise; Wallen, Michele; Wilson, Kelly L

2014-06-01

Teaching sexuality education to support young people's sexual development and overall sexual health is both needed and supported. Data continue to highlight the high rates of teen pregnancy, sexually transmitted disease, including human immunodeficiency virus (HIV) infections, among young people in the United States as well as the overwhelming public support for sexuality education instruction. In support of the implementation of the National Sexuality Education Standards, the current effort focuses on better preparing teachers to deliver sexuality education. An expert panel was convened by the Future of Sex Education Initiative to develop teacher-preparation standards for sexuality education. Their task was to develop standards and indicators that addressed the unique elements intrinsic to sexuality education instruction. Seven standards and associated indicators were developed that address professional disposition, diversity and equity, content knowledge, legal and professional ethics, planning, implementation, and assessment. The National Teacher-Preparation Standards for Sexuality Education represent an unprecedented unified effort to enable prospective health education teachers to become competent in teaching methodology, theory, practice of pedagogy, content, and skills, specific to sexuality education. Higher education will play a key role in ensuring the success of these standards. © 2014, American School Health Association.

Colorado Model Content Standards for Theatre: Voluntary Theatre Standards.

ERIC Educational Resources Information Center

Colorado State Dept. of Education, Denver.

Theater, the imagined and enacted world of human beings, is one of the primary ways children learn about life--about actions and consequences, about customs and beliefs, about others and themselves. Theater arts benefit the student because they cultivate the whole person, gradually building many kinds of literacy while developing intuition,…

Fostering Ethical Practice in HRD: Towards an Ethic of the Inner Voice

ERIC Educational Resources Information Center

Dirkx, John M.

2005-01-01

Recent development and dissemination of ethical standards for AHRD help focus attention on the ethical and moral foundations of the field. Attention to explicit standards, however, reflects an enduring commitment to an overarching ethic of rationality that denies or minimizes the dynamics, complexities, and depths of the human and organizational…

Pediatric Terminology

Cancer.gov

The National Institute of Child Health and Human Development (NICHD) works with NCI Enterprise Vocabulary Services (EVS) to provide standardized terminology for coding pediatric clinical trials and other research activities.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gardner, S.

Louisiana, now in a developmental stage of policy and planning, has completed a project aimed at reducing hazardous releases of air toxics in thee state. The state is also conducting a Comparative Risk Project and is using risk assessment practices to develop its waste quality standards. In developing an air toxic list, Louisiana incorporated four major criteria into the ranking: emission levels, human health effects, potential population exposure, and persistence or accumulation in the environment. For the human health effects criterion, data for each substance was gathered from numerous sources, although the Integrated Risk Information System (IRIS) database was usedmore » as a primary source for toxicological information. Following guidelines established by the Environmental Protection Agency (EPA), the Office of Water Resources, Water Pollution Control Division, has developed numerical criteria for human health protection based on risk assessment procedures in the 1989 Water Quality Standards Revision. Currently over 30 toxic substances have risk-based criteria for th protection of human health in the standards. Numerical criteria were calculated for carcinogenic substances having an EPA Classification of A, B1, B2, or C. Cancer class designations along with cancer potency slopes and reference doses were extracted from the IRIS database, with the exception of those chemicals that had not been assessed in IRIS as of December 1, 1988. The parameters necessary for calculating human health criteria for the missing chemicals were taken from 1980, 1984, and 1985 ambient water quality criteria documents: data on bioconcentration factors were included. Currently, Louisiana is working on a Comparative Risk Project, a ranking of the environmental issues in the state relative to potential risk to the public, which is the basis for a widespread 1991 public outreach effort.« less

Critical Software for Human Spaceflight

NASA Technical Reports Server (NTRS)

Preden, Antonio; Kaschner, Jens; Rettig, Felix; Rodriggs, Michael

2017-01-01

The NASA Orion vehicle that will fly to the moon in the next years is propelled along its mission by the European Service Module (ESM), developed by ESA and its prime contractor Airbus Defense and Space. This paper describes the development of the Propulsion Drive Electronics (PDE) Software that provides the interface between the propulsion hardware of the European Service Module with the Orion flight computers, and highlights the challenges that have been faced during the development. Particularly, the specific aspects relevant to Human Spaceflight in an international cooperation are presented, as the compliance to both European and US standards and the software criticality classification to the highest category A. An innovative aspect of the PDE SW is its Time- Triggered Ethernet interface with the Orion Flight Computers, which has never been flown so far on any European spacecraft. Finally the verification aspects are presented, applying the most exigent quality requirements defined in the European Cooperation for Space Standardization (ECSS) standards such as the structural coverage analysis of the object code and the recourse to an independent software verification and validation activity carried on in parallel by a different team.

Environmental pollutants and dysregulation of male puberty--a comparison among species.

PubMed

Magnusson, Ulf; Ljungvall, Karl

2014-04-01

The scientific literature on altered onset of puberty predominantly involves studies on females. This paper reviews current knowledge on the role of environmental pollutants in dysregulation of male puberty in humans, laboratory rodents and farm animals. The methods used to determine the onset of puberty are well developed in humans and farm animals, and standardized across studies in humans. In laboratory rodents standardized external morphological endpoints are used. There is an increasing weight of evidence from epidemiological studies in humans, as well as from experiments in animals, indicating that environmental pollutants dysregulate puberty in males. Most data are from studies on "classical" persistent environmental pollutants. Assessing the effect of multichemical environmental pollution on dysregulation of puberty in humans is more challenging; further solid epidemiological data would likely contribute most to our understanding, especially if combined with systematically collected field-data from selected wildlife. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

A standardized kit for automated quantitative assessment of candidate protein biomarkers in human plasma.

PubMed

Percy, Andrew J; Mohammed, Yassene; Yang, Juncong; Borchers, Christoph H

2015-12-01

An increasingly popular mass spectrometry-based quantitative approach for health-related research in the biomedical field involves the use of stable isotope-labeled standards (SIS) and multiple/selected reaction monitoring (MRM/SRM). To improve inter-laboratory precision and enable more widespread use of this 'absolute' quantitative technique in disease-biomarker assessment studies, methods must be standardized. Results/methodology: Using this MRM-with-SIS-peptide approach, we developed an automated method (encompassing sample preparation, processing and analysis) for quantifying 76 candidate protein markers (spanning >4 orders of magnitude in concentration) in neat human plasma. The assembled biomarker assessment kit - the 'BAK-76' - contains the essential materials (SIS mixes), methods (for acquisition and analysis), and tools (Qualis-SIS software) for performing biomarker discovery or verification studies in a rapid and standardized manner.

Nanoparticles in medicine: Current challenges facing inorganic nanoparticle toxicity assessments and standardizations.

PubMed

Hofmann-Amtenbrink, Margarethe; Grainger, David W; Hofmann, Heinrich

2015-10-01

Although nanoparticles research is ongoing since more than 30years, the development of methods and standard protocols required for their safety and efficacy testing for human use is still in development. The review covers questions on toxicity, safety, risk and legal issues over the lifecycle of inorganic nanoparticles for medical applications. The following topics were covered: (i) In vitro tests may give only a very first indication of possible toxicity as in the actual methods interactions at systemic level are mainly neglected; (ii) the science-driven and the regulation-driven approaches do not really fit for decisive strategies whether or not a nanoparticle should be further developed and may receive a kind of "safety label". (iii) Cost and time of development are the limiting factors for the drug pipeline. Knowing which property of a nanoparticle makes it toxic it may be feasible to re-engineer the particle for higher safety (safety by design). Testing the safety and efficacy of nanoparticles for human use is still in need of standardization. In this concise review, the author described and discussed the current unresolved issues over the application of inorganic nanoparticles for medical applications. Copyright © 2015 Elsevier Inc. All rights reserved.

Validating Human Performance Models of the Future Orion Crew Exploration Vehicle

NASA Technical Reports Server (NTRS)

Wong, Douglas T.; Walters, Brett; Fairey, Lisa

2010-01-01

NASA's Orion Crew Exploration Vehicle (CEV) will provide transportation for crew and cargo to and from destinations in support of the Constellation Architecture Design Reference Missions. Discrete Event Simulation (DES) is one of the design methods NASA employs for crew performance of the CEV. During the early development of the CEV, NASA and its prime Orion contractor Lockheed Martin (LM) strived to seek an effective low-cost method for developing and validating human performance DES models. This paper focuses on the method developed while creating a DES model for the CEV Rendezvous, Proximity Operations, and Docking (RPOD) task to the International Space Station. Our approach to validation was to attack the problem from several fronts. First, we began the development of the model early in the CEV design stage. Second, we adhered strictly to M&S development standards. Third, we involved the stakeholders, NASA astronauts, subject matter experts, and NASA's modeling and simulation development community throughout. Fourth, we applied standard and easy-to-conduct methods to ensure the model's accuracy. Lastly, we reviewed the data from an earlier human-in-the-loop RPOD simulation that had different objectives, which provided us an additional means to estimate the model's confidence level. The results revealed that a majority of the DES model was a reasonable representation of the current CEV design.

Confronting Professional Values and Ethical Issues: An Innovative Session on Development of a Casebook on Ethics and Integrity. Innovative Session 4. [Concurrent Innovative Session at AHRD Annual Conference, 2000.

ERIC Educational Resources Information Center

Burns, Janet Z.; Hatcher, Tim; Russ-Eft, Darlene

The Academy of Human Resource Development (AHRD) Standards on Ethics and Integrity, which were first presented in 1999, constituted one of three new initiatives to take the AHRD to a new level of leadership in the HRD profession. Although the initial standards were intentionally brief and easy to read, their application in specific situations may…

Coordinating Communities and Building Governance in the Development of Schematic and Semantic Standards: the Key to Solving Global Earth and Space Science Challenges in the 21st Century.

NASA Astrophysics Data System (ADS)

Wyborn, L. A.

2007-12-01

The Information Age in Science is being driven partly by the data deluge as exponentially growing volumes of data are being generated by research. Such large volumes of data cannot be effectively processed by humans and efficient and timely processing by computers requires development of specific machine readable formats. Further, as key challenges in earth and space sciences, such as climate change, hazard prediction and sustainable development resources require a cross disciplinary approach, data from various domains will need to be integrated from globally distributed sources also via machine to machine formats. However, it is becoming increasingly apparent that the existing standards can be very domain specific and most existing data transfer formats require human intervention. Where groups from different communities do try combine data across the domain/discipline boundaries much time is spent reformatting and reorganizing the data and it is conservatively estimated that this can take 80% of a project's time and resources. Four different types of standards are required for machine to machine interaction: systems, syntactic, schematic and semantic. Standards at the systems (WMS, WFS, etc) and at the syntactic level (GML, Observation and Measurement, SensorML) are being developed through international standards bodies such as ISO, OGC, W3C, IEEE etc. In contrast standards at the schematic level (e.g., GeoSciML, LandslidesML, WaterML, QuakeML) and at the semantic level (ie ontologies and vocabularies) are currently developing rapidly, in a very uncoordinated way and with little governance. As the size of the community that can machine read each others data depends on the size of the community that has developed the schematic or semantic standards, it is essential that to achieve global integration of earth and space science data, the required standards need to be developed through international collaboration using accepted standard proceedures. Once developed the standards also require some form of governance to maintain and then extend the standard as the science evolves to meet new challenges. A standard that does have some governance is GeoSciML, a data transfer standard for geoscience map data. GeoSciML is currently being developed by a consortium of 7 countries under the auspices of the Commission for the Management of and Application of Geoscience Information (CGI), a commission of the International Union of Geological Sciences. Perhaps other `ML' or ontology and vocabulary development `teams' need to look to their international domain specific specialty societies for endorsement and governance. But the issue goes beyond Earth and Space Sciences, as increasingly cross and intra disciplinary science requires machine to machine interaction with other science disciplines such as physics, chemistry and astronomy. For example, for geochemistry do we develop GeochemistryML or do we extend the existing Chemical Markup Language? Again, the question is who will provide the coordination of the development of the required schematic and semantic standards that underpin machine to machine global integration of science data. Is this a role for ICSU or CODATA or who? In order to address this issue, Geoscience Australia and CSIRO established the Solid Earth and Environmental Grid Community website to enable communities to `advertise' standards development and to provide a community TWIKI where standards can be developed in a globally `open' environment.

Human Research Program Requirements Document (Revision C)

NASA Technical Reports Server (NTRS)

Vargas, Paul R.

2009-01-01

The purpose of this document is to define, document, and allocate the Human Research Program (HRP) requirements to the HRP Program Elements. It establishes the flow-down of requirements from Exploration Systems Mission Directorate (ESMD) and Office of the Chief Health and Medical Officer (OCHMO) to the various Program Elements of the HRP to ensure that human research and technology countermeasure investments are made to insure the delivery of countermeasures and technologies that satisfy ESMD's and OCHMO's exploration mission requirements. Requirements driving the HRP work and deliverables are derived from the exploration architecture, as well as Agency standards regarding the maintenance of human health and performance. Agency human health and performance standards will define acceptable risk for each type and duration of exploration mission. It is critical to have the best available scientific and clinical evidence in setting and validating these standards. In addition, it is imperative that the best available evidence on preventing and mitigating human health and performance risks is incorporated into exploration mission and vehicle designs. These elements form the basis of the HRP research and technology development requirements and highlight the importance of HRP investments in enabling NASA's exploration missions. This PRD defines the requirements of the HRP which is comprised of the following major Program Elements: Behavioral Health and Performance (BHP), Exploration Medical Capability (ExMC), Human Health Countermeasures (HHC), ISS Medical Project (ISSMP), Space Human Factors and Habitability (SHFH), and Space Radiation (SR).

[Standards and guidelines of radiation protection and safety in dental X-ray examinations].

PubMed

Guo, X L; Li, G; Cheng, Y; Yu, Q; Wang, H; Zhang, Z Y

2017-12-09

With the rapid development of imaging technology, the application of dental imaging in diagnosis, treatment planning, intraoperative surgical navigation, monitoring of treatment or lesion development and assessment of treatment outcomes is playing an essential role in oral healthcare. The increased total number of dental X-ray examinations is accompanied by a relatively significant increase in collective dose to patients as well as to dental healthcare workers, which is harmful to human bodies to a certain degree. Some radiation protection standards and guidelines in dental radiology have been published in European countries, US, Canada and Australia, etc. Adherence to these standards and guidelines helps to achieve images with diagnostic quality and avoid unnecessary and repeated exposures. However, no radiation protection standard or guideline with regard to dental X-ray examinations has been put in force so far in mainland China. Therefore, a literature review on available radiation protection standards and guidelines was conducted to provide reference to the development of radiation protection standards or guidelines in mainland China.

LC-MS/MS-based approach for obtaining exposure estimates of metabolites in early clinical trials using radioactive metabolites as reference standards.

PubMed

Zhang, Donglu; Raghavan, Nirmala; Chando, Theodore; Gambardella, Janice; Fu, Yunlin; Zhang, Duxi; Unger, Steve E; Humphreys, W Griffith

2007-12-01

An LC-MS/MS-based approach that employs authentic radioactive metabolites as reference standards was developed to estimate metabolite exposures in early drug development studies. This method is useful to estimate metabolite levels in studies done with non-radiolabeled compounds where metabolite standards are not available to allow standard LC-MS/MS assay development. A metabolite mixture obtained from an in vivo source treated with a radiolabeled compound was partially purified, quantified, and spiked into human plasma to provide metabolite standard curves. Metabolites were analyzed by LC-MS/MS using the specific mass transitions and an internal standard. The metabolite concentrations determined by this approach were found to be comparable to those determined by valid LC-MS/MS assays. This approach does not requires synthesis of authentic metabolites or the knowledge of exact structures of metabolites, and therefore should provide a useful method to obtain early estimates of circulating metabolites in early clinical or toxicological studies.

Simultaneous determination of domperidone and Itopride in pharmaceuticals and human plasma using RP-HPLC/UV detection: Method development, validation and application of the method in in-vivo evaluation of fast dispersible tablets.

PubMed

Khan, Amjad; Iqbal, Zafar; Khadra, Ibrahim; Ahmad, Lateef; Khan, Abad; Khan, Muhammad Imran; Ullah, Zia; Ismail

2016-03-20

Domperidone and Itopride are pro-kinetic agents, regulating the gastric motility and are commonly prescribed as anti emetic drugs. In the present study a simple, rapid and sensitive RP-HPLC/UV method was developed for simultaneous determination of Domperidone and Itopride in pharmaceutical samples and human plasma, using Tenofavir as internal standard. Experimental conditions were optimized and method was validated according to the standard guidelines. Combination of water (pH 3.0) and acetonitrile (65:35 v/v) was used as mobile phase, pumped at the flow rate of 1.5 ml/min. Detector wavelength was set at 210 nm and column oven temperature was 40oC. Unlike conventional liquid-liquid extraction, simple precipitation technique was applied for drug extraction from human plasma using acetonitrile for deprotienation. The method showed adequate separation of both the analytes and best resolution was achieved using Hypersil BDS C8 column (150 mm × 4.6 mm, 5 μm). The method was quite linear in the range of 20-600 ng/ml. Recovery of the method was 92.31% and 89.82% for Domperidone and Itopride, respectively. Retention time of both the analytes and internal standard was below 15 min. The lower limit of detection (LLOD) and lower limit of quantification (LLOQ) for Domperidone were 5 and 10 ng/ml while for Itopride was 12 and 15 ng/ml, respectively. The developed method was successfully applied for in-vivo analysis of fast dispersible tablets of Domperidone in healthy human volunteer. The proposed method was a part of formulation development study and was efficiently applied for determination of the two drugs in various pharmaceutical products and human plasma. Copyright © 2015 Elsevier B.V. All rights reserved.

Employers' Perspectives on the Roles of Human Capital Development and Management in Creating Value. OECD Education Working Papers, No. 18

ERIC Educational Resources Information Center

Bassi, Laurie J.; McMurrer, Daniel P.

2006-01-01

Human capital--the productive capacity that is embedded in people--is one of the most important contributors to the growth in nations' output and standard of living. Globalisation and technological change have increased the importance of human capital in recent years, to the point that there are now only two options to sustain high profits and…

Human Factors Engineering Guidelines for Overhead Cranes

NASA Technical Reports Server (NTRS)

Chandler, Faith; Delgado, H. (Technical Monitor)

2001-01-01

This guideline provides standards for overhead crane cabs that can be applied to the design and modification of crane cabs to reduce the potential for human error due to design. This guideline serves as an aid during the development of a specification for purchases of cranes or for an engineering support request for crane design modification. It aids human factors engineers in evaluating existing cranes during accident investigations or safety reviews.

Human Milk Fatty Acid Composition: Comparison of Novel Dried Milk Spot Versus Standard Liquid Extraction Methods.

PubMed

Rudolph, Michael C; Young, Bridget E; Jackson, Kristina Harris; Krebs, Nancy F; Harris, William S; MacLean, Paul S

2016-12-01

Accurate assessment of the long chain polyunsaturated fatty acid (LC-PUFA) content of human milk (HM) provides a powerful means to evaluate the FA nutrient status of breastfed infants. The conventional standard for FA composition analysis of HM is liquid extraction, trans-methylation, and analyte detection resolved by gas chromatography. This standard approach requires fresh or frozen samples, storage in deep freeze, organic solvents, and specialized equipment in processing and analysis. Further, HM collection is often impractical for many studies in the free living environment, particularly for studies in developing countries. In the present study, we compare a novel and more practical approach to sample collection and processing that involves the spotting and drying ~50 μL of HM on a specialized paper stored and transported at ambient temperatures until analysis. Deming regression indicated the two methods aligned very well for all LC-PUFA and the abundant HM FA. Additionally, strong correlations (r > 0.85) were observed for DHA, ARA, EPA, linoleic (LA), and alpha-linolenic acids (ALA), which are of particular interest to the health of the developing infant. Taken together, our data suggest this more practical and inexpensive method of collection, storage, and transport of HM milk samples could dramatically facilitate studies of HM, as well as understanding its lipid composition influences on human health and development.

Blood-Banking Techniques for Plateletpheresis in Swine

PubMed Central

Sondeen, Jill L; Prince, Malcolm D; Polykratis, Irene A; Hernandez, Orlando; Torres-Mendoza, Jaime; Guzman, Rodolfo De; Aden, James K; Dubick, Michael A

2014-01-01

During the past several years, trauma resuscitation in human patients has evolved from decreased use of crystalloids to increased use of blood products. Of high interest is the role of platelets in trauma resuscitation. Because conducting prehospital resuscitation in human trauma patients is very difficult, swine are often the animal model of choice for such studies because their coagulation and hemodynamic systems are similar to those in humans. However, consistent production of sufficient swine platelets for such studies has not previously been achieved. We developed a method for producing swine platelets by using standard human techniques and equipment. We assessed pH, pO2, pCO2, lactate, thromboelastography, and platelet aggregation over 5 d of storage to determine whether the swine platelet product met the American Association of Blood Banks (AABB) standards for transfusion. Swine platelets met AABB standards at 24 h but not at later time points. In addition, we fluorescently labeled nonautologous platelets and then measured their percentage recovery over 5 h (the time used in subsequent experimental studies) when transfused into a recipient pig. We showed that 80% of the platelets stored for 24 h remained in the circulation and increased the recipient pigs’ thromboelastographic responses, indicating that the platelets were viable and active. Therefore, swine platelets stored for 24 h by using standard human products met the AABB criteria and were functional. PMID:24827574

Consistency Across Standards or Standards in a New Business Model

NASA Technical Reports Server (NTRS)

Russo, Dane M.

2010-01-01

Presentation topics include: standards in a changing business model, the new National Space Policy is driving change, a new paradigm for human spaceflight, consistency across standards, the purpose of standards, danger of over-prescriptive standards, a balance is needed (between prescriptive and general standards), enabling versus inhibiting, characteristics of success-oriented standards, characteristics of success-oriented standards, and conclusions. Additional slides include NASA Procedural Requirements 8705.2B identifies human rating standards and requirements, draft health and medical standards for human rating, what's been done, government oversight models, examples of consistency from anthropometry, examples of inconsistency from air quality and appendices of government and non-governmental human factors standards.

Water Quality Criteria

EPA Pesticide Factsheets

EPA develops water quality criteria based on the latest scientific knowledge to protect human health and aquatic life. This information serves as guidance to states and tribes in adopting water quality standards.

Considerations for human exposure standards for fast-rise-time high-peak-power electromagnetic pulses.

PubMed

Merritt, J H; Kiel, J L; Hurt, W D

1995-06-01

Development of new emitter systems capable of producing high-peak-power electromagnetic pulses with very fast rise times and narrow pulse widths is continuing. Such directed energy weapons systems will be used in the future to defeat electronically vulnerable targets. Human exposures to these pulses can be expected during testing and operations. Development of these technologies for radar and communications purposes has the potential for wider environmental exposure, as well. Current IEEE C95.1-1991 human exposure guidelines do not specifically address these types of pulses, though limits are stated for pulsed emissions. The process for developing standards includes an evaluation of the relevant bioeffects data base. A recommendation has been made that human exposure to ultrashort electromagnetic pulses that engender electromagnetic transients, called precursor waves, should be avoided. Studies that purport to show the potential for tissue damage induced by such pulses were described. The studies cited in support of the recommendation were not relevant to the issues of tissue damage by propagated pulses. A number of investigations are cited in this review that directly address the biological effects of electromagnetic pulses. These studies have not shown evidence of tissue damage as a result of exposure to high-peak-power pulsed microwaves. It is our opinion that the current guidelines are sufficiently protective for human exposure to these pulses.

Cognition in Space Workshop. 1; Metrics and Models

NASA Technical Reports Server (NTRS)

Woolford, Barbara; Fielder, Edna

2005-01-01

"Cognition in Space Workshop I: Metrics and Models" was the first in a series of workshops sponsored by NASA to develop an integrated research and development plan supporting human cognition in space exploration. The workshop was held in Chandler, Arizona, October 25-27, 2004. The participants represented academia, government agencies, and medical centers. This workshop addressed the following goal of the NASA Human System Integration Program for Exploration: to develop a program to manage risks due to human performance and human error, specifically ones tied to cognition. Risks range from catastrophic error to degradation of efficiency and failure to accomplish mission goals. Cognition itself includes memory, decision making, initiation of motor responses, sensation, and perception. Four subgoals were also defined at the workshop as follows: (1) NASA needs to develop a human-centered design process that incorporates standards for human cognition, human performance, and assessment of human interfaces; (2) NASA needs to identify and assess factors that increase risks associated with cognition; (3) NASA needs to predict risks associated with cognition; and (4) NASA needs to mitigate risk, both prior to actual missions and in real time. This report develops the material relating to these four subgoals.

Determination of tiropramide in human plasma by liquid chromatography-tandem mass spectrometry.

PubMed

Lee, Hye Won; Ji, Hye Young; Kim, Hee Hyun; Cho, Hea-Young; Lee, Yong-Bok; Lee, Hye Suk

2003-11-05

A rapid, sensitive and selective liquid chromatography-tandem mass spectrometric (LC/MS/MS) method for the determination of tiropramide in human plasma was developed. Tiropramide and internal standard, cisapride were extracted from human plasma by liquid-liquid extraction and analyzed on a Luna C8 column with the mobile phase of acetonitrile-ammonium formate (10mM, pH 4.5) (50:50, v/v). The analytes was detected using an electrospray ionization tandem mass spectrometry in the multiple-reaction-monitoring mode. The standard curve was linear (r=0.998) over the concentration range of 2.0-200 ng/ml. The intra- and inter-assay coefficients of variation ranged from 2.8 to 7.8 and 6.7 to 8.9%, respectively. The recoveries of tiropramide ranged from 50.2 to 53.1%, with that of cisapride (internal standard) being 60.9+/-5.3%. The lower limit of quantification for tiropramide was 2.0 ng/ml using 100 microl plasma sample. This method was applied to the pharmacokinetic study of tiropramide in human.

Development of lunar nomenclature. [conference of international scientists

NASA Technical Reports Server (NTRS)

Menzel, D. H.

1973-01-01

A system of unification and standardization for lunar nomenclature was developed. The following recommendations were made for use in future lunar cartography: (1) satellite craters, previously designated by letters will be named; (2) names will no longer be restricted to scientists, but will also include great contributors to human knowledge and human culture; and (3) a system of grids for dividing the moon into 144 regions and subdividing these regions into 2304 provinces will be used.

Water Security: What Else Can We Do?

DTIC Science & Technology

2013-03-01

lakes, 12.0% is in soil moisture , 9.5% is in the atmosphere, 8.5% is in wetlands, 1.5% is in rivers, and 1.0% is in vegetation. Humans primarily use...in standard of living for humans and other plant and animal species of the region. Meanwhile, developing countries, in order to achieve short-term...developing genetically modified (GM) plants which can produce larger crop yields. Technology has also produced monitoring techniques which allow for a

The case for applying tissue engineering methodologies to instruct human organoid morphogenesis.

PubMed

Marti-Figueroa, Carlos R; Ashton, Randolph S

2017-05-01

Three-dimensional organoids derived from human pluripotent stem cell (hPSC) derivatives have become widely used in vitro models for studying development and disease. Their ability to recapitulate facets of normal human development during in vitro morphogenesis produces tissue structures with unprecedented biomimicry. Current organoid derivation protocols primarily rely on spontaneous morphogenesis processes to occur within 3-D spherical cell aggregates with minimal to no exogenous control. This yields organoids containing microscale regions of biomimetic tissues, but at the macroscale (i.e. 100's of microns to millimeters), the organoids' morphology, cytoarchitecture, and cellular composition are non-biomimetic and variable. The current lack of control over in vitro organoid morphogenesis at the microscale induces aberrations at the macroscale, which impedes realization of the technology's potential to reproducibly form anatomically correct human tissue units that could serve as optimal human in vitro models and even transplants. Here, we review tissue engineering methodologies that could be used to develop powerful approaches for instructing multiscale, 3-D human organoid morphogenesis. Such technological mergers are critically needed to harness organoid morphogenesis as a tool for engineering functional human tissues with biomimetic anatomy and physiology. Human PSC-derived 3-D organoids are revolutionizing the biomedical sciences. They enable the study of development and disease within patient-specific genetic backgrounds and unprecedented biomimetic tissue microenvironments. However, their uncontrolled, spontaneous morphogenesis at the microscale yields inconsistences in macroscale organoid morphology, cytoarchitecture, and cellular composition that limits their standardization and application. Integration of tissue engineering methods with organoid derivation protocols could allow us to harness their potential by instructing standardized in vitro morphogenesis to generate organoids with biomimicry at all scales. Such advancements would enable the use of organoids as a basis for 'next-generation' tissue engineering of functional, anatomically mimetic human tissues and potentially novel organ transplants. Here, we discuss critical aspects of organoid morphogenesis where application of innovative tissue engineering methodologies would yield significant advancement towards this goal. Copyright © 2017. Published by Elsevier Ltd.

Industry Initiated Core Safety Attributes for Human Spaceflight for the 7th IAASS Conference

NASA Technical Reports Server (NTRS)

Mango, Edward J.

2014-01-01

Now that the NASA Commercial Crew Program (CCP) is beginning its full certification contract for crew transportation to the International Space Station (ISS), is it time for industry to embrace a minimum set of core safety attributes? Those attributes can then be evolved into an industry-led set of basic safety standards and requirements. After 50 years of human space travel sponsored by governments, there are two basic conditions that now exist within the international space industry. The first, there is enough of a space-faring history to encourage the space industry to design, develop and operate human spaceflight systems without government contracts for anything other than services. Second, industry is capable of defining and enforcing a set of industry-based safety attributes and standards for human spaceflight to low-Earth orbit (LEO). This paper will explore both of these basic conditions with a focus on the safety attributes and standards. In the United States, the Federal Aviation Administration (FAA) is now starting to dialogue with industry about the basic safety principles and attributes needed for potential future regulatory oversight. This process is not yet formalized and will take a number of years once approval is given to move forward. Therefore, throughout the next few years, it is an excellent time and opportunity for industry to collaborate together and develop the core set of attributes and standards. As industry engages and embraces a common set of safety attributes, then government agencies, like the FAA and NASA can use that industry-based product to strengthen their efforts on a safe commercial spaceflight foundation for the future. As the commercial space industry takes the lead role in establishing core safety attributes, and then enforcing those attributes, the entire planet can move away from governmental control of design and development and let industry expand safe and successful space operations in LEO. At that point the governmental agencies can focus on oversight of the industries' defined standards and enforcement for common welfare of the space-faring populous and overall public safety.

Agronomic Approach of Zinc Biofortification Can Increase Zinc Bioavailability in Wheat Flour and thereby Reduce Zinc Deficiency in Humans

PubMed Central

Liu, Dunyi; Liu, Yumin; Zhang, Wei; Chen, Xinping; Zou, Chunqin

2017-01-01

Zinc (Zn) deficiency is a common disorder of humans in developing countries. The effect of Zn biofortification (via application of six rates of Zn fertilizer to soil) on Zn bioavailability in wheat grain and flour and its impacts on human health was evaluated. Zn bioavailability was estimated with a trivariate model that included Zn homeostasis in the human intestine. As the rate of Zn fertilization increased, the Zn concentration increased in all flour fractions, but the percentages of Zn in standard flour (25%) and bran (75%) relative to total grain Zn were constant. Phytic acid (PA) concentrations in grain and flours were unaffected by Zn biofortification. Zn bioavailability and the health impact, as indicated by disability-adjusted life years (DALYs) saved, increased with the Zn application rate and were greater in standard and refined flour than in whole grain and coarse flour. The biofortified standard and refined flour obtained with application of 50 kg/ha ZnSO4·7H2O met the health requirement (3 mg of Zn obtained from 300 g of wheat flour) and reduced DALYs by >20%. Although Zn biofortification increased Zn bioavailability in standard and refined flour, it did not reduce the bioavailability of iron, manganese, or copper in wheat flour. PMID:28481273

Agronomic Approach of Zinc Biofortification Can Increase Zinc Bioavailability in Wheat Flour and thereby Reduce Zinc Deficiency in Humans.

PubMed

Liu, Dunyi; Liu, Yumin; Zhang, Wei; Chen, Xinping; Zou, Chunqin

2017-05-06

Zinc (Zn) deficiency is a common disorder of humans in developing countries. The effect of Zn biofortification (via application of six rates of Zn fertilizer to soil) on Zn bioavailability in wheat grain and flour and its impacts on human health was evaluated. Zn bioavailability was estimated with a trivariate model that included Zn homeostasis in the human intestine. As the rate of Zn fertilization increased, the Zn concentration increased in all flour fractions, but the percentages of Zn in standard flour (25%) and bran (75%) relative to total grain Zn were constant. Phytic acid (PA) concentrations in grain and flours were unaffected by Zn biofortification. Zn bioavailability and the health impact, as indicated by disability-adjusted life years (DALYs) saved, increased with the Zn application rate and were greater in standard and refined flour than in whole grain and coarse flour. The biofortified standard and refined flour obtained with application of 50 kg/ha ZnSO₄·7H₂O met the health requirement (3 mg of Zn obtained from 300 g of wheat flour) and reduced DALYs by >20%. Although Zn biofortification increased Zn bioavailability in standard and refined flour, it did not reduce the bioavailability of iron, manganese, or copper in wheat flour.

Index of Non-Government Standards on Human Engineering Design Criteria and Program Requirements/Guidelines. Version 3

DTIC Science & Technology

2002-10-01

the Seated Operator of Off-Highway Work Machines ♦ SAE J1013 1992 http://www.sae.org/servlets/ index http://standards.nasa.gov/NPTS/login.taf...Public Access permits users to view the NASA Preferred Technical Standards index , with the capability to download free of charge the NASA- Developed ...www.sae.org/servlets/ index http://www.techstreet.com/ Design of Ergonomic Requirements for the Design of Displays and Control Actuators -

NASA-STD-3001, Space Flight Human-System Standard and the Human Integration Design Handbook

NASA Technical Reports Server (NTRS)

Whitmore, Mihriban; Boyer, Jennifer; Holubec, Keith

2012-01-01

NASA-STD-3001 Space Flight Human-System Standard Volume 1, Crew Health, Volume 2, Human Factors, Habitability and Environmental Health, and the Human Integration Design Handbook (HIDH) have replaced the Man-Systems Integration Standards (MSIS), NASA-STD-3000. For decades, NASA-STD-3000 was a significant contribution to human spaceflight programs and to human-systems integration. However, with research program and project results being realized, advances in technology, and the availability of new information in a variety of topic areas, the time had arrived to update this extensive suite of standards and design information. NASA-STD-3001, Volume 2 contains the Agency level standards from the human and environmental factors disciplines that ensure human spaceflight operations are performed safely, efficiently, and effectively. The HIDH is organized in the same sequence and serves as the companion document to NASA-STD-3001, Volume 2, providing a compendium of human spaceflight history and knowledge. The HIDH is intended to aid interpretation of NASA-STD-3001, Volume 2 standards and to provide guidance for requirement writers and vehicle and habitat designers. Keywords Human Factors, Standards, Environmental Factors, NASA

Global variance in female population height: the influence of education, income, human development, life expectancy, mortality and gender inequality in 96 nations.

PubMed

Mark, Quentin J

2014-01-01

Human height is a heritable trait that is known to be influenced by environmental factors and general standard of living. Individual and population stature is correlated with health, education and economic achievement. Strong sexual selection pressures for stature have been observed in multiple diverse populations, however; there is significant global variance in gender equality and prohibitions on female mate selection. This paper explores the contribution of general standard of living and gender inequality to the variance in global female population heights. Female population heights of 96 nations were culled from previously published sources and public access databases. Factor analysis with United Nations international data on education rates, life expectancy, incomes, maternal and childhood mortality rates, ratios of gender participation in education and politics, the Human Development Index (HDI) and the Gender Inequality Index (GII) was run. Results indicate that population heights vary more closely with gender inequality than with population health, income or education.

Optimizing the early phase development of new analgesics by human pain biomarkers.

PubMed

Arendt-Nielsen, Lars; Hoeck, Hans Christian

2011-11-01

Human pain biomarkers are based on standardized acute activation of pain pathways/mechanisms and quantitative assessment of the evoked responses. This approach can be applied to healthy volunteers, to pain patients, and before and after pharmacological interventions to help understanding and profile the mode of action (proof-of-concept) of new and existing analgesic compounds. Standardized stimuli of different modalities can be applied to different tissues (multimodal and multi-tissue) for profiling analgesic compounds with respect to modulation of pain transduction, transmission, specific mechanisms and processing. This approach substantiates which specific compounds may work in particular clinical pain conditions. Human pain biomarkers can be translational and may bridge animal findings in clinical pain conditions, which in turn can provide new possibilities for designing more successful clinical trials. Biomarker based proof-of-concept drug studies in either volunteers or selected patient populations provide inexpensive, fast and reliable mechanism-based information about dose-efficacy relationships. This is important information in the early drug development phase and for designing large expensive clinical trials.

Ar+ and CuBr laser-assisted chemical bleaching of teeth: estimation of whiteness degree

NASA Astrophysics Data System (ADS)

Dimitrov, S.; Todorovska, Roumyana; Gizbrecht, Alexander I.; Raychev, L.; Petrov, Lyubomir P.

2003-11-01

In this work the results of adaptation of impartial methods for color determination aimed at developing of techniques for estimation of human teeth whiteness degree, sufficiently handy for common use in clinical practice are presented. For approbation and by the way of illustration of the techniques, standards of teeth colors were used as well as model and naturally discolored human teeth treated by two bleaching chemical compositions activated by three light sources each: Ar+ and CuBr lasers, and a standard halogen photopolymerization lamp. Typical reflection and fluorescence spectra of some samples are presented; the samples colors were estimated by a standard computer processing in RGB and B coordinates. The results of the applied spectral and colorimetric techniques are in a good agreement with those of the standard computer processing of the corresponding digital photographs and complies with the visually estimated degree of the teeth whiteness judged according to the standard reference scale commonly used in the aesthetic dentistry.

Informatics in radiology: an information model of the DICOM standard.

PubMed

Kahn, Charles E; Langlotz, Curtis P; Channin, David S; Rubin, Daniel L

2011-01-01

The Digital Imaging and Communications in Medicine (DICOM) Standard is a key foundational technology for radiology. However, its complexity creates challenges for information system developers because the current DICOM specification requires human interpretation and is subject to nonstandard implementation. To address this problem, a formally sound and computationally accessible information model of the DICOM Standard was created. The DICOM Standard was modeled as an ontology, a machine-accessible and human-interpretable representation that may be viewed and manipulated by information-modeling tools. The DICOM Ontology includes a real-world model and a DICOM entity model. The real-world model describes patients, studies, images, and other features of medical imaging. The DICOM entity model describes connections between real-world entities and the classes that model the corresponding DICOM information entities. The DICOM Ontology was created to support the Cancer Biomedical Informatics Grid (caBIG) initiative, and it may be extended to encompass the entire DICOM Standard and serve as a foundation of medical imaging systems for research and patient care. RSNA, 2010

5 CFR 2640.203 - Miscellaneous exemptions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... develop recommendations for new standards for AIDS vaccine trials involving human subjects. Even though the chemist's employer is in the process of developing an experimental AIDS vaccine and therefore will..., in advance, authority to make such approvals in accordance with agency policy. Example 4: A GS-14...

5 CFR 2640.203 - Miscellaneous exemptions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... develop recommendations for new standards for AIDS vaccine trials involving human subjects. Even though the chemist's employer is in the process of developing an experimental AIDS vaccine and therefore will..., in advance, authority to make such approvals in accordance with agency policy. Example 4: A GS-14...

5 CFR 2640.203 - Miscellaneous exemptions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... develop recommendations for new standards for AIDS vaccine trials involving human subjects. Even though the chemist's employer is in the process of developing an experimental AIDS vaccine and therefore will..., in advance, authority to make such approvals in accordance with agency policy. Example 4: A GS-14...

Development and application of a channelized Hotelling observer for DBT optimization on structured background test images with mass simulating targets

NASA Astrophysics Data System (ADS)

Petrov, Dimitar; Michielsen, Koen; Cockmartin, Lesley; Zhang, Gouzhi; Young, Kenneth; Marshall, Nicholas; Bosmans, Hilde

2016-03-01

Digital breast tomosynthesis (DBT) is a 3D mammography technique that promises better visualization of low contrast lesions than conventional 2D mammography. A wide range of parameters influence the diagnostic information in DBT images and a systematic means of DBT system optimization is needed. The gold standard for image quality assessment is to perform a human observer experiment with experienced readers. Using human observers for optimization is time consuming and not feasible for the large parameter space of DBT. Our goal was to develop a model observer (MO) that can predict human reading performance for standard detection tasks of target objects within a structured phantom and subsequently apply it in a first comparative study. The phantom consists of an acrylic semi-cylindrical container with acrylic spheres of different sizes and the remaining space filled with water. Three types of lesions were included: 3D printed spiculated and non-spiculated mass lesions along with calcification groups. The images of the two mass lesion types were reconstructed with 3 different reconstruction methods (FBP, FBP with SRSAR, MLTRpr) and read by human readers. A Channelized Hotelling model observer was created for the non-spiculated lesion detection task using five Laguerre-Gauss channels, tuned for better performance. For the non-spiculated mass lesions a linear relation between the MO and human observer results was found, with correlation coefficients of 0.956 for standard FBP, 0.998 for FBP with SRSAR and 0.940 for MLTRpr. Both the MO and human observer percentage correct results for the spiculated masses were close to 100%, and showed no difference from each other for every reconstruction algorithm.

A human factors approach to range scheduling for satellite control

NASA Technical Reports Server (NTRS)

Wright, Cameron H. G.; Aitken, Donald J.

1991-01-01

Range scheduling for satellite control presents a classical problem: supervisory control of a large-scale dynamic system, with unwieldy amounts of interrelated data used as inputs to the decision process. Increased automation of the task, with the appropriate human-computer interface, is highly desirable. The development and user evaluation of a semi-automated network range scheduling system is described. The system incorporates a synergistic human-computer interface consisting of a large screen color display, voice input/output, a 'sonic pen' pointing device, a touchscreen color CRT, and a standard keyboard. From a human factors standpoint, this development represents the first major improvement in almost 30 years to the satellite control network scheduling task.

The Human Settlements Authority Act, 1988 (No. 2 of 1988), 4 June 1986.

PubMed

1988-01-01

This Act establishes in Swaziland the Human Settlements Authority, whose members are appointed by the Minister responsible for human settlements. The Authority shall "1) assist the Government in formulating policy relating to human settlements and uphold and give effect to such policy; 2) ensure the orderly development of existing and future urban and rural settlements; 3) establish a finance mechanism for ensuring the supply and maintenance of improved shelter and infrastructure throughout Swaziland, which shall include a system of revenue recovery; 4) prepare appropriate standards for the provision of land, shelter and infrastructure by both private and public developers; 5) regulate real estate transactions including the standardization of lease agreements, rent control and sale of land and buildings; 6) encourage and support research in appropriate methods of providing affordable shelter and infrastructure; and 7) perform all other acts or things as are required by this Act." Under the Act, no person shall establish a human settlement, housing scheme, or private housing scheme without the written permission of the Authority. Further provisions of the Act deal with the membership and meetings of the Authority, the granting of permission for human settlements, and human settlement development plans, among other things. On 4 June 1986, the Government of Swaziland also enacted the National Housing Board Act, 1988 (No. 3 of 1988). This Act establishes a National Housing Board, subject to the provisions of the Human Settlements Act, 1988, to "provide affordable housing generally in Swaziland and take over such housing schemes as the Government may determine." Further provisions of the Act deal with the functions, membership, finances, staffing, assets, and administration of the Board. See Swaziland Government Gazette, Extraordinary, Vol. 26, No. 581, 2 March 1988, pp. S6-S11. full text

The "Public Opinion Survey of Human Attributes-Stuttering" (POSHA-S): Summary Framework and Empirical Comparisons

ERIC Educational Resources Information Center

St. Louis, Kenneth O.

2011-01-01

Purpose: The "Public Opinion Survey of Human Attributes-Stuttering" ("POSHA-S") was developed to make available worldwide a standard measure of public attitudes toward stuttering that is practical, reliable, valid, and translatable. Mean data from past field studies as comparisons for interpretation of "POSHA-S" results are reported. Method: Means…

Development of data representation standards by the human proteome organization proteomics standards initiative

PubMed Central

Albar, Juan Pablo; Binz, Pierre-Alain; Eisenacher, Martin; Jones, Andrew R; Mayer, Gerhard; Omenn, Gilbert S; Orchard, Sandra; Vizcaíno, Juan Antonio; Hermjakob, Henning

2015-01-01

Objective To describe the goals of the Proteomics Standards Initiative (PSI) of the Human Proteome Organization, the methods that the PSI has employed to create data standards, the resulting output of the PSI, lessons learned from the PSI’s evolution, and future directions and synergies for the group. Materials and Methods The PSI has 5 categories of deliverables that have guided the group. These are minimum information guidelines, data formats, controlled vocabularies, resources and software tools, and dissemination activities. These deliverables are produced via the leadership and working group organization of the initiative, driven by frequent workshops and ongoing communication within the working groups. Official standards are subjected to a rigorous document process that includes several levels of peer review prior to release. Results We have produced and published minimum information guidelines describing what information should be provided when making data public, either via public repositories or other means. The PSI has produced a series of standard formats covering mass spectrometer input, mass spectrometer output, results of informatics analysis (both qualitative and quantitative analyses), reports of molecular interaction data, and gel electrophoresis analyses. We have produced controlled vocabularies that ensure that concepts are uniformly annotated in the formats and engaged in extensive software development and dissemination efforts so that the standards can efficiently be used by the community. Conclusion In its first dozen years of operation, the PSI has produced many standards that have accelerated the field of proteomics by facilitating data exchange and deposition to data repositories. We look to the future to continue developing standards for new proteomics technologies and workflows and mechanisms for integration with other omics data types. Our products facilitate the translation of genomics and proteomics findings to clinical and biological phenotypes. The PSI website can be accessed at http://www.psidev.info. PMID:25726569

Sensitive and selective liquid chromatography-tandem mass spectrometry method for the quantification of aniracetam in human plasma.

PubMed

Zhang, Jingjing; Liang, Jiabi; Tian, Yuan; Zhang, Zunjian; Chen, Yun

2007-10-15

A rapid, sensitive and selective LC-MS/MS method was developed and validated for the quantification of aniracetam in human plasma using estazolam as internal standard (IS). Following liquid-liquid extraction, the analytes were separated using a mobile phase of methanol-water (60:40, v/v) on a reverse phase C18 column and analyzed by a triple-quadrupole mass spectrometer in the selected reaction monitoring (SRM) mode using the respective [M+H]+ ions, m/z 220-->135 for aniracetam and m/z 295-->205 for the IS. The assay exhibited a linear dynamic range of 0.2-100 ng/mL for aniracetam in human plasma. The lower limit of quantification (LLOQ) was 0.2 ng/mL with a relative standard deviation of less than 15%. Acceptable precision and accuracy were obtained for concentrations over the standard curve range. The validated LC-MS/MS method has been successfully applied to study the pharmacokinetics of aniracetam in healthy male Chinese volunteers.

A validated high-performance liquid chromatographic method for the determination of glibenclamide in human plasma and its application to pharmacokinetic studies.

PubMed

Niopas, Ioannis; Daftsios, Athanasios C

2002-05-15

Glibenclamide is a potent second generation oral sulfonylurea antidiabetic agent widely used for the treatment of type II diabetes melitus. A rapid, sensitive, precise, accurate and specific HPLC assay for the determination of glibenclamide in human plasma was developed and validated. After addition of flufenamic acid as internal standard, the analytes were isolated from human plasma by liquid-liquid extraction. The method was linear in the 10-400 ng/ml concentration range (r > 0.999). Recovery for glibenclamide was greater than 91.5% and for internal standard was 93.5%. Within-day and between-day precision, expressed as the relative standard deviation (RSD%), ranged from 1.4 to 5.9% and 5.8 to 6.6%, respectively. Assay accuracy was better than 93.4%. The assay was used to estimate the pharmacokinetics of glibenclamide after oral administration of a 5 mg tablet of glibenclamide to 18 healthy volunteers.

The New Educational Practice of Coaching, and the New Profession of the Coach

ERIC Educational Resources Information Center

Klarin, Mikhail

2015-01-01

The article provides a detailed description of coaching as a form of human development and professional activities. The article was written in the midst of developing professional standards of coaching in the Russian Federation. [This article was translated by Peter Golub.

Cultural Change, Human Activity, and Cognitive Development

ERIC Educational Resources Information Center

Gauvain, Mary; Munroe, Robert L.

2012-01-01

Differential cognitive performance across cultural contexts has been a standard result in comparative research. Here we discuss how societal changes occurring when a small-scale traditional community incorporates elements from industrialized society may contribute to cognitive development, and we illustrate this with an analysis of the cognitive…

Human Resource Consulting Education: Professional Development for the Personnel Consulting Industry.

ERIC Educational Resources Information Center

Bone, John

1996-01-01

Interviews and surveys of 200 personnel consultants revealed an urgent need for basic and ongoing professional development education and for national competence standards and accreditation. Skill needs clustered in three categories: recruitment, selection, and sales/marketing. Professional education should recognize lifelong learning, take…

Behavioral Health and Performance (BHP) Work-Rest Cycles

NASA Technical Reports Server (NTRS)

Leveton, Lauren B.; Whitmire, Alexandra

2011-01-01

BHP Program Element Goal: Identify, characterize, and prevent or reduce behavioral health and performance risks associated with space travel, exploration and return to terrestrial life. BHP Requirements: a) Characterize and assess risks (e.g., likelihood and consequences). b) Develop tools and technologies to prevent, monitor, and treat adverse outcomes. c) Inform standards. d) Develop technologies to: 1) reduce risks and human systems resource requirements (e.g., crew time, mass, volume, power) and 2) ensure effective human-system integration across exploration mission.

An Internal Review and Operational Trial of a Human Factors Engineering Self-Paced Course in Accordance with the Instructional Systems Development Process.

DTIC Science & Technology

1983-12-01

factors aspects of systems and equipments. 6. Identify the human factors principles which must be applied during the evaluation of a workspace and control...Curriculum Development Expert Questionnaires Three proven specialists in the field of curriculum evaluation who regularly apply the standards and criteria 67...which each terminal objective met each of the six criteria listed in Appendix E. Ordinal values ranging from 1 through 4, were applied to the verbal

Human Research Program: Space Human Factors and Habitability Element

NASA Technical Reports Server (NTRS)

Russo, Dane M.

2007-01-01

The three project areas of the Space Human Factors and Habitability Element work together to achieve a working and living environment that will keep crews healthy, safe, and productive throughout all missions -- from Earth orbit to Mars expeditions. The Advanced Environmental Health (AEH) Project develops and evaluates advanced habitability systems and establishes requirements and health standards for exploration missions. The Space Human Factors Engineering (SHFE) Project s goal is to ensure a safe and productive environment for humans in space. With missions using new technologies at an ever-increasing rate, it is imperative that these advances enhance crew performance without increasing stress or risk. The ultimate goal of Advanced Food Technology (AFT) Project is to develop and deliver technologies for human centered spacecraft that will support crews on missions to the moon, Mars, and beyond.

MDI Biological Laboratory Arsenic Summit: Approaches to Limiting Human Exposure to Arsenic

PubMed Central

Stanton, Bruce A.

2015-01-01

This report is the outcome of the meeting: “Environmental and Human Health Consequences of Arsenic”, held at the MDI Biological Laboratory in Salisbury Cove, Maine, August 13–15, 2014. Human exposure to arsenic represents a significant health problem worldwide that requires immediate attention according to the World Health Organization (WHO). One billion people are exposed to arsenic in food and more than 200 million people ingest arsenic via drinking water at concentrations greater than international standards. Although the U.S. Environmental Protection Agency (EPA) has set a limit of 10 micrograms per liter (10 μg/L) in public water supplies and the WHO has recommended an upper limit of 10 μg/L, recent studies indicate that these limits are not protective enough. In addition, there are currently few standards for arsenic in food. Those who participated in the Summit support citizens, scientists, policymakers, industry and educators at the local, state, national and international levels to: (1) Establish science-based evidence for setting standards at the local, state, national, and global levels for arsenic in water and food; (2) Work with government agencies to set regulations for arsenic in water and food, to establish and strengthen non-regulatory programs, and to strengthen collaboration among government agencies, NGOs, academia, the private sector, industry and others; (3) Develop novel and cost-effective technologies for identification and reduction of exposure to arsenic in water; (4) Develop novel and cost-effective approaches to reduce arsenic exposure in juice, rice, and other relevant foods, and (5) Develop an Arsenic Education Plan to guide the development of science curricula as well as community outreach and education programs that serve to inform students and consumers about arsenic exposure and engage them in well water testing and development of remediation strategies. PMID:26231509

MDI Biological Laboratory Arsenic Summit: Approaches to Limiting Human Exposure to Arsenic.

PubMed

Stanton, Bruce A; Caldwell, Kathleen; Congdon, Clare Bates; Disney, Jane; Donahue, Maria; Ferguson, Elizabeth; Flemings, Elsie; Golden, Meredith; Guerinot, Mary Lou; Highman, Jay; James, Karen; Kim, Carol; Lantz, R Clark; Marvinney, Robert G; Mayer, Greg; Miller, David; Navas-Acien, Ana; Nordstrom, D Kirk; Postema, Sonia; Rardin, Laurie; Rosen, Barry; SenGupta, Arup; Shaw, Joseph; Stanton, Elizabeth; Susca, Paul

2015-09-01

This report is the outcome of the meeting "Environmental and Human Health Consequences of Arsenic" held at the MDI Biological Laboratory in Salisbury Cove, Maine, August 13-15, 2014. Human exposure to arsenic represents a significant health problem worldwide that requires immediate attention according to the World Health Organization (WHO). One billion people are exposed to arsenic in food, and more than 200 million people ingest arsenic via drinking water at concentrations greater than international standards. Although the US Environmental Protection Agency (EPA) has set a limit of 10 μg/L in public water supplies and the WHO has recommended an upper limit of 10 μg/L, recent studies indicate that these limits are not protective enough. In addition, there are currently few standards for arsenic in food. Those who participated in the Summit support citizens, scientists, policymakers, industry, and educators at the local, state, national, and international levels to (1) establish science-based evidence for setting standards at the local, state, national, and global levels for arsenic in water and food; (2) work with government agencies to set regulations for arsenic in water and food, to establish and strengthen non-regulatory programs, and to strengthen collaboration among government agencies, NGOs, academia, the private sector, industry, and others; (3) develop novel and cost-effective technologies for identification and reduction of exposure to arsenic in water; (4) develop novel and cost-effective approaches to reduce arsenic exposure in juice, rice, and other relevant foods; and (5) develop an Arsenic Education Plan to guide the development of science curricula as well as community outreach and education programs that serve to inform students and consumers about arsenic exposure and engage them in well water testing and development of remediation strategies.

The Department of Defense Human factors standardization program.

PubMed

Chaikin, G

1984-09-01

The Department of Defense (DoD) Human Factors Standardization Program is the most far-reaching standardization programme in the USA. It is an integrated component of the overall DoD Standardization Program. While only ten major documents are contained in the human factors standardization area, their effects on human factors engineering programmes are profound and wide-ranging. Preparation and updating of the human engineering standardisation documents have grown out of the efforts of several military agencies, contractors, consultants, universities and individuals. New documents, engineering practice studies and revision efforts are continuously planned by the Tri-Service (Army, Navy, Air Force) Human Factors Standardization Steering Committee in collaboration with industry groups and technical societies. The present five-year plan and other standardisation documents are readily available for review and input by anyone with relevant interests. Human factors specialists and other readers of this journal may therefore influence the direction of the human factors standardisation programme and the content of its military specifications, standards and handbooks.

Human Factors Engineering Aspects of Modifications in Control Room Modernization

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hugo, Jacques; Clefton, Gordon; Joe, Jeffrey

This report describes the basic aspects of control room modernization projects in the U.S. nuclear industry and the need for supplementary guidance on the integration of human factors considerations into the licensing and regulatory aspects of digital upgrades. The report pays specific attention to the integration of principles described in NUREG-0711 (Human Factors Engineering Program Review Model) and how supplementary guidance can help to raise general awareness in the industry regarding the complexities of control room modernization projects created by many interdependent regulations, standards and guidelines. The report also describes how human factors engineering principles and methods provided by variousmore » resources and international standards can help in navigating through the process of licensing digital upgrades. In particular, the integration of human factors engineering guidance and requirements into the process of licensing digital upgrades can help reduce uncertainty related to development of technical bases for digital upgrades that will avoid the introduction of new failure modes.« less

Defining the Relationship Between Human Error Classes and Technology Intervention Strategies

NASA Technical Reports Server (NTRS)

Wiegmann, Douglas A.; Rantanen, Esa; Crisp, Vicki K. (Technical Monitor)

2002-01-01

One of the main factors in all aviation accidents is human error. The NASA Aviation Safety Program (AvSP), therefore, has identified several human-factors safety technologies to address this issue. Some technologies directly address human error either by attempting to reduce the occurrence of errors or by mitigating the negative consequences of errors. However, new technologies and system changes may also introduce new error opportunities or even induce different types of errors. Consequently, a thorough understanding of the relationship between error classes and technology "fixes" is crucial for the evaluation of intervention strategies outlined in the AvSP, so that resources can be effectively directed to maximize the benefit to flight safety. The purpose of the present project, therefore, was to examine the repositories of human factors data to identify the possible relationship between different error class and technology intervention strategies. The first phase of the project, which is summarized here, involved the development of prototype data structures or matrices that map errors onto "fixes" (and vice versa), with the hope of facilitating the development of standards for evaluating safety products. Possible follow-on phases of this project are also discussed. These additional efforts include a thorough and detailed review of the literature to fill in the data matrix and the construction of a complete database and standards checklists.

A tutorial for software development in quantitative proteomics using PSI standard formats☆

PubMed Central

Gonzalez-Galarza, Faviel F.; Qi, Da; Fan, Jun; Bessant, Conrad; Jones, Andrew R.

2014-01-01

The Human Proteome Organisation — Proteomics Standards Initiative (HUPO-PSI) has been working for ten years on the development of standardised formats that facilitate data sharing and public database deposition. In this article, we review three HUPO-PSI data standards — mzML, mzIdentML and mzQuantML, which can be used to design a complete quantitative analysis pipeline in mass spectrometry (MS)-based proteomics. In this tutorial, we briefly describe the content of each data model, sufficient for bioinformaticians to devise proteomics software. We also provide guidance on the use of recently released application programming interfaces (APIs) developed in Java for each of these standards, which makes it straightforward to read and write files of any size. We have produced a set of example Java classes and a basic graphical user interface to demonstrate how to use the most important parts of the PSI standards, available from http://code.google.com/p/psi-standard-formats-tutorial. This article is part of a Special Issue entitled: Computational Proteomics in the Post-Identification Era. Guest Editors: Martin Eisenacher and Christian Stephan. PMID:23584085

Engineering the Brain: Ethical Issues and the Introduction of Neural Devices.

PubMed

Klein, Eran; Brown, Tim; Sample, Matthew; Truitt, Anjali R; Goering, Sara

2015-01-01

Neural devices now under development stand to interact with and alter the human brain in ways that may challenge standard notions of identity, normality, authority, responsibility, privacy and justice.

An Australian perspective on developing standards and ensuring compliance.

PubMed

Thornber, Peter M

2010-01-01

Australia is a federation of states and territories, each with their own parliament and animal-welfare laws. Australian animal-welfare legislation imposes a "duty of care" on people responsible for the care and well-being of animals under their management. In the livestock sector, this responsibility is mirrored by the ongoing development of standards, guidelines, and codes of practice to assist people to understand their responsibilities and to meet expectations concerning animal welfare. The Australian Animal Welfare Strategy (AAWS) is the national animal-welfare policy blueprint for sustainable improvements in animal welfare, and one of its key goals is to achieve greater consistency in the development, implementation, and enforcement of animal-welfare standards. Standards, guidelines, and model codes also inform the development of contemporary, evidence-based quality assurance programs for individual livestock industries and provide the basis for competency-based training programs for animal handlers. Australian standards have been developed for pigs and land transport of livestock, and work is progressing on national standards for cattle, sheep, horses, zoo animals, dogs, and cats. Other achievements include the development of requirements for the care and use of animals in research and teaching, guidelines for the welfare of aquatic animals, and codes of practice for the humane killing of pest animals. State and territory governments are developing a framework for consistent regulation and compliance in consultation with industries and welfare organizations.

Certified reference materials (GBW09170 and 09171) of creatinine in human serum.

PubMed

Dai, Xinhua; Fang, Xiang; Shao, Mingwu; Li, Ming; Huang, Zejian; Li, Hongmei; Jiang, You; Song, Dewei; He, Yajuan

2011-02-15

Creatinine is the most widely used clinical marker for assessing renal function. Concentrations of creatinine in human serum need to be carefully checked in order to ensure accurate diagnosis of renal function. Therefore, development of certified reference materials (CRMs) of creatinine in serum is of increasing importance. In this study, two new CRMs (Nos. GBW09170 and 09171) for creatinine in human serum have been developed. They were prepared with mixtures of several dozens of healthy people's and kidney disease patient's serum, respectively. The certified values of 8.10, 34.1 mg/kg for these two CRMs have been assigned by liquid chromatography-isotope dilution mass spectrometry (LC-IDMS) method which was validated by using standard reference material (SRM) of SRM909b (a reference material obtained from National Institute of Standards and Technology, NIST). The expanded uncertainties of certified values for low and high concentrations were estimated to be 1.2 and 1.1%, respectively. The certified values were further confirmed by an international intercomparison for the determination of creatinine in human serum (Consultative Committee for Amount of Substance, CCQM) of K80 (CCQM-K80). These new CRMs of creatinine in human serum pool are totally native without additional creatinine spiked for enrichment. These new CRMs are capable of validating routine clinical methods for ensuring accuracy, reliability and comparability of analytical results from different clinical laboratories. They can also be used for instrument validation, development of secondary reference materials, and evaluating the accuracy of high order clinical methods for the determination of creatinine in human serum. Copyright © 2011 Elsevier B.V. All rights reserved.

Exposure Factors Resources: Contrasting EPA’s Exposure Factors Handbook with International Sources (Journal Article)

EPA Science Inventory

Efforts to compile and standardize exposure human factors have resulted in the development of a variety of resources available to the scientific community. For example, the U.S. EPA developed the Exposure Factors Handbook and Child-specific Exposure Factors Handbook to promote c...

Research and Development on a Public Attitude Instrument for Stuttering

ERIC Educational Resources Information Center

St. Louis, Kenneth O.

2012-01-01

This paper summarizes research associated with the development of the "Public Opinion Survey of Human Attributes-Stuttering" ("POSHA-S"), a survey instrument designed to provide a worldwide standard measure of public attitudes toward stuttering. Pilot studies with early experimental prototypes of the "POSHA-S" are summarized that relate to…

Competency-based training model for human resource management and development in public sector

NASA Astrophysics Data System (ADS)

Prabawati, I.; Meirinawati; AOktariyanda, T.

2018-01-01

Human Resources (HR) is a very important factor in an organization so that human resources are required to have the ability, skill or competence in order to be able to carry out the vision and mission of the organization. Competence includes a number of attributes attached to the individual which is a combination of knowledge, skills, and behaviors that can be used as a mean to improve performance. Concerned to the demands of human resources that should have the knowledge, skills or abilities, it is necessary to the development of human resources in public organizations. One form of human resource development is Competency-Based Training (CBT). CBT focuses on three issues, namely skills, competencies, and competency standard. There are 5 (five) strategies in the implementation of CBT, namely: organizational scanning, strategic planning, competency profiling, competency gap analysis, and competency development. Finally, through CBT the employees within the organization can reduce or eliminate the differences between existing performance with a potential performance that can improve the knowledge, expertise, and skills that are very supportive in achieving the vision and mission of the organization.

[Human resources for health in Ecuador's new model of care].

PubMed

Espinosa, Verónica; de la Torre, Daniel; Acuña, Cecilia; Cadena, Cristina

2017-06-08

Describe strategies implemented by Ecuador's Ministry of Public Health (MPH) to strengthen human resources for health leadership and respond to the new model of care, as a part of the reform process in the period 2012-2015. A documentary review was carried out of primary and secondary sources on development of human resources for health before and after the reform. In the study period, Ecuador developed a new institutional and regulatory framework for developing human resources for health to respond to the requirements of a model of care based on primary health care. The MPH consolidated its steering role by forging strategic partnerships, implementing human resources planning methods, and making an unprecedented investment in health worker training, hiring, and wage increases. These elements constitute the initial core for development of human resources for health policy and a health-services study program consistent with the reform's objectives. Within the framework of the reform carried out from 2012 to 2015, intersectoral work by the MPH has led to considerable achievements in development of human resources for health. Notable achievements include strengthening of the steering role, development and implementation of standards and regulatory instruments, creation of new professional profiles, and hiring of professionals to implement the comprehensive health care model, which helped to solve problems carried over from the years prior to the reform.

An integrated approach to develop, validate and operate thermo-physiological human simulator for the development of protective clothing.

PubMed

Psikuta, Agnes; Koelblen, Barbara; Mert, Emel; Fontana, Piero; Annaheim, Simon

2017-12-07

Following the growing interest in the further development of manikins to simulate human thermal behaviour more adequately, thermo-physiological human simulators have been developed by coupling a thermal sweating manikin with a thermo-physiology model. Despite their availability and obvious advantages, the number of studies involving these devices is only marginal, which plausibly results from the high complexity of the development and evaluation process and need of multi-disciplinary expertise. The aim of this paper is to present an integrated approach to develop, validate and operate such devices including technical challenges and limitations of thermo-physiological human simulators, their application and measurement protocol, strategy for setting test scenarios, and the comparison to standard methods and human studies including details which have not been published so far. A physical manikin controlled by a human thermoregulation model overcame the limitations of mathematical clothing models and provided a complementary method to investigate thermal interactions between the human body, protective clothing, and its environment. The opportunities of these devices include not only realistic assessment of protective clothing assemblies and equipment but also potential application in many research fields ranging from biometeorology, automotive industry, environmental engineering, and urban climate to clinical and safety applications.

An integrated approach to develop, validate and operate thermo-physiological human simulator for the development of protective clothing

PubMed Central

PSIKUTA, Agnes; KOELBLEN, Barbara; MERT, Emel; FONTANA, Piero; ANNAHEIM, Simon

2017-01-01

Following the growing interest in the further development of manikins to simulate human thermal behaviour more adequately, thermo-physiological human simulators have been developed by coupling a thermal sweating manikin with a thermo-physiology model. Despite their availability and obvious advantages, the number of studies involving these devices is only marginal, which plausibly results from the high complexity of the development and evaluation process and need of multi-disciplinary expertise. The aim of this paper is to present an integrated approach to develop, validate and operate such devices including technical challenges and limitations of thermo-physiological human simulators, their application and measurement protocol, strategy for setting test scenarios, and the comparison to standard methods and human studies including details which have not been published so far. A physical manikin controlled by a human thermoregulation model overcame the limitations of mathematical clothing models and provided a complementary method to investigate thermal interactions between the human body, protective clothing, and its environment. The opportunities of these devices include not only realistic assessment of protective clothing assemblies and equipment but also potential application in many research fields ranging from biometeorology, automotive industry, environmental engineering, and urban climate to clinical and safety applications. PMID:28966294

Molecular Identification of Human Fungal Pathogens

DTIC Science & Technology

2007-03-01

in mycology . Unfortunately, individuals with this training are in short supply in both civilian and military hospitals. The objective of this study...is to enable laboratory technicians to make proper identifications without experience in mycology by using standardized techniques developed in...regardless of mycological expertise, to identify any human fungal pathogen faster and more accurately than is presently possible, using a single

Role of non-human primates in malaria vaccine development: Memorandum from a WHO Meeting*

PubMed Central

1988-01-01

This Memorandum discusses the coordination and standardization of malaria vaccine research in non-human primates to encourage optimum use of the available animals in experiments that are fully justified both scientifically and ethically. The requirements for experimentation in non-human primates, the availability of suitable animals for malaria vaccine studies, and the criteria for testing candidate vaccines are considered. The policy and legislation relevant to the use of non-human primates in biomedical research are also briefly discussed. The Memorandum concludes with eight recommendations. PMID:3266112

Nomenclature for the KIR of non-human species.

PubMed

Robinson, James; Guethlein, Lisbeth A; Maccari, Giuseppe; Blokhuis, Jeroen; Bimber, Benjamin N; de Groot, Natasja G; Sanderson, Nicholas D; Abi-Rached, Laurent; Walter, Lutz; Bontrop, Ronald E; Hammond, John A; Marsh, Steven G E; Parham, Peter

2018-06-04

The increasing number of Killer Immunoglobulin-like Receptor (KIR) sequences available for non-human primate species and cattle has prompted development of a centralized database, guidelines for a standardized nomenclature, and minimum requirements for database submission. The guidelines and nomenclature are based on those used for human KIR and incorporate modifications made for inclusion of non-human species in the companion IPD-NHKIR database. Included in this first release are the rhesus macaque (Macaca mulatta), chimpanzee (Pan troglodytes), orangutan (Pongo abelii and Pongo pygmaeus), and cattle (Bos taurus).

Establishing a standardized dental record-keeping system for a small investigational colony of rhesus monkeys (Macaca mulatta).

PubMed

Gibson, B W; McGuffey, L; Raflo, C P; Niemiec, B A

2008-02-01

Dental hygiene is becoming an increasingly important component of quality health care for laboratory animals, especially non-human primates (NHPs). One key to a successful health care program is an effective and efficient record-keeping system. To standardize a dental hygiene program for a small colony of NHPs, we developed a dental recording chart specific for rhesus monkeys. This dental chart was developed using the modified Triadan system. This system numbers teeth across species according to location. An illustrative case report was presented to demonstrate the accurate record keeping and spatial relationship generated from this Old World NHP dental chart design. The development and implementation of a standardized dental chart, as part of a dental hygiene program will help minimize variables that may affect research data.

Variation is the universal: making cultural evolution work in developmental psychology.

PubMed

Kline, Michelle Ann; Shamsudheen, Rubeena; Broesch, Tanya

2018-04-05

Culture is a human universal, yet it is a source of variation in human psychology, behaviour and development. Developmental researchers are now expanding the geographical scope of research to include populations beyond relatively wealthy Western communities. However, culture and context still play a secondary role in the theoretical grounding of developmental psychology research, far too often. In this paper, we highlight four false assumptions that are common in psychology, and that detract from the quality of both standard and cross-cultural research in development. These assumptions are: (i) the universality assumption , that empirical uniformity is evidence for universality, while any variation is evidence for culturally derived variation; (ii) the Western centrality assumption , that Western populations represent a normal and/or healthy standard against which development in all societies can be compared; (iii) the deficit assumption , that population-level differences in developmental timing or outcomes are necessarily due to something lacking among non-Western populations; and (iv) the equivalency assumption , that using identical research methods will necessarily produce equivalent and externally valid data, across disparate cultural contexts. For each assumption, we draw on cultural evolutionary theory to critique and replace the assumption with a theoretically grounded approach to culture in development. We support these suggestions with positive examples drawn from research in development. Finally, we conclude with a call for researchers to take reasonable steps towards more fully incorporating culture and context into studies of development, by expanding their participant pools in strategic ways. This will lead to a more inclusive and therefore more accurate description of human development.This article is part of the theme issue 'Bridging cultural gaps: interdisciplinary studies in human cultural evolution'. © 2018 The Author(s).

Design Development Test and Evaluation (DDT and E) Considerations for Safe and Reliable Human Rated Spacecraft Systems

NASA Technical Reports Server (NTRS)

Miller, James; Leggett, Jay; Kramer-White, Julie

2008-01-01

A team directed by the NASA Engineering and Safety Center (NESC) collected methodologies for how best to develop safe and reliable human rated systems and how to identify the drivers that provide the basis for assessing safety and reliability. The team also identified techniques, methodologies, and best practices to assure that NASA can develop safe and reliable human rated systems. The results are drawn from a wide variety of resources, from experts involved with the space program since its inception to the best-practices espoused in contemporary engineering doctrine. This report focuses on safety and reliability considerations and does not duplicate or update any existing references. Neither does it intend to replace existing standards and policy.

A Community Standard Format for the Representation of Protein Affinity Reagents*

PubMed Central

Gloriam, David E.; Orchard, Sandra; Bertinetti, Daniela; Björling, Erik; Bongcam-Rudloff, Erik; Borrebaeck, Carl A. K.; Bourbeillon, Julie; Bradbury, Andrew R. M.; de Daruvar, Antoine; Dübel, Stefan; Frank, Ronald; Gibson, Toby J.; Gold, Larry; Haslam, Niall; Herberg, Friedrich W.; Hiltke, Tara; Hoheisel, Jörg D.; Kerrien, Samuel; Koegl, Manfred; Konthur, Zoltán; Korn, Bernhard; Landegren, Ulf; Montecchi-Palazzi, Luisa; Palcy, Sandrine; Rodriguez, Henry; Schweinsberg, Sonja; Sievert, Volker; Stoevesandt, Oda; Taussig, Michael J.; Ueffing, Marius; Uhlén, Mathias; van der Maarel, Silvère; Wingren, Christer; Woollard, Peter; Sherman, David J.; Hermjakob, Henning

2010-01-01

Protein affinity reagents (PARs), most commonly antibodies, are essential reagents for protein characterization in basic research, biotechnology, and diagnostics as well as the fastest growing class of therapeutics. Large numbers of PARs are available commercially; however, their quality is often uncertain. In addition, currently available PARs cover only a fraction of the human proteome, and their cost is prohibitive for proteome scale applications. This situation has triggered several initiatives involving large scale generation and validation of antibodies, for example the Swedish Human Protein Atlas and the German Antibody Factory. Antibodies targeting specific subproteomes are being pursued by members of Human Proteome Organisation (plasma and liver proteome projects) and the United States National Cancer Institute (cancer-associated antigens). ProteomeBinders, a European consortium, aims to set up a resource of consistently quality-controlled protein-binding reagents for the whole human proteome. An ultimate PAR database resource would allow consumers to visit one on-line warehouse and find all available affinity reagents from different providers together with documentation that facilitates easy comparison of their cost and quality. However, in contrast to, for example, nucleotide databases among which data are synchronized between the major data providers, current PAR producers, quality control centers, and commercial companies all use incompatible formats, hindering data exchange. Here we propose Proteomics Standards Initiative (PSI)-PAR as a global community standard format for the representation and exchange of protein affinity reagent data. The PSI-PAR format is maintained by the Human Proteome Organisation PSI and was developed within the context of ProteomeBinders by building on a mature proteomics standard format, PSI-molecular interaction, which is a widely accepted and established community standard for molecular interaction data. Further information and documentation are available on the PSI-PAR web site. PMID:19674966

Bridging international law and rights-based litigation: mapping health-related rights through the development of the Global Health and Human Rights Database.

PubMed

Meier, Benjamin Mason; Cabrera, Oscar A; Ayala, Ana; Gostin, Lawrence O

2012-06-15

The O'Neill Institute for National and Global Health Law at Georgetown University, the World Health Organization, and the Lawyers Collective have come together to develop a searchable Global Health and Human Rights Database that maps the intersection of health and human rights in judgments, international and regional instruments, and national constitutions. Where states long remained unaccountable for violations of health-related human rights, litigation has arisen as a central mechanism in an expanding movement to create rights-based accountability. Facilitated by the incorporation of international human rights standards in national law, this judicial enforcement has supported the implementation of rights-based claims, giving meaning to states' longstanding obligations to realize the highest attainable standard of health. Yet despite these advancements, there has been insufficient awareness of the international and domestic legal instruments enshrining health-related rights and little understanding of the scope and content of litigation upholding these rights. As this accountability movement evolves, the Global Health and Human Rights Database seeks to chart this burgeoning landscape of international instruments, national constitutions, and judgments for health-related rights. Employing international legal research to document and catalogue these three interconnected aspects of human rights for the public's health, the Database's categorization by human rights, health topics, and regional scope provides a comprehensive means of understanding health and human rights law. Through these categorizations, the Global Health and Human Rights Database serves as a basis for analogous legal reasoning across states to serve as precedents for future cases, for comparative legal analysis of similar health claims in different country contexts, and for empirical research to clarify the impact of human rights judgments on public health outcomes. Copyright © 2012 Meier, Nygren-Krug, Cabrera, Ayala, and Gostin.

Development of an Intracellular Screen for New Compounds Able To Inhibit Mycobacterium tuberculosis Growth in Human Macrophages.

PubMed

Sorrentino, Flavia; Gonzalez del Rio, Ruben; Zheng, Xingji; Presa Matilla, Jesus; Torres Gomez, Pedro; Martinez Hoyos, Maria; Perez Herran, Maria Esther; Mendoza Losana, Alfonso; Av-Gay, Yossef

2016-01-01

Here we describe the development and validation of an intracellular high-throughput screening assay for finding new antituberculosis compounds active in human macrophages. The assay consists of a luciferase-based primary identification assay, followed by a green fluorescent protein-based secondary profiling assay. Standard tuberculosis drugs and 158 previously recognized active antimycobacterial compounds were used to evaluate assay robustness. Data show that the assay developed is a short and valuable tool for the discovery of new antimycobacterial compounds. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Utilitarianism, poverty and development of disabled people.

PubMed

Xavier de França, Inacia Sátiro; Freitag Pagliuca, Lorita Marlena

2007-01-01

This study aims to analyze the influences of human development factors in the experience of disabled people based on social scenarios of inequality. The data collected were standardized and allocated in thematic categories. The analysis was based on liberal utilitarianism. The conclusion is that there is legislation in Brazil that guarantees the disabled people's development in areas such as health, education and work. However despite the attempts of decision makers in combating discriminatory behaviors and the theory based on equity, these people still face difficulties in breaking the barrier of poverty and achieving all humans rights deserved.

Children and Youth Camp Safety Act, 1978. Hearing Before the Subcommittee on Child and Human Development of the Committee on Human Resources, United States Senate, 95th Congress, 2nd Session on S. 258--To Provide for the Development and Implementation of Programs for Children and Youth Camp Safety (March 21, 1978).

ERIC Educational Resources Information Center

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

The product of some 10 years of work directed toward federal legislation addressing and defining youth camp safety, the Youth Camp Safety Act (S. 258), as presented in these hearings, calls for the federal government to assume a role in the development of state health and safety standards for children attending youth camps in any state in the…

Mapping and sequencing the human genome: Science, ethics, and public policy. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

McInerney, J.D.

1993-03-31

Development of Mapping and Sequencing the Human Genome: Science, Ethics, and Public Policy followed the standard process of curriculum development at the Biological Sciences Curriculum Study (BSCS), the process is described. The production of this module was a collaborative effort between BSCS and the American Medical Association (AMA). Appendix A contains a copy of the module. Copies of reports sent to the Department of Energy (DOE) during the development process are contained in Appendix B; all reports should be on file at DOE. Appendix B also contains copies of status reports submitted to the BSCS Board of Directors.

Human Augmentics: augmenting human evolution.

PubMed

Kenyon, Robert V; Leigh, Jason

2011-01-01

Human Augmentics (HA) refers to technologies for expanding the capabilities, and characteristics of humans. One can think of Human Augmentics as the driving force in the non-biological evolution of humans. HA devices will provide technology to compensate for human biological limitations either natural or acquired. The strengths of HA lie in its applicability to all humans. Its interoperability enables the formation of ecosystems whereby augmented humans can draw from other realms such as "the Cloud" and other augmented humans for strength. The exponential growth in new technologies portends such a system but must be designed for interaction through the use of open-standards and open-APIs for system development. We discuss the conditions needed for HA to flourish with an emphasis on devices that provide non-biological rehabilitation.

An Argument against Using Standardized Test Scores for Placement of International Undergraduate Students in English as a Second Language (ESL) Courses

ERIC Educational Resources Information Center

Kokhan, Kateryna

2013-01-01

Development and administration of institutional ESL placement tests require a great deal of financial and human resources. Due to a steady increase in the number of international students studying in the United States, some US universities have started to consider using standardized test scores for ESL placement. The English Placement Test (EPT)…

Defense Logistics Standard Systems Functional Requirements.

DTIC Science & Technology

1987-03-01

Artificial Intelligence - the development of a machine capability to perform functions normally concerned with human intelligence, such as learning , adapting...Basic Data Base Machine Configurations .... ......... D- 18 xx ~ ?f~~~vX PART I: MODELS - DEFENSE LOGISTICS STANDARD SYSTEMS FUNCTIONAL REQUIREMENTS...On-line, Interactive Access. Integrating user input and machine output in a dynamic, real-time, give-and- take process is considered the optimum mode

A Review of Federal and State Regulations for Day Care Programs and Facilities. Center for Human Services Development Report No. 10.

ERIC Educational Resources Information Center

Hollick, Rosemary; And Others

This report provides a review of U.S. regulatory standards for day care programs and facilities and makes recommendations for the revision of day care regulations in Pennsylvania. Following a brief discussion of federal interagency requirements, a number of short descriptive analyses compare individual state standards in the areas of licensing,…

Researching College- and Career Ready Standards to Improve Student Outcomes: Technical Working Group Meeting. Meeting Summary (Washington, DC, August 19-20, 2013)

ERIC Educational Resources Information Center

Institute of Education Sciences, 2013

2013-01-01

In August, IES worked with the National Science Foundation and the Eunice Kennedy Shriver National Institute of Child Health and Human Development to convene a technical working group to discuss research objectives related to college- and career-ready standards in English language arts and mathematics. Forty people (including researchers,…

Advancing sexual health through human rights: The role of the law

PubMed Central

Kismödi, Eszter; Cottingham, Jane; Gruskin, Sofia; Miller, Alice M.

2015-01-01

Since the International Conference on Population and Development, definitions of sexuality and sexual health have been greatly elaborated alongside widely accepted recognition that sexual health requires respect, protection and fulfilment of human rights. Considerable progress has also been made in enacting or changing laws that affect sexuality and sexual health, in line with human rights standards. These measures include legal guarantees against non-discrimination and violence, decriminalisation of consensual sexual conduct and guaranteeing availability, accessibility, acceptability and quality of sexual health information and services to all. Such legal actions have had positive effects on health and specifically on sexual health, particularly for marginalised populations. Yet in all regions of the world, laws still exist which jeopardise health, including sexual health, and violate human rights. In order to ensure accountability for the rights and health of their populations, states have an obligation to bring their laws into line with international, regional and national human rights standards. These rights-based legal guarantees, while insufficient alone, are essential for effective systems of accountability, achieving positive sexual health outcomes and the respect and protection of human rights. PMID:25539286

Advancing sexual health through human rights: the role of the law.

PubMed

Kismödi, Eszter; Cottingham, Jane; Gruskin, Sofia; Miller, Alice M

2015-01-01

Since the International Conference on Population and Development, definitions of sexuality and sexual health have been greatly elaborated alongside widely accepted recognition that sexual health requires respect, protection and fulfilment of human rights. Considerable progress has also been made in enacting or changing laws that affect sexuality and sexual health, in line with human rights standards. These measures include legal guarantees against non-discrimination and violence, decriminalisation of consensual sexual conduct and guaranteeing availability, accessibility, acceptability and quality of sexual health information and services to all. Such legal actions have had positive effects on health and specifically on sexual health, particularly for marginalised populations. Yet in all regions of the world, laws still exist which jeopardise health, including sexual health, and violate human rights. In order to ensure accountability for the rights and health of their populations, states have an obligation to bring their laws into line with international, regional and national human rights standards. These rights-based legal guarantees, while insufficient alone, are essential for effective systems of accountability, achieving positive sexual health outcomes and the respect and protection of human rights.

HGVS Recommendations for the Description of Sequence Variants: 2016 Update.

PubMed

den Dunnen, Johan T; Dalgleish, Raymond; Maglott, Donna R; Hart, Reece K; Greenblatt, Marc S; McGowan-Jordan, Jean; Roux, Anne-Francoise; Smith, Timothy; Antonarakis, Stylianos E; Taschner, Peter E M

2016-06-01

The consistent and unambiguous description of sequence variants is essential to report and exchange information on the analysis of a genome. In particular, DNA diagnostics critically depends on accurate and standardized description and sharing of the variants detected. The sequence variant nomenclature system proposed in 2000 by the Human Genome Variation Society has been widely adopted and has developed into an internationally accepted standard. The recommendations are currently commissioned through a Sequence Variant Description Working Group (SVD-WG) operating under the auspices of three international organizations: the Human Genome Variation Society (HGVS), the Human Variome Project (HVP), and the Human Genome Organization (HUGO). Requests for modifications and extensions go through the SVD-WG following a standard procedure including a community consultation step. Version numbers are assigned to the nomenclature system to allow users to specify the version used in their variant descriptions. Here, we present the current recommendations, HGVS version 15.11, and briefly summarize the changes that were made since the 2000 publication. Most focus has been on removing inconsistencies and tightening definitions allowing automatic data processing. An extensive version of the recommendations is available online, at http://www.HGVS.org/varnomen. © 2016 WILEY PERIODICALS, INC.

Surrogate matrix and surrogate analyte approaches for definitive quantitation of endogenous biomolecules.

PubMed

Jones, Barry R; Schultz, Gary A; Eckstein, James A; Ackermann, Bradley L

2012-10-01

Quantitation of biomarkers by LC-MS/MS is complicated by the presence of endogenous analytes. This challenge is most commonly overcome by calibration using an authentic standard spiked into a surrogate matrix devoid of the target analyte. A second approach involves use of a stable-isotope-labeled standard as a surrogate analyte to allow calibration in the actual biological matrix. For both methods, parallelism between calibration standards and the target analyte in biological matrix must be demonstrated in order to ensure accurate quantitation. In this communication, the surrogate matrix and surrogate analyte approaches are compared for the analysis of five amino acids in human plasma: alanine, valine, methionine, leucine and isoleucine. In addition, methodology based on standard addition is introduced, which enables a robust examination of parallelism in both surrogate analyte and surrogate matrix methods prior to formal validation. Results from additional assays are presented to introduce the standard-addition methodology and to highlight the strengths and weaknesses of each approach. For the analysis of amino acids in human plasma, comparable precision and accuracy were obtained by the surrogate matrix and surrogate analyte methods. Both assays were well within tolerances prescribed by regulatory guidance for validation of xenobiotic assays. When stable-isotope-labeled standards are readily available, the surrogate analyte approach allows for facile method development. By comparison, the surrogate matrix method requires greater up-front method development; however, this deficit is offset by the long-term advantage of simplified sample analysis.

A Serological Point-of-Care Test for the Detection of IgG Antibodies against Ebola Virus in Human Survivors.

PubMed

Brangel, Polina; Sobarzo, Ariel; Parolo, Claudio; Miller, Benjamin S; Howes, Philip D; Gelkop, Sigal; Lutwama, Julius J; Dye, John M; McKendry, Rachel A; Lobel, Leslie; Stevens, Molly M

2018-01-23

Ebola virus disease causes widespread and highly fatal epidemics in human populations. Today, there is still great need for point-of-care tests for diagnosis, patient management and surveillance, both during and post outbreaks. We present a point-of-care test comprising an immunochromatographic strip and a smartphone reader, which detects and semiquantifies Ebola-specific antibodies in human survivors. We developed a Sudan virus glycoprotein monoplex platform and validated it using sera from 90 human survivors and 31 local noninfected controls. The performance of the glycoprotein monoplex was 100% sensitivity and 98% specificity compared to standard whole antigen enzyme-linked immunosorbent assay (ELISA), and it was validated with freshly collected patient samples in Uganda. Moreover, we constructed a multiplex test for simultaneous detection of antibodies against three recombinant Sudan virus proteins. A pilot study comprising 15 survivors and 5 noninfected controls demonstrated sensitivity and specificity of 100% compared to standard ELISA. Finally, we developed a second multiplex subtype assay for the identification of exposure to three related EVD species: Sudan virus, Bundibugyo virus and Ebola virus (formerly Zaire) using recombinant viral glycoprotein. This multiplex test could distinguish between the host's immunity to specific viral species and identify cross-reactive immunity. These developed serological platforms consisted of capture ligands with high specificity and sensitivity, in-house developed strips and a compatible smartphone application. These platforms enabled rapid and portable testing, data storage and sharing as well as geographical tagging of the tested individuals in Uganda. This platform holds great potential as a field tool for diagnosis, vaccine development, and therapeutic evaluation.

Space Radiation Program Element

NASA Technical Reports Server (NTRS)

Krenek, Sam

2008-01-01

This poster presentation shows the various elements of the Space Radiation Program. It reviews the program requirements: develop and validate standards, quantify space radiation human health risks, mitigate risks through countermeasures and technologies, and treat and monitor unmitigated risks.

ESTABLISH AND STANDARDIZE METHODOLOGY FOR ...

EPA Pesticide Factsheets

Research is conducted to develop and standardize methods to detect and measure occurrence of human enteric viruses that cause waterborne disease. The viruses of concern include the emerging pathogens--hepatitis E virus and group B rotaviruses. Also of concern are the coxsackieviruses and echoviruses--two members of the Office of Water's Contaminant Candidate List (CCL). Under this task, indicators of fecal pollution are also being evaluated as to their importance in evaluating microbial water quality. Another focus of the research is to address the standardization, evaluation and promulgation of detection methods for bacterial viruses. Develop sensitive techniques to detect and identify emerging human waterborne pathogenic viruses and viruses on the CCL.Determine effectiveness of viral indicators to measure microbial quality in water matrices.Support activities: (a) culture and distribution of mammalian cells for Agency and scientific community research needs, (b) provide operator expertise for research requiring confocal and electron microscopy, (c) glassware cleaning, sterilization and biological waste disposal for the Cincinnati EPA facility, (d) operation of infectious pathogenic suite, (e) maintenance of walk-in constant temperature rooms and (f) provide Giardia cysts.

Joint American Nuclear Society and Health Physics Society Conference: Applicability of Radiation Response Models to Low Dose Protection Standards.

PubMed

Glines, Wayne M; Markham, Anna

2018-05-01

Seventy-five years after the Hanford Site was initially created as the primary plutonium production site for atomic weapons development under the Manhattan Project, the American Nuclear Society and the Health Physics Society are sponsoring a conference from 30 September through 3 October 2018, in Pasco, Washington, titled "Applicability of Radiation Response Models to Low Dose Protection Standards." The goal of this conference is to use current scientific data to update the approach to regulating low-level radiation doses; i.e., to answer a quintessential question of radiation protection-how to best develop radiation protection standards that protect human populations against detrimental effects while allowing the beneficial uses of radiation and radioactive materials. Previous conferences (e.g., "Wingspread Conference," "Arlie Conference") have attempted to address this question; but now, almost 20 y later, the key issues, goals, conclusions, and recommendations of those two conferences remain and are as relevant as they were then. Despite the best efforts of the conference participants and increased knowledge and understanding of the science underlying radiation effects in human populations, the bases of current radiation protection standards have evolved little. This 2018 conference seeks to provide a basis and path forward for evolving radiation protection standards to be more reflective of current knowledge and understanding of low dose response models.

Radiation Environment Modeling for Spacecraft Design: New Model Developments

NASA Technical Reports Server (NTRS)

Barth, Janet; Xapsos, Mike; Lauenstein, Jean-Marie; Ladbury, Ray

2006-01-01

A viewgraph presentation on various new space radiation environment models for spacecraft design is described. The topics include: 1) The Space Radiatio Environment; 2) Effects of Space Environments on Systems; 3) Space Radiatio Environment Model Use During Space Mission Development and Operations; 4) Space Radiation Hazards for Humans; 5) "Standard" Space Radiation Environment Models; 6) Concerns about Standard Models; 7) Inadequacies of Current Models; 8) Development of New Models; 9) New Model Developments: Proton Belt Models; 10) Coverage of New Proton Models; 11) Comparison of TPM-1, PSB97, AP-8; 12) New Model Developments: Electron Belt Models; 13) Coverage of New Electron Models; 14) Comparison of "Worst Case" POLE, CRESELE, and FLUMIC Models with the AE-8 Model; 15) New Model Developments: Galactic Cosmic Ray Model; 16) Comparison of NASA, MSU, CIT Models with ACE Instrument Data; 17) New Model Developmemts: Solar Proton Model; 18) Comparison of ESP, JPL91, KIng/Stassinopoulos, and PSYCHIC Models; 19) New Model Developments: Solar Heavy Ion Model; 20) Comparison of CREME96 to CREDO Measurements During 2000 and 2002; 21) PSYCHIC Heavy ion Model; 22) Model Standardization; 23) Working Group Meeting on New Standard Radiation Belt and Space Plasma Models; and 24) Summary.

Building human resources capability in health care: a global analysis of best practice--Part III.

PubMed

Zairi, M

1998-01-01

This is the last part of a series of three papers which discussed very comprehensively best practice applications in human resource management by drawing special inferences to the healthcare context. It emerged from parts I and II that high performing organisations plan and intend to build sustainable capability through a systematic consideration of the human element as the key asset and through a continuous process of training, developing, empowering and engaging people in all aspects of organisational excellence. Part III brings this debate to a close by demonstrating what brings about organisational excellence and proposes a road map for effective human resource development and management, based on world class standards. Healthcare human resource professionals can now rise to the challenge and plan ahead for building organisational capability and sustainable performance.

Piloting Vertical Flight Aircraft: A Conference on Flying Qualities and Human Factors

NASA Technical Reports Server (NTRS)

Blanken, Christopher L. (Editor); Whalley, Matthew S. (Editor)

1993-01-01

This document contains papers from a specialists' meeting entitled 'Piloting Vertical Flight Aircraft: A Conference on Flying Qualities and Human Factors.' Vertical flight aircraft, including helicopters and a variety of Vertical Takeoff and Landing (VTOL) concepts, place unique requirements on human perception, control, and performance for the conduct of their design missions. The intent of this conference was to examine, for these vehicles, advances in: (1) design of flight control systems for ADS-33C standards; (2) assessment of human factors influences of cockpit displays and operational procedures; (3) development of VTOL design and operational criteria; and (4) development of theoretical methods or models for predicting pilot/vehicle performance and mission suitability. A secondary goal of the conference was to provide an initial venue for enhanced interaction between human factors and handling qualities specialists.

Measurement standards for interdisciplinary medical rehabilitation.

PubMed

Johnston, M V; Keith, R A; Hinderer, S R

1992-12-01

Rehabilitation must address problems inherent in the measurement of human function and health-related quality of life, as well as problems in diagnosis and measurement of impairment. This educational document presents an initial set of standards to be used as guidelines for development and use of measurement and evaluation procedures and instruments for interdisciplinary, health-related rehabilitation. Part I covers general measurement principles and technical standards, beginning with validity, the central consideration for use of measures. Subsequent sections focus on reliability and errors of measurement, norms and scaling, development of measures, and technical manuals and guides. Part II covers principles and standards for use of measures. General principles of application of measures in practice are discussed first, followed by standards to protect persons being measured and then by standards for administrative applications. Many explanations, examples, and references are provided to help professionals understand measurement principles. Improved measurement will ensure the basis of rehabilitation as a science and nourish its success as a clinical service.

Scoring of Decomposition: A Proposed Amendment to the Method When Using a Pig Model for Human Studies.

PubMed

Keough, Natalie; Myburgh, Jolandie; Steyn, Maryna

2017-07-01

Decomposition studies often use pigs as proxies for human cadavers. However, differences in decomposition sequences/rates relative to humans have not been scientifically examined. Descriptions of five main decomposition stages (humans) were developed and refined by Galloway and later by Megyesi. However, whether these changes/processes are alike in pigs is unclear. Any differences can have significant effects when pig models are used for human PMI estimation. This study compared human decomposition models to the changes observed in pigs. Twenty pigs (50-90 kg) were decomposed over five months and decompositional features recorded. Total body scores (TBS) were calculated. Significant differences were observed during early decomposition between pigs and humans. An amended scoring system to be used in future studies was developed. Standards for PMI estimation derived from porcine models may not directly apply to humans and may need adjustment. Porcine models, however, remain valuable to study variables influencing decomposition. © 2016 American Academy of Forensic Sciences.

Economic Opportunities and Gender Differences in Human Capital: Experimental Evidence for India. NBER Working Paper No. 16021

ERIC Educational Resources Information Center

Jensen, Robert T.

2010-01-01

Gender differences in health and education are a concern for a number of developing countries. While standard theory predicts human capital should respond to market returns, social norms (e.g., disapproval of women working outside the home) may weaken or even sever this link for girls. Though many studies have examined the link between women's…

Analyzing Data from a Pretest-Posttest Control Group Design: The Importance of Statistical Assumptions

ERIC Educational Resources Information Center

Zientek, Linda; Nimon, Kim; Hammack-Brown, Bryn

2016-01-01

Purpose: Among the gold standards in human resource development (HRD) research are studies that test theoretically developed hypotheses and use experimental designs. A somewhat typical experimental design would involve collecting pretest and posttest data on individuals assigned to a control or experimental group. Data from such a design that…

Improving Sexuality Education: The Development of Teacher-Preparation Standards

ERIC Educational Resources Information Center

Barr, Elissa M.; Goldfarb, Eva S.; Russell, Susan; Seabert, Denise; Wallen, Michele; Wilson, Kelly L.

2014-01-01

Background: Teaching sexuality education to support young people's sexual development and overall sexual health is both needed and supported. Data continue to highlight the high rates of teen pregnancy, sexually transmitted disease, including human immunodeficiency virus (HIV) infections, among young people in the United States as well as the…

EVA Health and Human Performance Benchmarking Study

NASA Technical Reports Server (NTRS)

Abercromby, A. F.; Norcross, J.; Jarvis, S. L.

2016-01-01

Multiple HRP Risks and Gaps require detailed characterization of human health and performance during exploration extravehicular activity (EVA) tasks; however, a rigorous and comprehensive methodology for characterizing and comparing the health and human performance implications of current and future EVA spacesuit designs does not exist. This study will identify and implement functional tasks and metrics, both objective and subjective, that are relevant to health and human performance, such as metabolic expenditure, suit fit, discomfort, suited postural stability, cognitive performance, and potentially biochemical responses for humans working inside different EVA suits doing functional tasks under the appropriate simulated reduced gravity environments. This study will provide health and human performance benchmark data for humans working in current EVA suits (EMU, Mark III, and Z2) as well as shirtsleeves using a standard set of tasks and metrics with quantified reliability. Results and methodologies developed during this test will provide benchmark data against which future EVA suits, and different suit configurations (eg, varied pressure, mass, CG) may be reliably compared in subsequent tests. Results will also inform fitness for duty standards as well as design requirements and operations concepts for future EVA suits and other exploration systems.

Analysis of drugs in human tissues by supercritical fluid extraction/immunoassay

NASA Astrophysics Data System (ADS)

Furton, Kenneth G.; Sabucedo, Alberta; Rein, Joseph; Hearn, W. L.

1997-02-01

A rapid, readily automated method has been developed for the quantitative analysis of phenobarbital from human liver tissues based on supercritical carbon dioxide extraction followed by fluorescence enzyme immunoassay. The method developed significantly reduces sample handling and utilizes the entire liver homogenate. The current method yields comparable recoveries and precision and does not require the use of an internal standard, although traditional GC/MS confirmation can still be performed on sample extracts. Additionally, the proposed method uses non-toxic, inexpensive carbon dioxide, thus eliminating the use of halogenated organic solvents.

Development of Human-Murine Chimeric Immunoglobulin G for Use in the Serological Detection of Human Flavivirus and Alphavirus Antibodies▿

PubMed Central

Thibodeaux, Brett A.; Panella, Amanda N.; Roehrig, John T.

2010-01-01

Diagnosis of human arboviral infections relies heavily on serological techniques such as the immunoglobulin M (IgM) antibody capture enzyme-linked immunosorbent assay (MAC-ELISA) and the indirect IgG ELISA. Broad application of these assays is hindered by the lack of standardized positive human control sera that react with a wide variety of flaviviruses (e.g., dengue, West Nile, yellow fever, Japanese encephalitis, Saint Louis encephalitis, and Powassan viruses), or alphaviruses (e.g., Eastern equine encephalitis, Western equine encephalitis, Venezuelan equine encephalitis, and chikungunya viruses) that can cause human disease. We have created human-murine chimeric monoclonal antibodies (cMAbs) by combining the variable regions of flavivirus (6B6C-1) or alphavirus (1A4B-6) broadly cross-reactive murine MAbs (mMAbs) with the constant region of human IgG1. These cMAbs may be used as standardized reagents capable of replacing human infection-immune-positive control sera in indirect IgG ELISA for diagnosis of all human flaviviral or alphaviral infections. The IgG cMAbs secreted from plasmid-transformed Sp2/0-Ag14 cells had serological activity identical to that of the parent mMAbs, as measured by ELISA using multiple flaviviruses or alphaviruses. PMID:20739503

Development of human-murine chimeric immunoglobulin G for use in the serological detection of human flavivirus and alphavirus antibodies.

PubMed

Thibodeaux, Brett A; Panella, Amanda N; Roehrig, John T

2010-10-01

Diagnosis of human arboviral infections relies heavily on serological techniques such as the immunoglobulin M (IgM) antibody capture enzyme-linked immunosorbent assay (MAC-ELISA) and the indirect IgG ELISA. Broad application of these assays is hindered by the lack of standardized positive human control sera that react with a wide variety of flaviviruses (e.g., dengue, West Nile, yellow fever, Japanese encephalitis, Saint Louis encephalitis, and Powassan viruses), or alphaviruses (e.g., Eastern equine encephalitis, Western equine encephalitis, Venezuelan equine encephalitis, and chikungunya viruses) that can cause human disease. We have created human-murine chimeric monoclonal antibodies (cMAbs) by combining the variable regions of flavivirus (6B6C-1) or alphavirus (1A4B-6) broadly cross-reactive murine MAbs (mMAbs) with the constant region of human IgG1. These cMAbs may be used as standardized reagents capable of replacing human infection-immune-positive control sera in indirect IgG ELISA for diagnosis of all human flaviviral or alphaviral infections. The IgG cMAbs secreted from plasmid-transformed Sp2/0-Ag14 cells had serological activity identical to that of the parent mMAbs, as measured by ELISA using multiple flaviviruses or alphaviruses.

The caBIG annotation and image Markup project.

PubMed

Channin, David S; Mongkolwat, Pattanasak; Kleper, Vladimir; Sepukar, Kastubh; Rubin, Daniel L

2010-04-01

Image annotation and markup are at the core of medical interpretation in both the clinical and the research setting. Digital medical images are managed with the DICOM standard format. While DICOM contains a large amount of meta-data about whom, where, and how the image was acquired, DICOM says little about the content or meaning of the pixel data. An image annotation is the explanatory or descriptive information about the pixel data of an image that is generated by a human or machine observer. An image markup is the graphical symbols placed over the image to depict an annotation. While DICOM is the standard for medical image acquisition, manipulation, transmission, storage, and display, there are no standards for image annotation and markup. Many systems expect annotation to be reported verbally, while markups are stored in graphical overlays or proprietary formats. This makes it difficult to extract and compute with both of them. The goal of the Annotation and Image Markup (AIM) project is to develop a mechanism, for modeling, capturing, and serializing image annotation and markup data that can be adopted as a standard by the medical imaging community. The AIM project produces both human- and machine-readable artifacts. This paper describes the AIM information model, schemas, software libraries, and tools so as to prepare researchers and developers for their use of AIM.

Standardized Methods to Generate Mock (Spiked) Clinical Specimens by Spiking Blood or Plasma with Cultured Pathogens

PubMed Central

Dong, Ming; Fisher, Carolyn; Añez, Germán; Rios, Maria; Nakhasi, Hira L.; Hobson, J. Peyton; Beanan, Maureen; Hockman, Donna; Grigorenko, Elena; Duncan, Robert

2016-01-01

Aims To demonstrate standardized methods for spiking pathogens into human matrices for evaluation and comparison among diagnostic platforms. Methods and Results This study presents detailed methods for spiking bacteria or protozoan parasites into whole blood and virus into plasma. Proper methods must start with a documented, reproducible pathogen source followed by steps that include standardized culture, preparation of cryopreserved aliquots, quantification of the aliquots by molecular methods, production of sufficient numbers of individual specimens and testing of the platform with multiple mock specimens. Results are presented following the described procedures that showed acceptable reproducibility comparing in-house real-time PCR assays to a commercially available multiplex molecular assay. Conclusions A step by step procedure has been described that can be followed by assay developers who are targeting low prevalence pathogens. Significance and Impact of Study The development of diagnostic platforms for detection of low prevalence pathogens such as biothreat or emerging agents is challenged by the lack of clinical specimens for performance evaluation. This deficit can be overcome using mock clinical specimens made by spiking cultured pathogens into human matrices. To facilitate evaluation and comparison among platforms, standardized methods must be followed in the preparation and application of spiked specimens. PMID:26835651

Mechanical Model of Traditional Thai Massage for Integrated Healthcare.

PubMed

Rattanaphan, Salinee; Srichandr, Panya

2015-01-01

In this study, a mechanical model was developed, aiming to provide standardized and programmable traditional Thai massage (TTM) therapy to patients. The TTM was modeled and integrated into a mechanical hand (MH) system, and a prototype massage chair was built and tested for user satisfaction. Three fundamental principles of Thai massage were integrated: pull, press, and pin. Based on these principles, the mechanics of Thai massage was studied and a mathematical model was developed to describe the dynamics and conditions for the design and prototyping of an MH. On average, it was found that users were satisfied with the treatment and felt that the treatment was similar to that performed by human hands. According to the interview results, users indicated that they were likely to utilize the MH as an alternative to traditional massage. Therefore, integrated TTM with an MH may help healthcare providers deliver standardized, programmable massage therapy to patients as opposed to variable, inconsistent human massage.

The First Development of Human Factors Engineering Requirements for Application to Ground Task Design for a NASA Flight Program

NASA Technical Reports Server (NTRS)

Dischinger, H. Charles, Jr.; Stambolian, Damon B.; Miller, Darcy H.

2008-01-01

The National Aeronautics and Space Administration has long applied standards-derived human engineering requirements to the development of hardware and software for use by astronauts while in flight. The most important source of these requirements has been NASA-STD-3000. While there have been several ground systems human engineering requirements documents, none has been applicable to the flight system as handled at NASA's launch facility at Kennedy Space Center. At the time of the development of previous human launch systems, there were other considerations that were deemed more important than developing worksites for ground crews; e.g., hardware development schedule and vehicle performance. However, experience with these systems has shown that failure to design for ground tasks has resulted in launch schedule delays, ground operations that are more costly than they might be, and threats to flight safety. As the Agency begins the development of new systems to return humans to the moon, the new Constellation Program is addressing this issue with a new set of human engineering requirements. Among these requirements is a subset that will apply to the design of the flight components and that is intended to assure ground crew success in vehicle assembly and maintenance tasks. These requirements address worksite design for usability and for ground crew safety.

Role of the National Institute of Standards and Technology (NIST) in Support of the Vitamin D Initiative of the National Institutes of Health, Office of Dietary Supplements.

PubMed

Wise, Stephen A; Tai, Susan S-C; Burdette, Carolyn Q; Camara, Johanna E; Bedner, Mary; Lippa, Katrice A; Nelson, Michael A; Nalin, Federica; Phinney, Karen W; Sander, Lane C; Betz, Joseph M; Sempos, Christopher T; Coates, Paul M

2017-09-01

Since 2005, the National Institute of Standards and Technology (NIST) has collaborated with the National Institutes of Health (NIH), Office of Dietary Supplements (ODS) to improve the quality of measurements related to human nutritional markers of vitamin D status. In support of the NIH-ODS Vitamin D Initiative, including the Vitamin D Standardization Program (VDSP), NIST efforts have focused on (1) development of validated analytical methods, including reference measurement procedures (RMPs); (2) development of Standard Reference Materials (SRMs); (3) value assignment of critical study samples using NIST RMPs; and (4) development and coordination of laboratory measurement QA programs. As a result of this collaboration, NIST has developed RMPs for 25-hydroxyvitamin D2 [25(OH)D2], 25(OH)D3, and 24R,25-dihydroxyvitamin D3 [24R,25(OH)2D3]; disseminated serum-based SRMs with values assigned for 25(OH)D2, 25(OH)D3, 3-epi-25(OH)D3, and 24R,25(OH)2D3; assigned values for critical samples for VDSP studies, including an extensive interlaboratory comparison and reference material commutability study; provided an accuracy basis for the Vitamin D External Quality Assurance Scheme; coordinated the first accuracy-based measurement QA program for the determination of 25(OH)D2, 25(OH)D3, and 3-epi-25(OH)D3 in human serum/plasma; and developed methods and SRMs for the determination of vitamin D and 25(OH)D in food and supplement matrix SRMs. The details of these activities and their benefit and impact to the NIH-ODS Vitamin D Initiative are described.

Human milk fortifier with high versus standard protein content for promoting growth of preterm infants: A meta-analysis.

PubMed

Liu, Tian-Tian; Dang, Dan; Lv, Xiao-Ming; Wang, Teng-Fei; Du, Jin-Feng; Wu, Hui

2015-06-01

To compare the growth of preterm infants fed standard protein-fortified human milk with that containing human milk fortifier (HMF) with a higher-than-standard protein content. Published articles reporting randomized controlled trials and prospective observational intervention studies listed on the PubMed®, Embase®, CINAHL and Cochrane Library databases were searched using the keywords 'fortifier', 'human milk', 'breastfeeding', 'breast milk' and 'human milk fortifier'. The mean difference with 95% confidence intervals was used to compare the effect of HMF with a higher-than-standard protein content on infant growth characteristics. Five studies with 352 infants with birth weight ≤ 1750 g and a gestational age ≤ 34 weeks who were fed human milk were included in this meta-analysis. Infants in the experimental groups given human milk with higher-than-standard protein fortifier achieved significantly greater weight and length at the end of the study, and greater weight gain, length gain, and head circumference gain, compared with control groups fed human milk with the standard HMF. HMF with a higher-than-standard protein content can improve preterm infant growth compared with standard HMF. © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

How HRP Research Results Contribute to Human Space Exploration Risk Mitigation

NASA Technical Reports Server (NTRS)

Lumpkins, S. B.; Mindock, J. A.

2014-01-01

In addition to the scientific value of publications derived from research, results from Human Research Program (HRP) research also support HRP’s goals of mitigating crew health and performance risks in space flight. Research results are used to build the evidence base characterizing crew health and performance risks, to support risk research plan development, to inform crew health and performance standards, and to provide technologies to programs for meeting those standards and optimizing crew health and performance in space. This talk will describe examples of how research results support these efforts. For example, HRP research results are used to revise or even create new standards for human space flight, which have been established to protect crew health and performance during flight, and prevent negative long-term health consequences due to space flight. These standards are based on the best available clinical and scientific evidence, as well as operational experience from previous space flight missions, and are reviewed as new evidence emerges. Research results are also used to update the HRP evidence base, which is comprised of a set of reports that provide a current record of the state of knowledge from research and operations for each of the defined human health and performance risks for future NASA exploration missions. A discussion of the role of evidence within the HRP architecture will also be presented. The scope of HRP research results extends well beyond publications, as they are used in several capacities to support HRP deliverables and, ultimately, the advancement of human space exploration beyond low-Earth orbit.

How HRP Research Results Contribute to Human Space Exploration Risk Mitigation

NASA Technical Reports Server (NTRS)

Lumpkins, Sarah; Mindock, Jennifer

2014-01-01

In addition to the scientific value of publications derived from research, results from Human Research Program (HRP) research also support HRP's goals of mitigating crew health and performance risks in space flight. Research results are used to build the evidence base characterizing crew health and performance risks, to support risk research plan development, to inform crew health and performance standards, and to provide technologies to programs for meeting those standards and optimizing crew health and performance in space. This talk will describe examples of how research results support these efforts. For example, HRP research results are used to revise or even create new standards for human space flight, which have been established to protect crew health and performance during flight, and prevent negative long-term health consequences due to space flight. These standards are based on the best available clinical and scientific evidence, as well as operational experience from previous space flight missions, and are reviewed as new evidence emerges. Research results are also used to update the HRP evidence base, which is comprised of a set of reports that provide a current record of the state of knowledge from research and operations for each of the defined human health and performance risks for future NASA exploration missions. A discussion of the role of evidence within the HRP architecture will also be presented. The scope of HRP research results extends well beyond publications, as they are used in several capacities to support HRP deliverables and, ultimately, the advancement of human space exploration beyond low-Earth orbit.

Corneal cell culture models: a tool to study corneal drug absorption.

PubMed

Dey, Surajit

2011-05-01

In recent times, there has been an ever increasing demand for ocular drugs to treat sight threatening diseases such as glaucoma, age-related macular degeneration and diabetic retinopathy. As more drugs are developed, there is a great need to test in vitro permeability of these drugs to predict their efficacy and bioavailability in vivo. Corneal cell culture models are the only tool that can predict drug absorption across ocular layers accurately and rapidly. Cell culture studies are also valuable in reducing the number of animals needed for in vivo studies which can increase the cost of the drug developmental process. Currently, rabbit corneal cell culture models are used to predict human corneal absorption due to the difficulty in human corneal studies. More recently, a three dimensional human corneal equivalent has been developed using three different cell types to mimic the human cornea. In the future, human corneal cell culture systems need to be developed to be used as a standardized model for drug permeation.

Pilot factors guidelines for the operational inspection of navigation systems

NASA Technical Reports Server (NTRS)

Sadler, J. F.; Boucek, G. P.

1988-01-01

A computerized human engineered inspection technique is developed for use by FAA inspectors in evaluating the pilot factors aspects of aircraft navigation systems. The short title for this project is Nav Handbook. A menu-driven checklist, computer program and data base (Human Factors Design Criteria) were developed and merged to form a self-contained, portable, human factors inspection checklist tool for use in a laboratory or field setting. The automated checklist is tailored for general aviation navigation systems and can be expanded for use with other aircraft systems, transports or military aircraft. The Nav Handbook inspection concept was demonstrated using a lap-top computer and an Omega/VLF CDU. The program generates standardized inspection reports. Automated checklists for LORAN/C and R NAV were also developed. A Nav Handbook User's Guide is included.

Three concepts of cloning in human beings.

PubMed

Cui, Ke-Hui

2005-07-01

Human cloning, organ cloning and tissue cloning are various types of cloning that occur at different levels with different methodologies. According to three standards of terminology for an embryo (fertilization through germ cells, development in the uterus and having the potential to produce a human life), tissue cloning and type I organ cloning will not produce an embryo. In contrast, human cloning and type II organ cloning will produce an embryo. Thus, only non-germinal tissue cloning and type I organ cloning are beyond the ethical question and will not change human beings as a species. Using cloned tissues to make new tissues or organs is promising for the future of medicine.

DHM simulation in virtual environments: a case-study on control room design.

PubMed

Zamberlan, M; Santos, V; Streit, P; Oliveira, J; Cury, R; Negri, T; Pastura, F; Guimarães, C; Cid, G

2012-01-01

This paper will present the workflow developed for the application of serious games in the design of complex cooperative work settings. The project was based on ergonomic studies and development of a control room among participative design process. Our main concerns were the 3D human virtual representation acquired from 3D scanning, human interaction, workspace layout and equipment designed considering ergonomics standards. Using Unity3D platform to design the virtual environment, the virtual human model can be controlled by users on dynamic scenario in order to evaluate the new work settings and simulate work activities. The results obtained showed that this virtual technology can drastically change the design process by improving the level of interaction between final users and, managers and human factors team.

Results of the first-in-human clinical trial for MB-102, a novel fluorescent tracer agent for real-time measurement of glomerular filtration rate

NASA Astrophysics Data System (ADS)

Dorshow, Richard B.; Debreczeny, Martin P.; Dowling, Thomas C.

2015-03-01

The fluorescent tracer agent 2,5-bis[N-(1-carboxy-2-hydroxy)]carbamoyl-3,6-diaminopyrazine, designated MB-102, has been developed with properties and attributes necessary for use as a direct measure of glomerular filtration rate (GFR). Comparison to known standard exogenous GFR agents in animal models has demonstrated an excellent correlation. A clinical trial to demonstrate this same correlation in humans is in progress. This clinical trial is the first in a series of trials necessary to obtain regulatory clearance from the FDA. We report herein the comparison of plasma pharmacokinetics between MB-102 and the known standard exogenous GFR agent Iohexol in healthy subjects with normal renal function. Post simultaneous administration of both agents, blood samples over a period of 12 hours were collected from each subject to assess pharmacokinetic parameters including GFR. Urine samples were collected over this same period to assess percent injected dose recovered in the urine. Results indicate MB-102 is a GFR agent in humans from the comparison to the standard agent.

Determination of exposure multiples of human metabolites for MIST assessment in preclinical safety species without using reference standards or radiolabeled compounds.

PubMed

Ma, Shuguang; Li, Zhiling; Lee, Keun-Joong; Chowdhury, Swapan K

2010-12-20

A simple, reliable, and accurate method was developed for quantitative assessment of metabolite coverage in preclinical safety species by mixing equal volumes of human plasma with blank plasma of animal species and vice versa followed by an analysis using high-resolution full-scan accurate mass spectrometry. This approach provided comparable results (within (±15%) to those obtained from regulated bioanalysis and did not require synthetic standards or radiolabeled compounds. In addition, both qualitative and quantitative data were obtained from a single LC-MS analysis on all metabolites and, therefore, the coverage of any metabolite of interest can be obtained.

Bone augmentation for cancellous bone- development of a new animal model

PubMed Central

2013-01-01

Background Reproducible and suitable animal models are required for in vivo experiments to investigate new biodegradable and osteoinductive biomaterials for augmentation of bones at risk for osteoporotic fractures. Sheep have especially been used as a model for the human spine due to their size and similar bone metabolism. However, although sheep and human vertebral bodies have similar biomechanical characteristics, the shape of the vertebral bodies, the size of the transverse processes, and the different orientation of the facet joints of sheep are quite different from those of humans making the surgical approach complicated and unpredictable. Therefore, an adequate and safe animal model for bone augmentation was developed using a standardized femoral and tibia augmentation site in sheep. Methods The cancellous bone of the distal femur and proximal tibia were chosen as injection sites with the surgical approach via the medial aspects of the femoral condyle and proximal tibia metaphysis (n = 4 injection sites). For reproducible drilling and injection in a given direction and length, a custom-made c-shaped aiming device was designed. Exact positioning of the aiming device and needle positioning within the intertrabecular space of the intact bone could be validated in a predictable and standardized fashion using fluoroscopy. After sacrifice, bone cylinders (∅ 32 mm) were harvested throughout the tibia and femur by means of a diamond-coated core drill, which was especially developed to harvest the injected bone area exactly. Thereafter, the extracted bone cylinders were processed as non-decalcified specimens for μCT analysis, histomorphometry, histology, and fluorescence evaluation. Results The aiming device could be easily placed in 63 sheep and assured a reproducible, standardized injection area. In four sheep, cardiovascular complications occurred during surgery and pulmonary embolism was detected by computed tomography post surgery in all of these animals. The harvesting and evaluative methods assured a standardized analysis of all samples. Conclusions This experimental animal model provides an excellent basis for testing new biomaterials for their suitability as bone augmentation materials. Concomitantly, similar cardiovascular changes occur during vertebroplasties as in humans, thus making it a suitable animal model for studies related to vertebroplasty. PMID:23819858

Bone augmentation for cancellous bone- development of a new animal model.

PubMed

Klein, Karina; Zamparo, Enrico; Kronen, Peter W; Kämpf, Katharina; Makara, Mariano; Steffen, Thomas; von Rechenberg, Brigitte

2013-07-02

Reproducible and suitable animal models are required for in vivo experiments to investigate new biodegradable and osteoinductive biomaterials for augmentation of bones at risk for osteoporotic fractures. Sheep have especially been used as a model for the human spine due to their size and similar bone metabolism. However, although sheep and human vertebral bodies have similar biomechanical characteristics, the shape of the vertebral bodies, the size of the transverse processes, and the different orientation of the facet joints of sheep are quite different from those of humans making the surgical approach complicated and unpredictable. Therefore, an adequate and safe animal model for bone augmentation was developed using a standardized femoral and tibia augmentation site in sheep. The cancellous bone of the distal femur and proximal tibia were chosen as injection sites with the surgical approach via the medial aspects of the femoral condyle and proximal tibia metaphysis (n = 4 injection sites). For reproducible drilling and injection in a given direction and length, a custom-made c-shaped aiming device was designed. Exact positioning of the aiming device and needle positioning within the intertrabecular space of the intact bone could be validated in a predictable and standardized fashion using fluoroscopy. After sacrifice, bone cylinders (Ø 32 mm) were harvested throughout the tibia and femur by means of a diamond-coated core drill, which was especially developed to harvest the injected bone area exactly. Thereafter, the extracted bone cylinders were processed as non-decalcified specimens for μCT analysis, histomorphometry, histology, and fluorescence evaluation. The aiming device could be easily placed in 63 sheep and assured a reproducible, standardized injection area. In four sheep, cardiovascular complications occurred during surgery and pulmonary embolism was detected by computed tomography post surgery in all of these animals. The harvesting and evaluative methods assured a standardized analysis of all samples. This experimental animal model provides an excellent basis for testing new biomaterials for their suitability as bone augmentation materials. Concomitantly, similar cardiovascular changes occur during vertebroplasties as in humans, thus making it a suitable animal model for studies related to vertebroplasty.

UAS-NAS Integrated Human in the Loop: Test Environment Report

NASA Technical Reports Server (NTRS)

Murphy, Jim; Otto, Neil; Jovic, Srba

2015-01-01

The desire and ability to fly Unmanned Aircraft Systems (UAS) in the National Airspace System (NAS) is of increasing urgency. The application of unmanned aircraft to perform national security, defense, scientific, and emergency management are driving the critical need for less restrictive access by UAS to the NAS. UAS represent a new capability that will provide a variety of services in the government (public) and commercial (civil) aviation sectors. The growth of this potential industry has not yet been realized due to the lack of a common understanding of what is required to safely operate UAS in the NAS. NASA's UAS Integration in the NAS Project is conducting research in the areas of Separation Assurance/Sense and Avoid Interoperability (SSI), Human Systems Integration (HSI), and Communication to support reducing the barriers of UAS access to the NAS. This research was broken into two research themes namely, UAS Integration and Test Infrastructure. UAS Integration focuses on airspace integration procedures and performance standards to enable UAS integration in the air transportation system, covering Sense and Avoid (SAA) performance standards, command and control performance standards, and human systems integration. The focus of the Test Infrastructure theme was to enable development and validation of airspace integration procedures and performance standards, including the execution of integrated test and evaluation. In support of the integrated test and evaluation efforts, the Project developed an adaptable, scalable, and schedulable relevant test environment incorporating live, virtual, and constructive elements capable of validating concepts and technologies for unmanned aircraft systems to safely operate in the NAS. To accomplish this task, the Project planned to conduct three integrated events: a Human-in-the-Loop simulation and two Flight Test series that integrated key concepts, technologies and/or procedures in a relevant air traffic environment. Each of the integrated events were built on the technical achievements, fidelity and complexity of previous simulations and tests, resulting in research findings that support the development of regulations governing the access of UAS into the NAS. The purpose of this document is to describe how well the system under test was representative

Modular Power Standard for Space Explorations Missions

NASA Technical Reports Server (NTRS)

Oeftering, Richard C.; Gardner, Brent G.

2016-01-01

Future human space exploration will most likely be composed of assemblies of multiple modular spacecraft elements with interconnected electrical power systems. An electrical system composed of a standardized set modular building blocks provides significant development, integration, and operational cost advantages. The modular approach can also provide the flexibility to configure power systems to meet the mission needs. A primary goal of the Advanced Exploration Systems (AES) Modular Power System (AMPS) project is to establish a Modular Power Standard that is needed to realize these benefits. This paper is intended to give the space exploration community a "first look" at the evolving Modular Power Standard and invite their comments and technical contributions.

Human Factors Engineering as a System in the Vision for Exploration

NASA Technical Reports Server (NTRS)

Whitmore, Mihriban; Smith, Danielle; Holden, Kritina

2006-01-01

In order to accomplish NASA's Vision for Exploration, while assuring crew safety and productivity, human performance issues must be well integrated into system design from mission conception. To that end, a two-year Technology Development Project (TDP) was funded by NASA Headquarters to develop a systematic method for including the human as a system in NASA's Vision for Exploration. The specific goals of this project are to review current Human Systems Integration (HSI) standards (i.e., industry, military, NASA) and tailor them to selected NASA Exploration activities. Once the methods are proven in the selected domains, a plan will be developed to expand the effort to a wider scope of Exploration activities. The methods will be documented for inclusion in NASA-specific documents (such as the Human Systems Integration Standards, NASA-STD-3000) to be used in future space systems. The current project builds on a previous TDP dealing with Human Factors Engineering processes. That project identified the key phases of the current NASA design lifecycle, and outlined the recommended HFE activities that should be incorporated at each phase. The project also resulted in a prototype of a webbased HFE process tool that could be used to support an ideal HFE development process at NASA. This will help to augment the limited human factors resources available by providing a web-based tool that explains the importance of human factors, teaches a recommended process, and then provides the instructions, templates and examples to carry out the process steps. The HFE activities identified by the previous TDP are being tested in situ for the current effort through support to a specific NASA Exploration activity. Currently, HFE personnel are working with systems engineering personnel to identify HSI impacts for lunar exploration by facilitating the generation of systemlevel Concepts of Operations (ConOps). For example, medical operations scenarios have been generated for lunar habitation in order to identify HSI requirements for the lunar communications architecture. Throughout these ConOps exercises, HFE personnel are testing various tools and methodologies that have been identified in the literature. A key part of the effort is the identification of optimal processes, methods, and tools for these early development phase activities, such as ConOps, requirements development, and early conceptual design. An overview of the activities completed thus far, as well as the tools and methods investigated will be presented.

Thermal stress, human performance, and physical employment standards.

PubMed

Cheung, Stephen S; Lee, Jason K W; Oksa, Juha

2016-06-01

Many physically demanding occupations in both developed and developing economies involve exposure to extreme thermal environments that can affect work capacity and ultimately health. Thermal extremes may be present in either an outdoor or an indoor work environment, and can be due to a combination of the natural or artificial ambient environment, the rate of metabolic heat generation from physical work, processes specific to the workplace (e.g., steel manufacturing), or through the requirement for protective clothing impairing heat dissipation. Together, thermal exposure can elicit acute impairment of work capacity and also chronic effects on health, greatly contributing to worker health risk and reduced productivity. Surprisingly, in most occupations even in developed economies, there are rarely any standards regarding enforced heat or cold safety for workers. Furthermore, specific physical employment standards or accommodations for thermal stressors are rare, with workers commonly tested under near-perfect conditions. This review surveys the major occupational impact of thermal extremes and existing employment standards, proposing guidelines for improvement and areas for future research.

Liquid chromatography-tandem mass spectrometry method of loxoprofen in human plasma.

PubMed

Lee, Hye Won; Ji, Hye Young; Sohn, Dong Hwan; Kim, Se-Mi; Lee, Yong Bok; Lee, Hye Suk

2009-07-01

A rapid, sensitive and selective liquid chromatography-electrospray ionization mass spectrometric method for the determination of loxoprofen in human plasma was developed. Loxoprofen and ketoprofen (internal standard) were extracted from 20 microL of human plasma sample using ethyl acetate at acidic pH and analyzed on an Atlantis dC(18) column with the mobile phase of methanol:water (75:25, v/v). The analytes were quantified in the selected reaction monitoring mode. The standard curve was linear over the concentration range of 0.1-20 microg/mL with a lower limit of quantification of 0.1 microg/mL. The coefficient of variation and relative error for intra- and inter-assay at four quality control levels were 2.8-5.2 and 4.8-7.0%, respectively. The recoveries of loxoprofen and ketoprofen were 69.7 and 67.6%, respectively. The matrix effects for loxoprofen and ketoprofen were practically absent. This method was successfully applied to the pharmacokinetic study of loxoprofen in humans. (c) 2009 John Wiley & Sons, Ltd.

Human Performance Optimization Metrics: Consensus Findings, Gaps, and Recommendations for Future Research.

PubMed

Nindl, Bradley C; Jaffin, Dianna P; Dretsch, Michael N; Cheuvront, Samuel N; Wesensten, Nancy J; Kent, Michael L; Grunberg, Neil E; Pierce, Joseph R; Barry, Erin S; Scott, Jonathan M; Young, Andrew J; OʼConnor, Francis G; Deuster, Patricia A

2015-11-01

Human performance optimization (HPO) is defined as "the process of applying knowledge, skills and emerging technologies to improve and preserve the capabilities of military members, and organizations to execute essential tasks." The lack of consensus for operationally relevant and standardized metrics that meet joint military requirements has been identified as the single most important gap for research and application of HPO. In 2013, the Consortium for Health and Military Performance hosted a meeting to develop a toolkit of standardized HPO metrics for use in military and civilian research, and potentially for field applications by commanders, units, and organizations. Performance was considered from a holistic perspective as being influenced by various behaviors and barriers. To accomplish the goal of developing a standardized toolkit, key metrics were identified and evaluated across a spectrum of domains that contribute to HPO: physical performance, nutritional status, psychological status, cognitive performance, environmental challenges, sleep, and pain. These domains were chosen based on relevant data with regard to performance enhancers and degraders. The specific objectives at this meeting were to (a) identify and evaluate current metrics for assessing human performance within selected domains; (b) prioritize metrics within each domain to establish a human performance assessment toolkit; and (c) identify scientific gaps and the needed research to more effectively assess human performance across domains. This article provides of a summary of 150 total HPO metrics across multiple domains that can be used as a starting point-the beginning of an HPO toolkit: physical fitness (29 metrics), nutrition (24 metrics), psychological status (36 metrics), cognitive performance (35 metrics), environment (12 metrics), sleep (9 metrics), and pain (5 metrics). These metrics can be particularly valuable as the military emphasizes a renewed interest in Human Dimension efforts, and leverages science, resources, programs, and policies to optimize the performance capacities of all Service members.

A STANDARDIZED ASSESSMENT METHOD (SAM) FOR RIVERINE MACROINVERTEBRATES

EPA Science Inventory

A macroinvertebrate sampling method for large rivers based on desirable characteristics of existing nonwadeable methods was developed and tested. Six sites each were sampled on the Great Miami and Kentucky Rivers, reflecting a human disturbance gradient. Samples were collected ...

Observational Needs for Four-Dimensional Air Quality Characterization

EPA Science Inventory

Surface-based monitoring programs provide the foundation for associating air pollution and causal effects in human health studies, and they support the development of air quality standards and the preparation of emission reduction strategies. While surface oriented networks remai...

SCRL-Model for Human Space Flight Operations Enterprise Supply Chain

NASA Technical Reports Server (NTRS)

Tucker, Brian

2010-01-01

Standard approach to evaluate and configure adaptable and sustainable program and mission supply chains at an enterprise level. End-to-end view. Total Lifecycle. Evaluate the readiness of the supply chain during the supply chain development phase.

Design and Implementation of a REST API for the Human Well Being Index (HWBI)

EPA Science Inventory

Interoperable software development uses principles of component reuse, systems integration, flexible data transfer, and standardized ontological documentation to promote access, reuse, and integration of code. While interoperability principles are increasingly considered technolo...

Altered Axial Skeletal Development

EPA Science Inventory

The axial skeleton is routinely examined in standard developmental toxicity bioassays and has proven to be sensitive to a wide variety of chemical agents. Dysmorphogenesis in the skull, vertebral column and ribs has been described in both human populations and in laboratory anima...

Design and Implementation of a REST API for the ?Human Well Being Index (HWBI)

EPA Science Inventory

Interoperable software development uses principles of component reuse, systems integration, flexible data transfer, and standardized ontological documentation to promote access, reuse, and integration of code. While interoperability principles are increasingly considered technolo...

Animal research as a basis for clinical trials.

PubMed

Faggion, Clovis M

2015-04-01

Animal experiments are critical for the development of new human therapeutics because they provide mechanistic information, as well as important information on efficacy and safety. Some evidence suggests that authors of animal research in dentistry do not observe important methodological issues when planning animal experiments, for example sample-size calculation. Low-quality animal research directly interferes with development of the research process in which multiple levels of research are interconnected. For example, high-quality animal experiments generate sound information for the further planning and development of randomized controlled trials in humans. These randomized controlled trials are the main source for the development of systematic reviews and meta-analyses, which will generate the best evidence for the development of clinical guidelines. Therefore, adequate planning of animal research is a sine qua non condition for increasing efficacy and efficiency in research. Ethical concerns arise when animal research is not performed with high standards. This Focus article presents the latest information on the standards of animal research in dentistry, more precisely in the field of implant dentistry. Issues on precision and risk of bias are discussed, and strategies to reduce risk of bias in animal research are reported. © 2015 Eur J Oral Sci.

Ethical review issues in collaborative research between us and low-middle income country partners: a case example.

PubMed

McIntosh, Scott; Sierra, Essie; Dozier, Ann; Diaz, Sergio; Quiñones, Zahira; Primack, Aron; Chadwick, Gary; Ossip-Klein, Deborah J

2008-09-01

The current ethical structure for collaborative international health research stems largely from developed countries' standards of proper ethical practices. The result is that ethical committees in developing countries are required to adhere to standards that might impose practices that conflict with local culture and unintended interpretations of ethics, treatments, and research. This paper presents a case example of a joint international research project that successfully established inclusive ethical review processes as well as other groundwork and components necessary for the conduct of human behavior research and research capacity building in the host country.

Advanced Good Cell Culture Practice for human primary, stem cell-derived and organoid models as well as microphysiological systems.

PubMed

Pamies, David; Bal-Price, Anna; Chesné, Christophe; Coecke, Sandra; Dinnyes, Andras; Eskes, Chantra; Grillari, Regina; Gstraunthaler, Gerhard; Hartung, Thomas; Jennings, Paul; Leist, Marcel; Martin, Ulrich; Passier, Robert; Schwamborn, Jens C; Stacey, Glyn N; Ellinger-Ziegelbauer, Heidrun; Daneshian, Mardas

2018-04-13

A major reason for the current reproducibility crisis in the life sciences is the poor implementation of quality control measures and reporting standards. Improvement is needed, especially regarding increasingly complex in vitro methods. Good Cell Culture Practice (GCCP) was an effort from 1996 to 2005 to develop such minimum quality standards also applicable in academia. This paper summarizes recent key developments in in vitro cell culture and addresses the issues resulting for GCCP, e.g. the development of induced pluripotent stem cells (iPSCs) and gene-edited cells. It further deals with human stem-cell-derived models and bioengineering of organo-typic cell cultures, including organoids, organ-on-chip and human-on-chip approaches. Commercial vendors and cell banks have made human primary cells more widely available over the last decade, increasing their use, but also requiring specific guidance as to GCCP. The characterization of cell culture systems including high-content imaging and high-throughput measurement technologies increasingly combined with more complex cell and tissue cultures represent a further challenge for GCCP. The increasing use of gene editing techniques to generate and modify in vitro culture models also requires discussion of its impact on GCCP. International (often varying) legislations and market forces originating from the commercialization of cell and tissue products and technologies are further impacting on the need for the use of GCCP. This report summarizes the recommendations of the second of two workshops, held in Germany in December 2015, aiming map the challenge and organize the process or developing a revised GCCP 2.0.

Water quality standards for the protection of human health and aquatic ecosystems in Korea: current state and future perspective.

PubMed

Kwak, Jin Il; Nam, Sun-Hwa; An, Youn-Joo

2018-02-01

Since the Korean Ministry of the Environment established the Master Plan for Water Environment (2006-2015), the need to revise the water quality standards (WQSs) has driven government projects to expand the standards for the protection of human health and aquatic ecosystems. This study aimed to provide an historical overview of how these WQSs were established, amended, and expanded over the past 10 years in Korea. Here, major projects related to national monitoring in rivers and the amendment of WQSs were intensely reviewed, including projects on the categorization of hazardous chemicals potentially discharged into surface water, the chemical ranking and scoring methodology for surface water (CRAFT, Chemical RAnking of surFace water polluTants), whole effluent toxicity (WET) management systems, the 4th, 5th, and 6th revisions of the water quality standards for the protection of human health, and efforts toward developing the 7th revision. In this review, we assimilated the past and current status as well as future perspectives of Korean surface WQSs. This research provides information that aids our understanding of how surface WQSs have been expanded, and how scientific approaches to ensure water quality have been applied at each step of the process in Korea.

Understanding the Potential Content and Structure of an International Convention on the Human Rights of People with Disabilities: Sample Treaty Provisions Drawn from Existing International Instruments. A Reference Tool.

ERIC Educational Resources Information Center

Lord, Janet E.

This document is designed to prepare advocates in the international disability community for productive participation in the development of international conventions on the human rights of people with disabilities. Knowledge of the standard categories of international law provisions will help participants address issues related to the structure of…

Surface Plasmon Resonance imaging-based sensing for anti-bovine immunoglobulins detection in human milk and serum.

PubMed

Scarano, S; Scuffi, C; Mascini, M; Minunni, M

2011-11-30

Only few papers deal with Surface Plasmon Resonance imaging (SPRi) direct detection on complex matrices, limiting the biosensor application to real analytical problems. In this work a SPRi biosensor for anti-bovine IgG detection in untreated human bodily fluids, i.e. diluted human serum and milk, was developed. Enhanced levels of cow's milk antibodies in children's serum are suspected for their possible correlation with Type 1 diabetes during childhood and their detection in real samples was up to now performed by classical immunoassays based on indirect detection. The biosensor was optimised in standard samples and then in untreated human milk for anti-bovine IgG direct detection. The key novelty of the work is the evaluation of matrix effect by applying to real samples an experimental and ex ante method previously developed for SPRi signal sampling in standard solutions, called "Data Analyzer"; it punctually visualises and analyses the behaviour of receptor spots of the array, to select only spot areas with the best specific vs. unspecific signal values. In this way, benefits provide by SPRi image analysis are exploited here to quantify and minimise drawbacks due to the matrix effect, allowing to by-pass every matrix pre-treatment except dilution. Copyright © 2011 Elsevier B.V. All rights reserved.

A stochastic visco-hyperelastic model of human placenta tissue for finite element crash simulations.

PubMed

Hu, Jingwen; Klinich, Kathleen D; Miller, Carl S; Rupp, Jonathan D; Nazmi, Giseli; Pearlman, Mark D; Schneider, Lawrence W

2011-03-01

Placental abruption is the most common cause of fetal deaths in motor-vehicle crashes, but studies on the mechanical properties of human placenta are rare. This study presents a new method of developing a stochastic visco-hyperelastic material model of human placenta tissue using a combination of uniaxial tensile testing, specimen-specific finite element (FE) modeling, and stochastic optimization techniques. In our previous study, uniaxial tensile tests of 21 placenta specimens have been performed using a strain rate of 12/s. In this study, additional uniaxial tensile tests were performed using strain rates of 1/s and 0.1/s on 25 placenta specimens. Response corridors for the three loading rates were developed based on the normalized data achieved by test reconstructions of each specimen using specimen-specific FE models. Material parameters of a visco-hyperelastic model and their associated standard deviations were tuned to match both the means and standard deviations of all three response corridors using a stochastic optimization method. The results show a very good agreement between the tested and simulated response corridors, indicating that stochastic analysis can improve estimation of variability in material model parameters. The proposed method can be applied to develop stochastic material models of other biological soft tissues.

Teacher-Child Relationship Quality and Academic Achievement in Elementary School: Does Gender Matter?

ERIC Educational Resources Information Center

McCormick, Meghan P.; O'Connor, Erin E.

2015-01-01

Using data from the National Institute of Child Health and Human Development Study of Early Child Care and Youth Development (N = 1,364) and 2-level hierarchical linear models with site fixed effects, we examined between- and within-child associations between teacher-child relationship closeness and conflict and standardized measures of children's…

Use of Statechart Assertions for Modeling Human-in-the-Loop Security Analysis and Decision-Making Processes

DTIC Science & Technology

2012-06-01

THIS PAGE INTENTIONALLY LEFT BLANK xv LIST OF ACRONYMS AND ABBREVIATIONS BPM Business Process Model BPMN Business Process Modeling Notation C&A...checking leads to an improvement in the quality and success of enterprise software development. Business Process Modeling Notation ( BPMN ) is an...emerging standard that allows business processes to be captured in a standardized format. BPMN lacks formal semantics which leaves many of its features

Animal behavior and well-being symposium: Farm animal welfare assurance: science and application.

PubMed

Rushen, J; Butterworth, A; Swanson, J C

2011-04-01

Public and consumer pressure for assurances that farm animals are raised humanely has led to a range of private and public animal welfare standards, and for methods to assess compliance with these standards. The standards usually claim to be science based, but even though researchers have developed measures of animal welfare and have tested the effects of housing and management variables on welfare within controlled laboratory settings, there are challenges in extending this research to develop on-site animal welfare standards. The standards need to be validated against a definition of welfare that has broad support and which is amenable to scientific investigation. Ensuring that such standards acknowledge scientific uncertainty is also challenging, and balanced input from all scientific disciplines dealing with animal welfare is needed. Agencies providing animal welfare audit services need to integrate these scientific standards and legal requirements into successful programs that effectively measure and objectively report compliance. On-farm assessment of animal welfare requires a combination of animal-based measures to assess the actual state of welfare and resource-based measures to identify risk factors. We illustrate this by referring to a method of assessing welfare in broiler flocks. Compliance with animal welfare standards requires buy-in from all stakeholders, and this will be best achieved by a process of inclusion in the development of pragmatic assessment methods and the development of audit programs verifying the conditions and continuous improvement of farm animal welfare.

Developing an ANSI standard for image quality tools for the testing of active millimeter wave imaging systems

NASA Astrophysics Data System (ADS)

Barber, Jeffrey; Greca, Joseph; Yam, Kevin; Weatherall, James C.; Smith, Peter R.; Smith, Barry T.

2017-05-01

In 2016, the millimeter wave (MMW) imaging community initiated the formation of a standard for millimeter wave image quality metrics. This new standard, American National Standards Institute (ANSI) N42.59, will apply to active MMW systems for security screening of humans. The Electromagnetic Signatures of Explosives Laboratory at the Transportation Security Laboratory is supporting the ANSI standards process via the creation of initial prototypes for round-robin testing with MMW imaging system manufacturers and experts. Results obtained for these prototypes will be used to inform the community and lead to consensus objective standards amongst stakeholders. Images collected with laboratory systems are presented along with results of preliminary image analysis. Future directions for object design, data collection and image processing are discussed.

The Design of the Internet's Architecture by the Internet Engineering Task Force (IETF) and Human Rights.

PubMed

Cath, Corinne; Floridi, Luciano

2017-04-01

The debate on whether and how the Internet can protect and foster human rights has become a defining issue of our time. This debate often focuses on Internet governance from a regulatory perspective, underestimating the influence and power of the governance of the Internet's architecture. The technical decisions made by Internet Standard Developing Organisations (SDOs) that build and maintain the technical infrastructure of the Internet influences how information flows. They rearrange the shape of the technically mediated public sphere, including which rights it protects and which practices it enables. In this article, we contribute to the debate on SDOs' ethical responsibility to bring their work in line with human rights. We defend three theses. First, SDOs' work is inherently political. Second, the Internet Engineering Task Force (IETF), one of the most influential SDOs, has a moral obligation to ensure its work is coherent with, and fosters, human rights. Third, the IETF should enable the actualisation of human rights through the protocols and standards it designs by implementing a responsibility-by-design approach to engineering. We conclude by presenting some initial recommendations on how to ensure that work carried out by the IETF may enable human rights.

Review and standardization of cell phone exposure calculations using the SAM phantom and anatomically correct head models.

PubMed

Beard, Brian B; Kainz, Wolfgang

2004-10-13

We reviewed articles using computational RF dosimetry to compare the Specific Anthropomorphic Mannequin (SAM) to anatomically correct models of the human head. Published conclusions based on such comparisons have varied widely. We looked for reasons that might cause apparently similar comparisons to produce dissimilar results. We also looked at the information needed to adequately compare the results of computational RF dosimetry studies. We concluded studies were not comparable because of differences in definitions, models, and methodology. Therefore we propose a protocol, developed by an IEEE standards group, as an initial step in alleviating this problem. The protocol calls for a benchmark validation study comparing the SAM phantom to two anatomically correct models of the human head. It also establishes common definitions and reporting requirements that will increase the comparability of all computational RF dosimetry studies of the human head.

Infusing Climate and Energy Literacy Throughout the Curriculum: Challenges and Opportunities

NASA Astrophysics Data System (ADS)

McCaffrey, M. S.

2012-12-01

Climate change and human activities, particularly fossil fuel energy consumption-- both related and crosscutting concepts vital to addressing 21st century societal challenges-- are largely missing from traditional science education curriculum and standards. Whether due to deliberate misinformation, efforts to "teach the controversy", lack of teacher training and professional development or availability of engaging resources, students have for decades graduated from high school and even college without learning the basics of how human activities, particularly our reliance on fossil fuels, impact the environment in general and climate system in particular. The Climate Literacy, Energy Literacy and related frameworks and curriculum, as well as the Next Generation Science Standards (NGSS) and other innovative initiatives, provide new tools for educators and learners that hold strong potential for helping infuse these important topics across the curriculum and thereby better prepare society to minimize human impacts on the planet and prepare for changes that are already well underway.

Review and standardization of cell phone exposure calculations using the SAM phantom and anatomically correct head models

PubMed Central

Beard, Brian B; Kainz, Wolfgang

2004-01-01

We reviewed articles using computational RF dosimetry to compare the Specific Anthropomorphic Mannequin (SAM) to anatomically correct models of the human head. Published conclusions based on such comparisons have varied widely. We looked for reasons that might cause apparently similar comparisons to produce dissimilar results. We also looked at the information needed to adequately compare the results of computational RF dosimetry studies. We concluded studies were not comparable because of differences in definitions, models, and methodology. Therefore we propose a protocol, developed by an IEEE standards group, as an initial step in alleviating this problem. The protocol calls for a benchmark validation study comparing the SAM phantom to two anatomically correct models of the human head. It also establishes common definitions and reporting requirements that will increase the comparability of all computational RF dosimetry studies of the human head. PMID:15482601

International standards for pandemic screening using infrared thermography

NASA Astrophysics Data System (ADS)

Pascoe, D. D.; Ring, E. F.; Mercer, J. B.; Snell, J.; Osborn, D.; Hedley-Whyte, J.

2010-03-01

The threat of a virulent strain of influenza, severe acute respiratory syndrome (SARS), tuberculosis, H1N1/A virus (swine flu) and possible mutations are a constant threat to global health. Implementation of pandemic infrared thermographic screening is based on the detection of febrile temperatures (inner canthus of the eyes) that are correlated with an infectious disease. Previous attempts at pandemic thermal screening have experienced problems (e.g. SARS outbreak, Singapore 2003) associated with the deployment plan, implementation and operation of the screening thermograph. Since this outbreak, the International Electrotechnical Commission has developed international standards that set minimum requirements for thermographic system fever screening and procedures that insure reliable and reproducible measurements. These requirements are published in IEC 80601-2-59:2008, Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening. The International Organization for Standardization has developed ISO/TR 13154:2009, Medical Electrical Equipment - which provides deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph. These new standards includes recommendations for camera calibrations, use of black body radiators, view field, focus, pixels within measurement site, image positioning, and deployment locations. Many current uses of thermographic screening at airports do not take into account critical issues addressed in the new standard, and are operating below the necessary effectiveness and efficiency. These documents, related thermal research, implications for epidemiology screening, and the future impact on medical thermography are discussed.

Guidelines on Good Clinical Laboratory Practice

PubMed Central

Ezzelle, J.; Rodriguez-Chavez, I. R.; Darden, J. M.; Stirewalt, M.; Kunwar, N.; Hitchcock, R.; Walter, T.; D’Souza, M. P.

2008-01-01

A set of Good Clinical Laboratory Practice (GCLP) standards that embraces both the research and clinical aspects of GLP were developed utilizing a variety of collected regulatory and guidance material. We describe eleven core elements that constitute the GCLP standards with the objective of filling a gap for laboratory guidance, based on IND sponsor requirements, for conducting laboratory testing using specimens from human clinical trials. These GCLP standards provide guidance on implementing GLP requirements that are critical for laboratory operations, such as performance of protocol-mandated safety assays, peripheral blood mononuclear cell processing and immunological or endpoint assays from biological interventions on IND-registered clinical trials. The expectation is that compliance with the GCLP standards, monitored annually by external audits, will allow research and development laboratories to maintain data integrity and to provide immunogenicity, safety, and product efficacy data that is repeatable, reliable, auditable and that can be easily reconstructed in a research setting. PMID:18037599

The establishment of a WHO Reference Reagent for anti-malaria (Plasmodium falciparum) human serum.

PubMed

Bryan, Donna; Silva, Nilupa; Rigsby, Peter; Dougall, Thomas; Corran, Patrick; Bowyer, Paul W; Ho, Mei Mei

2017-08-05

At a World Health Organization (WHO) sponsored meeting it was concluded that there is an urgent need for a reference preparation that contains antibodies against malaria antigens in order to support serology studies and vaccine development. It was proposed that this reference would take the form of a lyophilized serum or plasma pool from a malaria-endemic area. In response, an immunoassay standard, comprising defibrinated human plasma has been prepared and evaluated in a collaborative study. A pool of human plasma from a malaria endemic region was collected from 140 single plasma donations selected for reactivity to Plasmodium falciparum apical membrane antigen-1 (AMA-1) and merozoite surface proteins (MSP-1 19 , MSP-1 42 , MSP-2 and MSP-3). This pool was defibrinated, filled and freeze dried into a single batch of ampoules to yield a stable source of naturally occurring antibodies to P. falciparum. The preparation was evaluated by an enzyme-linked immunosorbent assay (ELISA) in a collaborative study with sixteen participants from twelve different countries. This anti-malaria human serum preparation (NIBSC Code: 10/198) was adopted by the WHO Expert Committee on Biological Standardization (ECBS) in October 2014, as the first WHO reference reagent for anti-malaria (Plasmodium falciparum) human serum with an assigned arbitrary unitage of 100 units (U) per ampoule. Analysis of the reference reagent in a collaborative study has demonstrated the benefit of this preparation for the reduction in inter- and intra-laboratory variability in ELISA. Whilst locally sourced pools are regularly use for harmonization both within and between a few laboratories, the presence of a WHO-endorsed reference reagent should enable optimal harmonization of malaria serological assays either by direct use of the reference reagent or calibration of local standards against this WHO reference. The intended uses of this reference reagent, a multivalent preparation, are (1) to allow cross-comparisons of results of vaccine trials performed in different centres/with different products; (2) to facilitate standardization and harmonization of immunological assays used in epidemiology research; and (3) to allow optimization and validation of immunological assays used in malaria vaccine development.

Recent technology products from Space Human Factors research

NASA Technical Reports Server (NTRS)

Jenkins, James P.

1991-01-01

The goals of the NASA Space Human Factors program and the research carried out concerning human factors are discussed with emphasis given to the development of human performance models, data, and tools. The major products from this program are described, which include the Laser Anthropometric Mapping System; a model of the human body for evaluating the kinematics and dynamics of human motion and strength in microgravity environment; an operational experience data base for verifying and validating the data repository of manned space flights; the Operational Experience Database Taxonomy; and a human-computer interaction laboratory whose products are the display softaware and requirements and the guideline documents and standards for applications on human-computer interaction. Special attention is given to the 'Convoltron', a prototype version of a signal processor for synthesizing the head-related transfer functions.

45 CFR 164.530 - Administrative requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

....530 Public Welfare Department of Health and Human Services ADMINISTRATIVE DATA STANDARDS AND RELATED REQUIREMENTS SECURITY AND PRIVACY Privacy of Individually Identifiable Health Information § 164.530... privacy official who is responsible for the development and implementation of the policies and procedures...

COMPUTERIZED ASSESSMENT OF HUMAN NEUROTOXICITY: SENSITIVITY TO NITROUS OXIDE EXPOSURE

EPA Science Inventory

The authors recently developed a flexible, portable, computer based neurobehavioral evaluation system (NES) to standardize data collection in epidemiologic field studies of individuals at risk for neurobehavioral toxicity. The current study was performed to examine the system's s...

45 CFR 1336.40 - General.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Regulations Relating to Public Welfare (Continued) OFFICE OF HUMAN DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH... sufficient information for ANA to determine the extent to which the recipient meets ANA project evaluation standards. Sufficient information means information adequate to enable ANA to compare the recipient's...

45 CFR 1336.40 - General.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Regulations Relating to Public Welfare (Continued) OFFICE OF HUMAN DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH... sufficient information for ANA to determine the extent to which the recipient meets ANA project evaluation standards. Sufficient information means information adequate to enable ANA to compare the recipient's...

45 CFR 1336.40 - General.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Regulations Relating to Public Welfare (Continued) OFFICE OF HUMAN DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH... sufficient information for ANA to determine the extent to which the recipient meets ANA project evaluation standards. Sufficient information means information adequate to enable ANA to compare the recipient's...

45 CFR 1336.40 - General.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Regulations Relating to Public Welfare (Continued) OFFICE OF HUMAN DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH... sufficient information for ANA to determine the extent to which the recipient meets ANA project evaluation standards. Sufficient information means information adequate to enable ANA to compare the recipient's...

An effective strategy for decontamination, ex vivo expansion, and storage of human fetal liver hematopoietic stem cells.

PubMed

Rice, H E; Skarsgard, E D; Emani, V R; Zanjani, E D; Harrison, M R; Flake, A W

1994-12-01

The transplantation of human fetal tissue has the potential to cure a variety of life-threatening diseases. The strategy for procurement, quality control, and functional assessment of human fetal liver HSC may prove useful for the transplantation of other fetal tissues. In addition to technical limitations, there are ethical and legal issues which need to be resolved before widespread use of fetal tissue. Further development of regulatory standards for the acquisition and distribution of fetal tissues will foster the application of this novel technology.

Integrated Test and Evaluation Flight Test 3 Flight Test Plan

NASA Technical Reports Server (NTRS)

Marston, Michael Lawrence

2015-01-01

The desire and ability to fly Unmanned Aircraft Systems (UAS) in the National Airspace System (NAS) is of increasing urgency. The application of unmanned aircraft to perform national security, defense, scientific, and emergency management are driving the critical need for less restrictive access by UAS to the NAS. UAS represent a new capability that will provide a variety of services in the government (public) and commercial (civil) aviation sectors. The growth of this potential industry has not yet been realized due to the lack of a common understanding of what is required to safely operate UAS in the NAS. NASA's UAS Integration into the NAS Project is conducting research in the areas of Separation Assurance/Sense and Avoid Interoperability, Human Systems Integration (HSI), and Communication to support reducing the barriers of UAS access to the NAS. This research is broken into two research themes namely, UAS Integration and Test Infrastructure. UAS Integration focuses on airspace integration procedures and performance standards to enable UAS integration in the air transportation system, covering Sense and Avoid (SAA) performance standards, command and control performance standards, and human systems integration. The focus of Test Infrastructure is to enable development and validation of airspace integration procedures and performance standards, including the integrated test and evaluation. In support of the integrated test and evaluation efforts, the Project will develop an adaptable, scalable, and schedulable relevant test environment capable of evaluating concepts and technologies for unmanned aircraft systems to safely operate in the NAS. To accomplish this task, the Project will conduct a series of Human-in-the-Loop and Flight Test activities that integrate key concepts, technologies and/or procedures in a relevant air traffic environment. Each of the integrated events will build on the technical achievements, fidelity and complexity of the previous tests and technical simulations, resulting in research findings that support the development of regulations governing the access of UAS into the NAS.

UAS Integration in the NAS Project: Integrated Test and Evaluation (IT&E) Flight Test 3. Revision E

NASA Technical Reports Server (NTRS)

Marston, Michael

2015-01-01

The desire and ability to fly Unmanned Aircraft Systems (UAS) in the National Airspace System (NAS) is of increasing urgency. The application of unmanned aircraft to perform national security, defense, scientific, and emergency management are driving the critical need for less restrictive access by UAS to the NAS. UAS represent a new capability that will provide a variety of services in the government (public) and commercial (civil) aviation sectors. The growth of this potential industry has not yet been realized due to the lack of a common understanding of what is required to safely operate UAS in the NAS. NASA's UAS Integration into the NAS Project is conducting research in the areas of Separation Assurance/Sense and Avoid Interoperability, Human Systems Integration (HSI), and Communication to support reducing the barriers of UAS access to the NAS. This research is broken into two research themes namely, UAS Integration and Test Infrastructure. UAS Integration focuses on airspace integration procedures and performance standards to enable UAS integration in the air transportation system, covering Sense and Avoid (SAA) performance standards, command and control performance standards, and human systems integration. The focus of Test Infrastructure is to enable development and validation of airspace integration procedures and performance standards, including the integrated test and evaluation. In support of the integrated test and evaluation efforts, the Project will develop an adaptable, scalable, and schedulable relevant test environment capable of evaluating concepts and technologies for unmanned aircraft systems to safely operate in the NAS. To accomplish this task, the Project will conduct a series of Human-in-the-Loop and Flight Test activities that integrate key concepts, technologies and/or procedures in a relevant air traffic environment. Each of the integrated events will build on the technical achievements, fidelity and complexity of the previous tests and technical simulations, resulting in research findings that support the development of regulations governing the access of UAS into the NAS.

The impact of leadership and team behavior on standard of care delivered during human patient simulation: a pilot study for undergraduate medical students.

PubMed

Carlson, Jim; Min, Elana; Bridges, Diane

2009-01-01

Methodology to train team behavior during simulation has received increased attention, but standard performance measures are lacking, especially at the undergraduate level. Our purposes were to develop a reliable team behavior measurement tool and explore the relationship between team behavior and the delivery of an appropriate standard of care specific to the simulated case. Authors developed a unique team measurement tool based on previous work. Trainees participated in a simulated event involving the presentation of acute dyspnea. Performance was rated by separate raters using the team behavior measurement tool. Interrater reliability was assessed. The relationship between team behavior and the standard of care delivered was explored. The instrument proved to be reliable for this case and group of raters. Team behaviors had a positive relationship with the standard of medical care delivered specific to the simulated case. The methods used provide a possible method for training and assessing team performance during simulation.

Spectra, chromatograms, Metadata: mzML-the standard data format for mass spectrometer output.

PubMed

Turewicz, Michael; Deutsch, Eric W

2011-01-01

This chapter describes Mass Spectrometry Markup Language (mzML), an XML-based and vendor-neutral standard data format for storage and exchange of mass spectrometer output like raw spectra and peak lists. It is intended to replace its two precursor data formats (mzData and mzXML), which had been developed independently a few years earlier. Hence, with the release of mzML, the problem of having two different formats for the same purposes is solved, and with it the duplicated effort of maintaining and supporting two data formats. The new format has been developed by a broad-based consortium of major instrument vendors, software vendors, and academic researchers under the aegis of the Human Proteome Organisation (HUPO), Proteomics Standards Initiative (PSI), with full participation of the main developers of the precursor formats. This comprehensive approach helped mzML to become a generally accepted standard. Furthermore, the collaborative development insured that mzML has adopted the best features of its precursor formats. In this chapter, we discuss mzML's development history, its design principles and use cases, as well as its main building components. We also present the available documentation, an example file, and validation software for mzML.

Environmental contamination due to shale gas development.

PubMed

Annevelink, M P J A; Meesters, J A J; Hendriks, A J

2016-04-15

Shale gas development potentially contaminates both air and water compartments. To assist in governmental decision-making on future explorations, we reviewed scattered information on activities, emissions and concentrations related to shale gas development. We compared concentrations from monitoring programmes to quality standards as a first indication of environmental risks. Emissions could not be estimated accurately because of incomparable and insufficient data. Air and water concentrations range widely. Poor wastewater treatment posed the highest risk with concentrations exceeding both Natural Background Values (NBVs) by a factor 1000-10,000 and Lowest Quality Standards (LQSs) by a factor 10-100. Concentrations of salts, metals, volatile organic compounds (VOCs) and hydrocarbons exceeded aquatic ecotoxicological water standards. Future research must focus on measuring aerial and aquatic emissions of toxic chemicals, generalisation of experimental setups and measurement technics and further human and ecological risk assessment. Copyright © 2016 Elsevier B.V. All rights reserved.

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

PubMed

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.

Development and validation of criterion-referenced clinically relevant fitness standards for maintaining physical independence in later years.

PubMed

Rikli, Roberta E; Jones, C Jessie

2013-04-01

To develop and validate criterion-referenced fitness standards for older adults that predict the level of capacity needed for maintaining physical independence into later life. The proposed standards were developed for use with a previously validated test battery for older adults-the Senior Fitness Test (Rikli, R. E., & Jones, C. J. (2001). Development and validation of a functional fitness test for community--residing older adults. Journal of Aging and Physical Activity, 6, 127-159; Rikli, R. E., & Jones, C. J. (1999a). Senior fitness test manual. Champaign, IL: Human Kinetics.). A criterion measure to assess physical independence was identified. Next, scores from a subset of 2,140 "moderate-functioning" older adults from a larger cross-sectional database, together with findings from longitudinal research on physical capacity and aging, were used as the basis for proposing fitness standards (performance cut points) associated with having the ability to function independently. Validity and reliability analyses were conducted to test the standards for their accuracy and consistency as predictors of physical independence. Performance standards are presented for men and women ages 60-94 indicating the level of fitness associated with remaining physically independent until late in life. Reliability and validity indicators for the standards ranged between .79 and .97. The proposed standards provide easy-to-use, previously unavailable methods for evaluating physical capacity in older adults relative to that associated with physical independence. Most importantly, the standards can be used in planning interventions that target specific areas of weakness, thus reducing risk for premature loss of mobility and independence.

Health, Human Capital, and Development*

PubMed Central

Bleakley, Hoyt

2013-01-01

How much does disease depress development in human capital and income around the world? I discuss a range of micro evidence, which finds that health is both human capital itself and an input to producing other forms of human capital. I use a standard model to integrate these results, and suggest a re-interpretation of much of the micro literature. I then discuss the aggregate implications of micro estimates, but note the complications in extrapolating to general equilibrium, especially because of health’s effect on population size. I also review the macro evidence on this topic, which consists of either cross-country comparisons or measuring responses to health shocks. Micro estimates are 1–2 orders of magnitude smaller than the cross-country relationship, but nevertheless imply high benefit-to-cost ratios from improving certain forms of health. PMID:24147187

Brief report: human figure drawings by children with Asperger's syndrome.

PubMed

Lim, Hui Keow; Slaughter, Virginia

2008-05-01

Twenty-nine children with Asperger's syndrome and 28 typically developing children, matched on gender, chronological age and nonverbal IQ, were asked to produce a free drawing, then requested to draw a person, a house and a tree. The drawings were scored using standardized procedures for assessing accuracy, detail and complexity. There were no differences between the diagnostic groups on the tree or house drawing scores. The human figure drawing scores of children with Asperger's syndrome were significantly lower than those of the typically developing children, and there was a positive correlation between human figure drawing scores and communication sub-scores on the Vineland Adaptive Behaviour Scales, for the Asperger's group. These results suggest that the selective deficit in generating human figure representations may derive from a relative lack of interest in the social world, and/or limited practice in drawing people.

UAS Integration into the NAS: Detect and Avoid Display Evaluations in Support of SC-228 MOPS Development

NASA Technical Reports Server (NTRS)

Fern, Lisa; Rorie, Conrad; Shively, Jay

2015-01-01

This presentation provides an overview of the work the Human Systems Integration (HSI) sub-project has done on detect and avoid (DAA) displays while working on the UAS Integration into the NAS project. Much of the work has been used to support the ongoing development of minimum operational performance standards (MOPS) for UAS by RTCA Special Committee 228. The design and results of three different human-in-the-loop simulations are discussed, with particular emphasis on the role of the UAS pilot in the Self Separation Timeline.

Fake news and post-truth pronouncements in general and in early human development.

PubMed

Grech, Victor

2017-12-01

Fake news and post-truth pronouncements are increasingly common, and are unfortunately also progressively being applied to the sciences, including the medical sciences. This editorial briefly reviews this unsavoury trend and highlights recent debunking of fake truths in early human development. Science is arguably the last metanarrative with any significant cachet in the postmodern period. We, as scientists, must strive to ensure that our work is transparent and of the highest possible standard so as to continue to uphold science's integrity and probity. Copyright © 2017 Elsevier B.V. All rights reserved.

Issues in protection of human subjects in internet research.

PubMed

Im, Eun-Ok; Chee, Wonshik

2002-01-01

Despite the increasing use of the Internet among nurses, the use of the Internet in nursing research has been rarely discussed and critiqued in terms of issues in protection of human subjects. In this article, issues in protection of human subjects in Internet research are explored by analyzing an Internet study to propose directions for human protection in Internet research. Issues raised through the study include those related to (a) anonymity and confidentiality, (b) security, (c) self-determination and authenticity, (d) full disclosure, and (e) fair treatment. Based on discussion of the five issues, development of standardized guidelines, investigator triangulation, and information sharing are proposed as directions for protection of human subjects in Internet research.

Reasserting the primacy of human needs to reclaim the 'lost half' of sustainable development.

PubMed

Everard, Mark; Longhurst, James W S

2018-04-15

The concept of sustainable development evolved from growing awareness of the interdependence of social and economic progress with the limits of the supporting natural environment, becoming progressively integrated into global agreements and transposition into local regulatory and implementation frameworks. We argue that transposition of the concept into regulation and supporting tools reduced the focus to minimal environmental and social standards, perceived as imposing constraints rather than opportunities for innovation to meet human needs. The aspirational 'half' of the concept of sustainable development specifically addressing human needs was thus lost in transposing high ideals into regulatory instruments. The Sustainable Development Goals (SDGs) restore focus on interlinked human needs, stimulating innovation of products and processes to satisfy them. Through three case studies - PVC water pipes, river quality management in England, and UK local air quality management - we explore the current operationalisation of the concept in diverse settings, using the SDG framework to highlight the broader societal purposes central to sustainable development. Partnerships involving civil society support evolution of regulatory instruments and their implementation, optimising social and ecological benefits thereby serving more human needs. Restoring the visionary 'lost half' of sustainable development - meeting human needs in sustainable ways - creates incentives for innovation and partnership; an innovation framework rather than a perceived constraint. Copyright © 2017 Elsevier B.V. All rights reserved.

Study to design and develop remote manipulator systems

NASA Technical Reports Server (NTRS)

Hill, J. W.; Salisbury, J. K., Jr.

1977-01-01

A description is given of part of a continuing effort both to develop models for and to augment the performance of humans controlling remote manipulators. The project plan calls for the performance of several standard tasks with a number of different manipulators, controls, and viewing conditions, using an automated performance measuring system; in addition, the project plan calls for the development of a force-reflecting joystick and supervisory display system.

A new LC-MS/MS bioanalytical method for atenolol in human plasma and milk.

PubMed

Phyo Lwin, Ei Mon; Gerber, Cobus; Song, Yunmei; Leggett, Catherine; Ritchie, Usha; Turner, Sean; Garg, Sanjay

2017-04-01

A new sensitive LC-MS/MS method for the quantification of atenolol in human plasma and milk has been developed for clinical lactation studies. Atenolol and the internal standard, phenazone, were extracted from biological matrices by protein precipitation. A Phenomenex ® C-18 column and gradient chromatographic conditions were used for separation of the analyte, followed by detection with MS. Stability of samples was confirmed for atenolol in human plasma and milk for up to 3 months. Linearity range of 1-800 ng/ml (r 2 = 0.9995), the precision within 15% CV and the recovery of the analyte (80-100% range) were achieved. A new validated analytical method for atenolol in plasma and milk was developed.

Development and production of good manufacturing practice grade human embryonic stem cell lines as source material for clinical application.

PubMed

De Sousa, P A; Downie, J M; Tye, B J; Bruce, K; Dand, P; Dhanjal, S; Serhal, P; Harper, J; Turner, M; Bateman, M

2016-09-01

From 2006 to 2011, Roslin Cells Ltd derived 17 human embryonic stem cells (hESC) while developing (RCM1, RC-2 to -8, -10) and implementing (RC-9, -11 to -17) quality assured standards of operation in a facility operating in compliance with European Union (EU) directives and United Kingdom (UK) licensure for procurement, processing and storage of human cells as source material for clinical application, and targeted to comply with an EU Good Manufacturing Practice specification. Here we describe the evolution and specification of the facility, its operation and outputs, complementing hESC resource details communicated in Stem Cell Research Lab Resources. Copyright © 2016. Published by Elsevier B.V.

Source Identification of Human Biological Materials and Its Prospect in Forensic Science.

PubMed

Zou, K N; Gui, C; Gao, Y; Yang, F; Zhou, H G

2016-06-01

Source identification of human biological materials in crime scene plays an important role in reconstructing the crime process. Searching specific genetic markers to identify the source of different human biological materials is the emphasis and difficulty of the research work of legal medical experts in recent years. This paper reviews the genetic markers which are used for identifying the source of human biological materials and studied widely, such as DNA methylation, mRNA, microRNA, microflora and protein, etc. By comparing the principles and methods of source identification of human biological materials using different kinds of genetic markers, different source of human biological material owns suitable marker types and can be identified by detecting single genetic marker or combined multiple genetic markers. Though there is no uniform standard and method for identifying the source of human biological materials in forensic laboratories at present, the research and development of a series of mature and reliable methods for distinguishing different human biological materials play the role as forensic evidence which will be the future development direction. Copyright© by the Editorial Department of Journal of Forensic Medicine.

Management of Service Projects in Support of Space Flight Research

NASA Technical Reports Server (NTRS)

Love, J.

2009-01-01

Goal:To provide human health and performance countermeasures, knowledge, technologies, and tools to enable safe, reliable, and productive human space exploration . [HRP-47051] Specific Objectives: 1) Develop capabilities, necessary countermeasures, and technologies in support of human space exploration, focusing on mitigating the highest risks to human health and performance. 2) Define and improve human spaceflight medical, environmental, and human factors standards. 3) Develop technologies that serve to reduce medical and environmental risks, to reduce human systems resource requirements (mass, volume, power, data, etc.) and to ensure effective human-system integration across exploration systems. 4) Ensure maintenance of Agency core competencies necessary to enable risk reduction in the following areas: A. Space medicine B. Physiological and behavioral effects of long duration spaceflight on the human body C. Space environmental effects, including radiation, on human health and performance D. Space "human factors" [HRP-47051]. Service projects can form integral parts of research-based project-focused programs to provide specialized functions. Traditional/classic project management methodologies and agile approaches are not mutually exclusive paradigms. Agile strategies can be combined with traditional methods and applied in the management of service projects functioning in changing environments. Creative collaborations afford a mechanism for mitigation of constrained resource limitations.

Cytomegalovirus-targeted immunotherapy and glioblastoma: hype or hope?

PubMed

Ferguson, Sherise D; Srinivasan, Visish M; Ghali, Michael Gz; Heimberger, Amy B

2016-01-01

Malignant gliomas, including glioblastoma (GBM), are the most common primary brain tumors. Despite extensive research only modest gains have been made in long-term survival. Standard of care involves maximizing safe surgical resection followed by concurrent chemoradiation with temozolomide. Immunotherapy for GBM is an area of intense research in recent years. New immunotherapies, although promising, have not been integrated into standard practice. Human cytomegalovirus (HCMV) is a DNA virus of the family Herpesviridae. Human seroprevalence is approximately 80%, and in most cases, is associated with asymptomatic infection. HCMV may be an important agent in the initiation, promotion and/or progression of tumorigenesis. Regardless of a possible etiologic role in GBM, interest has centered on exploiting this association for development of immunomodulatory therapies.

Best practice guidelines for the operation of a donor human milk bank in an Australian NICU.

PubMed

Hartmann, B T; Pang, W W; Keil, A D; Hartmann, P E; Simmer, K

2007-10-01

Until the establishment of the PREM Bank (Perron Rotary Express Milk Bank) donor human milk banking had not occurred in Australia for the past 20 years. In re-establishing donor human milk banking in Australia, the focus of the PREM Bank has been to develop a formal and consistent approach to safety and quality in processing during the operation of the human milk bank. There is currently no existing legislation in Australia that specifically regulates the operation of donor human milk banks. For this reason the PREM Bank has utilised existing and internationally recognised management practices for managing hazards during food production. These tools (specifically HACCP) have been used to guide the development of Standard Operating Procedures and Good Manufacturing Practice for the screening of donors and processing of donor human milk. Donor screening procedures are consistent with those recommended by other human milk banks operating internationally, and also consistent with the requirements for blood and tissue donation in Australia. Controlled documentation and record keep requirements have also been developed that allow complete traceability from individual donation to individual feed dispensed to recipient and maintain a record of all processing and storage conditions. These operational requirements have been developed to reduce any risk associated with feeding pasteurised donor human milk to hospitalised preterm or ill infants to acceptable levels.

Standards for the user interface - Developing a user consensus. [for Space Station Information System

NASA Technical Reports Server (NTRS)

Moe, Karen L.; Perkins, Dorothy C.; Szczur, Martha R.

1987-01-01

The user support environment (USE) which is a set of software tools for a flexible standard interactive user interface to the Space Station systems, platforms, and payloads is described in detail. Included in the USE concept are a user interface language, a run time environment and user interface management system, support tools, and standards for human interaction methods. The goals and challenges of the USE are discussed as well as a methodology based on prototype demonstrations for involving users in the process of validating the USE concepts. By prototyping the key concepts and salient features of the proposed user interface standards, the user's ability to respond is greatly enhanced.

Lunar Plant Growth Chamber: Human Exploration Project STS-118 Design Challenge. A Standards-Based High School Unit Guide. Engineering by Design: Advancing Technological Literacy. A Standards-Based Program Series. EP-2007-08-94-MSFC

ERIC Educational Resources Information Center

Caron, Daniel W.; Fuller, Jeremy; Watson, Janice; St. Hilaire, Katherine

2007-01-01

In May 2005, the International Technology Education Association (ITEA) was funded by the National Aeronautics and Space Administration (NASA) to develop curricular units for Grades K-12 on Space Exploration. The units focus on aspects of the themes that NASA Engineers and Scientists--as well as future generations of explorers--must consider, such…

A Microbial Murder Mystery.

ERIC Educational Resources Information Center

Mitchell, Melissa A.; Mitchell, James K.

2002-01-01

Proposes a microbial mystery activity to test students' knowledge of human anatomy and their ability to identify microbes. Provides an opportunity for students to develop logical deductive reasoning. Includes national science education standards related to this activity, activity sheets with whole procedures, and Internet resources. (KHR)

5 CFR 7501.102 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Administrative Personnel DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT..., as used also in 5 CFR part 2635, means the Associate General Counsel for Human Resources Law, the Assistant General Counsel, Ethics Law Division, and the HUD Field Office Assistant General Counsels; the...

5 CFR 7501.102 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Administrative Personnel DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT..., as used also in 5 CFR part 2635, means the Associate General Counsel for Human Resources Law, the Assistant General Counsel, Ethics Law Division, and the HUD Field Office Assistant General Counsels; the...

5 CFR 7501.102 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Administrative Personnel DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT..., as used also in 5 CFR part 2635, means the Associate General Counsel for Human Resources Law, the Assistant General Counsel, Ethics Law Division, and the HUD Field Office Assistant General Counsels; the...

Human factors considerations in the evaluation of processor-based signal and train control systems

DOT National Transportation Integrated Search

2007-06-01

In August 2001, the Federal Railroad Administration issued the notice of proposed rulemaking: Standards for Development and : Use of Processor-Based Signal and Train Control Systems (49 Code of Federal Regulations Part 236). This proposed rule addres...

Method Development and Monitoring of Cyanotoxins in Water (ACS Central Presentation)

EPA Science Inventory

Increasing occurrence of cyanobacterial harmful algal blooms (HABs) in ambient waters has become a worldwide concern. Numerous cyanotoxins can be produced during HAB events which are toxic to animals and humans. Validated standardized methods that are rugged, selective and sensit...

Gold internal standard correction for elemental imaging of soft tissue sections by LA-ICP-MS: element distribution in eye microstructures.

PubMed

Konz, Ioana; Fernández, Beatriz; Fernández, M Luisa; Pereiro, Rosario; González, Héctor; Alvarez, Lydia; Coca-Prados, Miguel; Sanz-Medel, Alfredo

2013-04-01

Laser ablation coupled to inductively coupled plasma mass spectrometry has been developed for the elemental imaging of Mg, Fe and Cu distribution in histological tissue sections of fixed eyes, embedded in paraffin, from human donors (cadavers). This work presents the development of a novel internal standard correction methodology based on the deposition of a homogeneous thin gold film on the tissue surface and the use of the (197)Au(+) signal as internal standard. Sample preparation (tissue section thickness) and laser conditions were carefully optimized, and internal normalisation using (197)Au(+) was compared with (13)C(+) correction for imaging applications. (24)Mg(+), (56)Fe(+) and (63)Cu(+) distributions were investigated in histological sections of the anterior segment of the eye (including the iris, ciliary body, cornea and trabecular meshwork) and were shown to be heterogeneously distributed along those tissue structures. Reproducibility was assessed by imaging different human eye sections from the same donor and from ten different eyes from adult normal donors, which showed that similar spatial maps were obtained and therefore demonstrate the analytical potential of using (197)Au(+) as internal standard. The proposed analytical approach could offer a robust tool with great practical interest for clinical studies, e.g. to investigate trace element distribution of metals and their alterations in ocular diseases.

Human rights at work: Physical standards for employment and human rights law.

PubMed

Adams, Eric M

2016-06-01

This review focuses on the human rights dimensions of creating and implementing physical standards for employment for prospective and incumbent employees. The review argues that physical standards for employment engage two fundamental legal concepts of employment law: freedom of contract and workplace human rights. While the former promotes an employer's right to set workplace standards and make decisions of whom to hire and terminate, the latter prevents employers from discriminating against individuals contrary to human rights legislation. With reference to applicable human rights legislative regimes and their judicial interpretation in Canada, the United States, the United Kingdom, and Australia, this review demonstrates the judicial preference for criterion validation in testing mechanisms in the finding of bona fide occupational requirements. With particular attention to the Supreme Court of Canada decision in Meiorin, this review argues that an effective balance between workplace safety and human rights concerns can be found, not in applying different standards to different groups of individuals, but in an approach that holds employers to demonstrating a sufficient connection between a uniform physical standard of employment and the actual minimum requirements to perform the job safety and efficiently. Combined with an employer's duty to accommodate, such an approach to lawful physical standards for employment conceives of worker and public safety and workplace diversity as emanating from a shared concern for human rights.

EVA Human Health and Performance Benchmarking Study Overview and Development of a Microgravity Protocol

NASA Technical Reports Server (NTRS)

Norcross, Jason; Jarvis, Sarah; Bekdash, Omar; Cupples, Scott; Abercromby, Andrew

2017-01-01

The primary objective of this study is to develop a protocol to reliably characterize human health and performance metrics for individuals working inside various EVA suits under realistic spaceflight conditions. Expected results and methodologies developed during this study will provide the baseline benchmarking data and protocols with which future EVA suits and suit configurations (e.g., varied pressure, mass, center of gravity [CG]) and different test subject populations (e.g., deconditioned crewmembers) may be reliably assessed and compared. Results may also be used, in conjunction with subsequent testing, to inform fitness-for-duty standards, as well as design requirements and operations concepts for future EVA suits and other exploration systems.

Further Development and Test of an Artificial Hand for Communication with Deaf-Blind People. Final Report.

ERIC Educational Resources Information Center

Laenger, Charles J., Sr.; Peel, H. Herbert

The report details the development and design of a mechanical hand for communicating with deaf blind persons. It is explained that the device, which looks and functions like the human hand, forms the symbols of the one-hand manual alphabet upon command from a standard electric typewriter keyboard. The report addresses the following topics (sample…

A Standardized Certification Program for Case Managers Serving Frail Elderly Texans. Module II: Assessment and Care Plan Development.

ERIC Educational Resources Information Center

Lusky, Richard A.; And Others

This learning module is one of three training modules that were developed for members of the Texas Gerontological Consortium for Continuing Education to use in preparing case managers working in human service professions coordinating community-based programs for frail elderly Texans. Module II deals with the following topics: assessment (role of…

A Comparison of Pathophysiology in Humans and Rodent Models of Subarachnoid Hemorrhage

PubMed Central

Leclerc, Jenna L.; Garcia, Joshua M.; Diller, Matthew A.; Carpenter, Anne-Marie; Kamat, Pradip K.; Hoh, Brian L.; Doré, Sylvain

2018-01-01

Non-traumatic subarachnoid hemorrhage (SAH) affects an estimated 30,000 people each year in the United States, with an overall mortality of ~30%. Most cases of SAH result from a ruptured intracranial aneurysm, require long hospital stays, and result in significant disability and high fatality. Early brain injury (EBI) and delayed cerebral vasospasm (CV) have been implicated as leading causes of morbidity and mortality in these patients, necessitating intense focus on developing preclinical animal models that replicate clinical SAH complete with delayed CV. Despite the variety of animal models currently available, translation of findings from rodent models to clinical trials has proven especially difficult. While the explanation for this lack of translation is unclear, possibilities include the lack of standardized practices and poor replication of human pathophysiology, such as delayed cerebral vasospasm and ischemia, in rodent models of SAH. In this review, we summarize the different approaches to simulating SAH in rodents, in particular elucidating the key pathophysiology of the various methods and models. Ultimately, we suggest the development of standardized model of rodent SAH that better replicates human pathophysiology for moving forward with translational research. PMID:29623028

Development of new method and protocol for cryopreservation related to embryo and oocytes freezing in terms of fertilization rate: A comparative study including review of literature.

PubMed

Barik, Mayadhar; Bajpai, Minu; Patnaik, Santosh; Mishra, Pravash; Behera, Priyamadhaba; Dwivedi, Sada Nanda

2016-01-01

Cryopreservation is basically related to meritorious thin samples or small clumps of cells that are cooled quickly without loss. Our main objective is to establish and formulate an innovative method and protocol development for cryopreservation as a gold standard for clinical uses in laboratory practice and treatment. The knowledge regarding usefulness of cryopreservation in clinical practice is essential to carry forward the clinical practice and research. We are trying to compare different methods of cryopreservation (in two dozen of cells) at the same time we compare the embryo and oocyte freezing interms of fertilization rate according to the International standard protocol. The combination of cryoprotectants and regimes of rapid cooling and rinsing during warming often allows successful cryopreservation of biological materials, particularly cell suspensions or thin tissue samples. Examples include semen, blood, tissue samples like tumors, histological cross-sections, human eggs and human embryos. Although presently many studies have reported that the children born from frozen embryos or "frosties," show consistently positive results with no increase in birth defects or development abnormalities is quite good enough and similar to our study (50-85%). We ensure that cryopreservation technology provided useful cell survivability, tissue and organ preservation in a proper way. Although it varies according to different laboratory conditions, it is certainly beneficial for patient's treatment and research. Further studies are needed for standardization and development of new protocol.

Human Rights and Values Education: Using the International Standards.

ERIC Educational Resources Information Center

Reardon, Betty A.

1994-01-01

Asserts that, in teaching about human rights, the international standards should be the fundamental core of the content and values to be communicated. Recommends that teachers should use the Universal Declaration of Human Rights as the standard by which the actions of individuals and governments should be compared. (CFR)

HFE Process Guidance and Standards for potential application to updating NRC guidance

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jacques Hugo; J. J. Persensky

2012-07-01

The U.S. Nuclear Regulatory Commission (NRC) reviews and evaluates the human factors engineering (HFE) programs of applicants for nuclear power plant construction permits, operating licenses, standard design certifications, and combined operating licenses. The purpose of these safety reviews is to help ensure that personnel performance and reliability are appropriately supported. Detailed design review procedures and guidance for the evaluations is provided in three key documents: the Standard Review Plan (NUREG-0800), the HFE Program Review Model (NUREG-0711), and the Human-System Interface Design Review Guidelines (NUREG-0700). These documents were last revised in 2007, 2004 and 2002, respectively. The NRC is committed tomore » the periodic update and improvement of these guidance documents to ensure that they remain state-of-the-art design evaluation tools. Thus, the NRC has initiated a project with BNL to update the NRC guidance to remain current with recent research on human performance, advances in HFE methods and tools, and new technology. INL supported Brookhaven National Lab (BNL) to update the detailed HFE review criteria contained in NUREG-0711 and NUREG-0700 based on (1) feedback obtained from end users, (2) the results of NRC research and development efforts supporting the NRC staff’s HFE safety reviews, and (3) other material the project staff identify as applicable to the update effort. INL submitted comments on development plans and sections of NUREGs 0800, 0711, and 0700. The contractor prepared the report attached here as the deliverable for this work.« less

Tellurium notebooks-An environment for reproducible dynamical modeling in systems biology.

PubMed

Medley, J Kyle; Choi, Kiri; König, Matthias; Smith, Lucian; Gu, Stanley; Hellerstein, Joseph; Sealfon, Stuart C; Sauro, Herbert M

2018-06-01

The considerable difficulty encountered in reproducing the results of published dynamical models limits validation, exploration and reuse of this increasingly large biomedical research resource. To address this problem, we have developed Tellurium Notebook, a software system for model authoring, simulation, and teaching that facilitates building reproducible dynamical models and reusing models by 1) providing a notebook environment which allows models, Python code, and narrative to be intermixed, 2) supporting the COMBINE archive format during model development for capturing model information in an exchangeable format and 3) enabling users to easily simulate and edit public COMBINE-compliant models from public repositories to facilitate studying model dynamics, variants and test cases. Tellurium Notebook, a Python-based Jupyter-like environment, is designed to seamlessly inter-operate with these community standards by automating conversion between COMBINE standards formulations and corresponding in-line, human-readable representations. Thus, Tellurium brings to systems biology the strategy used by other literate notebook systems such as Mathematica. These capabilities allow users to edit every aspect of the standards-compliant models and simulations, run the simulations in-line, and re-export to standard formats. We provide several use cases illustrating the advantages of our approach and how it allows development and reuse of models without requiring technical knowledge of standards. Adoption of Tellurium should accelerate model development, reproducibility and reuse.

From confluent human iPS cells to self-forming neural retina and retinal pigmented epithelium

PubMed Central

Reichman, Sacha; Terray, Angélique; Slembrouck, Amélie; Nanteau, Céline; Orieux, Gaël; Habeler, Walter; Nandrot, Emeline F.; Sahel, José-Alain; Monville, Christelle; Goureau, Olivier

2014-01-01

Progress in retinal-cell therapy derived from human pluripotent stem cells currently faces technical challenges that require the development of easy and standardized protocols. Here, we developed a simple retinal differentiation method, based on confluent human induced pluripotent stem cells (hiPSC), bypassing embryoid body formation and the use of exogenous molecules, coating, or Matrigel. In 2 wk, we generated both retinal pigmented epithelial cells and self-forming neural retina (NR)-like structures containing retinal progenitor cells (RPCs). We report sequential differentiation from RPCs to the seven neuroretinal cell types in maturated NR-like structures as floating cultures, thereby revealing the multipotency of RPCs generated from integration-free hiPSCs. Furthermore, Notch pathway inhibition boosted the generation of photoreceptor precursor cells, crucial in establishing cell therapy strategies. This innovative process proposed here provides a readily efficient and scalable approach to produce retinal cells for regenerative medicine and for drug-screening purposes, as well as an in vitro model of human retinal development and disease. PMID:24912154

Prenatal development of the normal human vertebral corpora in different segments of the spine.

PubMed

Nolting, D; Hansen, B F; Keeling, J; Kjaer, I

1998-11-01

Vertebral columns from 13 normal human fetuses (10-24 weeks of gestation) that had aborted spontaneously were investigated as part of the legal autopsy procedure. The investigation included spinal cord analysis. To analyze the formation of the normal human vertebral corpora along the spine, including the early location and disappearance of the notochord. Reference material on the development of the normal human vertebral corpora is needed for interpretation of published observations on prenatal malformations in the spine, which include observations of various types of malformation (anencephaly, spina bifida) and various genotypes (trisomy 18, 21 and 13, as well as triploidy). The vertebral columns were studied by using radiography (Faxitron X-ray apparatus, Faxitron Model 43,855, Hewlett Packard) in lateral, frontal, and axial views and histology (decalcification, followed by toluidine blue and alcian blue staining) in and axial view. Immunohistochemical marking with Keratin Wide Spectrum also was done. Notochordal tissue (positive on marking with Keratin Wide Spectrum [DAKO, Denmark]) was located anterior to the cartilaginous body center in the youngest fetuses. The process of disintegration of the notochord and the morphology of the osseous vertebral corpora in the lumbosacral, thoracic, and cervical segments are described. Marked differences appeared in axial views, which were verified on horizontal histologic sections. Also, the increase in size was different in the different segments, being most pronounced in the thoracic and upper lumbar bodies. The lower thoracic bodies were the first to ossify. The morphologic changes observed by radiography were verified histologically. In this study, normal prenatal standards were established for the early development of the vertebral column. These standards can be used in the future--for evaluation of pathologic deviations in the human vertebral column in the second trimester.

Development of health-based screening levels for use in state- or local-scale water-quality assessments

USGS Publications Warehouse

Toccalino, Patricia L.; Nowell, Lisa; Wilber, William; Zogorski, John S.; Donohue, Joyce; Eiden, Catherine; Krietzman, Sandra; Post, Gloria

2003-01-01

The U.S. Geological Survey (USGS) has a need to communicate the significance of the water-quality findings of its National Water-Quality Assessment (NAWQA) Program in a human-health context. Historically, the USGS has assessed water-quality conditions by comparing water concentration data against established drinking-water standards and guidelines. However, because drinking- water standards and guidelines do not exist for many of the contaminants analyzed by the NAWQA Program and other USGS studies, this approach has proven to be insufficient for placing USGS data in a human-health context. To help meet this need, health-based screening level (HBSL) concentrations or ranges are being determined for unregulated compounds (that is, those for which Federal or State drinking-water standards have not been established), using a consensus approach that was developed collaboratively by the USGS, U.S. Environmental Protection Agency(USEPA), New Jersey Department of Environmental Protection, and Oregon Health & Science University. USEPA Office of Water methodologies for calculating Lifetime Health Advisory and Risk-Specific Dose values for drinking water are being used to develop HBSL concentrations (for unregulated noncarcinogens) and HBSL concentration ranges (for most unregulated carcinogens). This report describes the methodologies used to develop HBSL concentrations and ranges for unregulated compounds in State- and local-scale analyses, and discusses how HBSL values can be used as tools in water-quality assessments. Comparisons of measured water concentrations with Maximum Contaminant Level values and HBSL values require that water-quality data be placed in the proper context, with regard to both hydrology and human health. The use of these HBSL concentrations and ranges by USGS will increase by 27 percent the number of NAWQA contaminants for which health-based benchmarks are available for comparison with USGS water-quality data. USGS can use HBSL values to assist the USEPA and State and local agencies by providing them with comparisons of measured water concentrations to scientifically defensible human health-based benchmarks, and by alerting them when measured concentrations approach or exceed these benchmarks.

Skin models for the testing of transdermal drugs

PubMed Central

Abd, Eman; Yousef, Shereen A; Pastore, Michael N; Telaprolu, Krishna; Mohammed, Yousuf H; Namjoshi, Sarika; Grice, Jeffrey E; Roberts, Michael S

2016-01-01

The assessment of percutaneous permeation of molecules is a key step in the evaluation of dermal or transdermal delivery systems. If the drugs are intended for delivery to humans, the most appropriate setting in which to do the assessment is the in vivo human. However, this may not be possible for ethical, practical, or economic reasons, particularly in the early phases of development. It is thus necessary to find alternative methods using accessible and reproducible surrogates for in vivo human skin. A range of models has been developed, including ex vivo human skin, usually obtained from cadavers or plastic surgery patients, ex vivo animal skin, and artificial or reconstructed skin models. Increasingly, largely driven by regulatory authorities and industry, there is a focus on developing standardized techniques and protocols. With this comes the need to demonstrate that the surrogate models produce results that correlate with those from in vivo human studies and that they can be used to show bioequivalence of different topical products. This review discusses the alternative skin models that have been developed as surrogates for normal and diseased skin and examines the concepts of using model systems for in vitro–in vivo correlation and the demonstration of bioequivalence. PMID:27799831

Cloning of non-human primates: the road “less traveled by”

PubMed Central

SPARMAN, MICHELLE L.; TACHIBANA, MASAHITO; MITALIPOV, SHOUKHRAT M.

2011-01-01

Early studies on cloning of non-human primates by nuclear transfer utilized embryonic blastomeres from preimplantation embryos which resulted in the reproducible birth of live offspring. Soon after, the focus shifted to employing somatic cells as a source of donor nuclei (somatic cell nuclear transfer, SCNT). However, initial efforts were plagued with inefficient nuclear reprogramming and poor embryonic development when standard SCNT methods were utilized. Implementation of several key SCNT modifications was critical to overcome these problems. In particular, a non-invasive method of visualizing the metaphase chromosomes during enucleation was developed to preserve the reprogramming capacity of monkey oocytes. These modifications dramatically improved the efficiency of SCNT, yielding high blastocyst development in vitro. To date, SCNT has been successfully used to derive pluripotent embryonic stem cells (ESCs) from adult monkey skin fibroblasts. These remarkable advances have the potential for development of human autologous ESCs and cures for many human diseases. Reproductive cloning of nonhuman primates by SCNT has not been achieved yet. We have been able to establish several pregnancies with SCNT embryos which, so far, did not progress to term. In this review, we summarize the approaches, obstacles and accomplishments of SCNT in a non-human primate model. PMID:21404187

Cloning of non-human primates: the road "less traveled by".

PubMed

Sparman, Michelle L; Tachibana, Masahito; Mitalipov, Shoukhrat M

2010-01-01

Early studies on cloning of non-human primates by nuclear transfer utilized embryonic blastomeres from preimplantation embryos which resulted in the reproducible birth of live offspring. Soon after, the focus shifted to employing somatic cells as a source of donor nuclei (somatic cell nuclear transfer, SCNT). However, initial efforts were plagued with inefficient nuclear reprogramming and poor embryonic development when standard SCNT methods were utilized. Implementation of several key SCNT modifications was critical to overcome these problems. In particular, a non-invasive method of visualizing the metaphase chromosomes during enucleation was developed to preserve the reprogramming capacity of monkey oocytes. These modifications dramatically improved the efficiency of SCNT, yielding high blastocyst development in vitro. To date, SCNT has been successfully used to derive pluripotent embryonic stem cells (ESCs) from adult monkey skin fibroblasts. These remarkable advances have the potential for development of human autologous ESCs and cures for many human diseases. Reproductive cloning of nonhuman primates by SCNT has not been achieved yet. We have been able to establish several pregnancies with SCNT embryos which, so far, did not progress to term. In this review, we summarize the approaches, obstacles and accomplishments of SCNT in a non-human primate model.

CDISC SHARE, a Global, Cloud-based Resource of Machine-Readable CDISC Standards for Clinical and Translational Research

PubMed Central

Hume, Samuel; Chow, Anthony; Evans, Julie; Malfait, Frederik; Chason, Julie; Wold, J. Darcy; Kubick, Wayne; Becnel, Lauren B.

2018-01-01

The Clinical Data Interchange Standards Consortium (CDISC) is a global non-profit standards development organization that creates consensus-based standards for clinical and translational research. Several of these standards are now required by regulators for electronic submissions of regulated clinical trials’ data and by government funding agencies. These standards are free and open, available for download on the CDISC Website as PDFs. While these documents are human readable, they are not amenable to ready use by electronic systems. CDISC launched the CDISC Shared Health And Research Electronic library (SHARE) to provide the standards metadata in machine-readable formats to facilitate the automated management and implementation of the standards. This paper describes how CDISC SHARE’S standards can facilitate collecting, aggregating and analyzing standardized data from early design to end analysis; and its role as a central resource providing information systems with metadata that drives process automation including study setup and data pipelining. PMID:29888049

Premise for Standardized Sepsis Models.

PubMed

Remick, Daniel G; Ayala, Alfred; Chaudry, Irshad; Coopersmith, Craig M; Deutschman, Clifford; Hellman, Judith; Moldawer, Lyle; Osuchowski, Marcin

2018-06-05

Sepsis morbidity and mortality exacts a toll on patients and contributes significantly to healthcare costs. Preclinical models of sepsis have been used to study disease pathogenesis and test new therapies, but divergent outcomes have been observed with the same treatment even when using the same sepsis model. Other disorders such as diabetes, cancer, malaria, obesity and cardiovascular diseases have used standardized, preclinical models that allow laboratories to compare results. Standardized models accelerate the pace of research and such models have been used to test new therapies or changes in treatment guidelines. The National Institutes of Health (NIH) mandated that investigators increase data reproducibility and the rigor of scientific experiments and has also issued research funding announcements about the development and refinement of standardized models. Our premise is that refinement and standardization of preclinical sepsis models may accelerate the development and testing of potential therapeutics for human sepsis, as has been the case with preclinical models for other disorders. As a first step towards creating standardized models, we suggest 1) standardizing the technical standards of the widely used cecal ligation and puncture model and 2) creating a list of appropriate organ injury and immune dysfunction parameters. Standardized sepsis models could enhance reproducibility and allow comparison of results between laboratories and may accelerate our understanding of the pathogenesis of sepsis.

Ethical Review Issues in Collaborative Research between US and Low – Middle Income Country Partners: A Case Example

PubMed Central

McIntosh, Scott; Sierra, Essie; Dozier, Ann; Diaz, Sergio; Quiñones, Zahira; Primack, Aron; Chadwick, Gary; Ossip-Klein, Deborah J.

2012-01-01

The current ethical structure for collaborative international health research stems largely from developed countries’ standards of proper ethical practices. The result is that ethical committees in developing countries are required to adhere to standards that might impose practices that conflict with local culture and unintended interpretations of ethics, treatments, and research. This paper presents a case example of a joint international research project that successfully established inclusive ethical review processes as well as other groundwork and components necessary for the conduct of human behavior research and research capacity building in the host country. PMID:18554278

Rapid determination of tafenoquine in small volume human plasma samples by high-performance liquid chromatography-tandem mass spectrometry.

PubMed

Doyle, E; Fowles, S E; Summerfield, S; White, T J

2002-03-25

A method was developed for the determination of tafenoquine (I) in human plasma using high-performance liquid chromatography-tandem mass spectrometry. Prior to analysis, the protein in plasma samples was precipitated with methanol containing [2H3(15N)]tafenoquine (II) to act as an internal standard. The supernatant was injected onto a Genesis-C18 column without any further clean-up. The mass spectrometer was operated in the positive ion mode, employing a heat assisted nebulisation, electrospray interface. Ions were detected in multiple reaction monitoring mode. The assay required 50 microl of plasma and was precise and accurate within the range 2 to 500 ng/ml. The average within-run and between-run relative standard deviations were < 7% at 2 ng/ml and greater concentrations. The average accuracy of validation standards was generally within +/- 4% of the nominal concentration. There was no evidence of instability of I in human plasma following three complete freeze-thaw cycles and samples can safely be stored for at least 8 months at approximately -70 degrees C. The method was very robust and has been successfully applied to the analysis of clinical samples from patients and healthy volunteers dosed with I.

Use of human engineering standards in design

NASA Technical Reports Server (NTRS)

Rogers, J. G.; Armstrong, R.

1977-01-01

Results are presented for a research study intended to assess the impact of present human engineering standards on product design. The approach consisted of three basic steps: a comparison of two display panels to determine if, in fact, products designed to the same standards are truly standardized; a review of two existing standards to determine how well their information can be used to solve design problems; and a survey of human factors specialists to assess their opinions about standards. It is shown that standards have less than the desired influence on product design. This is evidenced by a lack of standardization between hardware designed under common standards, by deficiencies within the standards that detract from their usefulness and encourage users to ignore them, and by the respondents of the survey who consider standards less valuable than other reference sources for design implementation. Recommendations aimed at enhancing the use of standards are set forth.

45 CFR 1308.18 - Disabilities/health services coordination.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 4 2011-10-01 2011-10-01 false Disabilities/health services coordination. 1308.18... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR CHILDREN, YOUTH AND... DISABILITIES Health Services Performance Standards § 1308.18 Disabilities/health services coordination. (a) The...

45 CFR 1308.18 - Disabilities/health services coordination.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 4 2012-10-01 2012-10-01 false Disabilities/health services coordination. 1308.18... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR CHILDREN, YOUTH AND... DISABILITIES Health Services Performance Standards § 1308.18 Disabilities/health services coordination. (a) The...

45 CFR 1308.7 - Eligibility criteria: Health impairment.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 4 2011-10-01 2011-10-01 false Eligibility criteria: Health impairment. 1308.7... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR CHILDREN, YOUTH AND... DISABILITIES Health Services Performance Standards § 1308.7 Eligibility criteria: Health impairment. (a) A...

45 CFR 1308.7 - Eligibility criteria: Health impairment.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 4 2012-10-01 2012-10-01 false Eligibility criteria: Health impairment. 1308.7... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR CHILDREN, YOUTH AND... DISABILITIES Health Services Performance Standards § 1308.7 Eligibility criteria: Health impairment. (a) A...

45 CFR 1308.18 - Disabilities/health services coordination.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false Disabilities/health services coordination. 1308.18... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR CHILDREN, YOUTH AND... DISABILITIES Health Services Performance Standards § 1308.18 Disabilities/health services coordination. (a) The...

45 CFR 1308.18 - Disabilities/health services coordination.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 4 2013-10-01 2013-10-01 false Disabilities/health services coordination. 1308.18... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR CHILDREN, YOUTH AND... DISABILITIES Health Services Performance Standards § 1308.18 Disabilities/health services coordination. (a) The...

45 CFR 1308.7 - Eligibility criteria: Health impairment.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 4 2013-10-01 2013-10-01 false Eligibility criteria: Health impairment. 1308.7... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR CHILDREN, YOUTH AND... DISABILITIES Health Services Performance Standards § 1308.7 Eligibility criteria: Health impairment. (a) A...

45 CFR 1308.18 - Disabilities/health services coordination.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 4 2014-10-01 2014-10-01 false Disabilities/health services coordination. 1308.18... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR CHILDREN, YOUTH AND... DISABILITIES Health Services Performance Standards § 1308.18 Disabilities/health services coordination. (a) The...

45 CFR 1308.7 - Eligibility criteria: Health impairment.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 4 2014-10-01 2014-10-01 false Eligibility criteria: Health impairment. 1308.7... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR CHILDREN, YOUTH AND... DISABILITIES Health Services Performance Standards § 1308.7 Eligibility criteria: Health impairment. (a) A...

45 CFR 1308.7 - Eligibility criteria: Health impairment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false Eligibility criteria: Health impairment. 1308.7... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR CHILDREN, YOUTH AND... DISABILITIES Health Services Performance Standards § 1308.7 Eligibility criteria: Health impairment. (a) A...

Grading--Why Are School Policies Necessary? What Are the Issues?

ERIC Educational Resources Information Center

Thomas, William C.

1986-01-01

Argues that current grading practices in some schools lack consistency in several critical areas, including criteria for failure, absolute or relative standards, and motivation of slower students. Policies are suggested that will help educators develop fairer and more humane marking systems. (TE)

Wide-area situation awareness in electric power grid

NASA Astrophysics Data System (ADS)

Greitzer, Frank L.

2010-04-01

Two primary elements of the US energy policy are demand management and efficiency and renewable sources. Major objectives are clean energy transmission and integration, reliable energy transmission, and grid cyber security. Development of the Smart Grid seeks to achieve these goals by lowering energy costs for consumers, achieving energy independence and reducing greenhouse gas emissions. The Smart Grid is expected to enable real time wide-area situation awareness (SA) for operators. Requirements for wide-area SA have been identified among interoperability standards proposed by the Federal Energy Regulatory Commission and the National Institute of Standards and Technology to ensure smart-grid functionality. Wide-area SA and enhanced decision support and visualization tools are key elements in the transformation to the Smart Grid. This paper discusses human factors research to promote SA in the electric power grid and the Smart Grid. Topics that will be discussed include the role of human factors in meeting US energy policy goals, the impact and challenges for Smart Grid development, and cyber security challenges.

Abacavir Pharmacogenetics – From Initial Reports to Standard of Care

PubMed Central

Martin, Michael A.; Kroetz, Deanna L.

2013-01-01

Abacavir is a nucleoside analogue reverse transcriptase inhibitor (NRTI) indicated for the treatment of human immunodeficiency virus (HIV) infection as part of a multidrug, highly active antiretroviral therapy (HAART) regimen. Despite its efficacy in treating HIV, approximately 5% of individuals that receive abacavir develop an immune-mediated hypersensitivity reaction (HSR) that warrants immediate discontinuation of abacavir and switching to an alternative antiretroviral regimen. Abacavir HSR is associated with individuals that carry the *57:01 variant in the human leukocyte antigen B (HLA-B) gene. There is a large volume of evidence to show that those who carry HLA-B*57:01 are at significantly increased risk of developing HSR and should not receive abacavir. Using pharmacogenetic screening to ensure individuals who carry y HLA-B*57:01 do not receive abacavir can reduce the incidence of abacavir HSR and is now considered the standard of care before prescribing abacavir. Genetic testing for abacavir HSR is currently one of the best examples of integrating pharmacogenetic testing into clinical practice. PMID:23649914

Abacavir pharmacogenetics--from initial reports to standard of care.

PubMed

Martin, Michael A; Kroetz, Deanna L

2013-07-01

Abacavir is a nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of human immunodeficiency virus infection as part of a multidrug, highly active antiretroviral therapy regimen. Despite its efficacy, approximately 5% of individuals who receive abacavir develop an immune-mediated hypersensitivity reaction (HSR) that warrants immediate discontinuation of abacavir and switching to an alternative antiretroviral regimen. Abacavir HSR is associated with individuals who carry the *57:01 variant in the human leukocyte antigen B (HLA-B) gene. There is a large volume of evidence to show that those who carry HLA-B*57:01 are at significantly increased risk of developing HSR and should not receive abacavir. Pharmacogenetic screening to ensure individuals who carry HLA-B*57:01 do not receive abacavir can reduce the incidence of HSR and is now considered the standard of care before prescribing abacavir. Genetic testing to prevent abacavir HSR is currently one of the best examples of integrating pharmacogenetic testing into clinical practice. © 2013 Pharmacotherapy Publications, Inc.

Elements of a next generation time-series ASCII data file format for Earth Sciences

NASA Astrophysics Data System (ADS)

Webster, C. J.

2015-12-01

Data in ASCII comma separated value (CSV) format are recognized as the most simple, straightforward and readable type of data present in the geosciences. Many scientific workflows developed over the years rely on data using this simple format. However, there is a need for a lightweight ASCII header format standard that is easy to create and easy to work with. Current OGC grade XML standards are complex and difficult to implement for researchers with few resources. Ideally, such a format should provide the data in CSV for easy consumption by generic applications such as spreadsheets. The format should use an existing time standard. The header should be easily human readable as well as machine parsable. The metadata format should be extendable to allow vocabularies to be adopted as they are created by external standards bodies. The creation of such a format will increase the productivity of software engineers and scientists because fewer translators and checkers would be required. Data in ASCII comma separated value (CSV) format are recognized as the most simple, straightforward and readable type of data present in the geosciences. Many scientific workflows developed over the years rely on data using this simple format. However, there is a need for a lightweight ASCII header format standard that is easy to create and easy to work with. Current OGC grade XML standards are complex and difficult to implement for researchers with few resources. Ideally, such a format would provide the data in CSV for easy consumption by generic applications such as spreadsheets. The format would use existing time standard. The header would be easily human readable as well as machine parsable. The metadata format would be extendable to allow vocabularies to be adopted as they are created by external standards bodies. The creation of such a format would increase the productivity of software engineers and scientists because fewer translators would be required.

Standardized Metadata for Human Pathogen/Vector Genomic Sequences

PubMed Central

Dugan, Vivien G.; Emrich, Scott J.; Giraldo-Calderón, Gloria I.; Harb, Omar S.; Newman, Ruchi M.; Pickett, Brett E.; Schriml, Lynn M.; Stockwell, Timothy B.; Stoeckert, Christian J.; Sullivan, Dan E.; Singh, Indresh; Ward, Doyle V.; Yao, Alison; Zheng, Jie; Barrett, Tanya; Birren, Bruce; Brinkac, Lauren; Bruno, Vincent M.; Caler, Elizabet; Chapman, Sinéad; Collins, Frank H.; Cuomo, Christina A.; Di Francesco, Valentina; Durkin, Scott; Eppinger, Mark; Feldgarden, Michael; Fraser, Claire; Fricke, W. Florian; Giovanni, Maria; Henn, Matthew R.; Hine, Erin; Hotopp, Julie Dunning; Karsch-Mizrachi, Ilene; Kissinger, Jessica C.; Lee, Eun Mi; Mathur, Punam; Mongodin, Emmanuel F.; Murphy, Cheryl I.; Myers, Garry; Neafsey, Daniel E.; Nelson, Karen E.; Nierman, William C.; Puzak, Julia; Rasko, David; Roos, David S.; Sadzewicz, Lisa; Silva, Joana C.; Sobral, Bruno; Squires, R. Burke; Stevens, Rick L.; Tallon, Luke; Tettelin, Herve; Wentworth, David; White, Owen; Will, Rebecca; Wortman, Jennifer; Zhang, Yun; Scheuermann, Richard H.

2014-01-01

High throughput sequencing has accelerated the determination of genome sequences for thousands of human infectious disease pathogens and dozens of their vectors. The scale and scope of these data are enabling genotype-phenotype association studies to identify genetic determinants of pathogen virulence and drug/insecticide resistance, and phylogenetic studies to track the origin and spread of disease outbreaks. To maximize the utility of genomic sequences for these purposes, it is essential that metadata about the pathogen/vector isolate characteristics be collected and made available in organized, clear, and consistent formats. Here we report the development of the GSCID/BRC Project and Sample Application Standard, developed by representatives of the Genome Sequencing Centers for Infectious Diseases (GSCIDs), the Bioinformatics Resource Centers (BRCs) for Infectious Diseases, and the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), informed by interactions with numerous collaborating scientists. It includes mapping to terms from other data standards initiatives, including the Genomic Standards Consortium’s minimal information (MIxS) and NCBI’s BioSample/BioProjects checklists and the Ontology for Biomedical Investigations (OBI). The standard includes data fields about characteristics of the organism or environmental source of the specimen, spatial-temporal information about the specimen isolation event, phenotypic characteristics of the pathogen/vector isolated, and project leadership and support. By modeling metadata fields into an ontology-based semantic framework and reusing existing ontologies and minimum information checklists, the application standard can be extended to support additional project-specific data fields and integrated with other data represented with comparable standards. The use of this metadata standard by all ongoing and future GSCID sequencing projects will provide a consistent representation of these data in the BRC resources and other repositories that leverage these data, allowing investigators to identify relevant genomic sequences and perform comparative genomics analyses that are both statistically meaningful and biologically relevant. PMID:24936976

Standardized metadata for human pathogen/vector genomic sequences.

PubMed

Dugan, Vivien G; Emrich, Scott J; Giraldo-Calderón, Gloria I; Harb, Omar S; Newman, Ruchi M; Pickett, Brett E; Schriml, Lynn M; Stockwell, Timothy B; Stoeckert, Christian J; Sullivan, Dan E; Singh, Indresh; Ward, Doyle V; Yao, Alison; Zheng, Jie; Barrett, Tanya; Birren, Bruce; Brinkac, Lauren; Bruno, Vincent M; Caler, Elizabet; Chapman, Sinéad; Collins, Frank H; Cuomo, Christina A; Di Francesco, Valentina; Durkin, Scott; Eppinger, Mark; Feldgarden, Michael; Fraser, Claire; Fricke, W Florian; Giovanni, Maria; Henn, Matthew R; Hine, Erin; Hotopp, Julie Dunning; Karsch-Mizrachi, Ilene; Kissinger, Jessica C; Lee, Eun Mi; Mathur, Punam; Mongodin, Emmanuel F; Murphy, Cheryl I; Myers, Garry; Neafsey, Daniel E; Nelson, Karen E; Nierman, William C; Puzak, Julia; Rasko, David; Roos, David S; Sadzewicz, Lisa; Silva, Joana C; Sobral, Bruno; Squires, R Burke; Stevens, Rick L; Tallon, Luke; Tettelin, Herve; Wentworth, David; White, Owen; Will, Rebecca; Wortman, Jennifer; Zhang, Yun; Scheuermann, Richard H

2014-01-01

High throughput sequencing has accelerated the determination of genome sequences for thousands of human infectious disease pathogens and dozens of their vectors. The scale and scope of these data are enabling genotype-phenotype association studies to identify genetic determinants of pathogen virulence and drug/insecticide resistance, and phylogenetic studies to track the origin and spread of disease outbreaks. To maximize the utility of genomic sequences for these purposes, it is essential that metadata about the pathogen/vector isolate characteristics be collected and made available in organized, clear, and consistent formats. Here we report the development of the GSCID/BRC Project and Sample Application Standard, developed by representatives of the Genome Sequencing Centers for Infectious Diseases (GSCIDs), the Bioinformatics Resource Centers (BRCs) for Infectious Diseases, and the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), informed by interactions with numerous collaborating scientists. It includes mapping to terms from other data standards initiatives, including the Genomic Standards Consortium's minimal information (MIxS) and NCBI's BioSample/BioProjects checklists and the Ontology for Biomedical Investigations (OBI). The standard includes data fields about characteristics of the organism or environmental source of the specimen, spatial-temporal information about the specimen isolation event, phenotypic characteristics of the pathogen/vector isolated, and project leadership and support. By modeling metadata fields into an ontology-based semantic framework and reusing existing ontologies and minimum information checklists, the application standard can be extended to support additional project-specific data fields and integrated with other data represented with comparable standards. The use of this metadata standard by all ongoing and future GSCID sequencing projects will provide a consistent representation of these data in the BRC resources and other repositories that leverage these data, allowing investigators to identify relevant genomic sequences and perform comparative genomics analyses that are both statistically meaningful and biologically relevant.

XML Based Markup Languages for Specific Domains

NASA Astrophysics Data System (ADS)

Varde, Aparna; Rundensteiner, Elke; Fahrenholz, Sally

A challenging area in web based support systems is the study of human activities in connection with the web, especially with reference to certain domains. This includes capturing human reasoning in information retrieval, facilitating the exchange of domain-specific knowledge through a common platform and developing tools for the analysis of data on the web from a domain expert's angle. Among the techniques and standards related to such work, we have XML, the eXtensible Markup Language. This serves as a medium of communication for storing and publishing textual, numeric and other forms of data seamlessly. XML tag sets are such that they preserve semantics and simplify the understanding of stored information by users. Often domain-specific markup languages are designed using XML, with a user-centric perspective. Standardization bodies and research communities may extend these to include additional semantics of areas within and related to the domain. This chapter outlines the issues to be considered in developing domain-specific markup languages: the motivation for development, the semantic considerations, the syntactic constraints and other relevant aspects, especially taking into account human factors. Illustrating examples are provided from domains such as Medicine, Finance and Materials Science. Particular emphasis in these examples is on the Materials Markup Language MatML and the semantics of one of its areas, namely, the Heat Treating of Materials. The focus of this chapter, however, is not the design of one particular language but rather the generic issues concerning the development of domain-specific markup languages.

Human-rating Automated and Robotic Systems - (How HAL Can Work Safely with Astronauts)

NASA Technical Reports Server (NTRS)

Baroff, Lynn; Dischinger, Charlie; Fitts, David

2009-01-01

Long duration human space missions, as planned in the Vision for Space Exploration, will not be possible without applying unprecedented levels of automation to support the human endeavors. The automated and robotic systems must carry the load of routine housekeeping for the new generation of explorers, as well as assist their exploration science and engineering work with new precision. Fortunately, the state of automated and robotic systems is sophisticated and sturdy enough to do this work - but the systems themselves have never been human-rated as all other NASA physical systems used in human space flight have. Our intent in this paper is to provide perspective on requirements and architecture for the interfaces and interactions between human beings and the astonishing array of automated systems; and the approach we believe necessary to create human-rated systems and implement them in the space program. We will explain our proposed standard structure for automation and robotic systems, and the process by which we will develop and implement that standard as an addition to NASA s Human Rating requirements. Our work here is based on real experience with both human system and robotic system designs; for surface operations as well as for in-flight monitoring and control; and on the necessities we have discovered for human-systems integration in NASA's Constellation program. We hope this will be an invitation to dialog and to consideration of a new issue facing new generations of explorers and their outfitters.

Studying frequency processing of the brain to enhance long-term memory and develop a human brain protocol.

PubMed

Friedrich, Wernher; Du, Shengzhi; Balt, Karlien

2015-01-01

The temporal lobe in conjunction with the hippocampus is responsible for memory processing. The gamma wave is involved with this process. To develop a human brain protocol, a better understanding of the relationship between gamma and long-term memory is vital. A more comprehensive understanding of the human brain and specific analogue waves it uses will support the development of a human brain protocol. Fifty-eight participants aged between 6 and 60 years participated in long-term memory experiments. It is envisaged that the brain could be stimulated through binaural beats (sound frequency) at 40 Hz (gamma) to enhance long-term memory capacity. EEG recordings have been transformed to sound and then to an information standard, namely ASCII. Statistical analysis showed a proportional relationship between long-term memory and gamma activity. Results from EEG recordings indicate a pattern. The pattern was obtained through the de-codification of an EEG recording to sound and then to ASCII. Stimulation of gamma should enhance long term memory capacity. More research is required to unlock the human brains' protocol key. This key will enable the processing of information directly to and from human memory via gamma, the hippocampus and the temporal lobe.

Standardized 3D Bioprinting of Soft Tissue Models with Human Primary Cells.

PubMed

Rimann, Markus; Bono, Epifania; Annaheim, Helene; Bleisch, Matthias; Graf-Hausner, Ursula

2016-08-01

Cells grown in 3D are more physiologically relevant than cells cultured in 2D. To use 3D models in substance testing and regenerative medicine, reproducibility and standardization are important. Bioprinting offers not only automated standardizable processes but also the production of complex tissue-like structures in an additive manner. We developed an all-in-one bioprinting solution to produce soft tissue models. The holistic approach included (1) a bioprinter in a sterile environment, (2) a light-induced bioink polymerization unit, (3) a user-friendly software, (4) the capability to print in standard labware for high-throughput screening, (5) cell-compatible inkjet-based printheads, (6) a cell-compatible ready-to-use BioInk, and (7) standard operating procedures. In a proof-of-concept study, skin as a reference soft tissue model was printed. To produce dermal equivalents, primary human dermal fibroblasts were printed in alternating layers with BioInk and cultured for up to 7 weeks. During long-term cultures, the models were remodeled and fully populated with viable and spreaded fibroblasts. Primary human dermal keratinocytes were seeded on top of dermal equivalents, and epidermis-like structures were formed as verified with hematoxylin and eosin staining and immunostaining. However, a fully stratified epidermis was not achieved. Nevertheless, this is one of the first reports of an integrative bioprinting strategy for industrial routine application. © 2015 Society for Laboratory Automation and Screening.

Medications Development for the Treatment of Alcohol Use Disorder: Insights into the Predictive Value of Animal and Human Laboratory Models

PubMed Central

Yardley, Megan M.; Ray, Lara A.

2016-01-01

Development of effective treatments for alcohol use disorder (AUD) represents an important public health goal. This review provides a summary of completed preclinical and clinical studies testing pharmacotherapies for treatment of AUD. We discuss opportunities for improving the translation from preclinical findings to clinical trial outcomes, focusing on the validity and predictive value of animal and human laboratory models of AUD. Specifically, while preclinical studies of medications development have offered important insights into the neurobiology of the disorder and alcohol's molecular targets, limitations include the lack of standardized methods and streamlined processes whereby animal studies can readily inform human studies. Behavioral pharmacology studies provide a less expensive and valuable opportunity to assess the feasibility of a pharmacotherapy prior to initiating larger scale clinical trials by providing insights into the mechanism of the drug, which can then inform recruitment, analyses, and assessments. Summary tables are provided to illustrate the wide range of preclinical, human laboratory, and clinical studies of medications development for alcoholism. Taken together, this review highlights the challenges associated with animal paradigms, human laboratory studies and clinical trials with the overarching goal of advancing treatment development and highlighting opportunities to bridge the gap between preclinical and clinical research. PMID:26833803

10 CFR 63.322 - Human intrusion scenario.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Human intrusion scenario. 63.322 Section 63.322 Energy... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Postclosure Public Health and Environmental Standards Human Intrusion Standard § 63.322 Human intrusion scenario. For the purposes of the analysis of human intrusion, DOE must...

40 CFR 197.26 - What are the circumstances of the human intrusion?

Code of Federal Regulations, 2010 CFR

2010-07-01

... human intrusion? 197.26 Section 197.26 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... YUCCA MOUNTAIN, NEVADA Public Health and Environmental Standards for Disposal Human-Intrusion Standard § 197.26 What are the circumstances of the human intrusion? For the purposes of the analysis of human...

High-throughput identification of small molecules that affect human embryonic vascular development

PubMed Central

Vazão, Helena; Rosa, Susana; Barata, Tânia; Costa, Ricardo; Pitrez, Patrícia R.; Honório, Inês; de Vries, Margreet R.; Papatsenko, Dimitri; Benedito, Rui; Saris, Daniel; Khademhosseini, Ali; Quax, Paul H. A.; Pereira, Carlos F.; Mercader, Nadia; Ferreira, Lino

2017-01-01

Birth defects, which are in part caused by exposure to environmental chemicals and pharmaceutical drugs, affect 1 in every 33 babies born in the United States each year. The current standard to screen drugs that affect embryonic development is based on prenatal animal testing; however, this approach yields low-throughput and limited mechanistic information regarding the biological pathways and potential adverse consequences in humans. To develop a screening platform for molecules that affect human embryonic development based on endothelial cells (ECs) derived from human pluripotent stem cells, we differentiated human pluripotent stem cells into embryonic ECs and induced their maturation under arterial flow conditions. These cells were then used to screen compounds that specifically affect embryonic vasculature. Using this platform, we have identified two compounds that have higher inhibitory effect in embryonic than postnatal ECs. One of them was fluphenazine (an antipsychotic), which inhibits calmodulin kinase II. The other compound was pyrrolopyrimidine (an antiinflammatory agent), which inhibits vascular endothelial growth factor receptor 2 (VEGFR2), decreases EC viability, induces an inflammatory response, and disrupts preformed vascular networks. The vascular effect of the pyrrolopyrimidine was further validated in prenatal vs. adult mouse ECs and in embryonic and adult zebrafish. We developed a platform based on human pluripotent stem cell-derived ECs for drug screening, which may open new avenues of research for the study and modulation of embryonic vasculature. PMID:28348206

High-throughput identification of small molecules that affect human embryonic vascular development.

PubMed

Vazão, Helena; Rosa, Susana; Barata, Tânia; Costa, Ricardo; Pitrez, Patrícia R; Honório, Inês; de Vries, Margreet R; Papatsenko, Dimitri; Benedito, Rui; Saris, Daniel; Khademhosseini, Ali; Quax, Paul H A; Pereira, Carlos F; Mercader, Nadia; Fernandes, Hugo; Ferreira, Lino

2017-04-11

Birth defects, which are in part caused by exposure to environmental chemicals and pharmaceutical drugs, affect 1 in every 33 babies born in the United States each year. The current standard to screen drugs that affect embryonic development is based on prenatal animal testing; however, this approach yields low-throughput and limited mechanistic information regarding the biological pathways and potential adverse consequences in humans. To develop a screening platform for molecules that affect human embryonic development based on endothelial cells (ECs) derived from human pluripotent stem cells, we differentiated human pluripotent stem cells into embryonic ECs and induced their maturation under arterial flow conditions. These cells were then used to screen compounds that specifically affect embryonic vasculature. Using this platform, we have identified two compounds that have higher inhibitory effect in embryonic than postnatal ECs. One of them was fluphenazine (an antipsychotic), which inhibits calmodulin kinase II. The other compound was pyrrolopyrimidine (an antiinflammatory agent), which inhibits vascular endothelial growth factor receptor 2 (VEGFR2), decreases EC viability, induces an inflammatory response, and disrupts preformed vascular networks. The vascular effect of the pyrrolopyrimidine was further validated in prenatal vs. adult mouse ECs and in embryonic and adult zebrafish. We developed a platform based on human pluripotent stem cell-derived ECs for drug screening, which may open new avenues of research for the study and modulation of embryonic vasculature.

Assessing the Mechanisms of MDS and Its Transformation to Leukemia in a Novel Humanized Mouse

DTIC Science & Technology

2016-05-01

achievements N/A References N/A References: 1. Rongvaux, A., et al., Development and function of human innate immune cells in a...in cancer survivors. MDS is inherently difficult to study. MDS stem cells cannot be grown in culture and in vivo models are thus the gold standard...However, MDS stem cells are diseased and fail to efficiently engraft in current immunodeficient mouse models. We have optimized engraftment of

Simultaneous determination of acetaminophen and dihydrocodeine in human plasma by UPLC-MS/MS: Its pharmacokinetic application.

PubMed

Qiu, Xiangjun; Lou, Dan; Su, Ding; Liu, Zebin; Gao, Pengtao; Zhang, Nan-sheng

2015-06-15

An ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method was developed and validated to determine acetaminophen (AAP) and dihydrocodeine (DHC) in human plasma simultaneously. Plasma samples were prepared using protein precipitation with acetonitrile, the two analytes and the internal standard midazolam were separated on an Acquity UPLC BEH C18 column and mass spectrometric analysis was performed using a QTrap5500 mass spectrometer coupled with an electro-spray ionization (ESI) source in the positive ion mode. The MRM transitions of m/z 151.2→110.0 and m/z 302.3→199.2 were used to quantify for AAP and DHC, respectively. The linearity of this method was found to be within the concentration range of 50-10000ng/mL for AAP, and 1-100ng/mL for DHC in human plasma, respectively. The lower limit of quantification (LLOQ) was 50ng/mL and 1ng/mL for AAP and DHC in human plasma, respectively. The relative standard deviations (RSD) of intra and inter precision were less than 10% for both AAP and DHC. The analysis time of per sample was 1.0min. The developed and validated method was successfully applied to a pharmacokinetic study of AAP (500mg) with DHC (20mg) capsule in Chinese healthy volunteers (N=20). Copyright © 2015 Elsevier B.V. All rights reserved.

The knowns and unknowns of human milk banking.

PubMed

Simmer, Karen

2011-01-01

The provision of donor human milk instead of formula is an important contribution to the nutrition and protection from infections for preterm infants. Systematic reviews suggest a lower risk of necrotizing enterocolitis with pasteurized donor human milk (PDHM) as opposed to artificial formula, although evidence supporting PDHM use from randomized control trials is limited. Human milk banks (HMBs) must have a risk management system to maintain a safe product especially as many operate in an unregulated environment. To ensure safety, the HMB in Australia has committed to meet the appropriate standards recommended in the Code of Good Manufacturing Practices (Blood and Tissues) and models risk management during processing on Codex HACCP (Hazard Analysis Critical Control Point) requirements. There is scope to continually reevaluate the screening of donors and quality standards recommended during HMB. This will be most effective if strong networks of HMBs are developed with regional reference laboratories to encourage compliance with safety guidelines. Further research and development is needed to refine technology for treating donor milk such as thermal ultrasound and ultraviolet light, aimed at the retention of full bioactivity. HMB networks will facilitate collection of evidence for refining HMB practice which should translate to improved outcomes for preterm and sick infants. Cost effectiveness is most likely when HMBs are associated with large neonatal intensive care units. Copyright © 2011 S. Karger AG, Basel.

Design of a visible-light spectroscopy clinical tissue oximeter.

PubMed

Benaron, David A; Parachikov, Ilian H; Cheong, Wai-Fung; Friedland, Shai; Rubinsky, Boris E; Otten, David M; Liu, Frank W H; Levinson, Carl J; Murphy, Aileen L; Price, John W; Talmi, Yair; Weersing, James P; Duckworth, Joshua L; Hörchner, Uwe B; Kermit, Eben L

2005-01-01

We develop a clinical visible-light spectroscopy (VLS) tissue oximeter. Unlike currently approved near-infrared spectroscopy (NIRS) or pulse oximetry (SpO2%), VLS relies on locally absorbed, shallow-penetrating visible light (475 to 625 nm) for the monitoring of microvascular hemoglobin oxygen saturation (StO2%), allowing incorporation into therapeutic catheters and probes. A range of probes is developed, including noncontact wands, invasive catheters, and penetrating needles with injection ports. Data are collected from: 1. probes, standards, and reference solutions to optimize each component; 2. ex vivo hemoglobin solutions analyzed for StO2% and pO2 during deoxygenation; and 3. human subject skin and mucosal tissue surfaces. Results show that differential VLS allows extraction of features and minimization of scattering effects, in vitro VLS oximetry reproduces the expected sigmoid hemoglobin binding curve, and in vivo VLS spectroscopy of human tissue allows for real-time monitoring (e.g., gastrointestinal mucosal saturation 69+/-4%, n=804; gastrointestinal tumor saturation 45+/-23%, n=14; and p<0.0001), with reproducible values and small standard deviations (SDs) in normal tissues. FDA approved VLS systems began shipping earlier this year. We conclude that VLS is suitable for the real-time collection of spectroscopic and oximetric data from human tissues, and that a VLS oximeter has application to the monitoring of localized subsurface hemoglobin oxygen saturation in the microvascular tissue spaces of human subjects.

ASK Talks with Dennis Grounds

NASA Technical Reports Server (NTRS)

2003-01-01

Dennis Grounds recently finished a one-year assignment at NASA Headquarters in the Office of Bioastronautics as the Acting Flight Program Manager He has returned to Johnson Space Center (JSC), where he is Director of the International Space Station Bioastronautics Research Program Office with the NASA Life Sciences Projects Division. Under his management, the Human Research Facility (HRF) was developed to support a broad range of scientific investigations pertaining to human adaptation to the spaceflight environment and issues of human space exploration. The HRF rack was developed to international standards in order to be compatible with payloads developed anywhere in the world, thereby streamlining the process of getting payloads on the Space Station. Grounds has worked with NASA for more than 15 years. Prior to joining ISS, he worked with General Electric as a manager of payloads and analysis in support of the NASA Life Science Projects Division at JSC. ASK spoke with Grounds in Washington, D.C., during his Headquarters assignment.

Development and Application of Health-Based Screening Levels for Use in Water-Quality Assessments

USGS Publications Warehouse

Toccalino, Patricia L.

2007-01-01

Health-Based Screening Levels (HBSLs) are non-enforceable water-quality benchmarks that were developed by the U.S. Geological Survey in collaboration with the U.S. Environmental Protection Agency (USEPA) and others. HBSLs supplement existing Federal drinking-water standards and guidelines, thereby providing a basis for a more comprehensive evaluation of contaminant-occurrence data in the context of human health. Since the original methodology used to calculate HBSLs for unregulated contaminants was published in 2003, revisions have been made to the HBSL methodology in order to reflect updates to relevant USEPA policies. These revisions allow for the use of the most recent, USEPA peer-reviewed, publicly available human-health toxicity information in the development of HBSLs. This report summarizes the revisions to the HBSL methodology for unregulated contaminants, and updates the guidance on the use of HBSLs for interpreting water-quality data in the context of human health.

A UML profile for the OBO relation ontology.

PubMed

Guardia, Gabriela D A; Vêncio, Ricardo Z N; de Farias, Cléver R G

2012-01-01

Ontologies have increasingly been used in the biomedical domain, which has prompted the emergence of different initiatives to facilitate their development and integration. The Open Biological and Biomedical Ontologies (OBO) Foundry consortium provides a repository of life-science ontologies, which are developed according to a set of shared principles. This consortium has developed an ontology called OBO Relation Ontology aiming at standardizing the different types of biological entity classes and associated relationships. Since ontologies are primarily intended to be used by humans, the use of graphical notations for ontology development facilitates the capture, comprehension and communication of knowledge between its users. However, OBO Foundry ontologies are captured and represented basically using text-based notations. The Unified Modeling Language (UML) provides a standard and widely-used graphical notation for modeling computer systems. UML provides a well-defined set of modeling elements, which can be extended using a built-in extension mechanism named Profile. Thus, this work aims at developing a UML profile for the OBO Relation Ontology to provide a domain-specific set of modeling elements that can be used to create standard UML-based ontologies in the biomedical domain.

Using human rights for sexual and reproductive health: improving legal and regulatory frameworks

PubMed Central

Kismodi, Eszter; Hilber, Adriane Martin; Lincetto, Ornella; Stahlhofer, Marcus; Gruskin, Sofia

2010-01-01

Abstract This paper describes the development of a tool that uses human rights concepts and methods to improve relevant laws, regulations and policies related to sexual and reproductive health. This tool aims to improve awareness and understanding of States’ human rights obligations. It includes a method for systematically examining the status of vulnerable groups, involving non-health sectors, fostering a genuine process of civil society participation and developing recommendations to address regulatory and policy barriers to sexual and reproductive health with a clear assignment of responsibility. Strong leadership from the ministry of health, with support from the World Health Organization or other international partners, and the serious engagement of all involved in this process can strengthen the links between human rights and sexual and reproductive health, and contribute to national achievement of the highest attainable standard of health. PMID:20616975

Development and human factors analysis of neuronavigation vs. augmented reality.

PubMed

Pandya, Abhilash; Siadat, Mohammad-Reza; Auner, Greg; Kalash, Mohammad; Ellis, R Darin

2004-01-01

This paper is focused on the human factors analysis comparing a standard neuronavigation system with an augmented reality system. We use a passive articulated arm (Microscribe, Immersion technology) to track a calibrated end-effector mounted video camera. In real time, we superimpose the live video view with the synchronized graphical view of CT-derived segmented object(s) of interest within a phantom skull. Using the same robotic arm, we have developed a neuronavigation system able to show the end-effector of the arm on orthogonal CT scans. Both the AR and the neuronavigation systems have been shown to be within 3mm of accuracy. A human factors study was conducted in which subjects were asked to draw craniotomies and answer questions to gage their understanding of the phantom objects. The human factors study included 21 subjects and indicated that the subjects performed faster, with more accuracy and less errors using the Augmented Reality interface.

Unmanned Aircraft Systems (UAS) Integration in the National Airspace System (NAS) Project: Detect and Avoid Display Evaluations in Support of SC-228 Minimum Operational Performance Standards Development

NASA Technical Reports Server (NTRS)

Fern, Lisa Carolynn

2017-01-01

The primary activity for the UAS-NAS Human Systems Integration (HSI) sub-project in Phase 1 was support of RTCA Special Committee 228 Minimum Operational Performance Standards (MOPS). We provide data on the effect of various Detect and Avoid (DAA) display features with respect to pilot performance of the remain well clear function in order to determine the minimum requirements for DAA displays.

Evidence based herbal drug standardization approach in coping with challenges of holistic management of diabetes: a dreadful lifestyle disorder of 21st century

PubMed Central

2013-01-01

Plants by virtue of its composition of containing multiple constituents developed during its growth under various environmental stresses providing a plethora of chemical families with medicinal utility. Researchers are exploring this wealth and trying to decode its utility for enhancing health standards of human beings. Diabetes is dreadful lifestyle disorder of 21st century caused due to lack of insulin production or insulin physiological unresponsiveness. The chronic impact of untreated diabetes significantly affects vital organs. The allopathic medicines have five classes of drugs, or otherwise insulin in Type I diabetes, targeting insulin secretion, decreasing effect of glucagon, sensitization of receptors for enhanced glucose uptake etc. In addition, diet management, increased food fiber intake, Resistant Starch intake and routine exercise aid in managing such dangerous metabolic disorder. One of the key factors that limit commercial utility of herbal drugs is standardization. Standardization poses numerous challenges related to marker identification, active principle(s), lack of defined regulations, non-availability of universally acceptable technical standards for testing and implementation of quality control/safety standard (toxicological testing). The present study proposed an integrated herbal drug development & standardization model which is an amalgamation of Classical Approach of Ayurvedic Therapeutics, Reverse Pharmacological Approach based on Observational Therapeutics, Technical Standards for complete product cycle, Chemi-informatics, Herbal Qualitative Structure Activity Relationship and Pharmacophore modeling and, Post-Launch Market Analysis. Further studies are warranted to ensure that an effective herbal drug standardization methodology will be developed, backed by a regulatory standard guide the future research endeavors in more focused manner. PMID:23822656

Evidence based herbal drug standardization approach in coping with challenges of holistic management of diabetes: a dreadful lifestyle disorder of 21st century.

PubMed

Chawla, Raman; Thakur, Pallavi; Chowdhry, Ayush; Jaiswal, Sarita; Sharma, Anamika; Goel, Rajeev; Sharma, Jyoti; Priyadarshi, Smruti Sagar; Kumar, Vinod; Sharma, Rakesh Kumar; Arora, Rajesh

2013-07-04

Plants by virtue of its composition of containing multiple constituents developed during its growth under various environmental stresses providing a plethora of chemical families with medicinal utility. Researchers are exploring this wealth and trying to decode its utility for enhancing health standards of human beings. Diabetes is dreadful lifestyle disorder of 21st century caused due to lack of insulin production or insulin physiological unresponsiveness. The chronic impact of untreated diabetes significantly affects vital organs. The allopathic medicines have five classes of drugs, or otherwise insulin in Type I diabetes, targeting insulin secretion, decreasing effect of glucagon, sensitization of receptors for enhanced glucose uptake etc. In addition, diet management, increased food fiber intake, Resistant Starch intake and routine exercise aid in managing such dangerous metabolic disorder. One of the key factors that limit commercial utility of herbal drugs is standardization. Standardization poses numerous challenges related to marker identification, active principle(s), lack of defined regulations, non-availability of universally acceptable technical standards for testing and implementation of quality control/safety standard (toxicological testing). The present study proposed an integrated herbal drug development & standardization model which is an amalgamation of Classical Approach of Ayurvedic Therapeutics, Reverse Pharmacological Approach based on Observational Therapeutics, Technical Standards for complete product cycle, Chemi-informatics, Herbal Qualitative Structure Activity Relationship and Pharmacophore modeling and, Post-Launch Market Analysis. Further studies are warranted to ensure that an effective herbal drug standardization methodology will be developed, backed by a regulatory standard guide the future research endeavors in more focused manner.

Implied Maximum Dose Analysis of Standard Values of 25 Pesticides Based on Major Human Exposure Pathways

PubMed Central

Li, Zijian; Jennings, Aaron A.

2017-01-01

Worldwide jurisdictions are making efforts to regulate pesticide standard values in residential soil, drinking water, air, and agricultural commodity to lower the risk of pesticide impacts on human health. Because human may exposure to pesticides from many ways, such as ingestion, inhalation, and dermal contact, it is important to examine pesticide standards by considering all major exposure pathways. Analysis of implied maximum dose limits for commonly historical and current used pesticides was adopted in this study to examine whether worldwide pesticide standard values are enough to prevent human health impact or not. Studies show that only U.S. has regulated pesticides standard in the air. Only 4% of the total number of implied maximum dose limits is based on three major exposures. For Chlorpyrifos, at least 77.5% of the total implied maximum dose limits are above the acceptable daily intake. It also shows that most jurisdictions haven't provided pesticide standards in all major exposures yet, and some of the standards are not good enough to protect human health. PMID:29546224

Polarization sensitive optical low-coherence reflectometry for blood glucose monitoring in human subjects

NASA Astrophysics Data System (ADS)

Solanki, Jitendra; Choudhary, Om Prakash; Sen, P.; Andrews, J. T.

2013-07-01

A device based on polarization sensitive optical low-coherence reflectometry is developed to monitor blood glucose levels in human subjects. The device was initially tested with tissue phantom. The measurements with human subjects for various glucose concentration levels are found to be linearly dependent on the ellipticity obtainable from the home-made phase-sensitive optical low-coherence reflectometry device. The linearity obtained between glucose concentration and ellipticity are explained with theoretical calculations using Mie theory. A comparison of results with standard clinical methods establishes the utility of the present device for non-invasive glucose monitoring.

Lunar architecture and urbanism

NASA Astrophysics Data System (ADS)

Sherwood, Brent

1992-09-01

Human civilization and architecture have defined each other for over 5000 years on Earth. Even in the novel environment of space, persistent issues of human urbanism will eclipse, within a historically short time, the technical challenges of space settlement that dominate our current view. By adding modern topics in space engineering, planetology, life support, human factors, material invention, and conservation to their already renaissance array of expertise, urban designers can responsibly apply ancient, proven standards to the exciting new opportunities afforded by space. Inescapable facts about the Moon set real boundaries within which tenable lunar urbanism and its component architecture must eventually develop.

Lunar architecture and urbanism

NASA Technical Reports Server (NTRS)

Sherwood, Brent

1992-01-01

Human civilization and architecture have defined each other for over 5000 years on Earth. Even in the novel environment of space, persistent issues of human urbanism will eclipse, within a historically short time, the technical challenges of space settlement that dominate our current view. By adding modern topics in space engineering, planetology, life support, human factors, material invention, and conservation to their already renaissance array of expertise, urban designers can responsibly apply ancient, proven standards to the exciting new opportunities afforded by space. Inescapable facts about the Moon set real boundaries within which tenable lunar urbanism and its component architecture must eventually develop.

Challenges of Biobanking in South Africa to Facilitate Indigenous Research in an Environment Burdened with Human Immunodeficiency Virus, Tuberculosis, and Emerging Noncommunicable Diseases

PubMed Central

Christoffels, Alan; Grewal, Ravnit; Karam, Locunda A.; Rossouw, Catherine; Staunton, Ciara; Swanepoel, Carmen; van Rooyen, Beverley

2013-01-01

The high burden of infectious diseases and the growing problem of noncommunicable and metabolic disease syndromes in South Africa (SA) forces a more focused research approach to facilitate cutting-edge scientific growth and public health development. Increased SA research on these diseases and syndromes and the collection of associated biospecimens has ensured a plethora of biobanks created by individuals, albeit without the foresight of prospective and collective use by other local and international researchers. As the need for access to high-quality specimens in statistically relevant numbers has increased, so has the necessity for the development of national human biobanks in SA and across the Continent. The prospects of achieving sustainable centralized biobanks are still an emerging and evolving concept, primarily and recently driven by the launch of the H3Africa consortium, which includes the development of harmonized and standardized biobanking operating procedures. This process is hindered by a myriad of complex societal considerations and ethico-legal challenges. Efforts to consolidate and standardize biological sample collections are further compromised by the lack of full appreciation by national stakeholders of the biological value inherent in these collections, and the availability of high quality human samples with well-annotated data for future scientific research and development. Inadequate or nonexistent legislative structures that specifically regulate the storage, use, dispersal, and disposal of human biological samples are common phenomena and pose further challenges. Furthermore, concerns relating to consent for unspecified future uses, as well as access to information and data protection, are all new paradigms that require further consideration and public engagement. This article reviews important fundamental issues such as governance, ethics, infrastructure, and bioinformatics that are important foundational prerequisites for the establishment and evolution of successful human biobanking in South Africa. PMID:24835364

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

PubMed Central

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

Total brain death: a reply to Alan Shewmon.

PubMed

Lee, Patrick; GriseZ, Germain

2012-06-01

D. Alan Shewmon has advanced a well-documented challenge to the widely accepted total brain death criterion for death of the human being. We show that Shewmon’s argument against this criterion is unsound, though he does refute the standard argument for that criterion. We advance a distinct argument for the total brain death criterion and answer likely objections. Since human beings are rational animals--sentient organisms of a specific type--the loss of the radical capacity for sentience (the capacity to sense or to develop the capacity to sense) involves a substantial change, the passing away of the human organism. In human beings total brain death involves the complete loss of the radical capacity for sentience, and so in human beings total brain death is death.

Cognitive Aspects of Power in a Two-Level Game

NASA Astrophysics Data System (ADS)

Juvina, Ion; Lebiere, Christian; Martin, Jolie; Gonzalez, Cleotilde

The Intergroup Prisoner's Dilemma with Intragroup Power Dynamics (IPD^2) is a new game paradigm for studying human behavior in conflict situations. IPD^2 adds the concept of intragroup power to an intergroup version of the standard Iterated Prisoner's Dilemma game. We conducted an exploratory laboratory study in which individual human participants played the game against computer strategies of various complexities. We also developed a cognitive model of human decision making in this game. The model was run in place of the human participant under the same conditions as in the laboratory study. Results from the human study and the model simulations are presented and discussed, emphasizing the value of including intragroup power in game theoretic models of conflict.

Development of anti-slip sustainable tiles from agricultural waste

NASA Astrophysics Data System (ADS)

Zulkefli, Zainordin Firdaus; Zainol, Mohd Remy Rozainy Mohd Arif; Osman, Norhayati

2017-04-01

In general of 80% the human activities is located in the building. Buildings constructed should be in line with full functions and optimum safety features. Aspects to be emphasized is the slip on the floor of the building. The selection of tiles must have anti-slip characteristics and achieve standard strength stress. This study is conducted to develop anti-slip tiles modification using agricultural waste. The material used is agricultural waste such rice husks, palm fibre and saw dusk mixed into the clay and then baked at a temperature of 900-1185 C °. Agricultural waste mixture ratio is 5%, 10% and 15%. The samples of tiles are produced for experiments. The results of agricultural waste tiles show that the strength is higher than standard strength, the water absorption less than standard tiles and pendulum value test is exceeds 36.

JPRS Report, Science & Technology, China.

DTIC Science & Technology

1992-12-08

impor- tance of the computer information industry to the develop- ment of the national economy and the people’s standard of living. Forecasts call...past several years, and the application of computers has permeated every trade and industry , providing powerful SCIENCE & TECHNOLOGY POLICY JPRS...system and ample human talent; market potential is large; and it has potential for low cost develop- ment. However, the scale of its industrial

Human genomic DNA quantitation system, H-Quant: development and validation for use in forensic casework.

PubMed

Shewale, Jaiprakash G; Schneida, Elaine; Wilson, Jonathan; Walker, Jerilyn A; Batzer, Mark A; Sinha, Sudhir K

2007-03-01

The human DNA quantification (H-Quant) system, developed for use in human identification, enables quantitation of human genomic DNA in biological samples. The assay is based on real-time amplification of AluYb8 insertions in hominoid primates. The relatively high copy number of subfamily-specific Alu repeats in the human genome enables quantification of very small amounts of human DNA. The oligonucleotide primers present in H-Quant are specific for human DNA and closely related great apes. During the real-time PCR, the SYBR Green I dye binds to the DNA that is synthesized by the human-specific AluYb8 oligonucleotide primers. The fluorescence of the bound SYBR Green I dye is measured at the end of each PCR cycle. The cycle at which the fluorescence crosses the chosen threshold correlates to the quantity of amplifiable DNA in that sample. The minimal sensitivity of the H-Quant system is 7.6 pg/microL of human DNA. The amplicon generated in the H-Quant assay is 216 bp, which is within the same range of the common amplifiable short tandem repeat (STR) amplicons. This size amplicon enables quantitation of amplifiable DNA as opposed to a quantitation of degraded or nonamplifiable DNA of smaller sizes. Development and validation studies were performed on the 7500 real-time PCR system following the Quality Assurance Standards for Forensic DNA Testing Laboratories.

Toward a harmonized approach to animal welfare law in Canada.

PubMed

Fraser, David; Koralesky, Katherine E; Urton, Geoff

2018-03-01

Animal protection law in Canada varies across the country. Federal animal protection law exists in the Criminal Code, in regulations for the transport of animals, and in regulations for humane handling and slaughter at abattoirs that are inspected by the Canadian Food Inspection Agency. Provincial animal protection laws often include provisions that i) describe a duty of care toward animals; ii) prohibit causing or permitting animal "distress;" iii) specify exemptions from prosecution; and iv) reference various national and other standards. Inconsistencies lead to duplication of effort, create difficulty in working across jurisdictions, and may erode public trust. A more consistent approach might be achieved by i) referencing a common suite of standards in provincial statutes; ii) citing the federal transport and humane slaughter regulations in provincial regulations; iii) establishing agreements so provincial authorities may enforce federal regulations; iv) wider and more uniform adoption of enforcement tools that require people to take immediate action to protect animal welfare; v) developing new standards; and vi) national consultation to define frequently used terms.

Fluorescein isothiocyanate-labeled human plasma fibronectin in extracellular matrix remodeling.

PubMed

Hoffmann, Celine; Leroy-Dudal, Johanne; Patel, Salima; Gallet, Olivier; Pauthe, Emmanuel

2008-01-01

Fluorescein isothiocyanate (FITC) is a well-known probe for labeling biologically relevant proteins. However, the impact of the labeling procedure on protein structure and biological activities remains unclear. In this work, FITC-labeled human plasma fibronectin (Fn) was developed to gain insight into the dynamic relationship between cells and Fn. The similarities and differences concerning the structure and function between Fn-FITC and standard Fn were evaluated using biochemical as well as cellular approaches. By varying the FITC/Fn ratio, we demonstrated that overlabeling (>10 FITC molecules/Fn molecule) induces probe fluorescence quenching, protein aggregation, and cell growth modifications. A correct balance between reliable fluorescence for detection and no significant modifications to structure and biological function compared with standard Fn was obtained with a final ratio of 3 FITC molecules per Fn molecule (Fn-FITC3). Fn-FITC3, similar to standard Fn, is correctly recruited into the cell matrix network. Also, Fn-FITC3 is proposed to be a powerful molecular tool to investigate Fn organization and cellular behavior concomitantly.

New method for determination of ten pesticides in human blood.

PubMed

García-Repetto, R; Giménez, M P; Repetto, M

2001-01-01

An analytical method was developed for precise identification and quantitation of 10 pesticides in human blood. The pesticides studied, which have appeared frequently in actual cases, were endosulfan, lindane, parathion, ethyl-azinphos, diazinon, malathion, alachlor, tetradifon, fenthion and dicofol (o-p' and p-p' isomers). The current method replaces an earlier method which involved liquid-liquid extraction with a mixture of n-hexane-benzene (1 + 1). The extraction is performed by solid-phase extraction, with C18 cartridges and 2 internal standards, perthane and triphenylphosphate. Eluates were analyzed by gas chromatography (GC) with nitrogen-phosphorus and electrochemical detectors. Results were confirmed by GC-mass spectrometry in the electron impact mode. Blood blank samples spiked with 2 standard mixtures and an internal standard were used for quantitation. Mean recoveries ranged from 71.83 to 97.10%. Detection and quantitation limits are reported for each pesticide. Examples are provided to show the application of the present method to actual samples.

Standardization of an in vitro Model for Evaluating the Bioavailability of Topically Applied Compounds on Damaged Skin: Application to Sunscreen Analysis.

PubMed

Jacques-Jamin, Carine; Jeanjean-Miquel, Corinne; Domergue, Anaïs; Bessou-Touya, Sandrine; Duplan, Hélène

2017-01-01

Information is lacking on the dermal penetration of topically applied formulations on in vitro skin models, under conditions where the stratum corneum (SC) is damaged. Therefore, we have developed a standardized in vitro barrier-disrupted skin model using tape stripping. Different tape stripping conditions were evaluated using histology, transepidermal water loss, infrared densitometry, and caffeine absorption. The effects of tape stripping were comparable using pig and human skin. Optimized conditions were used to test the effect of SC damage and UV irradiation on the absorption of an UV filter combination present in a sunscreen. The bioavailability of the filters was extremely low regardless of the extent of skin damage, suggesting bioavailability would not be increased if the consumer applied the sunscreen to sun-damaged skin. This standardized in vitro methodology using pig or human skin for damaged skin will add valuable information for the safety assessment of topically applied products. © 2017 S. Karger AG, Basel.

‘THE NECESSITY MUST BE CONVINCINGLY SHOWN TO EXIST’: STANDARDS FOR COMPULSORY TREATMENT FOR MENTAL DISORDER UNDER THE MENTAL HEALTH ACT 1983

PubMed Central

Bartlett, Peter

2011-01-01

Current English law has few controls on the involuntary treatment of persons detained under the Mental Health Act 1983. In 2001, R (Wilkinson) v. Broadmoor Special Hospital Authority provided some hope that, in conjunction with the Human Rights Act and the European Convention on Human Rights (ECHR), meaningful substantive and procedural standards for compulsory psychiatric treatment might be developed, but that hope has not been fulfilled. Using Wilkinson and the ECHR jurisprudence as a starting point, this article considers when, if at all, compulsory psychiatric treatment might be justified. In particular, it considers the difference between the ‘appropriateness’ standard of the English legislation and the ECHR requirement of ‘therapeutic necessity’, the requirements for appropriate procedure and appropriate legislative clarity, how the courts should deal with disagreements among treating physicians, and the relevance of the capacity and best interests of the detained person. PMID:22057417

An Approach to Developing Numeric Water Quality Criteria for Using the SeaWiFS Satellite Data Record

EPA Science Inventory

Human activities on land increase nutrient loads to coastal waters, which can increase phytoplankton production and biomass and associated ecological impacts. Numeric nutrient water quality standards were needed to protect coastal waters from eutrophication impacts. The Environm...

45 CFR 1308.4 - Purpose and scope of disabilities service plan.

Code of Federal Regulations, 2010 CFR

2010-10-01

... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR CHILDREN, YOUTH AND FAMILIES, HEAD START PROGRAM HEAD START PROGRAM PERFORMANCE STANDARDS ON SERVICES FOR CHILDREN WITH... strategies for meeting the special needs of children with disabilities and their parents. The purposes of...

45 CFR 1308.4 - Purpose and scope of disabilities service plan.

Code of Federal Regulations, 2014 CFR

2014-10-01

... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR CHILDREN, YOUTH AND FAMILIES, HEAD START PROGRAM HEAD START PROGRAM PERFORMANCE STANDARDS ON SERVICES FOR CHILDREN WITH... strategies for meeting the special needs of children with disabilities and their parents. The purposes of...

45 CFR 1308.4 - Purpose and scope of disabilities service plan.

Code of Federal Regulations, 2013 CFR

2013-10-01

... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR CHILDREN, YOUTH AND FAMILIES, HEAD START PROGRAM HEAD START PROGRAM PERFORMANCE STANDARDS ON SERVICES FOR CHILDREN WITH... strategies for meeting the special needs of children with disabilities and their parents. The purposes of...

45 CFR 1308.4 - Purpose and scope of disabilities service plan.

Code of Federal Regulations, 2012 CFR

2012-10-01

... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR CHILDREN, YOUTH AND FAMILIES, HEAD START PROGRAM HEAD START PROGRAM PERFORMANCE STANDARDS ON SERVICES FOR CHILDREN WITH... strategies for meeting the special needs of children with disabilities and their parents. The purposes of...

45 CFR 1308.4 - Purpose and scope of disabilities service plan.

Code of Federal Regulations, 2011 CFR

2011-10-01

... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR CHILDREN, YOUTH AND FAMILIES, HEAD START PROGRAM HEAD START PROGRAM PERFORMANCE STANDARDS ON SERVICES FOR CHILDREN WITH... strategies for meeting the special needs of children with disabilities and their parents. The purposes of...

The Case for Forensic Toxicology

ERIC Educational Resources Information Center

Baker, William P.; DeBeus, Elizabeth; Jones, Carleton

2006-01-01

Understanding natural and human-induced hazards is an important part of the standards-based science curriculum. Experience, however, indicates that the topic is a difficult one for many students. We have developed an exciting investigative laboratory exercise that uses simulated food-based case studies to promote critical thinking and improve…

A Comprehensive Analysis of High School Genetics Standards: Are States Keeping Pace with Modern Genetics?

PubMed Central

Dougherty, M.J.; Pleasants, C.; Solow, L.; Wong, A.; Zhang, H.

2011-01-01

Science education in the United States will increasingly be driven by testing and accountability requirements, such as those mandated by the No Child Left Behind Act, which rely heavily on learning outcomes, or “standards,” that are currently developed on a state-by-state basis. Those standards, in turn, drive curriculum and instruction. Given the importance of standards to teaching and learning, we investigated the quality of life sciences/biology standards with respect to genetics for all 50 states and the District of Columbia, using core concepts developed by the American Society of Human Genetics as normative benchmarks. Our results indicate that the states’ genetics standards, in general, are poor, with more than 85% of the states receiving overall scores of Inadequate. In particular, the standards in virtually every state have failed to keep pace with changes in the discipline as it has become genomic in scope, omitting concepts related to genetic complexity, the importance of environment to phenotypic variation, differential gene expression, and the differences between inherited and somatic genetic disease. Clearer, more comprehensive genetics standards are likely to benefit genetics instruction and learning, help prepare future genetics researchers, and contribute to the genetic literacy of the U.S. citizenry. PMID:21885828

Cookstove Laboratory Research - Fiscal Year 2016 Report ...

EPA Pesticide Factsheets

This report provides an overview of the work conducted by the EPA cookstove laboratory research team in Fiscal Year 2016. The report describes research and activities including (1) ISO standards development, (2) capacity building for international testing and knowledge centers, (3) laboratory assessments of cookstove systems, (4) journal publications, and (5) cookstove events. The U.S. Environmental Protection Agency’s (EPA’s) cookstove laboratory research program was first developed to assist the EPA-led Partnership for Clean Indoor Air and is now part of the U.S. Government’s commitment to the Global Alliance for Clean Cookstoves (the Alliance). Goals of the program are to: (1) support the development of testing protocols and standards for cookstoves through ISO (International Organization for Standardization) TC (Technical Committee) 285: Clean Cookstoves and Clean Cooking Solutions, (2) support the development of international Regional Testing and Knowledge Centers (many sponsored by the Alliance) for scientifically evaluating and certifying cookstoves to international standards, and (3) provide an independent source of data to Alliance partners. This work supports EPA’s mission to protect human health and the environment. Household air pollution, mainly from solid-fuel cookstoves in the developing world, is estimated to cause approximately 4 million premature deaths per year, and emissions of black carbon and other pollutants from cookstoves aff

[Standard operating procedures in ethic committees].

PubMed

Czarkowski, Marek

2006-02-01

Polish ethic committees should have to work together in order to maintain and develop high quality standards in the protection of human subjects. Exchanging knowledge, know-how and information polish ethic committees should have to implement standard operating procedures. Procedures should improve quality and proficiency of all types of ethic committee's activities. Standard operating procedures should cover as important problems as conflict of interest, trial's insurance or elections of ethic committees. The opinions of experts who have been reviewing medical research projects for several years may prove to be especially valuable in this setting. Governmental initiatives and creation of forum for polish ethic committees are essential in the effective standardisation, coordination and implementation of procedures in regional ethic committees. These projects need support via public funding from our authorities.

Ultraviolet safety assessments of insect light traps.

PubMed

Sliney, David H; Gilbert, David W; Lyon, Terry

2016-01-01

Near-ultraviolet (UV-A: 315-400 nm), "black-light," electric lamps were invented in 1935 and ultraviolet insect light traps (ILTs) were introduced for use in agriculture around that time. Today ILTs are used indoors in several industries and in food-service as well as in outdoor settings. With recent interest in photobiological lamp safety, safety standards are being developed to test for potentially hazardous ultraviolet emissions. A variety of UV "Black-light" ILTs were measured at a range of distances to assess potential exposures. Realistic time-weighted human exposures are shown to be well below current guidelines for human exposure to ultraviolet radiation. These UV-A exposures would be far less than the typical UV-A exposure in the outdoor environment. Proposals are made for realistic ultraviolet safety standards for ILT products.

Human Thermal Model Evaluation Using the JSC Human Thermal Database

NASA Technical Reports Server (NTRS)

Bue, Grant; Makinen, Janice; Cognata, Thomas

2012-01-01

Human thermal modeling has considerable long term utility to human space flight. Such models provide a tool to predict crew survivability in support of vehicle design and to evaluate crew response in untested space environments. It is to the benefit of any such model not only to collect relevant experimental data to correlate it against, but also to maintain an experimental standard or benchmark for future development in a readily and rapidly searchable and software accessible format. The Human thermal database project is intended to do just so; to collect relevant data from literature and experimentation and to store the data in a database structure for immediate and future use as a benchmark to judge human thermal models against, in identifying model strengths and weakness, to support model development and improve correlation, and to statistically quantify a model s predictive quality. The human thermal database developed at the Johnson Space Center (JSC) is intended to evaluate a set of widely used human thermal models. This set includes the Wissler human thermal model, a model that has been widely used to predict the human thermoregulatory response to a variety of cold and hot environments. These models are statistically compared to the current database, which contains experiments of human subjects primarily in air from a literature survey ranging between 1953 and 2004 and from a suited experiment recently performed by the authors, for a quantitative study of relative strength and predictive quality of the models.

21 CFR 130.9 - Sulfites in standardized food.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Sulfites in standardized food. 130.9 Section 130.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD STANDARDS: GENERAL General Provisions § 130.9 Sulfites in standardized food...

21 CFR 130.9 - Sulfites in standardized food.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Sulfites in standardized food. 130.9 Section 130.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD STANDARDS: GENERAL General Provisions § 130.9 Sulfites in standardized food...

21 CFR 130.9 - Sulfites in standardized food.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Sulfites in standardized food. 130.9 Section 130.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD STANDARDS: GENERAL General Provisions § 130.9 Sulfites in standardized food...

21 CFR 130.9 - Sulfites in standardized food.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Sulfites in standardized food. 130.9 Section 130.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD STANDARDS: GENERAL General Provisions § 130.9 Sulfites in standardized food...

21 CFR 130.9 - Sulfites in standardized food.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Sulfites in standardized food. 130.9 Section 130.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD STANDARDS: GENERAL General Provisions § 130.9 Sulfites in standardized food...

21 CFR 640.55 - U.S. Standard preparation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false U.S. Standard preparation. 640.55 Section 640.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Cryoprecipitate § 640.55 U.S. Standard...

21 CFR 640.55 - U.S. Standard preparation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true U.S. Standard preparation. 640.55 Section 640.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Cryoprecipitate § 640.55 U.S. Standard...

Minimum Information about a Spinal Cord Injury Experiment: A Proposed Reporting Standard for Spinal Cord Injury Experiments

PubMed Central

Ferguson, Adam R.; Popovich, Phillip G.; Xu, Xiao-Ming; Snow, Diane M.; Igarashi, Michihiro; Beattie, Christine E.; Bixby, John L.

2014-01-01

Abstract The lack of reproducibility in many areas of experimental science has a number of causes, including a lack of transparency and precision in the description of experimental approaches. This has far-reaching consequences, including wasted resources and slowing of progress. Additionally, the large number of laboratories around the world publishing articles on a given topic make it difficult, if not impossible, for individual researchers to read all of the relevant literature. Consequently, centralized databases are needed to facilitate the generation of new hypotheses for testing. One strategy to improve transparency in experimental description, and to allow the development of frameworks for computer-readable knowledge repositories, is the adoption of uniform reporting standards, such as common data elements (data elements used in multiple clinical studies) and minimum information standards. This article describes a minimum information standard for spinal cord injury (SCI) experiments, its major elements, and the approaches used to develop it. Transparent reporting standards for experiments using animal models of human SCI aim to reduce inherent bias and increase experimental value. PMID:24870067

The changing well-being of older adult registered Indians: an analysis using the Registered Indian Human Development Index.

PubMed

Cooke, Martin; Guimond, Eric; McWhirter, Jennifer

2008-01-01

The demographic aging of the Registered Indian population suggests that the social, economic, and health conditions of older Registered Indians will be increasingly important for communities and policymakers. We have adapted the United Nations Development Program's Human Development Index using data from the Census of Canada and the Indian Register to measure whether improvements seen in the knowledge, standard of living, and health of the Registered Indian population between 1981 and 2001 are also observed among Registered Indians of older ages. The absolute levels of well-being of older Registered Indians were found to have improved, but gaps with other older Canadians had widened, particularly in terms of income and male life expectancy.

International Space Station medical standards and certification for space flight participants.

PubMed

Bogomolov, Valery V; Castrucci, Filippo; Comtois, Jean-Marc; Damann, Volker; Davis, Jeffrey R; Duncan, J Michael; Johnston, Smith L; Gray, Gary W; Grigoriev, Anatoly I; Koike, Yu; Kuklinski, Paul; Matveyev, Vladimir P; Morgun, Valery V; Pochuev, Vladimir I; Sargsyan, Ashot E; Shimada, Kazuhito; Straube, Ulrich; Tachibana, Shoichi; Voronkov, Yuri V; Williams, Richard S

2007-12-01

The medical community of the International Space Station (ISS) has developed joint medical standards and evaluation requirements for Space Flight Participants ("space tourists") which are used by the ISS medical certification board to determine medical eligibility of individuals other than professional astronauts (cosmonauts) for short-duration space flight to the ISS. These individuals are generally fare-paying passengers without operational responsibilities. By means of this publication, the medical standards and evaluation requirements for the ISS Space Flight Participants are offered to the aerospace medicine and commercial spaceflight communities for reference purposes. It is emphasized that the criteria applied to the ISS spaceflight participant candidates are substantially less stringent than those for professional astronauts and/or crewmembers of visiting and long-duration missions to the ISS. These medical standards are released by the government space agencies to facilitate the development of robust medical screening and medical risk assessment approaches in the context of the evolving commercial human spaceflight industry.

Chapter 17 Sterile Plate-Based Vitrification of Adherent Human Pluripotent Stem Cells and Their Derivatives Using the TWIST Method.

PubMed

Neubauer, Julia C; Stracke, Frank; Zimmermann, Heiko

2017-01-01

Due to their high biological complexity, e.g., their close cell-to-cell contacts, cryopreservation of human pluripotent stem cells with standard slow-rate protocols often is inefficient and can hardly be standardized. Vitrification that means ultrafast freezing already showed very good viability and recovery rates for this sensitive cell system, but is only applicable for low cell numbers, bears a high risk of contamination, and can hardly be implemented under GxP regulations. In this chapter, a sterile plate-based vitrification method for adherent pluripotent stem cells and their derivatives is presented based on a procedure and device for human embryonic stem cells developed by Beier et al. (Cryobiology 66:8-16, 2013). This protocol overcomes the limitations of conventional vitrification procedures resulting in the highly efficient preservation of ready-to-use adherent pluripotent stem cells with the possibility of vitrifying cells in multi-well formats for direct application in high-throughput screenings.

Surface-engineered substrates for improved human pluripotent stem cell culture under fully defined conditions.

PubMed

Saha, Krishanu; Mei, Ying; Reisterer, Colin M; Pyzocha, Neena Kenton; Yang, Jing; Muffat, Julien; Davies, Martyn C; Alexander, Morgan R; Langer, Robert; Anderson, Daniel G; Jaenisch, Rudolf

2011-11-15

The current gold standard for the culture of human pluripotent stem cells requires the use of a feeder layer of cells. Here, we develop a spatially defined culture system based on UV/ozone radiation modification of typical cell culture plastics to define a favorable surface environment for human pluripotent stem cell culture. Chemical and geometrical optimization of the surfaces enables control of early cell aggregation from fully dissociated cells, as predicted from a numerical model of cell migration, and results in significant increases in cell growth of undifferentiated cells. These chemically defined xeno-free substrates generate more than three times the number of cells than feeder-containing substrates per surface area. Further, reprogramming and typical gene-targeting protocols can be readily performed on these engineered surfaces. These substrates provide an attractive cell culture platform for the production of clinically relevant factor-free reprogrammed cells from patient tissue samples and facilitate the definition of standardized scale-up friendly methods for disease modeling and cell therapeutic applications.

Translating the human right to water and sanitation into public policy reform.

PubMed

Meier, Benjamin Mason; Kayser, Georgia Lyn; Kestenbaum, Jocelyn Getgen; Amjad, Urooj Quezon; Dalcanale, Fernanda; Bartram, Jamie

2014-12-01

The development of a human right to water and sanitation under international law has created an imperative to implement human rights in water and sanitation policy. Through forty-three interviews with informants in international institutions, national governments, and non-governmental organizations, this research examines interpretations of this new human right in global governance, national policy, and local practice. Exploring obstacles to the implementation of rights-based water and sanitation policy, the authors analyze the limitations of translating international human rights into local water and sanitation practice, concluding that system operators, utilities, and management boards remain largely unaffected by the changing public policy landscape for human rights realization. To understand the relevance of human rights standards to water and sanitation practitioners, this article frames a research agenda to ensure that human rights aspirations lead to public policy reforms and public health outcomes.

Energy evaluation of protection effectiveness of anti-vibration gloves.

PubMed

Hermann, Tomasz; Dobry, Marian Witalis

2017-09-01

This article describes an energy method of assessing protection effectiveness of anti-vibration gloves on the human dynamic structure. The study uses dynamic models of the human and the glove specified in Standard No. ISO 10068:2012. The physical models of human-tool systems were developed by combining human physical models with a power tool model. The combined human-tool models were then transformed into mathematical models from which energy models were finally derived. Comparative energy analysis was conducted in the domain of rms powers. The energy models of the human-tool systems were solved using numerical simulation implemented in the MATLAB/Simulink environment. The simulation procedure demonstrated the effectiveness of the anti-vibration glove as a method of protecting human operators of hand-held power tools against vibration. The desirable effect is achieved by lowering the flow of energy in the human-tool system when the anti-vibration glove is employed.

Commutability of the First World Health Organization International Standard for Human Cytomegalovirus

PubMed Central

Preiksaitis, J.; Tong, Y.; Pang, X.; Sun, Y.; Tang, L.; Cook, L.; Pounds, S.; Fryer, J.; Caliendo, A. M.

2015-01-01

Quantitative detection of cytomegalovirus (CMV) DNA has become a standard part of care for many groups of immunocompromised patients; recent development of the first WHO international standard for human CMV DNA has raised hopes of reducing interlaboratory variability of results. Commutability of reference material has been shown to be necessary if such material is to reduce variability among laboratories. Here we evaluated the commutability of the WHO standard using 10 different real-time quantitative CMV PCR assays run by eight different laboratories. Test panels, including aliquots of 50 patient samples (40 positive samples and 10 negative samples) and lyophilized CMV standard, were run, with each testing center using its own quantitative calibrators, reagents, and nucleic acid extraction methods. Commutability was assessed both on a pairwise basis and over the entire group of assays, using linear regression and correspondence analyses. Commutability of the WHO material differed among the tests that were evaluated, and these differences appeared to vary depending on the method of statistical analysis used and the cohort of assays included in the analysis. Depending on the methodology used, the WHO material showed poor or absent commutability with up to 50% of assays. Determination of commutability may require a multifaceted approach; the lack of commutability seen when using the WHO standard with several of the assays here suggests that further work is needed to bring us toward true consensus. PMID:26269622

Biochemical Fractionation and Stable Isotope Dilution Liquid Chromatography-mass Spectrometry for Targeted and Microdomain-specific Protein Quantification in Human Postmortem Brain Tissue*

PubMed Central

MacDonald, Matthew L.; Ciccimaro, Eugene; Prakash, Amol; Banerjee, Anamika; Seeholzer, Steven H.; Blair, Ian A.; Hahn, Chang-Gyu

2012-01-01

Synaptic architecture and its adaptive changes require numerous molecular events that are both highly ordered and complex. A majority of neuropsychiatric illnesses are complex trait disorders, in which multiple etiologic factors converge at the synapse via many signaling pathways. Investigating the protein composition of synaptic microdomains from human patient brain tissues will yield valuable insights into the interactions of risk genes in many disorders. These types of studies in postmortem tissues have been limited by the lack of proper study paradigms. Thus, it is necessary not only to develop strategies to quantify protein and post-translational modifications at the synapse, but also to rigorously validate them for use in postmortem human brain tissues. In this study we describe the development of a liquid chromatography-selected reaction monitoring method, using a stable isotope-labeled neuronal proteome standard prepared from the brain tissue of a stable isotope-labeled mouse, for the multiplexed quantification of target synaptic proteins in mammalian samples. Additionally, we report the use of this method to validate a biochemical approach for the preparation of synaptic microdomain enrichments from human postmortem prefrontal cortex. Our data demonstrate that a targeted mass spectrometry approach with a true neuronal proteome standard facilitates accurate and precise quantification of over 100 synaptic proteins in mammalian samples, with the potential to quantify over 1000 proteins. Using this method, we found that protein enrichments in subcellular fractions prepared from human postmortem brain tissue were strikingly similar to those prepared from fresh mouse brain tissue. These findings demonstrate that biochemical fractionation methods paired with targeted proteomic strategies can be used in human brain tissues, with important implications for the study of neuropsychiatric disease. PMID:22942359

Your New Role in the Organizational Drama: Measuring Effectiveness.

ERIC Educational Resources Information Center

Chalofsky, Neal E.; Reinhart, Carlene

1988-01-01

Presents a research-based model for human resource development effectiveness. Model standards specify that the HRD function has (1) the ability to diagnose problems, (2) the support of the corporate mission and culture, (3) a commitment to strategic planning and support for organizational change, (4) clearly defined staff roles and…

The Sociocultural Context of English Language Teaching in the Gulf.

ERIC Educational Resources Information Center

Syed, Zafar

2003-01-01

Discusses the challenges faced by English-as-a-Foreign-Language teachers in the Arabian Gulf. Seeks to identify structural and contextual issues that have contributed to the present state of language education there. Focuses on four central contributing aspects; contextual framework, human resource development, systems and standards, and research…

42 CFR 52h.5 - Conflict of interest.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS SCIENTIFIC PEER REVIEW OF RESEARCH GRANT APPLICATIONS AND RESEARCH AND DEVELOPMENT CONTRACT PROJECTS § 52h.5 Conflict of interest. (a... Government Ethics Standards of Ethical Conduct for Employees of the Executive Branch (5 CFR part 2635), and...

78 FR 52192 - Final Aquatic Life Ambient Water Quality Criteria For Ammonia-Freshwater 2013

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-22

... ambient water quality criteria for the protection of aquatic life from effects of ammonia in freshwater... life criteria are developed based on EPA's Guidelines for Deriving Numerical National Water Quality... quality standards for protecting aquatic life and human health. EPA's recommended water quality criteria...

77 FR 30280 - Final National Recommended Ambient Water Quality Criteria for Carbaryl-2012

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-22

... national recommended water quality criteria for the protection of aquatic life from effects of carbaryl... developed the aquatic life criteria based on EPA's Guidelines for Deriving Numerical National Water Quality... quality standards for protecting aquatic life and human health. These criteria are intended to protect...

Evaluating the Zebrafish Embryo Toxicity Test for Pesticide Hazard Screening

EPA Science Inventory

Given the numerous chemicals used in society, it is critical to develop tools for accurate and efficient evaluation of potential risks to human and ecological receptors. Fish embryo acute toxicity tests are 1 tool that has been shown to be highly predictive of standard, more reso...

Experiencing Organizational Work Design: Beyond Hackman and Oldham

ERIC Educational Resources Information Center

Fornaciari, Charles J.; Dean, Kathy Lund

2005-01-01

Standard organizational behavior survey courses usually introduce students to the "nuts and bolts" of organizational work design and models that mechanize work. This article develops an experiential exercise that simulates working conditions that can foster greater student understanding of the affective, ethical, and human aspects of work design.…

Attention of 4-Month Infants to Discrepancy and Babyishness.

ERIC Educational Resources Information Center

McCall, Robert B.; Kennedy, Cynthia Bellows

1980-01-01

Four facial stimuli derived from the Bolton standards of craniofacial development representing a human male at 6 months, 3, 8, and 18 years of age were used in a test of Lorenz's concept of babyishness and of the discrepancy hypothesis. Subjects were 87 four-month-old infants. (Author/MP)

Important Competencies for Future Health and Wellness Professionals: An Investigation of Employer Desired Skills

ERIC Educational Resources Information Center

Becker, Craig; Loy, Marty

2004-01-01

This study was designed to investigate the validity of the professional competencies developed by the Association of Worksite Health Promotion (AWHP) Professional Standards Task Force. The Task Force identified a competency framework that included business skills, program coordination skills, and human resource skills with corresponding…

Promoting Health Literacy through the Health Education Assessment Project

ERIC Educational Resources Information Center

Marx, Eva; Hudson, Nancy; Deal, Tami B.; Pateman, Beth; Middleton, Kathleen

2007-01-01

Background: The Council of Chief State School Officers' State Collaborative on Assessment and Student Standards Health Education Assessment Project (SCASS-HEAP) allows states to pool financial and human resources to develop effective ready-to-use health education assessment resources through a collaborative process. The purpose of this article is…

Infrared spectroscopy detection of fungal infections and mycotoxins for food safety concerns

USDA-ARS?s Scientific Manuscript database

Mycotoxins, which are toxins produced by fungi, can pose great danger to human health with their acute and chronic effects when contaminated foods (grains, fruits, meat, or milk) are ingested. Fungal infections in food crops are extremely common and many developed countries have set standards to mon...

(Review Draft) Radiation Site Cleanup Regulations: Technical Support Document For The Development Of Radionuclide Cleanup Levels For Soil

EPA Pesticide Factsheets

This document describes parts of the technical analysis being undertaken in support of standards that ensure certain sites are cleaned up to a level that is protective of human health and the environment before they are released for public use.

NHEXAS PHASE I ARIZONA STUDY--STANDARD OPERATING PROCEDURE FOR CODING: DESCRIPTIVE QUESTIONNAIRE (UA-D-6.0)

EPA Science Inventory

This purpose of this SOP is to define the coding strategy for the Descriptive Questionnaire. This questionnaire was developed for use in the Arizona NHEXAS project and the "Border" study. Keywords: data; coding; descriptive questionnaire.

The National Human Exposure Assessment...

NEIGHBORHOOD SCALE MODELING OF PM 2.5 AND AIR TOXICS CONCENTRATION DISTRIBUTIONS TO DRIVE HUMAN EXPOSURE MODELS

EPA Science Inventory

Air quality (AQ) simulation models provide a basis for implementing the National Ambient Air Quality Standards (NAAQS) and are a tool for performing risk-based assessments and for developing environmental management strategies. Fine particulate matter (PM 2.5), its constituent...

75 FR 70925 - Office of the National Coordinator for Health Information Technology; HIT; Standards Committee's...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-19

... the implementation of the Federal Health IT Strategic Plan, and in accordance with policies developed... DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the National Coordinator for Health Information... Coordinator for Health Information Technology, HHS. ACTION: Notice of meetings. This notice announces...

Nano-flow vs standard-flow: Which is the more suitable LC/MS method for quantifying hepcidin-25 in human serum in routine clinical settings?

PubMed

Vialaret, Jérôme; Picas, Alexia; Delaby, Constance; Bros, Pauline; Lehmann, Sylvain; Hirtz, Christophe

2018-06-01

Hepcidin-25 peptide is a biomarker which is known to have considerable clinical potential for diagnosing iron-related diseases. Developing analytical methods for the absolute quantification of hepcidin is still a real challenge, however, due to the sensitivity, specificity and reproducibility issues involved. In this study, we compare and discuss two MS-based assays for quantifying hepcidin, which differ only in terms of the type of liquid chromatography (nano LC/MS versus standard LC/MS) involved. The same sample preparation, the same internal standards and the same MS analyzer were used with both approaches. In the field of proteomics, nano LC chromatography is generally known to be more sensitive and less robust than standard LC methods. In this study, we established that the performances of the standard LC method are equivalent to those of our previously developed nano LC method. Although the analytical performances were very similar in both cases. The standard-flow platform therefore provides the more suitable alternative for accurately determining hepcidin in clinical settings. Copyright © 2018 Elsevier B.V. All rights reserved.

Predicting Rib Fracture Risk With Whole-Body Finite Element Models: Development and Preliminary Evaluation of a Probabilistic Analytical Framework

PubMed Central

Forman, Jason L.; Kent, Richard W.; Mroz, Krystoffer; Pipkorn, Bengt; Bostrom, Ola; Segui-Gomez, Maria

2012-01-01

This study sought to develop a strain-based probabilistic method to predict rib fracture risk with whole-body finite element (FE) models, and to describe a method to combine the results with collision exposure information to predict injury risk and potential intervention effectiveness in the field. An age-adjusted ultimate strain distribution was used to estimate local rib fracture probabilities within an FE model. These local probabilities were combined to predict injury risk and severity within the whole ribcage. The ultimate strain distribution was developed from a literature dataset of 133 tests. Frontal collision simulations were performed with the THUMS (Total HUman Model for Safety) model with four levels of delta-V and two restraints: a standard 3-point belt and a progressive 3.5–7 kN force-limited, pretensioned (FL+PT) belt. The results of three simulations (29 km/h standard, 48 km/h standard, and 48 km/h FL+PT) were compared to matched cadaver sled tests. The numbers of fractures predicted for the comparison cases were consistent with those observed experimentally. Combining these results with field exposure informantion (ΔV, NASS-CDS 1992–2002) suggests a 8.9% probability of incurring AIS3+ rib fractures for a 60 year-old restrained by a standard belt in a tow-away frontal collision with this restraint, vehicle, and occupant configuration, compared to 4.6% for the FL+PT belt. This is the first study to describe a probabilistic framework to predict rib fracture risk based on strains observed in human-body FE models. Using this analytical framework, future efforts may incorporate additional subject or collision factors for multi-variable probabilistic injury prediction. PMID:23169122

Examination of fluctuations in atmospheric pressure related to migraine.

PubMed

Okuma, Hirohisa; Okuma, Yumiko; Kitagawa, Yasuhisa

2015-01-01

Japan has four seasons and many chances of low atmospheric pressure or approaches of typhoon, therefore it has been empirically known that the fluctuation of weather induces migraine in people. Generally, its mechanism has been interpreted as follows: physical loading, attributed by atmospheric pressure to human bodies, compresses or dilates human blood vessels, which leads to abnormality in blood flow and induces migraine. We report our examination of the stage in which migraine tends to be induced focusing on the variation of atmospheric pressure. Subjects were 34 patients with migraine, who were treated in our hospital. The patients included 31 females and three males, whose mean age was 32 ± 6.7. 22 patients had migraine with aura and 12 patients had migraine without aura. All of patients with migraine maintained a headache diary to record atmospheric pressures when they developed a migraine. The standard atmospheric pressure was defined as 1013 hPa, and with this value as the criterion, we investigated slight fluctuations in the atmospheric pressure when they developed a migraine. It was found that the atmospheric pressure when the patients developed a migraine was within 1003-1007 hPa in the approach of low atmospheric pressure and that the patients developed a migraine when the atmospheric pressure decreased by 6-10 hPa, slightly less than the standard atmospheric pressure. Small decreases of 6-10 hPa relative to the standard atmospheric pressure of 1013 hPa induced migraine attacks most frequently in patients with migraine.

Development of new method and protocol for cryopreservation related to embryo and oocytes freezing in terms of fertilization rate: A comparative study including review of literature

PubMed Central

Barik, Mayadhar; Bajpai, Minu; Patnaik, Santosh; Mishra, Pravash; Behera, Priyamadhaba; Dwivedi, Sada Nanda

2016-01-01

Background: Cryopreservation is basically related to meritorious thin samples or small clumps of cells that are cooled quickly without loss. Our main objective is to establish and formulate an innovative method and protocol development for cryopreservation as a gold standard for clinical uses in laboratory practice and treatment. The knowledge regarding usefulness of cryopreservation in clinical practice is essential to carry forward the clinical practice and research. Materials and Methods: We are trying to compare different methods of cryopreservation (in two dozen of cells) at the same time we compare the embryo and oocyte freezing interms of fertilization rate according to the International standard protocol. Results: The combination of cryoprotectants and regimes of rapid cooling and rinsing during warming often allows successful cryopreservation of biological materials, particularly cell suspensions or thin tissue samples. Examples include semen, blood, tissue samples like tumors, histological cross-sections, human eggs and human embryos. Although presently many studies have reported that the children born from frozen embryos or “frosties,” show consistently positive results with no increase in birth defects or development abnormalities is quite good enough and similar to our study (50–85%). Conclusions: We ensure that cryopreservation technology provided useful cell survivability, tissue and organ preservation in a proper way. Although it varies according to different laboratory conditions, it is certainly beneficial for patient's treatment and research. Further studies are needed for standardization and development of new protocol. PMID:27512686

Incidence and mortality of kidney cancer and its relationship with HDI (Human Development Index) in the world in 2012.

PubMed

Mohammadian, Maryam; Pakzad, Reza; Towhidi, Farhad; Makhsosi, Behnam Reza; Ahmadi, Abbas; Salehiniya, Hamid

2017-01-01

Kidney cancer is among the cancers that have the highest growth rate in all age and racial groups in the world and is as the most deadly type of urinary tract cancer. Since awareness about this cancer incidence status and mortality is essential for better planning, this study aimed to investigate the incidence and mortality rate of kidney cancer and its relationship with the development index in the world in 2012. This study was an ecological study conducted based on GLOBOCAN project of the World Health Organization (WHO) for the countries in the world. The correlation between Standardized Incidence Rates (SIRs) and Standardized Mortality Rates (SMRs) of kidney cancer with HDI and its components was assessed using SPSS18. In total, 337,860 incidence cases (213,924 were men and 123,936 women) and 143,406 deaths (90,802 cases in men and 52,604 in women) of kidney cancer were recorded in 2012. A positive correlation of 0.731 was seen between SIR of kidney cancer and HDI (p≤0.001). Also, a negative correlation of 0.627 was seen between SMR of kidney cancer and HDI (p≤0.001). The incidence and mortality rate of kidney cancer is higher in developed countries. A significant positive correlation has been seen between the standardized incidence and mortality rate of kidney cancer with the Human Development Index and its components. We need more studies to examine variation in incidence and mortality of kidney cancer and its related factors in the world.

Standardized Modular Power Interfaces for Future Space Explorations Missions

NASA Technical Reports Server (NTRS)

Oeftering, Richard

2015-01-01

Earlier studies show that future human explorations missions are composed of multi-vehicle assemblies with interconnected electric power systems. Some vehicles are often intended to serve as flexible multi-purpose or multi-mission platforms. This drives the need for power architectures that can be reconfigured to support this level of flexibility. Power system developmental costs can be reduced, program wide, by utilizing a common set of modular building blocks. Further, there are mission operational and logistics cost benefits of using a common set of modular spares. These benefits are the goals of the Advanced Exploration Systems (AES) Modular Power System (AMPS) project. A common set of modular blocks requires a substantial level of standardization in terms of the Electrical, Data System, and Mechanical interfaces. The AMPS project is developing a set of proposed interface standards that will provide useful guidance for modular hardware developers but not needlessly constrain technology options, or limit future growth in capability. In 2015 the AMPS project focused on standardizing the interfaces between the elements of spacecraft power distribution and energy storage. The development of the modular power standard starts with establishing mission assumptions and ground rules to define design application space. The standards are defined in terms of AMPS objectives including Commonality, Reliability-Availability, Flexibility-Configurability and Supportability-Reusability. The proposed standards are aimed at assembly and sub-assembly level building blocks. AMPS plans to adopt existing standards for spacecraft command and data, software, network interfaces, and electrical power interfaces where applicable. Other standards including structural encapsulation, heat transfer, and fluid transfer, are governed by launch and spacecraft environments and bound by practical limitations of weight and volume. Developing these mechanical interface standards is more difficult but an essential part of defining physical building blocks of modular power. This presentation describes the AMPS projects progress towards standardized modular power interfaces.

The Interplanetary Internet: a communications infrastructure for Mars exploration.

PubMed

Burleigh, Scott; Cerf, Vinton; Durst, Robert; Fall, Kevin; Hooke, Adrian; Scott, Keith; Weiss, Howard

2003-01-01

A strategy is being developed whereby the current set of internationally standardized space data communications protocols can be incrementally evolved so that a first version of an operational "Interplanetary Internet" is feasible by the end of the decade. This paper describes its architectural concepts, discusses the current set of standard space data communications capabilities that exist to support Mars exploration and reviews proposed new developments. We also speculate that these current capabilities can grow to support future scenarios where human intelligence is widely distributed across the Solar System and day-to-day communications dialog between planets is routine. c2003 American Institute of Aeronautics and Astronautics. Published by Elsevier Science Ltd. All rights reserved.

The Interplanetary Internet: a communications infrastructure for Mars exploration

NASA Technical Reports Server (NTRS)

Burleigh, Scott; Cerf, Vinton; Durst, Robert; Fall, Kevin; Hooke, Adrian; Scott, Keith; Weiss, Howard

2003-01-01

A strategy is being developed whereby the current set of internationally standardized space data communications protocols can be incrementally evolved so that a first version of an operational "Interplanetary Internet" is feasible by the end of the decade. This paper describes its architectural concepts, discusses the current set of standard space data communications capabilities that exist to support Mars exploration and reviews proposed new developments. We also speculate that these current capabilities can grow to support future scenarios where human intelligence is widely distributed across the Solar System and day-to-day communications dialog between planets is routine. c2003 American Institute of Aeronautics and Astronautics. Published by Elsevier Science Ltd. All rights reserved.

System Software Framework for System of Systems Avionics

NASA Technical Reports Server (NTRS)

Ferguson, Roscoe C.; Peterson, Benjamin L; Thompson, Hiram C.

2005-01-01

Project Constellation implements NASA's vision for space exploration to expand human presence in our solar system. The engineering focus of this project is developing a system of systems architecture. This architecture allows for the incremental development of the overall program. Systems can be built and connected in a "Lego style" manner to generate configurations supporting various mission objectives. The development of the avionics or control systems of such a massive project will result in concurrent engineering. Also, each system will have software and the need to communicate with other (possibly heterogeneous) systems. Fortunately, this design problem has already been solved during the creation and evolution of systems such as the Internet and the Department of Defense's successful effort to standardize distributed simulation (now IEEE 1516). The solution relies on the use of a standard layered software framework and a communication protocol. A standard framework and communication protocol is suggested for the development and maintenance of Project Constellation systems. The ARINC 653 standard is a great start for such a common software framework. This paper proposes a common system software framework that uses the Real Time Publish/Subscribe protocol for framework-to-framework communication to extend ARINC 653. It is highly recommended that such a framework be established before development. This is important for the success of concurrent engineering. The framework provides an infrastructure for general system services and is designed for flexibility to support a spiral development effort.

DCS: A Case Study of Identification of Knowledge and Disposition Gaps Using Principles of Continuous Risk Management

NASA Technical Reports Server (NTRS)

Norcross, Jason; Steinberg, Susan; Kundrot, Craig; Charles, John

2011-01-01

The Human Research Program (HRP) is formulated around the program architecture of Evidence-Risk-Gap-Task-Deliverable. Review of accumulated evidence forms the basis for identification of high priority risks to human health and performance in space exploration. Gaps in knowledge or disposition are identified for each risk, and a portfolio of research tasks is developed to fill them. Deliverables from the tasks inform the evidence base with the ultimate goal of defining the level of risk and reducing it to an acceptable level. A comprehensive framework for gap identification, focus, and metrics has been developed based on principles of continuous risk management and clinical care. Research towards knowledge gaps improves understanding of the likelihood, consequence or timeframe of the risk. Disposition gaps include development of standards or requirements for risk acceptance, development of countermeasures or technology to mitigate the risk, and yearly technology assessment related to watching developments related to the risk. Standard concepts from clinical care: prevention, diagnosis, treatment, monitoring, rehabilitation, and surveillance, can be used to focus gaps dealing with risk mitigation. The research plan for the new HRP Risk of Decompression Sickness (DCS) used the framework to identify one disposition gap related to establishment of a DCS standard for acceptable risk, two knowledge gaps related to DCS phenomenon and mission attributes, and three mitigation gaps focused on prediction, prevention, and new technology watch. These gaps were organized in this manner primarily based on target for closure and ease of organizing interim metrics so that gap status could be quantified. Additional considerations for the knowledge gaps were that one was highly design reference mission specific and the other gap was focused on DCS phenomenon.

Genome-wide expression profiling of five mouse models identifies similarities and differences with human psoriasis.

PubMed

Swindell, William R; Johnston, Andrew; Carbajal, Steve; Han, Gangwen; Wohn, Christian; Lu, Jun; Xing, Xianying; Nair, Rajan P; Voorhees, John J; Elder, James T; Wang, Xiao-Jing; Sano, Shigetoshi; Prens, Errol P; DiGiovanni, John; Pittelkow, Mark R; Ward, Nicole L; Gudjonsson, Johann E

2011-04-04

Development of a suitable mouse model would facilitate the investigation of pathomechanisms underlying human psoriasis and would also assist in development of therapeutic treatments. However, while many psoriasis mouse models have been proposed, no single model recapitulates all features of the human disease, and standardized validation criteria for psoriasis mouse models have not been widely applied. In this study, whole-genome transcriptional profiling is used to compare gene expression patterns manifested by human psoriatic skin lesions with those that occur in five psoriasis mouse models (K5-Tie2, imiquimod, K14-AREG, K5-Stat3C and K5-TGFbeta1). While the cutaneous gene expression profiles associated with each mouse phenotype exhibited statistically significant similarity to the expression profile of psoriasis in humans, each model displayed distinctive sets of similarities and differences in comparison to human psoriasis. For all five models, correspondence to the human disease was strong with respect to genes involved in epidermal development and keratinization. Immune and inflammation-associated gene expression, in contrast, was more variable between models as compared to the human disease. These findings support the value of all five models as research tools, each with identifiable areas of convergence to and divergence from the human disease. Additionally, the approach used in this paper provides an objective and quantitative method for evaluation of proposed mouse models of psoriasis, which can be strategically applied in future studies to score strengths of mouse phenotypes relative to specific aspects of human psoriasis.

Automatic detection of end-diastolic and end-systolic frames in 2D echocardiography.

PubMed

Zolgharni, Massoud; Negoita, Madalina; Dhutia, Niti M; Mielewczik, Michael; Manoharan, Karikaran; Sohaib, S M Afzal; Finegold, Judith A; Sacchi, Stefania; Cole, Graham D; Francis, Darrel P

2017-07-01

Correctly selecting the end-diastolic and end-systolic frames on a 2D echocardiogram is important and challenging, for both human experts and automated algorithms. Manual selection is time-consuming and subject to uncertainty, and may affect the results obtained, especially for advanced measurements such as myocardial strain. We developed and evaluated algorithms which can automatically extract global and regional cardiac velocity, and identify end-diastolic and end-systolic frames. We acquired apical four-chamber 2D echocardiographic video recordings, each at least 10 heartbeats long, acquired twice at frame rates of 52 and 79 frames/s from 19 patients, yielding 38 recordings. Five experienced echocardiographers independently marked end-systolic and end-diastolic frames for the first 10 heartbeats of each recording. The automated algorithm also did this. Using the average of time points identified by five human operators as the reference gold standard, the individual operators had a root mean square difference from that gold standard of 46.5 ms. The algorithm had a root mean square difference from the human gold standard of 40.5 ms (P<.0001). Put another way, the algorithm-identified time point was an outlier in 122/564 heartbeats (21.6%), whereas the average human operator was an outlier in 254/564 heartbeats (45%). An automated algorithm can identify the end-systolic and end-diastolic frames with performance indistinguishable from that of human experts. This saves staff time, which could therefore be invested in assessing more beats, and reduces uncertainty about the reliability of the choice of frame. © 2017, Wiley Periodicals, Inc.

National plan to enhance aviation safety through human factors improvements

NASA Technical Reports Server (NTRS)

Foushee, Clay

1990-01-01

The purpose of this section of the plan is to establish a development and implementation strategy plan for improving safety and efficiency in the Air Traffic Control (ATC) system. These improvements will be achieved through the proper applications of human factors considerations to the present and future systems. The program will have four basic goals: (1) prepare for the future system through proper hiring and training; (2) develop a controller work station team concept (managing human errors); (3) understand and address the human factors implications of negative system results; and (4) define the proper division of responsibilities and interactions between the human and the machine in ATC systems. This plan addresses six program elements which together address the overall purpose. The six program elements are: (1) determine principles of human-centered automation that will enhance aviation safety and the efficiency of the air traffic controller; (2) provide new and/or enhanced methods and techniques to measure, assess, and improve human performance in the ATC environment; (3) determine system needs and methods for information transfer between and within controller teams and between controller teams and the cockpit; (4) determine how new controller work station technology can optimally be applied and integrated to enhance safety and efficiency; (5) assess training needs and develop improved techniques and strategies for selection, training, and evaluation of controllers; and (6) develop standards, methods, and procedures for the certification and validation of human engineering in the design, testing, and implementation of any hardware or software system element which affects information flow to or from the human.

Global Prostate Cancer Incidence and Mortality Rates According to the Human Development Index.

PubMed

Khazaei, Salman; Rezaeian, Shahab; Ayubi, Erfan; Gholamaliee, Behzad; Pishkuhi, Mahin Ahmadi; Khazaei, Somayeh; Mansori, Kamyar; Nematollahi, Shahrzad; Sani, Mohadeseh; Hanis, Shiva Mansouri

2016-01-01

Prostate cancer (PC) is one of the leading causes of death, especially in developed countries. The human development index (HDI) and its dimensions seem correlated with incidence and mortality rates of PC. This study aimed to assess the association of the specific components of HDI (life expectancy at birth, education, gross national income per 1000 capita, health, and living standards) with burden indicators of PC worldwide. Information of the incidence and mortality rates of PC was obtained from the GLOBOCAN cancer project in year 2012 and data about the HDI 2013 were obtained from the World Bank database. The correlation between incidence, mortality rates, and the HDI parameters were assessed using STATA software. A significant inequality of PC incidence rates was observed according to concentration indexes=0.25 with 95% CI (0.22, 0.34) and a negative mortality concentration index of -0.04 with 95% CI (-0.09, 0.01) was observed. A positive significant correlation was detected between the incidence rates of PC and the HDI and its dimensions including life expectancy at birth, education, income, urbanization level and obesity. However, there was a negative significant correlation between the standardized mortality rates and the life expectancy, income and HDI.

The Systems Engineering Process for Human Support Technology Development

NASA Technical Reports Server (NTRS)

Jones, Harry

2005-01-01

Systems engineering is designing and optimizing systems. This paper reviews the systems engineering process and indicates how it can be applied in the development of advanced human support systems. Systems engineering develops the performance requirements, subsystem specifications, and detailed designs needed to construct a desired system. Systems design is difficult, requiring both art and science and balancing human and technical considerations. The essential systems engineering activity is trading off and compromising between competing objectives such as performance and cost, schedule and risk. Systems engineering is not a complete independent process. It usually supports a system development project. This review emphasizes the NASA project management process as described in NASA Procedural Requirement (NPR) 7120.5B. The process is a top down phased approach that includes the most fundamental activities of systems engineering - requirements definition, systems analysis, and design. NPR 7120.5B also requires projects to perform the engineering analyses needed to ensure that the system will operate correctly with regard to reliability, safety, risk, cost, and human factors. We review the system development project process, the standard systems engineering design methodology, and some of the specialized systems analysis techniques. We will discuss how they could apply to advanced human support systems development. The purpose of advanced systems development is not directly to supply human space flight hardware, but rather to provide superior candidate systems that will be selected for implementation by future missions. The most direct application of systems engineering is in guiding the development of prototype and flight experiment hardware. However, anticipatory systems engineering of possible future flight systems would be useful in identifying the most promising development projects.

Standardisation of digital human models.

PubMed

Paul, Gunther; Wischniewski, Sascha

2012-01-01

Digital human models (DHM) have evolved as useful tools for ergonomic workplace design and product development, and found in various industries and education. DHM systems which dominate the market were developed for specific purposes and differ significantly, which is not only reflected in non-compatible results of DHM simulations, but also provoking misunderstanding of how DHM simulations relate to real world problems. While DHM developers are restricted by uncertainty about the user need and lack of model data related standards, users are confined to one specific product and cannot exchange results, or upgrade to another DHM system, as their previous results would be rendered worthless. Furthermore, origin and validity of anthropometric and biomechanical data is not transparent to the user. The lack of standardisation in DHM systems has become a major roadblock in further system development, affecting all stakeholders in the DHM industry. Evidently, a framework for standardising digital human models is necessary to overcome current obstructions. Practitioner Summary: This short communication addresses a standardisation issue for digital human models, which has been addressed at the International Ergonomics Association Technical Committee for Human Simulation and Virtual Environments. It is the outcome of a workshop at the DHM 2011 symposium in Lyon, which concluded steps towards DHM standardisation that need to be taken.

Human Factors Engineering Program Review Model

DTIC Science & Technology

2004-02-01

Institute, 1993). ANSI HFS-100: American National Standard for Human Factors Engineering of Visual Display Terminal Workstations (American National... American National Standard for Human Factors Engineering of Visual Display Terminal Workstations (ANSI HFS-100-1988). Santa Monica, California

An objectively-analyzed method for measuring the useful penetration of x-ray imaging systems.

PubMed

Glover, Jack L; Hudson, Lawrence T

2016-06-01

The ability to detect wires is an important capability of the cabinet x-ray imaging systems that are used in aviation security as well as the portable x-ray systems that are used by domestic law enforcement and military bomb squads. A number of national and international standards describe methods for testing this capability using the so called useful penetration test metric, where wires are imaged behind different thicknesses of blocking material. Presently, these tests are scored based on human judgments of wire visibility, which are inherently subjective. We propose a new method in which the useful penetration capabilities of an x-ray system are objectively evaluated by an image processing algorithm operating on digital images of a standard test object. The algorithm advantageously applies the Radon transform for curve parameter detection that reduces the problem of wire detection from two dimensions to one. The sensitivity of the wire detection method is adjustable and we demonstrate how the threshold parameter can be set to give agreement with human-judged results. The method was developed to be used in technical performance standards and is currently under ballot for inclusion in a US national aviation security standard.

An objectively-analyzed method for measuring the useful penetration of x-ray imaging systems

PubMed Central

Glover, Jack L.; Hudson, Lawrence T.

2016-01-01

The ability to detect wires is an important capability of the cabinet x-ray imaging systems that are used in aviation security as well as the portable x-ray systems that are used by domestic law enforcement and military bomb squads. A number of national and international standards describe methods for testing this capability using the so called useful penetration test metric, where wires are imaged behind different thicknesses of blocking material. Presently, these tests are scored based on human judgments of wire visibility, which are inherently subjective. We propose a new method in which the useful penetration capabilities of an x-ray system are objectively evaluated by an image processing algorithm operating on digital images of a standard test object. The algorithm advantageously applies the Radon transform for curve parameter detection that reduces the problem of wire detection from two dimensions to one. The sensitivity of the wire detection method is adjustable and we demonstrate how the threshold parameter can be set to give agreement with human-judged results. The method was developed to be used in technical performance standards and is currently under ballot for inclusion in a US national aviation security standard. PMID:27499586

An objectively-analyzed method for measuring the useful penetration of x-ray imaging systems

NASA Astrophysics Data System (ADS)

Glover, Jack L.; Hudson, Lawrence T.

2016-06-01

The ability to detect wires is an important capability of the cabinet x-ray imaging systems that are used in aviation security as well as the portable x-ray systems that are used by domestic law enforcement and military bomb squads. A number of national and international standards describe methods for testing this capability using the so called useful penetration test metric, where wires are imaged behind different thicknesses of blocking material. Presently, these tests are scored based on human judgments of wire visibility, which are inherently subjective. We propose a new method in which the useful penetration capabilities of an x-ray system are objectively evaluated by an image processing algorithm operating on digital images of a standard test object. The algorithm advantageously applies the Radon transform for curve parameter detection that reduces the problem of wire detection from two dimensions to one. The sensitivity of the wire detection method is adjustable and we demonstrate how the threshold parameter can be set to give agreement with human-judged results. The method was developed to be used in technical performance standards and is currently under ballot for inclusion in an international aviation security standard.

The ontogeny of visual–motor memory and its importance in handwriting and reading: a developing construct

PubMed Central

Waterman, Amanda H.; Havelka, Jelena; Culmer, Peter R.; Hill, Liam J. B.; Mon-Williams, Mark

2015-01-01

Humans have evolved a remarkable ability to remember visual shapes and use these representations to generate motor activity (from Palaeolithic cave drawings through Jiahu symbols to cursive handwriting). The term visual–motor memory (VMM) describes this psychological ability, which must have conveyed an evolutionary advantage and remains critically important to humans (e.g. when learning to write). Surprisingly, little empirical investigation of this unique human ability exists—almost certainly because of the technological difficulties involved in measuring VMM. We deployed a novel technique for measuring this construct in 87 children (6–11 years old, 44 females). Children drew novel shapes presented briefly on a tablet laptop screen, drawing their responses from memory on the screen using a digitizer stylus. Sophisticated algorithms (using point-registration techniques) objectively quantified the accuracy of the children's reproductions. VMM improved with age and performance decreased with shape complexity, indicating that the measure captured meaningful developmental changes. The relationship between VMM and scores on nationally standardized writing assessments were explored with the results showing a clear relationship between these measures, even after controlling for age. Moreover, a relationship between VMM and the nationally standardized reading test was mediated via writing ability, suggesting VMM's wider importance within language development. PMID:25429010

Wafer bonding process for building MEMS devices

NASA Astrophysics Data System (ADS)

Pabo, Eric F.; Meiler, Josef; Matthias, Thorsten

2014-06-01

The technology for the measurement of colour rendering and colour quality is not new, but many parameters related to this issue are currently changing. A number of standard methods were developed and are used by different specialty areas of the lighting industry. CIE 13.3 has been the accepted standard implemented by many users and used for many years. Light-emitting Diode (LED) technology moves at a rapid pace and, as this lighting source finds wider acceptance, it appears that traditional colour-rendering measurement methods produce inconsistent results. Practical application of various types of LEDs yielded results that challenged conventional thinking regarding colour measurement of light sources. Recent studies have shown that the anatomy and physiology of the human eye is more complex than formerly accepted. Therefore, the development of updated measurement methodology also forces a fresh look at functioning and colour perception of the human eye, especially with regard to LEDs. This paper includes a short description of the history and need for the measurement of colour rendering. Some of the traditional measurement methods are presented and inadequacies are discussed. The latest discoveries regarding the functioning of the human eye and the perception of colour, especially when LEDs are used as light sources, are discussed. The unique properties of LEDs when used in practical applications such as luminaires are highlighted.

The development and piloting of electronic standardized measures on nursing work: combining engineering and nursing knowledge.

PubMed

Bragadóttir, Helga; Gunnarsdóttir, Sigrún; Ingason, Helgi T

2013-05-01

This paper describes the development and piloting of electronic standardized measures on nursing work (e-SMNW) for rich data gathering on the work and work environment of registered nurses (RNs) and practical nurses (PNs). Efficient and valid methods are needed to measure nursing work to enhance the optimal use of the nursing workforce for safe patient care. The study combined human factors engineering (HFE) and nursing knowledge to develop electronic standardized measures for observational studies on nursing work in acute care. The work and work environment of RNs and PNs in acute care medical and surgical inpatient units was successfully measured using e-SMNW. With predetermined items of work activities and influencing factors in the work of nurses, and full use of computer technology, multi-layered rich standardized data were gathered, analysed and displayed. The combination of nursing knowledge, HFE and computer technology enables observational data collection for a rich picture of the complex work of nursing. Information collected by standardized and multi-layered measures makes it easier to identify potential improvements, with regard to influencing factors and management of the work and work environment of nurses. Further use of computer technology in health services research is encouraged. © 2012 Blackwell Publishing Ltd.

Human Rabies in the WHO Southeast Asia Region: Forward Steps for Elimination

PubMed Central

Gongal, Gyanendra; Wright, Alice E.

2011-01-01

There are eleven Member States in the WHO southeast Asia region (Bangladesh, Bhutan, Democratic People's Republic of Korea, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand, Timor-Leste) of which eight are endemic for rabies. More than 1.4 billion people in the Region are at risk of rabies infection, and approximately 45% of worldwide rabies deaths occur in Asia. Dog bites account for 96% of human rabies cases. Progress in preventing human rabies through control of the disease in dogs has been slow due to various factors. Innovative control tools and techniques have been developed and standardized in recent years. The introduction of cost-effective intradermal rabies vaccination regimens in Asian countries has increased the availability and affordability of postexposure prophylaxis. Elimination of rabies is not possible without regional and intersectoral cooperation. Considering the importance of consolidating achievements in rabies control in Member countries, the WHO Regional Office for southeast Asia has developed a regional strategy for elimination of human rabies transmitted by dogs in the Region. They have committed to provide technical leadership, to advocate national health authorities to develop major stakeholder consensus for a comprehensive rabies elimination programme, and to implement national strategies for elimination of human rabies. PMID:21991437

The Roles of Verification, Validation and Uncertainty Quantification in the NASA Standard for Models and Simulations

NASA Technical Reports Server (NTRS)

Zang, Thomas A.; Luckring, James M.; Morrison, Joseph H.; Blattnig, Steve R.; Green, Lawrence L.; Tripathi, Ram K.

2007-01-01

The National Aeronautics and Space Administration (NASA) recently issued an interim version of the Standard for Models and Simulations (M&S Standard) [1]. The action to develop the M&S Standard was identified in an internal assessment [2] of agency-wide changes needed in the wake of the Columbia Accident [3]. The primary goal of this standard is to ensure that the credibility of M&S results is properly conveyed to those making decisions affecting human safety or mission success criteria. The secondary goal is to assure that the credibility of the results from models and simulations meets the project requirements (for credibility). This presentation explains the motivation and key aspects of the M&S Standard, with a special focus on the requirements for verification, validation and uncertainty quantification. Some pilot applications of this standard to computational fluid dynamics applications will be provided as illustrations. The authors of this paper are the members of the team that developed the initial three drafts of the standard, the last of which benefited from extensive comments from most of the NASA Centers. The current version (number 4) incorporates modifications made by a team representing 9 of the 10 NASA Centers. A permanent version of the M&S Standard is expected by December 2007. The scope of the M&S Standard is confined to those uses of M&S that support program and project decisions that may affect human safety or mission success criteria. Such decisions occur, in decreasing order of importance, in the operations, the test & evaluation, and the design & analysis phases. Requirements are placed on (1) program and project management, (2) models, (3) simulations and analyses, (4) verification, validation and uncertainty quantification (VV&UQ), (5) recommended practices, (6) training, (7) credibility assessment, and (8) reporting results to decision makers. A key component of (7) and (8) is the use of a Credibility Assessment Scale, some of the details of which were developed in consultation with William Oberkampf, David Peercy and Timothy Trocano of Sandia National Laboratories. The focus of most of the requirements, including those for VV&UQ, is on the documentation of what was done and the reporting, using the Credibility Assessment Scale, of the level of rigor that was followed. The aspects of one option for the Credibilty Assessment Scale are (1) code verification, (2) solution verification, (3) validation, (4) predictive capability, (5) technical review, (6) process control, and (7) operator and analyst qualification.

[Argentina, Brazil and Mexico. Biomedical research and the defense of a single standard of attention in developing countries].

PubMed

Angeles-Llerenas, Angélica; Bello, María Alejandra; Dirce, Guilhem; Salinas, Mario Alberto

2004-01-01

In the Helsinki Declaration, which established the ethical principles for research with human subjects, article 5 states, "...concern about the well-being of human beings should always come before the interests of science and of society..." Research proposals should include this commitment, both in developed and developing countries. In countries like Argentina, Brazil and Mexico, much of the population experience situations of great injustice, including a lack of equal access to health care. In some cases, sectors of the pharmaceutical industry may see these deficiencies as offering opportunities for carrying out research and achieving economic profits, something which carries the risk of perpetuating and even intensifying the unjust situations and violations of human rights--these population groups already suffer from. This situation implies the need for commitment to and ethical reflection upon human rights related to health. Agreements are needed between the actors involved in health research: sources of funding, researchers, public policy makers, and the study subjects themselves, in order to protect the latter's rights, including continuity of medical treatment for research subjects, when necessary.

Human Microbiome Acquisition and Bioinformatic Challenges in Metagenomic Studies

PubMed Central

2018-01-01

The study of the human microbiome has become a very popular topic. Our microbial counterpart, in fact, appears to play an important role in human physiology and health maintenance. Accordingly, microbiome alterations have been reported in an increasing number of human diseases. Despite the huge amount of data produced to date, less is known on how a microbial dysbiosis effectively contributes to a specific pathology. To fill in this gap, other approaches for microbiome study, more comprehensive than 16S rRNA gene sequencing, i.e., shotgun metagenomics and metatranscriptomics, are becoming more widely used. Methods standardization and the development of specific pipelines for data analysis are required to contribute to and increase our understanding of the human microbiome relationship with health and disease status. PMID:29382070

Development and application of artificial neural network models to estimate values of a complex human thermal comfort index associated with urban heat and cool island patterns using air temperature data from a standard meteorological station

NASA Astrophysics Data System (ADS)

Moustris, Konstantinos; Tsiros, Ioannis X.; Tseliou, Areti; Nastos, Panagiotis

2018-04-01

The present study deals with the development and application of artificial neural network models (ANNs) to estimate the values of a complex human thermal comfort-discomfort index associated with urban heat and cool island conditions inside various urban clusters using as only inputs air temperature data from a standard meteorological station. The index used in the study is the Physiologically Equivalent Temperature (PET) index which requires as inputs, among others, air temperature, relative humidity, wind speed, and radiation (short- and long-wave components). For the estimation of PET hourly values, ANN models were developed, appropriately trained, and tested. Model results are compared to values calculated by the PET index based on field monitoring data for various urban clusters (street, square, park, courtyard, and gallery) in the city of Athens (Greece) during an extreme hot weather summer period. For the evaluation of the predictive ability of the developed ANN models, several statistical evaluation indices were applied: the mean bias error, the root mean square error, the index of agreement, the coefficient of determination, the true predictive rate, the false alarm rate, and the Success Index. According to the results, it seems that ANNs present a remarkable ability to estimate hourly PET values within various urban clusters using only hourly values of air temperature. This is very important in cases where the human thermal comfort-discomfort conditions have to be analyzed and the only available parameter is air temperature.

Development and application of artificial neural network models to estimate values of a complex human thermal comfort index associated with urban heat and cool island patterns using air temperature data from a standard meteorological station.

PubMed

Moustris, Konstantinos; Tsiros, Ioannis X; Tseliou, Areti; Nastos, Panagiotis

2018-04-11

The present study deals with the development and application of artificial neural network models (ANNs) to estimate the values of a complex human thermal comfort-discomfort index associated with urban heat and cool island conditions inside various urban clusters using as only inputs air temperature data from a standard meteorological station. The index used in the study is the Physiologically Equivalent Temperature (PET) index which requires as inputs, among others, air temperature, relative humidity, wind speed, and radiation (short- and long-wave components). For the estimation of PET hourly values, ANN models were developed, appropriately trained, and tested. Model results are compared to values calculated by the PET index based on field monitoring data for various urban clusters (street, square, park, courtyard, and gallery) in the city of Athens (Greece) during an extreme hot weather summer period. For the evaluation of the predictive ability of the developed ANN models, several statistical evaluation indices were applied: the mean bias error, the root mean square error, the index of agreement, the coefficient of determination, the true predictive rate, the false alarm rate, and the Success Index. According to the results, it seems that ANNs present a remarkable ability to estimate hourly PET values within various urban clusters using only hourly values of air temperature. This is very important in cases where the human thermal comfort-discomfort conditions have to be analyzed and the only available parameter is air temperature.

Epidemiology, incidence and mortality of lung cancer and their relationship with the development index in the world

PubMed Central

Rafiemanesh, Hosein; Mehtarpour, Mojtaba; Khani, Farah; Hesami, Sayed Mohammadali; Shamlou, Reza; Towhidi, Farhad; Makhsosi, Behnam Reza; Moini, Ali

2016-01-01

Background The highest incidence of lung cancer is seen in North America and the lowest incidence in central Africa. Socioeconomic factors of inequality reflect regional disparities in human development. Due to the importance of awareness about incidence and mortality of lung cancer in health programming and the possible role of the human development index (HDI), this study was done with the aim to investigate the epidemiology of lung cancer in the world and its relationship with HDI. Methods The study was conducted based on data from the world data of cancer and the World Bank (including the HDI and its components). Data about the age-specific incidence and mortality rate (ASR) for every country in 2012 were getting from the global cancer project. To analyze data, correlation tests between incidence and death rates, and HDI and its components were employed with a significance level of 0.05 using SPSS software. Results Lung cancer with standardized incidence rate (ASIR) and standardized mortality rate (ASMR), equal to 23.1 and 19.7 (in 100,000 people), respectively. The highest and lowest values of mortality incidence ratio (MIR) for lung cancer due to continents division were 0.93 and 0.71 for Eastern Africa and Australia/New Zealand, respectively. Univariate analysis showed significant relationship (P<0.0001) between ASIR and ASMR with life expectancy at birth and mean years of schooling. Conclusions The highest MIR for lung cancer was for medium human development countries. Linear regression analysis showed a reverse significant relationship between MIR and HDI. PMID:27293825

Epidemiology, incidence and mortality of lung cancer and their relationship with the development index in the world.

PubMed

Rafiemanesh, Hosein; Mehtarpour, Mojtaba; Khani, Farah; Hesami, Sayed Mohammadali; Shamlou, Reza; Towhidi, Farhad; Salehiniya, Hamid; Makhsosi, Behnam Reza; Moini, Ali

2016-06-01

The highest incidence of lung cancer is seen in North America and the lowest incidence in central Africa. Socioeconomic factors of inequality reflect regional disparities in human development. Due to the importance of awareness about incidence and mortality of lung cancer in health programming and the possible role of the human development index (HDI), this study was done with the aim to investigate the epidemiology of lung cancer in the world and its relationship with HDI. The study was conducted based on data from the world data of cancer and the World Bank (including the HDI and its components). Data about the age-specific incidence and mortality rate (ASR) for every country in 2012 were getting from the global cancer project. To analyze data, correlation tests between incidence and death rates, and HDI and its components were employed with a significance level of 0.05 using SPSS software. Lung cancer with standardized incidence rate (ASIR) and standardized mortality rate (ASMR), equal to 23.1 and 19.7 (in 100,000 people), respectively. The highest and lowest values of mortality incidence ratio (MIR) for lung cancer due to continents division were 0.93 and 0.71 for Eastern Africa and Australia/New Zealand, respectively. Univariate analysis showed significant relationship (P<0.0001) between ASIR and ASMR with life expectancy at birth and mean years of schooling. The highest MIR for lung cancer was for medium human development countries. Linear regression analysis showed a reverse significant relationship between MIR and HDI.

Use of the ICRP system for the protection of marine ecosystems.

PubMed

Telleria, D; Cabianca, T; Proehl, G; Kliaus, V; Brown, J; Bossio, C; Van der Wolf, J; Bonchuk, I; Nilsen, M

2015-06-01

The International Commission on Radiological Protection (ICRP) recently reinforced the international system of radiological protection, initially focused on humans, by identifying principles of environmental protection and proposing a framework for assessing impacts of ionising radiation on non-human species, based on a reference flora and fauna approach. For this purpose, ICRP developed dosimetric models for a set of Reference Animals and Plants, which are representative of flora and fauna in different environments (terrestrial, freshwater, marine), and produced criteria based on information on radiation effects, with the aim of evaluating the level of potential or actual radiological impacts, and as an input for decision making. The approach developed by ICRP for flora and fauna is consistent with the approach used to protect humans. The International Atomic Energy Agency (IAEA) includes considerations on the protection of the environment in its safety standards, and is currently developing guidelines to assess radiological impacts based on the aforementioned ICRP approach. This paper presents the method developed by IAEA, in a series of meetings with international experts, to enable assessment of the radiological impact to the marine environment in connection with the Convention on the Prevention of Marine Pollution by Dumping of Wastes and Other Matter 1972 (London Convention 1972). This method is based on IAEA's safety standards and ICRP's recommendations, and was presented in 2013 for consideration by representatives of the contracting parties of the London Convention 1972; it was approved for inclusion in its procedures, and is in the process of being incorporated into guidelines. © The International Society for Prosthetics and Orthotics Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Checklist and Scoring System for the Assessment of Soft Tissue Preservation in CT Examinations of Human Mummies.

PubMed

Panzer, Stephanie; Mc Coy, Mark R; Hitzl, Wolfgang; Piombino-Mascali, Dario; Jankauskas, Rimantas; Zink, Albert R; Augat, Peter

2015-01-01

The purpose of this study was to develop a checklist for standardized assessment of soft tissue preservation in human mummies based on whole-body computed tomography examinations, and to add a scoring system to facilitate quantitative comparison of mummies. Computed tomography examinations of 23 mummies from the Capuchin Catacombs of Palermo, Sicily (17 adults, 6 children; 17 anthropogenically and 6 naturally mummified) and 7 mummies from the crypt of the Dominican Church of the Holy Spirit of Vilnius, Lithuania (5 adults, 2 children; all naturally mummified) were used to develop the checklist following previously published guidelines. The scoring system was developed by assigning equal scores for checkpoints with equivalent quality. The checklist was evaluated by intra- and inter-observer reliability. The finalized checklist was applied to compare the groups of anthropogenically and naturally mummified bodies. The finalized checklist contains 97 checkpoints and was divided into two main categories, "A. Soft Tissues of Head and Musculoskeletal System" and "B. Organs and Organ Systems", each including various subcategories. The complete checklist had an intra-observer reliability of 98% and an inter-observer reliability of 93%. Statistical comparison revealed significantly higher values in anthropogenically compared to naturally mummified bodies for the total score and for three subcategories. In conclusion, the developed checklist allows for a standardized assessment and documentation of soft tissue preservation in whole-body computed tomography examinations of human mummies. The scoring system facilitates a quantitative comparison of the soft tissue preservation status between single mummies or mummy collections.

Behavioral Health and Performance Laboratory Standard Measures (BHP-SM)

NASA Technical Reports Server (NTRS)

Williams, Thomas J.; Cromwell, Ronita

2017-01-01

The Spaceflight Standard Measures is a NASA Johnson Space Center Human Research Project (HRP) project that proposes to collect a set of core measurements, representative of many of the human spaceflight risks, from astronauts before, during and after long-duration International Space Station (ISS) missions. The term "standard measures" is defined as a set of core measurements, including physiological, biochemical, psychosocial, cognitive, and functional, that are reliable, valid, and accepted in terrestrial science, are associated with a specific and measurable outcome known to occur as a consequence of spaceflight, that will be collected in a standardized fashion from all (or most) crewmembers. While such measures might be used to define standards of health and performance or readiness for flight, the prime intent in their collection is to allow longitudinal analysis of multiple parameters in order to answer a variety of operational, occupational, and research-based questions. These questions are generally at a high level, and the approach for this project is to populate the standard measures database with the smallest set of data necessary to indicate further detailed research is required. Also included as standard measures are parameters that are not outcome-based in and of-themselves, but provide ancillary information that supports interpretation of the outcome measures, e.g., nutritional assessment, vehicle environmental parameters, crew debriefs, etc. The project's main aim is to ensure that an optimized minimal set of measures is consistently captured from all ISS crewmembers until the end of Station in order to characterize the human in space. -This allows the HRP to identify, establish, and evaluate a common set of measures for use in spaceflight and analog research to: develop baselines, systematically characterize risk likelihood and consequences, and assess effectiveness of countermeasures that work for behavioral health and performance risk factors. -By standardizing the battery of measures on all crewmembers, it will allow the HRP to evaluate countermeasures that work for one physiological system and ensure another system is not negatively affected. -These measures, named "Standard Measures," will serve as a data repository and be available to other studies under data sharing agreements.

Role of chromatography in the development of Standard Reference Materials for organic analysis.

PubMed

Wise, Stephen A; Phinney, Karen W; Sander, Lane C; Schantz, Michele M

2012-10-26

The certification of chemical constituents in natural-matrix Standard Reference Materials (SRMs) at the National Institute of Standards and Technology (NIST) can require the use of two or more independent analytical methods. The independence among the methods is generally achieved by taking advantage of differences in extraction, separation, and detection selectivity. This review describes the development of the independent analytical methods approach at NIST, and its implementation in the measurement of organic constituents such as contaminants in environmental materials, nutrients and marker compounds in food and dietary supplement matrices, and health diagnostic and nutritional assessment markers in human serum. The focus of this review is the important and critical role that separation science techniques play in achieving the necessary independence of the analytical steps in the measurement of trace-level organic constituents in natural matrix SRMs. Published by Elsevier B.V.

A New Approach to Defining Human Touch Temperature Standards

NASA Technical Reports Server (NTRS)

Ungar, Eugene; Stroud, Kenneth

2010-01-01

Defining touch temperature limits for skin contact with both hot and cold objects is important to prevent pain and skin damage, which may affect task performance or become a safety concern. Pain and skin damage depend on the skin temperature during contact, which depends on the contact thermal conductance, the object's initial temperature, and its material properties. However, previous spacecraft standards have incorrectly defined touch temperature limits in terms of a single object temperature value for all materials, or have provided limited material-specific values which do not cover the gamut of likely designs. A new approach has been developed for updated NASA standards, which defines touch temperature limits in terms of skin temperature at pain onset for bare skin contact with hot and cold objects. The authors have developed an analytical verification method for safe hot and cold object temperatures for contact times from 1 second to infinity.

Donor human milk bank data collection in north america: an assessment of current status and future needs.

PubMed

Brownell, Elizabeth A; Lussier, Mary M; Herson, Victor C; Hagadorn, James I; Marinelli, Kathleen A

2014-02-01

The Human Milk Banking Association of North America (HMBANA) is a nonprofit association that standardizes and facilitates the establishment and operation of donor human milk (DHM) banks in North America. Each HMBANA milk bank in the network collects data on the DHM it receives and distributes, but a centralized data repository does not yet exist. In 2010, the Food and Drug Administration recognized the need to collect and disseminate systematic, standardized DHM bank data and suggested that HMBANA develop a DHM data repository. This study aimed to describe data currently collected by HMBANA DHM banks and evaluate feasibility and interest in participating in a centralized data repository. We conducted phone interviews with individuals in different HMBANA milk banks and summarized descriptive statistics. Eight of 13 (61.5%) sites consented to participate. All respondents collected donor demographics, and half (50%; n = 4) rescreened donors after 6 months of continued donation. The definition of preterm milk varied between DHM banks (≤ 32 to ≤ 40 weeks). The specific computer program used to house the data also differed. Half (50%; n = 4) indicated that they would consider participation in a centralized repository. Without standardized data across all HMBANA sites, the creation of a centralized data repository is not yet feasible. Lack of standardization and transparency may deter implementation of donor milk programs in the neonatal intensive care unit setting and hinder benchmarking, research, and quality improvement initiatives.

Automating a human factors evaluation of graphical user interfaces for NASA applications: An update on CHIMES

NASA Technical Reports Server (NTRS)

Jiang, Jian-Ping; Murphy, Elizabeth D.; Bailin, Sidney C.; Truszkowski, Walter F.

1993-01-01

Capturing human factors knowledge about the design of graphical user interfaces (GUI's) and applying this knowledge on-line are the primary objectives of the Computer-Human Interaction Models (CHIMES) project. The current CHIMES prototype is designed to check a GUI's compliance with industry-standard guidelines, general human factors guidelines, and human factors recommendations on color usage. Following the evaluation, CHIMES presents human factors feedback and advice to the GUI designer. The paper describes the approach to modeling human factors guidelines, the system architecture, a new method developed to convert quantitative RGB primaries into qualitative color representations, and the potential for integrating CHIMES with user interface management systems (UIMS). Both the conceptual approach and its implementation are discussed. This paper updates the presentation on CHIMES at the first International Symposium on Ground Data Systems for Spacecraft Control.

Modeling aspects of human memory for scientific study.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Caudell, Thomas P.; Watson, Patrick; McDaniel, Mark A.

Working with leading experts in the field of cognitive neuroscience and computational intelligence, SNL has developed a computational architecture that represents neurocognitive mechanisms associated with how humans remember experiences in their past. The architecture represents how knowledge is organized and updated through information from individual experiences (episodes) via the cortical-hippocampal declarative memory system. We compared the simulated behavioral characteristics with those of humans measured under well established experimental standards, controlling for unmodeled aspects of human processing, such as perception. We used this knowledge to create robust simulations of & human memory behaviors that should help move the scientific community closermore » to understanding how humans remember information. These behaviors were experimentally validated against actual human subjects, which was published. An important outcome of the validation process will be the joining of specific experimental testing procedures from the field of neuroscience with computational representations from the field of cognitive modeling and simulation.« less

Rapid dental development in a Middle Paleolithic Belgian Neanderthal.

PubMed

Smith, Tanya M; Toussaint, Michel; Reid, Donald J; Olejniczak, Anthony J; Hublin, Jean-Jacques

2007-12-18

The evolution of life history (pace of growth and reproduction) was crucial to ancient hominin adaptations. The study of dental development facilitates assessment of growth and development in fossil hominins with greater precision than other skeletal analyses. During tooth formation, biological rhythms manifest in enamel and dentine, creating a permanent record of growth rate and duration. Quantification of these internal and external incremental features yields developmental benchmarks, including ages at crown completion, tooth eruption, and root completion. Molar eruption is correlated with other aspects of life history. Recent evidence for developmental differences between modern humans and Neanderthals remains ambiguous. By measuring tooth formation in the entire dentition of a juvenile Neanderthal from Scladina, Belgium, we show that most teeth formed over a shorter time than in modern humans and that dental initiation and eruption were relatively advanced. By registering manifestations of stress across the dentition, we are able to present a precise chronology of Neanderthal dental development that differs from modern humans. At 8 years of age at death, this juvenile displays a degree of development comparable with modern human children who are several years older. We suggest that age at death in juvenile Neanderthals should not be assessed by comparison with modern human standards, particularly those derived from populations of European origin. Moreover, evidence from the Scladina juvenile and other similarly aged hominins suggests that a prolonged childhood and slow life history are unique to Homo sapiens.

Clinical-Grade Manufacturing of Therapeutic Human Mesenchymal Stem/Stromal Cells in Microcarrier-Based Culture Systems.

PubMed

Fernandes-Platzgummer, Ana; Carmelo, Joana G; da Silva, Cláudia Lobato; Cabral, Joaquim M S

2016-01-01

The therapeutic potential of mesenchymal stem/stromal cells (MSC) has triggered the need for high cell doses in a vast number of clinical applications. This demand requires the development of good manufacturing practices (GMP)-compliant ex vivo expansion protocols that should be effective to deliver a robust and reproducible supply of clinical-grade cells in a safe and cost-effective manner. Controlled stirred-tank bioreactor systems under xenogeneic (xeno)-free culture conditions offer ideal settings to develop and optimize cell manufacturing to meet the standards and needs of human MSC for cellular therapies. Herein we describe two microcarrier-based stirred culture systems using spinner flasks and controlled stirred-tank bioreactors under xeno-free conditions for the efficient ex vivo expansion of human bone marrow and adipose tissue-derived MSC.

An operational structured decision making framework for ...

EPA Pesticide Factsheets

Pressure to develop an operational framework for decision makers to employ the concepts of ecosystem goods and services for assessing changes to human well-being has been increasing since these concepts gained widespread notoriety after the Millennium Ecosystem Assessment Report. Many conceptual frameworks have been proposed, but most do not propose methodologies and tools to make this approach to decision making implementable. Building on common components of existing conceptual frameworks for ecosystem services and human well-being assessment we apply a structured decision making approach to develop a standardized operational framework and suggest tools and methods for completing each step. The structured decision making approach consists of six steps: 1) Clarify the Decision Context 2) Define Objectives and Evaluation Criteria 3) Develop Alternatives 4) Estimate Consequences 5) Evaluate Trade-Offs and Select and 6) Implement and Monitor. These six steps include the following activities, and suggested tools, when applied to ecosystem goods and services and human well-being conceptual frameworks: 1) Characterization of decision specific human beneficiaries using the Final Ecosystem Goods and Services (FEGS) approach and Classification System (FEGS-CS) 2) Determine beneficiaries’ relative priorities for human well-being domains in the Human Well-Being Index (HWBI) through stakeholder engagement and identify beneficiary-relevant metrics of FEGS using the Nat

Guidelines for investigating causality of sequence variants in human disease

PubMed Central

MacArthur, D. G.; Manolio, T. A.; Dimmock, D. P.; Rehm, H. L.; Shendure, J.; Abecasis, G. R.; Adams, D. R.; Altman, R. B.; Antonarakis, S. E.; Ashley, E. A.; Barrett, J. C.; Biesecker, L. G.; Conrad, D. F.; Cooper, G. M.; Cox, N. J.; Daly, M. J.; Gerstein, M. B.; Goldstein, D. B.; Hirschhorn, J. N.; Leal, S. M.; Pennacchio, L. A.; Stamatoyannopoulos, J. A.; Sunyaev, S. R.; Valle, D.; Voight, B. F.; Winckler, W.; Gunter, C.

2014-01-01

The discovery of rare genetic variants is accelerating, and clear guidelines for distinguishing disease-causing sequence variants from the many potentially functional variants present in any human genome are urgently needed. Without rigorous standards we risk an acceleration of false-positive reports of causality, which would impede the translation of genomic research findings into the clinical diagnostic setting and hinder biological understanding of disease. Here we discuss the key challenges of assessing sequence variants in human disease, integrating both gene-level and variant-level support for causality. We propose guidelines for summarizing confidence in variant pathogenicity and highlight several areas that require further resource development. PMID:24759409

Guidelines for investigating causality of sequence variants in human disease.

PubMed

MacArthur, D G; Manolio, T A; Dimmock, D P; Rehm, H L; Shendure, J; Abecasis, G R; Adams, D R; Altman, R B; Antonarakis, S E; Ashley, E A; Barrett, J C; Biesecker, L G; Conrad, D F; Cooper, G M; Cox, N J; Daly, M J; Gerstein, M B; Goldstein, D B; Hirschhorn, J N; Leal, S M; Pennacchio, L A; Stamatoyannopoulos, J A; Sunyaev, S R; Valle, D; Voight, B F; Winckler, W; Gunter, C

2014-04-24

The discovery of rare genetic variants is accelerating, and clear guidelines for distinguishing disease-causing sequence variants from the many potentially functional variants present in any human genome are urgently needed. Without rigorous standards we risk an acceleration of false-positive reports of causality, which would impede the translation of genomic research findings into the clinical diagnostic setting and hinder biological understanding of disease. Here we discuss the key challenges of assessing sequence variants in human disease, integrating both gene-level and variant-level support for causality. We propose guidelines for summarizing confidence in variant pathogenicity and highlight several areas that require further resource development.

Entomologic index for human risk of Lyme disease.

PubMed

Mather, T N; Nicholson, M C; Donnelly, E F; Matyas, B T

1996-12-01

An entomologic index based on density estimates of Lyme disease spirochete-infected nymphal deer ticks (lxodes scapularis) was developed to assess human risk of Lyme disease. The authors used a standardized protocol to determine tick density and infection in numerous forested sites in six Rhode Island towns. An entomologic risk index calculated for each town was compared with the number of human Lyme disease cases reported to the Rhode Island State Health Department for the same year. A strong positive relation between entomologic risk index and the Lyme disease case rate for each town suggested that the entomologic index was predictive of Lyme disease risk.

The development of a test methodology for the evaluation of EVA gloves

NASA Technical Reports Server (NTRS)

O'Hara, John M.; Cleland, John; Winfield, Dan

1988-01-01

This paper describes the development of a standardized set of tests designed to assess EVA-gloved hand capabilities in six measurement domains: range of motion, strength, tactile perception, dexterity, fatigue, and comfort. Based upon an assessment of general human-hand functioning and EVA task requirements, several tests within each measurement domain were developed to provide a comprehensive evaluation. All tests were designed to be conducted in a glove box with the bare hand as a baseline and the EVA glove at operating pressure.

Critical Thinking: Intellectual Standards Essential to Reasoning Well within Every Domain of Human Thought, Part Two

ERIC Educational Resources Information Center

Paul, Richard; Elder, Linda

2013-01-01

In our last critical thinking column we introduced the idea of intellectual standards and pointed out that all natural languages are repositories for such standards, which, when appropriately applied, serve as guides for assessing human reasoning. We argued that intellectual standards are necessary for cultivating the intellect and living a…

Ultraviolet safety assessments of insect light traps

PubMed Central

Sliney, David H.; Gilbert, David W.; Lyon, Terry

2016-01-01

ABSTRACT Near-ultraviolet (UV-A: 315–400 nm), “black-light,” electric lamps were invented in 1935 and ultraviolet insect light traps (ILTs) were introduced for use in agriculture around that time. Today ILTs are used indoors in several industries and in food-service as well as in outdoor settings. With recent interest in photobiological lamp safety, safety standards are being developed to test for potentially hazardous ultraviolet emissions. A variety of UV “Black-light” ILTs were measured at a range of distances to assess potential exposures. Realistic time-weighted human exposures are shown to be well below current guidelines for human exposure to ultraviolet radiation. These UV-A exposures would be far less than the typical UV-A exposure in the outdoor environment. Proposals are made for realistic ultraviolet safety standards for ILT products. PMID:27043058

Uniform neural tissue models produced on synthetic hydrogels using standard culture techniques.

PubMed

Barry, Christopher; Schmitz, Matthew T; Propson, Nicholas E; Hou, Zhonggang; Zhang, Jue; Nguyen, Bao K; Bolin, Jennifer M; Jiang, Peng; McIntosh, Brian E; Probasco, Mitchell D; Swanson, Scott; Stewart, Ron; Thomson, James A; Schwartz, Michael P; Murphy, William L

2017-11-01

The aim of the present study was to test sample reproducibility for model neural tissues formed on synthetic hydrogels. Human embryonic stem (ES) cell-derived precursor cells were cultured on synthetic poly(ethylene glycol) (PEG) hydrogels to promote differentiation and self-organization into model neural tissue constructs. Neural progenitor, vascular, and microglial precursor cells were combined on PEG hydrogels to mimic developmental timing, which produced multicomponent neural constructs with 3D neuronal and glial organization, organized vascular networks, and microglia with ramified morphologies. Spearman's rank correlation analysis of global gene expression profiles and a comparison of coefficient of variation for expressed genes demonstrated that replicate neural constructs were highly uniform to at least day 21 for samples from independent experiments. We also demonstrate that model neural tissues formed on PEG hydrogels using a simplified neural differentiation protocol correlated more strongly to in vivo brain development than samples cultured on tissue culture polystyrene surfaces alone. These results provide a proof-of-concept demonstration that 3D cellular models that mimic aspects of human brain development can be produced from human pluripotent stem cells with high sample uniformity between experiments by using standard culture techniques, cryopreserved cell stocks, and a synthetic extracellular matrix. Impact statement Pluripotent stem (PS) cells have been characterized by an inherent ability to self-organize into 3D "organoids" resembling stomach, intestine, liver, kidney, and brain tissues, offering a potentially powerful tool for modeling human development and disease. However, organoid formation must be quantitatively reproducible for applications such as drug and toxicity screening. Here, we report a strategy to produce uniform neural tissue constructs with reproducible global gene expression profiles for replicate samples from multiple experiments.